Weight-loss diets and 2-y changes in circulating amino acids in 2 randomized intervention trials.

PubMed

Zheng, Yan; Ceglarek, Uta; Huang, Tao; Li, Lerong; Rood, Jennifer; Ryan, Donna H; Bray, George A; Sacks, Frank M; Schwarzfuchs, Dan; Thiery, Joachim; Shai, Iris; Qi, Lu

2016-02-01

Circulating amino acids, such as branched-chain amino acids (BCAAs) and aromatic amino acids (AAAs), have been associated with diabetes risk; however, little is known about how a long-term dietary intervention for weight loss affects circulating amino acids. We examined the effects of weight-loss diets on long-term changes in plasma amino acids and the associations of these changes with weight loss and the improvement of insulin resistance. We repeatedly measured plasma amino acid profiles over 2 y in overweight or obese participants from 2 randomized, dietary intervention, weight-loss trials [774 subjects from the POUNDS LOST (Preventing Overweight Using Novel Dietary Strategies Trial) and 318 subjects from the DIRECT (Dietary Intervention Randomized Controlled Trial)]. Intervention diets consistently lowered most of the amino acid concentrations, including BCAAs and AAAs, in both trials. In the POUNDS LOST, average-protein diets (15% of daily energy) showed stronger effects than did high-protein diets (25% of daily energy) on reducing concentrations of the diabetes-associated BCAA valine at 6 mo independent of the weight change. In both trials, weight loss was directly related to the concurrent reduction of the BCAAs leucine and isoleucine, the AAAs tyrosine and phenylalanine, and 4 other amino acids. For example, per kilogram of weight loss, there was a 0.04-SD decrease in log tyrosine (∼0.6 μmol/L) in both trials. In addition, we showed that reductions in alanine and the AAA tyrosine were significantly related to improved insulin resistance (measured with the use of the homeostasis model assessment of insulin resistance), independent of weight loss, in both trials (both P < 0.05). For example, per 1-SD decrease in log tyrosine (∼17 μmol/L), there was a 0.04-SD (∼3%) improvement in insulin resistance in the POUNDS LOST and a 0.13-SD (∼8%) improvement in insulin resistance in the DIRECT. Our findings underscore the potential importance of dietary interventions in improving amino acid profiles (i.e., reducing diabetes risk-enhancing amino acid concentrations) along with and beyond weight loss. The POUNDS LOST and the DIRECT were registered at clinicaltrials.gov as NCT00072995 and NCT00160108, respectively. © 2016 American Society for Nutrition.

Systematic review: an evaluation of major commercial weight loss programs in the United States.

PubMed

Tsai, Adam Gilden; Wadden, Thomas A

2005-01-04

Each year millions of Americans enroll in commercial and self-help weight loss programs. Health care providers and their obese patients know little about these programs because of the absence of systematic reviews. To describe the components, costs, and efficacy of the major commercial and organized self-help weight loss programs in the United States that provide structured in-person or online counseling. Review of company Web sites, telephone discussion with company representatives, and search of the MEDLINE database. Randomized trials at least 12 weeks in duration that enrolled only adults and assessed interventions as they are usually provided to the public, or case series that met these criteria, stated the number of enrollees, and included a follow-up evaluation that lasted 1 year or longer. Data were extracted on study design, attrition, weight loss, duration of follow-up, and maintenance of weight loss. We found studies of eDiets.com, Health Management Resources, Take Off Pounds Sensibly, OPTIFAST, and Weight Watchers. Of 3 randomized, controlled trials of Weight Watchers, the largest reported a loss of 3.2% of initial weight at 2 years. One randomized trial and several case series of medically supervised very-low-calorie diet programs found that patients who completed treatment lost approximately 15% to 25% of initial weight. These programs were associated with high costs, high attrition rates, and a high probability of regaining 50% or more of lost weight in 1 to 2 years. Commercial interventions available over the Internet and organized self-help programs produced minimal weight loss. Because many studies did not control for high attrition rates, the reported results are probably a best-case scenario. With the exception of 1 trial of Weight Watchers, the evidence to support the use of the major commercial and self-help weight loss programs is suboptimal. Controlled trials are needed to assess the efficacy and cost-effectiveness of these interventions.

Obesity Reduction Black Intervention Trial (ORBIT): Design and Baseline Characteristics

PubMed Central

Stolley, Melinda; Schiffer, Linda; Sharp, Lisa; Singh, Vicky; Van Horn, Linda; Dyer, Alan

2008-01-01

Abstract Background Obesity is associated with many chronic diseases, and weight loss can reduce the risk of developing these diseases. Obesity is highly prevalent among Black women, but weight loss treatment for black women has been understudied until recently. The Obesity Reduction black Intervention Trial (ORBIT) is a randomized controlled trial designed to assess the efficacy of a culturally proficient weight loss and weight loss maintenance program for black women. This paper describes the design of the trial, the intervention, and baseline characteristics of the participants. Methods Two hundred thirteen obese black women aged 30–65 years were randomized to the intervention group or a general health control group. The intervention consists of a 6-month weight loss program followed by a 1-year maintenance program. Weight, dietary intake, and energy expenditure are measured at baseline, 6 months, and 18 months. Results More than 40% of participants had a baseline body mass index (BMI) >40 kg/m2 (class III obesity). Intake of fat and saturated fat was higher and consumption of fruit, vegetables, and fiber was lower than currently recommended guidelines. Self-reported moderate to vigorous physical activity was high (median 85 min/day). However, objectively measured physical activity among a subgroup of participants was lower (median 15 min/day). Conclusions Weight loss among obese black women has received inadequate attention in relation to the magnitude of the problem. Factors that contribute to successful weight loss and more importantly, weight loss maintenance need to be identified. PMID:18774895

Weight change with liraglutide and comparator therapies: an analysis of seven phase 3 trials from the liraglutide diabetes development programme.

PubMed

Niswender, K; Pi-Sunyer, X; Buse, J; Jensen, K H; Toft, A D; Russell-Jones, D; Zinman, B

2013-01-01

We investigated the relationship between weight change and related factors in subjects with type 2 diabetes mellitus (T2DM) treated with liraglutide versus comparator diabetes therapies. Twenty-six-week data from seven phase 3, randomized trials in the liraglutide T2DM development programme were analysed by trial and treatment group: liraglutide (1.2 and 1.8 mg), active comparator and placebo. Outcome measures included proportions of subjects in various weight change categories and their percentage weight change from baseline; impact of body mass index (BMI) and gastrointestinal (GI) adverse events (AEs) on weight change and correlation of weight change with change in glycosylated haemoglobin (HbA1c). A number of subjects experienced >5% weight loss during the trials (24.4% liraglutide 1.8 mg and 17.7% liraglutide 1.2 mg; 17.7% exenatide, 10.0% sitagliptin, 3.6-7.0% sulphonylurea, 2.6% thiazolidinedione and 2.6% glargine; 9.9% placebo). More weight loss was seen with liraglutide 1.2 and 1.8 mg than with active comparators except exenatide. Across trials, higher initial BMI was associated with slightly greater weight loss with liraglutide. Mean weight loss increased slightly the longer GI AEs persisted. Although HbA1c reduction was slightly larger in higher weight loss categories across treatments (including placebo), sample sizes were small and no clear correlation could be determined. Liraglutide-treated subjects experienced additional HbA1c reduction beyond that which appeared weight induced; thus, not all HbA1c-lowering effect appears weight mediated. The majority of liraglutide-treated T2DM subjects experienced weight loss in this analysis. Weight loss was greater and occurred more in glucagon-like peptide-1 receptor agonist-treated subjects than in active comparator-treated subjects. © 2012 Blackwell Publishing Ltd.

Weight loss referrals for adults in primary care (WRAP): protocol for a multi-centre randomised controlled trial comparing the clinical and cost-effectiveness of primary care referral to a commercial weight loss provider for 12 weeks, referral for 52 weeks, and a brief self-help intervention [ISRCTN82857232

PubMed Central

2014-01-01

Background Recent trials demonstrate the acceptability and short term efficacy of primary care referral to a commercial weight loss provider for weight management. Commissioners now need information on the optimal duration of intervention and the longer term outcomes and cost effectiveness of such treatment to give best value for money. Methods/Design This multicentre, randomised controlled trial with a parallel design will recruit 1200 overweight adults (BMI ≥28 kg/m2) through their primary care provider. They will be randomised in a 2:5:5 allocation to: Brief Intervention, Commercial Programme for 12 weeks, or Commercial Programme for 52 weeks. Participants will be followed up for two years, with assessments at 0, 3, 12 and 24 months. The sequential primary research questions are whether the CP interventions achieve significantly greater weight loss from baseline to 12 months than BI, and whether CP52 achieves significantly greater weight loss from baseline to 12 months than CP12. The primary outcomes will be an intention to treat analysis of between treatment differences in body weight at 12 months. Clinical effectiveness will be also be assessed by measures of weight, fat mass, and blood pressure at each time point and biochemical risk factors at 12 months. Self-report questionnaires will collect data on psychosocial factors associated with adherence, weight-loss and weight-loss maintenance. A within-trial and long-term cost-effectiveness analysis will be conducted from an NHS perspective. Qualitative methods will be used to examine the participant experience. Discussion The current trial compares the clinical and cost effectiveness of referral to a commercial provider with a brief intervention. This trial will specifically examine whether providing longer weight-loss treatment without altering content or intensity (12 months commercial referral vs. 12 weeks) leads to greater weight loss at one year and is sustained at 2 years. It will also evaluate the relative cost-effectiveness of the three interventions. This study has direct implications for primary care practice in the UK and will provide important information to inform the decisions of practitioners and commissioners about service provision. Trial Registration Current Controlled Trials ISRCTN82857232. Date registered: 15/10/2012. PMID:24943673

Liraglutide 3.0 mg for weight management: weight-loss dependent and independent effects.

PubMed

Bays, Harold; Pi-Sunyer, Xavier; Hemmingsson, Joanna Uddén; Claudius, Birgitte; Jensen, Christine B; Van Gaal, Luc

2017-02-01

As an adjunct to a reduced-calorie diet and increased physical activity, treatment with liraglutide 3.0 mg for weight management provides a statistically significant and clinically meaningful weight loss of 5.7%-8.0% compared to 1.6%-2.6% with placebo. The objective of this post hoc analysis was to quantify the relative contribution of weight loss to the treatment effects of liraglutide 3.0 mg on key efficacy endpoints. The analysis utilized data from 4725 participants across three randomized, placebo-controlled, double-blind trials that evaluated the efficacy and safety of liraglutide 3.0 mg versus placebo, as an adjunct to a reduced-calorie diet and increased physical activity (ClinicalTrials.gov identifiers: NCT01272219, NCT01272232 and NCT01557166). The duration of two of the trials was 56 weeks; one trial was of 32 weeks' duration. A mediation analysis was performed, which ranked the relative contribution of weight loss to the treatment effects of liraglutide 3.0 mg on key cardiometabolic efficacy endpoints, Apnea-Hypopnea Index (AHI) and health-related quality of life (QoL). A limitation of this type of analysis is that it cannot conclusively prove a causal relationship. In individuals without type 2 diabetes mellitus (T2DM), endpoints predominantly driven by liraglutide-induced weight loss included waist circumference, diastolic blood pressure, triglycerides, high density lipoprotein cholesterol, AHI, and Impact of Weight on Quality of Life-Lite total and physical function scores. Endpoints predominantly independent of weight loss included the glycemic endpoints hemoglobin A1c and fasting plasma glucose in individuals with and without T2DM. Regardless of the degree of dependence on weight loss according to the mediation analysis, greater weight loss was associated with greater improvement in all endpoints. Treatment with liraglutide 3.0 mg contributes to improved cardiometabolic parameters, AHI and health-related QoL through both weight-loss dependent and weight-loss independent mechanisms.

Quality of Life after Diet or Exercise-Induced Weight Loss in Overweight to Obese Postmenopausal Women: The SHAPE-2 Randomised Controlled Trial.

PubMed

van Gemert, Willemijn A M; van der Palen, Job; Monninkhof, Evelyn M; Rozeboom, Anouk; Peters, Roelof; Wittink, Harriet; Schuit, Albertine J; Peeters, Petra H

2015-01-01

This study investigates the effect of a modest weight loss either by a calorie restricted diet or mainly by increased physical exercise on health related quality of life (HRQoL) in overweight-to-obese and inactive postmenopausal women. We hypothesize that HRQoL improves with weight loss, and that exercise-induced weight loss is more effective for this than diet-induced weight loss. The SHAPE-2 trial was primarily designed to evaluate any additional effect of weight loss by exercise compared with a comparable amount of weight loss by diet on biomarkers relevant for breast cancer risk. In the present analysis we focus on HRQoL. We randomly assigned 243 eligible women to a diet (n = 97), exercise (n = 98), or control group (n = 48). Both interventions aimed for 5-6 kg weight loss. HRQoL was measured at baseline and after 16 weeks by the SF-36 questionnaire. Data of 214 women were available for analysis. Weight loss was 4.9 kg (6.1%) and 5.5 kg (6.9%) with diet and exercise, respectively. Scores of the SF-36 domain 'health change' increased significantly by 8.8 points (95% CI 1.6;16.1) with diet, and by 20.5 points (95% CI 13.2;27.7) with exercise when compared with control. Direct comparison of diet and exercise showed a statistically significantly stronger improvement with exercise. Both intervention groups showed a tendency towards improvements in most other domains, which were more pronounced in the exercise group, but not statistically different from control or each other. In a randomized trial in overweight-to-obese and inactive postmenopausal women a comparable 6%-7% weight loss was achieved by diet-only or mainly by exercise and showed improvements in physical and mental HRQoL domains, but results were not statistically significant in either the diet or exercise group. However, a modest weight loss does lead to a positive change in self-perceived health status. This effect was significantly larger with exercise-induced weight loss than with comparable diet-induced weight loss. ClinicalTrials.gov NCT01511276.

Reducing breast cancer recurrence with weight loss, a vanguard trial: the Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) Trial.

PubMed

Rock, Cheryl L; Byers, Tim E; Colditz, Graham A; Demark-Wahnefried, Wendy; Ganz, Patricia A; Wolin, Kathleen Y; Elias, Anthony; Krontiras, Helen; Liu, Jingxia; Naughton, Michael; Pakiz, Bilgé; Parker, Barbara A; Sedjo, Rebecca L; Wyatt, Holly

2013-03-01

Breast cancer is the most common invasive cancer among women in developed countries. Obesity is a major risk factor for breast cancer recurrence and mortality in both pre- and postmenopausal women. Co-morbid medical conditions are common among breast cancer survivors. The Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) study is a 4-year randomized clinical trial of 693 overweight/obese women aged ≥21years diagnosed with any early stage breast cancer (stages I[≥1cm]-III) within the previous five years, designed to demonstrate the feasibility of achieving sustained weight loss and to examine the impact of weight loss on quality of life and co-morbidities, and to enable future exploration of biochemical mechanisms linking obesity to lower likelihood of disease-free survival. This trial is strategically designed as a vanguard for a fully-powered trial of women who will be evaluated for breast cancer recurrence and disease-free survival. Participants were recruited between 2010 and 2012 at four sites, had completed initial therapies, and had a body mass index between 25 and 45kg/m(2). The intervention featured a group-based cognitive-behavioral weight loss program with telephone counseling and tailored newsletters to support initial weight loss and subsequent maintenance, with the goal of 7% weight loss at two years. This study has high potential to have a major impact on clinical management and outcomes after a breast cancer diagnosis. This trial initiates the effort to establish weight loss support for overweight or obese breast cancer survivors as a new standard of clinical care. Copyright © 2012 Elsevier Inc. All rights reserved.

Design and methods for a randomized clinical trial treating comorbid obesity and major depressive disorder

PubMed Central

Schneider, Kristin L; Bodenlos, Jamie S; Ma, Yunsheng; Olendzki, Barbara; Oleski, Jessica; Merriam, Philip; Crawford, Sybil; Ockene, Ira S; Pagoto, Sherry L

2008-01-01

Background Obesity is often comorbid with depression and individuals with this comorbidity fare worse in behavioral weight loss treatment. Treating depression directly prior to behavioral weight loss treatment might bolster weight loss outcomes in this population, but this has not yet been tested in a randomized clinical trial. Methods and design This randomized clinical trial will examine whether behavior therapy for depression administered prior to standard weight loss treatment produces greater weight loss than standard weight loss treatment alone. Obese women with major depressive disorder (N = 174) will be recruited from primary care clinics and the community and randomly assigned to one of the two treatment conditions. Treatment will last 2 years, and will include a 6-month intensive treatment phase followed by an 18-month maintenance phase. Follow-up assessment will occur at 6-months and 1- and 2 years following randomization. The primary outcome is weight loss. The study was designed to provide 90% power for detecting a weight change difference between conditions of 3.1 kg (standard deviation of 5.5 kg) at 1-year assuming a 25% rate of loss to follow-up. Secondary outcomes include depression, physical activity, dietary intake, psychosocial variables and cardiovascular risk factors. Potential mediators (e.g., adherence, depression, physical activity and caloric intake) of the intervention effect on weight change will also be examined. Discussion Treating depression before administering intensive health behavior interventions could potentially boost the impact on both mental and physical health outcomes. Trial registration NCT00572520 PMID:18793398

Effect of 1 year of an intentional weight loss intervention on bone mineral density in type 2 diabetes: Results from the Look AHEAD randomized trial

USDA-ARS?s Scientific Manuscript database

Intentional weight loss is an important component of treatment for overweight patients with type 2 diabetes, but the effects on bone density are not known. We used data from the Look AHEAD trial to determine the impact of an intensive lifestyle weight loss intervention (ILI) compared with diabetes s...

The role of physical activity in producing and maintaining weight loss.

PubMed

Catenacci, Victoria A; Wyatt, Holly R

2007-07-01

The majority of randomized, controlled trials (RCTs) show only modest weight loss with exercise intervention alone, and slight increases in weight loss when exercise intervention is added to dietary restriction. In most RCTs, the energy deficit produced by the prescribed exercise is far smaller than that usually produced by dietary restriction. In prospective studies that prescribed high levels of exercise, enrolled individuals achieved substantially greater weight loss-comparable to that obtained after similar energy deficits were produced by caloric restriction. High levels of exercise might, however, be difficult for overweight or obese adults to achieve and sustain. RCTs examining exercise and its effect on weight-loss maintenance demonstrated mixed results; however, weight maintenance interventions were usually of limited duration and long-term adherence to exercise was problematic. Epidemiologic, cross-sectional, and prospective correlation studies suggest an essential role for physical activity in weight-loss maintenance, and post hoc analysis of prospective trials shows a clear dose-response relationship between physical activity and weight maintenance. This article reviews the role of physical activity in producing and maintaining weight loss. We focus on prospective, RCTs lasting at least 4 months; however, other prospective trials, meta-analyses and large systematic reviews are included. Limitations in the current body of literature are discussed.

Weight loss referrals for adults in primary care (WRAP): protocol for a multi-centre randomised controlled trial comparing the clinical and cost-effectiveness of primary care referral to a commercial weight loss provider for 12 weeks, referral for 52 weeks, and a brief self-help intervention [ISRCTN82857232].

PubMed

Ahern, Amy L; Aveyard, Paul N; Halford, Jason Cg; Mander, Adrian; Cresswell, Lynne; Cohn, Simon R; Suhrcke, Marc; Marsh, Tim; Thomson, Ann M; Jebb, Susan A

2014-06-18

Recent trials demonstrate the acceptability and short term efficacy of primary care referral to a commercial weight loss provider for weight management. Commissioners now need information on the optimal duration of intervention and the longer term outcomes and cost effectiveness of such treatment to give best value for money. This multicentre, randomised controlled trial with a parallel design will recruit 1200 overweight adults (BMI ≥28 kg/m2) through their primary care provider. They will be randomised in a 2:5:5 allocation to: Brief Intervention, Commercial Programme for 12 weeks, or Commercial Programme for 52 weeks. Participants will be followed up for two years, with assessments at 0, 3, 12 and 24 months. The sequential primary research questions are whether the CP interventions achieve significantly greater weight loss from baseline to 12 months than BI, and whether CP52 achieves significantly greater weight loss from baseline to 12 months than CP12. The primary outcomes will be an intention to treat analysis of between treatment differences in body weight at 12 months. Clinical effectiveness will be also be assessed by measures of weight, fat mass, and blood pressure at each time point and biochemical risk factors at 12 months. Self-report questionnaires will collect data on psychosocial factors associated with adherence, weight-loss and weight-loss maintenance. A within-trial and long-term cost-effectiveness analysis will be conducted from an NHS perspective. Qualitative methods will be used to examine the participant experience. The current trial compares the clinical and cost effectiveness of referral to a commercial provider with a brief intervention. This trial will specifically examine whether providing longer weight-loss treatment without altering content or intensity (12 months commercial referral vs. 12 weeks) leads to greater weight loss at one year and is sustained at 2 years. It will also evaluate the relative cost-effectiveness of the three interventions. This study has direct implications for primary care practice in the UK and will provide important information to inform the decisions of practitioners and commissioners about service provision. Current Controlled Trials ISRCTN82857232. Date registered: 15/10/2012.

Predictors of weight loss in early treated Parkinson's disease from the NET-PD LS-1 cohort.

PubMed

Wills, Anne-Marie; Li, Ruosha; Pérez, Adriana; Ren, Xuehan; Boyd, James

2017-08-01

Weight loss is a common symptom of Parkinson's disease and is associated with impaired quality of life. Predictors of weight loss have not been studied in large clinical cohorts. We previously observed an association between change in body mass index and change in Unified Parkinson's Disease Rating Scale (UPDRS) motor and total scores. In this study, we performed a secondary analysis of longitudinal data (1-6 years) from 1619 participants in the NINDS Exploratory Trials in PD Long-term Study-1 (NET-PD LS1) to explore predictors of weight loss in a large prospective clinical trial cohort of early treated Parkinson's disease. The NET-PD LS1 study was a double-blind randomized placebo controlled clinical trial of creatine monohydrate 10 gm/day in early treated PD (within 5 years of diagnosis and within 2 years of starting dopaminergic medications). Linear mixed models were used to estimate the effect of baseline clinical covariates on weight change over time. On average, participants lost only 0.6 kg per year. Higher age, baseline weight, female gender, higher baseline UPDRS scores, greater postural instability, difficulty eating and drinking, lower cognitive scores and baseline levodopa use (compared to dopamine agonists) were all associated with weight loss. Surprisingly baseline difficulty swallowing, dyskinesia, depression, intestinal hypomotility (constipation) and self-reported nausea/vomiting/anorexia were not significantly associated with weight loss in this cohort of early treated Parkinson's disease patients. On average, participants with Parkinson's disease experience little weight loss during the first 1-6 years after starting dopaminergic replacement therapy, however levodopa use and postural instability were both predictors of early weight loss. Trial Registration clinicaltrials.gov identifier# NCT00449865.

Dietary intakes associated with successful weight loss and maintenance during the Weight Loss Maintenance Trial

PubMed Central

Champagne, Catherine M.; Broyles, Stephanie T; Moran, Laura D.; Cash, Katherine C.; Levy, Erma J.; Lin, Pao-Hwa; Batch, Bryan C.; Lien, Lillian F.; Funk, Kristine L.; Dalcin, Arlene; Loria, Catherine; Myers, Valerie H.

2011-01-01

Background Dietary components effective in weight maintenance efforts have not been adequately identified. Objective To determine impact of changes in dietary consumption on weight loss and maintenance during the Weight Loss Maintenance (WLM) clinical trial. Design WLM was a randomized controlled trial. Successful weight loss participants who completed Phase I of the trial and lost 4kg were randomized to one of three maintenance intervention arms in Phase II and followed for an additional 30 months. Participants/setting The multicenter trial was conducted from 2003–2007. This substudy included 828 successful weight loss participants. Methods Dietary Measures The Block Food Frequency Questionnaire (FFQ) was used to assess nutrient intake levels and food group servings. Carbohydrates, proteins, fats, dietary fiber and fruit/vegetable and dairy servings were utilized as predictor variables. Data collection The FFQ was collected on all participants at study entry (beginning of Phase I). Those randomized to Phase II completed the FFQ at three additional time points; randomization (beginning of Phase II), 12 and 30 months. Intervention The main intervention focused on long term maintenance of weight loss using the Dietary Approaches to Hypertension (DASH) diet. This substudy examined whether changes to specific dietary variables were associated with weight loss and maintenance. Statistical analyses performed Linear regression models that adjusted for change in total energy examined the relationship between changes in dietary intake and weight for each time period. Site, age, race, sex, and a race-sex interaction were included as covariates. Results Participants who substituted protein for fat lost, on average, 0.33 kg per 6-months during Phase I (p<0.0001) and 0.07 kg per 6-months during Phase II (p<0.0001) per 1% increase in protein. Increased intake of fruits and vegetables was associated with weight loss in Phases I and II: 0.29 kg per 6-months (p<0.0001) and 0.04 kg per 6-months (p=0.0062), respectively, per 1-serving increase. Substitution of carbohydrates for fat and protein for carbohydrates were associated with weight loss during both phases. Increasing dairy intake was associated with significant weight loss during Phase II (−0.17 kg per 6-months per 1-serving increase, p=0.0002), but not in Phase I. Dietary fiber revealed no significant findings. Conclusion Increasing fruits, vegetables, and low-fat dairy may help achieve weight loss and maintenance. PMID:22117658

The NULevel trial of a scalable, technology-assisted weight loss maintenance intervention for obese adults after clinically significant weight loss: study protocol for a randomised controlled trial.

PubMed

Evans, Elizabeth H; Araújo-Soares, Vera; Adamson, Ashley; Batterham, Alan M; Brown, Heather; Campbell, Miglena; Dombrowski, Stephan U; Guest, Alison; Jackson, Daniel; Kwasnicka, Dominika; Ladha, Karim; McColl, Elaine; Olivier, Patrick; Rothman, Alexander J; Sainsbury, Kirby; Steel, Alison J; Steen, Ian Nicholas; Vale, Luke; White, Martin; Wright, Peter; Sniehotta, Falko F

2015-09-22

Effective weight loss interventions are widely available but, after weight loss, most individuals regain weight. This article describes the protocol for the NULevel trial evaluating the effectiveness and cost-effectiveness of a systematically developed, inexpensive, scalable, technology-assisted, behavioural intervention for weight loss maintenance (WLM) in obese adults after initial weight loss. A 12-month single-centre, two-armed parallel group, participant randomised controlled superiority trial is underway, recruiting a total of 288 previously obese adults after weight loss of ≥5 % within the previous 12 months. Participants are randomly assigned to intervention or control arms, with a 1:1 allocation, stratified by sex and percentage of body weight lost (<10 % vs ≥10 %). Change in weight (kg) from baseline to 12 months is the primary outcome. Weight, other anthropometric variables and 7-day physical activity (assessed via accelerometer) measures are taken at 0 and 12 months. Questionnaires at 0, 6 and 12 months assess psychological process variables, health service use and participant costs. Participants in the intervention arm initially attend an individual face-to-face WLM consultation with an intervention facilitator and then use a mobile internet platform to self-monitor and report their diet, daily activity (via pedometer) and weight through daily weighing on wirelessly connected scales. Automated feedback via mobile phone, tailored to participants' weight regain and goal progress is provided. Participants in the control arm receive quarterly newsletters (via links embedded in text messages) and wirelessly connected scales. Qualitative process evaluation interviews are conducted with a subsample of up to 40 randomly chosen participants. Acceptability and feasibility of procedures, cost-effectiveness, and relationships among socioeconomic variables and WLM will also be assessed. It is hypothesised that participants allocated to the intervention arm will show significantly lower levels of weight regain from baseline than those in the control arm. To date, this is the first WLM trial using remote real-time weight monitoring and mobile internet platforms to deliver a flexible, efficient and scalable intervention, tailored to the individual. This trial addresses a key research need and has the potential to make a vital contribution to the evidence base to inform future WLM policy and provision. http://www.isrctn.com/ISRCTN14657176 (registration date 20 March 2014).

Validation of clinic weights from electronic health records against standardized weight measurements in weight loss trials.

PubMed

Xiao, Lan; Lv, Nan; Rosas, Lisa G; Au, David; Ma, Jun

2017-02-01

To validate clinic weights in electronic health records against researcher-measured weights for outcome assessment in weight loss trials. Clinic and researcher-measured weights from a published trial (BE WELL) were compared using Lin's concordance correlation coefficient, Bland and Altman's limits of agreement, and polynomial regression model. Changes in clinic and researcher-measured weights in BE WELL and another trial, E-LITE, were analyzed using growth curve modeling. Among BE WELL (n = 330) and E-LITE (n = 241) participants, 96% and 90% had clinic weights (mean [SD] of 5.8 [6.1] and 3.7 [3.9] records) over 12 and 15 months of follow-up, respectively. The concordance correlation coefficient was 0.99, and limits of agreement plots showed no pattern between or within treatment groups, suggesting overall good agreement between researcher-measured and nearest-in-time clinic weights up to 3 months. The 95% confidence intervals for predicted percent differences fell within ±3% for clinic weights within 3 months of the researcher-measured weights. Furthermore, the growth curve slopes for clinic and researcher-measured weights by treatment group did not differ significantly, suggesting similar inferences about treatment effects over time, in both trials. Compared with researcher-measured weights, close-in-time clinic weights showed high agreement and inference validity. Clinic weights could be a valid pragmatic outcome measure in weight loss studies. © 2017 The Obesity Society.

Genetic Predisposition to Weight Loss and Regain With Lifestyle Intervention: Analyses From the Diabetes Prevention Program and the Look AHEAD Randomized Controlled Trials

PubMed Central

Papandonatos, George D.; Pan, Qing; Pajewski, Nicholas M.; Delahanty, Linda M.; Peter, Inga; Erar, Bahar; Ahmad, Shafqat; Harden, Maegan; Chen, Ling; Fontanillas, Pierre; Wagenknecht, Lynne E.; Kahn, Steven E.; Wing, Rena R.; Jablonski, Kathleen A.; Huggins, Gordon S.; Knowler, William C.; Florez, Jose C.

2015-01-01

Clinically relevant weight loss is achievable through lifestyle modification, but unintentional weight regain is common. We investigated whether recently discovered genetic variants affect weight loss and/or weight regain during behavioral intervention. Participants at high-risk of type 2 diabetes (Diabetes Prevention Program [DPP]; N = 917/907 intervention/comparison) or with type 2 diabetes (Look AHEAD [Action for Health in Diabetes]; N = 2,014/1,892 intervention/comparison) were from two parallel arm (lifestyle vs. comparison) randomized controlled trials. The associations of 91 established obesity-predisposing loci with weight loss across 4 years and with weight regain across years 2–4 after a minimum of 3% weight loss were tested. Each copy of the minor G allele of MTIF3 rs1885988 was consistently associated with greater weight loss following lifestyle intervention over 4 years across the DPP and Look AHEAD. No such effect was observed across comparison arms, leading to a nominally significant single nucleotide polymorphism×treatment interaction (P = 4.3 × 10−3). However, this effect was not significant at a study-wise significance level (Bonferroni threshold P < 5.8 × 10−4). Most obesity-predisposing gene variants were not associated with weight loss or regain within the DPP and Look AHEAD trials, directly or via interactions with lifestyle. PMID:26253612

Results of the Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) Trial: A Behavioral Weight Loss Intervention in Overweight or Obese Breast Cancer Survivors

PubMed Central

Rock, Cheryl L.; Flatt, Shirley W.; Byers, Tim E.; Colditz, Graham A.; Demark-Wahnefried, Wendy; Ganz, Patricia A.; Wolin, Kathleen Y.; Elias, Anthony; Krontiras, Helen; Liu, Jingxia; Naughton, Michael; Pakiz, Bilgé; Parker, Barbara A.; Sedjo, Rebecca L.; Wyatt, Holly

2015-01-01

Purpose Obesity increases risk for all-cause and breast cancer mortality and comorbidities in women who have been diagnosed and treated for breast cancer. The Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) study is the largest weight loss intervention trial among survivors of breast cancer to date. Methods In this multicenter trial, 692 overweight/obese women who were, on average, 2 years since primary treatment for early-stage breast cancer were randomly assigned to either a group-based behavioral intervention, supplemented with telephone counseling and tailored newsletters, to support weight loss or a less intensive control intervention and observed for 2 years. Weight and blood pressure were measured at 6, 12, 18, and 24 months. Longitudinal mixed models were used to analyze change over time. Results At 12 months, mean weight loss was 6.0% of initial weight in the intervention group and 1.5% in the control group (P < .001). At 24 months, mean weight loss in the intervention and control groups was 3.7% and 1.3%, respectively (P < .001). Favorable effects of the intervention on physical activity and blood pressure were observed. The weight loss intervention was more effective among women older than 55 years than among younger women. Conclusion A behavioral weight loss intervention can lead to clinically meaningful weight loss in overweight/obese survivors of breast cancer. These findings support the need to conduct additional studies to test methods that support sustained weight loss and to examine the potential benefit of intentional weight loss on breast cancer recurrence and survival. PMID:26282657

Results of the Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) Trial: A Behavioral Weight Loss Intervention in Overweight or Obese Breast Cancer Survivors.

PubMed

Rock, Cheryl L; Flatt, Shirley W; Byers, Tim E; Colditz, Graham A; Demark-Wahnefried, Wendy; Ganz, Patricia A; Wolin, Kathleen Y; Elias, Anthony; Krontiras, Helen; Liu, Jingxia; Naughton, Michael; Pakiz, Bilgé; Parker, Barbara A; Sedjo, Rebecca L; Wyatt, Holly

2015-10-01

Obesity increases risk for all-cause and breast cancer mortality and comorbidities in women who have been diagnosed and treated for breast cancer. The Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) study is the largest weight loss intervention trial among survivors of breast cancer to date. In this multicenter trial, 692 overweight/obese women who were, on average, 2 years since primary treatment for early-stage breast cancer were randomly assigned to either a group-based behavioral intervention, supplemented with telephone counseling and tailored newsletters, to support weight loss or a less intensive control intervention and observed for 2 years. Weight and blood pressure were measured at 6, 12, 18, and 24 months. Longitudinal mixed models were used to analyze change over time. At 12 months, mean weight loss was 6.0% of initial weight in the intervention group and 1.5% in the control group (P<.001). At 24 months, mean weight loss in the intervention and control groups was 3.7% and 1.3%, respectively (P<.001). Favorable effects of the intervention on physical activity and blood pressure were observed. The weight loss intervention was more effective among women older than 55 years than among younger women. A behavioral weight loss intervention can lead to clinically meaningful weight loss in overweight/obese survivors of breast cancer. These findings support the need to conduct additional studies to test methods that support sustained weight loss and to examine the potential benefit of intentional weight loss on breast cancer recurrence and survival. © 2015 by American Society of Clinical Oncology.

The role of physical activity in producing and maintaining weight loss

PubMed Central

Catenacci, Victoria A; Wyatt, Holly R

2015-01-01

Summary The majority of randomized, controlled trials (RCTs) show only modest weight loss with exercise intervention alone, and slight increases in weight loss when exercise intervention is added to dietary restriction. In most RCTs, the energy deficit produced by the prescribed exercise is far smaller than that usually produced by dietary restriction. In prospective studies that prescribed high levels of exercise, enrolled individuals achieved substantially greater weight loss—comparable to that obtained after similar energy deficits were produced by caloric restriction. High levels of exercise might, however, be difficult for overweight or obese adults to achieve and sustain. RCTs examining exercise and its effect on weight-loss maintenance demonstrated mixed results; however, weight maintenance interventions were usually of limited duration and long-term adherence to exercise was problematic. Epidemiologic, cross-sectional, and prospective correlation studies suggest an essential role for physical activity in weight-loss maintenance, and post hoc analysis of prospective trials shows a clear dose–response relationship between physical activity and weight maintenance. This article reviews the role of physical activity in producing and maintaining weight loss. We focus on prospective, RCTs lasting at least 4 months; however, other prospective trials, meta-analyses and large systematic reviews are included. Limitations in the current body of literature are discussed. PMID:17581621

[A systematic review of the effectiveness of alternative weight-loss products' ingredients].

PubMed

de Lira-García, Cynthia; Souto-Gallardo, María; Bacardí-Gascón, Monserrat; Jiménez-Cruz, Arturo

2008-01-01

The high demand for obesity treatment and conventional therapies' lack of effectiveness increases the use of alternative products. This study was aimed at assessing evidence from randomised clinical trials regarding the effectiveness of alternative weight-loss products' ingredients. A survey was conducted in Ensenada, Baja California, to assess the frequency of consuming alternative products used for weight reduction. The ingredients in the products most in demand were included in this review. The Pubmed database was searched for all randomised clinical trial papers including these ingredients and assessing weight loss. Thirty-six percent of the subjects questioned had used alternative methods for weight-loss, 83% of them being women. The most frequently used products were shakes, tea, pills and flaxseed/linseed. Sixteen randomised clinical trials using four ingredients were used: Garcinia cambogia, green tea, L-carnitina and flaxseed. Only two studies (green tea and Garcinia cambogia) showed significant weight-loss (25%) amongst control and experimental groups. There was no significant difference between the groups in the studies regarding L-carnitina and flaxseed. There is a lack of evidence regarding quality studies justifying the use of alternative products for weight loss.

Cognitive and Self-regulatory Mechanisms of Obesity Study (COSMOS): Study protocol for a randomized controlled weight loss trial examining change in biomarkers, cognition, and self-regulation across two behavioral treatments.

PubMed

Hawkins, M A W; Colaizzi, Janna; Gunstad, John; Hughes, Joel W; Mullins, Larry L; Betts, Nancy; Smith, Caitlin E; Keirns, Natalie G; Vohs, Kathleen D; Moore, Shirley M; Forman, Evan M; Lovallo, William R

2018-03-01

Obesity is a global epidemic, yet successful interventions are rare. Up to 60% of people fail to achieve clinically meaningful, short-term weight loss (5-10% of start weight), whereas up to 72% are unsuccessful at achieving long-term weight loss (5-10% loss for ≥5years). Understanding how biological, cognitive, and self-regulatory factors work together to promote or to impede weight loss is clearly needed to optimize obesity treatment. This paper describes the methodology of the Cognitive and Self-regulatory Mechanisms of Obesity Study (the COSMOS trial). COSMOS is the first randomized controlled trial to investigate how changes in multiple biopsychosocial and cognitive factors relate to weight loss and one another across two weight loss treatments. The specific aims are to: 1) Confirm that baseline obesity-related physiological dysregulation is linked to cognitive deficits and poorer self-regulation, 2) Evaluate pre- to post-treatment change across time to assess individual differences in biomarkers, cognition, and self-regulation, and 3) Evaluate whether the acceptance-based treatment (ABT) group has greater improvements in outcomes (e.g., greater weight loss and less weight regain, improvements in biomarkers, cognition, and self-regulation), than the standard behavioral treatment group (SBT) from pre- to post-treatment and 1-year follow-up. The results of COSMOS will provide critical information about how dysregulation in biomarkers, cognition, and/or self-regulation is related to weight loss and whether weight loss treatments are differentially associated with these factors. This information will be used to identify promising treatment targets that are informed by biological, cognitive, and self-regulatory factors in order to advance obesity treatment. Copyright © 2017 Elsevier Inc. All rights reserved.

Relationship of cravings with weight loss and hunger: results from a 6 month worksite weight loss intervention

USDA-ARS?s Scientific Manuscript database

We examined the association of food cravings with weight loss and eating behaviors in a 6 month worksite lifestyle weight loss program. This randomized controlled trial of the intervention versus a wait-listed control was conducted at 4 worksites, and 95 participants completed outcome assessments ...

Cost of intervention delivery in a lifestyle weight loss trial in type 2 diabetes: results from the Look AHEAD clinical trial

PubMed Central

Wing, R.; Wadden, T. A.; Knowler, W. C.; Lawlor, M.; Evans, M.; Killean, T.; Montez, M.; Espeland, M. A.; Zhang, P.

2017-01-01

Summary Objective The Action for Health in Diabetes (Look AHEAD) trial was a randomized controlled clinical trial to compare the effects of 10 years of intensive lifestyle intervention (ILI) with a control condition of diabetes support and education (DSE) on health outcomes in over 5,000 participants with type 2 diabetes. The ILI had significantly greater weight losses than DSE throughout the trial. The goal of this analysis is to describe the cost of delivering the intervention. Methods The ILI was designed to promote weight loss and increase physical activity. It involved a combination of group plus individual intervention sessions, with decreasing frequency of contact over the 10 years. The intervention incorporated a variety of strategies, including meal replacement products, to improve weight loss outcomes. The costs of intervention delivery were derived from staff surveys of effort and from records of intervention materials from the 16 US academic clinical trial sites. Costs were calculated from the payer perspective and presented in 2012 dollars. Results During the first year, when intervention delivery was most intensive, the annual cost of intervention delivery, averaged (standard deviation) across clinical sites, was $2,864.6 ($513.3) per ILI participant compared with $202.4 ($76.6) per DSE participant. As intervention intensity declined, costs decreased, such that from years 5 to 9 of the trial, the annual cost of intervention was $1,119.8 ($227.7) per ILI participant and $102.9 ($33.0) per DSE participant. Staffing accounted for the majority of costs throughout the trial, with meal replacements and materials to promote adherence accounting for smaller shares. Conclusions The sustained weight losses produced by the Look AHEAD intervention were supported by intervention costs that were within the range of other weight loss programmes. Future work will include an evaluation of the cost‐effectiveness of the ILI and will contain additional follow‐up data. PMID:28392928

The WORD (Wholeness, Oneness, Righteousness, Deliverance): design of a randomized controlled trial testing the effectiveness of an evidence-based weight loss and maintenance intervention translated for a faith-based, rural, African American population using a community-based participatory approach.

PubMed

Yeary, Karen Hye-cheon Kim; Cornell, Carol E; Prewitt, Elaine; Bursac, Zoran; Tilford, J Mick; Turner, Jerome; Eddings, Kenya; Love, ShaRhonda; Whittington, Emily; Harris, Kimberly

2015-01-01

The positive effects of weight loss on obesity-related risk factors diminish unless weight loss is maintained. Yet little work has focused on the translation of evidence-based weight loss interventions with the aim of sustaining weight loss in underserved populations. Using a community-based participatory approach (CBPR) that engages the strong faith-based social infrastructure characteristic of rural African American communities is a promising way to sustain weight loss in African Americans, who bear a disproportionate burden of the obesity epidemic. Led by a collaborative community-academic partnership, The WORD aims to change dietary and physical activity behaviors to produce and maintain weight loss in rural, African American adults of faith. The WORD is a randomized controlled trial with 450 participants nested within 30 churches. All churches will receive a 16-session core weight loss intervention. Half of the churches will be randomized to receive an additional 12-session maintenance component. The WORD is a cultural adaptation of the Diabetes Prevention Program, whereby small groups will be led by trained church members. Participants will be assessed at baseline, 6, 12, and 18 months. A detailed cost-effectiveness and process evaluation will be included. The WORD aims to sustain weight loss in rural African Americans. The utilization of a CBPR approach and the engagement of the faith-based social infrastructure of African American communities will maximize the intervention's sustainability. Unique aspects of this trial include the focus on weight loss maintenance and the use of a faith-based CBPR approach in translating evidence-based obesity interventions. Copyright © 2014 Elsevier Inc. All rights reserved.

One-year weight losses in the Tianjin Gestational Diabetes Mellitus Prevention Programme: A randomized clinical trial.

PubMed

Liu, Huikun; Wang, Leishen; Zhang, Shuang; Leng, Junhong; Li, Nan; Li, Weiqin; Wang, Jing; Tian, Huiguang; Qi, Lu; Yang, Xilin; Yu, Zhijie; Tuomilehto, Jaakko; Hu, Gang

2018-05-01

To report the weight loss findings after the first year of a lifestyle intervention trial among women with gestational diabetes mellitus (GDM). A total of 1180 women with GDM were randomly assigned (1:1) to receive a 4-year lifestyle intervention (intervention group, n = 586) or standard care (control group, n = 594) between August 2009 and July 2011. Major elements of the intervention included 6 face-to-face sessions with study dieticians and two telephone calls in the first year, and two individual sessions and two telephone calls in each subsequent year. Among 79% of participants who completed the year 1 trial, mean weight loss was 0.82 kg (1.12% of initial weight) in the intervention group and 0.09 kg (0.03% of initial weight) in the control group (P = .001). In a prespecified subgroup analysis of people who completed the trial, weight loss was more pronounced in women who were overweight (body mass index ≥24 kg/m 2 ) at baseline: mean weight loss 2.01 kg (2.87% of initial weight) in the intervention group and 0.44 kg (0.52% of initial weight) in the control group (P < .001). Compared with those in the control group, women in the intervention group had a greater decrease in waist circumference (1.76 cm vs 0.73 cm; P = .003) and body fat (0.50% vs 0.05% increase; P = .001). The 1-year lifestyle intervention led to significant weight losses after delivery in women who had GDM, and the effect was more pronounced in women who were overweight at baseline. © 2018 John Wiley & Sons Ltd.

Design considerations and rationale of a multi-center trial to sustain weight loss: the Weight Loss Maintenance Trial.

PubMed

Brantley, Phillip; Appel, Lawrence; Hollis, Jack; Stevens, Victor; Ard, Jamy; Champagne, Catherine; Elmer, Patricia; Harsha, David; Myers, Valerie; Proschan, Michael; William, Vollmer; Svetkey, Laura

2008-01-01

The Weight Loss Maintenance Trial (WLM) is a multi-center, randomized, controlled trial that compares the effects of two 30-month maintenance interventions, i.e., Personal Contact (PC) and Interactive Technology (IT) to a self-directed usual care control group (SD), in overweight or obese individuals who are at high risk for cardiovascular disease. This paper provides an overview of the design and methods, and design considerations and lessons learned from this trial. All participants received a 6-month behavioral weight loss program consisting of weekly group sessions. Participants who lost 4 kg were randomized to one of three conditions (PC, IT, or SD). The PC condition provided monthly contacts with an interventionist primarily via telephone and quarterly face-to-face visits. The IT condition provided frequent, individualized contact through a tailored, website system. Both the PC and IT maintenance programs encouraged the DASH dietary pattern and employed theory-based behavioral techniques to promote maintenance. Design considerations included choice of study population, frequency and type of intervention visits, and choice of primary outcome. Overweight or obese persons with CVD risk factors were studied. The pros and cons of studying this population while excluding others are presented. We studied intervention contact strategies that made fewer demands on participant time and travel, while providing frequent opportunities for interaction. The primary outcome variable for the trial was change in weight from randomization to end of follow-up (30 months). Limits to generalizability are discussed. Individuals in need of weight loss strategies may have been excluded due to barriers associated with internet use. Other participants may have been excluded secondary to a comorbid condition. This paper highlights the design and methods of WLM and informs readers of discussions of critical issues and lessons learned from the trial.

Lorcaserin: an investigational serotonin 2C agonist for weight loss.

PubMed

Hurren, Kathryn M; Berlie, Helen D

2011-11-01

The pharmacology, pharmacokinetics, and adverse effects of the selective serotonin (5-HT) agonist lorcaserin are reviewed, with an emphasis on efficacy and safety data from Phase III clinical trials. Lorcaserin is highly selective for a subtype of 5-HT receptors important in appetite regulation, with low affinity for other 5-HT-receptor subtypes whose activation is thought to underlie serious cardiovascular adverse effects; such effects have been seen with nonselective serotonergic agents for weight loss (e.g., fenfluramine). In two Phase III trials of lorcaserin, the cumulative proportion of patients who achieved weight loss of ≥5% over 12 months was about 47% with lorcaserin use versus 20-25% among placebo users (p < 0.0001 for both trials). Lorcaserin was generally well tolerated in the clinical trials to date; nausea and vomiting, headache, and dizziness were the most commonly reported adverse effects. In two of the three Phase III trials to date, lorcaserin use was not found to increase the risk of cardiac valvulopathy; however, in the other Phase III trial, which focused on patients with diabetes, lorcaserin use was associated with an increased rate of new valvulopathy. In a carcinogenicity evaluation involving laboratory rats, lorcaserin was linked to the development of various malignancies, a finding with uncertain implications for its potential future use in humans. Lorcaserin, a 5-HT(2C) agonist, has demonstrated efficacy in patients who are obese or are overweight with associated comorbidities. Phase III trials have found that more than 35% of patients lost greater than 5% of their baseline weight. The maker of lorcaserin has indicated it will continue to seek U.S. marketing approval of the drug for the indications of long-term weight loss and weight-loss maintenance in specific patient populations.

Targeting the postpartum period to promote weight loss: a systematic review and meta-analysis.

PubMed

Dodd, Jodie M; Deussen, Andrea R; O'Brien, Cecelia M; Schoenaker, Danielle A J M; Poprzeczny, Amanda; Gordon, Adrienne; Phelan, Suzanne

2018-06-07

Many international clinical guidelines recommend that overweight and obese women lose weight prior to pregnancy to reduce the risk of adverse pregnancy outcomes. Women who have recently given birth and plan future pregnancies are an important target population for preconception weight-loss interventions. A systematic review to evaluate postpartum dietary and/or physical activity interventions to promote weight loss and improve health in a subsequent pregnancy was conducted. Five databases-the Cochrane Central Register of Controlled Trials, MEDLINE (through PubMed), Embase, the Australian New Zealand Clinical Trials Registry, and the International Clinical Trials Registry-were searched using the following terms: preconception, pregnancy, postpartum, pregnancy outcomes, body mass index, weight gain, weight loss, weight change, postpartum weight retention, dietary or lifestyle intervention, and randomiz(s)ed controlled trial. The date of last search was November 2017. Data were extracted from each identified study using a standard form. The primary outcomes were weight loss at the completion of the intervention and at follow-up assessments. Secondary endpoints included maternal and infant outcomes in a subsequent pregnancy. Mean differences (MDs) were calculated for continuous data and risk ratios for dichotomous data, both with 95%CIs. A total of 235 abstracts (193 after duplicates were excluded) were identified, from which 37 manuscripts were selected for full-text review. In total, 27 trials were identified for inclusion. Outcome data were available for approximately 75% of participants (n = 3485). A combined dietary and physical activity intervention provided post partum produced greater postpartum weight loss (MD, -2.49 kg; 95%CI, -3.34 to -1.63 kg [random-effects model]; 12 studies, 1156 women), which was maintained at 12 months post partum (MD, -2.41 kg; 95%CI, -3.89 to -0.93 kg [random-effects model]; 4 studies, 405 women), compared with no intervention. No studies reported maternal or infant health outcomes in a subsequent pregnancy. Providing a postpartum intervention is associated with weight loss after birth, but effects on maternal and infant health in a subsequent pregnancy are uncertain.

An Open Trial of an Acceptance-Based Behavioral Intervention for Weight Loss

ERIC Educational Resources Information Center

Forman, Evan M.; Butryn, Meghan L.; Hoffman, Kimberly L.; Herbert, James D.

2009-01-01

Innovative approaches are urgently needed to improve behavioral treatment for weight loss. The weight regain that is so common after treatment may be a result of an environment that makes it challenging to adhere, long-term, to a dietary and physical activity regimen. This study was designed to test, via a 12-week open trial, the preliminary…

Individual- versus group-based financial incentives for weight loss: a randomized, controlled trial.

PubMed

Kullgren, Jeffrey T; Troxel, Andrea B; Loewenstein, George; Asch, David A; Norton, Laurie A; Wesby, Lisa; Tao, Yuanyuan; Zhu, Jingsan; Volpp, Kevin G

2013-04-02

Data on the effectiveness of employer-sponsored financial incentives for employee weight loss are limited. To test the effectiveness of 2 financial incentive designs for promoting weight loss among obese employees. Randomized, controlled trial. (ClinicalTrials.gov: NCT01208350) Children's Hospital of Philadelphia. 105 employees with a body mass index between 30 and 40 kg/m2. 24 weeks of monthly weigh-ins (control group; n = 35); individual incentive, designed as $100 per person per month for meeting or exceeding weight-loss goals (n = 35); and group incentive, designed as $500 per month split among participants within groups of 5 who met or exceeded weight-loss goals (n = 35). Weight loss after 24 weeks (primary outcome) and 36 weeks and changes in behavioral mediators of weight loss (secondary outcomes). Group-incentive participants lost more weight than control participants (mean between-group difference, 4.4 kg [95% CI, 2.0 to 6.7 kg]; P < 0.001) and individual-incentive participants (mean between-group difference, 3.2 kg [CI, 0.9 to 5.5 kg]; P = 0.008). Twelve weeks after incentives ended and after adjustment for 3-group comparisons, group-incentive participants maintained greater weight loss than control group participants (mean between-group difference, 2.9 kg [CI, 0.5 to 5.3 kg]; P = 0.016) but not greater than individual-incentive participants (mean between-group difference, 2.7 kg [CI, 0.4 to 5.0 kg]; P = 0.024). Single employer and short follow-up. A group-based financial incentive was more effective than an individual incentive and monthly weigh-ins at promoting weight loss among obese employees at 24 weeks. National Institute on Aging.

Examination of mechanisms (E-MECHANIC) of exercise-induced weight compensation: study protocol for a randomized controlled trial.

PubMed

Myers, Candice A; Johnson, William D; Earnest, Conrad P; Rood, Jennifer C; Tudor-Locke, Catrine; Johannsen, Neil M; Cocreham, Shannon; Harris, Melissa; Church, Timothy S; Martin, Corby K

2014-06-07

Weight loss induced only by exercise is frequently less than expected, possibly because of compensatory changes in energy intake and/or energy expenditure. The purpose of the Examination of Mechanisms (E-MECHANIC) of Exercise-Induced Weight Compensation trial is to examine whether increased energy intake and/or reduced spontaneous activity or energy expenditure (outside of structured exercise) account for the less than expected, exercise-associated weight loss. E-MECHANIC is a three-arm, 6-month randomized (1:1:1) controlled trial. The two intervention arms are exercise doses that reflect current recommendations for (1) general health (8 kcal/kg body weight per week (8 KKW), about 900 kcal/wk) and (2) weight loss (20 KKW, about 2,250 kcal/wk). The third arm, a nonexercise control group, will receive health information only. The sample will include a combined total of 198sedentary, overweight or obese (body mass index: ≥25 kg/m² to ≤45 kg/m²) men and women ages 18 to 65 years. The exercise dose will be supervised and tightly controlled in an exercise training laboratory. The primary outcome variables are energy intake, which will be measured using doubly labeled water (adjusted for change in energy stores) and laboratory-based food intake tests, and the discrepancy between expected weight loss and observed weight loss. Secondary outcomes include changes in resting metabolic rate (adjusted for change in body mass), activity levels (excluding structured exercise) and body composition. In an effort to guide the development of future interventions, the participants will be behaviorally phenotyped and defined as those who do compensate (that is, fail to lose the amount of weight expected) or do not compensate (that is, lose the amount of weight expected or more). In this study, we will attempt to identify underlying mechanisms to explain why exercise elicits less weight loss than expected. This information will guide the development of interventions to increase exercise-induced weight loss and maximize weight loss retention and related health benefits. ClinicalTrials.gov ID: NCT01264406 (registration date: 20 December 2010).

Effect of Low-Fat vs. Other Diet Interventions on Long-Term Weight Change in Adults: A Systematic Review and Meta-Analysis

PubMed Central

Tobias, Deirdre K.; Chen, Mu; Manson, JoAnn E.; Ludwig, David S.; Willett, Walter; Hu, Frank B.

2015-01-01

Background The effectiveness of low-fat diets for long-term weight loss has been debated for decades, with dozens of randomized trials (RCTs) and recent reviews giving mixed results. Methods We conducted a random effects meta-analysis of RCTs to estimate the long-term effect of low-fat vs. higher fat dietary interventions on weight loss. Our search included RCTs conducted in adult populations reporting weight change outcomes at ≥1 year, comparing low-fat with higher fat interventions, published through July 2014. The primary outcome measure was mean difference in weight change between interventions. Findings Fifty-three studies met inclusion criteria representing 68,128 participants. In the setting of weight loss trials, low-carbohydrate interventions led to significantly greater weight loss than low-fat interventions (n comparisons=18; weighted mean difference [WMD]=1.15 kg, 95% CI=0.52 to 1.79; I2=10%). Low-fat did not lead to differences in weight change compared with other moderate fat weight loss interventions (n=19; WMD=0.36, 95% CI=-0.66 to 1.37; I2=82%), and were superior only when compared with “usual diet” (n=8; WMD=-5.41, 95% CI=-7.29 to −3.54; I2=68%). Similarly, non-weight loss trials and weight maintenance trials, for which there were no low-carbohydrate comparisons, had similar effects for low-fat vs moderate fat interventions, and were superior compared with “usual diet”. Weight loss trials achieving a greater difference in fat intake at follow-up significantly favored the higher fat dietary interventions, as indicated by difference of ≥5% of calories from fat (n=18; WMD=1.04, 95% CI=0.06 to 2.03; I2=78%) or by difference in change serum triglycerides of ≥5 mg/dL (n=17; WMD=1.38, 95% CI=0.50 to 2.25; I2=62%). Interpretation These findings suggest that the long-term effect of low-fat diets on body weight depends on the intensity of intervention in the comparison group. When compared to dietary interventions of similar intensity, evidence from RCTs does not support low-fat diets over other dietary interventions. PMID:26527511

Clinical Effectiveness of Weight Loss and Weight Maintenance Interventions for Men: A Systematic Review of Men-Only Randomized Controlled Trials (The ROMEO Project).

PubMed

Robertson, Clare; Avenell, Alison; Stewart, Fiona; Archibald, Daryll; Douglas, Flora; Hoddinott, Pat; van Teijlingen, Edwin; Boyers, Dwayne

2017-07-01

Men are underrepresented in obesity services, suggesting current weight loss service provision is suboptimal. This systematic review evaluated evidence-based strategies for treating obesity in men. Eight bibliographic databases and four clinical trials' registers were searched to identify randomized controlled trials (RCTs) of weight loss interventions in men only, with mean/median body mass index of ≥30 kg/m 2 (or ≥28 kg/m 2 with cardiac risk factors), with a minimum mean/median duration of ≥52 weeks. Interventions included diet, physical activity, behavior change techniques, orlistat, or combinations of these; compared against each other, placebo, or a no intervention control group; in any setting. Twenty-one reports from 14 RCTs were identified. Reducing diets produced more favorable weight loss than physical activity alone (mean weight change after 1 year from a reducing diet compared with an exercise program -3.2 kg, 95% confidence interval -4.8 to -1.6 kg, reported p < .01). The most effective interventions combined reducing diets, exercise, and behavior change techniques (mean difference in weight at 1 year compared with no intervention was -4.9 kg, 95% confidence interval -5.9 to -4.0, reported p < .0001). Group interventions produced favorable weight loss results. The average reported participant retention rate was 78.2%, ranging from 44% to 100% retention, indicating that, once engaged, men remained committed to a weight loss intervention. Weight loss for men is best achieved and maintained with the combination of a reducing diet, increased physical activity, and behavior change techniques. Strategies to increase engagement of men with weight loss services to improve the reach of interventions are needed.

Face-to-Face and Online Networks: College Students' Experiences in a Weight-Loss Trial.

PubMed

Merchant, Gina; Weibel, Nadir; Pina, Laura; Griswold, William G; Fowler, James H; Ayala, Guadalupe X; Gallo, Linda C; Hollan, James; Patrick, Kevin

2017-01-01

This study aimed to understand how college students participating in a 2-year randomized controlled trial (Project SMART: Social and Mobile Approach to Reduce Weight; N = 404) engaged their social networks and used social and mobile technologies to try and lose weight. Participants in the present study (n = 20 treatment, n = 18 control) were approached after a measurement visit and administered semi-structured interviews. Interviews were analyzed using principles from grounded theory. Treatment group participants appreciated the timely support provided by the study and the integration of content across multiple technologies. Participants in both groups reported using non-study-designed apps to help them lose weight, and many participants knew one another outside of the study. Individuals talked about weight-loss goals with their friends face to face and felt accountable to follow through with their intentions. Although seeing others' success online motivated many, there was a range of perceived acceptability in talking about personal health-related information on social media. The findings from this qualitative study can inform intervention trials using social and mobile technologies to promote weight loss. For example, weight-loss trials should measure participants' use of direct-to-consumer technologies and interconnectivity so that treatment effects can be isolated and cross-contamination accounted for.

The effects of water and non-nutritive sweetened beverages on weight loss and weight maintenance: A randomized clinical trial.

PubMed

Peters, John C; Beck, Jimikaye; Cardel, Michelle; Wyatt, Holly R; Foster, Gary D; Pan, Zhaoxing; Wojtanowski, Alexis C; Vander Veur, Stephanie S; Herring, Sharon J; Brill, Carrie; Hill, James O

2016-02-01

To evaluate the effects of water versus beverages sweetened with non-nutritive sweeteners (NNS) on body weight in subjects enrolled in a year-long behavioral weight loss treatment program. The study used a randomized equivalence design with NNS or water beverages as the main factor in a trial among 303 weight-stable people with overweight and obesity. All participants participated in a weight loss program plus assignment to consume 24 ounces (710 ml) of water or NNS beverages daily for 1 year. NNS and water treatments were non-equivalent, with NNS treatment showing greater weight loss at the end of 1 year. At 1 year subjects receiving water had maintained a 2.45 ± 5.59 kg weight loss while those receiving NNS beverages maintained a loss of 6.21 ± 7.65 kg (P < 0.001 for difference). Water and NNS beverages were not equivalent for weight loss and maintenance during a 1-year behavioral treatment program. NNS beverages were superior for weight loss and weight maintenance in a population consisting of regular users of NNS beverages who either maintained or discontinued consumption of these beverages and consumed water during a structured weight loss program. These results suggest that NNS beverages can be an effective tool for weight loss and maintenance within the context of a weight management program. © 2015 The Authors, Obesity published by Wiley Periodicals, Inc. on behalf of The Obesity Society (TOS).

Genetic Predisposition to Weight Loss and Regain With Lifestyle Intervention: Analyses From the Diabetes Prevention Program and the Look AHEAD Randomized Controlled Trials.

PubMed

Papandonatos, George D; Pan, Qing; Pajewski, Nicholas M; Delahanty, Linda M; Peter, Inga; Erar, Bahar; Ahmad, Shafqat; Harden, Maegan; Chen, Ling; Fontanillas, Pierre; Wagenknecht, Lynne E; Kahn, Steven E; Wing, Rena R; Jablonski, Kathleen A; Huggins, Gordon S; Knowler, William C; Florez, Jose C; McCaffery, Jeanne M; Franks, Paul W

2015-12-01

Clinically relevant weight loss is achievable through lifestyle modification, but unintentional weight regain is common. We investigated whether recently discovered genetic variants affect weight loss and/or weight regain during behavioral intervention. Participants at high-risk of type 2 diabetes (Diabetes Prevention Program [DPP]; N = 917/907 intervention/comparison) or with type 2 diabetes (Look AHEAD [Action for Health in Diabetes]; N = 2,014/1,892 intervention/comparison) were from two parallel arm (lifestyle vs. comparison) randomized controlled trials. The associations of 91 established obesity-predisposing loci with weight loss across 4 years and with weight regain across years 2-4 after a minimum of 3% weight loss were tested. Each copy of the minor G allele of MTIF3 rs1885988 was consistently associated with greater weight loss following lifestyle intervention over 4 years across the DPP and Look AHEAD. No such effect was observed across comparison arms, leading to a nominally significant single nucleotide polymorphism×treatment interaction (P = 4.3 × 10(-3)). However, this effect was not significant at a study-wise significance level (Bonferroni threshold P < 5.8 × 10(-4)). Most obesity-predisposing gene variants were not associated with weight loss or regain within the DPP and Look AHEAD trials, directly or via interactions with lifestyle. © 2015 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

Weight Maintenance with Litramine (IQP-G-002AS): A 24-Week Double-Blind, Randomized, Placebo-Controlled Study

PubMed Central

Grube, Barbara; Alt, Felix; Uebelhack, Ralf

2015-01-01

Background. Litramine (IQP-G-002AS) was shown to be effective and safe for weight loss in overweight and obese subjects. However, long-term effectiveness on maintenance of body weight loss has yet to be ascertained. Objective. To assess effect of Litramine on maintenance of body weight loss. Methods. A double-blind, randomised, placebo-controlled trial on overweight and obese patients was conducted over two sites in Germany for 24 weeks. Subjects with documented previous weight loss of 3% over the last 3–6 months were randomised to groups given either Litramine (3 g/day) or a matching placebo. Primary endpoints were difference of mean body weight (kg) between baseline and end of study and maintenance of initially lost body weight in verum group, where maintenance is defined as ≤1% weight gain. Results. Subjects who were taking Litramine lost significantly more body weight compared to the subjects taking placebo who gained weight instead (−0.62 ± 1.55 kg versus 1.62 ± 1.48 kg, p < 0.001). More importantly, 92% of subjects in Litramine group were able to maintain their body weight after initial weight loss, versus 25% in placebo group. No serious adverse events were reported throughout. Conclusion. Litramine is effective and safe for long-term body weight maintenance. Trial Registration. This trial is registered with Clinicaltrials.gov identifier: NCT01505387. PMID:26435849

Web-based weight loss in primary care: a randomized controlled trial.

PubMed

Bennett, Gary G; Herring, Sharon J; Puleo, Elaine; Stein, Evelyn K; Emmons, Karen M; Gillman, Matthew W

2010-02-01

Evidence is lacking regarding effective and sustainable weight loss approaches for use in the primary care setting. We conducted a 12-week randomized controlled trial to evaluate the short-term efficacy of a web-based weight loss intervention among 101 primary care patients with obesity and hypertension. Patients had access to a comprehensive website that used a moderate-intensity weight loss approach designed specifically for web-based implementation. Patients also participated in four (two in-person and two telephonic) counseling sessions with a health coach. Intent-to-treat analysis showed greater weight loss at 3 months (-2.56 kg; 95% CI -3.60, -1.53) among intervention participants (-2.28 +/- 3.21 kg), relative to usual care (0.28 +/- 1.87 kg). Similar findings were observed among intervention completers (-3.05 kg; 95% CI -4.24, -1.85). High rates of participant retention (84%) and website utilization were observed, with the greatest weight loss found among those with a high frequency of website logins (quartile 4 vs. 1: -4.16 kg; 95% CI -1.47, -6.84). The intervention's approach promoted moderate weight loss at 12 weeks, though greater weight loss was observed among those with higher levels of website utilization. Efficacious web-based weight loss interventions can be successfully offered in the primary care setting.

The Regulatory Perspectives on Endoscopic Devices for Obesity.

PubMed

Marrone, April K; Antonino, Mark J; Silverstein, Joshua S; Betz, Martha W; Venkataraman-Rao, Priya; Golding, Martin; Cordray, Diane; Cooper, Jeffrey W

2017-04-01

The recent increase in US Food and Drug Administration-approved weight-loss devices has diversified obesity treatment options. The regulatory pathways for endoscopically placed weight-loss devices and considerations for clinical trials are discussed, including the benefit-risk paradigm intended to aid in weight-loss-device trial development. Also discussed is the benefit-risk analysis of recently approved endoscopic devices. A strategic priority of the FDA Center for Devices and Radiological Health is to increase the use of patient input in decision making. Thus, we consider how endoscopic weight-loss devices with profiles similar to those that have been approved may be viewed in a patient preference study. Published by Elsevier Inc.

Intermittent Fasting: Is the Wait Worth the Weight?

PubMed

Stockman, Mary-Catherine; Thomas, Dylan; Burke, Jacquelyn; Apovian, Caroline M

2018-06-01

We review the underlying mechanisms and potential benefits of intermittent fasting (IF) from animal models and recent clinical trials. Numerous variations of IF exist, and study protocols vary greatly in their interpretations of this weight loss trend. Most human IF studies result in minimal weight loss and marginal improvements in metabolic biomarkers, though outcomes vary. Some animal models have found that IF reduces oxidative stress, improves cognition, and delays aging. Additionally, IF has anti-inflammatory effects, promotes autophagy, and benefits the gut microbiome. The benefit-to-harm ratio varies by model, IF protocol, age at initiation, and duration. We provide an integrated perspective on potential benefits of IF as well as key areas for future investigation. In clinical trials, caloric restriction and IF result in similar degrees of weight loss and improvement in insulin sensitivity. Although these data suggest that IF may be a promising weight loss method, IF trials have been of moderate sample size and limited duration. More rigorous research is needed.

A gender-sensitised weight loss and healthy living programme for overweight and obese men delivered by Scottish Premier League football clubs (FFIT): a pragmatic randomised controlled trial

PubMed Central

Hunt, Kate; Wyke, Sally; Gray, Cindy M; Anderson, Annie S; Brady, Adrian; Bunn, Christopher; Donnan, Peter T; Fenwick, Elisabeth; Grieve, Eleanor; Leishman, Jim; Miller, Euan; Mutrie, Nanette; Rauchhaus, Petra; White, Alan; Treweek, Shaun

2015-01-01

Summary Background The prevalence of male obesity is increasing but few men take part in weight loss programmes. We assessed the effect of a weight loss and healthy living programme on weight loss in football (soccer) fans. Methods We did a two-group, pragmatic, randomised controlled trial of 747 male football fans aged 35–65 years with a body-mass index (BMI) of 28 kg/m2 or higher from 13 Scottish professional football clubs. Participants were randomly assigned with SAS (version 9·2, block size 2–9) in a 1:1 ratio, stratified by club, to a weight loss programme delivered by community coaching staff in 12 sessions held every week. The intervention group started a weight loss programme within 3 weeks, and the comparison group were put on a 12 month waiting list. All participants received a weight management booklet. Primary outcome was mean difference in weight loss between groups at 12 months, expressed as absolute weight and a percentage of their baseline weight. Primary outcome assessment was masked. Analyses were based on intention to treat. The trial is registered with Current Controlled Trials, number ISRCTN32677491. Findings 374 men were allocated to the intervention group and 374 to the comparison group. 333 (89%) of the intervention group and 355 (95%) of the comparison group completed 12 month assessments. At 12 months the mean difference in weight loss between groups, adjusted for baseline weight and club, was 4·94 kg (95% CI 3·95–5·94) and percentage weight loss, similarly adjusted, was 4·36% (3·64–5·08), both in favour of the intervention (p<0·0001). Eight serious adverse events were reported, five in the intervention group (lost consciousness due to drugs for pre-existing angina, gallbladder removal, hospital admission with suspected heart attack, ruptured gut, and ruptured Achilles tendon) and three in the comparison group (transient ischaemic attack, and two deaths). Of these, two adverse events were reported as related to participation in the programme (gallbladder removal and ruptured Achilles tendon). Interpretation The FFIT programme can help a large proportion of men to lose a clinically important amount of weight; it offers one effective strategy to challenge male obesity. PMID:24457205

A comparison of categorization criteria used to define successful weight loss maintainers and regainers in the Look AHEAD and DPP trials

USDA-ARS?s Scientific Manuscript database

Introduction: While a variety of lifestyle interventions have resulted in successful weight loss, effective strategies to maintain weight loss are lacking, with many interventions reporting high rates of regain. Identifying characteristics of individuals who successfully maintained their weight afte...

Weight loss intervention for young adults using mobile technology: design and rationale of a randomized controlled trial - Cell Phone Intervention for You (CITY).

PubMed

Batch, Bryan C; Tyson, Crystal; Bagwell, Jacqueline; Corsino, Leonor; Intille, Stephen; Lin, Pao-Hwa; Lazenka, Tony; Bennett, Gary; Bosworth, Hayden B; Voils, Corrine; Grambow, Steven; Sutton, Aziza; Bordogna, Rachel; Pangborn, Matthew; Schwager, Jenifer; Pilewski, Kate; Caccia, Carla; Burroughs, Jasmine; Svetkey, Laura P

2014-03-01

The obesity epidemic has spread to young adults, leading to significant public health implications later in adulthood. Intervention in early adulthood may be an effective public health strategy for reducing the long-term health impact of the epidemic. Few weight loss trials have been conducted in young adults. It is unclear what weight loss strategies are beneficial in this population. To describe the design and rationale of the NHLBI-sponsored Cell Phone Intervention for You (CITY) study, which is a single center, randomized three-arm trial that compares the impact on weight loss of 1) a behavioral intervention that is delivered almost entirely via cell phone technology (Cell Phone group); and 2) a behavioral intervention delivered mainly through monthly personal coaching calls enhanced by self-monitoring via cell phone (Personal Coaching group), each compared to 3) a usual care, advice-only control condition. A total of 365 community-dwelling overweight/obese adults aged 18-35 years were randomized to receive one of these three interventions for 24 months in parallel group design. Study personnel assessing outcomes were blinded to group assignment. The primary outcome is weight change at 24 [corrected] months. We hypothesize that each active intervention will cause more weight loss than the usual care condition. Study completion is anticipated in 2014. If effective, implementation of the CITY interventions could mitigate the alarming rates of obesity in young adults through promotion of weight loss. ClinicalTrial.gov: NCT01092364. Published by Elsevier Inc.

Early Weight Loss with Liraglutide 3.0 mg Predicts 1-Year Weight Loss and is Associated with Improvements in Clinical Markers.

PubMed

Fujioka, Ken; O'Neil, Patrick M; Davies, Melanie; Greenway, Frank; C W Lau, David; Claudius, Birgitte; Skjøth, Trine Vang; Bjørn Jensen, Christine; P H Wilding, John

2016-11-01

To identify an early response criterion for predicting ≥5% weight loss with liraglutide 3.0 mg at week 56 and to compare efficacy outcomes in early responders (ERs) and early nonresponders (ENRs). Using pooled data from the SCALE Obesity and Prediabetes and SCALE Diabetes trials, weight loss of ≥4% at 16 weeks best predicted ≥5% weight loss after 56 weeks. Weight loss and changes in cardiometabolic risk factors and health-related quality of life were evaluated in ERs (≥4% weight loss at week 16) and ENRs (<4% weight loss at week 16) completing 56 weeks' treatment. Proportions of ERs/ENRs to liraglutide 3.0 mg were 77.3%/22.7% (individuals without type 2 diabetes, T2D) and 62.7%/37.3% (those with T2D). Greater mean weight loss was observed in ERs versus ENRs: 10.8% versus 3.0% (without T2D) and 8.5% versus 3.1% (T2D). In both trials, greater proportions of ERs versus ENRs achieved ≥5%, >10%, and >15% weight loss at week 56 with liraglutide 3.0 mg. Greater improvements in cardiometabolic risk factors and health-related quality of life scores were observed in ERs versus ENRs. The early response criterion was clinically useful to identify individuals who would achieve clinically meaningful weight loss at 56 weeks. © 2016 The Authors Obesity published by Wiley Periodicals, Inc. on behalf of The Obesity Society (TOS).

Early Weight Loss with Liraglutide 3.0 mg Predicts 1‐Year Weight Loss and is Associated with Improvements in Clinical Markers

PubMed Central

O'Neil, Patrick M.; Davies, Melanie; Greenway, Frank; C.W. Lau, David; Claudius, Birgitte; Skjøth, Trine Vang; Bjørn Jensen, Christine; P.H. Wilding, John

2016-01-01

Objective To identify an early response criterion for predicting ≥5% weight loss with liraglutide 3.0 mg at week 56 and to compare efficacy outcomes in early responders (ERs) and early nonresponders (ENRs). Methods Using pooled data from the SCALE Obesity and Prediabetes and SCALE Diabetes trials, weight loss of ≥4% at 16 weeks best predicted ≥5% weight loss after 56 weeks. Weight loss and changes in cardiometabolic risk factors and health‐related quality of life were evaluated in ERs (≥4% weight loss at week 16) and ENRs (<4% weight loss at week 16) completing 56 weeks’ treatment. Results Proportions of ERs/ENRs to liraglutide 3.0 mg were 77.3%/22.7% (individuals without type 2 diabetes, T2D) and 62.7%/37.3% (those with T2D). Greater mean weight loss was observed in ERs versus ENRs: 10.8% versus 3.0% (without T2D) and 8.5% versus 3.1% (T2D). In both trials, greater proportions of ERs versus ENRs achieved ≥5%, >10%, and >15% weight loss at week 56 with liraglutide 3.0 mg. Greater improvements in cardiometabolic risk factors and health‐related quality of life scores were observed in ERs versus ENRs. Conclusions The early response criterion was clinically useful to identify individuals who would achieve clinically meaningful weight loss at 56 weeks. PMID:27804269

Positive effect of mushrooms substituted for meat on body weight, body composition, and health parameters. A 1-year randomized clinical trial.

PubMed

Poddar, Kavita H; Ames, Meghan; Hsin-Jen, Chen; Feeney, Mary Jo; Wang, Youfa; Cheskin, Lawrence J

2013-12-01

Reducing energy density (ED) of the diet is an important strategy for controlling obesity. This 1-year, randomized clinical trial examined the effect of substituting mushrooms for red meat ('mushroom diet'), compared to a standard diet ('meat diet'), on weight loss and maintenance among 73 obese adults (64 women, 9 men). The subjects completed anthropometric measurements and 7-day food records four times during a standardized weight loss and maintenance regimen. At the end of the 1-year trial, compared to participants on the standard diet, participants on the mushroom diet (n=36) reported lower intakes of energy (mean ± [SE]=-123 ± 113 kcals) and fat (-4.25 ± 6.88 g), lost more pounds and percentage body weight (-7.03 ± 3.34 lbs, 3.6%), achieved lower body mass index (-1.53 ± 0.36), waist circumference (-2.6 ± 3.5 in.) and percent total body fat (-0.85 ± 0.53), and had lower systolic and diastolic pressure (-7.9 and -2.5 mmHg); their lipid profile and inflammatory markers also improved. After initial weight loss, subjects following the mushroom diet maintained that loss well. Those who completed the full 12-month trial still weighed a mean of 7 lbs less than baseline. Thus, encouraging adults to substitute mushrooms for red meat was a useful strategy for enhancing weight loss, weight maintenance, and health parameters. Copyright © 2013 Elsevier Ltd. All rights reserved.

Low Carbohydrate versus Isoenergetic Balanced Diets for Reducing Weight and Cardiovascular Risk: A Systematic Review and Meta-Analysis

PubMed Central

Naude, Celeste E.; Schoonees, Anel; Senekal, Marjanne; Young, Taryn; Garner, Paul; Volmink, Jimmy

2014-01-01

Background Some popular weight loss diets restricting carbohydrates (CHO) claim to be more effective, and have additional health benefits in preventing cardiovascular disease compared to balanced weight loss diets. Methods and Findings We compared the effects of low CHO and isoenergetic balanced weight loss diets in overweight and obese adults assessed in randomised controlled trials (minimum follow-up of 12 weeks), and summarised the effects on weight, as well as cardiovascular and diabetes risk. Dietary criteria were derived from existing macronutrient recommendations. We searched Medline, EMBASE and CENTRAL (19 March 2014). Analysis was stratified by outcomes at 3–6 months and 1–2 years, and participants with diabetes were analysed separately. We evaluated dietary adherence and used GRADE to assess the quality of evidence. We calculated mean differences (MD) and performed random-effects meta-analysis. Nineteen trials were included (n = 3209); 3 had adequate allocation concealment. In non-diabetic participants, our analysis showed little or no difference in mean weight loss in the two groups at 3–6 months (MD 0.74 kg, 95%CI −1.49 to 0.01 kg; I2 = 53%; n = 1745, 14 trials; moderate quality evidence) and 1–2 years (MD 0.48 kg, 95%CI −1.44 kg to 0.49 kg; I2 = 12%; n = 1025; 7 trials, moderate quality evidence). Furthermore, little or no difference was detected at 3–6 months and 1–2 years for blood pressure, LDL, HDL and total cholesterol, triglycerides and fasting blood glucose (>914 participants). In diabetic participants, findings showed a similar pattern. Conclusions Trials show weight loss in the short-term irrespective of whether the diet is low CHO or balanced. There is probably little or no difference in weight loss and changes in cardiovascular risk factors up to two years of follow-up when overweight and obese adults, with or without type 2 diabetes, are randomised to low CHO diets and isoenergetic balanced weight loss diets. PMID:25007189

EffectS of non-nutritive sWeetened beverages on appetITe during aCtive weigHt loss (SWITCH): Protocol for a randomized, controlled trial assessing the effects of non-nutritive sweetened beverages compared to water during a 12-week weight loss period and a follow up weight maintenance period.

PubMed

Masic, U; Harrold, J A; Christiansen, P; Cuthbertson, D J; Hardman, C A; Robinson, E; Halford, J C G

2017-02-01

Acute and medium-term intervention studies suggest that non-nutritive sweeteners (NNS) are beneficial for weight loss, however there is limited human data on the long-term effects of consuming NNS on weight loss, maintenance, and appetite. Further research is therefore required to elucidate the prolonged impact of NNS consumption on these outcome measures. A randomized parallel groups design will be used to assess whether regular NNS beverage intake is equivalent to a water control in promoting weight loss over 12-weeks (weekly weight loss sessions; Phase I), then supporting weight maintenance over 40-weeks (monthly sessions; Phase II) and subsequently independent weight maintenance over 52-weeks (Phase III) in 432 participants. A subset of these participants (n=116) will complete laboratory-based appetite probe days (15 sessions; 3 sessions each at baseline, at the start of phase I and the end of each phase). A separate subset (n=50) will complete body composition scans (DXA) at baseline and at the end of each phase. All participants will regularly be weighed and will complete questionnaires and cognitive tasks to assess changes in body weight and appetitive behaviours. Measures of physical activity and biochemical markers will also be taken. The trial will assess the efficacy of NNS beverages compared to water during a behavioural weight loss and maintenance programme. We aim to understand whether the impact of NNS on weight, dietary adherence and well-being are beneficial or transient and effects on prolonged successful weight loss and weight maintenance through sustained changes in appetite and eating behaviour. Clinical Trials: NCT02591134; registered: 23.10.2015. Crown Copyright © 2016. Published by Elsevier Inc. All rights reserved.

A Family and Community Focused Lifestyle Program Prevents Weight Regain in Pacific Islanders: A Pilot Randomized Controlled Trial

ERIC Educational Resources Information Center

Kaholokula, Joseph Keawe'aimoku; Mau, Marjorie K.; Efird, Jimmy T.; Leake, Anne; West, Margaret; Palakiko, Donna-Marie; Yoshimura, Sheryl R.; Kekauoha, B. Puni; Rose, Charles; Gomes, Henry

2012-01-01

Preventing weight regain after the loss of excess weight is challenging for people, especially for ethnic minorities in the United States. A 6-month weight loss maintenance intervention designed for Pacific Islanders, called the PILI Lifestyle Program (PLP), was compared with a 6-month standard behavioral weight loss maintenance program (SBP) in a…

Parent-only vs. parent-child (family-focused) approaches for weight loss in obese and overweight children: a systematic review and meta-analysis.

PubMed

Jull, A; Chen, R

2013-09-01

Families are recommended as the agents of change for weight loss in overweight and obese children; family approaches are more effective than those that focus on the child alone. However, interventions that focus on parents alone have not been summarized. The objective of this review was to assess the effectiveness of interventions that compared a parent-only (PO) condition with a parent-child (PC) condition. Four trials using a similar between-group background approaches to overweight and obese children's weight loss met the inclusion criteria, but only one trial reported sufficient data for meta-analysis. Further information was obtained from authors. Meta-analysis showed no significant difference in z-BMI from baseline to end of treatment between the conditions (three trials) or to end of follow up (two trials). The trials were at risk of bias and no single trial was at lower risk of bias than others. There is an absence of high quality evidence regarding the effect of parent-only interventions for weight loss in children compared to parent-child interventions, but current evidence suggests the need for further investigation. © 2013 The Authors. obesity reviews © 2013 International Association for the Study of Obesity.

Impact of weight loss on ankle-brachial index and interartery blood pressures

USDA-ARS?s Scientific Manuscript database

Objective: To assess whether weight loss improves markers of peripheral artery disease and vascular stenosis. Methods: The Action for Health in Diabetes randomized clinical trial compared intensive lifestyle intervention (ILI) for weight loss to a control condition of diabetes support and education...

Cell phone Intervention for You (CITY): A randomized, controlled trial of behavioral weight loss intervention for young adults using mobile technology

PubMed Central

Svetkey, LP; Batch, BC; Lin, P-H; Intille, SS; Corsino, L; Tyson, CC; Bosworth, HB; Grambow, SC; Voils, C; Loria, C; Gallis, JA; Schwager, J; Bennett, GB

2015-01-01

Objectives To determine the effect on weight of two Mobile technology-based (mHealth) behavioral weight loss interventions in young adults. Methods Randomized, controlled comparative effectiveness trial in 18–35 year olds with BMI ≥ 25 kg/m2 (overweight/obese), with participants randomized to 24 months of mHealth intervention delivered by interactive smartphone application on a cell phone (CP); personal coaching enhanced by smartphone self-monitoring (PC); or Control. Results The 365 randomized participants had mean baseline BMI of 35 kg/m2. Final weight was measured in 86% of participants. CP was not superior to Control at any measurement point. PC participants lost significantly more weight than Controls at 6 months (net effect −1.92 kg [CI −3.17, −0.67], p=0.003), but not at 12 and 24 months. Conclusions Despite high intervention engagement and study retention, the inclusion of behavioral principles and tools in both interventions, and weight loss in all treatment groups, CP did not lead to weight loss and PC did not lead to sustained weight loss relative to control. Although mHealth solutions offer broad dissemination and scalability, the CITY results sound a cautionary note concerning intervention delivery by mobile applications. Effective intervention may require the efficiency of mobile technology, the social support and human interaction of personal coaching, and an adaptive approach to intervention design. Trial Registration ClinicalTrials.gov Identifier NCT01092364. https://clinicaltrials.gov/ct2/show/NCT01092364?term=Cell+phone+intervention+for+you&rank=3 PMID:26530929

Dietary self-monitoring, but not dietary quality, improves with use of smartphone app technology in an 8-week weight loss trial.

PubMed

Wharton, Christopher M; Johnston, Carol S; Cunningham, Barbara K; Sterner, Danielle

2014-01-01

Dietary self-monitoring is linked to improved weight loss success. Mobile technologies, such as smartphone applications (apps), might allow for improved dietary tracking adherence. The authors assessed the use of a popular smartphone app for dietary self-monitoring and weight loss by comparing it with traditional diet counseling and entry methods. Diet tracking and weight loss were compared across participants during an 8-week weight loss trial. Participants tracked intake using 1 of 3 methods: the mobile app "Lose It!", the memo feature on a smartphone, or a traditional paper-and-pencil method. App users (n = 19) recorded dietary data more consistently compared with the paper-and-pencil group (n = 15; P = .042) but not the memo group (n = 13). All groups lost weight over the course of the study (P = .001), and no difference in weight loss was noted between groups. Smartphone apps could represent a novel and feasible dietary self-monitoring method for individuals. Copyright © 2014 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

Short- and Long-Term Changes in Health-Related Quality of Life with Weight Loss: Results from a Randomized Controlled Trial.

PubMed

Pearl, Rebecca L; Wadden, Thomas A; Tronieri, Jena Shaw; Berkowitz, Robert I; Chao, Ariana M; Alamuddin, Naji; Leonard, Sharon M; Carvajal, Raymond; Bakizada, Zayna M; Pinkasavage, Emilie; Gruber, Kathryn A; Walsh, Olivia A; Alfaris, Nasreen

2018-06-01

The objective of this study was to determine the effects of weight loss and weight loss maintenance (WLM) on weight-specific health-related quality of life in a 66-week trial. Adults with obesity (N = 137, 86.1% female, 68.6% black, mean age = 46.1 years) who had lost ≥ 5% of initial weight in a 14-week intensive lifestyle intervention/low-calorie diet (LCD) program were randomly assigned to lorcaserin or placebo for an additional 52-week WLM program. The Impact of Weight on Quality of Life-Lite (IWQOL-Lite) scale (including five subscales), Patient Health Questionnaire-9 (depression), and Perceived Stress Scale were administered at the start of the 14-week LCD program, randomization, and week 52 of the randomized controlled trial (i.e., 66 weeks total). Significant improvements in all outcomes, except weight-related public distress, were found following the 14-week LCD program (P values < 0.05). Improvements were largely maintained during the 52-week randomized controlled trial, despite weight regain of 2.0 to 2.5 kg across treatment groups. Participants who lost ≥ 10% of initial weight achieved greater improvements in physical function, self-esteem, sexual life, and the IWQOL-Lite total score than those who lost < 5% and did not differ from those who lost 5% to 9.9%. Improvements in weight-specific health-related quality of life were achieved with moderate weight loss and were sustained during WLM. © 2018 The Obesity Society.

Randomized trial of a telephone-based weight loss intervention in postmenopausal women with breast cancer receiving letrozole: the LISA trial.

PubMed

Goodwin, Pamela J; Segal, Roanne J; Vallis, Michael; Ligibel, Jennifer A; Pond, Gregory R; Robidoux, André; Blackburn, George L; Findlay, Brian; Gralow, Julie R; Mukherjee, Som; Levine, Mark; Pritchard, Kathleen I

2014-07-20

Obesity is associated with poor outcomes in women with operable breast cancer. Lifestyle interventions (LIs) that help women reduce their weight may improve outcomes. We conducted a multicenter randomized trial comparing mail-based delivery of general health information alone or combined with a 24-month standardized, telephone-based LI that included diet (500 to 1,000 kcal per day deficit) and physical activity (150 to 200 minutes of moderate-intensity physical activity per week) goals to achieve weight loss (up to 10%). Women receiving adjuvant letrozole for T1-3N0-3M0 breast cancer with a body mass index (BMI) ≥ 24 kg/m(2) were eligible. Weight was measured in the clinic, and self-report physical activity, quality-of-life (QOL), and diet questionnaires were completed. The primary outcome was disease-free survival. Accrual was terminated at 338 of 2,150 planned patients because of loss of funding. Mean weight loss was significantly (P < .001) greater in the LI arm versus the comparison arm (4.3 v 0.6 kg or 5.3% v 0.7% at 6 months and 3.1 v 0.3 kg or 3.6% v 0.4% at 24 months) and occurred consistently across strata (BMI 24 to < 30 v ≥ 30 kg/m(2); prior v no prior adjuvant chemotherapy). Weight loss was greatest in those with higher baseline levels of moderate-intensity physical activity or improvement in QOL. Hospitalization rates and medical events were similar. A telephone-based LI led to significant weight loss that was still evident at 24 months, without adverse effects on QOL, hospitalizations, or medical events. Adequately powered randomized trials with cancer end points are needed. © 2014 by American Society of Clinical Oncology.

Long term maintenance of weight loss with non-surgical interventions in obese adults: systematic review and meta-analyses of randomised controlled trials

PubMed Central

Dombrowski, S U; Knittle, K; Avenell, A; Araújo-Soares, V

2014-01-01

Objective To systematically review and describe currently available approaches to supporting maintenance of weight loss in obese adults and to assess the evidence for the effectiveness of these interventions. Design Systematic review with meta-analysis. Data sources Medline, PsycINFO, Embase, and the Cochrane Central Register of Controlled Trials. Study selection Studies were identified through to January 2014. Randomised trials of interventions to maintain weight loss provided to initially obese adults (aged ≥18) after weight loss of ≥5% body weight with long term (≥12 months) follow-up of weight change (main outcome) were included. Study appraisal and synthesis Potential studies were screened independently and in duplicate; study characteristics and outcomes were extracted. Meta-analyses were conducted to estimate the effects of interventions on weight loss maintenance with the inverse variance method and a random effects model. Results are presented as mean differences in weight change, with 95% confidence intervals. Results 45 trials involving 7788 individuals were included. Behavioural interventions focusing on both food intake and physical activity resulted in an average difference of −1.56 kg (95% confidence interval −2.27 to −0.86 kg; 25 comparisons, 2949 participants) in weight regain compared with controls at 12 months. Orlistat combined with behavioural interventions resulted in a −1.80 kg (−2.54 to −1.06; eight comparisons, 1738 participants) difference compared with placebo at 12 months. All orlistat studies reported higher frequencies of adverse gastrointestinal events in the experimental compared with placebo control groups. A dose-response relation for orlistat treatment was found, with 120 mg doses three times a day leading to greater weight loss maintenance (−2.34 kg, −3.03 to −1.65) compared with 60 mg and 30 mg three times a day (−0.70 kg, 95% confidence interval −1.92 to 0.52), P=0.02. Conclusions Behavioural interventions that deal with both diet and physical activity show small but significant benefits on weight loss maintenance. PMID:25134100

Effects of low-carbohydrate vs low-fat diets on weight loss and cardiovascular risk factors: a meta-analysis of randomized controlled trials.

PubMed

Nordmann, Alain J; Nordmann, Abigail; Briel, Matthias; Keller, Ulrich; Yancy, William S; Brehm, Bonnie J; Bucher, Heiner C

2006-02-13

Low-carbohydrate diets have become increasingly popular for weight loss. However, evidence from individual trials about benefits and risks of these diets to achieve weight loss and modify cardiovascular risk factors is preliminary. We used the Cochrane Collaboration search strategy to identify trials comparing the effects of low-carbohydrate diets without restriction of energy intake vs low-fat diets in individuals with a body mass index (calculated as weight in kilograms divided by the square of height in meters) of at least 25. Included trials had to report changes in body weight in intention-to-treat analysis and to have a follow-up of at least 6 months. Two reviewers independently assessed trial eligibility and quality of randomized controlled trials. Five trials including a total of 447 individuals fulfilled our inclusion criteria. After 6 months, individuals assigned to low-carbohydrate diets had lost more weight than individuals randomized to low-fat diets (weighted mean difference, -3.3 kg; 95% confidence interval [CI], -5.3 to -1.4 kg). This difference was no longer obvious after 12 months (weighted mean difference, -1.0 kg; 95% CI, -3.5 to 1.5 kg). There were no differences in blood pressure. Triglyceride and high-density lipoprotein cholesterol values changed more favorably in individuals assigned to low-carbohydrate diets (after 6 months, for triglycerides, weighted mean difference, -22.1 mg/dL [-0.25 mmol/L]; 95% CI, -38.1 to -5.3 mg/dL [-0.43 to -0.06 mmol/L]; and for high-density lipoprotein cholesterol, weighted mean difference, 4.6 mg/dL [0.12 mmol/L]; 95% CI, 1.5-8.1 mg/dL [0.04-0.21 mmol/L]), but total cholesterol and low-density lipoprotein cholesterol values changed more favorably in individuals assigned to low-fat diets (weighted mean difference in low-density lipoprotein cholesterol after 6 months, 5.4 mg/dL [0.14 mmol/L]; 95% CI, 1.2-10.1 mg/dL [0.03-0.26 mmol/L]). Low-carbohydrate, non-energy-restricted diets appear to be at least as effective as low-fat, energy-restricted diets in inducing weight loss for up to 1 year. However, potential favorable changes in triglyceride and high-density lipoprotein cholesterol values should be weighed against potential unfavorable changes in low-density lipoprotein cholesterol values when low-carbohydrate diets to induce weight loss are considered.

Impact of intermittent fasting on glucose homeostasis.

PubMed

Varady, Krista A

2016-07-01

This article provides an overview of the most recent human trials that have examined the impact of intermittent fasting on glucose homeostasis. Our literature search retrieved one human trial of alternate day fasting, and three trials of Ramadan fasting published in the past 12 months. Current evidence suggests that 8 weeks of alternate day fasting that produces mild weight loss (4% from baseline) has no effect on glucose homeostasis. As for Ramadan fasting, decreases in fasting glucose, insulin, and insulin resistance have been noted after 4 weeks in healthy normal weight individuals with mild weight loss (1-2% from baseline). However, Ramadan fasting may have little impact on glucoregulatory parameters in women with polycystic ovarian syndrome who failed to observe weight loss. Whether intermittent fasting is an effective means of regulating glucose homeostasis remains unclear because of the scarcity of studies in this area. Large-scale, longer-term randomized controlled trials will be required before the use of fasting can be recommended for the prevention and treatment of metabolic diseases.

Systematic Review of the Mediterranean Diet for Long-Term Weight Loss.

PubMed

Mancini, Joseph G; Filion, Kristian B; Atallah, Renée; Eisenberg, Mark J

2016-04-01

Although the long-term health benefits of the Mediterranean diet are well established, its efficacy for weight loss at ≥12 months in overweight or obese individuals is unclear. We therefore conducted a systematic review of randomized controlled trials (RCTs) to determine the effect of the Mediterranean diet on weight loss and cardiovascular risk factor levels after ≥12 months. We systematically searched MEDLINE, EMBASE, and the Cochrane Library of Clinical Trials for RCTs published in English or French and with follow-up ≥12 months that examined the effect of the Mediterranean diet on weight loss and cardiovascular risk factor levels in overweight or obese individuals trying to lose weight. Five RCTs (n = 998) met our inclusion criteria. Trials compared the Mediterranean diet to a low-fat diet (4 treatment arms), a low-carbohydrate diet (2 treatment arms), and the American Diabetes Association diet (1 treatment arm). The Mediterranean diet resulted in greater weight loss than the low-fat diet at ≥12 months (range of mean values: -4.1 to -10.1 kg vs 2.9 to -5.0 kg), but produced similar weight loss as other comparator diets (range of mean values: -4.1 to -10.1 kg vs -4.7 to -7.7 kg). Moreover, the Mediterranean diet was generally similar to comparator diets at improving other cardiovascular risk factor levels, including blood pressure and lipid levels. Our findings suggest that the Mediterranean diet results in similar weight loss and cardiovascular risk factor level reduction as comparator diets in overweight or obese individuals trying to lose weight. Copyright © 2016 Elsevier Inc. All rights reserved.

Can weight loss improve migraine headaches in obese women? Rationale and design of the WHAM randomized controlled trial

PubMed Central

Bond, Dale S.; O’Leary, Kevin C.; Thomas, J. Graham; Lipton, Richard B.; Papandonatos, George D.; Roth, Julie; Rathier, Lucille; Daniello, Richard; Wing, Rena R.

2013-01-01

Background Research demonstrates a link between migraine and obesity. Obesity increases the risk of frequent migraines and is associated with migraine prevalence among reproductive-aged women. These findings are substantiated by several plausible mechanisms and emerging evidence of migraine improvements after surgical and non-surgical weight loss. However, no previous study has examined the effect of weight loss on migraine within a treatment-controlled framework. The WHAM trial is a RCT to test the efficacy of behavioral weight loss as a treatment for migraine. Study design Overweight/obese women (n=140; BMI=25.0–49.9 kg/m2) who meet international diagnostic criteria for migraine and record ≥3 migraines and 4–20 migraine days using a smartphone-based headache diary during a 4-week baseline period, will be randomly assigned to 4 months of either group-based behavioral weight loss (intervention) or migraine education (control). Intervention participants will be taught strategies to increase physical activity and consume fewer calories in order to lose weight. Control participants will receive general education on migraine symptoms/triggers and various treatment approaches. Both groups will use smartphones to record their headaches for 4 weeks at baseline, after the 16-week treatment period, and at the end of a 16-week follow-up period. Changes in weight and other potential physiological (inflammation), psychological (depression), and behavioral (diet and physical activity) mediators of the intervention effect will also be assessed. Conclusion The WHAM trial will evaluate the efficacy of a standardized behavioral weight loss intervention for reducing migraine frequency, and the extent to which weight loss and other potential mediators account for intervention effects. PMID:23524340

The Efficacy of Psychological Therapies in Reducing Weight and Binge Eating in People with Bulimia Nervosa and Binge Eating Disorder Who Are Overweight or Obese—A Critical Synthesis and Meta-Analyses

PubMed Central

Palavras, Marly Amorim; Hay, Phillipa; dos Santos Filho, Celso Alves; Claudino, Angélica

2017-01-01

Recurrent binge eating episodes, the core feature of Bulimia Nervosa (BN) and Binge Eating Disorder (BED), are frequently comorbid with obesity. Psychological interventions, notably Cognitive Behavioural Therapy (CBT), are effective for binge eating reduction in BED or BN but less so for weight loss. Behavioural Weight Loss Therapy (BWLT) shows effectiveness for binge eating reduction and weight loss but the latter appears poorly sustained over time. Our aim was to review evidence for efficacy of psychological therapies for BN/BED associated with overweight or obesity in reducing binge frequency and weight. A systematic search for randomized controlled trials with adult samples who had BN or BED was conducted considering articles in English, French, Spanish and Portuguese with no restrictions for the timeline publication ending in March 2016. A quality appraisal of the trials and meta-analyses comparing BWLT to CBT were done. This review identified 2248 articles for screening and 19 published articles were selected. No trials of BN were identified. This review found CBT was favoured compared to BWLT with regard to short-term binge eating reduction. However, insufficient evidence was found for superiority for BWLT efficacy compared to CBT considering binge eating remission, reduction of binge eating frequency and weight loss. More research is needed to test the efficacy of psychological treatments for BED or BN with co-morbid overweight or obesity, including trials evaluating binge eating remission and weight loss in the long-term. PMID:28304341

The Efficacy of Psychological Therapies in Reducing Weight and Binge Eating in People with Bulimia Nervosa and Binge Eating Disorder Who Are Overweight or Obese-A Critical Synthesis and Meta-Analyses.

PubMed

Palavras, Marly Amorim; Hay, Phillipa; Filho, Celso Alves Dos Santos; Claudino, Angélica

2017-03-17

Recurrent binge eating episodes, the core feature of Bulimia Nervosa (BN) and Binge Eating Disorder (BED), are frequently comorbid with obesity. Psychological interventions, notably Cognitive Behavioural Therapy (CBT), are effective for binge eating reduction in BED or BN but less so for weight loss. Behavioural Weight Loss Therapy (BWLT) shows effectiveness for binge eating reduction and weight loss but the latter appears poorly sustained over time. Our aim was to review evidence for efficacy of psychological therapies for BN/BED associated with overweight or obesity in reducing binge frequency and weight. A systematic search for randomized controlled trials with adult samples who had BN or BED was conducted considering articles in English, French, Spanish and Portuguese with no restrictions for the timeline publication ending in March 2016. A quality appraisal of the trials and meta-analyses comparing BWLT to CBT were done. This review identified 2248 articles for screening and 19 published articles were selected. No trials of BN were identified. This review found CBT was favoured compared to BWLT with regard to short-term binge eating reduction. However, insufficient evidence was found for superiority for BWLT efficacy compared to CBT considering binge eating remission, reduction of binge eating frequency and weight loss. More research is needed to test the efficacy of psychological treatments for BED or BN with co-morbid overweight or obesity, including trials evaluating binge eating remission and weight loss in the long-term.

A pilot study comparing two weight loss maintenance interventions among low-income, mid-life women

PubMed Central

2013-01-01

Background Despite high obesity prevalence rates, few low-income midlife women participate in weight loss maintenance trials. This pilot study aims to assess the effectiveness of two weight loss maintenance interventions in this under-represented population. Methods Low-income midlife women who completed a 16-week weight loss intervention and lost ≥ 8 lbs (3.6 kg) were eligible to enroll in one of two 12-month maintenance programs. The programs were similar in content and had the same number of total contacts, but were different in the contact modality (Phone + Face-to-Face vs. Face-to-Face Only). Two criteria were used to assess successful weight loss maintenance at 12 months: (1) retaining a loss of ≥ 5% of body weight from the start of the weight loss phase and (2) a change in body weight of < 3%, from the start to the end of the maintenance program. Outcome measures of changes in physiologic and psychosocial factors, and evaluations of process measures and program acceptability (measured at 12 months) are also reported. For categorical variables, likelihood ratio or Fisher’s Exact (for small samples) tests were used to evaluate statistically significant relationships; for continuous variables, t-tests or their equivalents were used to assess differences between means and also to identify correlates of weight loss maintenance. Results Overall, during the 12-month maintenance period, 41% (24/58) of participants maintained a loss of ≥ 5% of initial weight and 43% (25/58) had a <3% change in weight. None of the comparisons between the two maintenance programs were statistically significant. However, improvements in blood pressure and dietary behaviors remained significant at the end of the 12-month maintenance period for participants in both programs. Participant attendance and acceptability were high for both programs. Conclusions The effectiveness of two pilot 12-month maintenance interventions provides support for further research in weight loss maintenance among high-risk, low-income women. Trial registration ClinicalTrials.gov Identifier: NCT00288301 PMID:23855318

Study protocol: the effectiveness and cost effectiveness of a brief behavioural intervention to promote regular self-weighing to prevent weight regain after weight loss: randomised controlled trial (The LIMIT Study).

PubMed

Madigan, Claire D; Jolly, Kate; Roalfe, Andrea; Lewis, Amanda L; Webber, Laura; Aveyard, Paul; Daley, Amanda J

2015-06-04

Although obesity causes many adverse health consequences, modest weight loss reduces the incidence. There are effective interventions that help people to lose weight but weight regain is common and long term maintenance remains a critical challenge. As a high proportion of the population of most high and middle income countries are overweight, there are many people who would benefit from weight loss and its maintenance. Therefore, we need to find effective low cost scalable interventions to help people achieve this. One such intervention that has shown promise is regular self-weighing, to check progress against a target, however there is no trial that has tested this using a randomised controlled design (RCT). The aim of this RCT is to evaluate the effectiveness and cost effectiveness of a brief behavioural intervention delivered by non-specialist staff to promote regular self-weighing to prevent weight regain after intentional weight loss. A randomised trial of 560 adults who have lost ≥ 5 % of their initial body weight through a 12 week weight loss programme. The comparator group receive a weight maintenance leaflet, a diagram representing healthy diet composition, and a list of websites for weight control. The intervention group receive the same plus minimally trained telephonists will ask participants to set a weight target and encourage them to weigh themselves daily, and provide support materials such as a weight record card. The primary outcome is the difference between groups in weight change from baseline to 12 months. If effective, this study will provide public health agencies with a simple, low cost maintenance intervention that could be implemented immediately. ISRCTN52341938 Date Registered: 31/03/2014.

Weight maintenance and additional weight loss with liraglutide after low-calorie-diet-induced weight loss: the SCALE Maintenance randomized study.

PubMed

Wadden, T A; Hollander, P; Klein, S; Niswender, K; Woo, V; Hale, P M; Aronne, L

2013-11-01

Liraglutide, a once-daily human glucagon-like peptide-1 analog, induced clinically meaningful weight loss in a phase 2 study in obese individuals without diabetes. The present randomized phase 3 trial assessed the efficacy of liraglutide in maintaining weight loss achieved with a low-calorie diet (LCD). Obese/overweight participants (≥18 years, body mass index ≥30 kg m(-2) or ≥27 kg m(-2) with comorbidities) who lost ≥5% of initial weight during a LCD run-in were randomly assigned to liraglutide 3.0 mg per day or placebo (subcutaneous administration) for 56 weeks. Diet and exercise counseling were provided throughout the trial. Co-primary end points were percentage weight change from randomization, the proportion of participants that maintained the initial ≥5% weight loss, and the proportion that lost ≥5% of randomization weight (intention-to-treat analysis). ClinicalTrials.gov identifier: NCT00781937. Participants (n=422) lost a mean 6.0% (s.d. 0.9) of screening weight during run-in. From randomization to week 56, weight decreased an additional mean 6.2% (s.d. 7.3) with liraglutide and 0.2% (s.d. 7.0) with placebo (estimated difference -6.1% (95% class intervals -7.5 to -4.6), P<0.0001). More participants receiving liraglutide (81.4%) maintained the ≥5% run-in weight loss, compared with those receiving placebo (48.9%) (estimated odds ratio 4.8 (3.0; 7.7), P<0.0001), and 50.5% versus 21.8% of participants lost ≥5% of randomization weight (estimated odds ratio 3.9 (2.4; 6.1), P<0.0001). Liraglutide produced small but statistically significant improvements in several cardiometabolic risk factors compared with placebo. Gastrointestinal (GI) disorders were reported more frequently with liraglutide than placebo, but most events were transient, and mild or moderate in severity. Liraglutide, with diet and exercise, maintained weight loss achieved by caloric restriction and induced further weight loss over 56 weeks. Improvements in some cardiovascular disease-risk factors were also observed. Liraglutide, prescribed as 3.0 mg per day, holds promise for improving the maintenance of lost weight.

The Impact of Accelerometers on Physical Activity and Weight Loss: A Systematic Review

PubMed Central

Goode, Adam P.; Hall, Katherine S.; Batch, Bryan C.; Huffman, Kim M.; Hastings, S. Nicole; Allen, Kelli D.; Shaw, Ryan J.; Kanach, Frances A.; McDuffie, Jennifer R.; Kosinski, Andrzej S.; Williams, John W.; Gierisch, Jennifer M.

2016-01-01

Background Regular physical activity is important for improving and maintaining health, but sedentary behavior is difficult to change. Providing objective, real-time feedback on physical activity with wearable motion-sensing technologies (activity monitors) may be a promising, scalable strategy to increase physical activity or decrease weight. Purpose We synthesized the literature on the use of wearable activity monitors for improving physical activity and weight-related outcomes and evaluated moderating factors that may have an impact on effectiveness. Methods We searched five databases from January 2000 to January 2015 for peer-reviewed, English-language randomized controlled trials among adults. Random-effects models were used to produce standardized mean differences (SMDs) for physical activity outcomes and mean differences (MDs) for weight outcomes. Heterogeneity was measured with I2. Results Fourteen trials (2,972 total participants) met eligibility criteria; accelerometers were used in all trials. Twelve trials examined accelerometer interventions for increasing physical activity. A small significant effect was found for increasing physical activity (SMD 0.26; 95% CI 0.04 to 0.49; I2=64.7%). Intervention duration was the only moderator found to significantly explain high heterogeneity for physical activity. Eleven trials examined effects of accelerometer interventions on weight. Pooled estimates showed a small significant effect for weight loss (MD −1.65 kg; 95% CI −3.03 to −0.28; I2=81%), and no moderators were significant. Conclusions Accelerometers demonstrated small positive effects on physical activity and weight loss. The small sample sizes with moderate to high heterogeneity in the current studies limit the conclusions that may be drawn. Future studies should focus on how best to integrate accelerometers with other strategies to increase physical activity and weight loss. PMID:27565168

Involving Support Partners in Obesity Treatment

ERIC Educational Resources Information Center

Gorin, Amy; Phelan, Suzanne; Tate, Deborah; Sherwood, Nancy; Jeffery, Robert; Wing, Rena

2005-01-01

In this study, the authors examined whether the number or success of weight loss partners influences participants' outcomes in behavioral weight loss treatment. Overweight participants (n=109) assigned to an exercise intensive group in a larger trial were encouraged to invite up to 3 partners to attend treatment. Weight losses at 6, 12, and 18…

The low-carbohydrate diet and cardiovascular risk factors: Evidence from epidemiologic studies

PubMed Central

Hu, T.; Bazzano, L. A.

2015-01-01

Aims Obesity is an important public health issue because of its high prevalence and concomitant increase in risk of cardiovascular diseases. Low carbohydrate diets are popular for weight loss and weight management but are not recommended in leading guidelines due to the perception that increases in dietary fat intake may lead to an adverse cardiovascular risk profile. To clarify the effects of a low-carbohydrate diet for weight loss on cardiovascular disease risk factors as compared to a low fat diet for weight loss, we systematically reviewed data from randomized controlled clinical trials and large observational studies. Data synthesis We searched the MEDLINE database (Jan 1966–Nov 2013) to identify studies that examined a low-carbohydrate diet as compared to a low-fat diet for weight loss or the improvement of cardiovascular disease risk factors. Conclusions Recent randomized controlled trials document that low-carbohydrate diets not only decrease body weight but also improve cardiovascular risk factors. In light of this evidence from randomized controlled trials, dietary guidelines should be re-visited advocating a healthy low carbohydrate dietary pattern as an alternative dietary strategy for the prevention of obesity and cardiovascular disease risk factors. PMID:24613757

The impact of supervised weight loss and intentional weight regain on sex hormone binding globulin and testosterone in premenopausal women.

PubMed

Aubuchon, Mira; Liu, Ying; Petroski, Gregory F; Thomas, Tom R; Polotsky, Alex J

2016-08-01

What is the impact of intentional weight loss and regain on serum androgens in women? We conducted an ancillary analysis of prospectively collected samples from a randomized controlled trial. The trial involved supervised 10% weight loss (8.5 kg on average) with diet and exercise over 4-6 months followed by supervised intentional regain of 50% of the lost weight (4.6 kg on average) over 4-6 months. Participants were randomized prior to the partial weight regain component to either continuation or cessation of endurance exercise. Analytic sample included 30 obese premenopausal women (mean age of 40 ± 5.9 years, mean baseline body mass index (BMI) of 32.9 ± 4.2 kg/m(2)) with metabolic syndrome. We evaluated sex hormone binding globulin (SHBG), total testosterone (T), free androgen index (FAI), and high molecular weight adiponectin (HMWAdp). Insulin, homeostasis model assessment (HOMA), and quantitative insulin sensitivity check index (QUICKI), and visceral adipose tissue (VAT) measured in the original trial were reanalyzed for the current analytic sample. Insulin, HOMA, and QUICKI improved with weight loss and were maintained despite weight regain. Log-transformed SHBG significantly increased from baseline to weight loss, and then significantly decreased with weight regain. LogFAI and logVAT decreased similarly and increased with weight loss followed by weight regain. No changes were found in logT and LogHMWAdp. There was no significant difference in any tested parameters by exercise between the groups. SHBG showed prominent sensitivity to body mass fluctuations, as reduction with controlled intentional weight regain showed an inverse relationship to VAT and occurred despite stable HMWAdp and sustained improvements with insulin resistance. FAI showed opposite changes to SHBG, while T did not change significantly with weight. Continued exercise during weight regain did not appear to impact these findings.

Weight management for overweight and obese men delivered through professional football clubs: a pilot randomized trial

PubMed Central

2013-01-01

Background The prevalence of male obesity is increasing, but men are less likely than women to attend existing weight management programmes. We have taken a novel approach to reducing perceived barriers to weight loss for men by using professional football (soccer) clubs to encourage participation in a weight management group programme, gender-sensitised in content and style of delivery. Football Fans in Training (FFIT) provides 12 weeks of weight loss, physical activity and healthy eating advice at top professional football clubs in Scotland. This pilot randomized trial explored the feasibility of using these clubs as a setting for a randomized controlled trial of 12 month weight loss following men’s participation in FFIT. Methods A two-arm pilot trial at two Scottish Premier League football clubs (one large, one smaller), with 103 men (aged 35–65, body mass index (BMI) ≥27 kg/m2) individually randomized to the intervention (n=51, received the pilot programme (p-FFIT) immediately) and waitlist comparison (n=52, received p-FFIT after four months) groups. Feasibility of recruitment, randomization, data collection and retention were assessed. Objective physical measurements (weight, waist circumference, blood pressure, body composition) and questionnaires (self-reported physical activity, diet, alcohol consumption, psychological outcomes) were obtained from both groups by fieldworkers trained to standard protocols at baseline and 12 weeks, and from the intervention group at 6 and 12 months. Qualitative methods elicited men’s experiences of participation in the pilot trial. Results Following a short recruitment period, the recruitment target was achieved at the large, but not smaller, club. Participants’ mean age was 47.1±8.4 years; mean BMI 34.5±5.0 kg/m2. Retention through the trial was good (>80% at 12 weeks and 6 months; >75% at 12 months), and 76% attended at least 80% of available programme delivery sessions. At 12 weeks, the intervention group lost significantly more weight than the comparison group (4.6% c.f. -0.6%, p<.001) and many maintained this to 12 months (intervention group baseline-12 month weight loss: 3.5%, p<.001). There were also improvements in self-reported physical activity and diet, many sustained long term. Conclusions The results demonstrated the feasibility of trial procedures and the potential of FFIT to engage men in sustained weight loss and positive lifestyle change. They supported the conduct of a fully-powered randomized controlled trial. PMID:24171842

Polymyositis

MedlinePlus

... pneumonia. Difficulty swallowing may cause weight loss and malnutrition. x Prognosis The prognosis for polymyositis varies. Most ... pneumonia. Difficulty swallowing may cause weight loss and malnutrition. View Full Prognosis Clinical Trials Throughout the U.S. ...

Human cardiovascular disease IBC chip-wide association with weight loss and weight regain in the look AHEAD trial.

PubMed

McCaffery, Jeanne M; Papandonatos, George D; Huggins, Gordon S; Peter, Inga; Erar, Bahar; Kahn, Steven E; Knowler, William C; Lipkin, Edward W; Kitabchi, Abbas E; Wagenknecht, Lynne E; Wing, Rena R

2013-01-01

The present study identified genetic predictors of weight change during behavioral weight loss treatment. Participants were 3,899 overweight/obese individuals with type 2 diabetes from Look AHEAD, a randomized controlled trial to determine the effects of intensive lifestyle intervention (ILI), including weight loss and physical activity, relative to diabetes support and education, on cardiovascular outcomes. Analyses focused on associations of single nucleotide polymorphisms (SNPs) on the Illumina CARe iSelect (IBC) chip (minor allele frequency >5%; n = 31,959) with weight change at year 1 and year 4, and weight regain at year 4, among individuals who lost ≥ 3% at year 1. Two novel regions of significant chip-wide association with year-1 weight loss in ILI were identified (p < 2.96E-06). ABCB11 rs484066 was associated with 1.16 kg higher weight per minor allele at year 1, whereas TNFRSF11A, or RANK, rs17069904 was associated with 1.70 kg lower weight per allele at year 1. This study, the largest to date on genetic predictors of weight loss and regain, indicates that SNPs within ABCB11, related to bile salt transfer, and TNFRSF11A, implicated in adipose tissue physiology, predict the magnitude of weight loss during behavioral intervention. These results provide new insights into potential biological mechanisms and may ultimately inform weight loss treatment. © 2013 S. Karger AG, Basel.

The drop it at last study: six-month results of a phone-based weight loss trial.

PubMed

Sherwood, Nancy E; Jeffery, Robert W; Welsh, Ericka M; Vanwormer, Jeff; Hotop, Ann Marie

2010-01-01

To address the translational research question regarding the optimal intervention "dose" to produce the most cost-effective rate of weight loss, we conducted the Drop It At Last (DIAL) study. DIAL is a 6-month pilot randomized trial to examine the efficacy of phone-based weight loss programs with varying levels of treatment contact (10 vs. 20 sessions) in comparison to self-directed treatment. Participants were recruited from the community via mailings and advertisement. Participants were 63 adults with a body mass index between 30 and 39 kg/m(2). Participants received a standard set of print materials and were randomized to either: (1) self-directed treatment; (2) 10 phone coaching sessions; or (3) 20 phone coaching sessions. Measured height, weight, and psychosocial and weight-related self-monitoring measures were collected at baseline and follow-up. General linear models were used to examine 6-month treatment group differences in weight loss and in psychosocial and behavioral measures. Weight losses were -2.3, -3.2, and -4.9 kg in the self-directed, 10-session, and 20-session groups, respectively (p < .21). Participants who completed 10 or more sessions lost more weight (-5.1 kg) compared to those completed four or fewer sessions (-.3 kg, p < .04). Phone-based weight loss program participation is associated with modest weight loss. The optimal dose and timing of intervention warrant further study.

Self-determination theory and weight loss in a Diabetes Prevention Program translation trial.

PubMed

Trief, Paula M; Cibula, Donald; Delahanty, Linda M; Weinstock, Ruth S

2017-06-01

We examined self-determination theory (SDT) and weight loss, and hypothesized that the Diabetes Prevention Program's (DPP) intervention would result in an increase in autonomous regulation of motivation (AR) in participants. Further, that those with higher AR, and those who perceived educators as supporting SDT-defined needs, would lose more weight. Support, Health Information, Nutrition and Exercise (SHINE) Study data (N = 257) were analyzed. SHINE was a randomized, controlled DPP translation trial (2-years, telephonic, primary care staff). Autonomous motivation in males increased significantly, while females showed no change. Males with high AR, but not females, lost more weight. However, the significance of these relationships varied over time. Participants who perceived educators as more supportive of psychological needs lost more weight (especially males). However, effect of support on weight loss was not mediated by AR change. Autonomous motivation and educator support are relevant to male weight loss. Future research might develop interventions to enhance autonomous motivation and educator support, and understand change pathways.

Using data mining to predict success in a weight loss trial.

PubMed

Batterham, M; Tapsell, L; Charlton, K; O'Shea, J; Thorne, R

2017-08-01

Traditional methods for predicting weight loss success use regression approaches, which make the assumption that the relationships between the independent and dependent (or logit of the dependent) variable are linear. The aim of the present study was to investigate the relationship between common demographic and early weight loss variables to predict weight loss success at 12 months without making this assumption. Data mining methods (decision trees, generalised additive models and multivariate adaptive regression splines), in addition to logistic regression, were employed to predict: (i) weight loss success (defined as ≥5%) at the end of a 12-month dietary intervention using demographic variables [body mass index (BMI), sex and age]; percentage weight loss at 1 month; and (iii) the difference between actual and predicted weight loss using an energy balance model. The methods were compared by assessing model parsimony and the area under the curve (AUC). The decision tree provided the most clinically useful model and had a good accuracy (AUC 0.720 95% confidence interval = 0.600-0.840). Percentage weight loss at 1 month (≥0.75%) was the strongest predictor for successful weight loss. Within those individuals losing ≥0.75%, individuals with a BMI (≥27 kg m -2 ) were more likely to be successful than those with a BMI between 25 and 27 kg m -2 . Data mining methods can provide a more accurate way of assessing relationships when conventional assumptions are not met. In the present study, a decision tree provided the most parsimonious model. Given that early weight loss cannot be predicted before randomisation, incorporating this information into a post randomisation trial design may give better weight loss results. © 2017 The British Dietetic Association Ltd.

Living well after breast cancer randomized controlled trial protocol: evaluating a telephone-delivered weight loss intervention versus usual care in women following treatment for breast cancer.

PubMed

Reeves, Marina M; Terranova, Caroline O; Erickson, Jane M; Job, Jennifer R; Brookes, Denise S K; McCarthy, Nicole; Hickman, Ingrid J; Lawler, Sheleigh P; Fjeldsoe, Brianna S; Healy, Genevieve N; Winkler, Elisabeth A H; Janda, Monika; Veerman, J Lennert; Ware, Robert S; Prins, Johannes B; Vos, Theo; Demark-Wahnefried, Wendy; Eakin, Elizabeth G

2016-10-28

Obesity, physical inactivity and poor diet quality have been associated with increased risk of breast cancer-specific and all-cause mortality as well as treatment-related side-effects in breast cancer survivors. Weight loss intervention trials in breast cancer survivors have shown that weight loss is safe and achievable; however, few studies have examined the benefits of such interventions on a broad range of outcomes and few have examined factors important to translation (e.g. feasible delivery method for scaling up, assessment of sustained changes, cost-effectiveness). The Living Well after Breast Cancer randomized controlled trial aims to evaluate a 12-month telephone-delivered weight loss intervention (versus usual care) on weight change and a range of secondary outcomes including cost-effectiveness. Women (18-75 years; body mass index 25-45 kg/m 2 ) diagnosed with stage I-III breast cancer in the previous 2 years are recruited from public and private hospitals and through the state-based cancer registry (target n = 156). Following baseline assessment, participants are randomized 1:1 to either a 12-month telephone-delivered weight loss intervention (targeting diet and physical activity) or usual care. Data are collected at baseline, 6-months (mid-intervention), 12-months (end-of-intervention) and 18-months (maintenance). The primary outcome is change in weight at 12-months. Secondary outcomes are changes in body composition, bone mineral density, cardio-metabolic and cancer-related biomarkers, metabolic health and chronic disease risk, physical function, patient-reported outcomes (quality of life, fatigue, menopausal symptoms, body image, fear of cancer recurrence) and behaviors (dietary intake, physical activity, sitting time). Data collected at 18-months will be used to assess whether outcomes achieved at end-of-intervention are sustained six months after intervention completion. Cost-effectiveness will be assessed, as will mediators and moderators of intervention effects. This trial will provide evidence needed to inform the wide-scale provision of weight loss, physical activity and dietary interventions as part of routine survivorship care for breast cancer survivors. Australian and New Zealand Clinical Trial Registry (ANZCTR) - ACTRN12612000997853 (Registered 18 September 2012).

Randomised controlled feasibility trial of a web-based weight management intervention with nurse support for obese patients in primary care

PubMed Central

2014-01-01

Background There is a need for cost-effective weight management interventions that primary care can deliver to reduce the morbidity caused by obesity. Automated web-based interventions might provide a solution, but evidence suggests that they may be ineffective without additional human support. The main aim of this study was to carry out a feasibility trial of a web-based weight management intervention in primary care, comparing different levels of nurse support, to determine the optimal combination of web-based and personal support to be tested in a full trial. Methods This was an individually randomised four arm parallel non-blinded trial, recruiting obese patients in primary care. Following online registration, patients were randomly allocated by the automated intervention to either usual care, the web-based intervention only, or the web-based intervention with either basic nurse support (3 sessions in 3 months) or regular nurse support (7 sessions in 6 months). The main outcome measure (intended as the primary outcome for the main trial) was weight loss in kg at 12 months. As this was a feasibility trial no statistical analyses were carried out, but we present means, confidence intervals and effect sizes for weight loss in each group, uptake and retention, and completion of intervention components and outcome measures. Results All randomised patients were included in the weight loss analyses (using Last Observation Carried Forward). At 12 months mean weight loss was: usual care group (n = 43) 2.44 kg; web-based only group (n = 45) 2.30 kg; basic nurse support group (n = 44) 4.31 kg; regular nurse support group (n = 47) 2.50 kg. Intervention effect sizes compared with usual care were: d = 0.01 web-based; d = 0.34 basic nurse support; d = 0.02 regular nurse support. Two practices deviated from protocol by providing considerable weight management support to their usual care patients. Conclusions This study demonstrated the feasibility of delivering a web-based weight management intervention supported by practice nurses in primary care, and suggests that the combination of the web-based intervention with basic nurse support could provide an effective solution to weight management support in a primary care context. Trial registration Current Controlled Trials ISRCTN31685626. PMID:24886516

Long-term effects of vitamin D supplementation in vitamin D deficient obese children participating in an integrated weight-loss programme (a double-blind placebo-controlled study) - rationale for the study design.

PubMed

Szlagatys-Sidorkiewicz, Agnieszka; Brzeziński, Michał; Jankowska, Agnieszka; Metelska, Paulina; Słomińska-Frączek, Magdalena; Socha, Piotr

2017-04-04

Obesity is associated not only with an array of metabolic disorders (e.g. insulin resistance, hiperinsulinemia, impaired tolerance of glucose, lipid disorders) but also skeletal and joint abnormalities. Recently, a pleiotropic role of vitamin D has been emphasized. Obese children frequently present with vitamin D deficiency, and greater fat mass is associated with lower serum concentration of this vitamin. Although some evidence suggests that weight loss may affect vitamin D status, this issue has not been studied extensively thus far. The aim of a double-blind placebo-controlled study is to assess long-term health effects of vitamin D supplementation in vitamin D deficient obese children participating in an integrated weight-loss programme. A randomized double-blind, placebo-controlled trial analysing the effects of vitamin D3 supplementation in overweight or obese vitamin D deficient (<30 ng/ml) children participating in an integrated weight-loss programme. Children are randomized to receive either vitamin D (1200 IU) or placebo for 26 weeks. Primary endpoints include changes in BMI (body mass index), body composition and bone mineral density at the end of the study period, and secondary endpoints - the changes in laboratory parameter reflecting liver and kidney function (transaminases, creatinine) and glucose homeostasis (glucose and insulin levels during oral glucose tolerance test). The effects of vitamin D supplementation in obese individuals, especially children, subjected to a weight-loss program are still poorly understood. Considering physiological processes associated with puberty and adolescent growth, we speculate that supplementation may enhance weight reduction and prevent bone loss in obese children deficient in this vitamin. NCT 02828228 ; Trial registration date: 8 Jun 2016; Registered in: ClinicalTrials.gov. The trial was registered retrospectively.

Interventions to reduce weight gain in schizophrenia.

PubMed

Faulkner, G; Cohn, T; Remington, G

2007-01-24

Weight gain is common for people with schizophrenia and this has serious implications for health and well being. To determine the effects of both pharmacological (excluding medication switching) and non pharmacological strategies for reducing or preventing weight gain in people with schizophrenia. We searched key databases and the Cochrane Schizophrenia Group's trials register (April 2006), reference sections within relevant papers, hand searched key journals, and contacted the first author of each relevant study and other experts to collect further information. We included all clinical randomised controlled trials comparing any pharmacological or non pharmacological intervention for weight gain (diet and exercise counselling) with standard care or other treatments for people with schizophrenia or schizophrenia-like illnesses. We reliably selected, quality assessed and extracted data from studies. As weight is a continuous outcome measurement, weighted mean differences (WMD) of the change from baseline were calculated. The primary outcome measure was weight loss. Twenty-three randomised controlled trials met the inclusion criteria for this review. Five trials assessed a cognitive/behavioural intervention and eighteen assessed a pharmacological adjunct. In terms of prevention, two cognitive/behavioural trials showed significant treatment effect (mean weight change) at end of treatment (n=104, 2 RCTs, WMD -3.38 kg CI -4.2 to -2.0). Pharmacological adjunct treatments were significant with a modest prevention of weight gain (n=274, 6 RCTs, WMD - 1.16 kg CI -1.9 to -0.4). In terms of treatments for weight loss, we found significantly greater weight reduction in the cognitive behavioural intervention group (n=129, 3 RCTs, WMD -1.69 kg CI -2.8 to -0.6) compared with standard care. Modest weight loss can be achieved with selective pharmacological and non pharmacological interventions. However, interpretation is limited by the small number of studies, small sample size, short study duration and by variability of the interventions themselves, their intensity and duration. Future studies adequately powered, with longer treatment duration and rigorous methodology will be needed in further evaluating the efficacy and safety of weight loss interventions for moderating weight gain. At this stage, there is insufficient evidence to support the general use of pharmacological interventions for weight management in people with schizophrenia.

A smartphone-supported weight loss program: design of the ENGAGED randomized controlled trial.

PubMed

Pellegrini, Christine A; Duncan, Jennifer M; Moller, Arlen C; Buscemi, Joanna; Sularz, Alyson; DeMott, Andrew; Pictor, Alex; Pagoto, Sherry; Siddique, Juned; Spring, Bonnie

2012-11-30

Obesity remains a major public health challenge, demanding cost-effective and scalable weight management programs. Delivering key treatment components via mobile technology offers a potential way to reduce expensive in-person contact, thereby lowering the cost and burden of intensive weight loss programs. The ENGAGED study is a theory-guided, randomized controlled trial designed to examine the feasibility and efficacy of an abbreviated smartphone-supported weight loss program. Ninety-six obese adults (BMI 30-39.9 kg/m2) will be randomized to one of three treatment conditions: (1) standard behavioral weight loss (STND), (2) technology-supported behavioral weight loss (TECH); or (3) self-guided behavioral weight loss (SELF). All groups will aim to achieve a 7% weight loss goal by reducing calorie and fat intake and progressively increasing moderate intensity physical activity to 175 minutes/week. STND and TECH will attend 8 group sessions and receive regular coaching calls during the first 6 months of the intervention; SELF will receive the Group Lifestyle Balance Program DVD's and will not receive coaching calls. During months 1-6, TECH will use a specially designed smartphone application to monitor dietary intake, body weight, and objectively measured physical activity (obtained from a Blue-tooth enabled accelerometer). STND and SELF will self-monitor on paper diaries. Linear mixed modeling will be used to examine group differences on weight loss at months 3, 6, and 12. Self-monitoring adherence and diet and activity goal attainment will be tested as mediators. ENGAGED is an innovative weight loss intervention that integrates theory with emerging mobile technologies. We hypothesize that TECH, as compared to STND and SELF, will result in greater weight loss by virtue of improved behavioral adherence and goal achievement. NCT01051713.

A review of technology-based interventions to maintain weight loss.

PubMed

Lee, Sohye; Lindquist, Ruth

2015-03-01

For many decades, healthcare providers and researchers have developed weight-loss interventions to help people achieve weight loss. Unfortunately, it is typical for people to lose weight quickly during the intervention period but then slowly regain weight until they return to their approximate baseline. Technology-based maintenance interventions are among the newest approaches to long-term weight loss. Several advantages make technology helpful for maintaining weight loss. The purpose of this article was to review and critique the randomized controlled trials of technology-based weight-loss maintenance interventions (WLMIs) for adults. A systematic search through electronic databases and a manual citation search were conducted. Limited numbers of controlled trials published since 2000 that included randomization, and technology-based WLMIs were identified. The characteristics of the eight studies were diverse. The average score of study design quality was moderate. The results of the effectiveness of technology-based WLMIs were mixed. Technology-based WLMIs are more likely to be effective than usual care but not more effective than personal contact. Based on the review, guidelines were established for the selection and potential success of technology-based WLMIs. The effectiveness of technology-based maintenance interventions for weight loss varied, and potential strategies and approaches are discussed to improve their effectiveness. Further studies are needed to better evaluate and refine the efficacy of technology-based WLMIs.

Assessing the evidence for weight loss strategies in people with and without type 2 diabetes

PubMed Central

Clifton, Peter

2017-01-01

This review will examine topical issues in weight loss and weight maintenance in people with and without diabetes. A high protein, low glycemic index diet would appear to be best for 12-mo weight maintenance in people without type 2 diabetes. This dietary pattern is currently being explored in a large prevention of diabetes intervention. Intermittent energy restriction is useful but no better than daily energy restriction but there needs to be larger and longer term trials performed. There appears to be no evidence that intermittent fasting or intermittent severe energy restriction has a metabolic benefit beyond the weight loss produced and does not spare lean mass compared with daily energy restriction. Meal replacements are useful and can produce weight loss similar to or better than food restriction alone. Very low calorie diets can produce weight loss of 11-16 kg at 12 mo with persistent weight loss of 1-2 kg at 4-6 years with a very wide variation in long term results. Long term medication or meal replacement support can produce more sustained weight loss. In type 2 diabetes very low carbohydrate diets are strongly recommended by some groups but the long term evidence is very limited and no published trial is longer than 12 mo. Although obesity is strongly genetically based the microbiome may play a small role but human evidence is currently very limited. PMID:29085571

Design and Methods of a Synchronous Online Motivational Interviewing Intervention for Weight Management

PubMed Central

DiLillo, Vicki; Ingle, Krista; Harvey, Jean Ruth; West, Delia Smith

2016-01-01

Background While Internet-based weight management programs can facilitate access to and engagement in evidence-based lifestyle weight loss programs, the results have generally not been as effective as in-person programs. Furthermore, motivational interviewing (MI) has shown promise as a technique for enhancing weight loss outcomes within face-to-face programs. Objective This paper describes the design, intervention development, and analysis of a therapist-delivered online MI intervention for weight loss in the context of an online weight loss program. Methods The MI intervention is delivered within the context of a randomized controlled trial examining the efficacy of an 18-month, group-based, online behavioral weight control program plus individually administered, synchronous online MI sessions relative to the group-based program alone. Six individual 30-minute MI sessions are conducted in private chat rooms over 18 months by doctoral-level psychologists. Sessions use a semistructured interview format for content and session flow and incorporate core MI components (eg, collaborative agenda setting, open-ended questions, reflective listening and summary statements, objective data, and a focus on evoking and amplifying change talk). Results The project was funded in 2010 and enrollment was completed in 2012. Data analysis is currently under way and the first results are expected in 2016. Conclusions This is the first trial to test the efficacy of a synchronous online, one-on-one MI intervention designed to augment an online group behavioral weight loss program. If the addition of MI sessions proves to be successful, this intervention could be disseminated to enhance other distance-based weight loss interventions. Trial Registration Clinicaltrials.gov NCT01232699; https://clinicaltrials.gov/ct2/show/NCT01232699 PMID:27095604

A double-blind, placebo-controlled trial of sibutramine for clozapine-associated weight gain.

PubMed

Henderson, D C; Fan, X; Copeland, P M; Borba, C P; Daley, T B; Nguyen, D D; Zhang, H; Hayden, D; Freudenreich, O; Cather, C; Evins, A E; Goff, D C

2007-02-01

This study sought to examine the effectiveness of sibutramine, a weight loss agent, on clozapine-associated weight gain. This was a 12-week double-blind, placebo controlled, randomized trial of sibutramine for weight loss in obese clozapine-treated schizophrenia or schizoaffective disorder subjects. Ten patients were enrolled into the placebo group and 11 patients into the sibutramine group. There were no significant baseline differences between the two groups on age, gender, education, ethnicity, diagnosis, weight, body mass index (BMI), and blood pressure. At week 12, there were no significant differences in changes in weight, BMI, abdominal and waist circumferences, Hba1c, fasting glucose, or cholesterol levels. Sibutramine treatment did not show significant weight loss compared with placebo in clozapine-treated patients with schizophrenia or schizoaffective disorder. Further research with a larger sample size and longer follow-up duration is warranted.

Role of Bupropion Plus Naltrexone for the Management of Obesity

PubMed Central

Booth, Kemper; Clements, Jennifer N.

2016-01-01

Objective. The pharmacology, pharmacokinetics, efficacy, and safety of bupropion plus naltrexone for weight loss were reviewed. Data Sources. A MEDLINE search (1970 to November 2015) was conducted for English-language articles using specific MESH terms. Study Selection and Data Extraction. Published Phase 3 clinical trials with primary endpoints related to weight loss were included and critiqued in this review. Study Selection and Data Extraction. Five trials were retrieved and reviewed regarding the efficacy and safety of bupropion plus naltrexone among obese and overweight patients. Data Synthesis. Bupropion is a dopamine/norepinephrine reuptake inhibitor, and naltrexone is an opioid receptor antagonist. The combination of these agents has led to increased weight loss, compared to placebo, among overweight and obese patients with a body mass index (BMI) at or above 30 or BMI at or above 27 with a comorbid condition. The combination of bupropion and naltrexone can produce an average placebo-subtracted weight loss of 4.25% over 56 weeks. Gastrointestinal (ie, nausea, vomiting, constipation) and central nervous system adverse events (ie, headache, dizziness) were commonly reported, and there was a high dropout rate among participants. Conclusions. Bupropion plus naltrexone has demonstrated effective weight loss, in conjunction with lifestyle modifications, among overweight and obese patients with and without comorbidities. Bupropion plus naltrexone has not been studied among special patient populations, such as those with sleep apnea, osteoarthritis, or extreme BMIs. Additional clinical trials and postmarketing data will provide a better understanding of this medication for weight loss.

Multi-component access to a commercially available weight loss program: A randomized controlled trial

USDA-ARS?s Scientific Manuscript database

This study examined weight loss between a community-based, intensive behavioral counseling program (Weight Watchers PointsPlus that included three treatment access modes and a self-help condition. A total of 292 participants were randomized to a Weight Watchers (WW; n=147) or a self-help condition (...

Weight loss intervention for young adults using mobile technology: design and rationale of a randomized controlled trial – Cell phone Intervention for You (CITY)

PubMed Central

Batch, Bryan C.; Tyson, Crystal; Bagwell, Jacqueline; Corsino, Leonor; Intille, Stephen; Lin, Pao-Hwa; Lazenka, Tony; Bennett, Gary; Bosworth, Hayden B.; Voils, Corrine; Grambow, Steven; Sutton, Aziza; Bordogna, Rachel; Pangborn, Matthew; Schwager, Jenifer; Pilewski, Kate; Caccia, Carla; Burroughs, Jasmine; Svetkey, Laura P.

2014-01-01

Background The obesity epidemic has spread to young adults, leading to significant public health implications later in adulthood. Intervention in early adulthood may be an effective public health strategy for reducing the long-term health impact of the epidemic. Few weight loss trials have been conducted in young adults. It is unclear what weight loss strategies are beneficial in this population. Purpose To describe the design and rationale of the NHLBI-sponsored Cell Phone Intervention for You (CITY) study, which is a single center, randomized three-arm trial that compares the impact on weight loss of 1) a behavioral intervention that is delivered almost entirely via cell phone technology (Cell Phone group); and 2) a behavioral intervention delivered mainly through monthly personal coaching calls enhanced by self-monitoring via cell phone (Personal Coaching group), each compared to; 3) a usual care, advice-only control condition. Methods A total of 365 community-dwelling overweight/obese adults aged 18–35 years were randomized to receive one of these three interventions for 24 months in parallel group design. Study personnel assessing outcomes were blinded to group assignment. The primary outcome is weight change at 12 months. We hypothesize that each active intervention will cause more weight loss than the usual care condition. Study completion is anticipated in 2014. Conclusions If effective, implementation of the CITY interventions could mitigate the alarming rates of obesity in young adults through promotion of weight loss. PMID:24462568

The EMPOWER study: randomized, prospective, double-blind, multicenter trial of vagal blockade to induce weight loss in morbid obesity.

PubMed

Sarr, Michael G; Billington, Charles J; Brancatisano, Roy; Brancatisano, Anthony; Toouli, James; Kow, Lilian; Nguyen, Ninh T; Blackstone, Robin; Maher, James W; Shikora, Scott; Reeds, Dominic N; Eagon, J Christopher; Wolfe, Bruce M; O'Rourke, Robert W; Fujioka, Ken; Takata, Mark; Swain, James M; Morton, John M; Ikramuddin, Sayeed; Schweitzer, Michael; Chand, Bipan; Rosenthal, Raul

2012-11-01

Intermittent, reversible intraabdominal vagal blockade (VBLOC® Therapy) demonstrated clinically important weight loss in feasibility trials. EMPOWER, a randomized, double-blind, prospective, controlled trial was conducted in USA and Australia. Five hundred three subjects were enrolled at 15 centers. After informed consent, 294 subjects were implanted with the vagal blocking system and randomized to the treated (n = 192) or control (n = 102) group. Main outcome measures were percent excess weight loss (percent EWL) at 12 months and serious adverse events. Subjects controlled duration of therapy using an external power source; therapy involved a programmed algorithm of electrical energy delivered to the subdiaphragmatic vagal nerves to inhibit afferent/efferent vagal transmission. Devices in both groups performed regular, low-energy safety checks. Data are mean ± SEM. Study subjects consisted of 90 % females, body mass index of 41 ± 1 kg/m(2), and age of 46 ± 1 years. Device-related complications occurred in 3 % of subjects. There was no mortality. 12-month percent EWL was 17 ± 2 % for the treated and 16 ± 2 % for the control group. Weight loss was related linearly to hours of device use; treated and controls with ≥ 12 h/day use achieved 30 ± 4 and 22 ± 8 % EWL, respectively. VBLOC® therapy to treat morbid obesity was safe, but weight loss was not greater in treated compared to controls; clinically important weight loss, however, was related to hours of device use. Post-study analysis suggested that the system electrical safety checks (low charge delivered via the system for electrical impedance, safety, and diagnostic checks) may have contributed to weight loss in the control group.

A gender-sensitised weight loss and healthy living programme for overweight and obese men delivered by Scottish Premier League football clubs (FFIT): a pragmatic randomised controlled trial.

PubMed

Hunt, Kate; Wyke, Sally; Gray, Cindy M; Anderson, Annie S; Brady, Adrian; Bunn, Christopher; Donnan, Peter T; Fenwick, Elisabeth; Grieve, Eleanor; Leishman, Jim; Miller, Euan; Mutrie, Nanette; Rauchhaus, Petra; White, Alan; Treweek, Shaun

2014-04-05

The prevalence of male obesity is increasing but few men take part in weight loss programmes. We assessed the effect of a weight loss and healthy living programme on weight loss in football (soccer) fans. We did a two-group, pragmatic, randomised controlled trial of 747 male football fans aged 35-65 years with a body-mass index (BMI) of 28 kg/m(2) or higher from 13 Scottish professional football clubs. Participants were randomly assigned with SAS (version 9·2, block size 2-9) in a 1:1 ratio, stratified by club, to a weight loss programme delivered by community coaching staff in 12 sessions held every week. The intervention group started a weight loss programme within 3 weeks, and the comparison group were put on a 12 month waiting list. All participants received a weight management booklet. Primary outcome was mean difference in weight loss between groups at 12 months, expressed as absolute weight and a percentage of their baseline weight. Primary outcome assessment was masked. Analyses were based on intention to treat. The trial is registered with Current Controlled Trials, number ISRCTN32677491. 374 men were allocated to the intervention group and 374 to the comparison group. 333 (89%) of the intervention group and 355 (95%) of the comparison group completed 12 month assessments. At 12 months the mean difference in weight loss between groups, adjusted for baseline weight and club, was 4·94 kg (95% CI 3·95-5·94) and percentage weight loss, similarly adjusted, was 4·36% (3·64-5·08), both in favour of the intervention (p<0·0001). Eight serious adverse events were reported, five in the intervention group (lost consciousness due to drugs for pre-existing angina, gallbladder removal, hospital admission with suspected heart attack, ruptured gut, and ruptured Achilles tendon) and three in the comparison group (transient ischaemic attack, and two deaths). Of these, two adverse events were reported as related to participation in the programme (gallbladder removal and ruptured Achilles tendon). The FFIT programme can help a large proportion of men to lose a clinically important amount of weight; it offers one effective strategy to challenge male obesity. Scottish Government and The UK Football Pools funded delivery of the programme through a grant to the Scottish Premier League Trust. The National Institute for Health Research Public Health Research Programme funded the assessment (09/3010/06). Copyright © 2014 Hunt et al. Open Access article distributed under the terms of CC BY-NC-ND. Published by Elsevier Ltd. All rights reserved.

Dietary Management of Obesity: Cornerstones of Healthy Eating Patterns.

PubMed

Smethers, Alissa D; Rolls, Barbara J

2018-01-01

Several dietary patterns, both macronutrient and food based, can lead to weight loss. A key strategy for weight management that can be applied across dietary patterns is to reduce energy density. Clinical trials show that reducing energy density is effective for weight loss and weight loss maintenance. A variety of practical strategies and tools can help facilitate successful weight management by reducing energy density, providing portion control, and improving diet quality. The flexibility of energy density gives patients options to tailor and personalize their dietary pattern to reduce energy intake for sustainable weight loss. Copyright © 2017 Elsevier Inc. All rights reserved.

The Effect of Cost Sharing on an Employee Weight Loss Program: A Randomized Trial.

PubMed

John, Leslie K; Troxel, Andrea B; Yancy, William S; Friedman, Joelle; Zhu, Jingsan; Yang, Lin; Galvin, Robert; Miller-Kovach, Karen; Halpern, Scott D; Loewenstein, George; Volpp, Kevin

2018-01-01

To test the effects of employer subsidies on employee enrollment, attendance, and weight loss in a nationally available weight management program. A randomized trial tested the impact of employer subsidy: 100%; 80%, 50%, and a hybrid 50% subsidy that could become a 100% subsidy by attaining attendance targets. NCT01756066. Twenty three thousand twenty-three employees of 2 US companies. The primary outcome was the percentage of employees who enrolled in the weight management program. We also tested whether the subsidies were associated with differential attendance and weight loss over 12 months, as might be predicted by the expectation that they attract employees with differing degrees of motivation. Analysis and Results: Enrollment differed significantly by subsidy level ( P < .0001). The 100% subsidy produced the highest enrollment (7.7%), significantly higher than each of the lower subsidies (vs 80% subsidy: 6.2%, P = .002; vs 50% subsidy: 3.9%, P < .0001; vs hybrid: 3.7%, P < .0001). Enrollment in the 80% subsidy group was significantly higher than both lower subsidy groups (vs 50% subsidy: 3.9%, P < .0001; vs hybrid: 3.7%, P < .0001). Among enrollees, there were no differences among the 4 groups in attendance or weight loss. This pragmatic trial, conducted in a real-world workplace setting, suggests that higher rates of employer subsidization help individuals to enroll in weight loss programs, without a decrement in program effectiveness. Future research could explore the cost-effectiveness of such subsidies or alternative designs.

Investigations of botanicals on food intake, satiety, weight loss, and oxidative stress: a study protocol of a double-blind, placebo-controlled, crossover study

PubMed Central

Anton, Stephen D.; Shuster, Jonathan; Leeuwenburgh, Christiaan

2013-01-01

Background Botanicals represent an important and underexplored source of potential new therapies that may facilitate caloric restriction and thereby produce long-term weight loss. In particular, one promising botanical that may reduce food intake and body weight by affecting neuroendocrine pathways related to satiety is Garcinia cambogia (Garcinia cambogia Desr.)-derived (−)-hydroxycitric acid (HCA). Methods and Design The objective of this article is to describe the protocol of a clinical trial designed to directly test the effect that Garcinia cambogia-derived HCA has on food intake, satiety, weight loss, and oxidative stress levels, and to serve as a model for similar trials. A total of 48 healthy, overweight and obese individuals (body mass index; BMI range = 25.0 – 39.9) between the ages of 50 to 70 will participate in this double-blind, placebo-controlled, crossover study designed to examine the effects of two doses of Garcinia cambogia-derived HCA on food intake, satiety, weight loss, and oxidative stress levels. This trial will take place at the University of Florida (UF)’s Aging and Rehabilitation Research Center (ARRC) and UF Clinical Research Center (CRC). Food intake represents the primary outcome measure and is calculated based on the total calories consumed at breakfast, lunch, and dinner meals during each test meal day at the CRC. This study can be completed with far fewer subjects than a parallel design. Discussion Of the numerous botanical compounds, the compound Garcinia cambogia-derived HCA was selected for testing in the present study because of its potential to safely reduce food intake, body weight, and oxidative stress levels. We will review potential mechanisms of action and safety parameters throughout this clinical trial, which is registered at ClinicalTrials.gov under NCT01238887. Trial registration ClinicalTrials.gov (Identifier: NCT01238887). PMID:22088584

Genetic variation of fasting glucose and changes in glycemia in response to 2-year weight-loss diet intervention: the POUNDS Lost trial

PubMed Central

Wang, Tiange; Huang, Tao; Zheng, Yan; Rood, Jennifer; Bray, George A.; Sacks, Frank M.; Qi, Lu

2016-01-01

Objective Weight loss intervention through diet modification has been widely used to improve obesity-related hyperglycemia; however, little is known about whether genetic variation modifies the intervention effect. We examined the interaction between weight-loss diets and genetic variation of fasting glucose on changes in glycemic traits in a dietary intervention trial. Research Design and Methods The Preventing Overweight Using Novel Dietary Strategies (POUNDS LOST) trial is a randomized, controlled 2-year weight-loss trial. We assessed overall genetic variation of fasting glucose by calculating a genetic risk score (GRS) based on 14 fasting glucose-associated single nucleotide polymorphisms, and examined the progression in fasting glucose and insulin levels, and insulin resistance and insulin sensitivity in 733 adults from this trial. Results The GRS was associated with 6-month changes in fasting glucose (P<0.001), fasting insulin (P=0.042), homeostasis model assessment of insulin resistance (HOMA-IR, P=0.009) and insulin sensitivity (HOMA-S, P=0.043). We observed significant interaction between the GRS and dietary fat on 6-month changes in fasting glucose, HOMA-IR and HOMA-S after multivariable adjustment (P-interaction=0.007, 0.045, and 0.028, respectively). After further adjustment for weight loss, the interaction remained significant on change in fasting glucose (P=0.015). In the high-fat diet group, participants in the highest GRS tertile showed increased fasting glucose, whereas participants in the lowest tertile showed decreased fasting glucose (P-trend<0.001); in contrast, the genetic association was not significant in the low-fat diet group (P-trend=0.087). Conclusions Our data suggest that participants with a higher genetic risk may benefit more by eating a low-fat diet to improve glucose metabolism. PMID:27113490

Genetic variation of fasting glucose and changes in glycemia in response to 2-year weight-loss diet intervention: the POUNDS LOST trial.

PubMed

Wang, T; Huang, T; Zheng, Y; Rood, J; Bray, G A; Sacks, F M; Qi, L

2016-07-01

Weight-loss intervention through diet modification has been widely used to improve obesity-related hyperglycemia; however, little is known about whether genetic variation modifies the intervention effect. We examined the interaction between weight-loss diets and genetic variation of fasting glucose on changes in glycemic traits in a dietary intervention trial. The Preventing Overweight Using Novel Dietary Strategies (POUNDS LOST) trial is a randomized, controlled 2-year weight-loss trial. We assessed overall genetic variation of fasting glucose by calculating a genetic risk score (GRS) based on 14 fasting glucose-associated single nucleotide polymorphisms, and examined the progression in fasting glucose and insulin levels, and insulin resistance and insulin sensitivity in 733 adults from this trial. The GRS was associated with 6-month changes in fasting glucose (P<0.001), fasting insulin (P=0.042), homeostasis model assessment of insulin resistance (HOMA-IR, P=0.009) and insulin sensitivity (HOMA-S, P=0.043). We observed significant interaction between the GRS and dietary fat on 6-month changes in fasting glucose, HOMA-IR and HOMA-S after multivariable adjustment (P-interaction=0.007, 0.045 and 0.028, respectively). After further adjustment for weight loss, the interaction remained significant on change in fasting glucose (P=0.015). In the high-fat diet group, participants in the highest GRS tertile showed increased fasting glucose, whereas participants in the lowest tertile showed decreased fasting glucose (P-trend <0.001); in contrast, the genetic association was not significant in the low-fat diet group (P-trend=0.087). Our data suggest that participants with a higher genetic risk may benefit more by eating a low-fat diet to improve glucose metabolism.

A randomized controlled trial of a commercially available weight loss program

USDA-ARS?s Scientific Manuscript database

The U.S. Preventive Services Task Force (USPSTF) recommends that clinicians refer obese adults for intensive, multi-component behavioral counseling, yet most obese Americans choose a self-help approach to lose weight. The current study examined weight loss between a community-based, intensive behavi...

A Clinical Trial on Weight Loss among Truck Drivers.

PubMed

Thiese, M S; Effiong, A C; Ott, U; Passey, D G; Arnold, Z C; Ronna, B B; Muthe, P A; Wood, E M; Murtaugh, M A

2015-04-01

The high prevalence of obesity among commercial truck drivers may be related to sedentary nature of the job, lack of healthy eating choices, and lack of exercise. There may be a link between obesity and crash risk, therefore an intervention to reduce obesity in this population is needed. To assess feasibility of a 12-week weight loss intervention for truck drivers with a weight loss goal of 10% of initial body weight. Drivers were selected based on age (≥21 years) and body mass index (≥30 kg/m^2). The drivers participated in a before-after clinical trial. The intervention included a 12-week program that provided information on healthy diet and increasing exercise, and telephone-based coaching using SMART goals. Outcomes included change from baseline in reported energy intake, measured weight, waist, hip, and neck circumference, blood pressure, and point of care capillary blood lipids and hemoglobin A1c. Exit interviews were conducted to gain insight into driver opinions on the program features and usefulness. This study was registered with the NIH Clinical Trials Registry, number NCT02348983. 12 of 13 drivers completed the study. Weight loss was statistically significant (p=0.03). Reported energy (p=0.005), total fat consumption (p=0.04), and saturated fat consumption (p=0.02) intake were also lower after the 12-week intervention. Drivers attributed their weight loss to health coaching and suggested a longer intervention so that they could reach their goal and become accustomed to the changes. This weight loss intervention is feasible for this difficult population. Additional research is needed to compare this intervention with a control group.

TFAP2B Influences the Effect of Dietary Fat on Weight Loss under Energy Restriction

PubMed Central

Banasik, Karina; Harder, Marie N.; Taylor, Moira A.; Hager, Jörg; Arner, Peter; Oppert, Jean-Michel; Martinez, J. Alfredo; Polak, Jan; Rousseau, Francis; Langin, Dominique; Rössner, Stephan; Holst, Claus; MacDonald, Ian A.; Kamatani, Yoichiro; Pfeiffer, Andreas F. H.; Kunesova, Marie; Saris, Wim H. M.; Hansen, Torben; Pedersen, Oluf; Astrup, Arne; Sørensen, Thorkild I. A.

2012-01-01

Background Numerous gene loci are related to single measures of body weight and shape. We investigated if 55 SNPs previously associated with BMI or waist measures, modify the effects of fat intake on weight loss and waist reduction under energy restriction. Methods and Findings Randomized controlled trial of 771 obese adults. (Registration: ISRCTN25867281.) One SNP was selected for replication in another weight loss intervention study of 934 obese adults. The original trial was a 10-week 600 kcal/d energy-deficient diet with energy percentage from fat (fat%) in range of 20–25 or 40–45. The replication study used an 8-weeks diet of 880 kcal/d and 20 fat%; change in fat% intake was used for estimation of interaction effects. The main outcomes were intervention weight loss and waist reduction. In the trial, mean change in fat% intake was −12/+4 in the low/high-fat groups. In the replication study, it was −23/−12 among those reducing fat% more/less than the median. TFAP2B-rs987237 genotype AA was associated with 1.0 kg (95% CI, 0.4; 1.6) greater weight loss on the low-fat, and GG genotype with 2.6 kg (1.1; 4.1) greater weight loss on the high-fat (interaction p-value; p = 0.00007). The replication study showed a similar (non-significant) interaction pattern. Waist reduction results generally were similar. Study-strengths include (i) the discovery study randomised trial design combined with the replication opportunity (ii) the strict dietary intake control in both studies (iii) the large sample sizes of both studies. Limitations are (i) the low minor allele frequency of the TFAP2B polymorphism, making it hard to investigate non-additive genetic effects (ii) the different interventions preventing identical replication-discovery study designs (iii) some missing data for non-completers and dietary intake. No adverse effects/outcomes or side-effects were observed. Conclusions Under energy restriction, TFAP2B may modify the effect of dietary fat intake on weight loss and waist reduction. PMID:22952648

Intervening on spontaneous physical activity to prevent weight regain in older adults: design of a randomized, clinical trial.

PubMed

Nicklas, Barbara J; Gaukstern, Jill E; Legault, Claudine; Leng, Iris; Rejeski, W Jack

2012-03-01

There is a need to identify evidenced-based obesity treatments that are effective in maintaining lost weight. Weight loss results in reductions in energy expenditure, including spontaneous physical activity (SPA) which is defined as energy expenditure resulting primarily from unstructured mobility-related activities that occur during daily life. To date, there is little research, especially randomized, controlled trials, testing strategies that can be adopted and sustained to prevent declines in SPA that occur with weight loss. Self-monitoring is a successful behavioral strategy to facilitate behavior change, so a provocative question is whether monitoring SPA-related energy expenditure would override these reductions in SPA, and slow weight regain. This study is a randomized trial in older, obese men and women designed to test the hypothesis that adding a self-regulatory intervention (SRI), focused around self-monitoring of SPA, to a weight loss intervention will result in less weight and fat mass regain following weight loss than a comparable intervention that lacks this self-regulatory behavioral strategy. Participants (n=72) are randomized to a 5-month weight loss intervention with or without the addition of a behavioral component that includes an innovative approach to promoting increased SPA. Both groups then transition to self-selected diet and exercise behavior for a 5-month follow-up. Throughout the 10-month period, the SRI group is provided with an intervention designed to promote a SPA level that is equal to or greater than each individual's baseline SPA level, allowing us to isolate the effects of the SPA self-regulatory intervention component on weight and fat mass regain. Copyright © 2011 Elsevier Inc. All rights reserved.

The Effects of Metformin and Weight Loss on Biomarkers Associated With Breast Cancer Outcomes.

PubMed

Patterson, Ruth E; Marinac, Catherine R; Sears, Dorothy D; Kerr, Jacqueline; Hartman, Sheri J; Cadmus-Bertram, Lisa; Villaseñor, Adriana; Flatt, Shirley W; Godbole, Suneeta; Li, Hongying; Laughlin, Gail A; Oratowski-Coleman, Jesica; Parker, Barbara A; Natarajan, Loki

2018-05-18

This study investigated the effects of metformin and weight loss on biomarkers associated with breast cancer prognosis. Overweight/obese postmenopausal breast cancer survivors (n = 333) were randomly assigned to metformin vs placebo and to a weight loss intervention vs control (ie, usual care). The 2 × 2 factorial design allows a single randomized trial to investigate the effect of two factors and interactions between them. Outcomes were changes in fasting insulin, glucose, C-reactive protein (CRP), estradiol, testosterone, and sex-hormone binding globulin (SHBG). The trial was powered for a main effects analysis of metformin vs placebo and weight loss vs control. All tests of statistical significance were two-sided. A total of 313 women (94.0%) completed the six-month trial. High prescription adherence (ie, ≥80% of pills taken) ranged from 65.9% of participants in the metformin group to 81.3% of those in the placebo group (P < .002). Mean percent weight loss was statistically significantly higher in the weight loss group (-5.5%, 95% confidence interval [CI] = -6.3% to -4.8%) compared with the control group (-2.7%, 95% CI = -3.5% to -1.9%). Statistically significant group differences (ie, percent change in metformin group minus placebo group) were -7.9% (95% CI = -15.0% to -0.8%) for insulin, -10.0% (95% CI = -18.5% to -1.5%) for estradiol, -9.5% (95% CI = -15.2% to -3.8%) for testosterone, and 7.5% (95% CI = 2.4% to 12.6%) for SHBG. Statistically significant group differences (ie, percent change in weight loss group minus placebo group) were -12.5% (95% CI = -19.6% to -5.3%) for insulin and 5.3% (95% CI = 0.2% to 10.4%) for SHBG. As adjuvant therapy, weight loss and metformin were found to be a safe combination strategy that modestly lowered estrogen levels and advantageously affected other biomarkers thought to be on the pathway for reducing breast cancer recurrence and mortality.

Weight maintenance: challenges, tools and strategies for primary care physicians[Link

PubMed Central

Soleymani, T.; Daniel, S.

2015-01-01

Summary Obesity is recognized as a chronic disease and one of the major healthcare challenges facing us today. Weight loss can be achieved via lifestyle, pharmacological and surgical interventions, but weight maintenance remains a lifetime challenge for individuals with obesity. Guidelines for the management of obesity have highlighted the role of primary care providers (PCPs). This review examines the long‐term outcomes of clinical trials to identify effective weight maintenance strategies that can be utilized by PCPs. Because of the broad nature of the topic, a structured PubMed search was conducted to identify relevant research articles, peer‐reviewed reviews, guidelines and articles published by regulatory bodies. Trials have demonstrated the benefit of sustained weight loss in managing obesity and its comorbidities. Maintaining 5–10% weight loss for ≥1 year is known to ameliorate many comorbidities. Weight maintenance with lifestyle modification – although challenging – is possible but requires long‐term support to reinforce diet, physical activity and behavioural changes. The addition of pharmacotherapy to lifestyle interventions promotes greater and more sustained weight loss. Clinical evidence and recently approved pharmacotherapy has given PCPs improved strategies to support their patients with maintenance of weight loss. Further studies are needed to assess the translation of these strategies into clinical practice. PMID:26490059

A weight loss intervention using a commercial mobile application in Latino Americans-Adelgaza Trial.

PubMed

Fukuoka, Yoshimi; Vittinghoff, Eric; Hooper, Julie

2018-02-21

More than half of Latino adults living in the USA are expected to develop type 2 diabetes in their lifetime. Despite the growing interest in smartphone use for weight loss and diabetes prevention, relatively few clinical trials have evaluated the efficacy of mobile app-based interventions in Latino populations. The aim of this study was to evaluate the potential efficacy of an in-person weight loss intervention in conjunction with a commercially available Fitbit app in a Latino sample at risk for type 2 diabetes and explore significant predictors associated with weight loss. After the run-in period, 54 self-identified Latinos with body mass index (BMI) > 24.9 kg/m2 were enrolled in an 8-week uncontrolled pilot study, and received a Fitbit Zip, its app, and two in-person weight loss sessions adapted from the Diabetes Prevention Program. Mean age was 45.3 (SD ± 10.8) years, 61.1% were born in the USA, and mean BMI was 31.4 (SD ± 4.1) kg/m2. Participants lost an average of 3.3 (SD ± 3.4) % of their body weight (p < .0005). We also observed statistically significant reductions in hip and waist circumferences, and systolic and diastolic blood pressure (p < .001). After controlling for demographic factors, use of the mobile app weight diary at least twice a week (p = .01) and change in the International Physical Activity Questionnaire score (p = .03) were associated with change in percent body weight. The intervention showed the potential efficacy of this intervention, which should be formally evaluated in a randomized controlled trial.

Efficacy and safety of CP-945,598, a selective cannabinoid CB1 receptor antagonist, on weight loss and maintenance.

PubMed

Aronne, Louis J; Finer, Nick; Hollander, Priscilla A; England, Richard D; Klioze, Solomon S; Chew, Robert D; Fountaine, Robert J; Powell, Coralie M; Obourn, John D

2011-07-01

Three double-blind, placebo-controlled, three-parallel-group, multicenter phase 3 trials were conducted to assess the efficacy and safety of CP-945,598 for weight loss and weight-loss maintenance. Two trials were designed to be 2 years in duration (in obese and overweight patients) and one as a 1-year study (in obese and overweight patients with type 2 diabetes). However, the 2-year trials and the CP-945,598 development program were terminated before completion due to changing regulatory perspectives of CB1 receptor-related drugs. In total, 1,253 and 2,536 participants in the two 2-year multinational and North American studies were randomized to 10-mg CP-945,598 (n = 360; 718); 20-mg CP-945,598 (n = 534, 1,084) and placebo (n = 359, 734), respectively; and 975 participants were randomized to 10-mg CP-945,598 (n = 318); 20-mg CP-945,598 (n = 320); and placebo (n = 337) in the 1-year multinational diabetes trial. Baseline demographics were similar between treatment groups within each trial. One year of treatment with CP-945,598 resulted in a dose-related mean percentage reduction from baseline body-weight in all trials. A significant proportion of all participants also achieved 5% and 10% weight loss after 1 year. In participants with mainly well-controlled type 2 diabetes, the combination of lifestyle and CP-945,598 induced substantial improvements in glycemic control. The most frequent adverse events (AEs) for CP-945,598 were: diarrhea, nausea, nasopharyngitis, and headache. Self-reported experiences of anxiety and suicidal thoughts were higher with CP-945,598 than placebo, as were the incidence of depression and depressed mood. However, the reported increases in psychiatric symptoms were not consistently dose dependent.

Four-year analysis of cardiovascular disease risk factors, depression symptoms, and antidepressant medicine use in the Look AHEAD (Action for Health in Diabetes) clinical trial of weight loss in diabetes

USDA-ARS?s Scientific Manuscript database

OBJECTIVE To study the association of depressive symptoms or antidepressant medicine (ADM) use with subsequent cardiovascular disease (CVD) risk factor status in the Look AHEAD (Action for Health in Diabetes) trial of weight loss in type 2 diabetes. RESEARCH DESIGN AND METHODS Participants (n = 5,1...

Randomized controlled trial of a comprehensive home environment-focused weight loss program for adults

PubMed Central

Gorin, Amy A.; Raynor, Hollie A.; Fava, Joseph; Maguire, Kimberly; Robichaud, Erica; Trautvetter, Jennifer; Crane, Melissa; Wing, Rena R.

2012-01-01

Objective Behavioral weight loss programs (BWL) provide limited instruction on how to change the environmental context of weight-regulating behaviors, perhaps contributing to regain. Drawing on social ecological models, this trial evaluated a comprehensive weight loss program that targeted both an individual’s behavior and their physical and social home environment. Methods Overweight and obese adults (N=201; 48.9±10.5 years; 78.1% women) were randomized to BWL or to BWL plus home environment changes (BWL+H). Groups met weekly for 6 months and bi-monthly for 12 months. BWL+H participants were given items to facilitate healthy choices in their homes (e.g., exercise equipment, portion plates) and attended treatment with a household partner. Weight loss at 6 and 18 months was the primary outcome. Results BWL+H changed many aspects of the home environment and produced better 6 month weight losses than BWL (p=.017). At 18 months, no weight loss differences were observed (p=.19) and rates of regain were equivalent (p=.30). Treatment response was moderated by gender (6 month p=.01; 18 month p=.006). Women lost more weight in BWL+H than BWL at 6 and 18 months, whereas men in BWL lost more weight than those in BWL+H at 18 months. Partners, regardless of gender, lost more weight in BWL+H than BWL at both time points (ps<.0001). Conclusion The home food and exercise environment is malleable and targeting this microenvironment appears to improve initial weight loss, and in women, 18-month outcomes. Research is needed to understand this gender difference and to develop home-focused strategies with more powerful and sustained weight loss effects. PMID:22309885

A 6-month telephone-based weight loss intervention in overweight and obese subjects with idiopathic intracranial hypertension.

PubMed

Weil, Richard; Kovacs, Betty; Miller, Neil; McDermott, Michael P; Wall, Michael; Kupersmith, Mark; Pi-Sunyer, F Xavier

2016-06-01

The purpose of this paper is to measure the change in body weight after a 6-month telephone-based weight loss intervention in overweight and obese subjects with idiopathic intracranial hypertension (IIH) and mild visual loss randomized to receive either acetazolamide or placebo. One hundred sixty-five subjects with IIH, aged 29.1 ± 7.5 (mean ± SD) and BMI 39.9 + 8.3 kg/m 2 , enrolled at 38 academic and private practice sites in North America, participated in this trial. This was a randomized, double-masked, placebo-controlled trial of acetazolamide in subjects with IIH and mild visual loss. All participants received a reduced-sodium, weight-reduction diet and a 6-month telephone-based weight loss intervention. Six-month changes from baseline in body weight, perimetric mean deviation as assessed by automated perimetry and quality of life using the National Eye Institute Visual Function Questionnaire 25 and the 36-item Short Form Health Survey were measured. Mean percent weight change at 6 months was -5.9% ± 6.7% of initial body weight overall, -3.5% ± 5.9% in the placebo group and -7.8% ± 6.8% in the acetazolamide group. Weight change was not associated with changes in either mean deviation or quality of life scores. Patients with IIH and mild visual loss assigned to either acetazolamide or placebo, all of whom received a 6-month telephone-based weight loss intervention, lost an average of 5.9% of initial body weight, consistent with NHLBI guidelines of 5% to 10% of body weight loss for clinically significant health benefit.

The effectiveness of breakfast recommendations on weight loss: a randomized controlled trial123

PubMed Central

Dhurandhar, Emily J; Dawson, John; Alcorn, Amy; Larsen, Lesli H; Thomas, Elizabeth A; Cardel, Michelle; Bourland, Ashley C; Astrup, Arne; St-Onge, Marie-Pierre; Hill, James O; Apovian, Caroline M; Shikany, James M; Allison, David B

2014-01-01

Background: Breakfast is associated with lower body weight in observational studies. Public health authorities commonly recommend breakfast consumption to reduce obesity, but the effectiveness of adopting these recommendations for reducing body weight is unknown. Objective: We tested the relative effectiveness of a recommendation to eat or skip breakfast on weight loss in adults trying to lose weight in a free-living setting. Design: We conducted a multisite, 16-wk, 3-parallel-arm randomized controlled trial in otherwise healthy overweight and obese adults [body mass index (in kg/m2) between 25 and 40] aged 20–65 y. Our primary outcome was weight change. We compared weight change in a control group with weight loss in experimental groups told to eat breakfast or to skip breakfast [no breakfast (NB)]. Randomization was stratified by prerandomization breakfast eating habits. A total of 309 participants were randomly assigned. Results: A total of 283 of the 309 participants who were randomly assigned completed the intervention. Treatment assignment did not have a significant effect on weight loss, and there was no interaction between initial breakfast eating status and treatment. Among skippers, mean (±SD) baseline weight-, age-, sex-, site-, and race-adjusted weight changes were −0.71 ± 1.16, −0.76 ± 1.26, and −0.61 ± 1.18 kg for the control, breakfast, and NB groups, respectively. Among breakfast consumers, mean (±SD) baseline weight-, age-, sex-, site-, and race-adjusted weight changes were −0.53 ± 1.16, −0.59 ± 1.06, and −0.71 ± 1.17 kg for the control, breakfast, and NB groups, respectively. Self-reported compliance with the recommendation was 93.6% for the breakfast group and 92.4% for the NB group. Conclusions: A recommendation to eat or skip breakfast for weight loss was effective at changing self-reported breakfast eating habits, but contrary to widely espoused views this had no discernable effect on weight loss in free-living adults who were attempting to lose weight. This trial was registered at clinicaltrails.gov as NCT01781780. PMID:24898236

A weight-neutral versus weight-loss approach for health promotion in women with high BMI: A randomized-controlled trial.

PubMed

Mensinger, Janell L; Calogero, Rachel M; Stranges, Saverio; Tylka, Tracy L

2016-10-01

Weight loss is the primary recommendation for health improvement in individuals with high body mass index (BMI) despite limited evidence of long-term success. Alternatives to weight-loss approaches (such as Health At Every Size - a weight-neutral approach) have been met with their own concerns and require further empirical testing. This study compared the effectiveness of a weight-neutral versus a weight-loss program for health promotion. Eighty women, aged 30-45 years, with high body mass index (BMI ≥ 30 kg/m(2)) were randomized to 6 months of facilitator-guided weekly group meetings using structured manuals that emphasized either a weight-loss or weight-neutral approach to health. Health measurements occurred at baseline, post-intervention, and 24-months post-randomization. Measurements included blood pressure, lipid panels, blood glucose, BMI, weight, waist circumference, hip circumference, distress, self-esteem, quality of life, dietary risk, fruit and vegetable intake, intuitive eating, and physical activity. Intention-to-treat analyses were performed using linear mixed-effects models to examine group-by-time interaction effects and between and within-group differences. Group-by-time interactions were found for LDL cholesterol, intuitive eating, BMI, weight, and dietary risk. At post-intervention, the weight-neutral program had larger reductions in LDL cholesterol and greater improvements in intuitive eating; the weight-loss program had larger reductions in BMI, weight, and larger (albeit temporary) decreases in dietary risk. Significant positive changes were observed overall between baseline and 24-month follow-up for waist-to-hip ratio, total cholesterol, physical activity, fruit and vegetable intake, self-esteem, and quality of life. These findings highlight that numerous health benefits, even in the absence of weight loss, are achievable and sustainable in the long term using a weight-neutral approach. The trial positions weight-neutral programs as a viable health promotion alternative to weight-loss programs for women of high weight. Copyright © 2016 Elsevier Ltd. All rights reserved.

Are large dinners associated with excess weight, and does eating a smaller dinner achieve greater weight loss? A systematic review and meta-analysis.

PubMed

Fong, Mackenzie; Caterson, Ian D; Madigan, Claire D

2017-10-01

There are suggestions that large evening meals are associated with greater BMI. This study reviewed systematically the association between evening energy intake and weight in adults and aimed to determine whether reducing evening intake achieves weight loss. Databases searched were MEDLINE, PubMed, Cinahl, Web of Science, Cochrane Library of Clinical Trials, EMBASE and SCOPUS. Eligible observational studies investigated the relationship between BMI and evening energy intake. Eligible intervention trials compared weight change between groups where the proportion of evening intake was manipulated. Evening intake was defined as energy consumed during a certain time - for example 18.00-21.00 hours - or self-defined meal slots - that is 'dinner'. The search yielded 121 full texts that were reviewed for eligibility by two independent reviewers. In all, ten observational studies and eight clinical trials were included in the systematic review with four and five included in the meta-analyses, respectively. Four observational studies showed a positive association between large evening intake and BMI, five showed no association and one showed an inverse relationship. The meta-analysis of observational studies showed a non-significant trend between BMI and evening intake (P=0·06). The meta-analysis of intervention trials showed no difference in weight change between small and large dinner groups (-0·89 kg; 95 % CI -2·52, 0·75, P=0·29). This analysis was limited by significant heterogeneity, and many trials had an unknown or high risk of bias. Recommendations to reduce evening intake for weight loss cannot be substantiated by clinical evidence, and more well-controlled intervention trials are needed.

Reduced Reward-driven Eating Accounts for the Impact of a Mindfulness-Based Diet and Exercise Intervention on Weight Loss: Data from the SHINE Randomized Controlled Trial

PubMed Central

Mason, Ashley E.; Epel, Elissa S.; Aschbacher, Kirstin; Lustig, Robert H.; Acree, Michael; Kristeller, Jean; Cohn, Michael; Dallman, Mary; Moran, Patricia J.; Bacchetti, Peter; Laraia, Barbara; Hecht, Frederick M.; Daubenmier, Jennifer

2016-01-01

Many individuals with obesity report overeating despite intentions to maintain or lose weight. Two barriers to long-term weight loss are reward-driven eating, which is characterized by a lack of control over eating, a preoccupation with food, and a lack of satiety; and psychological stress. Mindfulness training may address these barriers by promoting awareness of hunger and satiety cues, self-regulatory control, and stress reduction. We examined these two barriers as potential mediators of weight loss in the Supporting Health by Integrating Nutrition and Exercise (SHINE) randomized controlled trial, which compared the effects of a 5.5-month diet and exercise intervention with or without mindfulness training on weight loss among adults with obesity. Intention-to-treat multiple mediation models tested whether post-intervention reward-driven eating and psychological stress mediated the impact of intervention arm on weight loss at 12-and 18-months post-baseline among 194 adults with obesity (BMI: 30–45). Mindfulness (relative to control) participants had significant reductions in reward-driven eating at 6 months (post-intervention), which, in turn, predicted weight loss at 12 months. Post-intervention reward-driven eating mediated 47.1% of the total intervention arm effect on weight loss at 12 months [β=-0.06, SE(β)=0.03, p=.030, 95% CI (−0.12, −0.01)]. This mediated effect was reduced when predicting weight loss at 18 months (p=.396), accounting for 23.0% of the total intervention effect, despite similar weight loss at 12 months. Psychological stress did not mediate the effect of intervention arm on weight loss at 12 or 18 months. In conclusion, reducing reward-driven eating, which can be achieved using a diet and exercise intervention that includes mindfulness training, may promote weight loss (clinicaltrials.gov registration: NCT00960414). PMID:26867697

Reduced reward-driven eating accounts for the impact of a mindfulness-based diet and exercise intervention on weight loss: Data from the SHINE randomized controlled trial.

PubMed

Mason, Ashley E; Epel, Elissa S; Aschbacher, Kirstin; Lustig, Robert H; Acree, Michael; Kristeller, Jean; Cohn, Michael; Dallman, Mary; Moran, Patricia J; Bacchetti, Peter; Laraia, Barbara; Hecht, Frederick M; Daubenmier, Jennifer

2016-05-01

Many individuals with obesity report over eating despite intentions to maintain or lose weight. Two barriers to long-term weight loss are reward-driven eating, which is characterized by a lack of control over eating, a preoccupation with food, and a lack of satiety; and psychological stress. Mindfulness training may address these barriers by promoting awareness of hunger and satiety cues, self-regulatory control, and stress reduction. We examined these two barriers as potential mediators of weight loss in the Supporting Health by Integrating Nutrition and Exercise (SHINE) randomized controlled trial, which compared the effects of a 5.5-month diet and exercise intervention with or without mindfulness training on weight loss among adults with obesity. Intention-to-treat multiple mediation models tested whether post-intervention reward-driven eating and psychological stress mediated the impact of intervention arm on weight loss at 12- and 18-months post-baseline among 194 adults with obesity (BMI: 30-45). Mindfulness (relative to control) participants had significant reductions in reward-driven eating at 6 months (post-intervention), which, in turn, predicted weight loss at 12 months. Post-intervention reward-driven eating mediated 47.1% of the total intervention arm effect on weight loss at 12 months [β = -0.06, SE(β) = 0.03, p = .030, 95% CI (-0.12, -0.01)]. This mediated effect was reduced when predicting weight loss at 18 months (p = .396), accounting for 23.0% of the total intervention effect, despite similar weight loss at 12 months. Psychological stress did not mediate the effect of intervention arm on weight loss at 12 or 18 months. In conclusion, reducing reward-driven eating, which can be achieved using a diet and exercise intervention that includes mindfulness training, may promote weight loss (clinicaltrials.gov registration: NCT00960414). Published by Elsevier Ltd.

Benefits of commercial weight-loss programs on blood pressure and lipids: a systematic review.

PubMed

Mehta, Ambereen K; Doshi, Ruchi S; Chaudhry, Zoobia W; Jacobs, David K; Vakil, Rachit M; Lee, Clare J; Bleich, Sara N; Clark, Jeanne M; Gudzune, Kimberly A

2016-09-01

Our objective was to compare the effect of commercial weight-loss programs on blood pressure and lipids to control/education or counseling among individuals with overweight/obesity. We conducted a systematic review by searching MEDLINE and Cochrane Database of Systematic Reviews from inception to November 2014 and references identified by the programs. We included randomized, controlled trials ≥12weeks in duration. Two reviewers extracted information on study design, interventions, and mean change in systolic blood pressure (SBP), diastolic blood pressure (DBP), low-density lipoprotein cholesterol (LDL-c), high-density lipoprotein cholesterol (HDL-c), triglycerides, and total cholesterol and assessed risk of bias. We included 27 trials. Participants' blood pressure and lipids were normal at baseline in most trials. At 12months, Weight Watchers showed little change in blood pressure or lipid outcomes as compared to control/education (2 trials). At 12months, Atkins' participants had higher HDL-c and lower triglycerides than counseling (4 trials). Other programs had inconsistent effects or lacked long-term studies. Risk of bias was high for most trials of all programs. In conclusion, limited data exist regarding most commercial weight-loss programs' long-term effects on blood pressure and lipids. Clinicians should be aware that Weight Watchers has limited data that demonstrate CVD risk factor benefits relative to control/education. Atkins may be a reasonable option for patients with dyslipidemia. Additional well-designed, long-term trials are needed to confirm these conclusions and evaluate other commercial programs. Copyright © 2016 Elsevier Inc. All rights reserved.

Effects of weight loss interventions for adults who are obese on mortality, cardiovascular disease, and cancer: systematic review and meta-analysis.

PubMed

Ma, Chenhan; Avenell, Alison; Bolland, Mark; Hudson, Jemma; Stewart, Fiona; Robertson, Clare; Sharma, Pawana; Fraser, Cynthia; MacLennan, Graeme

2017-11-14

Objective  To assess whether weight loss interventions for adults with obesity affect all cause, cardiovascular, and cancer mortality, cardiovascular disease, cancer, and body weight. Design  Systematic review and meta-analysis of randomised controlled trials (RCTs) using random effects, estimating risk ratios, and mean differences. Heterogeneity investigated using Cochran's Q and I 2 statistics. Quality of evidence assessed by GRADE criteria. Data sources  Medline, Embase, the Cochrane Central Register of Controlled Trials, and full texts in our trials' registry for data not evident in databases. Authors were contacted for unpublished data. Eligibility criteria for selecting studies  RCTs of dietary interventions targeting weight loss, with or without exercise advice or programmes, for adults with obesity and follow-up ≥1 year. Results  54 RCTs with 30 206 participants were identified. All but one trial evaluated low fat, weight reducing diets. For the primary outcome, high quality evidence showed that weight loss interventions decrease all cause mortality (34 trials, 685 events; risk ratio 0.82, 95% confidence interval 0.71 to 0.95), with six fewer deaths per 1000 participants (95% confidence interval two to 10). For other primary outcomes moderate quality evidence showed an effect on cardiovascular mortality (eight trials, 134 events; risk ratio 0.93, 95% confidence interval 0.67 to 1.31), and very low quality evidence showed an effect on cancer mortality (eight trials, 34 events; risk ratio 0.58, 95% confidence interval 0.30 to 1.11). Twenty four trials (15 176 participants) reported high quality evidence on participants developing new cardiovascular events (1043 events; risk ratio 0.93, 95% confidence interval 0.83 to 1.04). Nineteen trials (6330 participants) provided very low quality evidence on participants developing new cancers (103 events; risk ratio 0.92, 95% confidence interval 0.63 to 1.36). Conclusions  Weight reducing diets, usually low in fat and saturated fat, with or without exercise advice or programmes, may reduce premature all cause mortality in adults with obesity. Systematic review registration  PROSPERO CRD42016033217. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

The effect of dietary and exercise interventions on body weight in prostate cancer patients: a systematic review.

PubMed

Mohamad, Hamdan; McNeill, Geraldine; Haseen, Farhana; N'Dow, James; Craig, Leone C A; Heys, Steven D

2015-01-01

Prostate cancer prognosis may therefore be improved by maintaining healthy weight through diet and physical activity. This systematic review looked at the effect of diet and exercise interventions on body weight among men treated for prostate cancer. MEDLINE, EMBASE, CINAHL, and Cochrane Library databases were searched from the earliest record to August 2013. Randomized controlled trials of diet and exercise interventions in prostate cancer patients that reported body weight or body composition changes were included. A total of 20 trials were included in the review. Because of the heterogeneity of intervention components, a narrative review was conducted. Interventions were categorized as diet (n = 6), exercise (n = 8), or a combination of both diet and exercise (n = 6). The sample size ranged from 8 to 155 and the duration from 3 wk to 4 yr. Four diet interventions and 1 combined diet and exercise intervention achieved significant weight loss with mean values ranging from 0.8 kg to 6.1 kg (median 4.5 kg). Exercise alone did not lead to weight loss, though most of these trials aimed to increase fitness and quality of life rather than decrease body weight. Diet intervention, alone or in combination with exercise, can lead to weight loss in men treated for prostate cancer.

Social facilitation maintenance treatment for adults with obesity: study protocol for a randomised-controlled feasibility study (SFM study).

PubMed

Hilbert, Anja

2016-08-31

The long-term success of non-surgical weight loss treatment in adults with obesity is limited by substantial relapse, and only a few evidence-based weight loss maintenance treatments exist. This clinical trial investigates the feasibility and efficacy of a social facilitation maintenance programme for weight loss maintenance, tailored to meet the needs of obese adults who have undergone a lifestyle weight loss intervention. In a single-centre, open feasibility trial, 72 adults currently or previously obese or overweight who have undergone a lifestyle weight loss intervention are centrally randomised to 4 months of social facilitation maintenance treatment or treatment as a usual control condition. In 16 outpatient group sessions, the social facilitation maintenance treatment, based on a socioecological model and on evidence supporting social facilitation as a key process in maintaining weight loss, focuses on promoting interpersonal relationships to build up a healthy lifestyle for long-term weight loss maintenance. Primary outcome is the amount of weight regain at 6-month follow-up, compared with pre-treatment weight, derived from measured body weight. Secondary outcomes address feasibility, including recruitment, attrition, assessment non-completion, compliance and patients' programme evaluation; and in comparison with pre-weight loss maintenance, social and interpersonal functioning, eating behaviour and physical activity, psychological and physical symptoms, body composition and risk of comorbidity, and quality of life at post-treatment and follow-up assessments. The study was approved by the Ethical Committee at the University of Leipzig (165-13-15072013). The study results will be disseminated through peer-reviewed publications. DRKS00005182. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Clinical Effectiveness of Weight Loss and Weight Maintenance Interventions for Men: A Systematic Review of Men-Only Randomized Controlled Trials (The ROMEO Project)

PubMed Central

Robertson, Clare; Avenell, Alison; Stewart, Fiona; Archibald, Daryll; Douglas, Flora; Hoddinott, Pat; van Teijlingen, Edwin; Boyers, Dwayne

2015-01-01

Men are underrepresented in obesity services, suggesting current weight loss service provision is suboptimal. This systematic review evaluated evidence-based strategies for treating obesity in men. Eight bibliographic databases and four clinical trials’ registers were searched to identify randomized controlled trials (RCTs) of weight loss interventions in men only, with mean/median body mass index of ≥30 kg/m2 (or ≥28 kg/m2 with cardiac risk factors), with a minimum mean/median duration of ≥52 weeks. Interventions included diet, physical activity, behavior change techniques, orlistat, or combinations of these; compared against each other, placebo, or a no intervention control group; in any setting. Twenty-one reports from 14 RCTs were identified. Reducing diets produced more favorable weight loss than physical activity alone (mean weight change after 1 year from a reducing diet compared with an exercise program −3.2 kg, 95% confidence interval −4.8 to −1.6 kg, reported p < .01). The most effective interventions combined reducing diets, exercise, and behavior change techniques (mean difference in weight at 1 year compared with no intervention was −4.9 kg, 95% confidence interval −5.9 to −4.0, reported p < .0001). Group interventions produced favorable weight loss results. The average reported participant retention rate was 78.2%, ranging from 44% to 100% retention, indicating that, once engaged, men remained committed to a weight loss intervention. Weight loss for men is best achieved and maintained with the combination of a reducing diet, increased physical activity, and behavior change techniques. Strategies to increase engagement of men with weight loss services to improve the reach of interventions are needed. PMID:26130729

Maintained intentional weight loss reduces cardiovascular outcomes: results from the Sibutramine Cardiovascular OUTcomes (SCOUT) trial.

PubMed

Caterson, I D; Finer, N; Coutinho, W; Van Gaal, L F; Maggioni, A P; Torp-Pedersen, C; Sharma, A M; Legler, U F; Shepherd, G M; Rode, R A; Perdok, R J; Renz, C L; James, W P T

2012-06-01

The Sibutramine Cardiovascular OUTcomes trial showed that sibutramine produced greater mean weight loss than placebo but increased cardiovascular morbidity but not mortality. The relationship between 12-month weight loss and subsequent cardiovascular outcomes is explored. Overweight/obese subjects (N = 10 744), ≥55 years with cardiovascular disease and/or type 2 diabetes mellitus, received sibutramine plus weight management during a 6-week Lead-in Period before randomization to continue sibutramine (N = 4906) or to receive placebo (N = 4898). The primary endpoint was the time from randomization to first occurrence of a primary outcome event (non-fatal myocardial infarction, non-fatal stroke, resuscitated cardiac arrest or cardiovascular death). For the total population, mean weight change during Lead-in Period (sibutramine) was -2.54 kg. Post-randomization, mean total weight change to Month 12 was -4.18 kg (sibutramine) or -1.87 kg (placebo). Degree of weight loss during Lead-in Period or through Month 12 was associated with a progressive reduction in risk for the total population in primary outcome events and cardiovascular mortality over the 5-year assessment. Although more events occurred in the randomized sibutramine group, on an average, a modest weight loss of approximately 3 kg achieved in the Lead-in Period appeared to offset this increased event rate. Moderate weight loss (3-10 kg) reduced cardiovascular deaths in those with severe, moderate or mild cardiovascular disease. Modest weight loss over short-term (6 weeks) and longer-term (6-12 months) periods is associated with reduction in subsequent cardiovascular mortality for the following 4-5 years even in those with pre-existing cardiovascular disease. While the sibutramine group experienced more primary outcome events than the placebo group, greater weight loss reduced overall risk of these occurring in both groups. © 2011 Blackwell Publishing Ltd.

A 6‐month telephone‐based weight loss intervention in overweight and obese subjects with idiopathic intracranial hypertension

PubMed Central

Kovacs, Betty; Miller, Neil; McDermott, Michael P.; Wall, Michael; Kupersmith, Mark; Pi‐Sunyer, F. Xavier

2016-01-01

Summary Objectives The purpose of this paper is to measure the change in body weight after a 6‐month telephone‐based weight loss intervention in overweight and obese subjects with idiopathic intracranial hypertension (IIH) and mild visual loss randomized to receive either acetazolamide or placebo. Methods One hundred sixty‐five subjects with IIH, aged 29.1 ± 7.5 (mean ± SD) and BMI 39.9 + 8.3 kg/m2, enrolled at 38 academic and private practice sites in North America, participated in this trial. This was a randomized, double‐masked, placebo‐controlled trial of acetazolamide in subjects with IIH and mild visual loss. All participants received a reduced‐sodium, weight‐reduction diet and a 6‐month telephone‐based weight loss intervention. Six‐month changes from baseline in body weight, perimetric mean deviation as assessed by automated perimetry and quality of life using the National Eye Institute Visual Function Questionnaire 25 and the 36‐item Short Form Health Survey were measured. Results Mean percent weight change at 6 months was −5.9% ± 6.7% of initial body weight overall, −3.5% ± 5.9% in the placebo group and −7.8% ± 6.8% in the acetazolamide group. Weight change was not associated with changes in either mean deviation or quality of life scores. Conclusion Patients with IIH and mild visual loss assigned to either acetazolamide or placebo, all of whom received a 6‐month telephone‐based weight loss intervention, lost an average of 5.9% of initial body weight, consistent with NHLBI guidelines of 5% to 10% of body weight loss for clinically significant health benefit. PMID:29071096

Emotional eating is associated with weight loss success among adults enrolled in a weight loss program.

PubMed

Braden, Abby; Flatt, Shirley W; Boutelle, Kerri N; Strong, David; Sherwood, Nancy E; Rock, Cheryl L

2016-08-01

To examine associations between decreased emotional eating and weight loss success; and whether participation in a behavioral weight loss intervention was associated with a greater reduction in emotional eating over time compared to usual care. Secondary data analysis of a randomized controlled trial conducted at two university medical centers with 227 overweight adults with diabetes. Logistic and standard regression analyses examined associations between emotional eating change and weight loss success (i.e., weight loss of ≥7 % of body weight and decrease in BMI). After 6 months of intervention, decreased emotional eating was associated with greater odds of weight loss success (p = .05). The odds of weight loss success for subjects with decreased emotional eating at 12 months were 1.70 times higher than for subjects with increased emotional eating. No differences in change in emotional eating were found between subjects in the behavioral weight loss intervention and usual care. Strategies to reduce emotional eating may be useful to promote greater weight loss among overweight adults with diabetes.

Anabolic steroids for the treatment of weight loss in HIV-infected individuals.

PubMed

Johns, K; Beddall, M J; Corrin, R C

2005-10-19

Individuals with HIV infection often lose weight during the course of their disease. Furthermore, low serum concentrations of testosterone are common in individuals with HIV infection, particularly those with weight loss. Treatment of weight loss with anabolic steroids in HIV-infected individuals may be beneficial. Our objectives were to assess the efficacy and safety of anabolic steroids for the treatment of weight loss in adults with HIV infection. We searched the following databases: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, AIDSLINE, AIDSearch, EMBASE, CINAHL, Current Contents, and the National Library of Medicine Gateway Abstracts for controlled trials up to April 2005. We also searched the bibliographies of the identified studies and review the articles. In addition, pharmaceutical manufacturers of anabolic steroids were contacted. Randomized controlled trials that compared the use of an anabolic steroid to placebo to treat weight loss in adults with HIV were included. Randomized controlled trials that compared the use of anabolic steroids to placebo for the treatment of weight loss in adults with HIV were selected. Change from baseline in lean body mass or in body weight was reported as on outcome measure. Two reviewers independently assessed the trials for quality of randomization, blinding, withdrawals, and adequacy of allocation concealment. For continuous data, weighted mean differences (WMD) were calculated. For dichotomous outcomes, risk differences, were calculated. Because of uncertainty as to whether consistent true effects exist in such different populations and treatments, the authors decided a priori to use random effects models for all outcomes. Thirteen trials met the inclusion criteria. Two hundred ninety-four individuals randomized to anabolic steroid therapy and 238 individuals randomized to placebo were included in the analysis of efficacy for change from baseline in lean body mass. Three hundred forty-three individuals randomized to anabolic steroid and 286 randomized to placebo were included in the analysis of efficacy for change from baseline in body weight. The mean methodologic quality of the included studies was 4.1, of a maximum 5 points. Although significant heterogeneity was present for both outcomes, the average change in lean body mass was 1.3 kg (95% CI: 0.6, 2.0), while the average change in total body weight was 1.1 kg (95% CI: 0.3, 2.0). A total of eight deaths occurred during the treatment period; four in the anabolic steroid treatment groups and four in the placebo-treatment groups (risk difference 0.00, 95% CI -0.03, 0.03). The risk difference for withdrawals or discontinuations of study medication due to adverse events was 0.00 (95% CI: -0.02, 0.03). Although the results of the trials were heterogeneous, on average, the administration of anabolic steroids appeared to result in a small increase in both lean body mass and body weight as compared with placebo. While these results suggest that anabolic steroids may be useful in the treatment of weight loss in HIV infected individuals, due to limitations, treatment recommendations cannot be made. Further information is required regarding the long-term benefit and adverse effects of anabolic steroid use, the specific populations for which anabolic steroid therapy may be most beneficial, and the optimal regime. In addition, the correlation of improvement in lean body mass with more clinically relevant endpoints, such as physical functioning and survival, needs to be determined.

Patterns of Weight Change in Black Americans: Pooled Analysis from Three Behavioral Weight Loss Trials

PubMed Central

Morales, Knashawn H.; Kumanyika, Shiriki K.; Fassbender, Jennifer E.; Good, Jerene; Localio, A. Russell; Wadden, Thomas A.

2014-01-01

Objective Differentiating trajectories of weight change and identifying associated baseline predictors can provide insights for improving behavioral obesity treatment outcomes. Design and Methods Secondary, observational analyses using growth mixture models were conducted in pooled data for 604 black American, primarily female adults in three completed clinical trials. Covariates of identified patterns were evaluated. Results The best fitting model identified three patterns over 2 years: 1) mean weight loss of approximately 2 kg (n=519); 2) mean weight loss of approximately 3 kg at 1 year, followed by ~ 4 kg regain (n=61); and 3) mean weight loss of approximately 20 kg at 1 year followed by ~ 4 kg regain (n=24, with 23 from one study). In final multivariate analyses, higher BMI predicted having pattern 2 (OR[95% CI]) 1.10[1.03, 1.17]) or 3 (OR[95% CI] 1.42[1.25, 1.63]), and higher dietary fat score was predictive of a lower odds of having patterns 2 (OR[95% CI] 0.37[0.15, 0.94]) or 3 (OR[95% CI] 0.23[0.07, 0.79]). Conclusions Findings were consistent with moderate, clinically non-significant weight loss as the predominant pattern across all studies. Results underscore the need to develop novel and more carefully targeted and tailored approaches to facilitating weight loss in black American adults. PMID:25251464

Interventions to reduce weight gain in schizophrenia

PubMed Central

Faulkner, Guy; Cohn, Tony; Remington, Gary

2014-01-01

Background Weight gain is common for people with schizophrenia and this has serious implications for health and well being. Objectives To determine the effects of both pharmacological (excluding medication switching) and non pharmacological strategies for reducing or preventing weight gain in people with schizophrenia. Search methods We searched key databases and the Cochrane Schizophrenia Group’s trials register (April 2006), reference sections within relevant papers, hand searched key journals, and contacted the first author of each relevant study and other experts to collect further information. Selection criteria We included all clinical randomised controlled trials comparing any pharmacological or non pharmacological intervention for weight gain (diet and exercise counselling) with standard care or other treatments for people with schizophrenia or schizophrenia-like illnesses. Data collection and analysis We reliably selected, quality assessed and extracted data from studies. As weight is a continuous outcome measurement, weighted mean differences (WMD) of the change from baseline were calculated. The primary outcome measure was weight loss. Main results Twenty-three randomised controlled trials met the inclusion criteria for this review. Five trials assessed a cognitive/behavioural intervention and eighteen assessed a pharmacological adjunct. In terms of prevention, two cognitive/behavioural trials showed significant treatment effect (mean weight change) at end of treatment (n=104, 2 RCTs, WMD −3.38 kg CI −4.2 to −2.0). Pharmacological adjunct treatments were significant with a modest prevention of weight gain (n=274, 6 RCTs, WMD − 1.16 kg CI −1.9 to −0.4). In terms of treatments for weight loss, we found significantly greater weight reduction in the cognitive behavioural intervention group (n=129, 3 RCTs, WMD −1.69 kg CI −2.8 to −0.6) compared with standard care. Authors’ conclusions Modest weight loss can be achieved with selective pharmacological and non pharmacological interventions. However, interpretation is limited by the small number of studies, small sample size, short study duration and by variability of the interventions themselves, their intensity and duration. Future studies adequately powered, with longer treatment duration and rigorous methodology will be needed in further evaluating the efficacy and safety of weight loss interventions for moderating weight gain. At this stage, there is insufficient evidence to support the general use of pharmacological interventions for weight management in people with schizophrenia. PMID:17253540

Calorie Restriction in Overweight SeniorS: Response of Older Adults to a Dieting Study: The CROSSROADS Randomized Controlled Clinical Trial

PubMed Central

Haas, Marilyn C.; Bodner, Eric V.; Brown, Cynthia J.; Bryan, David; Buys, David R.; Keita, Akilah Dulin; Flagg, Lee Anne; Goss, Amy; Gower, Barbara; Hovater, Martha; Hunter, Gary; Ritchie, Christine S.; Roth, David L.; Wingo, Brooks C.; Ard, Jamy; Locher, Julie L.

2014-01-01

We conducted a study designed to evaluate whether the benefits of intentional weight loss exceed the potential risks in a group of community-dwelling, obese, older adults who were at increased risk for cardiometabolic disease. The CROSSROADS trial used a prospective randomized controlled design to compare the effects of changes in diet composition alone or combined with weight loss with an exercise only control intervention on body composition and adipose tissue deposition (Specific Aim #1: To compare the effects of changes in diet composition alone or combined with weight loss with an exercise only control intervention on body composition, namely visceral adipose tissue (VAT)), cardiometabolic disease risk (Specific Aim #2: To compare the effects of a change in diet composition alone or combined with weight loss with an exercise only control intervention on cardiometabolic disease risk), functional status and quality of life (Specific Aim #3: To compare the effects of a change in diet composition alone or combined with weight loss with an exercise only control intervention on functional status and quality of life). Participants were randomly assigned to one of three groups: Exercise Only (Control) Intervention, Exercise + Diet Quality + Weight Maintenance Intervention, or Exercise + Diet Quality + Weight Loss Intervention. CROSSROADS utilized a lifestyle intervention approach consisting of exercise, dietary, and behavioral components. The development and implementation of the CROSSROADS protocol, including a description of the methodology, detailing specific elements of the lifestyle intervention, assurances of treatment fidelity, and participant retention; outcome measures and adverse event monitoring; as well as unique data management features of the trial results, are presented in this article. PMID:25424512

Calorie restriction in overweight seniors: response of older adults to a dieting study: the CROSSROADS randomized controlled clinical trial.

PubMed

Haas, Marilyn C; Bodner, Eric V; Brown, Cynthia J; Bryan, David; Buys, David R; Keita, Akilah Dulin; Flagg, Lee Anne; Goss, Amy; Gower, Barbara; Hovater, Martha; Hunter, Gary; Ritchie, Christine S; Roth, David L; Wingo, Brooks C; Ard, Jamy; Locher, Julie L

2014-01-01

We conducted a study designed to evaluate whether the benefits of intentional weight loss exceed the potential risks in a group of community-dwelling obese older adults who were at increased risk for cardiometabolic disease. The CROSSROADS trial used a prospective randomized controlled design to compare the effects of changes in diet composition alone or combined with weight loss with an exercise only control intervention on body composition and adipose tissue deposition (Specific Aim #1: To compare the effects of changes in diet composition alone or combined with weight loss with an exercise only control intervention on body composition, namely visceral adipose tissue), cardiometabolic disease risk (Specific Aim #2: To compare the effects of a change in diet composition alone or combined with weight loss with an exercise only control intervention on cardiometabolic disease risk), and functional status and quality of life (Specific Aim #3: To compare the effects of a change in diet composition alone or combined with weight loss with an exercise only control intervention on functional status and quality of life). Participants were randomly assigned to one of three groups: Exercise Only (Control) Intervention, Exercise + Diet Quality + Weight Maintenance Intervention, or Exercise + Diet Quality + Weight Loss Intervention. CROSSROADS utilized a lifestyle intervention approach consisting of exercise, dietary, and behavioral components. The development and implementation of the CROSSROADS protocol, including a description of the methodology, detailing specific elements of the lifestyle intervention, assurances of treatment fidelity, and participant retention; outcome measures and adverse event monitoring; as well as unique data management features of the trial results, are presented in this article.

Calcium and vitamin D for obesity: a review of randomized controlled trials.

PubMed

Soares, M J; Chan She Ping-Delfos, W; Ghanbari, M H

2011-09-01

Obesity often coexists with low calcium intake and vitamin D insufficiency. There is emerging evidence of a role for these nutrients in the regulation of body weight. However, it is unclear whether increasing intakes of calcium and/or vitamin D during energy restriction, is a better strategy for weight and fat loss. We searched the literature from 2000 to date for randomized controlled trials (RCTs) on weight loss that had increased calcium or vitamin D per se, or in combination. Primary and secondary studies were included for this analysis. A total of 15 RCTs on calcium with or without vitamin D and seven on vitamin D alone met our criteria. Two studies reported that supplemental calcium significantly increased fat loss during caloric restriction by 1.8 and 2.2 kg, three found differences between 1 and 3.5 kg but were statistically nonsignificant, while nine trials were equivocal (±0.7 kg). The data on vitamin D supplementation during weight loss were too few to make firm conclusions. Current evidence from RCTs did not consistently support the contention that calcium and vitamin D accelerated weight or fat loss in obesity. There were studies that favoured the hypothesis but lacked the statistical power. There is a need for RCTs to examine the influence of vitamin D on body fat.

A pilot study comparing two weight loss maintenance interventions among low-income, mid-life women.

PubMed

Samuel-Hodge, Carmen D; Johnston, Larry F; Gizlice, Ziya; Garcia, Beverly A; Lindsley, Sara C; Gold, Alison D; Braxton, Danielle F; Keyserling, Thomas C

2013-07-15

Despite high obesity prevalence rates, few low-income midlife women participate in weight loss maintenance trials. This pilot study aims to assess the effectiveness of two weight loss maintenance interventions in this under-represented population. Low-income midlife women who completed a 16-week weight loss intervention and lost  ≥ 8 lbs (3.6 kg) were eligible to enroll in one of two 12-month maintenance programs. The programs were similar in content and had the same number of total contacts, but were different in the contact modality (Phone + Face-to-Face vs. Face-to-Face Only). Two criteria were used to assess successful weight loss maintenance at 12 months: (1) retaining a loss of  ≥ 5% of body weight from the start of the weight loss phase and (2) a change in body weight of  < 3%, from the start to the end of the maintenance program. Outcome measures of changes in physiologic and psychosocial factors, and evaluations of process measures and program acceptability (measured at 12 months) are also reported. For categorical variables, likelihood ratio or Fisher's Exact (for small samples) tests were used to evaluate statistically significant relationships; for continuous variables, t-tests or their equivalents were used to assess differences between means and also to identify correlates of weight loss maintenance. Overall, during the 12-month maintenance period, 41% (24/58) of participants maintained a loss of  ≥ 5% of initial weight and 43% (25/58) had a <3% change in weight. None of the comparisons between the two maintenance programs were statistically significant. However, improvements in blood pressure and dietary behaviors remained significant at the end of the 12-month maintenance period for participants in both programs. Participant attendance and acceptability were high for both programs. The effectiveness of two pilot 12-month maintenance interventions provides support for further research in weight loss maintenance among high-risk, low-income women. ClinicalTrials.gov Identifier: NCT00288301.

Increasing low-energy-dense foods and decreasing high-energy-dense foods differently influence weight loss trial outcomes

PubMed Central

Vadiveloo, M; Parker, H; Raynor, H

2018-01-01

BACKGROUND/OBJECTIVE Although reducing energy density (ED) enhances weight loss, it is unclear whether all dietary strategies that reduce ED are comparable, hindering effective ED guidelines for obesity treatment. This study examined how changes in number of low-energy-dense (LED) (<4.186 kJ/1.0 kcal g−1) and high-energy-dense (HED) (>12.56 kJ/3.0 kcal g−1) foods consumed affected dietary ED and weight loss within an 18-month weight loss trial. METHODS This secondary analysis examined data from participants randomized to an energy-restricted lifestyle intervention or lifestyle intervention plus limited non-nutrient dense, energy-dense food variety (n = 183). Number of daily LED and HED foods consumed was calculated from three, 24-h dietary recalls and anthropometrics were measured at 0, 6 and 18 months. Multivariable-adjusted generalized linear models and repeated-measures mixed linear models examined associations between 6-month changes in number of LED and HED foods and changes in ED, body mass index (BMI), and percent weight loss at 6 and 18 months. RESULTS Among mostly female (58%), White (92%) participants aged 51.9 years following an energy-restricted diet, increasing number of LED foods or decreasing number of HED foods consumed was associated with 6- and 18-month reductions in ED (β = − 0.25 to − 0.38 kJ g−1 (−0.06 to − 0.09 kcal g−1), P<0.001). Only increasing number of LED foods consumed was associated with 6- and 18-month reductions in BMI (β = − 0.16 to − 0.2 kg m−2, P<0.05) and 6-month reductions in percent weight loss (β = − 0.5%, P<0.05). Participants consuming ≤2 HED foods per day and ≥6.6 LED foods per day experienced better weight loss outcomes at 6- and 18-month than participants only consuming ≤2 HED foods per day. CONCLUSION Despite similar reductions in ED from reducing number of HED foods or increasing number of LED foods consumed, only increasing number of LED foods related to weight loss. This provides preliminary evidence that methods used to reduce dietary ED may differentially influence weight loss trajectories. Randomized controlled trials are needed to inform ED recommendations for weight loss. PMID:29406521

Current and Emerging Drug Treatments for Binge Eating Disorder

PubMed Central

Reas, Deborah L.; Grilo, Carlos M.

2014-01-01

Introduction This study evaluated controlled treatment studies of pharmacotherapy for binge eating disorder (BED). Areas Covered The primary focus of the review was on phase II and III controlled trials testing medications for BED. A total of 46 studies were considered and 26 were reviewed in detail. BED outcomes included binge-eating remission, binge-eating frequency, associated eating-disorder psychopathology, associated depression, and weight loss. Expert Opinion Data from controlled trials suggests that certain medications are superior to placebo for stopping binge-eating and for producing faster reductions in binge eating, and - to varying degrees - for reducing associated eating-disorder psychopathology, depression, and weight loss over the short-term. Almost no data exist regarding longer-term effects of medication for BED. Except for topiramate, which reduces both binge eating and weight, weight loss is minimal with medications tested for BED. Psychological interventions and the combination of medication with psychological interventions produce binge-eating outcomes that are superior to medication-only approaches. Combining medications with psychological interventions does not significantly enhance binge-eating outcomes, although the addition of certain medications enhances weight losses achieved with cognitive-behavioral therapy and behavioral weight loss, albeit modestly. PMID:24460483

A 12-week weight reduction intervention for overweight individuals taking antipsychotic medications.

PubMed

Green, Carla A; Janoff, Shannon L; Yarborough, Bobbi Jo H; Yarborough, Micah T

2014-11-01

People taking antipsychotic medications are at increased risk for obesity, diabetes, and early mortality. Few weight loss interventions have targeted this population. Thirty-six individuals were randomized to an evidence-based 12-week weight loss intervention (PREMIER with DASH diet, n = 18) or to usual care (n = 18) in this feasibility trial. Average attendance was 8.6 of 12 sessions. Intent-to-treat analyses of covariance, adjusted for baseline weight, showed significant changes in weight: Mean weight in intervention participants declined from 213.3 to 206.6 pounds, while control participants' weight was unchanged. It is possible to recruit, assess, intervene with, and retain participants taking antipsychotic medications in a dietary and exercise lifestyle change trial. Participants reported high levels of satisfaction with the intervention.

Efficacy of gamification-based smartphone application for weight loss in overweight and obese adolescents: study protocol for a phase II randomized controlled trial

PubMed Central

Timpel, Patrick; Cesena, Fernando Henpin Yue; da Silva Costa, Christiane; Soldatelli, Matheus Dorigatti; Gois, Emanuel; Castrillon, Eduardo; Díaz, Lina Johana Jaime; Repetto, Gabriela M.; Hagos, Fanah; Castillo Yermenos, Raul E.; Pacheco-Barrios, Kevin; Musallam, Wafaa; Braid, Zilda; Khidir, Nesreen; Romo Guardado, Marcela; Roepke, Roberta Muriel Longo

2018-01-01

Background: Overweight and obesity are significant public health concerns that are prevalent in younger age cohorts. Preventive or therapeutic interventions are difficult to implement and maintain over time. On the other hand, the majority of adolescents in the United States have a smartphone, representing a huge potential for innovative digitized interventions, such as weight loss programs delivered via smartphone applications. Although the number of available smartphone applications is increasing, evidence for their effectiveness in weight loss is insufficient. Therefore, the proposed study aims to assess the efficacy of a gamification-based smartphone application for weight loss in overweight and obese adolescents. The trial is designed to be a phase II, single-centre, two-arm, triple-blinded, randomized controlled trial (RCT) with a duration of 6 months. Method: The intervention consists of a smartphone application that provides both tracking and gamification elements, while the control arm consists of an identically designed application solely with tracking features of health information. The proposed trial will be conducted in an urban primary care clinic of an academic centre in the United States of America, with expertise in the management of overweight and obese adolescents. Eligible adolescents will be followed for 6 months. Changes in body mass index z score from baseline to 6 months will be the primary outcome. Secondary objectives will explore the effects of the gamification-based application on adherence, as well as anthropometric, metabolic and behavioural changes. A required sample size of 108 participants (54 participants per group) was calculated. Discussion: The benefits of the proposed study include mid-term effects in weight reduction for overweight and obese adolescents. The current proposal will contribute to fill a gap in the literature on the mid-term effects of gamification-based interventions to control weight in adolescents. This trial is a well-designed RCT that is in line with the Consolidated Standards of Reporting Trials statement. PMID:29854386

Efficacy of gamification-based smartphone application for weight loss in overweight and obese adolescents: study protocol for a phase II randomized controlled trial.

PubMed

Timpel, Patrick; Cesena, Fernando Henpin Yue; da Silva Costa, Christiane; Soldatelli, Matheus Dorigatti; Gois, Emanuel; Castrillon, Eduardo; Díaz, Lina Johana Jaime; Repetto, Gabriela M; Hagos, Fanah; Castillo Yermenos, Raul E; Pacheco-Barrios, Kevin; Musallam, Wafaa; Braid, Zilda; Khidir, Nesreen; Romo Guardado, Marcela; Roepke, Roberta Muriel Longo

2018-06-01

Overweight and obesity are significant public health concerns that are prevalent in younger age cohorts. Preventive or therapeutic interventions are difficult to implement and maintain over time. On the other hand, the majority of adolescents in the United States have a smartphone, representing a huge potential for innovative digitized interventions, such as weight loss programs delivered via smartphone applications. Although the number of available smartphone applications is increasing, evidence for their effectiveness in weight loss is insufficient. Therefore, the proposed study aims to assess the efficacy of a gamification-based smartphone application for weight loss in overweight and obese adolescents. The trial is designed to be a phase II, single-centre, two-arm, triple-blinded, randomized controlled trial (RCT) with a duration of 6 months. The intervention consists of a smartphone application that provides both tracking and gamification elements, while the control arm consists of an identically designed application solely with tracking features of health information. The proposed trial will be conducted in an urban primary care clinic of an academic centre in the United States of America, with expertise in the management of overweight and obese adolescents. Eligible adolescents will be followed for 6 months. Changes in body mass index z score from baseline to 6 months will be the primary outcome. Secondary objectives will explore the effects of the gamification-based application on adherence, as well as anthropometric, metabolic and behavioural changes. A required sample size of 108 participants (54 participants per group) was calculated. The benefits of the proposed study include mid-term effects in weight reduction for overweight and obese adolescents. The current proposal will contribute to fill a gap in the literature on the mid-term effects of gamification-based interventions to control weight in adolescents. This trial is a well-designed RCT that is in line with the Consolidated Standards of Reporting Trials statement.

Using mixed methods to develop and evaluate an online weight management intervention.

PubMed

Bradbury, Katherine; Dennison, Laura; Little, Paul; Yardley, Lucy

2015-02-01

This article illustrates the use of mixed methods in the development and evaluation of the Positive Online Weight Reduction (POWeR) programme, an e-health intervention designed to support sustainable weight loss. The studies outlined also explore how human support might enhance intervention usage and weight loss. Mixed methods were used to develop and evaluate POWeR. In the development phase, we drew on both quantitative and qualitative findings to plan and gain feedback on the intervention. Next, a feasibility trial, with nested qualitative study, explored what level of human support might lead to the most sustainable weight loss. Finally, a large community-based trial of POWeR, with nested qualitative study, explored whether the addition of brief telephone coaching enhances usage. Findings suggest that POWeR is acceptable and potentially effective. Providing human support enhanced usage in our trials, but was not unproblematic. Interestingly, there were some indications that more basic (brief) human support may produce more sustainable weight loss outcomes than more regular support. Qualitative interviews suggested that more regular support might foster reliance, meaning patients cannot sustain their weight losses when support ends. Qualitative findings in the community trial also suggested explanations for why many people may not take up the opportunity for human support. Integrating findings from both our qualitative and quantitative studies provided far richer insights than would have been gained using only a single method of inquiry. Further research should investigate the optimum delivery of human support needed to maximize sustainable weight loss in online interventions. Statement of contribution What is already known on this subject? There is evidence that human support may increase the effectiveness of e-health interventions. It is unclear what level of human support might be optimal or how human support improves effectiveness. Triangulation of quantitative and qualitative methods can be used to inform the design and implementation of interventions What does this study add? This paper demonstrates the value of a mixed methods approach when developing and evaluating an intervention. Qualitative methods provided complementary insights into the optimal level of human support. Brief human support is valued by some and may enhance usage and outcomes of an e-health intervention for weight loss. © 2014 The British Psychological Society.

Investigations of botanicals on food intake, satiety, weight loss and oxidative stress: study protocol of a double-blind, placebo-controlled, crossover study.

PubMed

Anton, Stephen D; Shuster, Jonathan; Leeuwenburgh, Christiaan

2011-11-01

Botanicals represent an important and underexplored source of potential new therapies that may facilitate caloric restriction and thereby may produce long-term weight loss. In particular, one promising botanical that may reduce food intake and body weight by affecting neuroendocrine pathways related to satiety is hydroxycitric acid (HCA) derived from Garcinia cambogia Desr. The objective of this article is to describe the protocol of a clinical trial designed to directly test the effects of Garcinia cambogia-derived HCA on food intake, satiety, weight loss and oxidative stress levels, and to serve as a model for similar trials. A total of 48 healthy, overweight or obese individuals (with a body mass index range of 25.0 to 39.9 kg/m(2)) between the ages of 50 to 70 will participate in this double-blind, placebo-controlled, crossover study designed to examine the effects of two doses of Garcinia cambogia-derived HCA on food intake, satiety, weight loss, and oxidative stress levels. Food intake represents the primary outcome measure and is calculated based on the total calories consumed at breakfast, lunch, and dinner meals during each test meal day. This study can be completed with far fewer subjects than a parallel design. Of the numerous botanical compounds, the compound Garcinia cambogia-derived HCA is selected for testing in the present study because of its potential to safely reduce food intake, body weight, and oxidative stress levels. We will review potential mechanisms of action and safety parameters throughout this clinical trial. ClinicalTrials.gov (Identifier: NCT01238887).

Ineffectiveness of commercial weight-loss programs for achieving modest but meaningful weight loss: Systematic review and meta-analysis.

PubMed

McEvedy, Samantha M; Sullivan-Mort, Gillian; McLean, Siân A; Pascoe, Michaela C; Paxton, Susan J

2017-10-01

This study collates existing evidence regarding weight loss among overweight but otherwise healthy adults who use commercial weight-loss programs. Systematic search of 3 databases identified 11 randomized controlled trials and 14 observational studies of commercial meal-replacement, calorie-counting, or pre-packaged meal programs which met inclusion criteria. In meta-analysis using intention-to-treat data, 57 percent of individuals who commenced a commercial weight program lost less than 5 percent of their initial body weight. One in two (49%) studies reported attrition ≥30 percent. A second meta-analysis found that 37 percent of program completers lost less than 5 percent of initial body weight. We conclude that commercial weight-loss programs frequently fail to produce modest but clinically meaningful weight loss with high rates of attrition suggesting that many consumers find dietary changes required by these programs unsustainable.

PDA+: A Personal Digital Assistant for Obesity Treatment - an RCT testing the use of technology to enhance weight loss treatment for veterans.

PubMed

Duncan, Jennifer M; Janke, E Amy; Kozak, Andrea T; Roehrig, Megan; Russell, Stephanie W; McFadden, H Gene; Demott, Andrew; Pictor, Alex; Hedeker, Don; Spring, Bonnie

2011-04-11

Obese adults struggle to make the changes necessary to achieve even modest weight loss, though a decrease in weight by as little as 10% can have significant health benefits. Failure to meet weight loss goals may in part be associated with barriers to obesity treatment. Wide-spread dissemination of evidence-based obesity treatment faces multiple challenges including cost, access, and implementing the programmatic characteristics on a large scale. The PDA+: A Personal Digital Assistant for Obesity Treatment randomized controlled trial (RCT) was designed to test whether a PDA-based behavioral intervention enhances the effectiveness of the existing group weight loss treatment program at VA Medical Centers Managing Overweight/Obese Veterans Everywhere (MOVE!). We also aim to introduce technology as a way to overcome systemic barriers of traditional obesity treatment. Veterans enrolled in the MOVE! group at the Hines Hospital VAMC with BMI ≥ 25 and ≤ 40 and weigh < 400 pounds, experience chronic pain (≥ 4 on the NRS-I scale for ≥ 6 months prior to enrollment) and are able to participate in a moderate intensity exercise program will be recruited and screened for eligibility. Participants will be randomized to receive either: a) MOVE! treatment alone (Standard Care) or b) Standard Care plus PDA (PDA+). Those randomized to PDA+ will record dietary intake, physical activity, and weight on the PDA. In addition, they will also record mood and pain intensity, and receive biweekly telephone support for the first 6-months of the 12-month study. All participants will attend in-person lab sessions every three months to complete questionnaires and for the collection of anthropomorphic data. Weight loss and decrease in pain level intensity are the primary outcomes. The PDA+ trial represents an important step in understanding ways to improve the use of technology in obesity treatment. The trial will address barriers to obesity care by implementing effective behavioral components of a weight loss intervention and delivering high intensity, low cost obesity treatment. This RCT also tests an intervention approach supported by handheld technology in a population traditionally considered to have lower levels of technology literacy. ClinicalTrials.gov: NCT00371462.

Financial incentive strategies for maintenance of weight loss: results from an internet-based randomized controlled trial.

PubMed

Yancy, William S; Shaw, Pamela A; Wesby, Lisa; Hilbert, Victoria; Yang, Lin; Zhu, Jingsan; Troxel, Andrea; Huffman, David; Foster, Gary D; Wojtanowski, Alexis C; Volpp, Kevin G

2018-05-25

Financial incentives can improve initial weight loss; we examined whether financial incentives can improve weight loss maintenance. Participants aged 30-80 years who lost at least 5 kg during the first 4-6 months in a nationally available commercial weight loss program were recruited via the internet into a three-arm randomized trial of two types of financial incentives versus active control during months 1-6 (Phase I) followed by passive monitoring during months 7-12 (Phase II). Interventions were daily self-weighing and text messaging feedback alone (control) or combined with a lottery-based incentive or a direct incentive. The primary outcome was weight change 6 months after initial weight loss. Secondary outcomes included weight change 12 months after initial weight loss (6 months after cessation of maintenance intervention), and self-reported physical activity and eating behaviors. Of 191 participants randomized, the mean age was 49.0 (SD = 10.5) years and weight loss prior to randomization was 11.4 (4.7) kg; 92% were women and 89% were White. Mean weight changes during the next 6 months (Phase I) were: lottery -3.0 (5.8) kg; direct -2.8 (5.8) kg; and control -1.4 (5.8) kg (all pairwise comparisons p > 0.1). Weight changes through the end of 12 months post-weight loss (Phase II) were: lottery -1.8 (10.5) kg; direct -0.7 (10.7) kg; and control -0.3 (9.4) kg (all pairwise comparisons p > 0.1). The percentages of participants who maintained their weight loss (defined as gaining ≤1.36 kg) were: lottery 79%, direct 76%, and control 67% at 6 months and lottery 66%, direct 62%, and control 59% at 12 months (all pairwise comparisons p > 0.1). At 6 and 12 months after initial weight loss, changes in self-reported physical activity or eating behaviors did not differ across arms. Compared with the active control of daily texting based on daily home weighing, lottery-based and direct monetary incentives provided no additional benefit for weight loss maintenance.

Clinical trial experience with fat-restricted vs. carbohydrate-restricted weight-loss diets.

PubMed

Klein, Samuel

2004-11-01

It is unlikely that one diet is optimal for all overweight or obese persons. Both low-fat and low-carbohydrate diets have been shown to induce weight loss and reduce obesity-related comorbidities. Low-carbohydrate diets cause greater short-term (up to 6 months) weight loss than low-fat diets, but the long-term clinical safety and efficacy of these diets has not been studied.

Cognitive-Behavioral Therapy, Behavioral Weight Loss, and Sequential Treatment for Obese Patients with Binge-Eating Disorder: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Grilo, Carlos M.; Masheb, Robin M.; Wilson, G. Terence; Gueorguieva, Ralitza; White, Marney A.

2011-01-01

Objective: Cognitive-behavioral therapy (CBT) is the best established treatment for binge-eating disorder (BED) but does not produce weight loss. The efficacy of behavioral weight loss (BWL) in obese patients with BED is uncertain. This study compared CBT, BWL, and a sequential approach in which CBT is delivered first, followed by BWL (CBT + BWL).…

Nutritional Approaches to Achieve Weight Loss in Nonalcoholic Fatty Liver Disease123

PubMed Central

Hsu, Christine C; Ness, Erik; Kowdley, Kris V

2017-01-01

Nonalcoholic fatty liver disease (NAFLD) can range in spectrum from simple hepatic steatosis to nonalcoholic steatohepatitis (NASH), which is characterized by lipotoxicity, hepatocellular ballooning, and inflammation and can progress to cirrhosis. Weight loss is the cornerstone treatment for NAFLD and NASH. Various randomized controlled trials have shown that weight loss of ≥5–10% leads to significant improvements in hepatic steatosis. Diets high in sodium and fructose have been implicated in the pathogenesis of NAFLD. Although some clinical studies suggest that an isocaloric high-fructose diet does not worsen NAFLD, these clinical studies are often short in duration. More recently, the Dietary Approaches to Stop Hypertension diet, a sodium-restricted diet, has been associated with less prevalence of NAFLD and has been shown to improve NAFLD. In addition, the Mediterranean diet has been promising in improving hepatic steatosis, and a larger randomized controlled trial is currently enrolling subjects. For those who are unable to pursue weight loss through dietary approaches, bariatric surgery has been shown to improve hepatic steatosis and steatohepatitis. This method has been variable in improving hepatic fibrosis. In conclusion, weight loss is crucial to the improvement of NAFLD and NASH, and patients should attempt various diets in an attempt to achieve weight loss. PMID:28298270

Nutritional Approaches to Achieve Weight Loss in Nonalcoholic Fatty Liver Disease.

PubMed

Hsu, Christine C; Ness, Erik; Kowdley, Kris V

2017-03-01

Nonalcoholic fatty liver disease (NAFLD) can range in spectrum from simple hepatic steatosis to nonalcoholic steatohepatitis (NASH), which is characterized by lipotoxicity, hepatocellular ballooning, and inflammation and can progress to cirrhosis. Weight loss is the cornerstone treatment for NAFLD and NASH. Various randomized controlled trials have shown that weight loss of ≥5-10% leads to significant improvements in hepatic steatosis. Diets high in sodium and fructose have been implicated in the pathogenesis of NAFLD. Although some clinical studies suggest that an isocaloric high-fructose diet does not worsen NAFLD, these clinical studies are often short in duration. More recently, the Dietary Approaches to Stop Hypertension diet, a sodium-restricted diet, has been associated with less prevalence of NAFLD and has been shown to improve NAFLD. In addition, the Mediterranean diet has been promising in improving hepatic steatosis, and a larger randomized controlled trial is currently enrolling subjects. For those who are unable to pursue weight loss through dietary approaches, bariatric surgery has been shown to improve hepatic steatosis and steatohepatitis. This method has been variable in improving hepatic fibrosis. In conclusion, weight loss is crucial to the improvement of NAFLD and NASH, and patients should attempt various diets in an attempt to achieve weight loss. © 2017 American Society for Nutrition.

Weight Loss Interventions in Older Adults with Obesity: A Systematic Review of Randomized Controlled Trials Since 2005

PubMed Central

Batsis, John A.; Gill, Lydia E.; Masutani, Rebecca; Adachi-Mejia, Anna M.; Blunt, Heather B.; Bagley, Pamela J.; Lopez-Jimenez, Francisco; Bartels, Stephen J.

2017-01-01

Objectives To identify geriatric obesity interventions that can guide clinical recommendations. Design Systematic review using Medline (PubMed), Cochrane Central Register of Controlled Trials, Web of Science, CINAHL, EMBASE (Ovid), and PsycINFO (Proquest) from January 1, 2005, to October 12, 2015, to identify English-language randomized controlled trials. Participants Individuals aged 60 and older (mean age ≥65) and classified as having obesity (body mass index ≥30 kg/m2). Interventions Behavioral weight loss interventions not involving pharmacological or procedural therapies lasting 6 months or longer. Measurements Two investigators performed the systematic review using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses criteria and achieved a high concordance rate (97.3%) in summarizing the primary outcomes. The three primary outcomes were weight loss, physical performance, and quality of life. Results Of 5,741 citations, 19 were included. (Six studies were unique, and the remaining 13 were based on the same study population.) Duration ranged from 6 to 18 months (n=405 participants, age range 66.7–71.1). Weight loss in the intervention groups ranged from 0.5 to 10.7 kg (0.1–9.3%). Five studies had a resistance exercise program accompanying a dietary component. Greater weight loss was observed in groups with a dietary component than those with exercise alone. Exercise alone led to better physical function but no significant weight loss. Combined dietary and exercise components led to the greatest improvement in physical performance measures and quality of life and mitigated reductions in muscle and bone mass observed in diet-only study arms. Heterogeneous outcomes were observed, which limited the ability to synthesize the data quantitatively. Conclusions The evidence supporting geriatric obesity interventions to improve physical function and quality of life is of low to moderate quality. Well-designed trials are needed in this population. PMID:27641543

A cost-controlling treatment strategy of adding liraglutide to insulin in type 2 diabetes.

PubMed

de Wit, H M; Vervoort, G M M; de Galan, B E; Tack, C J

2017-09-01

Addition of the GLP-1 receptor agonist liraglutide to insulin can reverse insulin-associated weight gain, improve HbA1c and decrease the need for insulin, but is expensive. From a cost perspective, such treatment should be discontinued when it is clear that treatment targets will not be achieved. Our aim was to find the best cost-controlling treatment strategy: the shortest possible trial period needed to discriminate successfully treated patients from those failing to achieve predefined targets of treatment success. We used data from the 'Effect of Liraglutide on insulin-associated wEight GAiN in patients with Type 2 diabetes' (ELEGANT) trial, comparing additional liraglutide (n = 47) and standard insulin therapy (n = 24) during 26 weeks, to calculate the costs associated with different trial periods. Treatment success after 26 weeks was defined by having achieved ≥ 2 of the following: ≥ 4% weight loss, HbA1c ≤ 53 mmol/mol (7%), and/or discontinuation of insulin. The additional direct costs of adding liraglutide for 26 weeks were € 699 per patient, or € 137 per 1 kg weight loss, compared with standard therapy. The best cost-controlling treatment strategy (identifying 21 of 23 responders, treating four non-responders) was to continue treatment in patients showing ≥ 3% weight loss or ≥ 60% decrease in insulin dose at 8 weeks, with a total cost of € 246 for this t rial period, saving € 453 in case of early discontinuation. An 8-week trial period of adding liraglutide to insulin in patients with insulin-associated weight gain is an effective cost-controlling treatment strategy if the liraglutide is discontinued in patients not showing an early response regarding weight loss or insulin reduction.

Intentional Weight Loss and Changes in Symptoms of Depression: A Systematic Review and Meta-Analysis

PubMed Central

Fabricatore, Anthony N.; Wadden, Thomas A.; Higginbotham, Allison J.; Faulconbridge, Lucy F.; Nguyen, Allison M.; Heymsfield, Steven B.; Faith, Myles S.

2011-01-01

Objective Obesity is related to increased risk of several health complications, including depression. Many studies have reported improvements in mood with weight loss, but results have been equivocal. The present meta-analysis examined changes in symptoms of depression that were reported in trials of weight loss interventions. Between-groups comparisons of different weight loss methods (e.g., lifestyle modification, diet alone, pharmacotherapy) were examined, as were within-group changes for each treatment type. Method MEDLINE was searched for articles published between 1950 and January 2009. Several obesity-related terms were intersected with terms related to depression. Results were filtered to return only studies of human subjects, published in English. Of 5971 articles, 394 were randomized controlled trials. Articles were excluded if they did not report mean changes in weight or symptoms of depression, included children or persons with psychiatric disorders (other than depression), or provided insufficient data for analysis. Thirty-one studies (n = 7937) were included. Two authors independently extracted a description of each study treatment, sample characteristics, assessment methods, and changes in weight and symptoms of depression. Treatments were categorized as: lifestyle modification, non-dieting, dietary counseling, diet-alone, exercise-alone, pharmacotherapy, placebo, or control interventions. Results Random effects models found that lifestyle modification was superior to control and non-dieting interventions for reducing symptoms of depression, and marginally better than dietary counseling and exercise-alone programs. Exercise-alone programs were superior to controls. No differences were found for comparisons of pharmacologic agents and placebos. Within-group analyses found significant reductions in symptoms of depression for nearly all active interventions. A meta-regression found no relationship between changes in weight and changes in symptoms of depression in lifestyle modification interventions. Conclusions On average, obese individuals in weight loss trials experienced reductions in symptoms of depression. Future studies should examine incidence and resolution of clinically significant depressive disorders with weight loss interventions. PMID:21343903

Enhancing physical activity and reducing obesity through smartcare and financial incentives: A pilot randomized trial.

PubMed

Shin, Dong Wook; Yun, Jae Moon; Shin, Jung-Hyun; Kwon, Hyuktae; Min, Hye Yeon; Joh, Hee-Kyung; Chung, Won Joo; Park, Jin Ho; Jung, Kee-Taig; Cho, BeLong

2017-02-01

A pilot randomized trial assessed the feasibility and effectiveness of an intervention combining Smartcare (activity tracker with a smartphone application) and financial incentives. A three-arm, open-label randomized controlled trial design involving traditional education, Smartcare, and Smartcare with financial incentives was involved in this study. The latter group received financial incentives depending on the achievement of daily physical activity goals (process incentive) and weight loss targets (outcome incentive). Male university students (N = 105) with body mass index of ≥27 were enrolled. The average weight loss in the traditional education, Smartcare, and Smartcare with financial incentives groups was -0.4, -1.1, and -3.1 kg, respectively, with significantly greater weight loss in the third group (both Ps < 0.01). The final weight loss goal was achieved by 0, 2, and 10 participants in the traditional education, Smartcare, and Smartcare with financial incentives groups (odds ratio for the Smartcare with financial incentive vs. Smartcare = 7.27, 95% confidence interval: 1.45-36.47). Levels of physical activity were significantly higher in this group. The addition of financial incentives to Smartcare was effective in increasing physical activity and reducing obesity. © 2017 The Obesity Society.

Weight loss effects from vegetable intake: a 12-month randomised controlled trial.

PubMed

Tapsell, L C; Batterham, M J; Thorne, R L; O'Shea, J E; Grafenauer, S J; Probst, Y C

2014-07-01

Direct evidence for the effects of vegetable intake on weight loss is qualified. The study aimed to assess the effect of higher vegetable consumption on weight loss. A single blind parallel controlled trial was conducted with 120 overweight adults (mean body mass index=29.98 kg/m(2)) randomised to two energy deficit healthy diet advice groups differing only by doubling the serving (portion) sizes of vegetables in the comparator group. Data were analysed as intention-to-treat using a linear mixed model. Spearmans rho bivariate was used to explore relationships between percentage energy from vegetables and weight loss. After 12 months, the study sample lost 6.5±5.2 kg (P<0.001 time) with no difference between groups (P>0.05 interaction). Both groups increased vegetable intake and lost weight in the first 3 months, and the change in weight was significantly correlated with higher proportions of energy consumed as vegetables (rho=-0.217, P=0.024). Fasting glucose, insulin and triglyceride levels decreased (P<0.001 time) and high-density lipoprotein cholesterol levels increased (P<0.001 time), with no difference between groups. Weight loss was sustained for 12 months by both groups, but the comparator group reported greater hunger satisfaction (P=0.005). Advice to consume a healthy low-energy diet leads to sustained weight loss, with reductions in cardiovascular disease risk factors regardless of an emphasis on more vegetables. In the short term, consuming a higher proportion of the dietary energy as vegetables may support a greater weight loss and the dietary pattern appears sustainable.

A virtual reality intervention (Second Life) to improve weight maintenance: Rationale and design for an 18-month randomized trial.

PubMed

Sullivan, D K; Goetz, J R; Gibson, C A; Mayo, M S; Washburn, R A; Lee, Y; Ptomey, L T; Donnelly, J E

2016-01-01

Despite the plethora of weight loss programs available in the US, the prevalence of overweight and obesity (BMI≥25kg/m(2)) among US adults continues to rise at least, in part, due to the high probability of weight regain following weight loss. Thus, the development and evaluation of novel interventions designed to improve weight maintenance are clearly needed. Virtual reality environments offer a promising platform for delivering weight maintenance interventions as they provide rapid feedback, learner experimentation, real-time personalized task selection and exploration. Utilizing virtual reality during weight maintenance allows individuals to engage in repeated experiential learning, practice skills, and participate in real-life scenarios without real-life repercussions, which may diminish weight regain. We will conduct an 18-month effectiveness trial (6 months weight loss, 12 months weight maintenance) in 202 overweight/obese adults (BMI 25-44.9kg/m(2)). Participants who achieve ≥5% weight loss following a 6month weight loss intervention delivered by phone conference call will be randomized to weight maintenance interventions delivered by conference call or conducted in a virtual environment (Second Life®). The primary aim of the study is to compare weight change during maintenance between the phone conference call and virtual groups. Secondarily, potential mediators of weight change including energy and macronutrient intake, physical activity, consumption of fruits and vegetables, self-efficacy for both physical activity and diet, and attendance and completion of experiential learning assignments will also be assessed. Copyright © 2015 Elsevier Inc. All rights reserved.

A virtual reality intervention (second life) to improve weight maintenance: Rationale and design for an 18 month randomized trial

PubMed Central

Sullivan, DK; Goetz, JR; Gibson, CA; Mayo, MS; Washburn, RA; Lee, Y; Ptomey, LT; Donnelly, JE

2015-01-01

Despite the plethora of weight loss programs available in the US, the prevalence of overweight and obesity (BMI ≥ 25 kg/m2) among US adults continues to rise at least, in part, due to the high probability of weight regain following weight loss. Thus, the development and evaluation of novel interventions designed to improve weight maintenance is clearly needed. Virtual reality environments offer a promising platform for delivering weight maintenance interventions as they provide rapid feedback, learner experimentation, real-time personalized task selection and exploration. Utilizing virtual reality during weight maintenance allows individuals to engage in repeated experiential learning, practice skills, and participate in real-life scenarios without reallife repercussions, which may diminish weight regain. We will conduct an 18-month effectiveness trial (6 months weight loss, 12 months weight maintenance) in 202 overweight/obese adults (BMI 25–44.9 kg/m2). Participants who achieve ≥ 5% weight loss following a 6 month weight loss intervention delivered by phone conference call will be randomized to weight maintenance interventions delivered by conference call or conducted in a virtual environment (Second Life®). The primary aim of the study is to compare weight change during maintenance between the phone conference call and virtual groups. Secondarily, potential mediators of weight change including energy and macronutrient intake, physical activity, consumption of fruits and vegetables, self-efficacy for both physical activity and diet, and attendance and completion of experiential learning assignments will also be assessed. PMID:26616535

Effectiveness of 6 Months of Tailored Text Message Reminders for Obese Male Participants in a Worksite Weight Loss Program: Randomized Controlled Trial

PubMed Central

Oh, Sohee; Steinhubl, Steven; Kim, Sohye; Bae, Woo Kyung; Han, Jong Soo; Kim, Jeong-Hyun; Lee, Keehyuck; Kim, Mi Jin

2015-01-01

Background Worksite nutrition and physical activity interventions are important to help overweight and obese employees lose weight, but costs and insufficient sustained motivation prevent the majority of these programs from succeeding. Tailored text messaging in aiding weight management has been effective in several studies, but no studies have evaluated the effect of a tailored text message service on weight loss in a worksite health promotion program. Objective We studied the efficacy of a tailored text-messaging intervention for obese male participants in a worksite weight loss program of 6 months duration. Methods The study was an unblinded, randomized controlled trial. Men with a body mass index greater than 25 kg/m2 were recruited from the Korea District Heating Corporation, the Korea Expressway Corporation, and the Korea Gas Corporation. The participants were identified by nurse managers. Participants were randomly allocated to 1 of the following 2 groups for 24 weeks: (1) intervention group, which received tailored text message reminders every other day plus 4 offline education sessions and brief counseling with monthly weight check by nurses for weight control over 6 months and (2) control group, which received the 4 offline education sessions and brief counseling with monthly weight check by nurses about weight control over 6 months. The primary outcome was the difference in weight loss at 6 months. A mixed-model repeated-measures analysis was performed to evaluate the effect of the intervention group’s weight loss compared with the control group. Results A total of 205 obese men were randomized into either the intervention (n=104) or the control group (n=101). At the end of 6 months, the intervention group (n=63) had lost 1.71 kg (95% CI –2.53 to –0.88) and the control group (n=59) had lost 1.56 kg (95% CI –2.45 to –0.66); the difference between the 2 groups was not significant (mean difference –0.15, 95% CI –1.36 to 1.07). At the end of the study, 60% (34/57) of the intervention group rated the message program as helpful for weight control and 46% (26/57) would recommend the text message service to their friends. Conclusions Tailored text message reminders did not have a significant effect on weight loss in obese men as part of a worksite weight loss program. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 39629189; http://www.isrctn.com/ISRCTN39629189?q=39629189&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10&searchType=basic-search (Archived by WebCite at http://www.webcitation.org/6VsFkwJH6). PMID:25648325

The design and conduct of Keep It Off: An online randomized trial of financial incentives for weight-loss maintenance.

PubMed

Shaw, Pamela A; Yancy, William S; Wesby, Lisa; Ulrich, Victoria; Troxel, Andrea B; Huffman, David; Foster, Gary D; Volpp, Kevin

2017-02-01

Background Obesity continues to be a serious public health challenge. Rates are increasing worldwide, with nearly 70% of the US adults overweight or obese, leading to increased clinical and economic burden. While successful approaches for achieving weight loss have been identified, techniques for long-term maintenance of initial weight loss have largely been unsuccessful. Financial incentive interventions have been shown in several settings to be successful in motivating participants to adopt healthy behaviors. Purpose Keep It Off is a three-arm randomized controlled trial that compares the efficacy of a lottery-based incentive, traditional direct payment incentive, and control of daily feedback without any incentive for weight-loss maintenance. This design allows comparison of a traditional direct payment incentive with one based on behavioral economic principles that consider the underlying psychology of decision-making. Methods Participants were randomized in a 2:1 ratio for each active arm relative to control, with a targeted 188 participants in total. Eligible participants were those aged 30-80 who lost at least 11 lb (5 kg) during the first 4 months of participation in Weight Watchers, a national weight-loss program, with whom we partnered. The interventions lasted 6 months (Phase I); participants were followed for an additional 6 months without intervention (Phase II). The primary outcome is weight change from baseline to the end of Phase I, with the change at the end of Phase II a key secondary endpoint. Keep It Off is a pragmatic trial that recruited, consented, enrolled, and followed patients electronically. Participants were provided a wireless weight scale that electronically transmitted daily self-monitored weights. Weights were verified every 3 months at a Weight Watchers center local to the participant and electronically transmitted. Results Using the study web-based platform, we integrated recruitment, enrollment, and follow-up procedures into a digital platform that required little staff effort to implement and manage. We randomized 191 participants in less than 1 year. We describe the design of Keep It Off and implementation of enrollment. Lessons Learned We demonstrated that our pragmatic design was successful in rapid accrual of participants in a trial of interventions to maintain weight loss. Limitations Despite the nationwide reach of Weight Watchers, the generalizability of study findings may be limited by the characteristics of its members. The interventions under study are appropriate for settings where an entity, such as an employer or health insurance company, could offer them as a benefit. Conclusions Keep It Off was implemented and conducted with minimal staff effort. This study has the potential to identify a practical and effective weight-loss maintenance strategy.

The design and conduct of Keep It Off: An online randomized trial of financial incentives for weight loss maintenance

PubMed Central

Shaw, Pamela A; Yancy, William S; Wesby, Lisa; Ulrich, Victoria; Troxel, Andrea B; Huffman, David; Foster, Gary D; Volpp, Kevin

2016-01-01

Background Obesity continues to be a serious public health challenge. Rates are increasing worldwide, with nearly 70% of US adults overweight or obese, leading to increased clinical and economic burden. While successful approaches for achieving weight loss have been identified, techniques for long-term maintenance of initial weight loss have largely been unsuccessful. Financial incentive interventions have been shown in several settings to be successful in motivating participants to adopt healthy behaviors. Purpose Keep It Off is a three-arm randomized controlled trial that compares the efficacy of a lottery-based incentive, traditional direct payment incentive, and control of daily feedback without any incentive, for weight loss maintenance. This design allows comparison of a traditional direct payment incentive with one based on behavioral economic principles that consider the underlying psychology of decision-making. Methods Participants were randomized in a 2:1 ratio for each active arm relative to control, with a targeted 188 participants total. Eligible participants were those aged 30–80 who lost at least 11 pounds (lb, 5 kilograms (kg)) during the first 4 months of participation in Weight Watchers, a national weight loss program, with whom we partnered. The interventions lasted 6 months (Phase I); participants were followed for 6 additional months without intervention (Phase II). The primary outcome is weight change from baseline to the end of Phase I, with the change at the end of Phase II a key secondary endpoint. Keep It Off is a pragmatic trial that recruited, consented, enrolled and followed patients electronically. Participants were provided a wireless weight scale that electronically transmitted daily self-monitored weights. Weights were verified every 3 months at a Weight Watchers center local to the participant and electronically transmitted. Results Using the study web-based platform, we integrated recruitment, enrollment and follow-up procedures into a digital platform that required little staff effort to implement and manage. We randomized 191 participants in less than one year. We describe the design of Keep It Off and implementation of enrollment. Lessons Learned We demonstrated that our pragmatic design was successful in rapid accrual of participants in a trial of interventions to maintain weight loss. Limitations Despite the nationwide reach of Weight Watchers, the generalizability of study findings may be limited by the characteristics of its members. The interventions under study are appropriate for settings where an entity, such as an employer or health insurance company, could offer them as a benefit. Conclusions Keep It Off was implemented and conducted with minimal staff effort. This study has the potential to identify a practical and effective weight loss maintenance strategy. PMID:27646508

High-protein, low-fat diets are effective for weight loss and favorably alter biomarkers in healthy adults.

PubMed

Johnston, Carol S; Tjonn, Sherrie L; Swan, Pamela D

2004-03-01

Although popular and effective for weight loss, low-carbohydrate, high-protein, high-fat (Atkins) diets have been associated with adverse changes in blood and renal biomarkers. High-protein diets low in fat may represent an equally appealing diet plan but promote a more healthful weight loss. Healthy adults (n = 20) were randomly assigned to 1 of 2 low-fat (<30% energy), energy-restricted groups: high-protein (30% energy) or high-carbohydrate (60% energy); 24-h intakes were strictly controlled during the 6-wk trial. One subject from each group did not complete the trial due to out-of-state travel; two subjects in the high-carbohydrate group withdrew from the trial due to extreme hunger. Body composition and metabolic indices were assessed pre- and post-trial. Both diets were equally effective at reducing body weight (-6%, P < 0.05) and fat mass (-9 to -11%, P < 0.05); however, subjects consuming the high-protein diet reported more satisfaction and less hunger in mo 1 of the trial. Both diets significantly lowered total cholesterol (-10 to -12%), insulin (-25%), and uric acid (-22 to -30%) concentrations in blood from fasting subjects. Urinary calcium excretion increased 42% in subjects consuming the high-protein diet, mirroring the 50% increase in dietary calcium with consumption of this diet; thus, apparent calcium balance was not adversely affected. Creatinine clearance was not altered by diet treatments, and nitrogen balance was more positive in subjects consuming the high-protein diet vs. the high-carbohydrate diet (3.9 +/- 1.4 and 0.7 +/- 1.7 g N/d, respectively, P < 0.05). Thus, low-fat, energy-restricted diets of varying protein content (15 or 30% energy) promoted healthful weight loss, but diet satisfaction was greater in those consuming the high-protein diet.

Who responds to financial incentives for weight loss? Evidence from a randomized controlled trial.

PubMed

Paloyo, Alfredo R; Reichert, Arndt R; Reuss-Borst, Monika; Tauchmann, Harald

2015-11-01

There is a paucity of evidence on the heterogeneous impacts of financial incentives on weight loss. Between March 2010 and January 2012, in a randomized controlled trial, we assigned 700 obese persons to three experimental arms. We test whether particular subgroups react differently to financial incentives for weight loss. Two treatment groups obtained a cash reward (€150 and €300 with 237 and 229 participants, respectively) for achieving an individually-assigned target weight within four months; the control group (234 participants) was not incentivized. Participants and administrators were not blinded to the intervention. We find that monetary rewards effectively induced obese individuals to reduce weight across all subgroups. However, there is no evidence for treatment-effect heterogeneity for those groups that were incentivized. Among those who were in the €300 group, statistically significant and large weight losses were observed for women, singles, and those who are not working (all above 4 kg in four months). In addition, the magnitude of the reward matters only for women and migrants. The effectiveness of financial incentives to reduce weight nevertheless raises sensitive ethical issues that should be taken into consideration by policymakers. Copyright © 2015 Elsevier Ltd. All rights reserved.

SMART trial: A randomized clinical trial of self-monitoring in behavioral weight management-design and baseline findings

PubMed Central

Burke, Lora E.; Styn, Mindi A.; Glanz, Karen; Ewing, Linda J.; Elci, Okan U.; Conroy, Margaret B.; Sereika, Susan M.; Acharya, Sushama D.; Music, Edvin; Keating, Alison L.; Sevick, Mary Ann

2009-01-01

Background The primary form of treatment for obesity today is behavioral therapy. Self-monitoring diet and physical activity plays an important role in interventions targeting behavior and weight change. The SMART weight loss trial examined the impact of replacing the standard paper record used for self-monitoring with a personal digital assistant (PDA). This paper describes the design, methods, intervention, and baseline sample characteristics of the SMART trial. Methods The SMART trial used a 3-group design to determine the effects of different modes of self-monitoring on short- and long-term weight loss and on adherence to self-monitoring in a 24-month intervention. Participants were randomized to one of three conditions (1) use of a standard paper record (PR); (2) use of a PDA with dietary and physical activity software (PDA); or (3), use of a PDA with the same software plus a customized feedback program (PDA + FB). Results We screened 704 individuals and randomized 210. There were statistically but not clinically significant differences among the three cohorts in age, education, HDL cholesterol, blood glucose and systolic blood pressure. At 24 months, retention rate for the first of three cohorts was 90%. Conclusions To the best of our knowledge, the SMART trial is the first large study to compare different methods of self-monitoring in a behavioral weight loss intervention and to compare the use of PDAs to conventional paper records. This study has the potential to reveal significant details about self-monitoring patterns and whether technology can improve adherence to this vital intervention component. PMID:19665588

Does Armodafinil Improve Driving Task Performance and Weight Loss in Sleep Apnea? A Randomized Trial.

PubMed

Chapman, Julia Louise; Cayanan, Elizabeth Anne; Hoyos, Camilla Miranda; Serinel, Yasmina; Comas, Maria; Yee, Brendon John; Wong, Keith Keat Huat; Grunstein, Ronald Robert; Marshall, Nathaniel Stuart

2018-05-18

RATIONALE Obstructive sleep apnea (OSA) patients unable to tolerate standard treatments have few alternatives. They may benefit from weight loss, but the major symptom of daytime performance impairment may remain during weight loss programs. OBJECTIVES We hypothesized that wakefulness-promoter armodafinil would improve driving task performance over placebo in patients undergoing weight loss. METHODS Placebo-controlled, double-blind, randomized trial of Armodafinil vs Placebo daily for 6 months in patients who were also randomized to one of two diets for six months with follow-up at one year in overweight, adult, OSA patients who had rejected standard treatment and suffered daytime sleepiness. MEASUREMENTS Primary outcome: change in steering deviation in the final 30 minutes of a 90 minute afternoon driving task (AusED) at six months. Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, fat mass measured by dual-emission X-ray absorptiometry (DXA). MAIN RESULTS Armodafinil improved driving task performance over placebo at three months (12.9cm, 95%CI 4.1 to 21.7, p=0.004), but not the primary timepoint of six months (5.5cm, 95%CI -3.3 to 14.3, p=0.223). Patients on armodafinil lost 2.4kg more fat than those on placebo at six months (95%CI 0.9 to 4.0, p=0.002). Other secondary outcomes were not significantly improved. CONCLUSIONS Armodafinil did not improve driving task performance at the primary endpoint of six months. Armodafinil might be a useful adjunctive to weight loss in OSA patients rejecting conventional treatments but this needs to be directly tested in a specifically designed, properly powered clinical trial. Clinical trial registration available at www.anzctr.org.au, ID ACTRN12611000847910.

Effects of high protein diets on fat-free mass and muscle protein synthesis following weight loss: a randomized controlled trial

USDA-ARS?s Scientific Manuscript database

Context: The benefits of high protein diets for sparing lean body mass and sustaining skeletal muscle protein metabolism during short-term weight loss in normal-weight adults are not well described. Objective: Determine the effects of varying levels of dietary protein intake on body compos...

Patient preferences and performance bias in a weight loss trial with a usual care arm☆☆☆

PubMed Central

McCambridge, Jim; Sorhaindo, Annik; Quirk, Alan; Nanchahal, Kiran

2014-01-01

Objectives This qualitative study examines performance bias, i.e. unintended differences between groups, in the context of a weight loss trial in which a novel patient counseling program was compared to usual care in general practice. Methods 14/381 consecutive interviewees (6 intervention group, 8 control group) within the CAMWEL (Camden Weight Loss) effectiveness trial process study were asked about their engagement with various features of the research study and a thematic content analysis undertaken. Results Decisions to participate were interwoven with decisions to change behavior, to the extent that for many participants the two were synonymous. The intervention group were satisfied with their allocation. The control group spoke of their disappointment at having been offered usual care when they had taken part in the trial to access new forms of help. Reactions to disappointment involved both movements toward and away from behavior change. Conclusion There is a prima facie case that reactions to disappointment may introduce bias, as they lead the randomized groups to differ in ways other than the intended experimental contrast. Practice implications In-depth qualitative studies nested within trials are needed to understand better the processes through which bias may be introduced. PMID:24492159

Study protocol for Log2Lose: A feasibility randomized controlled trial to evaluate financial incentives for dietary self-monitoring and interim weight loss in adults with obesity.

PubMed

Voils, Corrine I; Levine, Erica; Gierisch, Jennifer M; Pendergast, Jane; Hale, Sarah L; McVay, Megan A; Reed, Shelby D; Yancy, William S; Bennett, Gary; Strawbridge, Elizabeth M; White, Allison C; Shaw, Ryan J

2018-02-01

The obesity epidemic has negative physical, psychological, and financial consequences. Despite the existence of effective behavioral weight loss interventions, many individuals do not achieve adequate weight loss, and most regain lost weight in the year following intervention. We report the rationale and design for a 2×2 factorial study that involves financial incentives for dietary self-monitoring (yes vs. no) and/or interim weight loss (yes vs. no). Outpatients with obesity participate in a 24-week, group-based weight loss intervention. All participants are asked to record their daily dietary and liquid intake on a smartphone application (app) and to weigh themselves daily at home on a study-provided cellular scale. An innovative information technology (IT) solution collates dietary data from the app and weight from the scale. Using these data, an algorithm classifies participants weekly according to whether they met their group's criteria to receive a cash reward ranging from $0 to $30 for dietary self-monitoring and/or interim weight loss. Notice of the reward is provided via text message, and credit is uploaded to a gift card. This pilot study will provide information on the feasibility of using this novel IT solution to provide variable-ratio financial incentives in real time via its effects on recruitment, intervention adherence, retention, and cost. This study will provide the foundation for a comprehensive, adequately-powered, randomized controlled trial to promote short-term weight loss and long-term weight maintenance. If efficacious, this approach could reduce the prevalence, adverse outcomes, and costs of obesity for millions of Americans. Clinicaltrials.gov registration: NCT02691260. Published by Elsevier Inc.

A 12-week commercial web-based weight-loss program for overweight and obese adults: randomized controlled trial comparing basic versus enhanced features.

PubMed

Collins, Clare E; Morgan, Philip J; Jones, Penelope; Fletcher, Kate; Martin, Julia; Aguiar, Elroy J; Lucas, Ashlee; Neve, Melinda J; Callister, Robin

2012-04-25

The development and use of Web-based programs for weight loss is increasing rapidly, yet they have rarely been evaluated using randomized controlled trials (RCTs). Interestingly, most people who attempt weight loss use commercially available programs, yet it is very uncommon for commercial programs to be evaluated independently or rigorously. To compare the efficacy of a standard commercial Web-based weight-loss program (basic) versus an enhanced version of this Web program that provided additional personalized e-feedback and contact from the provider (enhanced) versus a wait-list control group (control) on weight outcomes in overweight and obese adults. This purely Web-based trial using a closed online user group was an assessor-blinded RCT with participants randomly allocated to the basic or enhanced 12-week Web-based program, based on social cognitive theory, or the control, with body mass index (BMI) as the primary outcome. We enrolled 309 adults (129/309, 41.8% male, BMI mean 32.3, SD 4 kg/m(2)) with 84.1% (260/309) retention at 12 weeks. Intention-to-treat analysis showed that both intervention groups reduced their BMI compared with the controls (basic: -0.72, SD 1.1 kg/m(2), enhanced: -1.0, SD 1.4, control: 0.15, SD 0.82; P < .001) and lost significant weight (basic: -2.1, SD 3.3 kg, enhanced: -3.0, SD 4.1, control: 0.4, SD 2.3; P < .001) with changes in waist circumference (basic: -2.0, SD 3.5 cm, enhanced: -3.2, SD 4.7, control: 0.5, SD 3.0; P < .001) and waist-to-height ratio (basic: -0.01, SD 0.02, enhanced: -0.02, SD 0.03, control: 0.0, SD 0.02; P < .001), but no differences were observed between the basic and enhanced groups. The addition of personalized e-feedback and contact provided limited additional benefits compared with the basic program. A commercial Web-based weight-loss program can be efficacious across a range of weight-related outcomes and lifestyle behaviors and achieve clinically important weight loss. Although the provision of additional personalized feedback did not facilitate greater weight loss after 12 weeks, the impact of superior participant retention on longer-term outcomes requires further study. Further research is required to determine the optimal mix of program features that lead to the biggest treatment impact over time. Australian New Zealand Clinical Trials Registry (ANZCTR): 12610000197033.

Dietary interventions for weight loss and cardiovascular risk reduction in people of African ancestry (blacks): a systematic review.

PubMed

Osei-Assibey, G; Boachie, C

2012-01-01

To systematically review weight and cardiovascular risk reduction in blacks by diet and lifestyle changes. Randomised and non-randomised controlled trials of diet with/without lifestyle changes with duration of intervention ≥3 months, and published between January 1990 and December 2009, were searched in electronic databases including MEDLINE, EMBASE, CINAHL and CCTR (Cochrane Controlled Trials Register). Studies were included if they reported weight/BMI changes with changes in at least one of the following: systolic and diastolic blood pressure, fasting plasma lipids and glucose, and glycated haemoglobin. Clinical, community and church-based interventions. Study participants were of African ancestry (blacks). Eighteen studies met the inclusion criteria. Average mean difference in weight loss was -2·66 kg, with improvements in all outcomes except total cholesterol. No significant difference was observed in outcome measures between all studies and studies that recruited only healthy participants or patients with type 2 diabetes. Diet and lifestyle changes result in weight loss with improvements in cardiovascular risk factors in blacks. However, more culturally tailored programmes have been suggested to motivate and encourage blacks to participate in intervention trials.

Effects of Popular Diets without Specific Calorie Targets on Weight Loss Outcomes: Systematic Review of Findings from Clinical Trials

PubMed Central

Anton, Stephen D.; Hida, Azumi; Heekin, Kacey; Sowalsky, Kristen; Karabetian, Christy; Mutchie, Heather; Leeuwenburgh, Christiaan; Manini, Todd M.; Barnett, Tracey E.

2017-01-01

The present review examined the evidence base for current popular diets, as listed in the 2016 U.S. News & World Report, on short-term (≤six months) and long-term (≥one year) weight loss outcomes in overweight and obese adults. For the present review, all diets in the 2016 U.S. News & World Report Rankings for “Best Weight-Loss Diets”, which did not involve specific calorie targets, meal replacements, supplementation with commercial products, and/or were not categorized as “low-calorie” diets were examined. Of the 38 popular diets listed in the U.S. News & World Report, 20 met our pre-defined criteria. Literature searches were conducted through PubMed, Cochrane Library, and Web of Science using preset key terms to identify all relevant clinical trials for these 20 diets. A total of 16 articles were identified which reported findings of clinical trials for seven of these 20 diets: (1) Atkins; (2) Dietary Approaches to Stop Hypertension (DASH); (3) Glycemic-Index; (4) Mediterranean; (5) Ornish; (6) Paleolithic; and (7) Zone. Of the diets evaluated, the Atkins Diet showed the most evidence in producing clinically meaningful short-term (≤six months) and long-term (≥one-year) weight loss. Other popular diets may be equally or even more effective at producing weight loss, but this is unknown at the present time since there is a paucity of studies on these diets. PMID:28758964

An overview of the Families Improving Together (FIT) for weight loss randomized controlled trial in African American families.

PubMed

Wilson, Dawn K; Kitzman-Ulrich, Heather; Resnicow, Ken; Van Horn, M Lee; St George, Sara M; Siceloff, E Rebekah; Alia, Kassandra A; McDaniel, Tyler; Heatley, VaShawn; Huffman, Lauren; Coulon, Sandra; Prinz, Ron

2015-05-01

The Families Improving Together (FIT) randomized controlled trial tests the efficacy of integrating cultural tailoring, positive parenting, and motivational strategies into a comprehensive curriculum for weight loss in African American adolescents. The overall goal of the FIT trial is to test the effects of an integrated intervention curriculum and the added effects of a tailored web-based intervention on reducing z-BMI in overweight African American adolescents. The FIT trial is a randomized group cohort design the will involve 520 African American families with an overweight adolescent between the ages of 11-16 years. The trial tests the efficacy of an 8-week face-to-face group randomized program comparing M + FWL (Motivational Plus Family Weight Loss) to a comprehensive health education program (CHE) and re-randomizes participants to either an 8-week on-line tailored intervention or control on-line program resulting in a 2 (M + FWL vs. CHE group) × 2 (on-line intervention vs. control on-line program) factorial design to test the effects of the intervention on reducing z-BMI at post-treatment and at 6-month follow-up. The interventions for this trial are based on a theoretical framework that is novel and integrates elements from cultural tailoring, Family Systems Theory, Self-Determination Theory and Social Cognitive Theory. The intervention targets positive parenting skills (parenting style, monitoring, communication); cultural values; teaching parents to increase youth motivation by encouraging youth to have input and choice (autonomy-support); and provides a framework for building skills and self-efficacy through developing weight loss action plans that target goal setting, monitoring, and positive feedback. Copyright © 2015. Published by Elsevier Inc.

Daily Self-Monitoring of Body Weight, Step Count, Fruit/Vegetable Intake and Water Consumption: A Feasible and Effective Long-Term Weight Loss Maintenance Approach

PubMed Central

Akers, Jeremy D.; Cornett, Rachel A.; Savla, Jyoti S.; Davy, Kevin P.; Davy, Brenda M.

2012-01-01

Maintenance of weight loss remains a challenge for most individuals, thus practical and effective weight loss maintenance (WTLM) strategies are needed. A two-group (WEV versus WEV+) 12-month WTLM intervention trial was conducted (June 2007–February 2010) to determine the feasibility and effectiveness of weight loss maintenance intervention for older adults using daily self-monitoring of body weight, step count, fruit/vegetable intake and water consumption. Forty weight-reduced (mean weight lost = 6.7 ± 0.6 kg; BMI 29.2 ± 1.1 kg/m2) individuals aged 63 ± 1 yrs, who had previously participated in a 12-week randomized controlled weight loss intervention trial, were instructed to record daily body weight (Weight), step count (Exercise), and fruit/vegetable intake (Vegetable). Experimental group (WEV+) participants were also instructed to consume 16 floz of water before each main meal (i.e., three times daily), and to record daily water intake. Outcome measures included weight change, diet/physical activity behaviors, theoretical constructs related to health behaviors, and other clinical measures. Statistical analyses included growth curve analyses and repeated measures ANOVA. Over 12 months, there was a linear decline in weight (β = −0.32, P < 0.001) and a quadratic trend (β = 0.02, P < 0.01) over time, but no group difference (β = −0.23, P = 0.08). Analysis of the 365 days of self-reported body weight for each participant determined that weight loss was greater over the study period in WEV+ than WEV, corresponding to weight changes of −0.67 kg and 1.00 kg respectively, and an 87% greater weight loss (β = −0.01, P < 0.01). Overall compliance to daily tracking was 76 ± 5%. Daily self-monitoring of weight, physical activity, and fruit/vegetable consumption is a feasible and effective approach for maintaining weight loss for 12 months, and daily self-monitoring of increased water consumption may provide additional WTLM benefits. PMID:22709772

Acarbose monotherapy and weight loss in Eastern and Western populations with hyperglycaemia: an ethnicity-specific meta-analysis.

PubMed

Li, Y; Tong, Y; Zhang, Y; Huang, L; Wu, T; Tong, N

2014-11-01

To demonstrate if weight loss achieved with acarbose in individuals with hyperglycaemia differs between Eastern and Western populations. Databases and reference lists of clinical trials on acarbose were searched. Eligible studies were randomised controlled trials of acarbose monotherapy in populations with hyperglycaemia of more than 12-week duration that provided data on body weight (BW) or body mass index (BMI). A total of 34 trials (6082 participants) were included. The effect of acarbose on BW was superior to that of placebo [weighted mean difference (WMD) = -0.52, 95% confidence interval (CI) -0.78 to -0.25], nateglinide (WMD = -1.33, 95% CI -1.51 to -0.75) and metformin (WMD = -0.67, 95% CI -1.14 to -0.20). Compared with placebo, there was a significantly greater weight loss of 0.92 kg (p < 0.05, I(2)  = 88.8%) with acarbose in Eastern populations (WMD = -1.20, 95% CI -1.51 to -0.75) than that in Western populations (WMD = -0.28, 95% CI -0.59 to 0.03). Across all studies, the acarbose group achieved a significantly larger absolute weight loss of (change from baseline) 1.35 kg (p < 0.05, I(2)  = 94.3%) in Eastern populations (WMD = -2.26, 95% CI -2.70 to -1.81) than in Western populations (WMD = -0.91, 95% CI -1.36 to -0.47). Nevertheless, the possible risk of bias in Eastern studies may influence the results. The effect of acarbose on weight loss seems to be more pronounced in Eastern than in Western populations with hyperglycaemia, and is superior to that of placebo, nateglinide and metformin across both ethnicities. © 2014 John Wiley & Sons Ltd.

Effect of Allowing Choice of Diet on Weight Loss: A Randomized Trial.

PubMed

Yancy, William S; Mayer, Stephanie B; Coffman, Cynthia J; Smith, Valerie A; Kolotkin, Ronette L; Geiselman, Paula J; McVay, Megan A; Oddone, Eugene Z; Voils, Corrine I

2015-06-16

Choosing a diet rather than being prescribed one could improve weight loss. To examine whether offering choice of diet improves weight loss. Double-randomized preference trial of choice between 2 diets (choice) versus random assignment to a diet (comparator) over 48 weeks. (ClinicalTrials.gov: NCT01152359). Outpatient clinic at a Veterans Affairs medical center. Outpatients with a body mass index of at least 30 kg/m2. Choice participants received information about their food preferences and 2 diet options (low-carbohydrate diet [LCD] or low-fat diet [LFD]) before choosing and were allowed to switch diets at 12 weeks. Comparator participants were randomly assigned to 1 diet for 48 weeks. Both groups received group and telephone counseling for 48 weeks. The primary outcome was weight at 48 weeks. Of 105 choice participants, 61 (58%) chose the LCD and 44 (42%) chose the LFD; 5 (3 on the LCD and 2 on the LFD) switched diets at 12 weeks, and 87 (83%) completed measurements at 48 weeks. Of 102 comparator participants, 53 (52%) were randomly assigned to the LCD and 49 (48%) were assigned to the LFD; 88 (86%) completed measurements. At 48 weeks, estimated mean weight loss was 5.7 kg (95% CI, 4.3 to 7.0 kg) in the choice group and 6.7 kg (CI, 5.4 to 8.0 kg) in the comparator group (mean difference, -1.1 kg [CI, -2.9 to 0.8 kg]; P = 0.26). Secondary outcomes of dietary adherence, physical activity, and weight-related quality of life were similar between groups at 48 weeks. Only 2 diet options were provided. Results from this sample of older veterans might not be generalizable to other populations. Contrary to expectations, the opportunity to choose a diet did not improve weight loss.

A lipid-based nutrient supplement mitigates weight loss among HIV-infected women in a factorial randomized trial to prevent mother-to-child transmission during exclusive breastfeeding.

PubMed

Kayira, Dumbani; Bentley, Margaret E; Wiener, Jeffrey; Mkhomawanthu, Chimwemwe; King, Caroline C; Chitsulo, Phindile; Chigwenembe, Maggie; Ellington, Sascha; Hosseinipour, Mina C; Kourtis, Athena P; Chasela, Charles; Tembo, Martin; Tohill, Beth; Piwoz, Ellen G; Jamieson, Denise J; van der Horst, Charles; Adair, Linda

2012-03-01

Breastfeeding increases metabolic demands on the mother, and excessive postnatal weight loss increases maternal mortality. We evaluated the efficacy of a lipid-based nutrient supplement (LNS) for prevention of excess weight loss in breastfeeding, HIV-infected women. The BAN (Breastfeeding, Antiretrovirals, and Nutrition) Study was a randomized controlled trial in Lilongwe, Malawi. At delivery, HIV-infected mothers and their infants were randomly assigned according to a 2-arm (with and without LNS) by 3-arm (maternal triple-antiretroviral prophylaxis, infant-nevirapine prophylaxis, or neither) factorial design. The 28-wk LNS intervention provided daily energy (700 kcal), protein (20 g), and micronutrients (except for vitamin A) to meet lactation needs. Women were counseled to breastfeed exclusively for 24 wk and to wean by 28 wk. Weight change (0-28 wk) was tested in an intent-to-treat analysis by using 2-factor ANOVA and with longitudinal mixed-effects models. At delivery, the LNS (n = 1184) and control (n = 1185) groups had similar mean weights and BMIs. Women receiving the LNS had less 0-28-wk weight loss (-1.97 compared with -2.56 kg, P = 0.003). This difference remained significant after adjustment for maternal antiretroviral drug therapy and baseline BMI. Women receiving antiretroviral drugs had more weight loss than did those not receiving antiretroviral drugs (-2.93 compared with -1.90 kg, P < 0.001). The benefit of the LNS for reducing weight loss was observed both in those receiving antiretroviral drugs (-2.56 compared with -3.32 kg, P = 0.019) and in those not receiving antiretroviral drugs (-1.63 compared with -2.16 kg, P = 0.034). The LNS reduced weight loss among HIV-infected, breastfeeding women, both in those taking maternal antiretroviral prophylaxis to prevent postnatal HIV transmission and in those not receiving antiretroviral prophylaxis. Provision of an LNS may benefit HIV-infected, breastfeeding women in resource-limited settings. This trial was registered at clinicaltrials.gov as NCT00164762.

Multicenter, placebo-controlled trial of lorcaserin for weight management.

PubMed

Smith, Steven R; Weissman, Neil J; Anderson, Christen M; Sanchez, Matilde; Chuang, Emil; Stubbe, Scott; Bays, Harold; Shanahan, William R

2010-07-15

Lorcaserin is a selective serotonin 2C receptor agonist that could be useful in reducing body weight. In this double-blind clinical trial, we randomly assigned 3182 obese or overweight adults (mean body-mass index [the weight in kilograms divided by the square of the height in meters] of 36.2) to receive lorcaserin at a dose of 10 mg, or placebo, twice daily for 52 weeks. All patients also underwent diet and exercise counseling. At week 52, patients in the placebo group continued to receive placebo but patients in the lorcaserin group were randomly reassigned to receive either placebo or lorcaserin. Primary outcomes were weight loss at 1 year and maintenance of weight loss at 2 years. Serial echocardiography was used to identify patients in whom valvulopathy (as defined by the Food and Drug Administration) developed. At 1 year, 55.4% of patients (883 of 1595) receiving lorcaserin and 45.1% of patients (716 of 1587) receiving placebo remained in the trial; 1553 patients continued into year 2. At 1 year, 47.5% of patients in the lorcaserin group and 20.3% in the placebo group had lost 5% or more of their body weight (P<0.001), corresponding to an average loss of 5.8+/-0.2 kg with lorcaserin and 2.2+/-0.1 kg with placebo during year 1 (P<0.001). Among the patients who received lorcaserin during year 1 and who had lost 5% or more of their baseline weight at 1 year, the loss was maintained in more patients who continued to receive lorcaserin during year 2 (67.9%) than in patients who received placebo during year 2 (50.3%, P<0.001). Among 2472 patients evaluated at 1 year and 1127 evaluated at 2 years, the rate of cardiac valvulopathy was not increased with the use of lorcaserin. Among the most frequent adverse events reported with lorcaserin were headache, dizziness, and nausea. The rates of serious adverse events in the two groups were similar. In conjunction with behavioral modification, lorcaserin was associated with significant weight loss and improved maintenance of weight loss, as compared with placebo. (Funded by Arena Pharmaceuticals; ClinicalTrials.gov number, NCT00395135.) 2010 Massachusetts Medical Society

Orlistat. No hurry....

PubMed Central

1999-01-01

Treatments for obesity are disappointing. None has yet shown an effect on morbidity and mortality. Nondrug treatments are poorly assessed. Stable long-term weight loss necessitates long-term management. Orlistat (Xenical, Hoffman-La Roche), a gastrointestinal lipase inhibitor, is indicated, in combination with a low-calorie diet, for management of obesity. The assessment file is bulky and methodologically sound, at least in terms of the weight loss end point. During medium-term trials (12 to 24 months), orlistat administered at a dose of 120 mg three times daily and combined with dietary intervention had a moderate positive effect on body weight (-3.5 kg on average). No longer-term trials have been done. It is unknown whether this drug affects morbidity and mortality linked to obesity. In clinical trials, patients treated with orlistat had an increased frequency of breast cancer. This potential risk is currently being assessed in a specific trial. Gastrointestinal adverse effects are frequent. Treatment is costly. PMID:10540693

Group motivational intervention in overweight/obese patients in primary prevention of cardiovascular disease in the primary healthcare area

PubMed Central

2010-01-01

Background The global mortality caused by cardiovascular disease increases with weight. The Framingham study showed that obesity is a cardiovascular risk factor independent of other risks such as type 2 diabetes mellitus, dyslipidemia and smoking. Moreover, the main problem in the management of weight-loss is its maintenance, if it is achieved. We have designed a study to determine whether a group motivational intervention, together with current clinical practice, is more efficient than the latter alone in the treatment of overweight and obesity, for initial weight loss and essentially to achieve maintenance of the weight achieved; and, secondly, to know if this intervention is more effective for reducing cardiovascular risk factors associated with overweight and obesity. Methods This 26-month follow up multi-centre trial, will include 1200 overweight/obese patients. Random assignment of the intervention by Basic Health Areas (BHA): two geographically separate groups have been created, one of which receives group motivational intervention (group intervention), delivered by a nurse trained by an expert phsychologist, in 32 group sessions, 1 to 12 fortnightly, and 13 to 32, monthly, on top of their standard program of diet, exercise, and the other (control group), receiving the usual follow up, with regular visits every 3 months. Discussion By addressing currently unanswered questions regarding the maintenance in weight loss in obesity/overweight, upon the expected completion of participant follow-up in 2012, the IMOAP trial should document, for the first time, the benefits of a motivational intervention as a treatment tool of weight loss in a primary care setting. Trial Registration ClinicalTrials.gov Identifier: NCT01006213 PMID:20298557

Salivary habituation to food stimuli in successful weight loss maintainers, obese and normal-weight adults

PubMed Central

Bond, DS; Raynor, HA; McCaffery, JM; Wing, RR

2017-01-01

Objective Research shows that slower habituation of salivary responses to food stimuli is related to greater energy intake and that obese (Ob) individuals habituate slower than those of normal weight (NW). No study has examined habituation rates in weight loss maintainers (WLMs) who have reduced from obese to normal weight, relative to those who are Ob or NW. Design Salivation to two baseline water trials and 10 lemon-flavored lollipop trials were studied in 14 WLMs, 15 Ob and 18 NW individuals comparable in age, gender and ethnicity. Linear mixed models were used to compare WLMs with Ob and NW groups. Results Salivation in the WLM and NW groups decreased significantly (for both P <0.005) across trials, indicative of habituation. Salivary responses in the Ob group did not habituate (P=0.46). When compared with Ob group, WLMs showed a quicker reduction in salivation (P<0.05). WLM and NW groups did not differ in habituation rate (P=0.49). Conclusions WLMs have habituation rates that are comparable to NW individuals without previous history of obesity, and show quicker habituation than those who are currently obese. These results suggest that physiological responses to food may ‘normalize’ with successful weight loss maintenance. PMID:20010900

Bone, body weight, and weight reduction: what are the concerns?

PubMed

Shapses, Sue A; Riedt, Claudia S

2006-06-01

Of the U.S. population, 65% is either overweight or obese, and weight loss is recommended to reduce co-morbid conditions. However, bone mobilization and loss may also occur with weight loss. The risk for bone loss depends on initial body weight, age, gender, physical activity, and conditions of dieting such as the extent of energy restriction and specific levels of nutrient intake. Older populations are more prone to bone loss with weight loss; in women, this is due at least in part to a reduced dietary Ca intake and/or efficiency of absorption. Potential hormonal mechanisms regulating bone loss during weight loss are discussed, including decreases in estrogen, leptin, glucagon-like peptide-2, growth hormone, and insulin-like growth factor-1, or an increase in cortisol. In contrast, the rise in adiponectin and ghrelin with weight reduction should not be detrimental to bone. Combining energy restriction with exercise does not necessarily prevent bone loss, but may attenuate loss as was shown with additional Ca intake or osteoporosis medications. Future controlled weight loss trials should be designed to further address mechanisms influencing the density and quality of bone sites vulnerable to fracture, in the prevention of osteoporosis.

A controlled trial of protein enrichment of meal replacements for weight reduction with retention of lean body mass

PubMed Central

Treyzon, Leo; Chen, Steve; Hong, Kurt; Yan, Eric; Carpenter, Catherine L; Thames, Gail; Bowerman, Susan; Wang, He-Jing; Elashoff, Robert; Li, Zhaoping

2008-01-01

Background While high protein diets have been shown to improve satiety and retention of lean body mass (LBM), this study was designed to determine effects of a protein-enriched meal replacement (MR) on weight loss and LBM retention by comparison to an isocaloric carbohydrate-enriched MR within customized diet plans utilizing MR to achieve high protein or standard protein intakes. Methods Single blind, placebo-controlled, randomized outpatient weight loss trial in 100 obese men and women comparing two isocaloric meal plans utilizing a standard MR to which was added supplementary protein or carbohydrate powder. MR was used twice daily (one meal, one snack). One additional meal was included in the meal plan designed to achieve individualized protein intakes of either 1) 2.2 g protein/kg of LBM per day [high protein diet (HP)] or 2) 1.1 g protein/kg LBM/day standard protein diet (SP). LBM was determined using bioelectrical impedance analysis (BIA). Body weight, body composition, and lipid profiles were measured at baseline and 12 weeks. Results Eighty-five subjects completed the study. Both HP and SP MR were well tolerated, with no adverse effects. There were no differences in weight loss at 12 weeks (-4.19 ± 0.5 kg for HP group and -3.72 ± 0.7 kg for SP group, p > 0.1). Subjects in the HP group lost significantly more fat weight than the SP group (HP = -1.65 ± 0.63 kg; SP = -0.64 ± 0.79 kg, P = 0.05) as estimated by BIA. There were no significant differences in lipids nor fasting blood glucose between groups, but within the HP group a significant decrease in cholesterol and LDL cholesterol was noted at 12 weeks. This was not seen in the SP group. Conclusion Higher protein MR within a higher protein diet resulted in similar overall weight loss as the standard protein MR plan over 12 weeks. However, there was significantly more fat loss in the HP group but no significant difference in lean body mass. In this trial, subject compliance with both the standard and protein-enriched MR strategy for weight loss may have obscured any effect of increased protein on weight loss demonstrated in prior weight loss studies using whole food diets. PMID:18752682

A controlled trial of protein enrichment of meal replacements for weight reduction with retention of lean body mass.

PubMed

Treyzon, Leo; Chen, Steve; Hong, Kurt; Yan, Eric; Carpenter, Catherine L; Thames, Gail; Bowerman, Susan; Wang, He-Jing; Elashoff, Robert; Li, Zhaoping

2008-08-27

While high protein diets have been shown to improve satiety and retention of lean body mass (LBM), this study was designed to determine effects of a protein-enriched meal replacement (MR) on weight loss and LBM retention by comparison to an isocaloric carbohydrate-enriched MR within customized diet plans utilizing MR to achieve high protein or standard protein intakes. Single blind, placebo-controlled, randomized outpatient weight loss trial in 100 obese men and women comparing two isocaloric meal plans utilizing a standard MR to which was added supplementary protein or carbohydrate powder. MR was used twice daily (one meal, one snack). One additional meal was included in the meal plan designed to achieve individualized protein intakes of either 1) 2.2 g protein/kg of LBM per day [high protein diet (HP)] or 2) 1.1 g protein/kg LBM/day standard protein diet (SP). LBM was determined using bioelectrical impedance analysis (BIA). Body weight, body composition, and lipid profiles were measured at baseline and 12 weeks. Eighty-five subjects completed the study. Both HP and SP MR were well tolerated, with no adverse effects. There were no differences in weight loss at 12 weeks (-4.19 +/- 0.5 kg for HP group and -3.72 +/- 0.7 kg for SP group, p > 0.1). Subjects in the HP group lost significantly more fat weight than the SP group (HP = -1.65 +/- 0.63 kg; SP = -0.64 +/- 0.79 kg, P = 0.05) as estimated by BIA. There were no significant differences in lipids nor fasting blood glucose between groups, but within the HP group a significant decrease in cholesterol and LDL cholesterol was noted at 12 weeks. This was not seen in the SP group. Higher protein MR within a higher protein diet resulted in similar overall weight loss as the standard protein MR plan over 12 weeks. However, there was significantly more fat loss in the HP group but no significant difference in lean body mass. In this trial, subject compliance with both the standard and protein-enriched MR strategy for weight loss may have obscured any effect of increased protein on weight loss demonstrated in prior weight loss studies using whole food diets.

A qualitative investigation of individuals' experiences and expectations before and after completing a trial of commercial weight loss programmes.

PubMed

Herriot, A M; Thomas, D E; Hart, K H; Warren, J; Truby, H

2008-02-01

To investigate the previous dieting experiences and expectations of individuals enrolled in a randomized trial of four commercial weight loss programmes and post-intervention to compare experiences across the diet groups. The purpose of this study was to enhance the understanding of why subjects volunteered to take part in a weight loss trial and also to ascertain their views on each of the diets tested. Focus groups containing both men and women were undertaken at baseline prior to randomization, and diet specific focus groups were held post-intervention. All group discussions were recorded and transcribed verbatim and analysed for emerging themes using the long-table approach. The main intrinsic motivators to enroling in the study were a current lack of self-esteem and confidence. The opportunity to take part in an academic study was also a motivator. Motivation and increasing efficacy were cited commonly among those who had successfully lost (or at least not gained) weight. The 'pros' identified for each of the commercial diets tested in the trial were in line with each of the diet's promotional materials; the 'cons' varied between groups. In this study, reducing health risks was not the main motivator for people deciding to lose weight. Increasing intrinsic sense of worth gained by losing weight and continued motivation appear to be related to success. The differing experiences of people undertaking each of the four diets suggest that matching diet regimen to individual is important.

Weight Loss Associated with Cholinesterase Inhibitors In Patients With Dementia in a National Healthcare System

PubMed Central

Sheffrin, Meera; Miao, Yinghui; Boscardin, W. John; Steinman, Michael A.

2016-01-01

Background/Objectives Inconsistent data from randomized trials suggest cholinesterase inhibitors may cause weight loss. We sought to determine if the initiation of cholinesterase inhibitors is associated with significant weight loss in a real-word clinical setting. Design Retrospective cohort study from 2007-2010, comparing weight loss in patients with dementia newly prescribed cholinesterase inhibitors and patients newly prescribed other chronic medications Setting National Veterans Affairs (VA) data Participants Patients 65 years or older with a diagnosis of dementia who received a new prescription for a cholinesterase inhibitor or other new other chronic medication. Measurements The primary outcome was time to 10 pound weight loss over 12 months. We used propensity score matching patients to control for the likelihood of receiving a cholinesterase inhibitor based on baseline characteristics. Data were analyzed in a priori defined subgroups by age, comorbid burden, and initial weight. Results Of 6,504 patients that met study criteria, 1188 patients started on cholinesterase inhibitors were matched to 2189 patients started on other medications. The propensity-matched cohorts were well balanced on baseline covariates. Patients initiated on cholinesterase inhibitors had a higher risk of weight loss compared to matched controls at 12 months, HR 1.23 (95% CI 1.07 - 1.41). At twelve months, 29.3% of patients on cholinesterase inhibitors had experienced weight loss compared to 22.8% of non-users, corresponding to a number needed to harm of 21.2 (95% CI 12.5 – 71.4) over one year. There were no significant differences across subgroups. Conclusion Patients with dementia started on cholinesterase inhibitors had a higher risk of clinically significant weight loss over a 12-month period compared to matched controls. These results are consistent with the available data from randomized controlled trials. Clinicians should consider the risk of weight loss when prescribing cholinesterase inhibitors. PMID:26234945

Diet and exercise for weight loss: a review of current issues.

PubMed

Volek, Jeff S; Vanheest, Jaci L; Forsythe, Cassandra E

2005-01-01

Obesity is a fast growing epidemic that is primarily due to environmental influences. Nutrition and exercise represent modifiable factors with a major impact on energy balance. Despite considerable research, there remains continued debate regarding the energy content and the optimal macronutrient distribution for promoting healthy and effective weight loss. Low-fat diets have been advised for many years to reduce obesity. However, their effectiveness has been recently challenged, partly because the prevalence of obesity continues to rise despite reductions in fat intake. There are also concerns regarding the methodology of clinical trials showing benefits of fat reduction on weight loss. Although often viewed as a fad diet, very low-carbohydrate (ketogenic) diets are very popular and several recent clinical trials indicate they are more effective at promoting short-term weight loss and improving characteristics of the metabolic syndrome than low-fat diets. However, there is a need to obtain long-term safety and efficacy data. Clearly, weight loss can be achieved with a variety of diet interventions but the effects on other health-related aspects also need to be considered and studied in more detail. Exercise can have positive effects on weight loss, weight control and overall general health, although debate exists concerning the most effective mode, duration and intensity of exercise required to achieve these effects. Importantly, any effective weight control treatment must consider a life-long plan or there will likely be weight regain. Perhaps the most challenging, but rewarding, question that faces researchers is how to predict individual responses to diet and exercise interventions.

An Intensive Lifestyle Intervention Is an Effective Treatment of Morbid Obesity: The TRAMOMTANA Study—A Two-Year Randomized Controlled Clinical Trial

PubMed Central

Burguera, Bartolomé; Jesús Tur, Juan; Escudero, Antonio Jorge; Alos, María; Pagán, Alberto; Cortés, Baltasar; González, Xavier Francesc; Soriano, Joan B.

2015-01-01

Bariatric surgery is currently the most effective therapy to induce weight loss in morbidly obese patients. Objective. This controlled, clinical trial with a two-year intervention was aimed at comparing the efficacy of two nonsurgical approaches versus bariatric surgery, on body weight changes and metabolic parameters in morbidly obese patients. Methods. Patients were randomized to an Intensive Lifestyle Intervention (ILI) (n = 60) or Conventional Obesity Therapy (COT) (n = 46). The ILI group received behavioral therapy and nutritional counseling. The COT group received standard medical treatment. They were compared with a third group, Surgical Obesity Group (SOG) (n = 37). Results. Patients who received ILI had a greater percentage of weight loss than patients receiving COT (−11.3% versus −1.6%; p < 0.0044). Interestingly 31.4% of patients included in the ILI group were no longer morbidly obese after just six months of intervention, increasing to 44.4% after 24 months of intervention. The percentage weight loss in SOG was −29.6% after that same period of time. Conclusions. ILI was associated with significant weight loss when compared to COT, in a group of patients with obesity. An ILI approach could be an alternative therapy to patients with obesity, who are not candidates to undergo bariatric surgery. This trial is registered with EudraCT 2009-013737-24. PMID:26257780

An Intensive Lifestyle Intervention Is an Effective Treatment of Morbid Obesity: The TRAMOMTANA Study-A Two-Year Randomized Controlled Clinical Trial.

PubMed

Burguera, Bartolomé; Jesús Tur, Juan; Escudero, Antonio Jorge; Alos, María; Pagán, Alberto; Cortés, Baltasar; González, Xavier Francesc; Soriano, Joan B

2015-01-01

Bariatric surgery is currently the most effective therapy to induce weight loss in morbidly obese patients. Objective. This controlled, clinical trial with a two-year intervention was aimed at comparing the efficacy of two nonsurgical approaches versus bariatric surgery, on body weight changes and metabolic parameters in morbidly obese patients. Methods. Patients were randomized to an Intensive Lifestyle Intervention (ILI) (n = 60) or Conventional Obesity Therapy (COT) (n = 46). The ILI group received behavioral therapy and nutritional counseling. The COT group received standard medical treatment. They were compared with a third group, Surgical Obesity Group (SOG) (n = 37). Results. Patients who received ILI had a greater percentage of weight loss than patients receiving COT (-11.3% versus -1.6%; p < 0.0044). Interestingly 31.4% of patients included in the ILI group were no longer morbidly obese after just six months of intervention, increasing to 44.4% after 24 months of intervention. The percentage weight loss in SOG was -29.6% after that same period of time. Conclusions. ILI was associated with significant weight loss when compared to COT, in a group of patients with obesity. An ILI approach could be an alternative therapy to patients with obesity, who are not candidates to undergo bariatric surgery. This trial is registered with EudraCT 2009-013737-24.

Rigorous control conditions diminish treatment effects in weight loss randomized controlled trials

PubMed Central

Dawson, John A.; Kaiser, Kathryn A.; Affuso, Olivia; Cutter, Gary R.; Allison, David B.

2015-01-01

Background It has not been established whether control conditions with large weight losses (WLs) diminish expected treatment effects in WL or prevention of weight gain (PWG) randomized controlled trials (RCTs). Subjects/Methods We performed a meta-analysis of 239 WL/PWG RCTs that include a control group and at least one treatment group. A maximum likelihood meta-analysis framework is used in order to model and understand the relationship between treatment effects and control group outcomes. Results Under the informed model, an increase in control group WL of one kilogram corresponds with an expected shrinkage of the treatment effect by 0.309 kg [95% CI (−0.480, −0.138), p = 0.00081]; this result is robust against violations of the model assumptions. Conclusions We find that control conditions with large weight losses diminish expected treatment effects. Our investigation may be helpful to clinicians as they design future WL/PWG studies. PMID:26449419

A worksite-based weight loss intervention for obesity prevention

USDA-ARS?s Scientific Manuscript database

Worksites are increasingly being used as locations for implementing healthy diet and weight loss interventions. Hence, there is an urgent need to identify programs that are both successful and sustainable. We conducted a 6-month pilot randomized controlled trial in overweight and obese employees a...

A randomized controlled trial to determine the efficacy of a high carbohydrate and high protein ready-to-eat food product for weight loss.

PubMed

Fuller, N R; Fong, M; Gerofi, J; Leung, L; Leung, C; Denyer, G; Caterson, I D

2016-04-01

Incorporating meal replacements has been shown to produce a significantly greater weight loss than a conventional reduced calorie diet. Ready-to-eat conventional foods may also be effective in this role and provide additional benefit because of their palatability, acceptance and enjoyment and thus increase dietary compliance. This trial investigated the efficacy of a ready-to-eat food product (Vita-Weat biscuit) that is both high in carbohydrate and high in protein as part of a diet prescription for weight loss in an overweight and obese population group. A total of 76 participants were randomized to a 6-week weight loss intervention including the ready-to-eat food product (intervention group) or advice on the 'Australian Guide to Healthy Eating' (control group). Both groups lost approximately 2 kg weight which equated to a reduction in body mass index of 0.70 kg m(-2) . There was no significant difference in percentage weight loss from screening to 6 weeks between the two groups; mean difference for the intervention vs. -0.20% (95% confidence interval: -0.96, 1.36); P = 0.73. Both diets were nutritionally matched and well-accepted over the 6-week period. This study shows that the inclusion of a ready-to-eat food product can be included as part of a dietary programme to achieve a clinically significant weight loss over a short period. This may have benefit when incorporated into an individual's meal plan intermittently to assist weight control. It also provides support for current public health nutritional guidelines as the participants in this study following such advice were also successful in achieving a clinically meaningful weight loss. © 2016 World Obesity.

Weight loss effects from vegetable intake: a 12-month randomised controlled trial

PubMed Central

Tapsell, L C; Batterham, M J; Thorne, R L; O'Shea, J E; Grafenauer, S J; Probst, Y C

2014-01-01

Background/Objectives: Direct evidence for the effects of vegetable intake on weight loss is qualified. The study aimed to assess the effect of higher vegetable consumption on weight loss. Subjects/Methods: A single blind parallel controlled trial was conducted with 120 overweight adults (mean body mass index=29.98 kg/m2) randomised to two energy deficit healthy diet advice groups differing only by doubling the serving (portion) sizes of vegetables in the comparator group. Data were analysed as intention-to-treat using a linear mixed model. Spearmans rho bivariate was used to explore relationships between percentage energy from vegetables and weight loss. Results: After 12 months, the study sample lost 6.5±5.2 kg (P<0.001 time) with no difference between groups (P>0.05 interaction). Both groups increased vegetable intake and lost weight in the first 3 months, and the change in weight was significantly correlated with higher proportions of energy consumed as vegetables (rho=–0.217, P=0.024). Fasting glucose, insulin and triglyceride levels decreased (P<0.001 time) and high-density lipoprotein cholesterol levels increased (P<0.001 time), with no difference between groups. Weight loss was sustained for 12 months by both groups, but the comparator group reported greater hunger satisfaction (P=0.005). Conclusions: Advice to consume a healthy low-energy diet leads to sustained weight loss, with reductions in cardiovascular disease risk factors regardless of an emphasis on more vegetables. In the short term, consuming a higher proportion of the dietary energy as vegetables may support a greater weight loss and the dietary pattern appears sustainable. PMID:24667750

Long-term Effects of Two Levels of Caloric Restriction on Body Composition, and Diet Satisfaction in CALERIE, a One Year Randomized Controlled Trial

USDA-ARS?s Scientific Manuscript database

There is little information on whether the extent of dietary energy restriction in a weight loss program influences long-term weight change. We examined the effects of two levels of caloric restriction (CR) over 12 months on body weight and fat loss, total energy expenditure (TEE), resting metabolic...

Noni-based nutritional supplementation and exercise interventions influence body composition

PubMed Central

Palu, Afa K.; West, Brett J.; Jensen, Jarakae

2011-01-01

Background: The prevalence of obesity and overweight in the Unites States has reached unprecedented levels, and so has the need for effective exercise and nutritional programs for prevention of unhealthy weight gain or safe weight loss. Aims: The present study was conducted in overweight men and women to assess the impact of noni-based nutritional supplementation and exercise interventions on body composition. Materials and Methods: Twenty two participants (16 women and 6 men), ages 18-65, were enrolled in a 12-week, open-label trial of a weight-loss program involving noni-based dietary supplements, gender-specific daily calorie restriction, and exercise interventions. Weight, percent body fat, and body mass index were measured before and after the trial. Results: All participants experienced weight loss. The average decrease in fat mass was highly significant (P < 0.0001), as were decreases in percent body fat and body mass index. Individual weight and fat mass losses were 17.55 ± 9.73 and 21.78 ± 8.34 lbs., respectively, and individual percent body fat and body mass index decreases were 8.91 ± 3.58 % and 2.6 ± 1.32, respectively. Conclusion: The nutritional and exercise interventions significantly influenced body composition among participants. PMID:22363077

Noni-based nutritional supplementation and exercise interventions influence body composition.

PubMed

Palu, Afa K; West, Brett J; Jensen, Jarakae

2011-12-01

The prevalence of obesity and overweight in the Unites States has reached unprecedented levels, and so has the need for effective exercise and nutritional programs for prevention of unhealthy weight gain or safe weight loss. The present study was conducted in overweight men and women to assess the impact of noni-based nutritional supplementation and exercise interventions on body composition. Twenty two participants (16 women and 6 men), ages 18-65, were enrolled in a 12-week, open-label trial of a weight-loss program involving noni-based dietary supplements, gender-specific daily calorie restriction, and exercise interventions. Weight, percent body fat, and body mass index were measured before and after the trial. All participants experienced weight loss. The average decrease in fat mass was highly significant (P < 0.0001), as were decreases in percent body fat and body mass index. Individual weight and fat mass losses were 17.55 ± 9.73 and 21.78 ± 8.34 lbs., respectively, and individual percent body fat and body mass index decreases were 8.91 ± 3.58 % and 2.6 ± 1.32, respectively. The nutritional and exercise interventions significantly influenced body composition among participants.

Applying economic incentives to increase effectiveness of an outpatient weight loss program (TRIO) - A randomized controlled trial.

PubMed

Finkelstein, Eric A; Tham, Kwang-Wei; Haaland, Benjamin A; Sahasranaman, Aarti

2017-07-01

The prevalence of overweight and obesity has more than doubled in the past three decades, leading to rising rates of non-communicable diseases. This study tests whether adding a payment/rewards (term reward) program to an existing evidence-based weight loss program can increase weight loss and weight loss maintenance. We conducted a parallel-group randomized controlled trial from October 2012 to October 2015 with 161 overweight or obese individuals randomized to either control or reward arm in a 1:2 ratio. Control and reward arm participants received a four month weight loss program at the LIFE (Lifestyle Improvement and Fitness Enhancement) Centre at Singapore General Hospital. Those in the reward arm paid a fee of S$165.00 (1US$ = 1.35S$) to access a program that provided rewards of up to S$660 for meeting weight loss and physical activity goals. Participants could choose to receive rewards as guaranteed cash payments or a lottery ticket with a 1 in 10 chance of winning but with the same expected value. The primary outcome was weight loss at months 4, 8, and 12. 161 participants were randomized to control (n = 54) or reward (n = 107) arms. Average weight loss was more than twice as great in the reward arm compared to the control arm at month 4 when the program concluded (3.4 kg vs 1.4 kg, p < 0.01), month 8 when rewards concluded (3.3 kg vs 1.8 kg, p < 0.05), and at month 12 (2.3 kg vs 0.8 kg, p < 0.05). These results reveal that a payment/rewards program can be used to improve weight loss and weight loss maintenance when combined with an evidence-based weight loss program. Future efforts should attempt to replicate this approach and identify how to cost effectively expand these programs to maximize their reach. This study is registered at www.clinicaltrials.gov (Identifier: NCT01533454). Copyright © 2017 Elsevier Ltd. All rights reserved.

Using mHealth Technology to Enhance Self-Monitoring for Weight Loss A Randomized Trial

PubMed Central

Burke, Lora E.; Styn, Mindi A.; Sereika, Susan M.; Conroy, Molly B.; Ye, Lei; Glanz, Karen; Sevick, Mary Ann; Ewing, Linda J.

2012-01-01

Background Self-monitoring for weight loss has traditionally been performed with paper diaries. Technologic advances could reduce the burden of self-monitoring and provide feedback to enhance adherence. Purpose To determine if self-monitoring diet using a PDA only or the PDA with daily tailored feedback (PDA+FB), was superior to using a paper diary on weight loss and maintenance. Design The Self-Monitoring and Recording Using Technology (SMART) Trial was a 24-month RCCT; participants were randomly assigned to one of three self-monitoring groups. Setting/participants From 2006 to 2008, 210 overweight/obese adults (84.8% female, 78.1% white) were recruited from the community. Data were analyzed in 2011. Intervention Participants received standard behavioral treatment for weight loss which included dietary and physical activity goals, encouraged the use of self-monitoring, and was delivered in group sessions. Main outcome measures Percentage weight change at 24 months, adherence to self-monitoring over time. Results Study retention was 85.6%. The mean percentage weight loss at 24 months was not different among groups (paper diary: −1.94% [95% CI= −3.88, 0.01], PDA: −1.38% [95% CI= – 3.38, 0.62], PDA+FB: –2.32% [95% CI= –4.29, −0.35]); only the PDA+FB group (p=0.02) demonstrated a significant loss. For adherence to self-monitoring, there was a time-by-treatment group interaction between the combined PDA groups and the paper diary group (p=0.03) but no difference between PDA and PDA+FB groups (p=0.49). Across all groups, weight loss was greater for those who were adherent ≥60% versus <30% of the time, p<0.001. Conclusions PDA+FB use resulted in a small weight loss at 24 months; PDA use resulted in greater adherence to dietary self-monitoring over time. However, for sustained weight loss, adherence to self-monitoring is more important than the method used to self-monitor. A daily feedback message delivered remotely enhanced adherence and improved weight loss, which suggests that technology can play a role in improving weight loss. PMID:22704741

Health consequences for mother and baby of substantial pre-conception weight loss in obese women: study protocol for a randomized controlled trial.

PubMed

Price, Sarah; Nankervis, Alison; Permezel, Michael; Prendergast, Luke; Sumithran, Priya; Proietto, Joseph

2018-04-24

Current guidelines for the management of obesity in women planning pregnancy suggest lifestyle modification before conception. However, there is little evidence that lifestyle modification alters pregnancy outcomes. Bariatric surgery results in significant weight loss. This appears to reduce the risk of adverse pregnancy outcomes for the mother but may increase the risk of adverse outcomes for the infant. In order to reduce the risks of obesity-related adverse pregnancy outcomes for both mother and offspring, alternative approaches to the management of obesity in women planning pregnancy are needed. This study, a two-arm, parallel group, randomized control trial, will be conducted at the Metabolic Disorders Centre, University of Melbourne. This trial will recruit 164 women aged 18-38 years with a body mass index of 30-55 kg/m 2 who plan to conceive in the next 6-12 months. Women will be randomized to one of two 12-week interventions (Group A and Group B). Group A will aim for modest weight loss (MWL; ≤ 3% body weight) using a hypocaloric diet. Group B will aim for substantial weight loss (SWL; 10-15% body weight) using a modified very low energy diet (VLED) program. All participants will be asked to comply with National Health and Medical Research Council (NHMRC) guidelines for exercise and will be provided with standard pre-pregnancy advice according to Royal Australian and New Zealand College of Obstetrics and Gynaecology guidelines. All participants will then be observed for the subsequent 12 months. If pregnancy occurs within the 12-month follow-up period, data on weight and metabolic status of the mother, and pregnancy outcomes of mother and offspring will be recorded. The primary outcome is maternal fasting plasma glucose at 26-28 weeks' gestation, given that this is known to correlate with pregnancy outcomes. Time to conception, live birth rate, gestational weight gain, and a composite of adverse pregnancy outcomes for mother and baby will comprise the secondary outcomes. There is increasing emphasis on obese women losing weight before conception. To date, no randomized controlled trial has demonstrated an effective means of weight loss that results in improved pregnancy outcomes for both mother and baby. This study intends to determine if substantial pre-conception weight loss, achieved using a VLED, improves pregnancy outcomes for mother and baby when compared with standard care. This research will potentially change clinical care of an obese woman planning pregnancy. ANZCTR, 12,614,001,160,628 . Registered on 5 November 2014.

A Randomized Controlled Trial of Employer Matching of Employees' Monetary Contributions to Deposit Contracts to Promote Weight Loss.

PubMed

Kullgren, Jeffrey T; Troxel, Andrea B; Loewenstein, George; Norton, Laurie A; Gatto, Dana; Tao, Yuanyuan; Zhu, Jingsan; Schofield, Heather; Shea, Judy A; Asch, David A; Pellathy, Thomas; Driggers, Jay; Volpp, Kevin G

2016-07-01

To test whether employer matching of employees' monetary contributions increases employees' (1) participation in deposit contracts to promote weight loss and (2) weight loss. A 36-week randomized trial. Large employer in the northeast United States. One hundred thirty-two obese employees. Over 24 weeks, participants were asked to lose 24 pounds and randomized to monthly weigh-ins or daily weigh-ins with monthly opportunities to deposit $1 to $3 per day that was not matched, matched 1:1, or matched 2:1. Deposits and matched funds were returned to participants for each day they were below their goal weight. Rates of making ≥1 deposit, weight loss at 24 weeks (primary outcome), and 36 weeks. Deposit rates were compared using χ(2) tests. Weight loss was compared using t tests. Among participants eligible to make deposits, 29% made ≥1 deposit and matching did not increase participation. At 24 weeks, control participants gained an average of 1.0 pound, whereas 1:1 match participants lost an average of 5.3 pounds (P = .005). After 36 weeks, control participants gained an average of 2.1 pounds, whereas no match participants lost an average of 5.1 pounds (P = .008). Participation in deposit contracts to promote weight loss was low, and matching deposits did not increase participation. For deposit contracts to impact population health, ongoing participation will need to be higher. © The Author(s) 2016.

Effect of a High-Protein Diet versus Standard-Protein Diet on Weight Loss and Biomarkers of Metabolic Syndrome: A Randomized Clinical Trial.

PubMed

Campos-Nonato, Ismael; Hernandez, Lucia; Barquera, Simon

2017-01-01

Some studies have shown that protein-enriched diets can lead to greater weight loss and improvements in biomarkers of metabolic syndrome (MeS) than standard protein diets. Therefore, the aim of this study was to determine the effect of increased protein intake on weight loss in Mexican adults with MeS. Randomized controlled trial in 118 adults aged 47.4 ± 11.5 years and meeting the established criteria for MeS were randomized to prescribed hypocaloric diets (500 kcal less than resting metabolic rate) providing either 0.8 g/kg body weight (standard protein diet (SPD)) or 1.34 g/kg body weight (higher protein diet (HPD)) for 6 months. Body weight, waist circumference, percent body fat by bioimpedance analysis, fasting blood glucose, fasting insulin, hemoglobin A1c, total cholesterol, high-density lipoprotein (HDL) cholesterol, very-low-density lipoprotein (VLDL) cholesterol, triglycerides, C-reactive protein, creatinine, blood urea nitrogen, alanine aminotransferase, aspartate aminotransferase, and gamma-glutamyl transferase were measured at baseline, 3 months and at 6 months. There were 105 subjects (51 for SPD and 54 for HPD) who completed the trial. Overall weight loss was 5.1 ± 3.6 kg in the SPD group compared to 7.0 ± 3.7 kg in the in HPD group. Both groups lost a significant percent of centimeters of waist circumference (SPD -6.5 ± 2.6 cm and HPD -8.8 ± 2.6 cm). There was no statistical difference Except for the varying weight losses the two groups did not show any further differences overall. However in the subgroup judged to be adherent more than 75% of the time with the prescribed diets, there was a significant difference in mean weight loss (SPD -5.8% vs. HPD -9.5%) after adjusting for baseline BMI. Both groups demonstrated significant decreases in waist circumference, glucose, insulin, triglycerides, and VLDL cholesterol, but there were no differences between the groups. There were no changes in blood tests for liver or renal function. There were no significant differences in weight loss and biomarkers of MeS when the overall group was examined, but the participants with more adherence rate in the HPD group lost significantly more weight than adherent participants in the SPD group. © 2017 The Author(s) Published by S. Karger GmbH, Freiburg.

Comparing Weight Loss-Maintenance Outcomes of a Worksite-Based Lifestyle Program Delivered via DVD and Face-to-Face: A Randomized Trial.

PubMed

Ing, Claire Townsend; Miyamoto, Robin E S; Fang, Rui; Antonio, Mapuana; Paloma, Diane; Braun, Kathryn L; Kaholokula, Joseph Keawe'aimoku

2018-03-01

Native Hawaiians and other Pacific Islanders have high rates of overweight and obesity compared with other ethnic groups in Hawai'i. Effective weight loss and weight loss-maintenance programs are needed to address obesity and obesity-related health inequities for this group. Compare the effectiveness of a 9-month, worksite-based, weight loss-maintenance intervention delivered via DVD versus face-to-face in continued weight reduction and weight loss maintenance beyond the initial weight loss phase. We tested DVD versus face-to-face delivery of the PILI@Work Program's 9-month, weight loss-maintenance phase in Native Hawaiian-serving organizations. After completing the 3-month weight loss phase, participants ( n = 217) were randomized to receive the weight loss-maintenance phase delivered via trained peer facilitators or DVDs. Participant assessments at randomization and postintervention included weight, height, blood pressure, physical functioning, exercise frequency, and fat intake. Eighty-three face-to-face participants were retained at 12 months (74.1%) compared with 73 DVD participants (69.5%). There was no significant difference between groups in weight loss or weight loss maintenance. The number of lessons attended in Phase 1 of the intervention (β = 0.358, p = .022) and baseline systolic blood pressure (β = -0.038, p = .048) predicted percent weight loss at 12 months. Weight loss maintenance was similar across groups. This suggests that low-cost delivery methods for worksite-based interventions targeting at-risk populations can help address obesity and obesity-related disparities. Additionally, attendance during the weight loss phase and lower baseline systolic blood pressure predicted greater percent weight loss during the weight loss-maintenance phase, suggesting that early engagement and initial physical functioning improve long-term weight loss outcomes.

Randomized Controlled Trial of Preconception Interventions in Infertile Women With Polycystic Ovary Syndrome.

PubMed

Legro, Richard S; Dodson, William C; Kris-Etherton, Penny M; Kunselman, Allen R; Stetter, Christy M; Williams, Nancy I; Gnatuk, Carol L; Estes, Stephanie J; Fleming, Jennifer; Allison, Kelly C; Sarwer, David B; Coutifaris, Christos; Dokras, Anuja

2015-11-01

Lifestyle modification is recommended in women with polycystic ovary syndrome (PCOS) prior to conception but there are few randomized trials to support its implementation or benefit. This study aimed to determine the relative efficacy of preconception intervention on reproductive and metabolic abnormalities in overweight/obese women with PCOS. This was a randomized controlled trial of preconception and infertility treatment at Academic Health Centers in women with infertility due to PCOS, age 18-40 y and body mass index 27-42 kg/m(2). Women were randomly assigned to receive either 16 weeks of 1) continuous oral contraceptive pills (OCPs) (ethinyl estradiol 20 mcg/1 mg norethindrone acetate) ("OCP"); 2) lifestyle modification consisting of caloric restriction with meal replacements, weight loss medication (either sibutramine, or orlistat), and increased physical activity to promote a 7% weight loss ("Lifestyle"); or 3) combined treatment with both OCP and lifestyle modification ("Combined"). After preconception intervention, women underwent standardized ovulation induction with clomiphene citrate and timed intercourse for four cycles. Pregnancies were followed with trimester visits until delivery. Weight, ovulation, and live birth were measured. We consented 216 and randomly assigned 149 women (Lifestyle: n = 50; OCP: n = 49; Combined: n = 50). We achieved significant weight loss with both Lifestyle (mean weight loss, -6.2%; 95% confidence interval (CI), -7.4--5.0; and Combined (mean weight loss, -6.4%; 95% CI, -7.6--5.2) compared with baseline and OCP (both P < .001). There was a significant increase in the prevalence of metabolic syndrome at the end of preconception treatment compared with baseline within OCP (odds ratio [OR, 2.47; 95% CI, 1.42-4.27) whereas no change in metabolic syndrome was detected in the Lifestyle (OR, 1.18; 95% CI, 0.63-2.19) or Combined (OR, 0.72; 95% CI, 0.44-1.17) groups. Cumulative ovulation rates were superior after weight loss: OCP, 46%; Lifestyle, 60%; and Combined, 67% (P < .05). Live birth rates were OCP, 12%; Lifestyle, 26%; and Combined, 24% (P = .13). A preconception weight loss intervention eliminates the adverse metabolic oral contraceptive effects and, compared with oral contraceptive pretreatment, leads to higher ovulation rates.

The role of self-regulatory skills and automaticity on the effectiveness of a brief weight loss habit-based intervention: secondary analysis of the 10 top tips randomised trial.

PubMed

Kliemann, Nathalie; Vickerstaff, Victoria; Croker, Helen; Johnson, Fiona; Nazareth, Irwin; Beeken, Rebecca J

2017-09-05

Habit-interventions are designed to promote the automaticity of healthy behaviours and may also enhance self-regulatory skills during the habit-formation process. A recent trial of habit-based advice for weight loss (10 Top Tips; 10TT), found that patients allocated to 10TT lost significantly more weight over 3 months than those allocated to usual care, and reported greater increases in automaticity for the target behaviours. The current study aimed to test the hypothesis that i) 10TT increased self-regulatory skills more than usual care, and ii) that self-regulatory skills and automaticity changes mediated the effect of 10TT on weight loss. 537 obese patients from 14 primary care practices in the UK were randomized to receive 10TT or usual care. Patients in the 10TT group received a leaflet containing tips for weight loss and healthy habits formation, a self-monitoring log book and a wallet-sized shopping guide on how to read food labels. Patients were weighed and completed validated questionnaires for self-regulation and automaticity at baseline and 3-month follow-up. Within-group and Between-group effects were explored using Paired T-test and ANCOVA, respectively. Mediation was assessed using bootstrapping to estimate indirect effects and the sobel test. Over 3 months patients who were given 10TT reported greater increases in self-regulatory skills (Mean difference: .08; 95% CI .01; .15) than those who received usual care. Changes in self-regulatory skills and automaticity over 3 months mediated the effect of the intervention on weight loss (β = .52, 95% Bias Corrected CI .17; .91). As hypothesised, 10TT enhanced self-regulatory skills and changes in self-regulatory skills and automaticity mediated the effect of the intervention on weight loss. This supports the proposition that self-regulatory training and habit formation are important features of weight loss interventions. This study was prospectively registered with the International Standard Randomised Controlled Trials ( ISRCTN16347068 ) on 26 September 2011.

Effects of anti-obesity drugs, diet, and exercise on weight-loss maintenance after a very-low-calorie diet or low-calorie diet: a systematic review and meta-analysis of randomized controlled trials.

PubMed

Johansson, Kari; Neovius, Martin; Hemmingsson, Erik

2014-01-01

Weight-loss maintenance remains a major challenge in obesity treatment. The objective was to evaluate the effects of anti-obesity drugs, diet, or exercise on weight-loss maintenance after an initial very-low-calorie diet (VLCD)/low-calorie diet (LCD) period (<1000 kcal/d). We conducted a systematic review by using MEDLINE, the Cochrane Controlled Trial Register, and EMBASE from January 1981 to February 2013. We included randomized controlled trials that evaluated weight-loss maintenance strategies after a VLCD/LCD period. Two authors performed independent data extraction by using a predefined data template. All pooled analyses were based on random-effects models. Twenty studies with a total of 27 intervention arms and 3017 participants were included with the following treatment categories: anti-obesity drugs (3 arms; n = 658), meal replacements (4 arms; n = 322), high-protein diets (6 arms; n = 865), dietary supplements (6 arms; n = 261), other diets (3 arms; n = 564), and exercise (5 arms; n = 347). During the VLCD/LCD period, the pooled mean weight change was -12.3 kg (median duration: 8 wk; range 3-16 wk). Compared with controls, anti-obesity drugs improved weight-loss maintenance by 3.5 kg [95% CI: 1.5, 5.5 kg; median duration: 18 mo (12-36 mo)], meal replacements by 3.9 kg [95% CI: 2.8, 5.0 kg; median duration: 12 mo (10-26 mo)], and high-protein diets by 1.5 kg [95% CI: 0.8, 2.1 kg; median duration: 5 mo (3-12 mo)]. Exercise [0.8 kg; 95% CI: -1.2, 2.8 kg; median duration: 10 mo (6-12 mo)] and dietary supplements [0.0 kg; 95% CI: -1.4, 1.4 kg; median duration: 3 mo (3-14 mo)] did not significantly improve weight-loss maintenance compared with control. Anti-obesity drugs, meal replacements, and high-protein diets were associated with improved weight-loss maintenance after a VLCD/LCD period, whereas no significant improvements were seen for dietary supplements and exercise.

Factors behind nonadherence to diet regimens among obese adults in Tanta, Egypt: a case-control study.

PubMed

Abo Ali, Ehab A; Atlam, Salwa A; Ghareeb, Wessam A

2016-03-01

Nonadherence to diet regimens is a major cause of treatment failure in the field of obesity management. It varies according to the study design and the type of intervention. In weight loss clinical trials, nonadherence rates range from 10 to 80%. Strategies to reduce dropout rates rely on precise identification of factors leading to premature program termination. The aim of this research was to study factors behind nonadherence to diet regimens among obese adults in Tanta, Egypt. A retrospective, case-control study was carried out during the year 2014 in an obesity management private clinic in Tanta, Gharbia Governorate, Egypt. The study included two groups of 150 participants each (adherents and nonadherents) matched for sex and BMI. Self-administered questionnaires were used to collect data concerning sociodemographic characteristics, weight changes, dieting, and behavioral, psychological, and medical factors. Personal perspectives on potential factors contributing to nonadherence to diet regimens were also investigated. Factors significantly associated with probabilities high probability of to loss of adherence to diet regimens were as follows: younger age, urban residence, higher educational levels, obesity of grades I and III, a higher frequency of previous weight loss trials, consumption of fruits and vegetables less than that recommended (<5 times/day), higher weight loss expectations, and binge eating. The most common personal perspectives on causes limiting adherence to diet regimens were as follows: unsatisfactory results (37.3%), difficulties in dieting practices (33.3%), logistics (30.0%), and fading of motives (27.3%). Obese individuals seeking weight reduction with young age, urban residence, higher educational levels, a higher frequency of previous weight loss trials, higher weight loss expectations, and those with perceived unsatisfactory results are more prone to lose their adherence to diet regimens. Individuals with factors of nonadherence should receive extra care to avoid their withdrawal from diet programs and to improve clinical outcomes.

Effect of Low-Fat vs Low-Carbohydrate Diet on 12-Month Weight Loss in Overweight Adults and the Association With Genotype Pattern or Insulin Secretion: The DIETFITS Randomized Clinical Trial.

PubMed

Gardner, Christopher D; Trepanowski, John F; Del Gobbo, Liana C; Hauser, Michelle E; Rigdon, Joseph; Ioannidis, John P A; Desai, Manisha; King, Abby C

2018-02-20

Dietary modification remains key to successful weight loss. Yet, no one dietary strategy is consistently superior to others for the general population. Previous research suggests genotype or insulin-glucose dynamics may modify the effects of diets. To determine the effect of a healthy low-fat (HLF) diet vs a healthy low-carbohydrate (HLC) diet on weight change and if genotype pattern or insulin secretion are related to the dietary effects on weight loss. The Diet Intervention Examining The Factors Interacting with Treatment Success (DIETFITS) randomized clinical trial included 609 adults aged 18 to 50 years without diabetes with a body mass index between 28 and 40. The trial enrollment was from January 29, 2013, through April 14, 2015; the date of final follow-up was May 16, 2016. Participants were randomized to the 12-month HLF or HLC diet. The study also tested whether 3 single-nucleotide polymorphism multilocus genotype responsiveness patterns or insulin secretion (INS-30; blood concentration of insulin 30 minutes after a glucose challenge) were associated with weight loss. Health educators delivered the behavior modification intervention to HLF (n = 305) and HLC (n = 304) participants via 22 diet-specific small group sessions administered over 12 months. The sessions focused on ways to achieve the lowest fat or carbohydrate intake that could be maintained long-term and emphasized diet quality. Primary outcome was 12-month weight change and determination of whether there were significant interactions among diet type and genotype pattern, diet and insulin secretion, and diet and weight loss. Among 609 participants randomized (mean age, 40 [SD, 7] years; 57% women; mean body mass index, 33 [SD, 3]; 244 [40%] had a low-fat genotype; 180 [30%] had a low-carbohydrate genotype; mean baseline INS-30, 93 μIU/mL), 481 (79%) completed the trial. In the HLF vs HLC diets, respectively, the mean 12-month macronutrient distributions were 48% vs 30% for carbohydrates, 29% vs 45% for fat, and 21% vs 23% for protein. Weight change at 12 months was -5.3 kg for the HLF diet vs -6.0 kg for the HLC diet (mean between-group difference, 0.7 kg [95% CI, -0.2 to 1.6 kg]). There was no significant diet-genotype pattern interaction (P = .20) or diet-insulin secretion (INS-30) interaction (P = .47) with 12-month weight loss. There were 18 adverse events or serious adverse events that were evenly distributed across the 2 diet groups. In this 12-month weight loss diet study, there was no significant difference in weight change between a healthy low-fat diet vs a healthy low-carbohydrate diet, and neither genotype pattern nor baseline insulin secretion was associated with the dietary effects on weight loss. In the context of these 2 common weight loss diet approaches, neither of the 2 hypothesized predisposing factors was helpful in identifying which diet was better for whom. clinicaltrials.gov Identifier: NCT01826591.

The relationship of social support with treatment adherence and weight loss in Latinos with type 2 diabetes.

PubMed

Marquez, Becky; Anderson, Andrea; Wing, Rena R; West, Delia S; Newton, Robert L; Meacham, Maria; Hazuda, Helen P; Peters, Anne; Montez, Maria G; Broyles, Stephanie T; Walker, Martha; Evans-Hudsnall, Gina

2016-03-01

Little is known about the effects of social support on weight loss in Latinos. This study determined whether sex moderated and treatment adherence mediated the association between social support and weight loss. Data from 278 Latino males and females with type 2 diabetes in the Intensive Lifestyle Intervention of the Look AHEAD trial were analyzed. Multivariable modeling tested for moderation and parallel multiple mediator modeling simultaneously tested the mediating effects of adherence to physical activity, diet, and session attendance on the relationship between baseline social support and percent weight loss at 1 year. Social support for physical activity (having family and friends join in physical activity) was related to weight loss. Adherence to physical activity was related to both social support for physical activity and weight loss. Sex did not moderate these relationships. Adherence to physical activity completely mediated the relationship between social support for physical activity and weight loss. Increasing companionship for physical activity may be an effective intervention strategy to promote behaviors important for weight loss among Latinos. © 2016 The Obesity Society.

The relationship of social support with treatment adherence and weight loss in Latinos with type 2 diabetes

PubMed Central

Marquez, Becky; Anderson, Andrea; Wing, Rena R.; West, Delia S.; Newton, Robert L.; Meacham, Maria; Hazuda, Helen P.; Peters, Anne; Montez, Maria G.; Broyles, Stephanie T.; Walker, Martha; Evans-Hudsnall, Gina

2016-01-01

Objective Little is known about the effects of social support on weight loss in Latinos. This study determined whether sex moderated and treatment adherence mediated the association between social support and weight loss. Methods Data from 278 Latino males and females with type 2 diabetes in the Intensive Lifestyle Intervention of the Look AHEAD trial were analyzed. Multivariable modeling tested for moderation and parallel multiple mediator modeling simultaneously tested the mediating effects of adherence to physical activity, diet, and session attendance on the relationship between baseline social support and percent weight loss at 1 year. Results Social support for physical activity (having family and friends join in physical activity) was related to weight loss. Adherence to physical activity was related to both social support for physical activity and weight loss. Sex did not moderate these relationships. Adherence to physical activity completely mediated the relationship between social support for physical activity and weight loss. Conclusion Increasing companionship for physical activity may be an effective intervention strategy to promote behaviors important for weight loss among Latinos. PMID:26833676

Lifestyle interventions for the treatment of urinary incontinence in adults.

PubMed

Imamura, Mari; Williams, Kate; Wells, Mandy; McGrother, Catherine

2015-12-02

Low cost, non-invasive alterations in lifestyle are frequently recommended by healthcare professionals or those presenting with incontinence. However, such recommendations are rarely based on good evidence. The objective of the review was to determine the effectiveness of specific lifestyle interventions (i.e. weight loss; dietary changes; fluid intake; reduction in caffeinated, carbonated and alcoholic drinks; avoidance of constipation; stopping smoking; and physical activity) in the management of adult urinary incontinence. We searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and MEDLINE in process, and handsearching of journals and conference proceedings (searched 3 July 2013), and the reference lists of relevant articles. We incorporated the results of these searches fully in the review. We undertook an updated search of the Specialised Register, which now includes searches of ClinicalTrials.gov and WHO ICTRP, on 27 October 2014; potentially eligible studies from this search are currently awaiting classification. Randomised and quasi-randomised studies of community-based lifestyle interventions compared with no treatment, other conservative therapies, or pharmacological interventions for the treatment of urinary incontinence in adults. Two authors independently assessed study quality and extracted data. We collected information on adverse effects from the trials. Data were combined in a meta-analysis when appropriate. We assessed the quality of the evidence using the GRADE approach. We included 11 trials in the review, involving a total of 5974 participants.Four trials involving 4701 women compared weight loss programmes with a control intervention. Low quality evidence from one trial suggested that more women following weight loss programmes reported improvement in symptoms of incontinence at six months (163/214 (76%) versus 49/90 (54%), risk ratio (RR) 1.40, 95% confidence interval (CI) 1.14 to 1.71), and this effect was sustained at 18 months (N = 291, 75% versus 62%, RR not estimable, reported P value 0.02). No data were available for self-reported cure and quality of life. One of the weight loss trials involving 1296 women reported very low quality evidence for a reduction in weekly urinary incontinence a mean of 2.8 years after following a lifestyle weight loss intervention that had been compared with a pharmacological weight loss intervention.Three trials involving 181 women and 11 men compared change in fluid intake with no change. Limited, very low quality evidence suggested that symptom-specific quality of life scores improved when fluid intake was reduced, although some people reported headaches, constipation or thirst. A further three trials involving 160 women and nine men compared reduction in caffeinated drinks with no change, and one trial involving 42 women compared a soy-rich diet with soy-free diet. However, it was not possible to reach any conclusions about the effects of these changes, due to methodological limitations, that resulted in very low quality evidence.Adverse effects appeared relatively uncommon for all interventions studied.All included studies had a high or unclear risk of bias across all bias parameters, but most notably for allocation concealment. The main factors for our downgrading of the evidence were risk of bias, indirect evidence (less than 12 months of follow-up; and not all participants having confirmed urinary incontinence at baseline in some studies), and imprecise results with wide confidence intervals.Other interventions such as reduction in consumption of sweetened fizzy or diet drinks; reduction in alcohol consumption; avoiding constipation; smoking cessation; restricting strenuous physical forces; or reducing high levels of, or increasing low levels of, physical activity, could not be assessed in this review, as no evidence from randomized controlled trials or quasi-randomised trials was available. Evidence for the effect of weight loss on urinary incontinence is building and should be a research priority. Generally, there was insufficient evidence to inform practice reliably about whether lifestyle interventions are helpful in the treatment of urinary incontinence.

Beneficial effect of high energy intake at lunch rather than dinner on weight loss in healthy obese women in a weight-loss program: a randomized clinical trial.

PubMed

Madjd, Ameneh; Taylor, Moira A; Delavari, Alireza; Malekzadeh, Reza; Macdonald, Ian A; Farshchi, Hamid R

2016-10-01

The association between the time of nutrient intake and health has been described in a few studies. To our knowledge, no study has evaluated the relation between high energy intakes at lunch compared with at dinner on weight loss in overweight and obese subjects. We compared the effect of high energy intake at lunch with that at dinner on weight loss and cardiometabolic risk factors in women during a weight-loss program. Overweight and obese women [n = 80; body mass index (BMI; in kg/m 2 ): 27-35; age: 18-45 y] were asked to eat either a main meal at lunch (LM) or a main meal at dinner (DM) for 12 wk while in a weight-loss program. A total of 80 participants were randomly assigned to one of 2 intervention groups. Sixty-nine subjects (86%) completed the trial (34 subjects in the DM group, and 35 subjects in the LM group). Baseline variables were not significantly different between groups. A significant reduction in anthropometric measurements and significant improvements in cardiometabolic risk characteristics were observed over 12 wk in both groups. Compared with the DM group, the LM group had greater mean ± SD reductions in weight (LM: -5.85 ± 1.96 kg; DM: -4.35 ± 1.98 kg; P = 0.003), BMI (LM: 2.27± 0.76; DM: 1.68 ± 0.76; P = 0.003), homeostasis model assessment of insulin resistance (LM: -0.66 ± 0.33; DM: -0.46 ± 0.24; P = 0.001), and fasting insulin (LM: -2.01 ± 1.10 mIU/mL; DM: -1.16 ± 0.72 mIU/mL; P < 0.001) after 12 wk. However, there were no significant differences for fasting plasma glucose and lipid profiles within both groups after 12 wk. The consumption of higher energy intake at lunch compared with at dinner may result in favorable changes in weight loss in overweight and obese women after a weight-loss program of 12 wk. The consumption may also offer clinical benefits to improve insulin resistance. This trial was registered at clinicaltrials.gov as NCT02399280. © 2016 American Society for Nutrition.

A systematic review and meta-analysis of mobile devices and weight loss with an intervention content analysis.

PubMed

Lyzwinski, Lynnette Nathalie

2014-06-30

Overweight and obesity constitute leading global public health challenges. Tackling overweight and obesity by influencing human behaviour is a complex task, requiring novel emerging health psychology interventions. The aims of this review will be to determine whether mobile devices induce weight loss and improvements in diet and physical activity levels when compared with standard controls without a weight loss intervention or controls allocated to non-mobile device weight loss interventions. A systematic review on mobile devices and weight loss was conducted. The inclusion criteria were all randomized controlled trials with baseline and post-intervention weight measures in adult subjects >18 years of age without pre-specified co-morbidities. Mobile device specifications included modern, portable devices in the form of smartphones, PDAs, iPods, and Mp3 players. Cohen's d for standardized differences in mean weight loss was calculated. A random effects meta-analysis was generated using Comprehensive meta-analysis software. Theories and intervention content were coded and analysed. A total of 17 studies were identified, of which 12 were primary trials and 5 were secondary analyses. The meta-analysis generated a medium significant effect size of 0.430 (95% CI 0.252-0.609) (p-value ≤ 0.01), favouring mobile interventions. Throughout the systematic review, mobile devices were found to induce weight loss relative to baseline weight. When comparing them with standard no intervention controls as well as controls receiving non-mobile weight loss interventions, results favoured mobile devices for weight loss. Reductions in Body mass index, waist circumference, and percentage body fat were also found in the review. Improvements in the determinants of weight loss in the form of improved dietary intake and physical activity levels were also found. Theory appears to largely inform intervention design, with the most common theories being Social Cognitive Theory, Elaboration Likelihood Theory, Control Theory, and Goal Theory. The use of behavioural change techniques was widespread across the studies, with a minimum of five per intervention. Mobile devices appear to induce positive changes in the behavioural determinants of weight and subsequently are associated with weight loss. Mobile device interventions are heavily informed by theory and behaviour change techniques. The use of theory appears to effectively enhance levels of constructs targeted by interventions.

A Systematic Review and Meta-Analysis of Mobile Devices and Weight Loss with an Intervention Content Analysis

PubMed Central

Lyzwinski, Lynnette Nathalie

2014-01-01

Introduction: Overweight and obesity constitute leading global public health challenges. Tackling overweight and obesity by influencing human behaviour is a complex task, requiring novel emerging health psychology interventions. The aims of this review will be to determine whether mobile devices induce weight loss and improvements in diet and physical activity levels when compared with standard controls without a weight loss intervention or controls allocated to non-mobile device weight loss interventions. Methods: A systematic review on mobile devices and weight loss was conducted. The inclusion criteria were all randomized controlled trials with baseline and post-intervention weight measures in adult subjects >18 years of age without pre-specified co-morbidities. Mobile device specifications included modern, portable devices in the form of smartphones, PDAs, iPods, and Mp3 players. Cohen’s d for standardized differences in mean weight loss was calculated. A random effects meta-analysis was generated using Comprehensive meta-analysis software. Theories and intervention content were coded and analysed. Results: A total of 17 studies were identified, of which 12 were primary trials and 5 were secondary analyses. The meta-analysis generated a medium significant effect size of 0.430 (95% CI 0.252–0.609) (p-value ≤ 0.01), favouring mobile interventions. Throughout the systematic review, mobile devices were found to induce weight loss relative to baseline weight. When comparing them with standard no intervention controls as well as controls receiving non-mobile weight loss interventions, results favoured mobile devices for weight loss. Reductions in Body mass index, waist circumference, and percentage body fat were also found in the review. Improvements in the determinants of weight loss in the form of improved dietary intake and physical activity levels were also found. Theory appears to largely inform intervention design, with the most common theories being Social Cognitive Theory, Elaboration Likelihood Theory, Control Theory, and Goal Theory. The use of behavioural change techniques was widespread across the studies, with a minimum of five per intervention. Conclusion: Mobile devices appear to induce positive changes in the behavioural determinants of weight and subsequently are associated with weight loss. Mobile device interventions are heavily informed by theory and behaviour change techniques. The use of theory appears to effectively enhance levels of constructs targeted by interventions. PMID:25563356

Physical activity in the treatment of the adulthood overweight and obesity: current evidence and research issues.

PubMed

Wing, R R

1999-11-01

The purpose of this paper is to review the evidence on the role of physical activity in the treatment of adult overweight and obesity. Three specific questions are addressed: (1) Does exercise alone produce weight loss? (2) Does exercise in combination with diet produce greater weight loss than diet only? and (3) Does exercise in combination with diet produce better maintenance of weight loss than diet alone? The literature initially identified by the Expert Panel on Clinical Guidelines for the Treatment of Obesity, three key meta analyses, and additional literature searches were used to identify randomized trials related to the three aforementioned topics. These articles were reviewed and tabulated. Six of 10 randomized studies found significantly greater weight loss in exercise alone versus no treatment controls. The magnitude of the effect averaged 1-2 kg. Only 2 of 13 studies found significant differences in initial weight loss for diet plus exercise versus diet only, although almost all studies pointed in this direction. Six studies were identified with maintenance periods of at least 1 yr. In two of the six there were significant long term differences favoring diet plus exercise, but in every study considered the direction of the difference favored diet plus exercise. Other strong evidence showing benefits of exercise for long-term weight loss comes from correlational analyses which consistently find that those individuals who report the greatest exercise have the best maintenance of weight loss. Randomized trials consistently show benefits of exercise for weight loss, but the effects are often modest. This may result from small sample sizes, short study duration, and poor adherence to the exercise prescriptions. To better define the doses and types of exercise that will promote long-term weight loss, it is necessary to develop better ways to measure exercise and promote adherence to exercise.

Motivation for Participating in a Weight Loss Program and Financial Incentives: An Analysis from a Randomized Trial

PubMed Central

Crane, Melissa M.; Tate, Deborah F.; Finkelstein, Eric A.; Linnan, Laura A.

2012-01-01

This analysis investigated if changes in autonomous or controlled motivation for participation in a weight loss program differed between individuals offered a financial incentive for weight loss compared to individuals not offered an incentive. Additionally, the same relationships were tested among those who lost weight and either received or did not receive an incentive. This analysis used data from a year-long randomized worksite weight loss program that randomly assigned employees in each worksite to either a low-intensity weight loss program or the same program plus small financial incentives for weight loss ($5.00 per percentage of initial weight lost). There were no differences in changes between groups on motivation during the study, however, increases in autonomous motivation were consistently associated with greater weight losses. This suggests that the small incentives used in this program did not lead to increases in controlled motivation nor did they undermine autonomous motivation. Future studies are needed to evaluate the magnitude and timing of incentives to more fully understand the relationship between incentives and motivation. PMID:22577524

Methodological quality of behavioural weight loss studies: a systematic review

PubMed Central

Lemon, S. C.; Wang, M. L.; Haughton, C. F.; Estabrook, D. P.; Frisard, C. F.; Pagoto, S. L.

2018-01-01

Summary This systematic review assessed the methodological quality of behavioural weight loss intervention studies conducted among adults and associations between quality and statistically significant weight loss outcome, strength of intervention effectiveness and sample size. Searches for trials published between January, 2009 and December, 2014 were conducted using PUBMED, MEDLINE and PSYCINFO and identified ninety studies. Methodological quality indicators included study design, anthropometric measurement approach, sample size calculations, intent-to-treat (ITT) analysis, loss to follow-up rate, missing data strategy, sampling strategy, report of treatment receipt and report of intervention fidelity (mean = 6.3). Indicators most commonly utilized included randomized design (100%), objectively measured anthropometrics (96.7%), ITT analysis (86.7%) and reporting treatment adherence (76.7%). Most studies (62.2%) had a follow-up rate >75% and reported a loss to follow-up analytic strategy or minimal missing data (69.9%). Describing intervention fidelity (34.4%) and sampling from a known population (41.1%) were least common. Methodological quality was not associated with reporting a statistically significant result, effect size or sample size. This review found the published literature of behavioural weight loss trials to be of high quality for specific indicators, including study design and measurement. Identified for improvement include utilization of more rigorous statistical approaches to loss to follow up and better fidelity reporting. PMID:27071775

Effect of weekly physical activity frequency on weight loss in healthy overweight and obese women attending a weight loss program: a randomized controlled trial.

PubMed

Madjd, Ameneh; Taylor, Moira A; Shafiei Neek, Leila; Delavari, Alireza; Malekzadeh, Reza; Macdonald, Ian A; Farshchi, Hamid R

2016-11-01

The effect of intensity and duration of physical activity (PA) on weight loss has been well described. However, the effect of the frequency of weekly PA on weight loss is still unknown. The purpose of this study was to evaluate the effect of the frequency of weekly PA sessions while maintaining the same total activity time on weight loss during a 24-wk weight loss program. Overweight and obese women [n = 75; body mass index (BMI; in kg/m 2 ): 27-37; age: 18-40 y] who had a normally sedentary lifestyle were randomly allocated to 1 of 2 intervention groups: a high-frequency physical activity (HF) or a low-frequency physical activity (LF) group. The HF group included 50 min/d PA, 6 d/wk (300 min/wk). The LF group included 100 min/d PA, 3 d/wk (300 min/wk). Both groups were advised to follow the same dietary weight loss program. Both groups showed a significant decrease in anthropometric measurements and significant improvements in cardiometabolic disease risk characteristics over the 24 wk of the study. Compared with the HF group, the LF group had a greater decrease in weight (mean ± SD; LF: 9.58 ± 3.77 kg; HF: 7.78 ± 2.68 kg; P = 0.028), BMI (LF: 3.62 ± 1.56; HF: 2.97 ± 1.02; P = 0.029) and waist circumference (LF: 9.36 ± 4.02 cm; HF: 7.86 ± 2.41 cm; P = 0.031). However, there were no significant differences in carbohydrate metabolism characteristics or lipid profile after the 24 wk of intervention. Weekly PA undertaken over fewer sessions of longer duration during the week could be more effective for weight loss than when undertaken as more frequent shorter sessions in overweight and obese women on a weight loss program. This may be helpful for those who are neither willing nor able to schedule time for PA almost every day to achieve weight loss. This trial was registered at www.irct.ir as IRCT201402157754N4. © 2016 American Society for Nutrition.

Copenhagen study of overweight patients with coronary artery disease undergoing low energy diet or interval training: the randomized CUT-IT trial protocol.

PubMed

Pedersen, Lene Rørholm; Olsen, Rasmus Huan; Frederiksen, Marianne; Astrup, Arne; Chabanova, Elizaveta; Hasbak, Philip; Holst, Jens Juul; Kjær, Andreas; Newman, John W; Walzem, Rosemary; Wisløff, Ulrik; Sajadieh, Ahmad; Haugaard, Steen Bendix; Prescott, Eva

2013-11-19

Coronary artery disease (CAD) is accountable for more than 7 million deaths each year according to the World Health Organization (WHO). In a European population 80% of patients diagnosed with CAD are overweight and 31% are obese. Physical inactivity and overweight are major risk factors in CAD, thus central strategies in secondary prevention are increased physical activity and weight loss. In a randomized controlled trial 70 participants with stable CAD, age 45-75, body mass index 28-40 kg/m2 and no diabetes are randomized (1:1) to 12 weeks of intensive exercise or weight loss both succeeded by a 40-week follow-up. The exercise protocol consist of supervised aerobic interval training (AIT) at 85-90% of VO2peak 3 times weekly for 12 weeks followed by supervised AIT twice weekly for 40 weeks. In the weight loss arm dieticians instruct the participants in a low energy diet (800-1000 kcal/day) for 12 weeks, followed by 40 weeks of weight maintenance combined with supervised AIT twice weekly. The primary endpoint of the study is change in coronary flow reserve after the first 12 weeks' intervention. Secondary endpoints include cardiovascular, metabolic, inflammatory and anthropometric measures. The study will compare the short and long-term effects of a protocol consisting of AIT alone or a rapid weight loss followed by AIT. Additionally, it will provide new insight in mechanisms behind the benefits of exercise and weight loss. We wish to contribute to the creation of effective secondary prevention and sustainable rehabilitation strategies in the large population of overweight and obese patients diagnosed with CAD. ClinicalTrials.gov: NCT01724567.

A pilot study of a weight management program with food provision in schizophrenia.

PubMed

Jean-Baptiste, Michel; Tek, Cenk; Liskov, Ellen; Chakunta, Umesh Rao; Nicholls, Sarah; Hassan, Akm Q; Brownell, Kelly D; Wexler, Bruce E

2007-11-01

Obesity is a serious medical problem that disproportionately affects people with severe mental illness. Behavioral strategies aimed at lifestyle modification have proven effective for weight loss in general population but have not been studied adequately among persons with schizophrenia. We have conducted a randomized controlled pilot trial of an established weight loss program, modified for this specific population, and supplemented with a novel food replacement program, as well as practical, community based teaching of shopping and preparing healthy food. The program not only arrested weight gain, and produced meaningful weight loss, but also weight loss continued 6 months after the intervention is completed. Cognitive impairment had no bearing to the extent a participant benefited from the program. As a conclusion, well designed simple behavioral programs can produce lasting weight loss for patients with schizophrenia and comorbid obesity, improve metabolic indices, and possibly decrease significant medical risks associated with obesity.

Daily self-monitoring of body weight, step count, fruit/vegetable intake, and water consumption: a feasible and effective long-term weight loss maintenance approach.

PubMed

Akers, Jeremy D; Cornett, Rachel A; Savla, Jyoti S; Davy, Kevin P; Davy, Brenda M

2012-05-01

Maintenance of weight loss remains a challenge for most individuals. Thus, practical and effective weight-loss maintenance (WTLM) strategies are needed. A two-group 12-month WTLM intervention trial was conducted from June 2007 to February 2010 to determine the feasibility and effectiveness of a WTLM intervention for older adults using daily self-monitoring of body weight, step count, fruit/vegetable (F/V) intake, and water consumption. Forty weight-reduced individuals (mean weight lost=6.7±0.6 kg; body mass index [calculated as kg/m²] 29.2±1.1), age 63±1 years, who had previously participated in a 12-week randomized controlled weight-loss intervention trial, were instructed to record daily body weight, step count, and F/V intake (WEV [defined as weight, exercise, and F/V]). Experimental group (WEV+) participants were also instructed to consume 16 fl oz of water before each main meal (ie, three times daily), and to record daily water intake. Outcome measures included weight change, diet/physical activity behaviors, theoretical constructs related to health behaviors, and other clinical measures. Statistical analyses included growth curve analyses and repeated measures analysis of variance. Over 12 months, there was a linear decrease in weight (β=-0.32, P<0.001) and a quadratic trend (β=0.02, P<0.01) over time, but no group difference (β=-0.23, P=0.08). Analysis of the 365 days of self-reported body weight for each participant determined that weight loss was greater over the study period in the WEV+ group than in the WEV group, corresponding to weight changes of -0.67 kg and 1.00 kg, respectively, and an 87% greater weight loss (β=-0.01, P<0.01). Overall compliance to daily tracking was 76%±5%. Daily self-monitoring of weight, physical activity, and F/V consumption is a feasible and effective approach for maintaining weight loss for 12 months, and daily self-monitoring of increased water consumption may provide additional WTLM benefits. Copyright © 2012 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.

Weight loss in a UK commercial all meal provision study: a randomised controlled trial.

PubMed

Mellor, D D; Whitham, C; Goodwin, S; Morris, M; Reid, M; Atkin, S L

2014-08-01

Effective approaches are needed to address the increasing prevalence of overweight and obesity. The present study investigated whether all meal provision was a more effective and acceptable method for weight loss than a self-directed diet. This randomised controlled trial recruited 112 men and women with a body mass index in the range 27-35 kg m(-2), who had no comorbidities, from the local area of Hull. Participants were randomised to receive either meal provision or follow a self-directed diet for a 12-week period that resulted in an estimated 2928 kJ day(-1) (700 kcal day(-1)) deficit. A dietitian supervised both dietary interventions. At 12 weeks [mean (SEM)], percentage weight loss in the meal provision group was 6.6% (0.5%) compared to 4.3% (0.6%) for those on the self-directed diet. In terms of clinically relevant weight loss, 61% of participants lost 5% or more of their body weight with meal provision compared to 22% on the self-directed diet (P < 0.001). Weight loss was associated with wellbeing in both groups. Attrition was less apparent with 7% of those participants receiving meal provision withdrawing from the study compared to 41% of those following the self-directed diet (P < 0.001). Meal provision was a more effective and accepted method for weight loss over a 12-week period compared to a self-directed diet. This may in part represent the difference between being given the meal provision food free of charge. However, longer-term maintenance studies need to be undertaken to ascertain their effects on the maintenance of weight loss. © 2013 The Authors. Journal of Human Nutrition and Dietetics published by John Wiley & Sons Ltd on behalf of British Dietetic Association Ltd.

Effects of dietary and exercise intervention on weight loss and body composition in obese postmenopausal women: a systematic review and meta-analysis.

PubMed

Cheng, Chao-Chun; Hsu, Ching-Yun; Liu, Jen-Fang

2018-03-12

This study examined the effects of dietary and exercise interventions on weight loss and body composition in overweight/obese peri- and postmenopausal women. Medline, Central, Embase, and Google Scholar databases were searched for relevant trials conducted until December 31, 2016. Randomized controlled trials (RCTs) and prospective studies of overweight/obese peri- or postmenopausal women that examined the effects of dietary or exercise interventions, alone or combined, on weight loss were included. The primary outcome was percentage reduction in body weight. From 292 studies initially identified, 11 studies with 12 sets of participants were included. Both dietary and exercise intervention groups had significantly greater weight loss than control groups (diet vs control: difference in means = -6.55, 95% CI, -9.51 to -3.59, P < 0.001; exercise vs control: difference in means = -3.49, 95% CI, -6.96 to -0.02, P = 0.049). Combined dietary and exercise interventions resulted in greater weight loss than dietary interventions alone (diet plus exercise vs diet: difference in means = -1.22, 95% CI, -2.14 to -0.29, P = 0.010). Diet plus exercise resulted in greater fat loss (difference in means = -0.44, 95% CI, -0.67 to -0.20, P < 0.001) and greater lean mass loss (difference in means = -0.84, 95% CI, -1.13 to -0.55, P < 0.001) than diet alone. Dietary interventions reduced body weight and body composition profile parameters in peri- and postmenopausal women more than exercise alone. The addition of exercise reinforced the effect of dietary interventions on changing body weight and composition.

A weight-loss program adapted to the menstrual cycle increases weight loss in healthy, overweight, premenopausal women: a 6-mo randomized controlled trial.

PubMed

Geiker, Nina Rw; Ritz, Christian; Pedersen, Sue D; Larsen, Thomas M; Hill, James O; Astrup, Arne

2016-07-01

Hormonal fluctuations during the menstrual cycle influence energy intake and expenditure as well as eating preferences and behavior. We examined the effect in healthy, overweight, premenopausal women of a diet and exercise weight-loss program that was designed to target and moderate the effects of the menstrual cycle compared with the effect of simple energy restriction. A total of 60 healthy, overweight, premenopausal women were included in a 6-mo weight-loss program in which each subject consumed a diet of 1600 kcal/d. Subjects were randomly assigned to either a combined diet and exercise program that was tailored to metabolic changes of the menstrual cycle (Menstralean) or to undergo simple energy restriction (control). Thirty-one women (19 Menstralean and 12 control women) completed the study [mean ± SD body mass index (in kg/m(2)): 32.0 ± 5.2]. Both groups lost weight during the study. In an intention-to-treat analysis, the Menstralean group did not achieve a clinically significant weight loss compared with that of the control group (P = 0.61). In per-protocol analyses, a more-pronounced weight loss of 4.3 ± 1.4 kg (P = 0.002) was shown in adherent Menstralean subjects than in the control group. A differentiated diet and exercise program that is tailored to counteract food cravings and metabolic changes throughout the menstrual cycle may increase weight loss above that achieved with a traditional diet and exercise program in women who can comply with the program. This trial was registered at clinicaltrials.gov as NCT01622114. © 2016 American Society for Nutrition.

Considering Patient Diet Preference to Optimize Weight Loss: Design Considerations of a Randomized Trial Investigating the Impact of Choice

PubMed Central

Yancy, William S.; Coffman, Cynthia J.; Geiselman, Paula J.; Kolotkin, Ronette L.; Almirall, Daniel; Oddone, Eugene Z.; Mayer, Stephanie B.; Gaillard, Leslie A.; Turner, Marsha; Smith, Valerie A.; Voils, Corrine I.

2015-01-01

A variety of diet approaches achieve moderate weight loss in many individuals. Yet, most diet interventions fail to achieve meaningful weight loss in more than a few individuals, likely due to inadequate adherence to the diet. It is widely conjectured that targeting the diet to an individual's food preferences will enhance adherence, thereby improving weight loss. This article describes the design considerations of a study protocol aimed at testing this hypothesis. The study is a 2-arm randomized trial recruiting 216 medical outpatients with BMI ≥30 kg/m2 followed for 48 weeks. Participants in the experimental arm (Choice) select from two of the most widely studied diets for weight loss, a low-carbohydrate, calorie-unrestricted diet (LCD) or a low-fat, reduced-calorie diet (LFD). The participant's choice is informed by results from a validated food preference questionnaire and a discussion of diet options with trained personnel. Choice participants are given the option to switch to the other diet after three months, if desired. Participants in the Control arm are randomly assigned to follow one of the two diets for the duration of follow-up. The primary outcome is weight assessed every 2-4 weeks for 48 weeks. Secondary outcomes include adherence to diet by food frequency questionnaire and obesity-specific health-related quality of life. If assisting patients to choose their diet enhances adherence and increases weight loss, the results will support the provision of diet options to patients who desire weight loss, and bring us one step closer to remediating the obesity epidemic faced by our healthcare systems. PMID:23506974

Cell phone intervention for you (CITY): A randomized, controlled trial of behavioral weight loss intervention for young adults using mobile technology.

PubMed

Svetkey, Laura P; Batch, Bryan C; Lin, Pao-Hwa; Intille, Stephen S; Corsino, Leonor; Tyson, Crystal C; Bosworth, Hayden B; Grambow, Steven C; Voils, Corrine; Loria, Catherine; Gallis, John A; Schwager, Jenifer; Bennett, Gary G; Bennett, Gary B

2015-11-01

To determine the effect on weight of two mobile technology-based (mHealth) behavioral weight loss interventions in young adults. Randomized, controlled comparative effectiveness trial in 18- to 35-year-olds with BMI ≥ 25 kg/m(2) (overweight/obese), with participants randomized to 24 months of mHealth intervention delivered by interactive smartphone application on a cell phone (CP); personal coaching enhanced by smartphone self-monitoring (PC); or Control. The 365 randomized participants had mean baseline BMI of 35 kg/m(2) . Final weight was measured in 86% of participants. CP was not superior to Control at any measurement point. PC participants lost significantly more weight than Controls at 6 months (net effect -1.92 kg [CI -3.17, -0.67], P = 0.003), but not at 12 and 24 months. Despite high intervention engagement and study retention, the inclusion of behavioral principles and tools in both interventions, and weight loss in all treatment groups, CP did not lead to weight loss, and PC did not lead to sustained weight loss relative to Control. Although mHealth solutions offer broad dissemination and scalability, the CITY results sound a cautionary note concerning intervention delivery by mobile applications. Effective intervention may require the efficiency of mobile technology, the social support and human interaction of personal coaching, and an adaptive approach to intervention design. © 2015 The Obesity Society.

Efficacy of First-Time Intragastric Balloon in Weight Loss: a Systematic Review and Meta-analysis of Randomized Controlled Trials.

PubMed

Saber, Alan A; Shoar, Saeed; Almadani, Mahmoud W; Zundel, Natan; Alkuwari, Mohammed J; Bashah, Moataz M; Rosenthal, Raul J

2017-02-01

The intragastric balloon (IGB) is an adjunctive treatment for obesity. This meta-analysis aimed to evaluate the efficacy and safety of IGB treatment by reviewing randomized controlled trials (RCTs). A total of 20 RCTs involving 1195 patients were identified. Weight loss results before and after 3 months were analyzed separately. The weight loss results of patients with and without IGB treatment were compared. Our meta-analysis calculated the following significant effect sizes: 1.59 and 1.34 kg/m 2 for overall and 3-month BMI loss, respectively; 14.25 and 11.16 % for overall and >3-month percentage of excess weight loss, respectively; 4.6 and 4.77 kg for overall and 3-month weight loss, respectively; and 2.81, 1.62, and 4.09 % for overall, 3-month, and >3-month percent of weight loss, respectively. A significant effect size was calculated that favored fluid-filled IGBs over air-filled IGBs. Flatulence (8.75 vs. 3.89 %, p = 0.0006), abdominal fullness (6.32 vs. 0.55 %, p = 0.001), abdominal pain (13.86 vs. 7.2 %, p = 0.0001), abdominal discomfort (4.37 vs. 0.55 %, p = 0.006), and gastric ulcer (12.5 vs. 1.2 %, p < 0.0001) were significantly more prevalent among IGB patients than among non-IGB control patients. No mortality was reported from IGB treatment. IGB treatment, in addition to lifestyle modification, is an effective short-term modality for weight loss. However, there is not sufficient evidence confirming its safety or long-term efficacy.

Naltrexone + bupropion (Mysimba). Too risky for only modest weight loss.

PubMed

2015-10-01

Weight loss and its long-term maintenance are mainly based on dietary measures and regular physical activity. There are currently no weight-loss medications with a favourable harm-benefit balance. Bupropion is chemically related to certain amphetamines, while naltrexone is an opioid receptor antagonist. A fixed-dose combination of these two drugs has received marketing authorisation in the European Union for obese patients and for over-weight patients with other cardiovascular risk factors. In five placebo-controlled, randomised, double-blind trials, the patients, weighing on average between 100 kg and 105 kg (average body mass index 36 kg/m2), the naltrexone + bupropion combination was associated with an average weight loss of a few additional kilograms compared with placebo, after 6 months or one year of treatment. There are no post-trial follow-up data to show whether or not the patients regained their lost weight after treatment discontinuation. One trial including more than 8900 patients examined the effect of the naltrexone + bupropion combination on the freauency of maior cardiovascular events, but poor handling of an interim analysis undermined the validity of the final results. The known adverse effects of bupropion consist of potentially severe neuropsychiatric disorders such as aggressiveness, depression and suicidal ideation, and also allergic reactions, including Stevens-Johnson syndrome. Misuse and excessive consumption have been reported. In trials in obese or overweight patients, the naltrexone + bupropion combination caused sometimes severe neuropsychiatric disorders, including seizures, cognitive impairment, dizziness, anxiety, sleep disorders and psychotic symptoms. In clinical trials, the combination led to an increase in blood pressure compared with placebo, and also an excess of cardiac arrhythmias. About half of patients who took naltrexone + bupropion experienced gastrointestinal disorders such as nausea, vomiting and constipation. The naltrexone + bupropion combination is subject to many pharmacokinetic interactions, as well as pharmacodynamic interactions leading to additive convulsive or hypertensive effects, or undermining the action of antihypertensive drugs. A teratogenic effect of bupropion cannot be ruled out. In practice, given the limited effect of the naltrexone + bupropion combination on weight loss (a few kilograms), along with the lack of evidence supporting a persistent benefit or a decrease in the clinical complications of obesity, there is no reason to expose patients to its many potentially severe adverse effects.

Clinical and metabolic effects associated with weight changes and obeticholic acid in non-alcoholic steatohepatitis.

PubMed

Hameed, B; Terrault, N A; Gill, R M; Loomba, R; Chalasani, N; Hoofnagle, J H; Van Natta, M L

2018-03-01

In a 72-week, randomised controlled trial of obeticholic acid (OCA) in non-alcoholic steatohepatitis (NASH), OCA was superior to placebo in improving serum ALT levels and liver histology. OCA therapy also reduced weight. Because weight loss by itself can improve histology, to perform a post hoc analysis of the effects of weight loss and OCA treatment in improving clinical and metabolic features of NASH. The analysis was limited to the 200 patients with baseline and end-of-treatment liver biopsies. Weight loss was defined as a relative decline from baseline of 2% or more at treatment end. Weight loss occurred in 44% (45/102) of OCA and 32% (31/98) of placebo-treated patients (P = 0.08). The NAFLD Activity score (NAS) improved more in those with than without weight loss in both the OCA- (-2.4 vs -1.2, P<0.001) and placebo-treated patients (-1.2 vs -0.5, P = 0.03). ALT levels also improved in those with vs without weight loss in OCA- (-43 vs -34 U/L, P = 0.12) and placebo-treated patients (-29 vs -10 U/L, P = 0.02). However, among those who lost weight, OCA was associated with opposite effects from placebo on changes in alkaline phosphatase (+21 vs -12 U/L, P<0.001), total (+13 vs -14 mg/dL, P = 0.02) and LDL cholesterol (+18 vs -12 mg/dL, P = 0.01), and HbA1c (+0.1 vs -0.4%, P = 0.01). OCA leads to weight loss in up to 44% of patients with NASH, and OCA therapy and weight loss have additive benefits on serum aminotransferases and histology. However, favourable effects of weight loss on alkaline phosphatase, lipids and blood glucose seen in placebo-treated patients were absent or reversed on OCA treatment. These findings stress the importance of assessing concomitant metabolic effects of new therapies of NASH. Clinical trial number: NCT01265498. © 2018 John Wiley & Sons Ltd.

Effects on weight loss in adults of replacing diet beverages with water during a hypoenergetic diet: a randomized, 24-wk clinical trial.

PubMed

Madjd, Ameneh; Taylor, Moira A; Delavari, Alireza; Malekzadeh, Reza; Macdonald, Ian A; Farshchi, Hamid R

2015-12-01

Obese people believe that drinking diet beverages (DBs) may be a simple strategy to achieve weight loss. However, nutritionists advise drinking water when attempting to lose weight. It is unclear how important drinking water instead of DBs is during a weight-loss program. In this study, we compared the effect on weight loss of either replacing DBs with water or continuing to consume DBs in adults during a 24-wk weight-loss program. Overweight and obese women [n = 89; body mass index (BMI; in kg/m(2)): 27-40; age: 18-50 y] who usually consumed DBs in their diet were asked to either substitute water for DBs (water group) or continue drinking DBs 5 times/wk after their lunch for 24 wk (DB group) while on a weight-loss program. Sixty-two participants (71%) completed the trial (32 in the DB group, 30 in the water group). Baseline variables were not statistically significantly different between groups. A statistically significant reduction in anthropometric measurements and statistically significant improvements in cardiometabolic risk characteristics were observed over 24 wk in both groups. Compared with the DB group, the water group had a greater decrease in weight (mean ± SD: water: -8.8 ± 1.9 kg; DBs: -7.6 ± 2.1 kg; P = 0.015, time × group), fasting insulin (mean ± SD: water: -2.84 ± 0.77 mU/L; DBs: -1.78 ± 1.25 mU/L, P < 0.001), homeostasis model assessment of insulin resistance (mean ± SD: water: -0.097 ± 0.049; DBs: -0.057 ± 0.042, P < 0.001), and 2-h postprandial glucose (mean ± SD: water: -1.02 ± 0.25 mmol/L; DBs: -0.72 ± 0.27 mmol/L; P < 0.001) over the 24 wk. However, there was no significant time × group interaction for waist circumference, fasting plasma glucose, and lipid profiles within both groups over 24 wk. Replacement of DBs with water after the main meal may lead to greater weight reduction during a weight-loss program. It may also offer clinical benefits to improve insulin resistance. This trial was registered at www.irct.ir/ as IRCT201402177754N5. © 2015 American Society for Nutrition.

Results of a faith-based weight loss intervention for black women.

PubMed

Fitzgibbon, Marian L; Stolley, Melinda R; Ganschow, Pamela; Schiffer, Linda; Wells, Anita; Simon, Nolanna; Dyer, Alan

2005-10-01

Obesity is a risk factor for a variety of chronic diseases. Although weight loss may reduce these risks, weight loss programs designed for black women have yielded mixed results. Studies suggest that religion/spirituality is a prominent component of black culture. Given this, the inclusion of religion/spirituality as an active component of a weight loss program may enhance the benefits of the program. The role of religion/spirituality, however, has not been specifically tested as a mechanism that enhances the weight loss process. This paper presents the results of "Faith on the Move," a randomized pilot study of a faith-based weight loss program for black women. The goals of the study were to estimate the effects of a 12-week culturally tailored, faith-based weight loss intervention on weight loss, dietary fat consumption and physical activity. The culturally tailored, faith-based weight loss intervention was compared to a culturally tailored weight loss intervention with no active faith component. Fifty-nine overweight/obese black women were randomized to one of the two interventions. Although the results were not statistically significant, the effect size suggests that the addition of the faith component improved results. These promising preliminary results will need to be tested in an adequately powered trial.

Survival and physiologic response of common Amakihi and Japanese white-eyes during simulated translocation

USGS Publications Warehouse

Work, Thierry M.; Massey, J. Gregory; Johnson, Luanne; Dougill, Steve; Banko, Paul C.

1999-01-01

We evaluated the effects of three translocation trials on Common Amakihi (Hemignathus virens) and Japanese White-eyes (Zosterops japonicus). Trial 1 involved capturing birds, transporting them on rough roads for 4 hr followed by holding in an aviary for 48 hr without overnight thermal support prior to release. Trial 2 involved capture, then holding in an aviary for 48 hr with overnight thermal support followed by transport for 4 hr prior to release. Trial 3 and 1 were identical except that overnight thermal support was provided during trial 3. We monitored survival, food consumption, weight change, and fecal production during captivity as well as changes in hematocrit, estimated total solids, heterophil to lymphocyte ratios, plasma uric acid, and creatinine phosphokinase (CPK) at capture and release. Survival was significantly lower for Amakihi during trial 1 (no thermal support). Birds that died lost significantly more weight than those that survived. Regardless of trial, birds responded to translocation by a combination of weight loss, anemia, hypoproteinemia, and elevated heterophil to lymphocyte ratio, uric acid, and CPK levels. The first 24 hr of captivity posed the greatest risk to birds regardless of whether transport or holding occurred first. Food consumption, fecal production, and weight all decreased at night, and overnight thermal support during holding was critical if ambient temperatures dipped to freezing. We recommend that if small passerines are to be held for > 12 hr, they be monitored individually for weight loss, food consumption, and fecal production.

Insulin sensitizing drugs for weight loss in women of reproductive age who are overweight or obese: systematic review and meta-analysis.

PubMed

Nieuwenhuis-Ruifrok, A E; Kuchenbecker, W K H; Hoek, A; Middleton, P; Norman, R J

2009-01-01

Women of reproductive age, who are overweight or obese, are prone to infertility. Weight loss in these women leads to increased fecundity, higher chances of conception after infertility treatment and improved pregnancy outcome. In spite of the advantages, most patients have difficulty in losing weight and often regain lost weight over time. This review assesses whether treatment with insulin sensitizing drugs contributes to weight loss, compared with diet or a lifestyle modification programme. After a systematic search of the literature, only randomized controlled trials (RCTs), investigating the effect of insulin sensitizing drugs on weight loss compared with placebo and diet and/or a lifestyle modification programme, were included. Subjects were restricted to women of reproductive age. The main outcome measure was change in body mass index (BMI). Only 14 trials, unintentionally all but two on women with polycystic ovary syndrome (PCOS) only, were included in the analysis. Treatment with metformin showed a statistically significant decrease in BMI compared with placebo (weighted mean difference, -0.68; 95% CI -1.13 to -0.24). There was some indication of greater effect with high-dose metformin (>1500 mg/day) and longer duration of therapy (>8 weeks). Limitations were power, low use of intention-to-treat analysis and heterogeneity of the studies. A structured lifestyle modification programme to achieve weight loss should still be the first line treatment in obese women with or without PCOS. Adequately powered RCTs are required to confirm the findings of this review and to assess whether the addition of high-dose metformin therapy to a structured lifestyle modification programme might contribute to more weight loss.

Hockey Fans in Training: A Pilot Pragmatic Randomized Controlled Trial.

PubMed

Petrella, Robert J; Gill, Dawn P; Zou, Guangyong; DE Cruz, Ashleigh; Riggin, Brendan; Bartol, Cassandra; Danylchuk, Karen; Hunt, Kate; Wyke, Sally; Gray, Cindy M; Bunn, Christopher; Zwarenstein, Merrick

2017-12-01

Hockey Fans in Training (Hockey FIT) is a gender-sensitized weight loss and healthy lifestyle program. We investigated 1) feasibility of recruiting and retaining overweight and obese men into a pilot pragmatic randomized controlled trial and 2) potential for Hockey FIT to lead to weight loss and improvements in other outcomes at 12 wk and 12 months. Male fans of two ice hockey teams (35-65 yr; body mass index ≥28 kg·m) located in Ontario (Canada) were randomized to intervention (Hockey FIT) or comparator (wait-list control). Hockey FIT includes a 12-wk active phase (weekly, coach-led group meetings including provision of dietary information, practice of behavior change techniques, and safe exercise sessions plus incremental pedometer walking) and a 40-wk minimally supported phase (smartphone app for sustaining physical activity, private online social network, standardized e-mails, booster session/reunion). Measurement at baseline and 12 wk (both groups) and 12 months (intervention group only) included clinical outcomes (e.g., weight) and self-reported physical activity, diet, and self-rated health. Eighty men were recruited in 4 wk; trial retention was >80% at 12 wk and >75% at 12 months. At 12 wk, the intervention group lost 3.6 kg (95% confidence interval, -5.26 to -1.90 kg) more than the comparator group (P < 0.001) and maintained this weight loss to 12 months. The intervention group also demonstrated greater improvements in other clinical measures, physical activity, diet, and self-rated health at 12 wk; most sustained to 12 months. Results suggest feasible recruitment/retention of overweight and obese men in the Hockey FIT program. Results provide evidence for the potential effectiveness of Hockey FIT for weight loss and improved health in at-risk men and, thus, evidence to proceed with a definitive trial.

Estrogens and women's health: interrelation of coronary heart disease, breast cancer and osteoporosis.

PubMed

Kuller, L H; Matthews, K A; Meilahn, E N

2000-11-30

The determinants of blood levels of estrogen, estrogen metabolites, and relation to receptors and post-transitional effects are the likely primary cause of breast cancer. Very high risk women for breast cancer can now be identified by measuring bone mineral density and hormone levels. These high risk women have rates of breast cancer similar to risk of myocardial infarction. They are candidates for SERM therapies to reduce risk of breast cancer. The completion of the Women's Health Initiative and other such trials will likely provide a definite association of risk and benefit of both estrogen alone and estrogen-progesterone therapy, coronary heart disease, osteoporotic fracture, and breast cancer. The potential intervention of hormone replacement therapy, obesity, or weight gain and increased atherogenic lipoproteinemia may be of concern and confound the results of clinical trials. Estrogens, clearly, are important in the risk of bone loss and osteoporotic fracture. Obesity is the primary determinant of postmenopausal estrogen levels and reduced risk of fracture. Weight reduction may increase rates of bone loss and fracture. Clinical trials that evaluate weight loss should monitor effects on bone. The beneficial addition of increased physical activity, higher dose of calcium or vitamin D, or use of bone reabsorption drugs in coordination with weight loss should be evaluated. Any therapy that raises blood estrogen or metabolite activity and decreases bone loss may increase risk of breast cancer. Future clinical trials must evaluate multiple endpoints such as CHD, osteoporosis, and breast cancer within the study. The use of surrogate markers such as bone mineral density, coronary calcium, carotid intimal medial thickness and plaque, endothelial function, breast density, hormone levels and metabolites could enhance the evaluation of risk factors, genetic-environmental intervention, and new therapies.

Treatment of Obese Non-Diabetic Patients with Phenformin. A Double-Blind Cross-Over Trial

PubMed Central

Hart, A.; Cohen, H.

1970-01-01

The effect of 50 mg. of sustained release phenformin capsules administered twice daily was compared with a placebo as an aid to weight reduction in obese non-diabetic patients. Phenformin and placebo were administered alternately in two three-month periods. Weight loss on a 1,200-calorie diet was greater in the first three months than in the second three months regardless of treatment. There was no difference in weight loss between the phenformin and placebo groups in either the first or second three-month period. Serum cholesterol levels tended to fall in association with weight loss, but not apparently in relation to the size of the weight loss or to the treatment. PMID:4904162

Potential effects of reward and loss avoidance in overweight adolescents.

PubMed

Reyes, Sussanne; Peirano, Patricio; Luna, Beatriz; Lozoff, Betsy; Algarín, Cecilia

2015-08-01

Reward system and inhibitory control are brain functions that exert an influence on eating behavior regulation. We studied the differences in inhibitory control and sensitivity to reward and loss avoidance between overweight/obese and normal-weight adolescents. We assessed 51 overweight/obese and 52 normal-weight 15-y-old Chilean adolescents. The groups were similar regarding sex and intelligence quotient. Using Antisaccade and Incentive tasks, we evaluated inhibitory control and the effect of incentive trials (neutral, loss avoidance, and reward) on generating correct and incorrect responses (latency and error rate). Compared to normal-weight group participants, overweight/obese adolescents showed shorter latency for incorrect antisaccade responses (186.0 (95% CI: 176.8-195.2) vs. 201.3 ms (95% CI: 191.2-211.5), P < 0.05) and better performance reflected by lower error rate in incentive trials (43.6 (95% CI: 37.8-49.4) vs. 53.4% (95% CI: 46.8-60.0), P < 0.05). Overweight/obese adolescents were more accurate on loss avoidance (40.9 (95% CI: 33.5-47.7) vs. 49.8% (95% CI: 43.0-55.1), P < 0.05) and reward (41.0 (95% CI: 34.5-47.5) vs. 49.8% (95% CI: 43.0-55.1), P < 0.05) compared to neutral trials. Overweight/obese adolescents showed shorter latency for incorrect responses and greater accuracy in reward and loss avoidance trials. These findings could suggest that an imbalance of inhibition and reward systems influence their eating behavior.

Experiences of a commercial weight-loss programme after primary care referral: a qualitative study.

PubMed

Allen, Jodie T; Cohn, Simon R; Ahern, Amy L

2015-04-01

Referral to a commercial weight-loss programme is a cost-effective intervention that is already used within the NHS. Qualitative research suggests this community-based, non-medical intervention accords with participants' view of weight management as a lifestyle issue. To examine the ways in which participants' attitudes and beliefs about accessing a commercial weight management programme via their doctor relate to their weight-loss experience, and to understand how these contextual factors influence motivation and adherence to the intervention. A qualitative study embedded in a randomised controlled trial evaluating primary care referral to a commercial weight-loss programme in adults who are overweight or obese in England. The study took place from June-September 2013. Twenty-nine participants (body mass index [BMI] ≥28 kg/m(2); age ≥18 years), who took part in the WRAP (Weight Loss Referrals for Adults in Primary Care) trial, were recruited at their 3-month assessment appointment to participate in a semi-structured interview about their experience of the intervention and weight management more generally. Interviews were audiorecorded, transcribed verbatim, and analysed inductively using a narrative approach. Although participants view the lifestyle-based, non-medical commercial programme as an appropriate intervention for weight management, the referral from the GP and subsequent clinical assessments frame their experience of the intervention as medically pertinent with clear health benefits. Referral by the GP and follow-up assessment appointments were integral to participant experiences of the intervention, and could be adapted for use in general practice potentially to augment treatment effects. © British Journal of General Practice 2015.

Group motivational intervention in overweight/obese patients in primary prevention of cardiovascular disease in the primary healthcare area.

PubMed

Rodríguez Cristóbal, Juan José; Panisello Royo, Josefa Ma; Alonso-Villaverde Grote, Carlos; Pérez Santos, José Ma; Muñoz Lloret, Anna; Rodríguez Cortés, Francisca; Travé Mercadé, Pere; Benavides Márquez, Francisca; Martí de la Morena, Pilar; González Burgillos, Ma José; Delclós Baulies, Marta; Bleda Fernández, Domingo; Quillama Torres, Elida

2010-03-18

The global mortality caused by cardiovascular disease increases with weight. The Framingham study showed that obesity is a cardiovascular risk factor independent of other risks such as type 2 diabetes mellitus, dyslipidemia and smoking. Moreover, the main problem in the management of weight-loss is its maintenance, if it is achieved. We have designed a study to determine whether a group motivational intervention, together with current clinical practice, is more efficient than the latter alone in the treatment of overweight and obesity, for initial weight loss and essentially to achieve maintenance of the weight achieved; and, secondly, to know if this intervention is more effective for reducing cardiovascular risk factors associated with overweight and obesity. This 26-month follow up multi-centre trial, will include 1200 overweight/obese patients. Random assignment of the intervention by Basic Health Areas (BHA): two geographically separate groups have been created, one of which receives group motivational intervention (group intervention), delivered by a nurse trained by an expert phsychologist, in 32 group sessions, 1 to 12 fortnightly, and 13 to 32, monthly, on top of their standard program of diet, exercise, and the other (control group), receiving the usual follow up, with regular visits every 3 months. By addressing currently unanswered questions regarding the maintenance in weight loss in obesity/overweight, upon the expected completion of participant follow-up in 2012, the IMOAP trial should document, for the first time, the benefits of a motivational intervention as a treatment tool of weight loss in a primary care setting. ClinicalTrials.gov Identifier: NCT01006213.

Effect of weight reduction on the quality of life in obese patients with fibromyalgia syndrome: a randomized controlled trial.

PubMed

Senna, Mohammed Kamal; Sallam, Rehab Abd-El Raouf; Ashour, Hala Salah; Elarman, Mohammed

2012-11-01

The aim of the study was to examine whether weight reduction can result in improvement of fibromyalgia impact questionnaire (FIQ) in the patients with fibromyalgia syndrome (FMS). This study was a randomized controlled trial. Obese patients with fibromyalgia were randomly assigned to 6-month dietary weight loss (n = 41) and no weight loss (n = 42) groups. Patients were assessed at baseline and at 6 months. The primary outcome measure was FIQ. Secondary measures included the tender point (TP) examination, Beck Depression Inventory-II, and Pittsburg Sleep Quality Index. Compared to the control group, patients who underwent weight reduction obtained significantly better FIQ (p = 0.007), lower mean TP count (p = 0.015), and lower mean TP pain rating in the lower body (p < 0.001). Patients who lost weight had less depression and better sleep quality than the controls. Patients who lost weight had significantly lower interleukin 6 and C-reactive protein levels than those in the control group (p = 0.034 and p = 0.007, respectively). Weight loss in obese patients with FMS leads to significant improvement in the quality of life as shown by the decrease in the FIQ score. Depression, sleep quality, and tender point count are also significantly improved by weight loss in obese patients with fibromyalgia. Our results suggest that weight reduction should be a part of fibromyalgia treatment.

Weight-loss and exercise for communities with arthritis in North Carolina (we-can): design and rationale of a pragmatic, assessor-blinded, randomized controlled trial.

PubMed

Messier, Stephen P; Callahan, Leigh F; Beavers, Daniel P; Queen, Kate; Mihalko, Shannon L; Miller, Gary D; Losina, Elena; Katz, Jeffrey N; Loeser, Richard F; Quandt, Sara A; DeVita, Paul; Hunter, David J; Lyles, Mary F; Newman, Jovita; Hackney, Betsy; Jordan, Joanne M

2017-02-22

Recently, we determined that in a rigorously monitored environment an intensive diet-induced weight loss of 10% combined with exercise was significantly more effective at reducing pain in men and women with symptomatic knee osteoarthritis (OA) than either intervention alone. Compared to previous long-term weight loss and exercise trials of knee OA, our intensive diet-induced weight loss and exercise intervention was twice as effective at reducing pain intensity. Whether these results can be generalized to less intensively monitored cohorts is unknown. Thus, the policy relevant and clinically important question is: Can we adapt this successful solution to a pervasive public health problem in real-world clinical and community settings? This study aims to develop a systematic, practical, cost-effective diet-induced weight loss and exercise intervention implemented in community settings and to determine its effectiveness in reducing pain and improving other clinical outcomes in persons with knee OA. This is a Phase III, pragmatic, assessor-blinded, randomized controlled trial. Participants will include 820 ambulatory, community-dwelling, overweight and obese (BMI ≥ 27 kg/m 2 ) men and women aged ≥ 50 years who meet the American College of Rheumatology clinical criteria for knee OA. The primary aim is to determine whether a community-based 18-month diet-induced weight loss and exercise intervention based on social cognitive theory and implemented in three North Carolina counties with diverse residential (from urban to rural) and socioeconomic composition significantly decreases knee pain in overweight and obese adults with knee OA relative to a nutrition and health attention control group. Secondary aims will determine whether this intervention improves self-reported function, health-related quality of life, mobility, and is cost-effective. Many physicians who treat people with knee OA have no practical means to implement weight loss and exercise treatments as recommended by numerous OA treatment guidelines. This study will establish the effectiveness of a community program that will serve as a blueprint and exemplar for clinicians and public health officials in urban and rural communities to implement a diet-induced weight loss and exercise program designed to reduce knee pain and improve other clinical outcomes in overweight and obese adults with knee OA. clinicaltrials.gov Identifier: NCT02577549 October 12, 2015.

Perfluoroalkyl substances and changes in body weight and resting metabolic rate in response to weight-loss diets: A prospective study

PubMed Central

Furtado, Jeremy D.; Liang, Liming; Qi, Lu; Bray, George A.; DeJonge, Lilian; Coull, Brent

2018-01-01

Background The potential endocrine-disrupting effects of perfluoroalkyl substances (PFASs) have been demonstrated in animal studies, but whether PFASs may interfere with body weight regulation in humans is largely unknown. This study aimed to examine the associations of PFAS exposure with changes in body weight and resting metabolic rate (RMR) in a diet-induced weight-loss setting. Methods and findings In the 2-year POUNDS Lost randomized clinical trial based in Boston, Massachusetts, and Baton Rouge, Louisiana, that examined the effects of energy-restricted diets on weight changes, baseline plasma concentrations of major PFASs were measured among 621 overweight and obese participants aged 30–70 years. Body weight was measured at baseline and 6, 12, 18, and 24 months. RMR and other metabolic parameters, including glucose, lipids, thyroid hormones, and leptin, were measured at baseline and 6 and 24 months. Participants lost an average of 6.4 kg of body weight during the first 6 months (weight-loss period) and subsequently regained an average of 2.7 kg of body weight during the period of 6–24 months (weight regain period). After multivariate adjustment, baseline PFAS concentrations were not significantly associated with concurrent body weight or weight loss during the first 6 months. In contrast, higher baseline levels of PFASs were significantly associated with a greater weight regain, primarily in women. In women, comparing the highest to the lowest tertiles of PFAS concentrations, the multivariate-adjusted mean weight regain (SE) was 4.0 (0.8) versus 2.1 (0.9) kg for perfluorooctanesulfonic acid (PFOS) (Ptrend = 0.01); 4.3 (0.9) versus 2.2 (0.8) kg for perfluorooctanoic acid (PFOA) (Ptrend = 0.007); 4.7 (0.9) versus 2.5 (0.9) kg for perfluorononanoic acid (PFNA) (Ptrend = 0.006); 4.9 (0.9) versus 2.7 (0.8) kg for perfluorohexanesulfonic acid (PFHxS) (Ptrend = 0.009); and 4.2 (0.8) versus 2.5 (0.9) kg for perfluorodecanoic acid (PFDA) (Ptrend = 0.03). When further adjusted for changes in body weight or thyroid hormones during the first 6 months, results remained similar. Moreover, higher baseline plasma PFAS concentrations, especially for PFOS and PFNA, were significantly associated with greater decline in RMR during the weight-loss period and less increase in RMR during the weight regain period in both men and women. Limitations of the study include the possibility of unmeasured or residual confounding by socioeconomic and psychosocial factors, as well as possible relapse to the usual diet prior to randomization, which could have been rich in foods contaminated by PFASs through food packaging and also dense in energy. Conclusions In this diet-induced weight-loss trial, higher baseline plasma PFAS concentrations were associated with a greater weight regain, especially in women, possibly explained by a slower regression of RMR levels. These data illustrate a potential novel pathway through which PFASs interfere with human body weight regulation and metabolism. The possible impact of environmental chemicals on the obesity epidemic therefore deserves attention. Trial registration ClinicalTrials.gov NCT00072995 PMID:29438414

Postmenopausal weight change and incidence of fracture: post hoc findings from Women's Health Initiative Observational Study and Clinical Trials.

PubMed

Crandall, Carolyn J; Yildiz, Vedat O; Wactawski-Wende, Jean; Johnson, Karen C; Chen, Zhao; Going, Scott B; Wright, Nicole C; Cauley, Jane A

2015-01-27

To determine associations between postmenopausal change in body weight and incidence of fracture and associations between voluntary and involuntary weight loss and risk of fracture. Post hoc analysis of data from the Women's Health Initiative Observational Study and Clinical Trials. 40 clinical centers in the United States. 120,566 postmenopausal women, aged 50-79 at baseline (1993-98), followed through 2013 (mean fracture follow-up duration 11 years from baseline). Annualized percentage change in measured body weight from baseline to year 3, classified as stable (<5% change), weight loss (≥ 5%), or weight gain (≥ 5%). Self assessment of whether weight loss was intentional or unintentional. Cox proportional hazards regression models were adjusted for age, race/ethnicity, baseline body mass index (BMI), smoking, alcohol intake, level of physical activity, energy expenditure, calcium and vitamin D intake, physical function score, oophorectomy, hysterectomy, previous fracture, comorbidity score, and drug use. Incident self reported fractures of the upper limbs, lower limbs, and central body; hip fractures confirmed by medical records. Mean participant age was 63.3. Mean annualized percent weight change was 0.30% (95% confidence interval 0.28 to 0.32). Overall, 79,279 (65.6%) had stable weight; 18,266 (15.2%) lost weight; and 23,021 (19.0%) gained weight. Compared with stable weight, weight loss was associated with a 65% higher incidence rates of fracture in hip (adjusted hazard ratio 1.65, 95% confidence interval 1.49 to 1.82), upper limb (1.09, 1.03 to 1.16), and central body (1.30, 1.20 to 1.39); weight gain was associated with higher incidence rates of fracture in upper limb (1.10, 1.05 to 1.18) and lower limb (1.18, 1.12 to 1.25). Compared with stable weight, unintentional weight loss was associated with a 33% higher incidence rates of hip fracture (1.33, 1.19 to 1.47) and increased incidence rates of vertebral fracture (1.16, 1.06 to 1.26); intentional weight loss was associated with increased incidence rates of lower limb fracture (1.11, 1.05 to 1.17) and decreased incidence of hip fracture (0.85, 0.76 to 0.95). Weight gain, weight loss, and intentional weight loss are associated with increased incidence of fracture, but associations differ by fracture location. Clinicians should be aware of fracture patterns after weight gain and weight loss. © Crandall et al 2015.

Lorcaserin: drug profile and illustrative model of the regulatory challenges of weight-loss drug development.

PubMed

Bays, Harold E

2011-03-01

Lorcaserin is a selective 5-hydroxytryptamine receptor 2c agonist developed as a weight-loss drug. Phase II and III clinical trials support lorcaserin as not only reducing adiposity (i.e., fat mass), but also as improving the metabolic diseases commonly associated with adiposopathy (i.e., fat dysfunction). At the time of this writing, regulatory processes continue towards evaluating lorcaserin as a potentially marketed weight-loss and weight-maintenance agent. Some of the challenges facing lorcaserin are similar to the difficulties encountered by all investigational weight-loss therapeutic agents, which include evolving paths towards approval. While important for clinicians to understand approval hurdles for all therapeutics, it is especially critical for researchers and developers to grasp the unique regulatory complexities of anti-obesity agents. This article profiles lorcaserin as an illustrative example of general drug development regulatory processes, and specifically details the unique challenge of weight-loss drug development.

A three-component cognitive behavioural lifestyle program for preconceptional weight-loss in women with polycystic ovary syndrome (PCOS): a protocol for a randomized controlled trial.

PubMed

Jiskoot, G; Benneheij, S H; Beerthuizen, A; de Niet, J E; de Klerk, C; Timman, R; Busschbach, J J; Laven, J S E

2017-03-06

Obesity in women with polycystic ovary syndrome (PCOS) negatively affects all clinical features, and a 5 to 10% weight loss has shown promising results on reproductive, metabolic and psychological level. Incorporating a healthy diet, increasing physical activity and changing dysfunctional thought patterns in women with PCOS are key points in losing weight. The biggest challenge in weight management programs is to achieve a reasonable and sustainable weight loss. The aim of this study is to explore whether Cognitive Behavioural Therapy (CBT) by a mental health professional, working in a multidisciplinary team with a dietician and a physical therapist (a three-component intervention), is more effective for weight loss in the long term, within 12 months. We will also explore whether mobile phone applications are effective in supporting behavioural change and sustainable weight loss. The present study is a longitudinal randomized controlled trial (RCT) to study the effectiveness of a three-component 1-year cognitive-behavioural lifestyle intervention in overweight/obese women with PCOS. A total of 210 participants are randomly assigned to three groups: 1) CBT provided by the multidisciplinary team or; 2) CBT provided by the multidisciplinary team and Short Message Service (SMS) or; 3) usual care: encourage weight loss through publicly available services (control group). The primary aim of the 12-month intervention is to explore whether a three-component 1-year cognitive-behavioural lifestyle intervention is effective to decrease weight, when compared to usual care. Secondary outcomes include: the effect of the intervention on the PCOS phenotype, waist circumference, waist to hip ratio, ovulation rates, total testosterone, SHBG, free androgen index (FAI), AMH, hirsutism, acne, fasting glucose, blood pressure and all psychological parameters. Additionally, we assessed time to pregnancy, ongoing pregnancies, clinical pregnancies, miscarriages and birth weight. All outcome variables are measured at the start of the study, and again at 3 months, 6 months, nine months and 12 months. We expect that CBT provided by a multidisciplinary team, especially combined with SMS, is effective in developing a healthy lifestyle and achieving a long-term weight loss in women with PCOS. Losing 5- 10% body weight improves various PCOS characteristics. Consequently, we expect to show that CBT provided by a multidisciplinary team improves reproductive and metabolic outcomes, as well as quality of life, while at the same time being cost-effective. Registered at the Netherlands National Trial Register with number NTR2450 on August 2nd, 2010.

75 FR 47821 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-09

..., heart disease, or diabetes). The BMI is a measure of body weight (mass) based on a person's weight and... SCOUT trial evaluated the potential benefits of weight loss with MERIDIA on major cardiovascular (heart...

Motivational interviewing fails to improve outcomes of a behavioral weight loss program for obese African American women: a pilot randomized trial.

PubMed

Befort, Christie A; Nollen, Nicole; Ellerbeck, Edward F; Sullivan, Debra K; Thomas, Janet L; Ahluwalia, Jasjit S

2008-10-01

Compared to other racial/ethnic groups, African American (AA) women are more likely to be obese but less likely to participate in weight loss interventions or to successfully lose weight. Sustained motivation for weight loss may be especially difficult for AA women due to socioeconomic and cultural factors. The purpose of this study was to examine whether the addition of motivational interviewing (MI) to a culturally-targeted behavioral weight loss program for AA women improved adherence to the program, diet and physical activity behaviors, and weight loss outcomes. Forty-four obese (mean BMI = 39.4, SD = 7.1) AA women were randomized to receive a 16-week behavioral weight loss program plus four MI sessions, or the same behavioral weight loss program plus four health education (HE; attention control) sessions. Results showed that participants in both MI and HE conditions lost a significant amount of weight, reduced their energy intake and percent calories from fat, and increased their fruit and vegetable consumption (ps < .05). However, adherence to the behavioral weight loss program and changes in diet, physical activity, and weight did not differ across MI and HE conditions. Future research is warranted to determine the subpopulations with which MI is most effective.

Effectiveness of weight loss interventions – is there a difference between men and women: a systematic review

PubMed Central

Williams, R L; Wood, L G; Collins, C E; Callister, R

2015-01-01

Effective strategies are required to reduce the prevalence of overweight and obesity; however, the effectiveness of current weight loss programmes is variable. One contributing factor may be the difference in weight loss success between men and women. A systematic review was conducted to determine whether the effectiveness of weight loss interventions differs between men and women. Randomized controlled trials published up until March 2014 were included. Effect sizes (Hedges' g) were used to examine the difference in weight outcomes between men and women. A total of 58 studies met the eligibility criteria with 49 studies of higher quality included in the final data synthesis. Eleven studies that directly compared weight loss in men and women reported a significant sex difference. Ten of these reported that men lost more weight than women; however, women also lost a significant amount of weight. Analysis of effect sizes found small differences in weight loss favouring men for both diet (g = 0.489) and diet plus exercise (g = 0.240) interventions. There is little evidence from this review to indicate that men and women should adopt different weight loss strategies. Current evidence supports moderate energy restriction in combination with exercise for weight loss in both men and women. PMID:25494712

A cost analysis of implementing a behavioral weight loss intervention in community mental health settings: Results from the ACHIEVE trial.

PubMed

Janssen, Ellen M; Jerome, Gerald J; Dalcin, Arlene T; Gennusa, Joseph V; Goldsholl, Stacy; Frick, Kevin D; Wang, Nae-Yuh; Appel, Lawrence J; Daumit, Gail L

2017-06-01

In the ACHIEVE randomized controlled trial, an 18-month behavioral intervention accomplished weight loss in persons with serious mental illness who attended community psychiatric rehabilitation programs. This analysis estimates costs for delivering the intervention during the study. It also estimates expected costs to implement the intervention more widely in a range of community mental health programs. Using empirical data, costs were calculated from the perspective of a community psychiatric rehabilitation program delivering the intervention. Personnel and travel costs were calculated using time sheet data. Rent and supply costs were calculated using rent per square foot and intervention records. A univariate sensitivity analysis and an expert-informed sensitivity analysis were conducted. With 144 participants receiving the intervention and a mean weight loss of 3.4 kg, costs of $95 per participant per month and $501 per kilogram lost in the trial were calculated. In univariate sensitivity analysis, costs ranged from $402 to $725 per kilogram lost. Through expert-informed sensitivity analysis, it was estimated that rehabilitation programs could implement the intervention for $68 to $85 per client per month. Costs of implementing the ACHIEVE intervention were in the range of other intensive behavioral weight loss interventions. Wider implementation of efficacious lifestyle interventions in community mental health settings will require adequate funding mechanisms. © 2017 The Obesity Society.

Intensive weight loss intervention in older individuals: results from the Action for Health in Diabetes Type 2 diabetes mellitus trial.

PubMed

Espeland, Mark A; Rejeski, W Jack; West, Delia S; Bray, George A; Clark, Jeanne M; Peters, Anne L; Chen, Haiying; Johnson, Karen C; Horton, Edward S; Hazuda, Helen P

2013-06-01

To compare the effects of 4 years of intensive lifestyle intervention on weight, fitness, and cardiovascular disease risk factors in older and younger individuals. Randomized controlled clinical trial. Sixteen U.S. clinical sites. Individuals with type 2 diabetes mellitus: 1,053 aged 65 to 76 and 4,092 aged 45 to 64. An intensive behavioral intervention designed to promote and maintain weight loss through caloric restriction and increased physical activity was compared with diabetes mellitus support and education. Standardized assessments of weight, fitness (based on graded exercise testing), and cardiovascular disease risk factors. Over 4 years, older individuals had greater intervention-related mean weight losses (6.2%) than younger participants (5.1%; interaction P = .006) and comparable relative mean increases in fitness (0.56 vs 0.53 metabolic equivalents; interaction P = .72). These benefits were seen consistently across subgroups of older adults formed according to many demographic and health factors. Of a panel of age-related health conditions, only self-reported worsening vision was associated with poorer intervention-related weight loss in older individuals. The intensive lifestyle intervention produced mean increases in high-density lipoprotein cholesterol (2.03 mg/dL; P < .001) and decreases in glycated hemoglobin (0.21%; P < .001) and waist circumference (3.52 cm; P < .001) over 4 years that were at least as large in older as in younger individuals. Intensive lifestyle intervention targeting weight loss and increased physical activity is effective in overweight and obese older individuals to produce sustained weight loss and improvements in fitness and cardiovascular risk factors. © 2013, Copyright the Authors Journal compilation © 2013, The American Geriatrics Society.

Weight Loss Outcomes in Laparoscopic Vertical Sleeve Gastrectomy (LVSG) Versus Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) Procedures: A Meta-Analysis and Systematic Review of Randomized Controlled Trials.

PubMed

Osland, Emma; Yunus, Rossita M; Khan, Shahjahan; Memon, Breda; Memon, Muhammed A

2017-02-01

Laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic vertical sleeve gastrectomy (LVSG) have been proposed as cost-effective strategies to manage morbid obesity. The aim of this meta-analysis was to compare the postoperative weight loss outcomes reported in randomized control trials (RCTs) for LVSG versus LRYGB procedures. RCTs comparing the weight loss outcomes following LVSG and LRYGB in adult population between January 2000 and November 2015 were selected from PubMed, Medline, Embase, Science Citation Index, Current Contents, and the Cochrane database. The review was prepared in accordance with Preferred Reporting of Systematic Reviews and Meta-Analyses (PRISMA). Nine unique RCTs described over 10 publications involving a total of 865 patients (LVSG, n=437; LRYGB, n=428) were analyzed. Postoperative follow-up ranged from 3 months to 5 years. Twelve-month excess weight loss (EWL) for LVSG ranged from 69.7% to 83%, and for LRYGB, ranged from 60.5% to 86.4%. A number of studies reported slow weight gain between the second and third years of postoperative follow-up ranging from 1.4% to 4.2%EWL. This trend was seen to continue to 5 years postoperatively (8% to 10%EWL) for both procedures. In conclusion, LRYGB and LVSG are comparable with regards to the weight loss outcomes in the short term, with LRYGB achieving slightly greater weight loss. Slow weight recidivism is observed after the first postoperative year following both procedures. Long-term reporting of outcomes obtained from well-designed studies using intention-to-treat analyses are identified as a major gap in the literature at present.

Web-Based Interventions for Weight Loss or Weight Loss Maintenance in Overweight and Obese People: A Systematic Review of Systematic Reviews

PubMed Central

Sorgente, Angela; Manzoni, Gian Mauro; Re, Federica; Simpson, Susan; Perona, Sara; Rossi, Alessandro; Cattivelli, Roberto; Innamorati, Marco; Jackson, Jeffrey B; Castelnuovo, Gianluca

2017-01-01

Background Weight loss is challenging and maintenance of weight loss is problematic. Web-based programs offer good potential for delivery of interventions for weight loss or weight loss maintenance. However, the precise impact of Web-based weight management programs is still unclear. Objective The purpose of this meta-systematic review was to provide a comprehensive summary of the efficacy of Web-based interventions for weight loss and weight loss maintenance. Methods Electronic databases were searched for systematic reviews and meta-analyses that included at least one study investigating the effect of a Web-based intervention on weight loss and/or weight loss maintenance among samples of overweight and/or obese individuals. Twenty identified reviews met the inclusion criteria. The Revised Assessment of Multiple SysTemAtic Reviews (R-AMSTAR) was used to assess methodological quality of reviews. All included reviews were of sufficient methodological quality (R-AMSTAR score ≥22). Key methodological and outcome data were extracted from each review. Results Web-based interventions for both weight loss and weight loss maintenance were more effective than minimal or control conditions. However, when contrasted with comparable non-Web-based interventions, results were less consistent across reviews. Conclusions Overall, the efficacy of weight loss maintenance interventions was stronger than the efficacy of weight loss interventions, but further evidence is needed to more clearly understand the efficacy of both types of Web-based interventions. Trial Registration PROSPERO 2015: CRD42015029377; http://www.crd.york.ac.uk/PROSPERO/display_record.asp? ID=CRD42015029377 (Archived by WebCite at http://www.webcitation.org/6qkSafdCZ) PMID:28652225

Adding evidence-based behavioral weight loss strategies to a statewide wellness campaign: a randomized clinical trial.

PubMed

Leahey, Tricia M; Thomas, Graham; Fava, Joseph L; Subak, Leslee L; Schembri, Michael; Krupel, Katie; Kumar, Rajiv; Weinberg, Brad; Wing, Rena R

2014-07-01

We determined the efficacy and cost-effectiveness of adding an evidence-based Internet behavioral weight loss intervention alone or combined with optional group sessions to ShapeUp Rhode Island 2011 (SURI), a 3-month statewide wellness campaign. We randomized participants (n = 230; body mass index = 34.3 ±6.8 kg/m(2); 84% female) to the standard SURI program (S) or to 1 of 2 enhanced programs: SURI plus Internet behavioral program (SI) or SI plus optional group sessions (SIG). The primary outcome was weight loss at the end of the 3-month program. Weight losses differed among all 3 conditions (S: 1.1% ±0.9%; SI: 4.2% ±0.6%; SIG: 6.1% ±0.6%; Ps ≤ .04). Both SI and SIG increased the percentage of individuals who achieved a 5% weight loss (SI: 42%; SIG: 54%; S: 7%; Ps < .001). Cost per kilogram of weight loss was similar for S ($39) and SI ($35); both were lower than SIG ($114). Although weight losses were greatest at the end of SURI with optional group sessions, the addition of an Internet behavioral program was the most cost-effective method to enhance weight losses.

Effects of matched weight loss from calorie restriction, exercise, or both on cardiovascular disease risk factors: a randomized intervention trial.

PubMed

Weiss, Edward P; Albert, Stewart G; Reeds, Dominic N; Kress, Kathleen S; McDaniel, Jennifer L; Klein, Samuel; Villareal, Dennis T

2016-09-01

Weight loss from calorie restriction (CR) and/or endurance exercise training (EX) is cardioprotective. However CR and EX also have weight loss-independent benefits. We tested the hypothesis that weight loss from calorie restriction and exercise combined (CREX) improves cardiovascular disease (CVD) risk factors more so than similar weight loss from CR or EX alone. Overweight, sedentary men and women (n = 52; aged 45-65 y) were randomly assigned to undergo 6-8% weight loss by using CR, EX, or CREX. Outcomes were measured before and after weight loss and included maximal oxygen consumption (VO2max), resting blood pressure, fasting plasma lipids, glucose, C-reactive protein, and arterial stiffness [carotid-femoral pulse wave velocity (PWV) and carotid augmentation index (AI)]. Values are means ± SEs. Reductions in body weight (∼7%) were similar in all groups. VO2max changed in proportion to the amount of exercise performed (CR, -1% ± 3%; EX, +22% ± 3%; and CREX, +11% ± 3%). None of the changes in CVD risk factors differed between groups. For all groups combined, decreases were observed for systolic and diastolic blood pressure (-5 ± 1 and -4 ± 1 mm Hg, respectively; both P < 0.0008), total cholesterol (-17 ± 4 mg/dL; P < 0.0001), non-HDL cholesterol (-16 ± 3 mg/dL; P < 0.0001), triglycerides (-18 ± 8 mg/dL; P = 0.03), and glucose (-3 ± 1 mg/dL; P = 0.0003). No changes were observed for HDL cholesterol (P = 0.30), C-reactive protein (P = 0.10), PWV (P = 0.30), or AI (P = 0.84). These changes would be expected to decrease the lifetime risk of CVD from 46% to 36%. Matched weight losses from CR, EX, and CREX have substantial beneficial effects on CVD risk factors. However, the effects are not additive when weight loss is matched. This trial was registered at clinicaltrials.gov as NCT00777621. © 2016 American Society for Nutrition.

A plant-based diet for overweight and obesity prevention and treatment

PubMed Central

Turner-McGrievy, Gabrielle; Mandes, Trisha; Crimarco, Anthony

2017-01-01

The goal of this paper is to review the evidence related to the effect of plant-based dietary patterns on obesity and weight loss, including both observational and intervention trials. Literature from plant-based diets (PBDs) epidemiological and clinical trial research was used to inform this review. In addition, data on dietary quality, adherence, and acceptability were evaluated and are presented. Both clinical trials and observational research indicate an advantage to adoption of PBDs for preventing overweight and obesity and promoting weight loss. PBDs may also confer higher levels of diet quality than are observed with other therapeutic diet approaches, with similar levels of adherence and acceptability. Future studies should utilize health behavior theory to inform intervention development and delivery of PBDs studies and new technologies to bring interventions to scale for greater public health impact. Research examining PBDs and weight loss is also needed with more diverse populations, including older adults. Based on the available evidence, PBDs should be considered a viable option for the treatment and prevention of overweight and obesity. PMID:28630616

A plant-based diet for overweight and obesity prevention and treatment.

PubMed

Turner-McGrievy, Gabrielle; Mandes, Trisha; Crimarco, Anthony

2017-05-01

The goal of this paper is to review the evidence related to the effect of plant-based dietary patterns on obesity and weight loss, including both observational and intervention trials. Literature from plant-based diets (PBDs) epidemiological and clinical trial research was used to inform this review. In addition, data on dietary quality, adherence, and acceptability were evaluated and are presented. Both clinical trials and observational research indicate an advantage to adoption of PBDs for preventing overweight and obesity and promoting weight loss. PBDs may also confer higher levels of diet quality than are observed with other therapeutic diet approaches, with similar levels of adherence and acceptability. Future studies should utilize health behavior theory to inform intervention development and delivery of PBDs studies and new technologies to bring interventions to scale for greater public health impact. Research examining PBDs and weight loss is also needed with more diverse populations, including older adults. Based on the available evidence, PBDs should be considered a viable option for the treatment and prevention of overweight and obesity.

A randomized pilot trial of a full subsidy vs. a partial subsidy for obesity treatment.

PubMed

Tsai, Adam G; Felton, Sue; Hill, James O; Atherly, Adam J

2012-09-01

Intensive obesity treatment is mandated by federal health care reform but is costly. A partial subsidy for obesity treatment could lower the cost of treatment, without reducing its efficacy. This study sought to test whether a partial subsidy for obesity treatment would be feasible, as compared to a fully subsidized intervention. The study was a pilot randomized trial. Participants (n = 50) were primary care patients with obesity and at least one comorbid condition (diabetes, hypertension, dyslipidemia, or obstructive sleep apnea). Each participant received eight weight loss counseling visits as well as portion-controlled foods for weight loss. Participants were randomized to full subsidy or partial subsidy (2 vs. 1 meal per day provided). The primary outcome was weight change after 4 months. Secondary outcomes included changes in blood pressure, waist circumference, and health-related quality of life. Participants in the full and partial subsidy groups lost 5.9 and 5.3 kg, equivalent to 5.3% and 5.1% of initial weight, respectively (P = 0.71). Changes in secondary outcomes were similar in the two groups. A partial subsidy was feasible and induced a clinically similar amount of weight loss, compared to a full subsidy. Large-scale testing of economic incentives for weight control is merited given the federal mandate to offer weight loss counseling to obese patients.

Weight loss among female health care workers- a 1-year workplace based randomized controlled trial in the FINALE-health study

PubMed Central

2012-01-01

Background Weight management constitutes a substantial problem particularly among groups of low socio-economic status. Interventions at work places may be a solution, but high quality worksite interventions documenting prolonged weight loss are lacking. This paper presents results of an intervention aimed to achieve a 12 months weight loss among overweight health care workers. Methods Ninety-eight overweight female health care workers were randomized into an intervention or a reference group. The intervention consisted of diet, physical exercise and cognitive behavioral training during working hours 1 hour/week. The reference group was offered monthly oral presentations. Several anthropometric measures, blood pressure, cardiorespiratory fitness, maximal muscle strength, and musculoskeletal pain were measured before and after the 12-months intervention period. Data were analyzed by intention-to-treat analysis. Results The intervention group significantly reduced body weight by 6 kg (p < 0.001), BMI by 2.2 (p < 0.001) and body fat percentage by 2.8 (p < 0.001). There were no statistical reductions in the control group, resulting in significant differences between the two groups over time. Conclusions The intervention generated substantial reductions in body weight, BMI and body fat percentage among overweight female health care workers over 12 months. The positive results support the workplace as an efficient arena for weight loss among overweight females. Trial registration NCT01015716. PMID:22871173

Weight Loss, Glycemic Control, and Cardiovascular Disease Risk Factors in Response to Differential Diet Composition in a Weight Loss Program in Type 2 Diabetes: A Randomized Controlled Trial

PubMed Central

Rock, Cheryl L.; Flatt, Shirley W.; Pakiz, Bilge; Taylor, Kenneth S.; Leone, Angela F.; Brelje, Kerrin; Heath, Dennis D.; Quintana, Elizabeth L.; Sherwood, Nancy E.

2014-01-01

OBJECTIVE To test whether a weight loss program promotes greater weight loss, glycemic control, and improved cardiovascular disease risk factors compared with control conditions and whether there is a differential response to higher versus lower carbohydrate intake. RESEARCH DESIGN AND METHODS This randomized controlled trial at two university medical centers enrolled 227 overweight or obese adults with type 2 diabetes and assigned them to parallel in-person diet and exercise counseling, with prepackaged foods in a planned menu during the initial phase, or to usual care (UC; two weight loss counseling sessions and monthly contacts). RESULTS Relative weight loss was 7.4% (95% CI 5.7–9.2%), 9.0% (7.1–10.9%), and 2.5% (1.3–3.8%) for the lower fat, lower carbohydrate, and UC groups (P < 0.001 intervention effect). Glycemic control markers and triglyceride levels were lower in the intervention groups compared with UC group at 1 year (fasting glucose 141 [95% CI 133–149] vs. 159 [144–174] mg/dL, P = 0.023; hemoglobin A1c 6.9% [6.6–7.1%] vs. 7.5% [7.1–7.9%] or 52 [49–54] vs. 58 [54–63] mmol/mol, P = 0.001; triglycerides 148 [134–163] vs. 204 [173–234] mg/dL, P < 0.001). The lower versus higher carbohydrate groups maintained lower hemoglobin A1c (6.6% [95% CI 6.3–6.8%] vs. 7.2% [6.8–7.5%] or 49 [45–51] vs. 55 [51–58] mmol/mol) at 1 year (P = 0.008). CONCLUSIONS The weight loss program resulted in greater weight loss and improved glycemic control in type 2 diabetes. PMID:24760261

Reduced-Calorie Dietary Weight Loss, Exercise, and Sex Hormones in Postmenopausal Women: Randomized Controlled Trial

PubMed Central

Campbell, Kristin L.; Foster-Schubert, Karen E.; Alfano, Catherine M.; Wang, Chia-Chi; Wang, Ching-Yun; Duggan, Catherine R.; Mason, Caitlin; Imayama, Ikuyo; Kong, Angela; Xiao, Liren; Bain, Carolyn E.; Blackburn, George L.; Stanczyk, Frank Z.; McTiernan, Anne

2012-01-01

Purpose Estrogens and androgens are elevated in obesity and associated with increased postmenopausal breast cancer risk, but the effect of weight loss on these biomarkers is unknown. We evaluated the individual and combined effects of a reduced-calorie weight loss diet and exercise on serum sex hormones in overweight and obese postmenopausal women. Patients and Methods We conducted a single-blind, 12-month, randomized controlled trial from 2005 to 2009. Participants (age 50 to 75 years; body mass index > 25.0 kg/m2, exercising < 100 minutes/wk) were randomly assigned using a computer-generated sequence to (1) reduced-calorie weight loss diet (“diet”; n = 118), (2) moderate- to vigorous-intensity aerobic exercise (“exercise”; n = 117), (3) combined reduced-calorie weight loss diet and moderate- to vigorous-intensity aerobic exercise (“diet + exercise”; n = 117), or (4) control (n = 87). Outcomes were estrone concentration (primary) and estradiol, free estradiol, total testosterone, free testosterone, androstenedione, and sex hormone–binding globulin (SHBG) concentrations (secondary). Results Mean age and body mass index were 58 years and 30.9 kg/m2, respectively. Compared with controls, estrone decreased 9.6% (P = .001) with diet, 5.5% (P = .01) with exercise, and 11.1% (P < .001) with diet + exercise. Estradiol decreased 16.2% (P < .001) with diet, 4.9% (P = .10) with exercise, and 20.3% (P < .001) with diet + exercise. SHBG increased 22.4% (P < .001) with diet and 25.8% (P < .001) with diet + exercise. Free estradiol decreased 21.4% (P < .001) with diet and 26.0% (P < .001) with diet + exercise. Free testosterone decreased 10.0% (P < .001) with diet and 15.6% (P < .001) with diet + exercise. Greater weight loss produced stronger effects on estrogens and SHBG. Conclusion Weight loss significantly lowered serum estrogens and free testosterone, supporting weight loss for risk reduction through lowering exposure to breast cancer biomarkers. PMID:22614972

Physical activity, diet and behaviour modification in the treatment of overweight and obese adults: a systematic review.

PubMed

Södlerlund, Anne; Fischer, Annika; Johansson, Titti

2009-05-01

The aim was to extend the body of knowledge through a systematic review that combines the strengths and partly fills the gaps from earlier reviews. The aim is to review randomized controlled trials of the long-term effectiveness of physical exercise/activity with or without diet and/or behaviour modification therapy in terms of training effect, weight loss and improvement of body composition in overweight and obese, healthy adults. Data for systematic review was collected via a search of databases for literature published between 1995 and 2006. The search yielded 12 articles. The studies showed that training intensity should be moderate. The treatment of overweight and obese individuals with training alone cannot be expected to result in any substantial weight loss but should be combined with diet and behaviour modification therapy. However training can be an important factor in preventing further weight gain, or in helping individuals maintain a lowered body weight. According to this systematic review of randomized controlled trials, the treatment that produced the best weight loss results included a combination of training, behaviour therapy and diet.

Decrease in Urinary Incontinence Management Costs in Women Enrolled in a Clinical Trial of Weight Loss to Treat Urinary Incontinence

PubMed Central

Subak, Leslee L.; Pinto, Angela Marinilli; Wing, Rena R.; Nakagawa, Sanae; Kusek, John W.; Herman, William H.; Kuppermann, Miriam

2012-01-01

Objective To estimate the effect of a decrease in urinary incontinence frequency on urinary incontinence management costs among women enrolled in a clinical trial of a weight loss intervention and to identify factors that predict change in cost. Methods This is a secondary cohort analysis of 338 obese and overweight women with ≥ 10 weekly episodes of urinary incontinence enrolled in an 18-month randomized clinical trial of a weight loss intervention compared to a structured education program to treat urinary incontinence. Quantities of resources used for incontinence management, including pads, additional laundry, and dry cleaning were reported by participants. Direct costs for urinary incontinence management (“cost”) were calculated by multiplying resources used by national resource costs (in 2006 U.S. dollars). Randomized groups were combined to examine the effects of change in incontinence frequency on cost. Possible predictors of change in cost were examined using generalized estimating equations controlling for factors associated with change in cost in univariable analyses. Results Mean (±SD) age was 53±10 years and baseline weight was 97+17 kg. Mean weekly urinary incontinence frequency was 24+18 at baseline and decreased by 37% at 6 months and 60% at 18 months follow-up (both P<0.001). At baseline, adjusted mean cost was $7.76±$14 per week, with costs increasing significantly with greater incontinence frequency. Mean cost decreased by 54% at 6 months and 81% at 18 months (both P<0.001). In multivariable analyses, cost independently decreased by 23% for each decrease of seven urinary incontinence episodes per week and 21% for each 5 kg of weight lost (P<0.001 for both). Conclusion In obese and overweight women enrolled in a clinical trial of weight loss for urinary incontinence, incontinence management cost decreased by 81% at 18 months ($327 per woman per year) and was strongly and independently associated with decreasing incontinence frequency. PMID:22825085

Mobile Phone Intervention and Weight Loss Among Overweight and Obese Adults: A Meta-Analysis of Randomized Controlled Trials

PubMed Central

Liu, Fangchao; Kong, Xiaomu; Cao, Jie; Chen, Shufeng; Li, Changwei; Huang, Jianfeng; Gu, Dongfeng; Kelly, Tanika N.

2015-01-01

We conducted a meta-analysis of randomized controlled trials to examine the association of mobile phone intervention with net change in weight-related measures among overweight and obese adults. We searched electronic databases and conducted a bibliography review to identify articles published between the inception date of each database and March 27, 2014. Fourteen trials (including 1,337 participants in total) that met the eligibility criteria were included. Two investigators independently abstracted information on study characteristics and study outcomes. Net change estimates comparing the intervention group with the control group were pooled across trials using random-effects models. Compared with the control group, mobile phone intervention was associated with significant changes in body weight and body mass index (weight (kg)/height (m)2) of −1.44 kg (95% confidence interval (CI): −2.12, −0.76) and −0.24 units (95% CI: −0.40, −0.08), respectively. Subgroup analyses revealed that the associations were consistent across study-duration and intervention-type subgroups. For example, net body weight changes were −0.92 kg (95% CI: −1.58, −0.25) and −1.85 kg (95% CI: −2.99, −0.71) in trials of shorter (<6 months) and longer (≥6 months) duration, respectively. These findings provide evidence that mobile phone intervention may be a useful tool for promoting weight loss among overweight and obese adults. PMID:25673817

Enhancement of Self-Monitoring in a Web-Based Weight Loss Program by Extra Individualized Feedback and Reminders: Randomized Trial

PubMed Central

Hutchesson, Melinda Jane; Tan, Chor Yin; Morgan, Philip; Callister, Robin

2016-01-01

Background Self-monitoring is an essential behavioral strategy for effective weight loss programs. Traditionally, self-monitoring has been achieved using paper-based records. However, technology is now more frequently used to deliver treatment programs to overweight and obese adults. Information technologies, such as the Internet and mobile phones, allow innovative intervention features to be incorporated into treatment that may facilitate greater adherence to self-monitoring processes, provide motivation for behavior change, and ultimately lead to greater weight loss success. Objective The objective of our study was to determine whether the consistency of self-monitoring differed between participants randomly assigned to a basic or an enhanced 12-week commercial Web-based weight loss program. Methods We randomly assigned a sample of 301 adults (mean age 42.3 years; body mass index 31.3 kg/m2; female 176/301, 58.5%) to the basic or enhanced group. The basic program included tools for self-monitoring (online food and exercise diary, and a weekly weigh-in log) with some feedback and reminders to weigh in (by text or email). The enhanced program included the basic components, as well as extra individualized feedback on self-monitoring entries and reminders (by text, email, or telephone) to engage with self-monitoring tools. We evaluated the level of self-monitoring by examining the consistency of self-monitoring of food, exercise, and weight during the 12 weeks. Consistency was defined as the number of weeks during which participants completed a criterion number of entries (ie, ≥3 days of online food or exercise diary records per week and ≥1 weigh-in per week). Results The enhanced group’s consistency of use of self-monitoring tools was significantly greater than that of the basic group throughout the 12 weeks (median consistency for food 8 vs 3 weeks, respectively, P<.001; for exercise 2.5 vs 1 weeks, respectively, P=.003). Conclusions Enhanced features, including additional individualized feedback and reminders, are effective in enhancing self-monitoring behaviors in a Web-based weight loss program. ClinicalTrial Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12610000197033; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=335159 (Archived by WebCite at http://www.webcitation.org/6gCQdj21G) PMID:27072817

Habitual physical activity and plasma metabolomics patterns distinguish individuals with low- versus high-weight loss during controlled energy restriction

USDA-ARS?s Scientific Manuscript database

Weight loss (WL) induced by energy restriction is highly variable even in controlled clinical trials. An integrative analysis of the plasma metabolome coupled to traditional clinical variables may reveal a WL “responder” phenotype. Therfore, we predicted WL in overweight and obese individuals on a...

Habitual physical activity and plasma metabolomic patterns distinguish individuals with low vs. high weight loss during controlled energy restriction

USDA-ARS?s Scientific Manuscript database

Weight loss (WL) induced by energy restriction is highly variable even in controlled clinical trials. An integrative analysis of the plasma metabolome coupled to traditional clinical variables may reveal a WL “responder” phenotype. Therfore, we predicted WL in overweight and obese individuals on a...

Regular self-weighing to promote weight maintenance after intentional weight loss: a quasi-randomized controlled trial.

PubMed

Madigan, Claire D; Aveyard, Paul; Jolly, Kate; Denley, John; Lewis, Amanda; Daley, Amanda J

2014-06-01

Many overweight people take action to lose weight but most regain this weight. To examine the effectiveness of a weight maintenance intervention focused on regular self-weighing after receiving a 12-week weight loss programme. Quasi-randomized controlled trial of 3768 obese or overweight men and women. The intervention group (n = 3290) received two telephone calls, the offer of free weighing scales, encouragement to weigh themselves weekly and record this on a card. The main outcome was change in weight between 3 and 12 months. Using intention to treat analysis both groups regained weight; however, the intervention group on average regained 1.23 kg, whereas the control group regained 1.83 kg. Adjusting for covariates resulted in a mean difference of 0.68 kg (95% CI 0.12, 1.24) at 12-month follow-up. Encouraging people who have recently lost weight to weigh themselves regularly prevents some weight regain. © The Author 2013. Published by Oxford University Press on behalf of Faculty of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

The relationship between pretreatment dietary composition and weight loss during a randomised trial of different diet approaches.

PubMed

McVay, M A; Jeffreys, A S; King, H A; Olsen, M K; Voils, C I; Yancy, W S

2015-02-01

Identifying pretreatment dietary habits that are associated with weight-loss intervention outcomes could help guide individuals' selection of weight-loss approach among competing options. A pretreatment factor that may influence weight-loss outcomes is macronutrient intake. Overweight and obese Durham Veterans Affairs outpatients were randomised to a weight-loss intervention with a low-carbohydrate diet (n = 71) or orlistat medication therapy plus a low-fat diet (n = 73). Percentage fat, carbohydrate and protein intake prior to treatment were measured using 4-day food records. Linear mixed-effects models were used to determine whether pretreatment percentage macronutrient intake influenced weight trajectories and weight loss in each weight-loss condition. Participant's mean age was 53 years, baseline body mass index was 39.3 kg m(-2) and 72% were male. A higher pretreatment percentage carbohydrate intake was associated with less rapid initial weight loss (P = 0.02) and less rapid weight regain (P = 0.03) in the low-carbohydrate diet condition but was not associated with weight trajectories in the orlistat plus low-fat diet condition. In both conditions, a higher pretreatment percentage fat intake was associated with more rapid weight regain (P < 0.01). Pretreatment percentage protein intake was not associated with weight trajectories. None of the pretreatment macronutrients were associated with weight loss on study completion in either condition. Selection of a weight-loss approach on the basis of pretreatment macronutrient intake is unlikely to improve weight outcomes at the end of a 1-year treatment. However, pretreatment macronutrient intake may have implications for tailoring of interventions to slow weight regain after weight loss. © 2013 The British Dietetic Association Ltd.

Weight loss versus muscle loss: re-evaluating inclusion criteria for future cancer cachexia interventional trials.

PubMed

Roeland, Eric J; Ma, Joseph D; Nelson, Sandahl H; Seibert, Tyler; Heavey, Sean; Revta, Carolyn; Gallivan, Andrea; Baracos, Vickie E

2017-02-01

Participation in cancer cachexia clinical trials requires a defined weight loss (WL) over time. A loss in skeletal muscle mass, measured by cross-sectional computed tomography (CT) image analysis, represents a possible alternative. Our aim was to compare WL versus muscle loss in patients who were screened to participate in a cancer cachexia clinical trial. This was a single-center, retrospective analysis in metastatic colorectal cancer patients screened for an interventional cancer cachexia trial requiring a ≥5 % WL over the preceding 6 months. Concurrent CT images obtained as part of standard oncology care were analyzed for changes in total muscle and fat (visceral, subcutaneous, and total). Of patients screened (n = 36), 3 (8 %) enrolled in the trial, 17 (47 %) were excluded due to insufficient WL (<5 %), 3 (8 %) were excluded due to excessive WL (>20 %), and 16 (44 %) met inclusion criteria for WL. Patients who met screening criteria for WL (5-20 %) had a mean ± SD of 7.7 ± 8.7 % muscle loss, 24.4 ± 37.5 % visceral adipose loss, 21.6 ± 22.3 % subcutaneous adipose loss, and 22.1 ± 24.7 % total adipose loss. Patients excluded due to insufficient WL had 2 ± 6.4 % muscle loss, but a gain of 8.5 ± 39.8 % visceral adipose, and 4.2 ± 28.2 % subcutaneous adipose loss and 0.8 ± 28.4 % total adipose loss. Of the patients excluded due to WL <5 % (n = 17), 7 (41 %) had a skeletal muscle loss >5 %. Defining cancer cachexia by WL over time may be limited as it does not capture skeletal muscle loss. Cross-sectional CT body composition analysis may improve early detection of muscle loss and patient participation in future cancer cachexia clinical trials.

Comparison of an alternative schedule of extended care contacts to a self-directed control: a randomized trial of weight loss maintenance.

PubMed

Dutton, Gareth R; Gowey, Marissa A; Tan, Fei; Zhou, Dali; Ard, Jamy; Perri, Michael G; Lewis, Cora E

2017-08-15

Behavioral interventions for obesity produce clinically meaningful weight loss, but weight regain following treatment is common. Extended care programs attenuate weight regain and improve weight loss maintenance. However, less is known about the most effective ways to deliver extended care, including contact schedules. We compared the 12-month weight regain of an extended care program utilizing a non-conventional, clustered campaign treatment schedule and a self-directed program among individuals who previously achieved ≥5% weight reductions. Participants (N = 108; mean age = 51.6 years; mean weight = 92.6 kg; 52% African American; 95% female) who achieved ≥5% weight loss during an initial 16-week behavioral obesity treatment were randomized into a 2-arm, 12-month extended care trial. A clustered campaign condition included 12 group-based visits delivered in three, 4-week clusters. A self-directed condition included provision of the same printed intervention materials but no additional treatment visits. The study was conducted in a U.S. academic medical center from 2011 to 2015. Prior to randomization, participants lost an average of -7.55 ± 3.04 kg. Participants randomized to the 12-month clustered campaign program regained significantly less weight (0.35 ± 4.62 kg) than self-directed participants (2.40 ± 3.99 kg), which represented a significant between-group difference of 2.28 kg (p = 0.0154) after covariate adjustments. This corresponded to maintaining 87% and 64% of lost weight in the clustered campaign and self-directed conditions, respectively, which was a significant between-group difference of 29% maintenance of lost weight after covariate adjustments, p = 0.0396. In this initial test of a clustered campaign treatment schedule, this novel approach effectively promoted 12-month maintenance of lost weight. Future trials should directly compare the clustered campaigns with conventional (e.g., monthly) extended care schedules. Clinicaltrials.gov NCT02487121 . Registered 06/26/2015 (retrospectively registered).

Weight management using the internet: A randomized controlled trial

USDA-ARS?s Scientific Manuscript database

Most weight-loss research targets obese individuals who desire large weight reductions. However, evaluation of weight-gain prevention in overweight individuals is also critical as most Americans become obese as a result of a gradual gain of 1-2 pounds per year over many years. This study evaluated t...

Differences in Weight Loss Between Persons on Standard Balanced vs Nutrigenetic Diets in a Randomized Controlled Trial.

PubMed

Frankwich, Karen A; Egnatios, Jeremy; Kenyon, Mandy L; Rutledge, Thomas R; Liao, Patricia S; Gupta, Samir; Herbst, Karen L; Zarrinpar, Amir

2015-09-01

Many companies provide genetic tests for obesity-related polymorphisms (nutrigenetics) and make dietary recommendations for weight loss that are based on the results. We performed a randomized controlled trial to determine whether more participants who followed a nutrigenetic-guided diet lost ≥5% of their body weight than participants on a standard balanced diet for 8 and 24 weeks. We performed a prospective study of 51 obese or overweight U.S. veterans on an established weight management program at the Veterans Administration San Diego Healthcare System (the MOVE! program). Participants were randomly assigned to groups placed on a nutrigenetic-guided diet (balanced, low-carbohydrate, low-fat, or Mediterranean; n = 30) or a standard balanced diet (n = 21). Nutrigenetic diets were selected on the basis of results from the Pathway FIT test. There was no significant difference in the percentage of participants on the balanced diet vs the nutrigenetic-guided diet who lost 5% of their body weight at 8 weeks (35.0% ± 20.9% vs 26.9% ± 17.1%, respectively; P = .28) or at 24 weeks. Both groups had difficulty adhering to the diets. However, adherence to the nutrigenetic-guided diet correlated with weight loss (r = 0.74; P = 4.0 × 10(-5)), but not adherence to standard therapy (r = 0.34; P = .23). Participants who had low-risk polymorphisms for obesity lost more weight than all other participants at 8 weeks (5.0% vs 2.9%, respectively; P = .02) and had significantly greater reductions in body mass index (6.4% vs 3.6%, respectively; P = .03) and waist circumference (6.5% vs 2.6%, respectively; P = .02) at 24 weeks. In a prospective study, a nutrigenetic-based diet did not increase weight loss compared with a standard balanced diet. However, genetic features can identify individuals most likely to benefit from a balanced diet weight loss strategy; these findings require further investigation. ClinicalTrials.gov number: NCT01859403. Copyright © 2015 AGA Institute. Published by Elsevier Inc. All rights reserved.

Fresh Start, a postpartum weight loss intervention for diverse low-income women: design and methods for a randomized clinical trial.

PubMed

Rosal, Milagros C; Haughton, Christina F; Estabrook, Barbara B; Wang, Monica L; Chiriboga, Germán; Nguyen, Oahn H T; Person, Sharina D; Lemon, Stephenie C

2016-09-09

Overweight and obesity are prevalent among young women and are greater among minority and low-income women. The postpartum period is critical in women's weight trajectories as many women do not lose their pregnancy weight, and others lose some and then plateau or experience weight gain. Excess weight puts women at greater risk of chronic disease and thus weight loss in the postpartum period may be key to the long-term health of young women. This paper describes the design and methods of a randomized clinical trial of Fresh Start, an innovative narrative-based group intervention aimed at promoting postpartum weight loss among low-income, diverse women. Study participants were recruited from the five sites of the Women, Infants and Children (WIC) program in central Massachusetts. Participants were English-speaking, age ≥ 18 years, 6 weeks to 6 months postpartum, with a body mass index (BMI) ≥ 27 kg/m(2). The Fresh Start postpartum weight loss intervention, adapted from the Diabetes Prevention Program (DPP) in collaboration with WIC staff and clients, consisted of an 8-week group-based curriculum followed by nine monthly telephone calls. It included a narrative component (i.e., storytelling), group discussions, print materials and access to exercise facilities. The study is a two-arm randomized controlled trial. The control condition included print materials and access to exercise facilities. In-person assessments were conducted at baseline and at 6 and 12 months following the eight-week intervention phase. The Fresh Start intervention translated key elements of an evidence-based weight loss protocol into a format that is hypothesized to be relevant, acceptable and effective for the target audience of low-SES postpartum women. This novel intervention was developed in collaboration with WIC to be sustainable within the context of its clinics, which reach approximately 9 million individuals per year across the U.S. via 10,000 clinics. clinicaltrials.gov NCT02176915 . Registered 25 June 2014.

Second-generation antipsychotic use in schizophrenia and associated weight gain: a critical review and meta-analysis of behavioral and pharmacologic treatments.

PubMed

Das, Chandan; Mendez, Guillermo; Jagasia, Sonal; Labbate, Lawrence A

2012-08-01

Weight gain in schizophrenia, particularly secondary to second-generation antipsychotic (SGA) use, is a common adverse effect and often is associated with significant physical and psychological morbidity. We performed a critical literature review of all controlled clinical trials for pharmacologic and/or behavioral management of SGA-induced weight gain in schizophrenia patients by searching PubMed and Google Scholar. A meta-analysis was performed to estimate and compare weight changes for various medications and behavioral interventions. Sample sizes generally were small. Clinical trials were 6 weeks to 1 year, and weight loss was modest with any treatment. Although several adjunctive pharmacologic treatments showed no weight loss, sibutramine, metformin, and topiramate showed some benefit. Amantadine and orlistat were somewhat less effective and had lower rates of tolerability. Among the behavioral therapies, nutritional counseling combined with exercise showed the most benefit. Behavioral therapies, although modest, showed the most consistent benefits compared with controls. Scheduled pharmacologic treatment to prevent weight gain or promote weight loss in schizophrenia patients on SGA therapy is limited based on current studies. Switching antipsychotic agents has not been established as a long-term solution. Additional long-term studies are required to influence clinical practice.

Randomized Controlled Trial of Preconception Interventions in Infertile Women With Polycystic Ovary Syndrome

PubMed Central

Dodson, William C.; Kris-Etherton, Penny M.; Kunselman, Allen R.; Stetter, Christy M.; Williams, Nancy I.; Gnatuk, Carol L.; Estes, Stephanie J.; Fleming, Jennifer; Allison, Kelly C.; Sarwer, David B.; Coutifaris, Christos; Dokras, Anuja

2015-01-01

Context: Lifestyle modification is recommended in women with polycystic ovary syndrome (PCOS) prior to conception but there are few randomized trials to support its implementation or benefit. Objective: This study aimed to determine the relative efficacy of preconception intervention on reproductive and metabolic abnormalities in overweight/obese women with PCOS. Design, Setting, and Participants: This was a randomized controlled trial of preconception and infertility treatment at Academic Health Centers in women with infertility due to PCOS, age 18–40 y and body mass index 27–42 kg/m2. Intervention: Women were randomly assigned to receive either 16 weeks of 1) continuous oral contraceptive pills (OCPs) (ethinyl estradiol 20 mcg/1 mg norethindrone acetate) (“OCP”); 2) lifestyle modification consisting of caloric restriction with meal replacements, weight loss medication (either sibutramine, or orlistat), and increased physical activity to promote a 7% weight loss (“Lifestyle”); or 3) combined treatment with both OCP and lifestyle modification (“Combined”). After preconception intervention, women underwent standardized ovulation induction with clomiphene citrate and timed intercourse for four cycles. Pregnancies were followed with trimester visits until delivery. Main Outcome Measures: Weight, ovulation, and live birth were measured. Results: We consented 216 and randomly assigned 149 women (Lifestyle: n = 50; OCP: n = 49; Combined: n = 50). We achieved significant weight loss with both Lifestyle (mean weight loss, −6.2%; 95% confidence interval (CI), −7.4–−5.0; and Combined (mean weight loss, −6.4%; 95% CI, −7.6–−5.2) compared with baseline and OCP (both P < .001). There was a significant increase in the prevalence of metabolic syndrome at the end of preconception treatment compared with baseline within OCP (odds ratio [OR, 2.47; 95% CI, 1.42–4.27) whereas no change in metabolic syndrome was detected in the Lifestyle (OR, 1.18; 95% CI, 0.63–2.19) or Combined (OR, 0.72; 95% CI, 0.44–1.17) groups. Cumulative ovulation rates were superior after weight loss: OCP, 46%; Lifestyle, 60%; and Combined, 67% (P < .05). Live birth rates were OCP, 12%; Lifestyle, 26%; and Combined, 24% (P = .13). Conclusions: A preconception weight loss intervention eliminates the adverse metabolic oral contraceptive effects and, compared with oral contraceptive pretreatment, leads to higher ovulation rates. PMID:26401593

Effects of anti-obesity drugs, diet, and exercise on weight-loss maintenance after a very-low-calorie diet or low-calorie diet: a systematic review and meta-analysis of randomized controlled trials123

PubMed Central

Neovius, Martin; Hemmingsson, Erik

2014-01-01

Background: Weight-loss maintenance remains a major challenge in obesity treatment. Objective: The objective was to evaluate the effects of anti-obesity drugs, diet, or exercise on weight-loss maintenance after an initial very-low-calorie diet (VLCD)/low-calorie diet (LCD) period (<1000 kcal/d). Design: We conducted a systematic review by using MEDLINE, the Cochrane Controlled Trial Register, and EMBASE from January 1981 to February 2013. We included randomized controlled trials that evaluated weight-loss maintenance strategies after a VLCD/LCD period. Two authors performed independent data extraction by using a predefined data template. All pooled analyses were based on random-effects models. Results: Twenty studies with a total of 27 intervention arms and 3017 participants were included with the following treatment categories: anti-obesity drugs (3 arms; n = 658), meal replacements (4 arms; n = 322), high-protein diets (6 arms; n = 865), dietary supplements (6 arms; n = 261), other diets (3 arms; n = 564), and exercise (5 arms; n = 347). During the VLCD/LCD period, the pooled mean weight change was −12.3 kg (median duration: 8 wk; range 3–16 wk). Compared with controls, anti-obesity drugs improved weight-loss maintenance by 3.5 kg [95% CI: 1.5, 5.5 kg; median duration: 18 mo (12–36 mo)], meal replacements by 3.9 kg [95% CI: 2.8, 5.0 kg; median duration: 12 mo (10–26 mo)], and high-protein diets by 1.5 kg [95% CI: 0.8, 2.1 kg; median duration: 5 mo (3–12 mo)]. Exercise [0.8 kg; 95% CI: −1.2, 2.8 kg; median duration: 10 mo (6–12 mo)] and dietary supplements [0.0 kg; 95% CI: −1.4, 1.4 kg; median duration: 3 mo (3–14 mo)] did not significantly improve weight-loss maintenance compared with control. Conclusion: Anti-obesity drugs, meal replacements, and high-protein diets were associated with improved weight-loss maintenance after a VLCD/LCD period, whereas no significant improvements were seen for dietary supplements and exercise. PMID:24172297

Dietary Intake of Protein from Different Sources and Weight Regain, Changes in Body Composition and Cardiometabolic Risk Factors after Weight Loss: The DIOGenes Study.

PubMed

van Baak, Marleen A; Larsen, Thomas M; Jebb, Susan A; Martinez, Alfredo; Saris, Wim H M; Handjieva-Darlenska, Teodora; Kafatos, Anthony; Pfeiffer, Andreas F H; Kunešová, Marie; Astrup, Arne

2017-12-06

An increase in dietary protein intake has been shown to improve weight loss maintenance in the DIOGenes trial. Here, we analysed whether the source of the dietary proteins influenced changes in body weight, body composition, and cardiometabolic risk factors during the weight maintenance period while following an energy-restricted diet. 489 overweight or obese participants of the DIOGenes trial from eight European countries were included. They successfully lost >8% of body weight and subsequently completed a six month weight maintenance period, in which they consumed an ad libitum diet varying in protein content and glycemic index. Dietary intake was estimated from three-day food diaries. A higher plant protein intake with a proportional decrease in animal protein intake did not affect body weight maintenance or cardiometabolic risk factors. A higher plant protein intake from non-cereal products instead of cereal products was associated with benefits for body weight maintenance and blood pressure. Substituting meat protein for protein from other animal sources increased insulin and HOMA-IR (homeostasis model assessment of insulin resistance). This analysis suggests that not only the amount of dietary proteins, but also the source may be important for weight and cardiometabolic risk management. However, randomized trials are needed to test the causality of these associations.

Dietary Intake of Protein from Different Sources and Weight Regain, Changes in Body Composition and Cardiometabolic Risk Factors after Weight Loss: The DIOGenes Study

PubMed Central

Jebb, Susan A.; Saris, Wim H. M.; Handjieva-Darlenska, Teodora; Kafatos, Anthony; Kunešová, Marie; Astrup, Arne

2017-01-01

An increase in dietary protein intake has been shown to improve weight loss maintenance in the DIOGenes trial. Here, we analysed whether the source of the dietary proteins influenced changes in body weight, body composition, and cardiometabolic risk factors during the weight maintenance period while following an energy-restricted diet. 489 overweight or obese participants of the DIOGenes trial from eight European countries were included. They successfully lost >8% of body weight and subsequently completed a six month weight maintenance period, in which they consumed an ad libitum diet varying in protein content and glycemic index. Dietary intake was estimated from three-day food diaries. A higher plant protein intake with a proportional decrease in animal protein intake did not affect body weight maintenance or cardiometabolic risk factors. A higher plant protein intake from non-cereal products instead of cereal products was associated with benefits for body weight maintenance and blood pressure. Substituting meat protein for protein from other animal sources increased insulin and HOMA-IR (homeostasis model assessment of insulin resistance). This analysis suggests that not only the amount of dietary proteins, but also the source may be important for weight and cardiometabolic risk management. However, randomized trials are needed to test the causality of these associations. PMID:29211027

Effect of Attendance of the Child on Body Weight, Energy Intake, and Physical Activity in Childhood Obesity Treatment: A Randomized Clinical Trial.

PubMed

Boutelle, Kerri N; Rhee, Kyung E; Liang, June; Braden, Abby; Douglas, Jennifer; Strong, David; Rock, Cheryl L; Wilfley, Denise E; Epstein, Leonard H; Crow, Scott J

2017-07-01

Family-based weight loss treatment (FBT) is considered the gold-standard treatment for childhood obesity and is provided to the parent and child. However, parent-based treatment (PBT), which is provided to the parent without the child, could be similarly effective and easier to disseminate. To determine whether PBT is similarly effective as FBT on child weight loss over 24 months. Secondary aims evaluated the effect of these 2 treatments on parent weight loss, child and parent dietary intake, child and parent physical activity, parenting style, and parent feeding behaviors. Randomized 2-arm noninferiority trial conducted at an academic medical center, University of California, San Diego, between July 2011 and July 2015. Participants included 150 overweight and obese 8- to 12-year-old children and their parents. Both PBT and FBT were delivered in 20 one-hour group meetings with 30-minute individualized behavioral coaching sessions over 6 months. Treatments were similar in content; the only difference was the attendance of the child. The primary outcome measure was child weight loss (body mass index [BMI] and BMI z score) at 6, 12, and 18 months post treatment. Secondary outcomes were parent weight loss (BMI), child and parent energy intake, child and parent physical activity (moderate to vigorous physical activity minutes), parenting style, and parent feeding behaviors. One hundred fifty children (mean BMI, 26.4; mean BMI z score, 2.0; mean age, 10.4 years; 66.4% girls) and their parent (mean BMI, 31.9; mean age, 42.9 years; 87.3% women; and 31% Hispanic, 49% non-Hispanic white, and 20% other race/ethnicity) were randomly assigned to either FBT or PBT. Child weight loss after 6 months was -0.25 BMI z scores in both PBT and FBT. Intention-to-treat analysis using mixed linear models showed that PBT was noninferior to FBT on all outcomes at 6-, 12-, and 18-month follow-up with a mean difference in child weight loss of 0.001 (95% CI, -0.06 to 0.06). Parent-based treatment was as effective on child weight loss and several secondary outcomes (parent weight loss, parent and child energy intake, and parent and child physical activity). Parent-based treatment is a viable model to provide weight loss treatment to children. Clinicaltrials.gov Identifier: NCT01197443.

Predictors of long-term weight loss in adults with modest initial weight loss, by sex and race.

PubMed

Svetkey, Laura P; Ard, Jamy D; Stevens, Victor J; Loria, Catherine M; Young, Deb Y; Hollis, Jack F; Appel, Lawrence J; Brantley, Phillip J; Kennedy, Betty M; Kumanyika, Shiriki K; Batch, Bryan C; Corsino, Leonor; Lien, Lillian F; Vollmer, William M

2012-09-01

Effective weight management interventions could reduce race-sex disparities in cardiovascular disease (CVD), yet little is known about factors associated with successful weight loss maintenance in race-sex subgroups. In the Weight Loss Maintenance trial (WLM), overweight/obese (BMI 25-45 kg/m(2)) adults who lost ≥4 kg in a 6-month behavioral weight loss intervention (phase I) were randomized into one of three 30-month maintenance interventions (phase II). To investigate predictors in subgroups, randomized groups were combined for this analysis. Of 1,685 phase I participants, 1,032 (61%) entered phase II, including 12% black men (BM), 26% black women (BW), 25% white men (WM), and 37% white women (WW). Weight change over the 36-month study ranged from -2.3% (95% confidence interval = -3.1 to -1.5%) in BW to -4.5% (95% confidence interval = -5.7 to -4.0%) in WM, the result of differential weight loss during phase I. Within race, men lost significantly more weight than women, but within sex group, weight loss did not differ significantly between races. Although participants regained weight during phase II, regain did not differ by race-sex group, and mean weight at the end of the study was significantly lower than phase I entry weight for each subgroup. In regression models, phase I weight loss predicted overall 36-month weight loss in all race-sex groups. Healthy dietary pattern at entry, improvement in dietary pattern, or both were predictive in three of four race-sex groups. Few other variables other than initial weight loss and dietary pattern were predictive. Future research should identify additional modifiable influences on long-term maintenance after a modest weight loss.

Effect of sibutramine on weight reduction in women with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial.

PubMed

Lindholm, Asa; Bixo, Marie; Björn, Inger; Wölner-Hanssen, Pål; Eliasson, Mats; Larsson, Anders; Johnson, Owe; Poromaa, Inger Sundström

2008-05-01

To examine the efficacy of sibutramine together with brief lifestyle modification for weight reduction in obese women with polycystic ovary syndrome (PCOS). Investigator-initiated, multicenter, double-blind, randomized, parallel-group clinical trial. Departments of Obstetrics and Gynecology in primary care, referral centers, and private practice. Forty-two patients with confirmed PCOS were included in the study, and 34 patients completed the study. Sibutramine 15 mg once daily together with brief lifestyle modification was compare with placebo together with brief lifestyle modification. The primary endpoint was to assess weight loss. Secondary endpoints included the efficacy of sibutramine for treatment of menstrual pattern and cardiovascular risk factors. After 6 months the sibutramine group had lost 7.8 +/- 5.1 kg compared with a weight loss of 2.8 +/- 6.2 kg in the placebo group. Sibutramine treatment resulted in significant decreases in apolipoprotein B, apolipoprotein B/apolipoprotein A ratio, triglycerides, and cystatin C levels. Sibutramine in combination with lifestyle intervention results in significant weight reduction in obese patients with PCOS. In addition to the weight loss, sibutramine seems to have beneficial effects on metabolic and cardiovascular risk factors.

A randomized controlled trial testing an Internet delivered cost-benefit approach to weight loss maintenance.

PubMed

Leahey, Tricia M; Fava, Joseph L; Seiden, Andrew; Fernandes, Denise; Doyle, Caroline; Kent, Kimberly; La Rue, Molly; Mitchell, Marc; Wing, Rena R

2016-11-01

Weight loss maintenance is a significant challenge in obesity treatment. During maintenance the "costs" of adhering to weight management behaviors may outweigh the "benefits." This study examined the efficacy of a novel approach to weight loss maintenance based on modifying the cost-benefit ratio. Individuals who achieved a 5% weight loss (N=75) were randomized to one of three, 10-month maintenance interventions. All interventions were delivered primarily via the Internet. The Standard arm received traditional weight maintenance strategies. To increase benefits, or rewards, for maintenance behaviors, the two cost-benefit intervention conditions received weekly monetary rewards for self-monitoring and social reinforcement via e-coaching. To decrease behavioral costs (boredom) and increase novelty, participants in the cost-benefit conditions also monitored different evidence-based behaviors every two weeks (e.g., Weeks 1 & 2: steps; Week 3 & 4: red foods). The primary difference between the cost-benefit interventions was type of e-coach providing social reinforcement: Professional (CB Pro) or Peer (CB Peer). Study procedures took place in Providence, RI from 2013 to 2014. Retention was 99%. There were significant group differences in weight regain (p=.01). The Standard arm gained 3.5±5.7kg. In contrast, participants in CB Pro and CB Peer lost an additional 1.8±7.0kg and 0.5±6.4kg, respectively. These results suggest that an Internet delivered cost-benefit approach to weight loss maintenance may be effective for long-term weight control. In addition, using peer coaches to provide reinforcement may be a particularly economic alternative to professionals. These data are promising and provide support for a larger, longer trial. Copyright © 2016 Elsevier Inc. All rights reserved.

A randomized controlled trial testing an Internet delivered cost-benefit approach to weight loss maintenance

PubMed Central

Leahey, Tricia M.; Fava, Joseph L.; Seiden, Andrew; Fernandes, Denise; Doyle, Caroline; Kent, Kimberly; La Rue, Molly; Mitchell, Marc; Wing, Rena R.

2016-01-01

Weight loss maintenance is a significant challenge in obesity treatment. During maintenance the “costs” of adhering to weight management behaviors may outweigh the “benefits.” This study examined the efficacy of a novel approach to weight loss maintenance based on modifying the cost-benefit ratio. Individuals who achieved a 5% weight loss (N=75) were randomized to one of three, 10-month maintenance interventions. All interventions were delivered primarily via the Internet. The Standard arm received traditional weight maintenance strategies. To increase benefits, or rewards, for maintenance behaviors, the two cost-benefit intervention conditions received weekly monetary rewards for self-monitoring and social reinforcement via e-coaching. To decrease behavioral costs (boredom) and increase novelty, participants in the cost-benefit conditions also monitored different evidence-based behaviors every two weeks (e.g., Weeks 1 & 2: steps; Week 3 & 4: red foods). The primary difference between the cost-benefit interventions was type of e-coach providing social reinforcement: Professional (CB Pro) or Peer (CB Peer). Study procedures took place in Providence, RI from 2013–2014. Retention was 99%. There were significant group differences in weight regain (p=.01). The Standard arm gained 3.5±5.7kg. In contrast, participants in CB Pro and CB Peer lost an additional 1.8±7.0kg and 0.5±6.4kg, respectively. These results suggest that an Internet delivered cost-benefit approach to weight loss maintenance may be effective for long-term weight control. In addition, using peer coaches to provide reinforcement may be a particularly economic alternative to professionals. These data are promising and provide support for a larger, longer trial. Clinicaltrials.gov Identifier NCT01760486 PMID:27095323

They say coconut oil can aid weight loss, but can it really?

PubMed

Clegg, M E

2017-10-01

There has in recent years, been much media speculation and consumer interest in the beneficial satiating properties of consuming coconut oil and its potential to aid weight loss. However, the media has primarily cited studies using medium-chain triglycerides (MCT) oil. The current perspective looks at the research that is available on coconut oil. It examines if and how MCT-related research can be applied to coconut oil and if there is potential for coconut oil to aid weight loss. The current report indicates a lack of consistent evidence on the topic of coconut oil, satiety and weight loss. Given both the publicity and the increased consumption of coconut oil further research, particularly long-term clinical trials, in this area are warranted.

Self-expansion is associated with better adherence and obesity treatment outcomes in adults

PubMed Central

Xu, Xiaomeng; Leahey, Tricia M.; Boguszewski, Katherine; Krupel, Katie; Mailloux, Kimberly A.; Wing, Rena R.

2016-01-01

Background Previous studies have shown that self-expansion (e.g., increasing positive self-content via engaging in novel, rewarding activities) is associated with smoking cessation and attenuated cigarette cue-reactivity. Purpose This study examined whether self-expansion is associated with better adherence, weight loss, and physical activity (PA) outcomes within a weight loss intervention. Methods Participants from Shape Up Rhode Island 2012, a Web-based community wellness initiative, took part in a randomized controlled trial that involved a 12-week behavioral weight loss intervention (1). At baseline and post-intervention, objective weights and self-reported self-expansion and PA were obtained from 239 participants. Treatment adherence was assessed objectively. Results Self-expansion during treatment was significantly associated with percent weight loss including clinically significant weight loss (i.e. 5%), minutes of PA, and treatment adherence. These results held after controlling for relevant covariates. Conclusions This is the first study to show that self-expansion is associated with better behavioral weight loss outcomes including weight loss, adherence, and PA. These results suggest that self-expansion is a promising novel target for future research which could inform health interventions. PMID:27436226

Smartphone Technology and Text Messaging for Weight Loss in Young Adults: A Randomized Controlled Trial.

PubMed

Stephens, Janna D; Yager, Allison M; Allen, Jerilyn

Using smartphone technology and text messaging for health is a growing field. This type of technology is well integrated into the lives of young adults. However, few studies have tested the effect of this type of technology to promote weight loss in young adults OBJECTIVE:: The purpose of this study is to test the effectiveness of a behaviorally based smartphone application for weight loss combined with text messaging from a health coach on weight, body mass index (BMI), and waist circumference in young adults as compared with a control condition. Sixty-two young adults, aged 18 to 25 years, were randomized to receive (1) a smartphone application + health coach intervention and counseling sessions or (2) control condition with a counseling session. All outcome measures were tested at baseline and 3 months. These included weight, BMI, waist circumference, dietary habits, physical activity habits, and self-efficacy for healthy eating and physical activity. The sample was 71% female and 39% white, with an average age of 20 years and average BMI of 28.5 kg/m. Participants in the smartphone + health coach group lost significantly more weight (P = .026) and had a significant reduction in both BMI (P = .024) and waist circumference (P < .01) compared with controls. The results of this weight loss trial support the use of smartphone technology and feedback from a health coach on improving weight in a group of diverse young adults.

Effect of a high protein diet and/or resistance exercise on the preservation of fat free mass during weight loss in overweight and obese older adults: a randomized controlled trial.

PubMed

Verreijen, Amely M; Engberink, Mariëlle F; Memelink, Robert G; van der Plas, Suzanne E; Visser, Marjolein; Weijs, Peter J M

2017-02-06

Intentional weight loss in obese older adults is a risk factor for accelerated muscle mass loss. We investigated whether a high protein diet and/or resistance exercise preserves fat free mass (FFM) during weight loss in overweight and obese older adults. We included 100 overweight and obese adults (55-80 year) in a randomized controlled trial (RCT) with a 2 × 2 factorial design and intention-to-treat analysis. During a 10-week weight loss program all subjects followed a hypocaloric diet. Subjects were randomly allocated to either a high protein (1.3 g/kg body weight) or normal protein diet (0.8 g/kg), with or without a resistance exercise program 3 times/week. FFM was assessed by air displacement plethysmography. At baseline, mean (±SD) BMI was 32 ± 4 kg/m 2 . During intervention, protein intake was 1.13 ± 0.35 g/kg in the high protein groups vs. 0.98 ± 0.29 in the normal protein groups, which reflects a 16.3 ± 5.2 g/d higher protein intake in the high protein groups. Both high protein diet and exercise did not significantly affect change in body weight, FFM and fat mass (FM). No significant protein*exercise interaction effect was observed for FFM. However, within-group analysis showed that high protein in combination with exercise significantly increased FFM (+0.6 ± 1.3 kg, p = 0.011). A high protein diet, though lower than targeted, did not significantly affect changes in FFM during modest weight loss in older overweight and obese adults. There was no significant interaction between the high protein diet and resistance exercise for change in FFM. However, only the group with the combined intervention of high protein diet and resistance exercise significantly increased in FFM. Dutch Trial Register, number NTR4556, date 05-01-2014.

Reduction in weight and cardiovascular diasease risk factors in individuals with type 2 diabetes: One-year results of the Look AHEAD trial

USDA-ARS?s Scientific Manuscript database

The effectiveness of intentional weight loss in reducing cardiovascular disease (CVD) events in type 2 diabetes is unknown. This report describes 1-year changes in CVD risk factors in a trial designed to examine the long-term effects of an intensive lifestyle intervention on the incidence of major C...

Comparison of 2 weight-loss diets of different protein content on bone health: a randomized trial.

PubMed

Jesudason, David; Nordin, Be Christopher; Keogh, Jennifer; Clifton, Peter

2013-11-01

It has been hypothesized that hip-fracture rates are higher in developed than in developing countries because high-protein (HP) Western diets induce metabolic acidosis and hypercalciuria. Confounders include interactions between dietary protein and calcium, sodium, and potassium. We determined whether an HP or a high-normal-protein (HNP) weight-loss diet caused greater loss in bone mineral density (BMD) over 24 mo. The Weight Loss, Protein and Bone Density Study was conducted from 2008 to 2011 in 323 overweight [body mass index (BMI; in kg/m(2)) >27] postmenopausal women, with a total hip BMD t score less than -2.0. Subjects were randomly assigned to receive an isocaloric calcium-replete HP (≥90 g protein/d) or HNP (<80 g protein/d) weight-loss diet, with the aim of a difference of 20 g protein/d. A total of 186 subjects (90 subjects in the HP group, 96 subjects in the HNP group) completed 12 mo, and 137 subjects (69 subjects in the HP group, 68 subjects in the HNP group) completed 24 mo. Biomarkers confirmed a difference in protein intake of 16 and 13.1 g at 12 and 24 mo, respectively. Mean (±SE) weight loss was equal; HP subjects lost 7.9 ± 0.9 kg and HNP subjects lost 8.9 ± 0.9 kg at 24 mo. Subjects lost 1-2% BMD annually at lumbar spine vertebrae 2-4, the forearm, the femoral neck, and hip. ANCOVA showed no effect of the HP or HNP diet (P > 0.05 for diet and diet-time interactions). A diet-by-time analysis showed that the HNP diet increased C-terminal telopeptide and osteocalcin (P ≤ 0.001 for each) despite hypercalciuria (P = 0.029). High dietary protein intake during weight loss has no clinically significant effect on bone density but slows bone turnover. This trial was registered at the Australian and New Zealand Clinical Trials Registry (http://www.anzctr.org.au) as ACTRN12608000229370.

Nutrient Intake During Diet-Induced Weight Loss and Exercise Interventions in a Randomized Trial in Older Overweight and Obese Adults.

PubMed

Miller, G D; Beavers, D P; Hamm, D; Mihalko, S L; Messier, S P

2017-01-01

Dietary restriction in obese older adults undergoing weight loss may exacerbate nutrient deficiencies common in this group; the nutritional health of older adults is a factor in their quality of life, disability, and mortality. This study examined the effect of an 18-month weight loss program based in social cognitive theory incorporating partial meal replacements, on nutrient intake in older overweight and obese adults. The following analysis is from the Intensive Diet and Exercise for Arthritis (IDEA) trial, a single-blind, randomized controlled trial. Individuals were randomized into one of three 18-month interventions: exercise (E); intensive diet-induced weight loss (D); or intensive diet-induced weight loss plus exercise (D+E). The study setting was at a university research facility. Overweight and obese older adults (n=388; BMI=33.7±3.8 kg/m2; 65.8±6.1 years) were recruited. The D and D+E interventions (group mean goal of ≥10% loss by 18-months) utilized partial meal replacements (2 meal replacement shakes/day for 6-months). Exercise training for E and D+E was 3 days/week, 60 minutes/day. Three day food records were collected at baseline, 6-months, and 18-months and analyzed for total energy and macro- and micronutrient intake. Comparisons of dietary intake among treatment groups were performed at 6 and 18 months using mixed linear models. Weight loss at 18-months was 11.3±8.3% (D), 10.3±6.8% (D+E), and 1.2±4.2% (E). Meal replacements were used by more than 60% (6-months) and 50% (18-months) of D and D+E participants, compared to ≤15% for E. Both D and D+E consumed less energy and fat, and more carbohydrates and selected micronutrients than E during follow-up. More than 50% of all participants consumed less than the recommended intake of particular vitamins and minerals. The diet intervention improved intakes of several nutrients. However, inadequate intake of several vitamins and minerals of concern for older adults suggests they need further guidance to assure adequate intake.

Potential effects of reward and loss avoidance in overweight adolescents

PubMed Central

Reyes, Sussanne; Peirano, Patricio; Luna, Beatriz; Lozoff, Betsy; Algarín, Cecilia

2015-01-01

Background Reward system and inhibitory control are brain functions that exert an influence on eating behavior regulation. We studied the differences in inhibitory control and sensitivity to reward and loss avoidance between overweight/obese and normal-weight adolescents. Methods We assessed 51 overweight/obese and 52 normal-weight 15-y-old Chilean adolescents. The groups were similar regarding sex and intelligence quotient. Using Antisaccade and Incentive tasks, we evaluated inhibitory control and the effect of incentive trials (neutral, loss avoidance, and reward) on generating correct and incorrect responses (latency and error rate). Results Compared to normal-weight group participants, overweight/obese adolescents showed shorter latency for incorrect antisaccade responses (186.0 (95% CI: 176.8–195.2) vs. 201.3 ms (95% CI: 191.2–211.5), P < 0.05) and better performance reflected by lower error rate in incentive trials (43.6 (95% CI: 37.8–49.4) vs. 53.4% (95% CI: 46.8–60.0), P < 0.05). Overweight/obese adolescents were more accurate on loss avoidance (40.9 (95% CI: 33.5–47.7) vs. 49.8% (95% CI: 43.0–55.1), P < 0.05) and reward (41.0 (95% CI: 34.5–47.5) vs. 49.8% (95% CI: 43.0–55.1), P < 0.05) compared to neutral trials. Conclusion Overweight/obese adolescents showed shorter latency for incorrect responses and greater accuracy in reward and loss avoidance trials. These findings could suggest that an imbalance of inhibition and reward systems influence their eating behavior. PMID:25927543

Thyroid hormones and changes in body weight and metabolic parameters in response to weight loss diets: the POUNDS LOST trial.

PubMed

Liu, G; Liang, L; Bray, G A; Qi, L; Hu, F B; Rood, J; Sacks, F M; Sun, Q

2017-06-01

The role of thyroid hormones in diet-induced weight loss and subsequent weight regain is largely unknown. To examine the associations between thyroid hormones and changes in body weight and resting metabolic rate (RMR) in a diet-induced weight loss setting. Data analysis was conducted among 569 overweight and obese participants aged 30-70 years with normal thyroid function participating in the 2-year Prevention of Obesity Using Novel Dietary Strategies (POUNDS) LOST randomized clinical trial. Changes in body weight and RMR were assessed during the 2-year intervention. Thyroid hormones (free triiodothyronine (T3), free thyroxine (T4), total T3, total T4 and thyroid-stimulating hormone (TSH)), anthropometric measurements and biochemical parameters were assessed at baseline, 6 months and 24 months. Participants lost an average of 6.6 kg of body weight during the first 6 months and subsequently regained an average of 2.7 kg of body weight over the remaining period from 6 to 24 months. Baseline free T3 and total T3 were positively associated, whereas free T4 was inversely associated, with baseline body weight, body mass index and RMR. Total T4 and TSH were not associated with these parameters. Higher baseline free T3 and free T4 levels were significantly associated with a greater weight loss during the first 6 months (P<0.05) after multivariate adjustments including dietary intervention groups and baseline body weight. Comparing extreme tertiles, the multivariate-adjusted weight loss±s.e. was -3.87±0.9 vs -5.39±0.9 kg for free T3 (P trend =0.02) and -4.09±0.9 vs -5.88±0.9 kg for free T4 (P trend =0.004). The thyroid hormones did not predict weight regain in 6-24 months. A similar pattern of associations was also observed between baseline thyroid hormones and changes in RMR. In addition, changes in free T3 and total T3 levels were positively associated with changes in body weight, RMR, body fat mass, blood pressure, glucose, insulin, triglycerides and leptin at 6 months and 24 months (all P<0.05). In this diet-induced weight loss setting, higher baseline free T3 and free T4 predicted more weight loss, but not weight regain among overweight and obese adults with normal thyroid function. These findings reveal a novel role of thyroid hormones in body weight regulation and may help identify individuals more responsive to weight loss diets.

A behavioral weight-loss intervention in persons with serious mental illness.

PubMed

Daumit, Gail L; Dickerson, Faith B; Wang, Nae-Yuh; Dalcin, Arlene; Jerome, Gerald J; Anderson, Cheryl A M; Young, Deborah R; Frick, Kevin D; Yu, Airong; Gennusa, Joseph V; Oefinger, Meghan; Crum, Rosa M; Charleston, Jeanne; Casagrande, Sarah S; Guallar, Eliseo; Goldberg, Richard W; Campbell, Leslie M; Appel, Lawrence J

2013-04-25

Overweight and obesity are epidemic among persons with serious mental illness, yet weight-loss trials systematically exclude this vulnerable population. Lifestyle interventions require adaptation in this group because psychiatric symptoms and cognitive impairment are highly prevalent. Our objective was to determine the effectiveness of an 18-month tailored behavioral weight-loss intervention in adults with serious mental illness. We recruited overweight or obese adults from 10 community psychiatric rehabilitation outpatient programs and randomly assigned them to an intervention or a control group. Participants in the intervention group received tailored group and individual weight-management sessions and group exercise sessions. Weight change was assessed at 6, 12, and 18 months. Of 291 participants who underwent randomization, 58.1% had schizophrenia or a schizoaffective disorder, 22.0% had bipolar disorder, and 12.0% had major depression. At baseline, the mean body-mass index (the weight in kilograms divided by the square of the height in meters) was 36.3, and the mean weight was 102.7 kg (225.9 lb). Data on weight at 18 months were obtained from 279 participants. Weight loss in the intervention group increased progressively over the 18-month study period and differed significantly from the control group at each follow-up visit. At 18 months, the mean between-group difference in weight (change in intervention group minus change in control group) was -3.2 kg (-7.0 lb, P=0.002); 37.8% of the participants in the intervention group lost 5% or more of their initial weight, as compared with 22.7% of those in the control group (P=0.009). There were no significant between-group differences in adverse events. A behavioral weight-loss intervention significantly reduced weight over a period of 18 months in overweight and obese adults with serious mental illness. Given the epidemic of obesity and weight-related disease among persons with serious mental illness, our findings support implementation of targeted behavioral weight-loss interventions in this high-risk population. (Funded by the National Institute of Mental Health; ACHIEVE ClinicalTrials.gov number, NCT00902694.).

Impact of a Behavioral Weight Loss Intervention on Comorbidities in Overweight and Obese Breast Cancer Survivors

PubMed Central

Sedjo, Rebecca L.; Flatt, Shirley W.; Byers, Tim; Colditz, Graham A.; Demark-Wahnefried, Wendy; Ganz, Patricia A.; Wolin, Kathleen Y.; Elias, Anthony; Krontiras, Helen; Liu, Jingxia; Naughton, Michael; Pakiz, Bilgé; Parker, Barbara A.; Wyatt, Holly; Rock, Cheryl L.

2017-01-01

Purpose Comorbid medical conditions are common among breast cancer survivors, contribute to poorer long-term survival and increased overall mortality, and may be ameliorated by weight loss. This secondary analysis evaluated the impact of a weight loss intervention on comorbid medical conditions immediately following an intervention (12-months) and one-year post-intervention (24-month) using data from the Exercise and Nutrition to Enhance Recovery and Good health for You (ENERGY) trial – a phase III trial which was aimed at and successfully promoted weight loss. Methods ENERGY randomized 692 overweight/obese women who had completed treatment for early stage breast cancer to either a one-year group-based behavioral intervention designed to achieve and maintain weight loss or to a less intensive control intervention. Minimal support was provided post-intervention. New medical conditions, medical conditions in which non-cancer medications were prescribed, hospitalizations, and emergency room visits were compared at baseline, year 1 and 2. Changes over time were analyzed using chi-squared tests, Kaplan-Meier and logistic regression analyses. Results At 12 months, women randomized to the intervention had fewer new medical conditions compared to the control group (19.6% vs. 32.2%, p<0.001); however, by 24 months, there was no longer a significant difference. No difference was observed in each of four conditions for which non-cancer medications were prescribed, hospital visits, or emergency visits at either 12 or 24 months. Conclusions These results support a short-term benefit of modest weight loss on the likelihood of comorbid conditions; however, recidivism and weight regain likely explain no benefit at one-year post-intervention follow-up. PMID:26945570

A high whey protein-, leucine-, and vitamin D-enriched supplement preserves muscle mass during intentional weight loss in obese older adults: a double-blind randomized controlled trial.

PubMed

Verreijen, Amely M; Verlaan, Sjors; Engberink, Mariëlle F; Swinkels, Sophie; de Vogel-van den Bosch, Johan; Weijs, Peter J M

2015-02-01

Intentional weight loss in obese older adults is a risk factor for muscle loss and sarcopenia. The objective was to examine the effect of a high whey protein-, leucine-, and vitamin D-enriched supplement on muscle mass preservation during intentional weight loss in obese older adults. We included 80 obese older adults in a double-blind randomized controlled trial. During a 13-wk weight loss program, all subjects followed a hypocaloric diet (-600 kcal/d) and performed resistance training 3×/wk. Subjects were randomly allocated to a high whey protein-, leucine-, and vitamin D-enriched supplement including a mix of other macro- and micronutrients (150 kcal, 21 g protein; 10×/wk, intervention group) or an isocaloric control. The primary outcome was change in appendicular muscle mass. The secondary outcomes were body composition, handgrip strength, and physical performance. Data were analyzed by using ANCOVA and mixed linear models with sex and baseline value as covariates. At baseline, mean ± SD age was 63 ± 5.6 y, and body mass index (in kg/m(2)) was 33 ± 4.4. During the trial, protein intake was 1.11 ± 0.28 g · kg body weight(-1) · d(-1) in the intervention group compared with 0.85 ± 0.24 g · kg body weight(-1) · d(-1) in the control group (P < 0.001). Both intervention and control groups decreased in body weight (-3.4 ± 3.6 kg and -2.8 ± 2.8 kg; both P < 0.001) and fat mass (-3.2 ± 3.1 kg and -2.5 ± 2.4 kg; both P < 0.001), with no differences between groups. The 13-wk change in appendicular muscle mass, however, was different in the intervention and control groups [+0.4 ± 1.2 kg and -0.5 ± 2.1 kg, respectively; β = 0.95 kg (95% CI: 0.09, 1.81); P = 0.03]. Muscle strength and function improved over time without significant differences between groups. A high whey protein-, leucine-, and vitamin D-enriched supplement compared with isocaloric control preserves appendicular muscle mass in obese older adults during a hypocaloric diet and resistance exercise program and might therefore reduce the risk of sarcopenia. This trial was registered at the Dutch Trial Register (http://www.trialregister.nl) as NTR2751. © 2015 American Society for Nutrition.

Safety and efficacy of lorcaserin: a combined analysis of the BLOOM and BLOSSOM trials.

PubMed

Aronne, Louis; Shanahan, William; Fain, Randi; Glicklich, Alan; Soliman, William; Li, Yuhan; Smith, Steven

2014-10-01

Lorcaserin, a novel selective 5-HT2C receptor agonist, is approved by the US Food and Drug Administration (FDA) for weight management in combination with lifestyle modification for adults with obesity and adults with overweight and ≥ 1 weight-related comorbid condition. The safety and effectiveness of lorcaserin in adult patients without type 2 diabetes mellitus was established based on 2 phase III clinical trials of similar design: Behavioral Modification and Lorcaserin for Overweight and Obesity Management (BLOOM) and Behavioral Modification and Lorcaserin Second Study for Obesity Management (BLOSSOM). This report presents a prespecified analysis of pooled data from these trials. Co-primary end points in this analysis include the proportion of patients with a reduction in baseline body weight of ≥ 5% and ≥ 10%, and a change in weight from baseline. Key secondary end points include changes from baseline values in lipid parameters, quality-of-life measures, glycemic indicators, and vital signs. At week 52, more than twice as many lorcaserin-treated patients achieved a weight loss of ≥ 5% compared with placebo (lorcaserin, 47.1%; placebo, 22.6%), and lorcaserin-treated patients lost significantly more body weight (lorcaserin, -5.8%; placebo, -2.5%). A significantly greater proportion of lorcaserin-treated patients achieved a weight loss of ≥ 10% (lorcaserin, 22.4%; placebo, 8.7%). There were statistically significant improvements in lipid parameters, glycemic indicators, quality-of-life measures, and vital signs in the lorcaserin group compared with placebo. The most common adverse events associated with lorcaserin treatment were headache, upper respiratory tract infection, and nasopharyngitis. Lorcaserin-treated patients had a rate of FDA-defined valvulopathy similar to placebo. This pooled analysis of the phase III BLOOM and BLOSSOM trials shows that lorcaserin 10 mg twice daily, in combination with diet and exercise, is safe and tolerable, and is associated with statistically significant weight loss and clinically relevant improvements in cardiometabolic parameters.

Lifestyle intervention reduces body weight and improves cardiometabolic risk factors in worksites.

PubMed

Salinardi, Taylor C; Batra, Payal; Roberts, Susan B; Urban, Lorien E; Robinson, Lisa M; Pittas, Anastassios G; Lichtenstein, Alice H; Deckersbach, Thilo; Saltzman, Edward; Das, Sai Krupa

2013-04-01

Worksites are potentially effective locations for obesity control because they provide opportunities for group intervention and social support. Studies are needed to identify effective interventions in these settings. We examined the effects of a multicomponent lifestyle intervention on weight loss and prevention of regain in 4 worksites (2 intervention and 2 control sites). Overweight and obese employees (n = 133) enrolled in this pilot worksite-randomized controlled trial with a 0-6-mo weight-loss phase and a 6-12-mo structured weight-maintenance phase. The intervention combined recommendations to consume a reduced-energy, low-glycemic load, high-fiber diet with behavioral change education. Outcome measurements included changes in body weight and cardiometabolic risk factors. The mean ± SEM weight loss was substantial in intervention participants, whereas control subjects gained weight (-8.0 ± 0.7 compared with +0.9 ± 0.5 kg, respectively; P < 0.001), and 89% of participants completed the weight-loss phase. Intervention effects were not significant at the 0.05 level but would have been at the 0.10 level (P = 0.08) in a mixed model in which the worksite nested within group was a random factor. There were also significant improvements in cardiometabolic risk factors in intervention compared with control subjects regarding fasting total cholesterol, glucose, systolic blood pressure, and diastolic blood pressure (P ≤ 0.02 for each). No significant weight regain was observed in participants who enrolled in the structured weight-maintenance program (0.5 ± 0.7 kg; P = 0.65), and overweight and obese employees in intervention worksites who were not enrolled in the weight-loss program lost weight compared with subjects in control worksites (-1.3 ± 0.5 compared with +0.7 ± 0.2 kg, respectively; P = 0.02). Worksites can be effective for achieving clinically important reductions in body weight and improved cardiometabolic risk factors. This trial was registered at clinicaltrials.gov as NCT01470222.

Long-term weight loss observed with olanzapine orally disintegrating tablets in overweight patients with chronic schizophrenia. A 1 year open-label, prospective trial.

PubMed

Chawla, Bharat; Luxton-Andrew, Heather

2008-04-01

To investigate the long-term weight loss outcomes during usual clinical practice after switching from olanzapine standard oral tablet (SOT) to olanzapine orally disintegrating tablets (ODT). In this open-label prospective study, 26 patients with schizophrenia who were clinically stable on olanzapine SOT treatment were switched to olanzapine ODT. All other aspects of treatment remained constant. Weight was recorded at 3, 6, and 12 months. Patients incurred an average weight loss of 2.7 +/- 0.7 kg (p = 0.001) after switching patients from olanzapine SOT to olanzapine ODT at 12 months. Peak weight loss was observed at 6 months; however, significant weight loss was achieved as early as 3 months. The majority (81.9%) of patients lost weight, while 18.1% had no weight change or weight gain. Body mass index (BMI) significantly decreased by 1.0 +/- 0.3 kg/m(2) (p = 0.001). Interestingly, patients treated with higher doses of olanzapine (> or = 20 mg) incurred a greater weight loss of their body weight (5.6%), compared to those treated with lower doses (< 20 mg), who lost 1.9% of their body weight (p = 0.04). This study demonstrated that, in usual clinical practice, switching patients from olanzapine SOT to olanzapine ODT treatment resulted in significant weight loss that was maintained over 12 months. 2008 John Wiley & Sons, Ltd.

Industry funding and the reporting quality of large long-term weight loss trials

PubMed Central

Thomas, Olivia; Thabane, Lehana; Douketis, James; Chu, Rong; Westfall, Andrew O.; Allison, David B.

2009-01-01

Background Quality of reporting (QR) in industry-funded research is a concern of the scientific community. Greater scrutiny of industry-sponsored research reporting has been suggested, although differences in QR by sponsorship type have not been evaluated in weight loss interventions. Objective To evaluate the association of funding source and QR of long-term obesity randomized clinical trials. Methods We analyzed papers that reported long-term weight loss trials. Articles were obtained through searches of MEDLINE, HealthStar, and the Cochrane Controlled Trials Register between the years 1966–2003. QR scores were determined for each study based upon expanded criteria from the Consolidated Standards for Reporting Trials (CONSORT) checklist for a maximum score of 44 points. Studies were coded by category of industry support (0=no industry support, 1= industry support, 2= in kind contribution from industry and 3=duality of interest reported). Individual CONSORT reporting criteria were tabulated by funding type. An independent samples t-test compared differences in QR scores by funding source and the Wilcox-Mann-Whitney test and generalized estimating equations (GEE) were used for sensitivity analyses. Results Of the 63 RCTs evaluated, 67% were industry-supported trials. Industry funding was associated with higher QR score in long-term weight loss trials compared to non-industry funded studies (Mean QR (SD): Industry = 27.9 (4.1), Non-Industry =23.4 (4.1); p < 0.0005). The Wilcox-Mann-Whitney test confirmed this result (p<0.0005). Controlling for the year of publication and whether paper was published before the CONSORT statement was released in a GEE regression analysis, the direction and magnitude of effect was similar and statistically significant (p=0.035). Of the individual criteria that prior research has associated with biases, industry funding was associated with greater reporting of intent-to-treat analysis (p=0.0158), but was not different from non-industry studies in reporting of treatment allocation and blinding. Conclusion Our findings suggest that efforts to improve reporting quality be directed at all obesity RCTs irrespective of funding source. PMID:18711388

Industry funding and the reporting quality of large long-term weight loss trials.

PubMed

Thomas, O; Thabane, L; Douketis, J; Chu, R; Westfall, A O; Allison, D B

2008-10-01

Quality of reporting (QR) in industry-funded research is a concern of the scientific community. Greater scrutiny of industry-sponsored research reporting has been suggested, although differences in QR by sponsorship type have not been evaluated in weight loss interventions. To evaluate the association of funding source and QR of long-term obesity randomized clinical trials (RCT). We analysed papers that reported long-term weight loss trials. Articles were obtained through searches of Medline, HealthStar, and the Cochrane Controlled Trials Register between the years 1966 and 2003. QR scores were determined for each study based upon expanded criteria from the Consolidated Standards for Reporting Trials (CONSORT) checklist for a maximum score of 44 points. Studies were coded by category of industry support (0=no industry support, 1=industry support, 2=in kind contribution from industry and 3=duality of interest reported). Individual CONSORT reporting criteria were tabulated by funding type. An independent samples t-test compared the differences in QR scores by funding source and the Wilcox-Mann-Whitney test and generalised estimating equations (GEE) were used for sensitivity analyses. Of the 63 RCTs evaluated, 67% were industry-supported trials. Industry funding was associated with higher QR score in long-term weight loss trials compared with nonindustry-funded studies (mean QR (s.d.): industry=27.9 (4.1), nonindustry=23.4 (4.1); P<0.0005). The Wilcox-Mann-Whitney test confirmed this result (P<0.0005). Controlling for the year of publication and whether the paper was published before the CONSORT statement was released in the GEE regression analysis, the direction and magnitude of effect were similar and statistically significant (P=0.035). Of the individual criteria that prior research has associated with biases, industry funding was associated with greater reporting of intent-to-treat analysis (P=0.0158), but was not different from nonindustry studies in reporting of treatment allocation and blinding. Our findings suggest that the efforts to improve reporting quality be directed to all obesity RCTs, irrespective of funding source.

Design and Implementation of a Randomized Controlled Social and Mobile Weight Loss Trial for Young Adults (project SMART)

PubMed Central

Patrick, K; Marshall, SJ; Davila, EP; Kolodziejczyk, JK; Fowler, J; Calfas, KJ; Huang, J; Rock, CL; Griswold, W; Gupta, A; Merchant, G; Norman, GJ; Raab, F; Donohue, M; Fogg, BJ; Robinson, TN

2014-01-01

Purpose To describe the theoretical rationale, intervention design, and clinical trial of a two-year weight control intervention for young adults deployed via social and mobile media. Methods A total of 404 overweight or obese college students from three Southern California universities (Mage = 22(±4) years; MBMI=29(±2.8); 70% female) were randomized to participate in the intervention or to receive an informational web-based weight loss program. The intervention is based on behavioral theory and integrates intervention elements across multiple touch points, including Facebook, SMS, smartphone applications, blogs, and e-mail. Participants are encouraged to seek social support among their friends, self-monitor their weight weekly, post their health behaviors on Facebook, and e-mail their weight loss questions/concerns to a health coach. The intervention is adaptive because new theory-driven and iteratively tailored intervention elements are developed and released over the course of the two-year intervention in response to patterns of use and user feedback. Measures of body mass index, waist circumference, physical activity (PA), sedentary behavior (SED), diet, weight management practices, smoking, alcohol, sleep, body image, self-esteem, and depression occur at 6, 12, 18, and 24 months. Currently, all participants have been recruited, and all are in the final year of the trial. Conclusion Theory-driven, evidence-based strategies for PA, SED, and dietary intake can be embedded in an intervention using social and mobile technologies to promote healthy weight-related behaviors in young adults. PMID:24215774

Design and implementation of a randomized controlled social and mobile weight loss trial for young adults (project SMART).

PubMed

Patrick, K; Marshall, S J; Davila, E P; Kolodziejczyk, J K; Fowler, J H; Calfas, K J; Huang, J S; Rock, C L; Griswold, W G; Gupta, A; Merchant, G; Norman, G J; Raab, F; Donohue, M C; Fogg, B J; Robinson, T N

2014-01-01

To describe the theoretical rationale, intervention design, and clinical trial of a two-year weight control intervention for young adults deployed via social and mobile media. A total of 404 overweight or obese college students from three Southern California universities (M(age) = 22( ± 4) years; M(BMI) = 29( ± 2.8); 70% female) were randomized to participate in the intervention or to receive an informational web-based weight loss program. The intervention is based on behavioral theory and integrates intervention elements across multiple touch points, including Facebook, text messaging, smartphone applications, blogs, and e-mail. Participants are encouraged to seek social support among their friends, self-monitor their weight weekly, post their health behaviors on Facebook, and e-mail their weight loss questions/concerns to a health coach. The intervention is adaptive because new theory-driven and iteratively tailored intervention elements are developed and released over the course of the two-year intervention in response to patterns of use and user feedback. Measures of body mass index, waist circumference, diet, physical activity, sedentary behavior, weight management practices, smoking, alcohol, sleep, body image, self-esteem, and depression occur at 6, 12, 18, and 24 months. Currently, all participants have been recruited, and all are in the final year of the trial. Theory-driven, evidence-based strategies for physical activity, sedentary behavior, and dietary intake can be embedded in an intervention using social and mobile technologies to promote healthy weight-related behaviors in young adults. Copyright © 2013 Elsevier Inc. All rights reserved.

A randomized controlled trial of the effect of intrapartum intravenous fluid management on breastfed newborn weight loss.

PubMed

Watson, Jo; Hodnett, Ellen; Armson, B Anthony; Davies, Barbara; Watt-Watson, Judy

2012-01-01

To determine the effect of conservative versus usual intrapartum intravenous (IV) fluid management for low-risk women receiving epidural analgesia on weight loss in breastfed newborns. A randomized controlled trial. A tertiary perinatal center in a large urban setting. Women experiencing uncomplicated pregnancies who planned to have epidural analgesia and to breastfeed. Healthy pregnant women were randomized to receive an IV epidural preload volume of <500 mLs continuing at an hourly rate of 75-100 mL/h (conservative care) or an epidural preload volume of ≥500 mLs and an hourly rate >125 mL/h (usual care). The primary study outcome was breastfed newborn weight loss >7% prior to hospital discharge. Secondary study outcomes included breastfeeding exclusivity, referral to outpatient breastfeeding clinic support, and delayed discharge. Other outcomes were admission to the neonatal intensive care unit and cord blood pH <7.25. Two hundred women participated (100 in the conservative care and 100 in the usual care groups). Forty-eight of 100 infants in the usual care group and 44 of the 100 infants in the conservative care group lost >7% of their birth weight prior to discharge, p < 0.52 RR 0.92 [0.68-1.24]. A policy of restricted IV fluids did not affect newborn weight loss. Women and their care providers should be reassured that the volumes of IV fluid <2500 mLs are unlikely to have a clinically meaningful effect on breastfed newborn weight loss >7%. Exploratory analyses suggest that breastfed newborn weight loss increases when intrapartum volumes infused are >2500 mLs. Care providers are encouraged to consider volumes of IV fluid infused intrapartum as a factor that may have contributed to early newborn weight loss in the first 48 h of life. © 2012 AWHONN, the Association of Women's Health, Obstetric and Neonatal Nurses.

Weight loss in individuals with metabolic syndrome given DASH diet counseling when provided a low sodium vegetable juice: A randomized controlled trial

USDA-ARS?s Scientific Manuscript database

Metabolic syndrome, a constellation of metabolic risk factors for type 2 diabetes and cardiovascular disease, is one of the fastest growing disease entities in the world. Weight loss is thought to be a key to improving all aspects of metabolic syndrome. Research studies have suggested benefits from ...

Using social media to deliver weight loss programming to young adults: Design and rationale for the Healthy Body Healthy U (HBHU) trial.

PubMed

Napolitano, Melissa A; Whiteley, Jessica A; Mavredes, Meghan N; Faro, Jamie; DiPietro, Loretta; Hayman, Laura L; Neighbors, Charles J; Simmens, Samuel

2017-09-01

The transitional period from late adolescence to early adulthood is a vulnerable period for weight gain, with a twofold increase in overweight/obesity during this life transition. In the United States, approximately one-third of young adults have obesity and are at a high risk for weight gain. To describe the design and rationale of a National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) sponsored randomized, controlled clinical trial, the Healthy Body Healthy U (HBHU) study, which compares the differential efficacy of three interventions on weight loss among young adults aged 18-35years. The intervention is delivered via Facebook and SMS Text Messaging (text messaging) and includes: 1) targeted content (Targeted); 2) tailored or personalized feedback (Tailored); or 3) contact control (Control). Recruitment is on-going at two campus sites, with the intervention delivery conducted by the parent site. A total of 450 students will be randomly-assigned to receive one of three programs for 18months. We hypothesize that: a) the Tailored group will lose significantly more weight at the 6, 12, 18month follow-ups compared with the Targeted group; and that b) both the Tailored and Targeted groups will have greater weight loss at the 6, 12, 18month follow-ups than the Control group. We also hypothesize that participants who achieve a 5% weight loss at 6 and 18months will have greater improvements in their cardiometabolic risk factors than those who do not achieve this target. We will examine intervention costs to inform implementation and sustainability other universities. Expected study completion date is 2019. This project has significant public health impact, as the successful translation could reach as many as 20 million university students each year, and change the current standard of practice for promoting weight management within university campus communities. ClinicalTrial.gov: NCT02342912. Copyright © 2017. Published by Elsevier Inc.

Evidence for efficacy and effectiveness of changes in eating frequency for body weight management.

PubMed

Kant, Ashima K

2014-11-01

In self-reported diets of free living individuals, frequent eating is associated with higher energy intake, yet beliefs about the possible beneficial effect of higher eating frequency for managing body weight persist. Prospective cohort studies and controlled trials of manipulation of eating frequency published by 31 December 2012 were reviewed to assess whether variation in eating frequency may be an adjunct to weight management. Four prospective cohort studies were identified; 2 of these included adults followed for 10 y and 2 followed pre-adolescent/adolescent girls for 6 or 10 y. Within each age category, the findings of the 2 studies were contradictory. Six controlled trials with adult subjects serving as their own controls found no significant changes in body weight due to manipulation of eating frequency interventions lasting 6-8 wk. In 6 additional intervention trials of 8-52 wk duration, free-living adults were counseled to change the eating frequency of self-selected food intake with no significant differences in weight loss attributable to eating frequency. Overall, the consistency of the null findings from controlled trials of manipulation of eating frequency for promoting weight loss suggests that beliefs about the role of higher eating frequency in adult weight management are not supported by evidence. Interpretation of the evidence from published observational studies is complicated by differences in definition of eating frequency and limited knowledge of systematic and random errors in measurement of eating frequency. © 2014 American Society for Nutrition.

Impact of Disordered Eating and Psychological Functioning on Overweight Adolescents Participating in a Placebo-Controlled Medication and Behavioral Weight Loss Trial

DTIC Science & Technology

2009-11-23

1997; Sothern et al., 2000)), and therefore induce greater and faster weight loss compared to other hypocaloric diets . However, similar to other...between VLCD and a hypocaloric diet +behavior modification and their combination. International Journal of Obesity and Related Metabolic Disorders, 21(7...taking diet pills, self-induced vomiting, and using laxatives or diuretics, as well as “unhealthy” weight control behaviors, including fasting

Optimization of remotely delivered intensive lifestyle treatment for obesity using the Multiphase Optimization Strategy: Opt-IN study protocol.

PubMed

Pellegrini, Christine A; Hoffman, Sara A; Collins, Linda M; Spring, Bonnie

2014-07-01

Obesity-attributable medical expenditures remain high, and interventions that are both effective and cost-effective have not been adequately developed. The Opt-IN study is a theory-guided trial using the Multiphase Optimization Strategy (MOST) to develop an optimized, scalable version of a technology-supported weight loss intervention. Opt-IN aims to identify which of 5 treatment components or component levels contribute most meaningfully and cost-efficiently to the improvement of weight loss over a 6 month period. Five hundred and sixty obese adults (BMI 30-40 kg/m(2)) between 18 and 60 years old will be randomized to one of 16 conditions in a fractional factorial design involving five intervention components: treatment intensity (12 vs. 24 coaching calls), reports sent to primary care physician (No vs. Yes), text messaging (No vs. Yes), meal replacement recommendations (No vs. Yes), and training of a participant's self-selected support buddy (No vs. Yes). During the 6-month intervention, participants will monitor weight, diet, and physical activity on the Opt-IN smartphone application downloaded to their personal phone. Weight will be assessed at baseline, 3, and 6 months. The Opt-IN trial is the first study to use the MOST framework to develop a weight loss treatment that will be optimized to yield the best weight loss outcome attainable for $500 or less. Copyright © 2014 Elsevier Inc. All rights reserved.

Psychosocial enhancement of the Green Prescription for obesity recovery: a randomised controlled trial.

PubMed

Sellman, Doug; Schroder, Ria; Deering, Daryle; Elmslie, Jane; Foulds, James; Frampton, Chris

2017-02-17

Kia Ākina is a low-cost obesity recovery network providing ongoing addiction-orientated psychosocial support. This study explored the impact of Kia Ākina when added to the Green Prescription, a key government-funded health promotion programme in New Zealand. A randomised controlled trial (ACTRN12613001160729) involving 108 participants recruited from primary care compared Green Prescription plus Kia Ākina (KA/GRx) with Green Prescription alone (GRx) over 12 months. The primary a priori outcome measure was achieving 5% loss of weight from baseline. KA/GRx participants lost more weight overall than GRx (3.6kg vs 0.7kg, p=0.03), while 39% of the GRx group gained weight compared with 21% of KA/GRx (p=0.04). However, KA/GRx and GRx had similar proportions with weight loss of 5% or greater (20% vs 17%, p=0.62). KA/GRx participants had greater changes in confidence about recovery (p=0.02), and quality of life measures (p=0.03) and greater overall satisfaction with assistance received (p<0.001) compared with GRx participants. Psychosocial support provided through Kia Ākina enhanced treatment outcomes for people with obesity at 12 months when added to GRx, although weight-loss outcomes were modest. Before Kia Ākina is expanded, improved weight-loss outcomes are required, which may be achieved through individualised assessment and targeted dietary assistance.

Association of Pharmacological Treatments for Obesity With Weight Loss and Adverse Events

PubMed Central

Khera, Rohan; Murad, Mohammad Hassan; Chandar, Apoorva K.; Dulai, Parambir S.; Wang, Zhen; Prokop, Larry J.; Loomba, Rohit; Camilleri, Michael; Singh, Siddharth

2017-01-01

IMPORTANCE Five medications have been approved for the management of obesity, but data on comparative effectiveness are limited. OBJECTIVE To compare weight loss and adverse events among drug treatments for obesity using a systematic review and network meta-analysis. DATA SOURCES MEDLINE, EMBASE, Web of Science, Scopus, and Cochrane Central from inception to March 23, 2016; clinical trial registries. STUDY SELECTION Randomized clinical trials conducted among overweight and obese adults treated with US Food and Drug Administration–approved long-term weight loss agents (orlistat, lorcaserin, naltrexone-bupropion, phentermine-topiramate, or liraglutide) for at least 1 year compared with another active agent or placebo. DATA EXTRACTION AND SYNTHESIS Two investigators identified studies and independently abstracted data using a predefined protocol. A Bayesian network meta-analysis was performed and relative ranking of agents was assessed using surface under the cumulative ranking (SUCRA) probabilities. Quality of evidence was assessed using GRADE criteria. MAIN OUTCOMES AND MEASURES Proportions of patients with at least 5%weight loss and at least 10% weight loss, magnitude of decrease in weight, and discontinuation of therapy because of adverse events at 1 year. RESULTS Twenty-eight randomized clinical trials with 29018 patients (median age, 46 years; 74%women; median baseline body weight, 100.5 kg; median baseline body mass index, 36.1) were included. A median 23%of placebo participants had at least 5%weight loss vs 75%of participants taking phentermine-topiramate (odds ratio [OR], 9.22; 95%credible interval [CrI], 6.63–12.85; SUCRA, 0.95), 63%of participants taking liraglutide (OR, 5.54; 95%CrI, 4.16–7.78; SUCRA, 0.83), 55%taking naltrexone-bupropion (OR, 3.96; 95%CrI, 3.03–5.11; SUCRA, 0.60), 49%taking lorcaserin (OR, 3.10; 95%CrI, 2.38–4.05; SUCRA, 0.39), and 44%taking orlistat (OR, 2.70; 95%CrI, 2.34–3.09; SUCRA, 0.22). All active agents were associated with significant excess weight loss compared with placebo at 1 year—phentermine-topiramate, 8.8 kg (95%CrI, −10.20 to −7.42 kg); liraglutide, 5.3 kg (95%CrI, −6.06 to −4.52 kg); naltrexone-bupropion, 5.0 kg (95%CrI, −5.94 to −3.96 kg); lorcaserin, 3.2 kg (95%CrI, −3.97 to −2.46 kg); and orlistat, 2.6 kg (95%CrI, −3.04 to −2.16 kg). Compared with placebo, liraglutide (OR, 2.95; 95%CrI, 2.11–4.23) and naltrexone-bupropion (OR, 2.64; 95%CrI, 2.10–3.35) were associated with the highest odds of adverse event–related treatment discontinuation. High attrition rates (30%–45%in all trials) were associated with lower confidence in estimates. CONCLUSIONS AND RELEVANCE Among overweight or obese adults, orlistat, lorcaserin, naltrexone-bupropion, phentermine-topiramate, and liraglutide, compared with placebo, were each associated with achieving at least 5%weight loss at 52 weeks. Phentermine-topiramate and liraglutide were associated with the highest odds of achieving at least 5%weight loss. PMID:27299618

Transtheoretical model stages of change for dietary and physical exercise modification in weight loss management for overweight and obese adults.

PubMed

Mastellos, Nikolaos; Gunn, Laura H; Felix, Lambert M; Car, Josip; Majeed, Azeem

2014-02-05

Obesity is a global public health threat. The transtheoretical stages of change (TTM SOC) model has long been considered a useful interventional approach in lifestyle modification programmes, but its effectiveness in producing sustainable weight loss in overweight and obese individuals has been found to vary considerably.  To assess the effectiveness of dietary intervention or physical activity interventions, or both, and other interventions based on the transtheoretical model (TTM) stages of change (SOC) to produce sustainable (one year and longer) weight loss in overweight and obese adults. Studies were obtained from searches of multiple electronic bibliographic databases. We searched The Cochrane Library, MEDLINE, EMBASE and PsycINFO. The date of the last search, for all databases, was 17 December 2013. Trials were included if they fulfilled the criteria of randomised controlled clinical trials (RCTs) using the TTM SOC as a model, that is a theoretical framework or guideline in designing lifestyle modification strategies, mainly dietary and physical activity interventions, versus a comparison intervention of usual care; one of the outcome measures of the study was weight loss, measured as change in weight or body mass index (BMI); participants were overweight or obese adults only; and the intervention was delivered by healthcare professionals or trained lay people at the hospital and community level, including at home. Two review authors independently extracted the data, assessed studies for risk of bias and evaluated overall study quality according to GRADE (Grading of Recommendations Assessment, Development and Evaluation). We resolved disagreements by discussion or consultation with a third party. A narrative, descriptive analysis was conducted for the systematic review. A total of three studies met the inclusion criteria, allocating 2971 participants to the intervention and control groups. The total number of participants randomised to the intervention groups was 1467, whilst 1504 were randomised to the control groups. The length of intervention was 9, 12 and 24 months in the different trials. The use of TTM SOC in combination with diet or physical activity, or both, and other interventions in the included studies produced inconclusive evidence that TTM SOC interventions led to sustained weight loss (the mean difference between intervention and control groups varied from 2.1 kg to 0.2 kg at 24 months; 2971 participants; 3 trials; low quality evidence). Following application of TTM SOC there were improvements in physical activity and dietary habits, such as increased exercise duration and frequency, reduced dietary fat intake and increased fruit and vegetable consumption (very low quality evidence). Weight gain was reported as an adverse event in one of the included trials. None of the trials reported health-related quality of life, morbidity, or economic costs as outcomes. The small number of studies and their variable methodological quality limit the applicability of the findings to clinical practice. The main limitations include inadequate reporting of outcomes and the methods for allocation, randomisation and blinding; extensive use of self-reported measures to estimate the effects of interventions on a number of outcomes, including weight loss, dietary consumption and physical activity levels; and insufficient assessment of sustainability due to lack of post-intervention assessments. The evidence to support the use of TTM SOC in weight loss interventions is limited by risk of bias and imprecision, not allowing firm conclusions to be drawn. When combined with diet or physical activity, or both, and other interventions we found very low quality evidence that it might lead to better dietary and physical activity habits. This systematic review highlights the need for well-designed RCTs that apply the principles of the TTM SOC appropriately to produce conclusive evidence about the effect of TTM SOC lifestyle interventions on weight loss and other health outcomes.

A within-trial cost-effectiveness analysis of primary care referral to a commercial provider for weight loss treatment, relative to standard care—an international randomised controlled trial

PubMed Central

Fuller, N R; Colagiuri, S; Schofield, D; Olson, A D; Shrestha, R; Holzapfel, C; Wolfenstetter, S B; Holle, R; Ahern, A L; Hauner, H; Jebb, S A; Caterson, I D

2013-01-01

Background: Due to the high prevalence of overweight and obesity there is a need to identify cost-effective approaches for weight loss in primary care and community settings. Objective: We evaluated the cost effectiveness of two weight loss programmes of 1-year duration, either standard care (SC) as defined by national guidelines, or a commercial provider (Weight Watchers) (CP). Design: This analysis was based on a randomised controlled trial of 772 adults (87% female; age 47.4±12.9 years; body mass index 31.4±2.6 kg m−2) recruited by health professionals in primary care in Australia, United Kingdom and Germany. Both a health sector and societal perspective were adopted to calculate the cost per kilogram of weight loss and the ICER, expressed as the cost per quality adjusted life year (QALY). Results: The cost per kilogram of weight loss was USD122, 90 and 180 for the CP in Australia, the United Kingdom and Germany, respectively. For SC the cost was USD138, 151 and 133, respectively. From a health-sector perspective, the ICER for the CP relative to SC was USD18 266, 12 100 and 40 933 for Australia, the United Kingdom and Germany, respectively. Corresponding societal ICER figures were USD31 663, 24 996 and 51 571. Conclusion: The CP was a cost-effective approach from a health funder and societal perspective. Despite participants in the CP group attending two to three times more meetings than the SC group, the CP was still cost effective even including these added patient travel costs. This study indicates that it is cost effective for general practitioners (GPs) to refer overweight and obese patients to a CP, which may be better value than expending public funds on GP visits to manage this problem. PMID:22929209

Application of Latent Class Analysis to Identify Behavioral Patterns of Response to Behavioral Lifestyle Interventions in Overweight and Obese Adults

PubMed Central

Fitzpatrick, Stephanie L.; Coughlin, Janelle W.; Appel, Lawrence J.; Tyson, Crystal; Stevens, Victor J.; Jerome, Gerald J.; Dalcin, Arlene; Brantley, Phillip J.; Hill-Briggs, Felicia

2016-01-01

Background Examining responders and non-responders to behavioral lifestyle interventions among overweight/obese adults with additional comorbidities may aid in refining and tailoring obesity treatment. Purpose The purpose of this study is to demonstrate the use of latent class analysis to identify patterns of response to behavioral lifestyle interventions based on adherence to diet and exercise recommendations. Method Repeated measures latent class analysis was applied to two clinical trial datasets, combination of two active interventions in the PREMIER Trial (n=501) and phase 1 of the Weight Loss Maintenance Trial (WLM; n=1685), to identify patterns of response to behavioral lifestyle interventions. Treatment response was based on adherence to daily recommendations for fruit/vegetable, fat, saturated fat, sodium, and exercise at baseline and 6 months. Results In PREMIER, three distinct latent classes emerged: responders (45.9 %), non-responders (23.6 %), and early adherers (30.5 %). Responders and Early Adherers had greater weight loss at 6 and 18 months and were more likely to meet behavioral recommendations at 18 months than Non-responders. For WLM, there were four latent classes: partial responders (16 %), non-responders (40 %), early adherers (2 %), and fruit/veggie only responders (41 %). Non-responders in WLM had significantly less weight loss at 6 months compared to that of the other three latent classes. Conclusion Latent class analysis is a useful method to apply to clinical trial data to identify distinct patterns of response to behavioral interventions. Overweight/ obese participants who respond to behavioral lifestyle treatment (i.e., meet behavioral recommendations) have significantly greater weight loss than that of participants who do not make behavioral changes. PMID:25331853

Application of Latent Class Analysis to Identify Behavioral Patterns of Response to Behavioral Lifestyle Interventions in Overweight and Obese Adults.

PubMed

Fitzpatrick, Stephanie L; Coughlin, Janelle W; Appel, Lawrence J; Tyson, Crystal; Stevens, Victor J; Jerome, Gerald J; Dalcin, Arlene; Brantley, Phillip J; Hill-Briggs, Felicia

2015-08-01

Examining responders and non-responders to behavioral lifestyle interventions among overweight/obese adults with additional comorbidities may aid in refining and tailoring obesity treatment. The purpose of this study is to demonstrate the use of latent class analysis to identify patterns of response to behavioral lifestyle interventions based on adherence to diet and exercise recommendations. Repeated measures latent class analysis was applied to two clinical trial datasets, combination of two active interventions in the PREMIER Trial (n = 501) and phase 1 of the Weight Loss Maintenance Trial (WLM; n = 1685), to identify patterns of response to behavioral lifestyle interventions. Treatment response was based on adherence to daily recommendations for fruit/vegetable, fat, saturated fat, sodium, and exercise at baseline and 6 months. In PREMIER, three distinct latent classes emerged: responders (45.9%), non-responders (23.6%), and early adherers (30.5%). Responders and Early Adherers had greater weight loss at 6 and 18 months and were more likely to meet behavioral recommendations at 18 months than Non-responders. For WLM, there were four latent classes: partial responders (16%), non-responders (40%), early adherers (2%), and fruit/veggie only responders (41%). Non-responders in WLM had significantly less weight loss at 6 months compared to that of the other three latent classes. Latent class analysis is a useful method to apply to clinical trial data to identify distinct patterns of response to behavioral interventions. Overweight/ obese participants who respond to behavioral lifestyle treatment (i.e., meet behavioral recommendations) have significantly greater weight loss than that of participants who do not make behavioral changes.

Intramyocellular triacylglycerol accumulation across weight loss strategies; Sub-study of the CENTRAL trial.

PubMed

Gepner, Yftach; Shelef, Ilan; Schwarzfuchs, Dan; Cohen, Noa; Bril, Nitzan; Rein, Michal; Tsaban, Gal; Zelicha, Hila; Yaskolka Meir, Anat; Tene, Lilac; Sarusy, Benjamin; Rosen, Philip; Hoffman, Jay R; Stout, Jeffrey R; Thiery, Joachim; Ceglarek, Uta; Stumvoll, Michael; Blüher, Matthias; Stampfer, Meir J; Shai, Iris

2017-01-01

Intramyocellular triacylglycerol (IMTG) is utilized as metabolic fuel during exercise and is linked to insulin resistance, but the long-term effect of weight loss strategies on IMTG among participants with abdominal fat, remain unclear. In an 18-month trial, sedentary participants with abdominal fat/dyslipidemia were randomized to either a low-fat (LF) or Mediterranean/low-carbohydrate (MED/LC) diet (including 28g·day-1 of walnuts). After 6-months, the participants were re-randomized to moderate intense physical activity (PA+) or non-physical activity (PA-). Magnetic resonance imaging (MRI) was used to quantify changes of IMTG, abdominal sub-depots, hepatic and intermuscular fats. Across the 277 participants [86% men, age = 48 years, body-mass-index (BMI) = 31kg/m2, visceral fat = 33%] 86% completed the 18-m trial. At baseline, women had higher IMTG than men (3.4% vs. 2.3%, p<0.001) and increased IMTG was associated with aging and higher BMI, visceral and intermuscular fats, HbA1c%, HDL-c and leptin(p<0.05), but not with intra-hepatic fat. After 18 month of intervention and a -3 kg mean weight loss, participants significantly increased IMTG by 25%, with a distinct effect in the MED/LCPA+ group as compared to the other intervention groups (57% vs. 9.5-18.5%, p<0.05). Changes in IMTG were associated with visceral and intermuscular fat, metabolic syndrome, insulin and leptin (p<0.05 for all), however, these associations did not remain after adjustment for visceral fat changes. Lifestyle strategies differentially affect IMTG accumulation; combination of exercise with decreased carbohydrate/increased unsaturated fat proportion intake greatly increase IMTG. Our findings suggest that increased IMTG during diet-induced moderate weight loss may not be directly related to cardiometabolic risk. ClinicalTrials.gov NCT01530724.

The experimental evidence for weight-loss treatment of essential hypertension: a critical review.

PubMed Central

Hovell, M F

1982-01-01

The empirical evidence concerning the therapeutic effects of weight loss for hypertension treatment was reviewed. Interventions were critically reviewed for strength of measures and experimental design. Six of 21 intervention studies proved to be methodologically strong. However, only one study was considered a randomized clinical trial, testing the combined effects of weight reduction and pharmacological treatment of hypertension. Average blood pressure decrease obtained from the methodologically strongest studies was -21 mmHg and -13 mmHg, for systolic and diastolic measures, respectively. This magnitude change suggests that weight loss may be a clinically and statistically significant treatment. Confounding and bias variables, such as adherence to diet, medication, salt consumption, etc., were discussed and future areas of research were outlined. It was concluded that weight loss appears to be an effective and safe treatment of hypertension. PMID:7039371

Adding Evidence-Based Behavioral Weight Loss Strategies to a Statewide Wellness Campaign: A Randomized Clinical Trial

PubMed Central

Thomas, Graham; Fava, Joseph L.; Subak, Leslee L.; Schembri, Michael; Krupel, Katie; Kumar, Rajiv; Weinberg, Brad; Wing, Rena R.

2014-01-01

Objectives. We determined the efficacy and cost-effectiveness of adding an evidence-based Internet behavioral weight loss intervention alone or combined with optional group sessions to ShapeUp Rhode Island 2011 (SURI), a 3-month statewide wellness campaign. Methods. We randomized participants (n = 230; body mass index = 34.3 ±6.8 kg/m2; 84% female) to the standard SURI program (S) or to 1 of 2 enhanced programs: SURI plus Internet behavioral program (SI) or SI plus optional group sessions (SIG). The primary outcome was weight loss at the end of the 3-month program. Results. Weight losses differed among all 3 conditions (S: 1.1% ±0.9%; SI: 4.2% ±0.6%; SIG: 6.1% ±0.6%; Ps ≤ .04). Both SI and SIG increased the percentage of individuals who achieved a 5% weight loss (SI: 42%; SIG: 54%; S: 7%; Ps < .001). Cost per kilogram of weight loss was similar for S ($39) and SI ($35); both were lower than SIG ($114). Conclusions. Although weight losses were greatest at the end of SURI with optional group sessions, the addition of an Internet behavioral program was the most cost-effective method to enhance weight losses. PMID:24832424

Contrasting weight changes with LY2605541, a novel long-acting insulin, and insulin glargine despite similar improved glycaemic control in T1DM and T2DM.

PubMed

Jacober, S J; Rosenstock, J; Bergenstal, R M; Prince, M J; Qu, Y; Beals, J M

2014-04-01

The basal insulin analogue LY2605541, a PEGylated insulin lispro with prolonged duration of action, was previously shown to be associated with modest weight loss in Phase 2, randomized, open-label trials in type 2 (N=288) and type 1 (N=137) diabetes mellitus (T2DM and T1DM), compared with modest weight gain with insulin glargine. Exploratory analyses were conducted to further characterize these findings. Pearson correlations between change in body weight and other variables were calculated. Continuous variables were analysed using a mixed linear model with repeated measurements. Proportions of subjects with weight loss were analysed using Fisher's exact test for T2DM and Nagelkerke's method for T1DM. Weight loss was more common in LY2605541-treated patients than in patients treated with insulin glargine (T2DM: 56.9 vs. 40.2%, p=0.011; T1DM: 66.1 vs. 40.3%, p<0.001). More LY2605541-treated patients experienced ≥5% weight loss compared to patients treated with glargine (T2DM: 4.8 vs. 0%, p=0.033; T1DM: 11.9 vs. 0.8%, p<0.001). In both the T1DM and T2DM studies, weight change did not correlate with baseline body mass index (BMI), or change in HDL-cholesterol in either treatment group. No consistent correlations were found across both studies between weight change and any of the variables assessed; however, weight change was significantly correlated with hypoglycaemia rate in glargine-treated T2DM patients. In two Phase 2 trials, improved glycaemic control with long-acting basal insulin analogue LY2605541 is associated with weight loss in previously insulin-treated patients. This weight change is independent of baseline BMI or hypoglycaemia.

Efficacy of lifestyle modification for long-term weight control.

PubMed

Wadden, Thomas A; Butryn, Meghan L; Byrne, Kirstin J

2004-12-01

A comprehensive program of lifestyle modification induces loss of approximately 10% of initial weight in 16 to 26 weeks, as revealed by a review of recent randomized controlled trials, including the Diabetes Prevention Program. Long-term weight control is facilitated by continued patient-therapist contact, whether provided in person or by telephone, mail, or e-mail. High levels of physical activity and the consumption of low-calorie, portion-controlled meals, including liquid meal replacements, can also help maintain weight loss. Additional studies are needed of the effects of macronutrient content (e.g., low-fat vs. low-carbohydrate diets) on long-term changes in weight and health. Research also is needed on effective methods of providing comprehensive weight loss control to the millions of Americans who need it.

Genetic predictors of weight loss and weight regain after intensive lifestyle modification, metformin treatment, or standard care in the Diabetes Prevention Program.

PubMed

Delahanty, Linda M; Pan, Qing; Jablonski, Kathleen A; Watson, Karol E; McCaffery, Jeanne M; Shuldiner, Alan; Kahn, Steven E; Knowler, William C; Florez, Jose C; Franks, Paul W

2012-02-01

We tested genetic associations with weight loss and weight regain in the Diabetes Prevention Program, a randomized controlled trial of weight loss-inducing interventions (lifestyle and metformin) versus placebo. Sixteen obesity-predisposing single nucleotide polymorphisms (SNPs) were tested for association with short-term (baseline to 6 months) and long-term (baseline to 2 years) weight loss and weight regain (6 months to study end). Irrespective of treatment, the Ala12 allele at PPARG associated with short- and long-term weight loss (-0.63 and -0.93 kg/allele, P ≤ 0.005, respectively). Gene-treatment interactions were observed for short-term (LYPLAL1 rs2605100, P(lifestyle*SNP) = 0.032; GNPDA2 rs10938397, P(lifestyle*SNP) = 0.016; MTCH2 rs10838738, P(lifestyle*SNP) = 0.022) and long-term (NEGR1 rs2815752, P(metformin*SNP) = 0.028; FTO rs9939609, P(lifestyle*SNP) = 0.044) weight loss. Three of 16 SNPs were associated with weight regain (NEGR1 rs2815752, BDNF rs6265, PPARG rs1801282), irrespective of treatment. TMEM18 rs6548238 and KTCD15 rs29941 showed treatment-specific effects (P(lifestyle*SNP) < 0.05). Genetic information may help identify people who require additional support to maintain reduced weight after clinical intervention.

Efficacy of polyglucosamine for weight loss-confirmed in a randomized double-blind, placebo-controlled clinical investigation.

PubMed

Pokhis, Karina; Bitterlich, Norman; Cornelli, Umberto; Cassano, Giuseppina

2015-01-01

The purpose of this clinical study was to ascertain whether low molecular weight chitosan polyglucosamine is able to produce significantly better weight loss than placebo. 115 participants were included in the study. We used a two-center randomized, double blind, placebo-controlled design. The participants followed a standard treatment (ST), which included the combination of a low-calorie diet achieved through creating a daily calorie deficit (500 cal) and an increased daily physical activity (7 MET-h/week). They were randomized to receive standard treatment plus placebo (ST + PL) or standard treatment plus polyglucosamine (ST + PG), respectively. Participants were instructed to take 2 × 2 tablets before the two meals containing the highest fat content for at least 24 weeks. Body weight, BMI, waist circumference and the time needed for a 5 % body weight reduction (5R) were taken as main variables. The average weight loss over a period of 25 weeks in the ITT population was 5.8 ± 4.09 kg in the ST + PG group versus 4.0 ± 2.94 kg in the ST + PL (pU = 0.023; pt = 0.010). After 25 weeks, 34 participants achieved 5R in the ST + PG group (64.1 %) compared to only 23 participants in the ST + PL group (42.6 %) (ITT) (p Fisher = 0.033). Weight loss through hypo-caloric diets have been found to be effective. The additional effect of PG in combination with standard treatment is able to produce significantly better weight loss than placebo. Participants treated with ST + PG showed a significant amount of weight loss, an additional 1.8 kg, compared to controls treated with ST + PL. Trial Registration at ClinicalTrials.gov: NCT02410785 Registered 07 April 2015.

A randomized, double-blind, placebo-controlled clinical trial of megestrol acetate as an appetite stimulant in children with weight loss due to cancer and/or cancer therapy.

PubMed

Cuvelier, Geoff D E; Baker, Tina J; Peddie, Elaine F; Casey, Linda M; Lambert, Pascal J; Distefano, Dianne S; Wardle, Marlene G; Mychajlunow, Beth A; Romanick, Marcel A; Dix, David B; Wilson, Beverly A

2014-04-01

Megestrol acetate (MA) is an appetite stimulant with efficacy in promoting weight gain in adults with cancer-associated anorexia-cachexia. Studies documenting MA efficacy in children, however, are limited. We present the first randomized, double-blind, placebo-controlled clinical trial of MA versus placebo in children with cancer and weight loss. Subjects <18 years of age with weight loss (minimum 5% from highest previous weight; or %ideal body weight <90%) due to cancer and/or cancer therapy were randomized to either MA (7.5 mg/kg/day) or placebo for a planned study duration of 90 days. Primary outcome was the difference between groups in mean percent weight change from beginning to end of the study period. Secondary outcomes included effects on anthropometrics, body composition, need for tube feeding or parenteral nutrition, and toxicities. Twenty-six patients were randomly assigned (13 MA, 13 placebo). The MA group experienced a mean weight gain of +19.7% compared to a mean weight loss of -1.2% in the placebo group, for a difference of +20.9% (95%CI: +11.3% to +30.5%, P = 0.003) in favor of MA over placebo. MA subjects experienced significant increases in weight for age z-scores, body mass index z-scores, and mid upper arm circumference compared to placebo. DXA scanning suggested disproportionate increases in fat accrual. Adrenal suppression was the main toxicity of MA. In children with high-risk malignancies, MA resulted in significant increases in mean percent weight change compared to placebo. Further studies of MA should be pursued to better delineate the effect on nutritional status. © 2013 Wiley Periodicals, Inc.

Effect of 1 year of an intentional weight loss intervention on bone mineral density in type 2 diabetes: results from the Look AHEAD randomized trial.

PubMed

Schwartz, Ann V; Johnson, Karen C; Kahn, Steven E; Shepherd, John A; Nevitt, Michael C; Peters, Anne L; Walkup, Michael P; Hodges, Amelia; Williams, Carrie C; Bray, George A

2012-03-01

Intentional weight loss is an important component of treatment for overweight patients with type 2 diabetes, but the effects on bone density are not known. We used data from the Look AHEAD trial to determine the impact of an intensive lifestyle weight loss intervention (ILI) compared with diabetes support and education (DSE) on changes in bone mineral density (BMD) over 12 months. Overweight and obese adults with type 2 diabetes were randomly assigned to ILI or DSE. In a substudy of BMD conducted at 5 of 16 clinical centers, hip, spine, and whole body dual X-ray absorptiometry scans were obtained at baseline and 1-year later on 642 of 739 ILI and 632 of 740 DSE participants. At baseline, mean age was 58.4 years, and average body mass index was 35.2 kg/m(2). Total hip BMD T-score was <-2.5 in 1% and <-1.0 in 8%. At 1 year, weight loss was greater in ILI than DSE (-8.6% versus -0.7%), and glycemic control and fitness were also improved. Bone loss over 1 year was greater in ILI at the total hip (-1.4% versus -0.4%; p < 0.001) and femoral neck (-1.5% versus -0.8%; p = 0.009), but change in BMD for the lumbar spine and whole body did not differ between groups. In ILI, bone loss at the total hip was independently associated with weight loss in men and women and with poorer glycemic control in men, but was not associated with changes in fitness. One year of an intensive lifestyle intervention in adults with type 2 diabetes, resulting in weight loss, was associated with a modest increase in hip bone loss despite improved fitness and glycemic control. Copyright © 2012 American Society for Bone and Mineral Research.

Concomitant changes in sleep duration and body weight and body composition during weight loss and 3-mo weight maintenance.

PubMed

Verhoef, Sanne P M; Camps, Stefan G J A; Gonnissen, Hanne K J; Westerterp, Klaas R; Westerterp-Plantenga, Margriet S

2013-07-01

An inverse relation between sleep duration and body mass index (BMI) has been shown. We assessed the relation between changes in sleep duration and changes in body weight and body composition during weight loss. A total of 98 healthy subjects (25 men), aged 20-50 y and with BMI (in kg/m(2)) from 28 to 35, followed a 2-mo very-low-energy diet that was followed by a 10-mo period of weight maintenance. Body weight, body composition (measured by using deuterium dilution and air-displacement plethysmography), eating behavior (measured by using a 3-factor eating questionnaire), physical activity (measured by using the validated Baecke's questionnaire), and sleep (estimated by using a questionnaire with the Epworth Sleepiness Scale) were assessed before and immediately after weight loss and 3- and 10-mo follow-ups. The average weight loss was 10% after 2 mo of dieting and 9% and 6% after 3- and 10-mo follow-ups, respectively. Daytime sleepiness and time to fall asleep decreased during weight loss. Short (≤7 h) and average (>7 to <9 h) sleepers increased their sleep duration, whereas sleep duration in long sleepers (≥9 h) did not change significantly during weight loss. This change in sleep duration was concomitantly negatively correlated with the change in BMI during weight loss and after the 3-mo follow-up and with the change in fat mass after the 3-mo follow-up. Sleep duration benefits from weight loss or vice versa. Successful weight loss, loss of body fat, and 3-mo weight maintenance in short and average sleepers are underscored by an increase in sleep duration or vice versa. This trial was registered at clinicaltrials.gov as NCT01015508.

Effectiveness of Workplace Weight Management Interventions: a Systematic Review.

PubMed

Weerasekara, Yasoma Kumari; Roberts, Susan B; Kahn, Mira A; LaVertu, Amy E; Hoffman, Ben; Das, Sai Krupa

2016-06-01

A systematic review was conducted of randomized trials of workplace weight management interventions, including trials with dietary, physical activity, environmental, behavioral, and incentive-based components. Main outcomes were defined as change in weight-related measures. Keywords related to weight management and workplace interventions were used to search relevant databases, and 23 eligible studies were reviewed in detail using a data extraction form and quality assessment checklist. The trials were conducted mainly in the USA and Europe, with four additional countries represented. Interventions were mostly multicomponent and were implemented in both sexes and in a range of employment categories. Intervention effectiveness appeared unrelated to region of the world and was highest in 6-12-month trials. The results ranged widely from clinically significant 8.8-kg weight loss in one trial to less effective than the control treatment in others. Some workplace interventions achieve clinically significant benefits, and further studies are needed to replicate those results in wider sociocultural and geographical contexts.

What is the effect of diet and/or exercise interventions on behavioural compensation in non-exercise physical activity and related energy expenditure of free-living adults? A systematic review.

PubMed

Silva, Analiza M; Júdice, Pedro B; Carraça, Eliana V; King, Neil; Teixeira, Pedro J; Sardinha, Luís B

2018-06-01

Non-exercise physical activity (NEPA) and/or non-exercise activity thermogenesis (NEAT) reductions may occur from diet and/or exercise-induced negative energy balance interventions, resulting in less-than-expected weight loss. This systematic review describes the effects of prescribed diet and/or physical activity (PA)/exercise on NEPA and/or NEAT in adults. Studies were identified from PubMed, web-of-knowledge, Embase, SPORTDiscus, ERIC and PsycINFO searches up to 1 March 2017. Eligibility criteria included randomised controlled trials (RCT), randomised trials (RT) and non-randomised trials (NRT); objective measures of PA and energy expenditure; data on NEPA, NEAT and spontaneous PA; ≥10 healthy male/female aged>18 years; and ≥7 d length. The trial is registered at PROSPERO-2017-CRD42017052635. In all, thirty-six articles (RCT-10, RT-9, NRT-17) with a total of seventy intervention arms (diet, exercise, combined diet/exercise), with a total of 1561 participants, were included. Compensation was observed in twenty-six out of seventy intervention arms (fifteen studies out of thirty-six reporting declines in NEAT (eight), NEPA (four) or both (three)) representing 63, 27 and 23 % of diet-only, combined diet/exercise, and exercise-only intervention arms, respectively. Weight loss observed in participants who decreased NEAT was double the weight loss found in those who did not compensate, suggesting that the energy imbalance degree may lead to energy conservation. Although these findings do not support the hypothesis that prescribed diet and/or exercise results in decreased NEAT and NEPA in healthy adults, the underpowered trial design and the lack of state-of-the-art methods may limit these conclusions. Future studies should explore the impact of weight-loss magnitude, energetic restriction degree, exercise dose and participant characteristics on NEAT and/or NEPA.

Intramyocellular triacylglycerol accumulation across weight loss strategies; Sub-study of the CENTRAL trial

PubMed Central

Gepner, Yftach; Shelef, Ilan; Schwarzfuchs, Dan; Cohen, Noa; Bril, Nitzan; Rein, Michal; Tsaban, Gal; Zelicha, Hila; Yaskolka Meir, Anat; Tene, Lilac; Sarusy, Benjamin; Rosen, Philip; Hoffman, Jay R.; Stout, Jeffrey R.; Thiery, Joachim; Ceglarek, Uta; Stumvoll, Michael; Blüher, Matthias; Stampfer, Meir J.; Shai, Iris

2017-01-01

Background Intramyocellular triacylglycerol (IMTG) is utilized as metabolic fuel during exercise and is linked to insulin resistance, but the long-term effect of weight loss strategies on IMTG among participants with abdominal fat, remain unclear. Methods In an 18-month trial, sedentary participants with abdominal fat/dyslipidemia were randomized to either a low-fat (LF) or Mediterranean/low-carbohydrate (MED/LC) diet (including 28g·day-1 of walnuts). After 6-months, the participants were re-randomized to moderate intense physical activity (PA+) or non-physical activity (PA-). Magnetic resonance imaging (MRI) was used to quantify changes of IMTG, abdominal sub-depots, hepatic and intermuscular fats. Results Across the 277 participants [86% men, age = 48 years, body-mass-index (BMI) = 31kg/m2, visceral fat = 33%] 86% completed the 18-m trial. At baseline, women had higher IMTG than men (3.4% vs. 2.3%, p<0.001) and increased IMTG was associated with aging and higher BMI, visceral and intermuscular fats, HbA1c%, HDL-c and leptin(p<0.05), but not with intra-hepatic fat. After 18 month of intervention and a -3 kg mean weight loss, participants significantly increased IMTG by 25%, with a distinct effect in the MED/LCPA+ group as compared to the other intervention groups (57% vs. 9.5–18.5%, p<0.05). Changes in IMTG were associated with visceral and intermuscular fat, metabolic syndrome, insulin and leptin (p<0.05 for all), however, these associations did not remain after adjustment for visceral fat changes. Conclusions Lifestyle strategies differentially affect IMTG accumulation; combination of exercise with decreased carbohydrate/increased unsaturated fat proportion intake greatly increase IMTG. Our findings suggest that increased IMTG during diet-induced moderate weight loss may not be directly related to cardiometabolic risk. Trial registration ClinicalTrials.gov NCT01530724 PMID:29190720

Sex differences in the composition of weight gain and loss in overweight and obese adults.

PubMed

Millward, D Joe; Truby, Helen; Fox, Kenneth R; Livingstone, M Barbara E; Macdonald, Ian A; Tothill, Peter

2014-03-14

Sex differences in the ratio of fat mass (FM):fat-free mass (FFM) during weight change should differentially affect the extent of weight change during energy imbalance in men and women. In the present study, we determined FM and FFM contents by dual-energy X-ray absorptiometry and calculated the P-ratios (protein energy/total energy) of excess weight and weight loss during a randomised controlled trial of four commercial weight loss regimens. Overweight and obese women (n 210) and men (n 77) were studied at baseline and at 2 and 6 months during weight loss on four dietary regimens: Dr Atkins' New Diet Revolution; The Slim-Fast Plan; Weight-Watchers programme; Rosemary Conley's Diet and Fitness Plan. At baseline, the percentage of FFM (%FFM) and P-ratios of excess weight were 40 % and 0·071 for men and 27 % and 0·039 for women. At 2 months, men had lost twice as much weight as women and three times more FFM than women, indicating higher FFM content and P-ratios of weight loss for men, 0·052, than for women, 0·029, with no dietary effects. Between 2 and 6 months, the rate at which weight was lost decreased and the %FFM of weight loss decreased to similar low levels in men (7 %) and women (5 %): i.e. P-ratios of 0·009 and 0·006, respectively, with no dietary effects. Thus, for men compared with women, there were greater FFM content and P-ratios of weight change, which could partly, but not completely, explain their greater weight loss at 2 months. However, protein-conserving adaptations occur with increasing weight loss and over time, more extensively in men, eventually eliminating any sex difference in the composition of weight loss.

Challenges of a community based pragmatic, randomised controlled trial of weight loss maintenance.

PubMed

Randell, Elizabeth; McNamara, Rachel; Shaw, Christine; Espinasse, Aude; Simpson, Sharon Anne

2015-12-18

Randomised controlled trials (RCTs) have a reputation for being inherently difficult to deliver as planned and often face unforeseen challenges and delays, particularly in relation to organisational and governance difficulties, participant interest, constraints due to allocation of costs, local investigator interest and lengthy bureaucracy. Recruitment is often difficult and the challenges faced often impact on the cost and delivery of a successful trial within the funded period. This paper reflects upon the challenges faced in delivering a pragmatic RCT of weight loss maintenance in a community setting and suggests some potential solutions. The weight loss maintenance in adults trial aimed to evaluate the impact of a 12 month, individually tailored weight maintenance intervention on BMI 3 years from randomisation. Participants were recruited primarily from participant identification centres (PICs)-GP surgeries, exercise on referral schemes and slimming world. The intervention was delivered in community settings. A recruitment strategy implementation plan was drafted to address and monitor poor recruitment. Delays in opening and recruitment were experienced early on. Some were beyond the control of the study team such as; disagreement over allocation of national health service costs and PIC classification as well as difficulties in securing support from research networks. That the intervention was delivered in community settings was often at the root of these issues. Key items to address at the design stage of future trials include feasibility of eligibility criteria. The most effective element of the recruitment implementation plan was to refocus sources of recruitment and target only those who could fulfil the eligibility criteria immediately. Learnings from this trial should be kept in mind by those designing similar studies in the future. Considering potential governance, cost and research network support implications at the design stage of pragmatic trials of any community-based complex intervention is paramount. The appropriateness and viability of inclusion criteria also require careful consideration as does use of a targeted advertising strategy. ISRCTN35774128, 12/01/2010.

Hockey Fans in Training: A Pilot Pragmatic Randomized Controlled Trial

PubMed Central

PETRELLA, ROBERT J.; GILL, DAWN P.; ZOU, GUANGYONG; DE CRUZ, ASHLEIGH; RIGGIN, BRENDAN; BARTOL, CASSANDRA; DANYLCHUK, KAREN; HUNT, KATE; WYKE, SALLY; GRAY, CINDY M.; BUNN, CHRISTOPHER; ZWARENSTEIN, MERRICK

2017-01-01

ABSTRACT Introduction Hockey Fans in Training (Hockey FIT) is a gender-sensitized weight loss and healthy lifestyle program. We investigated 1) feasibility of recruiting and retaining overweight and obese men into a pilot pragmatic randomized controlled trial and 2) potential for Hockey FIT to lead to weight loss and improvements in other outcomes at 12 wk and 12 months. Methods Male fans of two ice hockey teams (35–65 yr; body mass index ≥28 kg·m−2) located in Ontario (Canada) were randomized to intervention (Hockey FIT) or comparator (wait-list control). Hockey FIT includes a 12-wk active phase (weekly, coach-led group meetings including provision of dietary information, practice of behavior change techniques, and safe exercise sessions plus incremental pedometer walking) and a 40-wk minimally supported phase (smartphone app for sustaining physical activity, private online social network, standardized e-mails, booster session/reunion). Measurement at baseline and 12 wk (both groups) and 12 months (intervention group only) included clinical outcomes (e.g., weight) and self-reported physical activity, diet, and self-rated health. Results Eighty men were recruited in 4 wk; trial retention was >80% at 12 wk and >75% at 12 months. At 12 wk, the intervention group lost 3.6 kg (95% confidence interval, −5.26 to −1.90 kg) more than the comparator group (P < 0.001) and maintained this weight loss to 12 months. The intervention group also demonstrated greater improvements in other clinical measures, physical activity, diet, and self-rated health at 12 wk; most sustained to 12 months. Conclusions Results suggest feasible recruitment/retention of overweight and obese men in the Hockey FIT program. Results provide evidence for the potential effectiveness of Hockey FIT for weight loss and improved health in at-risk men and, thus, evidence to proceed with a definitive trial. PMID:28719494

Effects of weight management program on postural stability and neuromuscular function among obese children: study protocol for a randomized controlled trial.

PubMed

Sun, Fenghua; Wang, Li-Juan; Wang, Lin

2015-04-10

Childhood obesity is one of the most critical public health problems in the world. It is associated with low neuromuscular function and postural deformities. Whether weight loss can improve postural stability and neuromuscular control, benefit daily activities, or prevent injury is unknown. Therefore, this study attempts to investigate the effect of a 6 month weight management program on postural stability and neuromuscular control among obese children. We will conduct a prospective, single-blind, randomized controlled trial with 120 prepubescent obese children. Participants will be randomly assigned to a weight management group or a control group. The weight management group will participate in a dietary and exercise program. The control group will receive health education. After the intervention, participants will be followed for 6 months with no active intervention. The primary and secondary outcomes will be assessed at the baseline, and after 6 months and 12 months. Primary outcome measures will include body weight, body height, body mass index, waist circumference, hip circumference, and body fat percentage. Secondary outcome measures will include three-dimensional functional biomechanics in different tasks, proprioception tests of the knee and ankle, neuromuscular response of the leg muscles, and muscle strength tests of the knee and ankle. Furthermore, adverse events will be recorded and analyzed. An intention-to-treat analysis will be performed if any participants withdraw from the trial. The important features of this trial include the randomization procedures and large sample size. This study attempts to estimate the effect of weight loss intervention on outcomes, including daily life function, postural stability, and neuromuscular control in prepubescent obese children. Therefore, our results can be useful for obese children, medical staff, and healthcare decision makers. Chinese Clinical Trial Registry ChiCTR-IOB-15005874.

Does bone loss begin after weight loss ends? Results 2 years after weight loss or regain in postmenopausal women.

PubMed

Von Thun, Nancy L; Sukumar, Deeptha; Heymsfield, Steven B; Shapses, Sue A

2014-05-01

Short-term weight loss is accompanied by bone loss in postmenopausal women. The longer-term impact of weight loss on bone in reduced overweight/obese women compared with women who regained their weight was examined in this study using a case-control design. Postmenopausal women (N = 42; mean [SD] body mass index, 28.3 [2.8] kg/m; mean [SD] age, 60.7 [5.5] y) were recruited 2 years after the start of a 6-month weight loss trial; those who maintained their weight (weight loss maintainer [WL-M] group) were matched to a cohort of women who regained their weight (weight loss regainer [WL-R] group). Serum hormones and bone markers were measured in a subset. Bone mineral density (BMD) at the femoral neck, trochanter, spine, radius, and total body, and soft-tissue composition were taken at baseline, 0.5 years, and 2 years. During weight loss, both groups lost 9.3% (3.4%) of body weight, with no significant difference between the groups. After weight loss, weight change was -0.1% (2.7%) and 6.0% (3.3%) in the WL-M (n = 22) and WL-R (n = 20) groups, respectively. After 2 years, both groups lost BMD at the femoral neck and trochanter (P ≤ 0.01), whereas only the WL-M group reduced BMD at the 1/3 radius (P < 0.001). There was greater BMD loss at the trochanter (-6.8% [5.7%]) and 1/3 radius (-4.5% [3.3%]) in the WL-M group compared with the WL-R group after 2 years. Multiple linear regression showed that change in leg fat mass (but not trunk fat) contributed to trochanter BMD loss (P < 0.05). After 2 years, there is no BMD recovery of weight reduction-induced bone loss, irrespective of weight regain. These data suggest that the period after weight loss may be an important point in time to prevent bone loss for those who maintain weight and those who regain weight.

Multilevel Approach of a 1-Year Program of Dietary and Exercise Interventions on Bone Mineral Content and Density in Metabolic Syndrome – the RESOLVE Randomized Controlled Trial

PubMed Central

Courteix, Daniel; Valente-dos-Santos, João; Ferry, Béatrice; Lac, Gérard; Lesourd, Bruno; Chapier, Robert; Naughton, Geraldine; Marceau, Geoffroy; João Coelho-e-Silva, Manuel; Vinet, Agnès; Walther, Guillaume; Obert, Philippe; Dutheil, Frédéric

2015-01-01

Background Weight loss is a public health concern in obesity-related diseases such as metabolic syndrome (MetS). However, restrictive diets might induce bone loss. The nature of exercise and whether exercise with weight loss programs can protect against potential bone mass deficits remains unclear. Moreover, compliance is essential in intervention programs. Thus, we aimed to investigate the effects that modality and exercise compliance have on bone mineral content (BMC) and density (BMD). Methods We investigated 90 individuals with MetS who were recruited for the 1-year RESOLVE trial. Community-dwelling seniors with MetS were randomly assigned into three different modalities of exercise (intensive resistance, intensive endurance, moderate mixed) combined with a restrictive diet. They were compared to 44 healthy controls who did not undergo the intervention. Results This intensive lifestyle intervention (15–20 hours of training/week + restrictive diet) resulted in weight loss, body composition changes and health improvements. Baseline BMC and BMD for total body, lumbar spine and femoral neck did not differ between MetS groups and between MetS and controls. Despite changes over time, BMC or BMD did not differ between the three modalities of exercise and when compared with the controls. However, independent of exercise modality, compliant participants increased their BMC and BMD compared with their less compliant peers. Decreases in total body lean mass and negative energy balance significantly and independently contributed to decreases in lumbar spine BMC. Conclusion After the one year intervention, differences relating to exercise modalities were not evident. However, compliance with an intensive exercise program resulted in a significantly higher bone mass during energy restriction than non-compliance. Exercise is therefore beneficial to bone in the context of a weight loss program. Trial Registration ClinicalTrials.gov NCT00917917 PMID:26376093

Weight loss is associated with improvements in cognitive function among overweight and obese people: A systematic review and meta-analysis.

PubMed

Veronese, Nicola; Facchini, Silvia; Stubbs, Brendon; Luchini, Claudio; Solmi, Marco; Manzato, Enzo; Sergi, Giuseppe; Maggi, Stefania; Cosco, Theodore; Fontana, Luigi

2017-01-01

Whilst obesity is associated with a higher risk of cognitive impairment, the influence of weight loss on cognitive function in obese/overweight people is equivocal. We conducted a meta-analysis of randomized controlled trials (RCTs) and longitudinal studies evaluating the influence of voluntary weight loss on cognitive function in obese/overweight individuals. Articles were acquired from a systematic search of major databases from inception till 01/2016. A random effect meta-analysis of weight loss interventions (diet, physical activity, bariatric surgery) on different cognitive domains (memory, attention, executive functions, language and motor speed) was conducted. Twenty studies (13 longitudinal studies=551 participants; 7 RCTs=328 treated vs. 140 controls) were included. Weight loss was associated with a significant improvement in attention and memory in both longitudinal studies and RCTs, whereas executive function and language improved in longitudinal and RCT studies, respectively. In conclusion, intentional weight loss in obese/overweight people is associated with improvements in performance across various cognitive domains. Future adequately powered RCTs are required to confirm/refute these findings. Copyright © 2016 Elsevier Ltd. All rights reserved.

Vegetarian Diets and Weight Reduction: a Meta-Analysis of Randomized Controlled Trials.

PubMed

Huang, Ru-Yi; Huang, Chuan-Chin; Hu, Frank B; Chavarro, Jorge E

2016-01-01

Vegetarian diets may promote weight loss, but evidence remains inconclusive. PubMed, EMBASE and UpToDate databases were searched through September 22, 2014, and investigators extracted data regarding study characteristics and assessed study quality among selected randomized clinical trials. Population size, demographic (i.e., gender and age) and anthropometric (i.e., body mass index) characteristics, types of interventions, follow-up periods, and trial quality (Jadad score) were recorded. The net changes in body weight of subjects were analyzed and pooled after assessing heterogeneity with a random effects model. Subgroup analysis was performed based on type of vegetarian diet, type of energy restriction, study population, and follow-up period. Twelve randomized controlled trials were included, involving a total of 1151 subjects who received the intervention over a median duration of 18 weeks. Overall, individuals assigned to the vegetarian diet groups lost significantly more weight than those assigned to the non-vegetarian diet groups (weighted mean difference, -2.02 kg; 95 % confidence interval [CI]: -2.80 to -1.23). Subgroup analysis detected significant weight reduction in subjects consuming a vegan diet (-2.52 kg; 95 % CI: -3.02 to -1.98) and, to a lesser extent, in those given lacto-ovo-vegetarian diets (-1.48 kg; 95 % CI: -3.43 to 0.47). Studies on subjects consuming vegetarian diets with energy restriction (ER) revealed a significantly greater weight reduction (-2.21 kg; 95 % CI: -3.31 to -1.12) than those without ER (-1.66 kg; 95 % CI: -2.85 to -0.48). The weight loss for subjects with follow-up of <1 year was greater (-2.05 kg; 95 % CI: -2.85 to -1.25) than those with follow-up of ≥1 year (-1.13 kg; 95 % CI: -2.04 to -0.21). Vegetarian diets appeared to have significant benefits on weight reduction compared to non-vegetarian diets. Further long-term trials are needed to investigate the effects of vegetarian diets on body weight control.

Whey Protein Supplementation Enhances Body Fat and Weight Loss in Women Long After Bariatric Surgery: a Randomized Controlled Trial.

PubMed

Lopes Gomes, Daniela; Moehlecke, Milene; Lopes da Silva, Fernanda Bassan; Dutra, Eliane Said; D'Agord Schaan, Beatriz; Baiocchi de Carvalho, Kenia Mara

2017-02-01

The ideal nutritional approach for weight regain after bariatric surgery remains unclear. The objective of this study is to assess the effect of whey protein supplementation on weight loss and body composition of women who regained weight 24 or more months after bariatric surgery. This is a 16-week open-label, parallel-group, randomized controlled trial of women who regained at least 5 % of their lowest postoperative weight after a Roux-en-Y gastric bypass (RYGB). A total of 34 participants were treated with hypocaloric diet and randomized (1:1) to receive or not supplementation with whey protein, 0.5 g/kg of the ideal body weight. The primary outcomes were changes in body weight, fat free mass (FFM), and fat mass (FM), evaluated by tetrapolar bioelectrical impedance analysis (BIA). Secondary outcomes included resting energy expenditure, blood glucose, lipids, adiponectin, interleukin 6 (IL-6), and cholecystokinin levels. Statistical analyses included generalized estimating equations adjusted for age and physical activity. Fifteen patients in each group were evaluated: mean age was 45 ± 11 years, body mass index (BMI) was 35.7 ± 5.2 kg/m 2 , and time since surgery was 69 ± 23 months. Protein intake during follow-up increased by approximately 75 % in the intervention group (p = 0.01). The intervention group presented more body weight loss (1.86 kg, p = 0.017), accounted for FM loss (2.78, p = 0.021) and no change in FFM, as compared to controls (gain of 0.42 kg of body weight and 0.6 kg of FM). No differences in secondary outcomes were observed between groups. Whey protein supplementation promoted body weight and FM loss in women with long-term weight regain following RYGB.

Allelic Variants of Melanocortin 3 Receptor Gene (MC3R) and Weight Loss in Obesity: A Randomised Trial of Hypo-Energetic High- versus Low-Fat Diets

PubMed Central

Santos, José L.; De la Cruz, Rolando; Holst, Claus; Grau, Katrine; Naranjo, Carolina; Maiz, Alberto; Astrup, Arne; Saris, Wim H. M.; MacDonald, Ian; Oppert, Jean-Michel; Hansen, Torben; Pedersen, Oluf; Sorensen, Thorkild I. A.; Martinez, J. Alfredo

2011-01-01

Introduction The melanocortin system plays an important role in energy homeostasis. Mice genetically deficient in the melanocortin-3 receptor gene have a normal body weight with increased body fat, mild hypophagia compared to wild-type mice. In humans, Thr6Lys and Val81Ile variants of the melanocortin-3 receptor gene (MC3R) have been associated with childhood obesity, higher BMI Z-score and elevated body fat percentage compared to non-carriers. The aim of this study is to assess the association in adults between allelic variants of MC3R with weight loss induced by energy-restricted diets. Subjects and Methods This research is based on the NUGENOB study, a trial conducted to assess weight loss during a 10-week dietary intervention involving two different hypo-energetic (high-fat and low-fat) diets. A total of 760 obese patients were genotyped for 10 single nucleotide polymorphisms covering the single exon of MC3R gene and its flanking regions, including the missense variants Thr6Lys and Val81Ile. Linear mixed models and haplotype-based analysis were carried out to assess the potential association between genetic polymorphisms and differential weight loss, fat mass loss, waist change and resting energy expenditure changes. Results No differences in drop-out rate were found by MC3R genotypes. The rs6014646 polymorphism was significantly associated with weight loss using co-dominant (p = 0.04) and dominant models (p = 0.03). These p-values were not statistically significant after strict control for multiple testing. Haplotype-based multivariate analysis using permutations showed that rs3827103–rs1543873 (p = 0.06), rs6014646–rs6024730 (p = 0.05) and rs3746619–rs3827103 (p = 0.10) displayed near-statistical significant results in relation to weight loss. No other significant associations or gene*diet interactions were detected for weight loss, fat mass loss, waist change and resting energy expenditure changes. Conclusion The study provided overall sufficient evidence to support that there is no major effect of genetic variants of MC3R and differential weight loss after a 10-week dietary intervention with hypo-energetic diets in obese Europeans. PMID:21695122

Evaluation of early weight loss thresholds for identifying nonresponders to an intensive lifestyle intervention.

PubMed

Unick, Jessica L; Hogan, Patricia E; Neiberg, Rebecca H; Cheskin, Lawrence J; Dutton, Gareth R; Evans-Hudnall, Gina; Jeffery, Robert; Kitabchi, Abbas E; Nelson, Julie A; Pi-Sunyer, F Xavier; West, Delia Smith; Wing, Rena R

2014-07-01

Weight losses in lifestyle interventions are variable, yet prediction of long-term success is difficult. The utility of using various weight loss thresholds in the first 2 months of treatment for predicting 1-year outcomes was examined. Participants included 2327 adults with type 2 diabetes (BMI:35.8 ± 6.0) randomized to the intensive lifestyle intervention (ILI) of the Look AHEAD trial. ILI included weekly behavioral sessions designed to increase physical activity and reduce caloric intake. 1-month, 2-month, and 1-year weight changes were calculated. Participants failing to achieve a ≥2% weight loss at Month 1 were 5.6 (95% CI:4.5, 7.0) times more likely to also not achieve a ≥10% weight loss at Year 1, compared to those losing ≥2% initially. These odds were increased to 11.6 (95% CI:8.6, 15.6) when using a 3% weight loss threshold at Month 2. Only 15.2% and 8.2% of individuals failing to achieve the ≥2% and ≥3% thresholds at Months 1 and 2, respectively, go on to achieve a ≥10% weight loss at Year 1. Given the association between initial and 1-year weight loss, the first few months of treatment may be an opportune time to identify those who are unsuccessful and utilize rescue efforts. clinicaltrials.gov Identifier: NCT00017953. © 2014 The Obesity Society.

MILEPOST Multicenter Randomized Controlled Trial: 12-Month Weight Loss and Satiety Outcomes After pose SM vs. Medical Therapy.

PubMed

Miller, Karl; Turró, R; Greve, J W; Bakker, C M; Buchwald, J N; Espinós, J C

2017-02-01

Pose SM is an endolumenal weight-loss intervention in which suture anchors are placed endoscopically in the gastric fundus/distal gastric body. Observational studies of pose have shown safe, effective weight loss. Twelve-month results of a randomized controlled trial comparing weight loss and satiety after pose vs. conventional medical therapy are reported. Subjects with classes I-II obesity were randomized in a 3:1 ratio to pose or diet/exercise guidance only (control). Pose subjects received gastric fundus and distal body suture-anchor plications with diet/exercise counseling. Total body (%TBWL) and excess weight loss (%EWL) were assessed at 6 and 12 months. Analysis of covariance (ANCOVA) was used to analyze 12-month %TBWL. Satiety changes were assessed at 6 and 12 months. From November 2013 to July 2014, 44 subjects were randomized (34, 77.3 % female; mean age, 38.3 ± 10.7 years; body mass index, 36.5 ± 3.4 kg/m 2 ) to pose (n = 34) or control (n = 10) groups in three centers. Mean pose procedure time was 51.8 ± 14.5 min; pose subjects received a mean 8.8 ± 1.3 fundal and 4.2 ± 0.7 distal body plications. Twelve-month TBWL: pose, 13.0 % (EWL, 45.0 %), n = 30 vs. control group, 5.3 % (18.1 %), n = 9; significant mean difference, 7.7 % (95 % CI 2.2, 13.2; p < 0.01). Pose subjects showed significant reductions in satiety parameters (p < 0.001); controls experienced reduced caloric intake and satiety volume (p < 0.05). No serious device- or procedure-related adverse events occurred. In a randomized controlled trial at 12 months, pose-treated subjects had significantly greater weight loss than those treated with diet/exercise guidance alone. At 6 and 12 months, pose subjects showed significant reduction in satiety parameters. clinicaltrials.gov identifier # NCT01843231.

Consumers' salient beliefs regarding dairy products in the functional food era: a qualitative study using concepts from the theory of planned behaviour.

PubMed

Nolan-Clark, Deborah J; Neale, Elizabeth P; Probst, Yasmine C; Charlton, Karen E; Tapsell, Linda C

2011-11-03

Inadequate consumption of dairy products without appropriate dietary substitution may have deleterious health consequences. Social research reveals the factors that may impede compliance with dietary recommendations. This is particularly important given the recent introduction of functional dairy products. One of the challenges for public health professionals is to demonstrate the efficacy of nutrition education in improving attitudes toward nutrient rich foods. The aim of this study was to explore the salient beliefs of adult weight loss trial participants regarding both traditional and functional dairy products and to compare these with a control group not exposed to nutrition education. Six focus groups were conducted, three with weight loss trial completers (n = 15) that had received nutrition education and three with individuals from the same region (n = 14) to act as controls. Transcribed focus groups were coded using the Theory of Planned Behaviour theoretical framework. Non-trial participants perceived dairy foods as weight inducing and were sceptical of functional dairy products. A lack of time/ability to decipher dairy food labels was also discussed by these individuals. In contrast trial participants discussed several health benefits related to dairy foods, practised label reading and were confident in their ability to incorporate dairy foods into their diet. Normative beliefs expressed were similar for both groups indicating that these were more static and less amenable to change through nutrition education than control and behavioural beliefs. Nutrition education provided as a result of weight loss trial participation influenced behavioural and control beliefs relating to dairy products. This study provides a proof of concept indication that nutrition education may improve attitudes towards dairy products and may thus be an important target for public health campaigns seeking to increase intake of this food group.

The effect of macronutrients on glycaemic control: a systematic review of dietary randomised controlled trials in overweight and obese adults with type 2 diabetes in which there was no difference in weight loss between treatment groups.

PubMed

Emadian, Amir; Andrews, Rob C; England, Clare Y; Wallace, Victoria; Thompson, Janice L

2015-11-28

Weight loss is crucial for treating type 2 diabetes mellitus (T2DM). It remains unclear which dietary intervention is best for optimising glycaemic control, or whether weight loss itself is the main reason behind observed improvements. The objective of this study was to assess the effects of various dietary interventions on glycaemic control in overweight and obese adults with T2DM when controlling for weight loss between dietary interventions. A systematic review of randomised controlled trials (RCT) was conducted. Electronic searches of Medline, Embase, Cinahl and Web of Science databases were conducted. Inclusion criteria included RCT with minimum 6 months duration, with participants having BMI≥25·0 kg/m2, a diagnosis of T2DM using HbA1c, and no statistically significant difference in mean weight loss at the end point of intervention between dietary arms. Results showed that eleven studies met the inclusion criteria. Only four RCT indicated the benefit of a particular dietary intervention over another in improving HbA1c levels, including the Mediterranean, vegan and low glycaemic index (GI) diets. However the findings from one of the four studies showing a significant benefit are questionable because of failure to control for diabetes medications and poor adherence to the prescribed diets. In conclusion there is currently insufficient evidence to suggest that any particular diet is superior in treating overweight and obese patients with T2DM. Although the Mediterranean, vegan and low-GI diets appear to be promising, further research that controls for weight loss and the effects of diabetes medications in larger samples is needed.

The effects of exercise training in a weight loss lifestyle intervention on asthma control, quality of life and psychosocial symptoms in adult obese asthmatics: protocol of a randomized controlled trial.

PubMed

Freitas, Patricia D; Ferreira, Palmira G; da Silva, Analuci; Trecco, Sonia; Stelmach, Rafael; Cukier, Alberto; Carvalho-Pinto, Regina; Salge, João Marcos; Fernandes, Frederico L A; Mancini, Marcio C; Martins, Milton A; Carvalho, Celso R F

2015-10-21

Asthma and obesity are public health problems with increasing prevalence worldwide. Clinical and epidemiologic studies have demonstrated that obese asthmatics have worse clinical control and health related quality of life (HRQL) despite an optimized medical treatment. Bariatric surgery is successful to weight-loss and improves asthma control; however, the benefits of nonsurgical interventions remain unknown. This is a randomized controlled trial with 2-arms parallel. Fifty-five moderate or severe asthmatics with grade II obesity (BMI ≥ 35 kg/m(2)) under optimized medication will be randomly assigned into either weight-loss program + sham (WL + S group) or weight-loss program + exercise (WL + E group). The weight loss program will be the same for both groups including nutrition and psychological therapies (every 15 days, total of 6 sessions, 60 min each). Exercise program will include aerobic and resistance muscle training while sham treatment will include a breathing and stretching program (both programs twice a week, 3 months, 60 min each session). The primary outcome variable will be asthma clinical control. Secondary outcomes include HRQL, levels of depression and anxiety, lung function, daily life physical activity, body composition, maximal aerobic capacity, strength muscle and sleep disorders. Potential mechanism (changes in lung mechanical and airway/systemic inflammation) will also be examined to explain the benefits in both groups. This study will bring a significant contribution to the literature evaluating the effects of exercise conditioning in a weight loss intervention in obese asthmatics as well as will evaluate possible involved mechanisms. NCT02188940.

A double-blind, placebo-controlled randomized trial of creatine for the cancer anorexia/weight loss syndrome (N02C4): an Alliance trial.

PubMed

Jatoi, A; Steen, P D; Atherton, P J; Moore, D F; Rowland, K M; Le-Lindqwister, N A; Adonizio, C S; Jaslowski, A J; Sloan, J; Loprinzi, C

2017-08-01

Multiple pilot studies, including one in colorectal cancer patients, suggest that creatine, an amino acid derivative, augments muscle, improves strength, and thereby could palliate the cancer anorexia/weight loss syndrome. In this randomized, double-blind, placebo-controlled trial, incurable patients with this syndrome were assigned creatine (20 g/day load×5 days followed by 2 g/day orally) versus identical placebo. Patients were weighed once a week for 1 month and then monthly. Patients were also assessed over 1 month for appetite and quality of life (validated questionnaires), fist grip strength, body composition (bioelectrical impedance), and adverse events. The primary endpoint was 10% or greater weight gain from baseline during the first month. Within this combined cohort of 263 evaluable patients (134 received creatine and 129 placebo), only 3 gained ≥10% of their baseline weight by 1 month: two creatine-treated and the other placebo-exposed (P = 1.00). Questionnaire data on appetite, quality of life, and activities of daily living showed no statistically significant differences between groups. Similarly, no statistically significant differences between groups were observed for fist-grip strength or body composition. Rates and severity of adverse events were comparable between groups. Finally, a median survival of 230 and 239 days were observed in the creatine and placebo groups, respectively (P = 0.70). Creatine, as prescribed in this trial, had no effect on the cancer anorexia/weight loss syndrome. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

A systematic review of the interrelation between diet- and surgery-induced weight loss and vitamin D status.

PubMed

Himbert, Caroline; Ose, Jennifer; Delphan, Mahmoud; Ulrich, Cornelia M

2017-02-01

Obesity is a major global health problem and has been associated with vitamin D deficiency. Intentional weight loss may alter vitamin D status and, conversely, vitamin D supplementation has been hypothesized to aid in weight loss. A systematic literature search in PubMed/Medline identified 3173 articles of which 37 studies (randomized controlled trials (RCT) [n=17], non-RCTs [n=20]) are summarized as effect of: (I) diet-induced weight loss on vitamin D status (n=7), (II) vitamin D supplementation on diet-induced weight loss (n=11), (III) surgery-induced weight loss on vitamin D status (n=15), and (IV) vitamin D supplementation after surgery-induced weight loss on vitamin D status (n=5). While all studies on the effect of diet-induced weight loss on vitamin D status have consistently reported increased vitamin D levels, the targeted percentage of weight loss that is necessary for an increase has varied between 5% and >10%. N=11 RCTs testing the effect of vitamin D supplementation observe that vitamin D supplementation does not result in increased weight loss, but may affect body fat loss. Vitamin D deficiency and subsequent hyperparathyroidism have been detected in post-surgery patients, and there is evidence that vitamin D supplementation improves these post-surgery complications. We review the current evidence addressing the role of vitamin D status and supplementation in diet- and surgery-induced weight loss. Subsequently, we highlight gaps in current research and suggest directions for future research including differences in vitamin D supplementation dosages, indoor vs. outdoor exercise, and the assessment of vitamin D status in different body pools. Published by Elsevier Inc.

Building research in diet and cognition: The BRIDGE randomized controlled trial.

PubMed

Tussing-Humphreys, Lisa; Lamar, Melissa; Blumenthal, James A; Babyak, Michael; Fantuzzi, Giamila; Blumstein, Lara; Schiffer, Linda; Fitzgibbon, Marian L

2017-08-01

Obesity has been linked to cognitive impairment, cognitive decline and dementia. Given that 38.5% of U.S. adults 60years and older are obese and these numbers are rapidly increasing, strategies to decouple obesity from cognitive decline are needed. Innovative lifestyle strategies that may postpone the onset of subclinical symptoms or even arrest the transition to overt dementia in at-risk individuals are critically needed. Poor diet is central to the development of obesity and diet may affect cognition. Adherence to a Mediterranean Diet (MedDiet) is associated with reduced risk of cognitive impairment and dementia. Furthermore, weight loss through caloric restriction improves cognitive function. This paper describes the Building Research in Diet and CoGnition (BRIDGE) study, a randomized trial examining the effect of the MedDiet, with and without weight loss, on cognitive functioning in obese older adults. Obese (BMI≥30 and ≤50kg/m 2 ) older adults (≥55years) (n=180) will be randomized in a 2:2:1 allocation scheme to: Typical Diet Control; MedDiet alone, without weight loss; or MedDiet lifestyle intervention to promote weight loss and weight loss maintenance. Both MedDiet intervention groups will meet for one individual session and 27 group sessions over an 8-month period. Individuals in the control group will not receive instruction on changing lifestyle habits. Outcomes will be assessed at baseline, 8 and 14months. The primary outcome is cognitive functioning; secondary outcomes will include changes in body weight, diet, cardiovascular, metabolic, and inflammatory biomarkers. Copyright © 2017. Published by Elsevier Inc.

A structured diet and exercise program promotes favorable changes in weight loss, body composition, and weight maintenance.

PubMed

Kreider, Richard B; Serra, Monica; Beavers, Kristen M; Moreillon, Jen; Kresta, Julie Y; Byrd, Mike; Oliver, Jonathan M; Gutierrez, Jean; Hudson, Geoffrey; Deike, Erika; Shelmadine, Brian; Leeke, Patricia; Rasmussen, Chris; Greenwood, Mike; Cooke, Matthew B; Kerksick, Chad; Campbell, Jessica K; Beiseigel, Jeannemarie; Jonnalagadda, Satya S

2011-06-01

A number of diet and exercise programs purport to help promote and maintain weight loss. However, few studies have compared the efficacy of different methods. To determine whether adherence to a meal-replacement-based diet program (MRP) with encouragement to increase physical activity is as effective as following a more structured meal-plan-based diet and supervised exercise program (SDE) in sedentary obese women. Randomized comparative effectiveness trial. From July 2007 to October 2008, 90 obese and apparently healthy women completed a 10-week university-based weight loss trial while 77 women from this cohort also completed a 24-week weight maintenance phase. Participants were matched and randomized to participate in an MRP or SDE program. Weight loss, health, and fitness-related data were assessed at 0 and 10 weeks on all subjects as well as at 14, 22, and 34 weeks on participants who completed the weight maintenance phase. Data were analyzed by multivariate analysis of variance for repeated measures. During the 10-week weight loss phase, moderate and vigorous physical activity levels were significantly higher in the SDE group with no differences observed between groups in daily energy intake. The SDE group lost more weight (-3.1 ± 3.7 vs -1.6 ± 2.5 kg; P = 0.03); fat mass (-2.3 ± 3.5 vs -0.9 ± 1.6 kg; P = 0.02); centimeters from the hips (-4.6 ± 7 vs -0.2 ± 6 cm; P = 0.002) and waist (-2.9 ± 6 vs -0.6 ± 5 cm; P = 0.05); and, experienced a greater increase in peak aerobic capacity than participants in the MRP group. During the 24-week maintenance phase, participants in the SDE group maintained greater moderate and vigorous physical activity levels, weight loss, fat loss, and saw greater improvement in maximal aerobic capacity and strength. In sedentary and obese women, an SDE-based program appears to be more efficacious in promoting and maintaining weight loss and improvements in markers of health and fitness compared to an MRP type program with encouragement to increase physical activity. Copyright © 2011 American Dietetic Association. Published by Elsevier Inc. All rights reserved.

Narrative review of yoga intervention clinical trials including weight-related outcomes.

PubMed

Rioux, Jennifer Grace; Ritenbaugh, Cheryl

2013-01-01

Medical authorities have identified obesity as a causal factor in the development of diabetes, hypertension, and cardiovascular disease (CVD), and more broadly, of metabolic syndrome/insulin resistance syndrome. To provide solutions that can modify this risk factor, researchers need to identify methods of effective risk reduction and primary prevention of obesity. Research on the effectiveness of yoga as a treatment for obesity is limited, and studies vary in overall quality and methodological rigor. This narrative review assessed the quantity and quality of clinical trials of yoga as an intervention for weight loss or as a means of risk reduction or treatment for obesity and diseases in which obesity is a causal factor. This review summarized the studies' research designs and evaluated the efficacy of yoga for weight loss via the current evidence base. The research team evaluated published studies to determine the appropriateness of research designs, comparability of programs' intervention elements, and standardization of outcome measures. The research team's literature search used the key terms yoga and obesity or yoga and weight loss in three primary medical-literature databases (PubMed, PsychInfo, and Web of Science). The study excluded clinical trials with no quantitative obesity related measure. Extracted data included each study's (1) design; (2) setting and population; (3) nature, duration, and frequency of interventions; (4) comparison groups; (5) recruitment strategies; (6) outcome measures; (7) data analysis and presentation; and (8) results and conclusions. The research team developed an overall evaluation parameter to compare disparate trials. The research team reviewed each study to determine its key features, each worth a specified number of points, with a maximum total of 20 points. The features included a study's (1) duration, (2) frequency of yoga practice, (3) intensity of (length of) each practice, (4) number of yogic elements, (5) inclusion of dietary modification, (6) inclusion of a residential component, (7) the number of weight-related outcome measures, and (8) a discussion of the details of the yogic elements. Overall, therapeutic yoga programs are frequently effective in promoting weight loss and/or improvements in body composition. The effectiveness of yoga for weight loss is related to the following key features: (1) an increased frequency of practice; (2) a longer intervention duration (3) a yogic dietary component; (4) a residential component; (5) the comprehensive inclusion of yogic components; (5) and a home-practice component. Yoga appears to be an appropriate and potentially successful intervention for weight maintenance, prevention of obesity, and risk reduction for diseases in which obesity plays a significant causal role.

One-year changes in symptoms of depression and weight in overweight/obese individuals with type 2 diabetes in the look AHEAD study

USDA-ARS?s Scientific Manuscript database

Depressed individuals are frequently excluded from weight loss trials because of fears that weight reduction may precipitate mood disorders, as well as concerns that depressed participants will not lose weight satisfactorily. The present study examined participants in the Look AHEAD study to determi...

One-year changes in symptoms of depression and weight in overweight/obese individuals with type 2 diabetes in the Look AHEAD study

USDA-ARS?s Scientific Manuscript database

Depressed individuals are frequently excluded from weight loss trials because of fears that weight reduction may precipitate mood disorders, as well as concerns that depressed participants will not lose weight satisfactorily. The present study examined participants in the Look AHEAD study to determi...

A High-Carbohydrate, High-Fiber, Low-Fat Diet Results in Weight Loss among Adults at High Risk of Type 2 Diabetes.

PubMed

Sylvetsky, Allison C; Edelstein, Sharon L; Walford, Geoffrey; Boyko, Edward J; Horton, Edward S; Ibebuogu, Uzoma N; Knowler, William C; Montez, Maria G; Temprosa, Marinella; Hoskin, Mary; Rother, Kristina I; Delahanty, Linda M

2017-11-01

Background: Weight loss is a key factor in reducing diabetes risk. The Diabetes Prevention Program (DPP) is a completed clinical trial that randomly assigned individuals at high risk of diabetes to a placebo (PLBO), metformin (MET), or intensive lifestyle intervention (ILS) group, which included physical activity (PA) and reduced dietary fat intake. Objective: We aimed to evaluate the associations between diet and weight at baseline and to identify specific dietary factors that predicted weight loss among DPP participants. Methods: Diet was assessed by a food frequency questionnaire. The associations between intakes of macronutrients and various food groups and body weight among DPP participants at baseline were assessed by linear regression, adjusted for race/ethnicity, age, sex, calorie intake, and PA. Models that predicted weight loss at year 1 were adjusted for baseline weight, change in calorie intake, and change in PA and stratified by treatment allocation (MET, ILS, and PLBO). All results are presented as estimates ± SEs. Results: A total of 3234 participants were enrolled in the DPP; 2924 had completed dietary data (67.5% women; mean age: 50.6 ± 10.7 y). Adjusted for calorie intake, baseline weight was negatively associated with carbohydrate intake (-1.14 ± 0.18 kg body weight/100 kcal carbohydrate, P < 0.0001) and, specifically, dietary fiber (-1.26 ± 0.28 kg/5 g fiber, P < 0.0001). Baseline weight was positively associated with total fat (1.25 ± 0.21 kg/100 kcal, P < 0.0001), saturated fat (1.96 ± 0.46 kg/100 kcal, P < 0.0001), and protein (0.21 ± 0.05 kg/100 kcal, P < 0.0001). For all groups, weight loss after 1 y was associated with increases in carbohydrate intake, specifically dietary fiber, and decreases in total fat and saturated fat intake. Conclusions: Higher carbohydrate consumption among DPP participants, specifically high-fiber carbohydrates, and lower total and saturated fat intake best predicted weight loss when adjusted for changes in calorie intake. Our results support the benefits of a high-carbohydrate, high-fiber, low-fat diet in the context of overall calorie reduction leading to weight loss, which may prevent diabetes in high-risk individuals. This trial was registered at clinicaltrials.gov as NCT00004992. © 2017 American Society for Nutrition.

Describing patterns of weight changes using principal components analysis: results from the Action for Health in Diabetes (Look AHEAD) research group.

PubMed

Espeland, Mark A; Bray, George A; Neiberg, Rebecca; Rejeski, W Jack; Knowler, William C; Lang, Wei; Cheskin, Lawrence J; Williamson, Don; Lewis, C Beth; Wing, Rena

2009-10-01

To demonstrate how principal components analysis can be used to describe patterns of weight changes in response to an intensive lifestyle intervention. Principal components analysis was applied to monthly percent weight changes measured on 2,485 individuals enrolled in the lifestyle arm of the Action for Health in Diabetes (Look AHEAD) clinical trial. These individuals were 45 to 75 years of age, with type 2 diabetes and body mass indices greater than 25 kg/m(2). Associations between baseline characteristics and weight loss patterns were described using analyses of variance. Three components collectively accounted for 97.0% of total intrasubject variance: a gradually decelerating weight loss (88.8%), early versus late weight loss (6.6%), and a mid-year trough (1.6%). In agreement with previous reports, each of the baseline characteristics we examined had statistically significant relationships with weight loss patterns. As examples, males tended to have a steeper trajectory of percent weight loss and to lose weight more quickly than women. Individuals with higher hemoglobin A(1c) (glycosylated hemoglobin; HbA(1c)) tended to have a flatter trajectory of percent weight loss and to have mid-year troughs in weight loss compared to those with lower HbA(1c). Principal components analysis provided a coherent description of characteristic patterns of weight changes and is a useful vehicle for identifying their correlates and potentially for predicting weight control outcomes.

Behavioral and pharmacologic therapies for obesity

PubMed Central

Vetter, Marion L.; Faulconbridge, Lucy F.; Webb, Victoria L.; Wadden, Thomas A.

2011-01-01

This article reviews novel developments in the behavioral and pharmacologic treatment of obesity and explores the potential contribution of genomics research to weight control. A comprehensive program of lifestyle modification, comprised of diet, physical activity and behavior therapy, induces a mean loss of 7–10% of initial weight in individuals with obesity. Two trials demonstrated that weight loss of this magnitude, combined with increased physical activity, substantially reduced the risk of developing type 2 diabetes mellitus in individuals with impaired glucose tolerance. A third trial is now investigating whether a lifestyle intervention will reduce cardiovascular morbidity and mortality in overweight individuals who already have diabetes mellitus. Pharmacotherapy is recommended, in some patients, as an adjunct to lifestyle modification. Two medications—orlistat and sibutramine—are currently approved in the US for long-term weight loss. Both are efficacious when combined with lifestyle modification, although health concerns have been raised about the use of sibutramine. Several novel combination therapies, which target multiple hypothalamic pathways that regulate appetite and body weight, are currently under investigation. Genomic studies provide further evidence for the role of these pathways in the regulation of body weight. Identification of new genes controlling satiety and energy expenditure may yield valuable clues for the development of novel pharmacologic treatments. PMID:20680034

ANP system activity predicts variability of fat mass reduction and insulin sensitivity during weight loss.

PubMed

Brachs, Maria; Wiegand, Susanna; Leupelt, Verena; Ernert, Andrea; Kintscher, Ulrich; Jumpertz von Schwarzenberg, Reiner; Decker, Anne-Marie; Bobbert, Thomas; Hübner, Norbert; Chen, Wei; Krude, Heiko; Spranger, Joachim; Mai, Knut

2016-06-01

In weight loss trials, a considerable inter-individual variability in reduction of fat mass and changes of insulin resistance is observed, even under standardized study conditions. The underlying mechanisms are not well understood. Given the metabolic properties of the atrial natriuretic peptide (ANP) system, we hypothesized that ANP signaling might be involved in this phenomenon by changes of ANP secretion or receptor balance. Therefore, we investigated the impact of systemic, adipose and myocellular ANP system on metabolic and anthropometric improvements during weight loss. We comprehensively investigated 143 subjects (31 male, 112 female) before and after a 3 month-standardized weight loss program. The time course of BMI, fat mass, insulin sensitivity, circulating mid-regional proANP (MR-proANP) levels as well as adipose and myocellular natriuretic receptor A (NPR-A) and C (NPR-C) mRNA expression were investigated. BMI decreased by -12.6±3.7%. This was accompanied by a remarkable decrease of adipose NPR-C expression (1005.0±488.4 vs. 556.7±465.6; p<0.001) as well as a tendency towards increased adipose NPR-A expression (4644.7±946.8 vs. 4877.6±869.8; p=0.051). Weight loss induced changes in NPR-C (ΔNPR-C) was linked to relative reduction of total fat mass (ΔFM) (r=0.281; p<0.05), reduction of BMI (r=0.277; p<0.01), and increase of free fatty acids (ΔFFA) (r=-0.258; p<0.05). Basal NPR-C expression and weight loss induced ΔNPR-C independently explained 22.7% of ΔFM. In addition, ΔMR-proANP was independently associated with improvement of insulin sensitivity (standardized ß=0.246, p<0.01). ANP receptor expression predicted the degree of weight loss induced fat mass reduction. Our comprehensive human data support that peripheral ANP signalling is involved in control of adipose tissue plasticity and function during weight loss. (Funded by the Deutsche Forschungsgemeinschaft (KFO281/2), the Berlin Institute of Health (BIH) and the German Centre for Cardiovascular Research (DZHK/BMBF); ClinicalTrials.gov number: NCT00850629). Copyright © 2016 Elsevier Inc. All rights reserved.

Effect of nandrolone decanoate therapy on weight and lean body mass in HIV-infected women with weight loss: a randomized, double-blind, placebo-controlled, multicenter trial.

PubMed

Mulligan, Kathleen; Zackin, Robert; Clark, Rebecca A; Alston-Smith, Beverly; Liu, Tun; Sattler, Fred R; Delvers, Thomas B; Currier, Judith S

2005-03-14

Weight loss is associated with accelerated mortality and disease progression in patients with human immunodeficiency virus (HIV) infection. Although studies have examined a variety of anabolic therapies in HIV-infected men, the safety and efficacy of such treatments in women have not been adequately studied. In this randomized, double-blind, placebo-controlled, multicenter, phase I/II study, 38 HIV-infected women with documented weight loss of 5% or greater in the preceding year or a body mass index of less than 20 kg/m(2) were randomized to receive nandrolone decanoate (100 mg) or an equivalent volume of placebo every other week by intramuscular injection. Subjects received blinded treatment for 12 weeks, followed by open-label therapy for 12 weeks. Lean body mass and fat (bioelectrical impedance analysis) and weight were measured at baseline and at weeks 6, 12, 18, and 24. Biochemical assessments of safety (hematologic analyses, liver function tests, and sex hormone measurements) were performed at these same time points. Clinical signs and symptoms were monitored biweekly. Subjects randomized to receive nandrolone had significant increases in weight and lean body mass during blinded treatment (4.6 kg [9.0%] and 3.5 kg [8.6%], respectively; P<.001 vs baseline and placebo in each case). Fat mass did not change statistically significantly in either group. Although there were no statistically significant differences between groups in biochemical measures, the number of grade 3 or greater toxicities, or reports of virilizing effects, a full assessment of safety cannot be made in a trial of this size. Nandrolone decanoate therapy may prove to be generally safe and beneficial in reversing weight loss and lean tissue loss in women with HIV infection and other chronic catabolic diseases.

The Dietary Intervention to Enhance Tracking with mobile (DIET Mobile) study: A six-month randomized weight loss trial

PubMed Central

Turner-McGrievy, Gabrielle M.; Wilcox, Sara; Boutté, Alycia; Hutto, Brent E.; Singletary, Camelia; Muth, Eric R.; Hoover, Adam

2017-01-01

Objective To examine the use of two different mobile diet self-monitoring methods for weight loss. Methods Overweight adults (n=81; mean BMI 34.7±5.6 kg/m2) were randomized to self-monitor their diet with a mobile app (App, n=42) or wearable Bite Counter device (Bite, n=39). Both groups received the same behavioral weight loss information via twice weekly podcasts. Weight, physical activity (International Physical Activity Questionnaire), and energy intake (2 dietary recalls) were assessed at 0, 3, and 6 months. Results At six months, 75% of participants completed the trial. The App group lost significantly more weight (-6.8±0.8 kg) than the Bite group (-3.0±0.8 kg; group×time interaction: P<0.001). Changes in energy intake (-621±157 App, -456±167 Bite; P=0.47) or number of days diet was tracked (90.7±59.2 App, 68.4±61.2 Bite; P=0.09) did not differ between groups, but the Bite group had significant increases in physical activity METs min/wk (+2015.4±684.6; P=0.02) compared to little change in the App group (-136.5±630.6; P=0.02). Total weight loss was significantly correlated with number of podcasts downloaded (r=-0.33, P<0.01) and number of days diet was tracked (r=-0.33, P<0.01). Conclusions While frequency of diet tracking was similar between the App and Bite groups, there was greater weight loss observed in the App group. PMID:28600833

Thyroid Hormones and Changes in Body Weight and Metabolic Parameters in Response to Weight-Loss Diets: The POUNDS LOST Trial

PubMed Central

Liu, Gang; Liang, Liming; Bray, George A.; Qi, Lu; Hu, Frank B.; Rood, Jennifer; Sacks, Frank M.; Sun, Qi

2017-01-01

Background The role of thyroid hormones in diet-induced weight loss and subsequent weight regain is largely unknown. Objectives To examine the associations between thyroid hormones and changes in body weight and resting metabolic rate (RMR) in a diet-induced weight-loss setting. Subjects/Methods Data analysis was conducted among 569 overweight and obese participants aged 30–70 years with normal thyroid function participating in the 2-year POUNDS LOST randomized clinical trial. Changes in body weight and RMR were assessed during the 2-year intervention. Thyroid hormones (free triiodothyronine [T3], free thyroxine [T4], total T3, total T4, and thyroid stimulating hormone [TSH]), anthropometric measurements, and biochemical parameters were assessed at baseline, 6 months, and 24 months. Results Participants lost an average of 6.6 kg of body weight during the first 6 months and subsequently regained an average of 2.7 kg of body weight over the remaining period from 6–24 months. Baseline free T3 and total T3 were positively associated, whereas free T4 was inversely associated, with baseline body weight, body mass index, and RMR. Total T4 and TSH were not associated with these parameters. Higher baseline free T3 and free T4 levels were significantly associated with a greater weight loss during the first 6 months (P<0.05) after multivariate adjustments including dietary intervention groups and baseline body weight. Comparing extreme tertiles, the multivariate-adjusted weight loss ± standard error was −3.87±0.9 vs −5.39±0.9 kg for free T3 (P trend=0.02) and −4.09±0.9 vs −5.88±0.9 kg for free T4 (P trend=0.004). The thyroid hormones did not predict weight regain in 6–24 months. A similar pattern of associations was also observed between baseline thyroid hormones and changes in RMR. In addition, changes in free T3 and total T3 levels were positively associated with changes in body weight, RMR, body fat mass, blood pressure, glucose, insulin, triglycerides, and leptin at 6 months and 24 months (all P<0.05). Conclusions In this diet-induced weight-loss setting, higher baseline free T3 and free T4 predicted more weight loss, but not weight regain among overweight and obese adults with normal thyroid function. These findings reveal a novel role of thyroid hormones in body weight regulation and may help identify individuals more responsive to weight-loss diets. PMID:28138133

Diet or exercise, or both, for weight reduction in women after childbirth.

PubMed

Amorim Adegboye, Amanda R; Linne, Yvonne M

2013-07-23

Weight retention after pregnancy may contribute to obesity. It is known that diet and exercise are recommended components of any weight loss programme in the general population. However, strategies to achieve healthy body weight among postpartum women have not been adequately evaluated. The objectives of this review were to evaluate the effect of diet, exercise or both for weight reduction in women after childbirth, and to assess the impact of these interventions on maternal body composition, cardiorespiratory fitness, breastfeeding performance and other child and maternal outcomes. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 January 2012) and LILACS (31 January 2012). We scanned secondary references and contacted experts in the field. We updated the search of the Cochrane Pregnancy and Childbirth Group's Trials Register on 30 April 2013 and added the results to the awaiting classification section of the review. All published and unpublished randomised controlled trials (RCTs) and quasi-randomised trials of diet or exercise or both, among women during the postpartum period. Both review authors independently assessed trial quality and extracted data. Results are presented using risk ratio (RR) for categorical data and mean difference (MD) for continuous data. Data were analysed with a fixed-effect model. A random-effects model was used in the presence of heterogeneity. Fourteen trials were included, but only 12 trials involving 910 women contributed data to outcome analysis. Women who exercised did not lose significantly more weight than women in the usual care group (two trials; n = 53; MD -0.10 kg; 95% confidence interval (CI) -1.90 to 1.71). Women who took part in a diet (one trial; n = 45; MD -1.70 kg; 95% CI -2.08 to -1.32), or diet plus exercise programme (seven trials; n = 573; MD -1.93 kg; 95% CI -2.96 to -0.89; random-effects, T² = 1.09, I² = 71%), lost significantly more weight than women in the usual care group. There was no difference in the magnitude of weight loss between diet alone and diet plus exercise group (one trial; n = 43; MD 0.30 kg; 95% CI -0.06 to 0.66). The interventions seemed not to affect breastfeeding performance adversely. Evidence from this review suggests that both diet and exercise together and diet alone help women to lose weight after childbirth. Nevertheless, it may be preferable to lose weight through a combination of diet and exercise as this improves maternal cardiorespiratory fitness and preserves fat-free mass, while diet alone reduces fat-free mass. This needs confirmation in large trials of high methodological quality. For women who are breastfeeding, more evidence is required to confirm whether diet or exercise, or both, is not detrimental for either mother or baby.

Effects of lupin-enriched foods on body composition and cardiovascular disease risk factors: a 12-month randomized controlled weight loss trial.

PubMed

Belski, R; Mori, T A; Puddey, I B; Sipsas, S; Woodman, R J; Ackland, T R; Beilin, L J; Dove, E R; Carlyon, N B; Jayaseena, V; Hodgson, J M

2011-06-01

Regular consumption of diets with increased protein or fibre intakes may benefit body weight and composition and cardiovascular disease risk factors. Lupin flour is a novel food ingredient high in protein and fibre. To investigate the effects of a lupin-enriched diet, during and following energy restriction, on body weight and composition and cardiovascular disease risk factors in overweight individuals. Participants (n = 131) were recruited to a 12-month parallel-design trial. They were randomly assigned to consume lupin-enriched foods or matching high-carbohydrate control foods. All participants underwent 3 months of weight loss, 1 month of weight stabilization and 8 months of weight maintenance. Body weight and composition and cardiovascular disease risk factors were assessed at baseline, 4 and 12 months. Lupin, relative to control, did not significantly influence (mean difference (95% CI)) weight loss at 4 months (0.1 kg (-1.2, 1.4)) and 12 months (-0.6 kg (-2.0, 0.8)), maintenance of weight loss from 4 to 12 months (-0.7 kg (-1.83, 0.48)) or measures of body fat and fat-free mass. Relative to control, 24-h ambulatory systolic (-1.3 mm Hg (-2.4, -0.3), P = 0.016) and diastolic (-1.0 mm Hg (-1.9, -0.2), P = 0.021) blood pressures were lower at 12 months but not at 4 months; fasting insulin concentrations and homeostasis model assessment (HOMA) scores were significantly lower at 4 months (-1.2 mU l(-1) (-1.3, -1.1), P = 0.004 and -0.6 units (-1.0, -0.19), P = 0.004) and 12 months (-1.3 mU l(-1) (-1.4, -1.1), P < 0.001 and -0.7 units (-1.1, -0.24), P = 0.002). A diet higher in protein and fibre derived from lupin-enriched foods does not enhance weight loss or improve the maintenance of weight loss. However, such a diet may provide cardiovascular health benefits in terms of insulin sensitivity and blood pressure.

A systematic review of commercial weight loss programmes' effect on glycemic outcomes among overweight and obese adults with and without type 2 diabetes mellitus.

PubMed

Chaudhry, Z W; Doshi, R S; Mehta, A K; Jacobs, D K; Vakil, R M; Lee, C J; Bleich, S N; Kalyani, R R; Clark, J M; Gudzune, K A

2016-08-01

We examined the glycemic benefits of commercial weight loss programmes as compared with control/education or counselling among overweight and obese adults with and without type 2 diabetes mellitus (T2DM). We searched MEDLINE, Cochrane Database of Systematic Reviews, and references cited by individual programmes. We included randomized controlled trials of ≥12 weeks duration. Two reviewers extracted information on study design, population characteristics, interventions, and mean changes in haemoglobin A1c and glucose. We included 18 randomized controlled trials. Few trials occurred among individuals with T2DM. In this population, Jenny Craig reduced A1c at least 0.4% more than counselling at 12 months, Nutrisystem significantly reduced A1c 0.3% more than counselling at 6 months, and OPTIFAST reduced A1c 0.3% more than counselling at 6 months. Among individuals without T2DM, few studies evaluated glycemic outcomes, and when reported, most did not show substantial reductions. Few trials have examined whether commercial weight loss programmes result in glycemic benefits for their participants, particularly among overweight and obese individuals without T2DM. Jenny Craig, Nutrisystem and OPTIFAST show promising glycemic lowering benefits for patients with T2DM, although additional studies are needed to confirm these conclusions. © 2016 World Obesity. © 2016 World Obesity.

Relationship of cravings with weight loss and hunger. Results from a 6 month worksite weight loss intervention.

PubMed

Batra, Payal; Das, Sai Krupa; Salinardi, Taylor; Robinson, Lisa; Saltzman, Edward; Scott, Tammy; Pittas, Anastassios G; Roberts, Susan B

2013-10-01

We examined the association of food cravings with weight loss and eating behaviors in a lifestyle intervention for weight loss in worksites. This research was part of a randomized controlled trial of a 6-month weight loss intervention versus a wait-listed control in 4 Massachusetts worksites. The intervention emphasized reducing energy intake by adherence to portion-controlled menu suggestions, and assessments were obtained in 95 participants at baseline and 6 months including non-fasting body weight, food cravings (Craving Inventory and Food Craving Questionnaire for state and trait) and the eating behavior constructs restraint, disinhibition and hunger (Eating Inventory). There were statistically significant reductions in all craving variables in the intervention group compared to the controls. Within the intervention group, changes in craving-trait were significantly associated with weight loss after controlling for baseline weight, age, gender and worksite. However, in a multivariate model with craving-trait and eating behaviors (restraint, disinhibition and hunger), hunger was the only significant predictor of weight change. In contrast to some previous reports of increased food cravings with weight loss in lifestyle interventions, this study observed a broad reduction in cravings associated with weight loss. In addition, greater reductions in craving-trait were associated with greater weight change, but craving-trait was not a significant independent correlate of weight change when hunger was included in statistical models. Studies are needed to examine the effectiveness of hunger suppressing versus craving-suppressing strategies in lifestyle interventions for obesity. Copyright © 2013 Elsevier Ltd. All rights reserved.

Replacing caloric beverages with water or diet beverages for weight loss in adults: main results of the Choose Healthy Options Consciously Everyday (CHOICE) randomized clinical trial1234

PubMed Central

Turner-McGrievy, Gabrielle; Lyons, Elizabeth; Stevens, June; Erickson, Karen; Polzien, Kristen; Diamond, Molly; Wang, Xiaoshan; Popkin, Barry

2012-01-01

Background: Replacement of caloric beverages with noncaloric beverages may be a simple strategy for promoting modest weight reduction; however, the effectiveness of this strategy is not known. Objective: We compared the replacement of caloric beverages with water or diet beverages (DBs) as a method of weight loss over 6 mo in adults and attention controls (ACs). Design: Overweight and obese adults [n = 318; BMI (in kg/m2): 36.3 ± 5.9; 84% female; age (mean ± SD): 42 ± 10.7 y; 54% black] substituted noncaloric beverages (water or DBs) for caloric beverages (≥200 kcal/d) or made dietary changes of their choosing (AC) for 6 mo. Results: In an intent-to-treat analysis, a significant reduction in weight and waist circumference and an improvement in systolic blood pressure were observed from 0 to 6 mo. Mean (±SEM) weight losses at 6 mo were −2.5 ± 0.45% in the DB group, −2.03 ± 0.40% in the Water group, and −1.76 ± 0.35% in the AC group; there were no significant differences between groups. The chance of achieving a 5% weight loss at 6 mo was greater in the DB group than in the AC group (OR: 2.29; 95% CI: 1.05, 5.01; P = 0.04). A significant reduction in fasting glucose at 6 mo (P = 0.019) and improved hydration at 3 (P = 0.0017) and 6 (P = 0.049) mo was observed in the Water group relative to the AC group. In a combined analysis, participants assigned to beverage replacement were 2 times as likely to have achieved a 5% weight loss (OR: 2.07; 95% CI: 1.02, 4.22; P = 0.04) than were the AC participants. Conclusions: Replacement of caloric beverages with noncaloric beverages as a weight-loss strategy resulted in average weight losses of 2% to 2.5%. This strategy could have public health significance and is a simple, straightforward message. This trial was registered at clinicaltrials.gov as NCT01017783. PMID:22301929

Predictors of initial weight loss among women with abdominal obesity: a path model using self-efficacy and health-promoting behaviour.

PubMed

Choo, Jina; Kang, Hyuncheol

2015-05-01

To identify predictors of initial weight loss among women with abdominal obesity by using a path model. Successful weight loss in the initial stages of long-term weight management may promote weight loss maintenance. A longitudinal study design. Study participants were 75 women with abdominal obesity, who were enrolled in a 12-month Community-based Heart and Weight Management Trial and followed until a 6-month assessment. The Weight Efficacy Lifestyle, Exercise Self-Efficacy and Health Promoting Lifestyle Profile-II measured diet self-efficacy, exercise self-efficacy and health-promoting behaviour respectively. All endogenous and exogenous variables used in our path model were change variables from baseline to 6 months. Data were collected between May 2011-May 2012. Based on the path model, increases in both diet and exercise self-efficacy had significant effects on increases in health-promoting behaviour. Increases in diet self-efficacy had a significant indirect effect on initial weight loss via increases in health-promoting behaviour. Increases in health-promoting behaviour had a significant effect on initial weight loss. Among women with abdominal obesity, increased diet self-efficacy and health-promoting behaviour were predictors of initial weight loss. A mechanism by which increased diet self-efficacy predicts initial weight loss may be partially attributable to health-promoting behavioural change. However, more work is still needed to verify causality. Based on the current findings, intensive nursing strategies for increasing self-efficacy for weight control and health-promoting behaviour may be essential components for better weight loss in the initial stage of a weight management intervention. © 2015 John Wiley & Sons Ltd.

The utility of monetary contingency contracts for weight loss: a systematic review and meta-analysis.

PubMed

Sykes-Muskett, Bianca J; Prestwich, Andrew; Lawton, Rebecca J; Armitage, Christopher J

2015-01-01

Financial incentives to improve health have received increasing attention, but are subject to ethical concerns. Monetary Contingency Contracts (MCCs), which require individuals to deposit money that is refunded contingent on reaching a goal, are a potential alternative strategy. This review evaluates systematically the evidence for weight loss-related MCCs. Randomised controlled trials testing the effect of weight loss-related MCCs were identified in online databases. Random-effects meta-analyses were used to calculate overall effect sizes for weight loss and participant retention. The association between MCC characteristics and weight loss/participant retention effects was calculated using meta-regression. There was a significant small-to-medium effect of MCCs on weight loss during treatment when one outlier study was removed. Group refunds, deposit not paid as lump sum, participants setting their own deposit size and additional behaviour change techniques were associated with greater weight loss during treatment. Post-treatment, there was no significant effect of MCCs on weight loss. There was a significant small-to-medium effect of MCCs on participant retention during treatment. Researcher-set deposits paid as one lump sum, refunds delivered on an all-or-nothing basis and refunds contingent on attendance at classes were associated with greater retention during treatment. Post-treatment, there was no significant effect of MCCs on participant retention. The results support the use of MCCs to promote weight loss and participant retention up to the point that the incentive is removed and identifies the conditions under which MCCs work best.

Comprehensive behavioral-motivational nutrition education improves depressive symptoms following bariatric surgery: a randomized, controlled trial of obese Hispanic Americans.

PubMed

Petasne Nijamkin, Monica; Campa, Adriana; Samiri Nijamkin, Shani; Sosa, Jorge

2013-01-01

To evaluate the effect of 2 post-bariatric support interventions on depressive symptoms of Hispanic Americans treated with gastric bypass for morbid or severe obesity. Prospective randomized, controlled trial conducted in a laparoscopic institution. During the Phase 1 clinical trial (from preoperative evaluation to 6 months after surgery), all participants received standard care. During Phase 2 (6-12 months after surgery), participants were randomly assigned to receive either standard care (n = 72) or comprehensive support (n = 72). Comprehensive group participants received 6 educational sessions focused on behavior change strategies and motivation with nutrition counseling. Depression scores and weight change over time. Independent samples t tests and regression analysis assessed relationships among depression scores and excess weight loss. Participants receiving behavioral-motivational intervention scored significantly lower on Beck's Depression Inventory questionnaire scores than those receiving standard care. For those with depressive symptoms at randomization, 24% of participants who received the comprehensive intervention reported no depressive symptoms at 12 months after surgery, compared with 6% of those who received standard care (P < .001). Patients' depressive mood improvement was significantly and positively associated with excess weight loss and attendance at educational sessions (P < .001). Findings support the importance of post-bariatric comprehensive behavioral-motivational nutrition education for decreasing risk for depression and improving weight loss. Copyright © 2013 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

Randomized Clinical Trial of Portion-Controlled Prepackaged Foods to Promote Weight Loss

PubMed Central

Rock, Cheryl L.; Flatt, Shirley W.; Pakiz, Bilgé; Barkai, Hava-Shoshana; Heath, Dennis D.; Krumhar, Kim C.

2017-01-01

Objective Providing portion-controlled prepackaged foods in a behavioral counseling intervention may promote more weight and fat loss than a standard self-selected diet. Methods: The primary aim was to test whether providing portion-controlled prepackaged lunch and dinner entrées within a behavioral weight loss intervention promotes greater weight loss at 12 weeks in overweight/obese adults compared to self-selected foods. Other aims were to examine effects on biological factors, fitness, and meal satisfaction. One-half of those assigned to prepackaged entrées were provided items with a higher protein level (>25% energy) as an exploratory aim. Results Participants (N=183) had a baseline weight of 95.9 (15.6) kg (mean [SD]) and BMI of 33.2 (3.5) kg/m2. Weight data at 12 weeks were available for 180 subjects. Weight loss for regular entrée, higher protein entrée and control groups was 8.6 (3.9), 7.8 (5.1), and 6.0 (4.4)%, respectively (P<0.05, intervention vs. control). Intervention participants lost more body fat than controls (5.7 [3.4] vs. 4.4 [3.3] kg, P<0.05). Conclusions A meal plan incorporating portion-controlled prepackaged entrées promotes greater weight and fat loss than a standard self-selected diet, with comparable meal satisfaction. Initial weight loss predicts long-term weight loss so these results are relevant to likelihood of longer term success. PMID:27225596

A one-year randomized trial of lorcaserin for weight loss in obese and overweight adults: the BLOSSOM trial.

PubMed

Fidler, Meredith C; Sanchez, Matilde; Raether, Brian; Weissman, Neil J; Smith, Steven R; Shanahan, William R; Anderson, Christen M

2011-10-01

Lorcaserin is a novel selective agonist of the serotonin 2C receptor. Our objective was to evaluate the effects of lorcaserin on body weight, cardiovascular risk factors, and safety in obese and overweight patients. This randomized, placebo-controlled, double-blind, parallel arm trial took place at 97 U.S. research centers. Patients included 4008 patients, aged 18-65 yr, with a body mass index between 30 and 45 kg/m(2) or between 27 and 29.9 kg/m(2) with an obesity-related comorbid condition. Patients were randomly assigned in a 2:1:2 ratio to receive lorcaserin 10 mg twice daily (BID), lorcaserin 10 mg once daily (QD), or placebo. All patients received diet and exercise counseling. The ordered primary endpoints were proportion of patients achieving at least 5% reduction in body weight, mean change in body weight, and proportion of patients achieving at least 10% reduction in body weight at 1 yr. Serial echocardiograms monitored heart valve function. Significantly more patients treated with lorcaserin 10 mg BID and QD lost at least 5% of baseline body weight (47.2 and 40.2%, respectively) as compared with placebo (25.0%, P < 0.001 vs. lorcaserin BID). Least squares mean (95% confidence interval) weight loss with lorcaserin BID and QD was 5.8% (5.5-6.2%) and 4.7% (4.3-5.2%), respectively, compared with 2.8% (2.5-3.2%) with placebo (P < 0.001 vs. lorcaserin BID; least squares mean difference, 3.0%). Weight loss of at least 10% was achieved by 22.6 and 17.4% of patients receiving lorcaserin 10 mg BID and QD, respectively, and 9.7% of patients in the placebo group (P < 0.001 vs. lorcaserin BID). Headache, nausea, and dizziness were the most common lorcaserin-related adverse events. U.S. Food and Drug Administration-defined echocardiographic valvulopathy occurred in 2.0% of patients on placebo and 2.0% on lorcaserin 10 mg BID. Lorcaserin administered in conjunction with a lifestyle modification program was associated with dose-dependent weight loss that was significantly greater than with placebo.

Adherence to Hunger Training over 6 Months and the Effect on Weight and Eating Behaviour: Secondary Analysis of a Randomised Controlled Trial.

PubMed

Jospe, Michelle R; Taylor, Rachael W; Athens, Josie; Roy, Melyssa; Brown, Rachel C

2017-11-17

Monitoring blood glucose prior to eating can teach individuals to eat only when truly hungry, but how adherence to 'hunger training' influences weight loss and eating behaviour is uncertain. This exploratory, secondary analysis from a larger randomized controlled trial examined five indices of adherence to 'hunger training', chosen a priori, to examine which adherence measure best predicted weight loss over 6 months. We subsequently explored how the best measure of adherence influenced eating behavior in terms of intuitive and emotional eating. Retention was 72% ( n = 36/50) at 6 months. Frequency of hunger training booklet entry most strongly predicted weight loss, followed by frequency of blood glucose measurements. Participants who completed at least 60 days of booklet entry (of recommended 63 days) lost 6.8 kg (95% CI: 2.6, 11.0; p < 0.001) more weight than those who completed fewer days. They also had significantly higher intuitive eating scores than those who completed 30 days or less of booklet entry; a difference (95% CI) of 0.73 (0.12, 1.35) in body-food choice congruence and 0.79 (0.06, 1.51) for eating for physical rather than emotional reasons. Adherent participants also reported significantly lower scores for emotional eating of -0.70 (-1.13, -0.27). Following hunger training and focusing on simply recording ratings of hunger on a regular basis can produce clinically significant weight loss and clinically relevant improvements in eating behaviour.

Lorcaserin for weight management

PubMed Central

Taylor, James R; Dietrich, Eric; Powell, Jason

2013-01-01

Type 2 diabetes and obesity commonly occur together. Obesity contributes to insulin resistance, a main cause of type 2 diabetes. Modest weight loss reduces glucose, lipids, blood pressure, need for medications, and cardiovascular risk. A number of approaches can be used to achieve weight loss, including lifestyle modification, surgery, and medication. Lorcaserin, a novel antiobesity agent, affects central serotonin subtype 2A receptors, resulting in decreased food intake and increased satiety. It has been studied in obese patients with type 2 diabetes and results in an approximately 5.5 kg weight loss, on average, when used for one year. Headache, back pain, nasopharyngitis, and nausea were the most common adverse effects noted with lorcaserin. Hypoglycemia was more common in the lorcaserin groups in the clinical trials, but none of the episodes were categorized as severe. Based on the results of these studies, lorcaserin was approved at a dose of 10 mg twice daily in patients with a body mass index ≥30 kg/m2 or ≥27 kg/m2 with at least one weight-related comorbidity, such as hypertension, type 2 diabetes mellitus, or dyslipidemia, in addition to a reduced calorie diet and increased physical activity. Lorcaserin is effective for weight loss in obese patients with and without type 2 diabetes, although its specific role in the management of obesity is unclear at this time. This paper reviews the clinical trials of lorcaserin, its use from the patient perspective, and its potential role in the treatment of obesity. PMID:23788837

Lorcaserin for weight management.

PubMed

Taylor, James R; Dietrich, Eric; Powell, Jason

2013-01-01

Type 2 diabetes and obesity commonly occur together. Obesity contributes to insulin resistance, a main cause of type 2 diabetes. Modest weight loss reduces glucose, lipids, blood pressure, need for medications, and cardiovascular risk. A number of approaches can be used to achieve weight loss, including lifestyle modification, surgery, and medication. Lorcaserin, a novel antiobesity agent, affects central serotonin subtype 2A receptors, resulting in decreased food intake and increased satiety. It has been studied in obese patients with type 2 diabetes and results in an approximately 5.5 kg weight loss, on average, when used for one year. Headache, back pain, nasopharyngitis, and nausea were the most common adverse effects noted with lorcaserin. Hypoglycemia was more common in the lorcaserin groups in the clinical trials, but none of the episodes were categorized as severe. Based on the results of these studies, lorcaserin was approved at a dose of 10 mg twice daily in patients with a body mass index ≥30 kg/m(2) or ≥27 kg/m(2) with at least one weight-related comorbidity, such as hypertension, type 2 diabetes mellitus, or dyslipidemia, in addition to a reduced calorie diet and increased physical activity. Lorcaserin is effective for weight loss in obese patients with and without type 2 diabetes, although its specific role in the management of obesity is unclear at this time. This paper reviews the clinical trials of lorcaserin, its use from the patient perspective, and its potential role in the treatment of obesity.

Psychological effects of belonging to a Facebook weight management group in overweight and obese adults: Results of a randomised controlled trial.

PubMed

Jane, Monica; Foster, Jonathan; Hagger, Martin; Ho, Suleen; Kane, Robert; Pal, Sebely

2018-05-18

This study was conducted to test whether the weight outcomes in an online social networking group were mediated by changes to psychological outcome measures in overweight and obese individuals, following a weight management programme delivered via Facebook. The data analysed in this study were collected during a three-armed, randomised, controlled clinical weight management trial conducted with overweight and obese adults over 24 weeks. Two intervention groups were given the same weight management programme: one within a Facebook group, along with peer support from other group members (the Facebook Group); the other group received the same programme in a pamphlet (the Pamphlet Group). A Control Group was given standard care. The primary outcome was weight; secondary outcomes included the following domains from self-reported questionnaires: energy intake and expenditure; psychological health, social relationships, physical health, quality of life, depression, anxiety, stress, health anxiety, happiness, as well as Facebook Group participants' opinion of this group. The Facebook Group experienced a reduction in their baseline weight measurement by week 24, significantly compared to the Control Group (p = .016). The Facebook Group recorded a significant increase in the psychological health domain during the trial (at week 12) relative to their baseline measurement, and significant compared to the Control Group (p = .022). Mediation analysis indicated a statistical trend, but not statistical significance, for psychological health as a mediator to weight loss in the Facebook Group. While both intervention groups showed significant changes in psychological outcome measures, the Facebook Group was the only group to experience statistically significant weight loss by the end of the 24 weeks. Therefore, an examination of other psychological and/or behavioural outcome measures undertaken in larger studies in the future may help to identify significant mediators to improved weight loss outcomes in online social networking groups. © 2018 John Wiley & Sons Ltd.

Yogurt and weight management.

PubMed

Jacques, Paul F; Wang, Huifen

2014-05-01

A large body of observational studies and randomized controlled trials (RCTs) has examined the role of dairy products in weight loss and maintenance of healthy weight. Yogurt is a dairy product that is generally very similar to milk, but it also has some unique properties that may enhance its possible role in weight maintenance. This review summarizes the human RCT and prospective observational evidence on the relation of yogurt consumption to the management and maintenance of body weight and composition. The RCT evidence is limited to 2 small, short-term, energy-restricted trials. They both showed greater weight losses with yogurt interventions, but the difference between the yogurt intervention and the control diet was only significant in one of these trials. There are 5 prospective observational studies that have examined the association between yogurt and weight gain. The results of these studies are equivocal. Two of these studies reported that individuals with higher yogurt consumption gained less weight over time. One of these same studies also considered changes in waist circumference (WC) and showed that higher yogurt consumption was associated with smaller increases in WC. A third study was inconclusive because of low statistical power. A fourth study observed no association between changes in yogurt intake and weight gain, but the results suggested that those with the largest increases in yogurt intake during the study also had the highest increase in WC. The final study examined weight and WC change separately by sex and baseline weight status and showed benefits for both weight and WC changes for higher yogurt consumption in overweight men, but it also found that higher yogurt consumption in normal-weight women was associated with a greater increase in weight over follow-up. Potential underlying mechanisms for the action of yogurt on weight are briefly discussed.

Behavioral and psychosocial correlates of adiposity and healthy lifestyle in Asian Indians.

PubMed

Weber, Mary Beth; Ranjani, Harish; Anjana, Ranjit Mohan; Mohan, Viswanathan; Narayan, K M Venkat; Gazmararian, Julie A

2015-12-01

Adiposity is an important diabetes risk factor, and Asian Indians have elevated diabetes risk. This analysis assessed the relationship between behavioral and psychosocial factors and adiposity among Asian Indians to better understand factors driving elevated weight/waist circumference in this population. This study used screening data (N=1285) from the D-CLIP study, a randomized controlled diabetes prevention trial in Chennai, India. Correlation tests and linear regression models were done to describe relationships among exposure variables (weight loss/exercise self-efficacy, fruit/vegetable intake, weekly exercise, past weight loss experience) and between these exposures and BMI or waist circumference. Exercise and weight loss self-efficacy were positively correlated with average minutes per week exercising (R=0.26, p<0.0001) and fruit (R=0.07, p<0.05) and vegetable intake (R=0.12, p<0.0001). Weekly fruit consumption, past weight loss experience, and weight loss self-efficacy, along with sex, age, and marital status, explained 13.6% and 25.9% in the variation in BMI and waist circumference, respectively. Low fruit consumption, unsuccessful past weight loss attempts, and low self-efficacy for weight loss are associated with higher BMI and waist circumference in this population. Understanding factors related to adiposity is important for preventing and treating weight gain. Copyright © 2015 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.

First versus repeat treatment with a lifestyle intervention program: attendance and weight loss outcomes.

PubMed

Venditti, E M; Bray, G A; Carrion-Petersen, M L; Delahanty, L M; Edelstein, S L; Hamman, R F; Hoskin, M A; Knowler, W C; Ma, Y

2008-10-01

Following unblinding of the Diabetes Prevention Program (DPP) results, a 16-session lifestyle intervention program was offered to all study participants, including those who had initially been randomized to lifestyle treatment. This study compares the effects of the lifestyle program between participants who had previous exposure and those who had not. A 16-session behavioral intervention was conducted in groups at each of the 27 DPP sites during a transitional (bridge) period from the DPP trial to the DPP Outcomes Study (DPPOS). Session participation for this 6-month behavioral weight loss program was confirmed by originally randomized treatment groups. Independently assessed weight measurements were available within a 7-month period before and after the program for 2808 ethnically diverse participants. Participants from the lifestyle group in the DPP were the least likely to attend a repeat offering of a 16-session behavioral weight loss program conducted in groups. Weight loss during the transitional lifestyle program was strongly related to the duration of attendance in the three groups that were participating in the program for the first time (metformin, placebo and troglitazone), but not related to amount of earlier weight loss. Individuals who were naive to the behavioral program lost a greater amount of weight and this was strongly related to their degree of participation. A second exposure to a behavioral weight loss program resulted in unsatisfactory low attendance rates and weight loss.

Primary care referral to a commercial provider for weight loss treatment versus standard care: a randomised controlled trial.

PubMed

Jebb, Susan A; Ahern, Amy L; Olson, Ashley D; Aston, Louise M; Holzapfel, Christina; Stoll, Julia; Amann-Gassner, Ulrike; Simpson, Annie E; Fuller, Nicholas R; Pearson, Suzanne; Lau, Namson S; Mander, Adrian P; Hauner, Hans; Caterson, Ian D

2011-10-22

The increasing prevalence of overweight and obesity needs effective approaches for weight loss in primary care and community settings. We compared weight loss with standard treatment in primary care with that achieved after referral by the primary care team to a commercial provider in the community. In this parallel group, non-blinded, randomised controlled trial, 772 overweight and obese adults were recruited by primary care practices in Australia, Germany, and the UK. Participants were randomly assigned with a computer-generated simple randomisation sequence to receive either 12 months of standard care as defined by national treatment guidelines, or 12 months of free membership to a commercial programme (Weight Watchers), and followed up for 12 months. The primary outcome was weight change over 12 months. Analysis was by intention to treat (last observation carried forward [LOCF] and baseline observation carried forward [BOCF]) and in the population who completed the 12-month assessment. This trial is registered, number ISRCTN85485463. 377 participants were assigned to the commercial programme, of whom 230 (61%) completed the 12-month assessment; and 395 were assigned to standard care, of whom 214 (54%) completed the 12-month assessment. In all analyses, participants in the commercial programme group lost twice as much weight as did those in the standard care group. Mean weight change at 12 months was -5·06 kg (SE 0·31) for those in the commercial programme versus -2·25 kg (0·21) for those receiving standard care (adjusted difference -2·77 kg, 95% CI -3·50 to -2·03) with LOCF; -4·06 kg (0·31) versus -1·77 kg (0·19; adjusted difference -2·29 kg, -2·99 to -1·58) with BOCF; and -6·65 kg (0·43) versus -3·26 kg (0·33; adjusted difference -3·16 kg, -4·23 to -2·11) for those who completed the 12-month assessment. Participants reported no adverse events related to trial participation. Referral by a primary health-care professional to a commercial weight loss programme that provides regular weighing, advice about diet and physical activity, motivation, and group support can offer a clinically useful early intervention for weight management in overweight and obese people that can be delivered at large scale. Weight Watchers International, through a grant to the UK Medical Research Council. Copyright © 2011 Elsevier Ltd. All rights reserved.

Whole-body protein turnover response to short-term high-protein diets during weight loss: a randomized controlled trial

USDA-ARS?s Scientific Manuscript database

Objective: Determine whole-body protein turnover responses to high protein diets during weight loss. Design: Thirty-nine adults (age, 21 ± 1 yr; VO2peak, 48 ± 1 ml'kg-1'min-1; body mass index, 25 ± 1 kg•m2) were randomized to diets providing protein at the recommend dietary allowance (RDA), 2X-RD...

Avoiding Weight Gain in Cardiometabolic Disease: A Systematic Review

PubMed Central

Maruthur, Nisa M.; Fawole, Oluwakemi A.; Wilson, Renee F.; Lau, Brandyn D.; Anderson, Cheryl A. M.; Bleich, Sara N.; Segal, Jodi

2014-01-01

Patients with cardiometabolic disease are at higher risk for obesity-related adverse effects. Even without weight loss, weight maintenance may be beneficial. We performed a systematic review to identify the effect of nonweight loss-focused lifestyle interventions in adults with cardiometabolic disease. We searched MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials to identify comparative studies of lifestyle interventions (self-management, diet, exercise, or their combination) without a weight loss focus in adults with or at risk for diabetes and cardiovascular disease. Weight, BMI, and waist circumference at ≥12 months were the primary outcomes. Of 24,870 citations, we included 12 trials (self-management, n = 2; diet, n = 2; exercise, n = 2; combination, n = 6) studying 4,206 participants. Self-management plus physical activity ± diet versus minimal/no intervention avoided meaningful weight (−0.65 to −1.3 kg) and BMI (−0.4 to −0.7 kg/m2) increases. Self-management and/or physical activity prevented meaningful waist circumference increases versus control (−2 to −4 cm). In patients with cardiometabolic disease, self-management plus exercise may prevent weight and BMI increases and self-management and/or exercise may prevent waist circumference increases versus minimal/no intervention. Future studies should confirm these findings and evaluate additional risk factors and clinical outcomes. PMID:25610639

Randomized trial of a phone- and web-based weight loss program for women at elevated breast cancer risk: the HELP study.

PubMed

Cadmus-Bertram, Lisa; Nelson, Sandahl H; Hartman, Sheri; Patterson, Ruth E; Parker, Barbara A; Pierce, John P

2016-08-01

Excess weight and physical inactivity are modifiable risk factors for breast cancer. Behavioral intervention is particularly important among women with an elevated risk profile. This trial tested an intervention that trained women to use a self-monitoring website to increase activity and lose weight. Women with BMI ≥27.5 kg/m(2) at elevated breast cancer risk were randomized to the intervention (N = 71) or usual care (N = 34). The intervention group received telephone-based coaching and used web-based self-monitoring tools. At 6 months, significant weight loss was observed in the intervention group (4.7 % loss from starting weight; SD = 4.7 %) relative to usual care (0.4 % gain; SD = 3.0 %) (p < 0.0001). By 12 months, the intervention group had lost 3.7 % of weight (SD = 5.4 %), compared to 1.3 % (SD = 4.2) for usual care (p = 0.003). At 12 months, accelerometer-measured moderate-to-vigorous physical activity increased by 12 min/day (SD = 24) compared to no change in usual care (p = 0.04. In summary, this web- and phone-based approach produced modest but significant improvements in weight and physical activity for women at elevated breast cancer risk.

Incretin-based therapy in type 2 diabetes: An evidence based systematic review and meta-analysis.

PubMed

Waldrop, Greer; Zhong, Jixin; Peters, Matthew; Goud, Aditya; Chen, Yin-Hsiu; Davis, Stephen N; Mukherjee, Bhramar; Rajagopalan, Sanjay

2018-01-01

Incretin based therapies such as dipeptidyl peptidase-4 inhibitors (DPP-4i) and glucagon-like peptide-1 receptor agonists (GLP-1Ra) are increasingly used for the treatment of Type 2 diabetes mellitus. In clinical practice and in previously performed clinical trials, these agents are often used in combination with other oral anti-diabetic agents (OADs) and Insulin. Prior meta-analytic reviews however do not adequately address the impact of background therapy and active comparator arms. Accordingly, we aimed to further investigate the efficacy of incretin based therapies by updating existing reviews by including clinical trial evidence after 2008; estimating the pooled effect of incretin therapies on glycemic efficacy and weight-loss, stratified by comparator therapy (placebo, mono-therapy, etc.), estimating the impact of background OADs and within class (GLP-1Ra or DPP-4i) comparative efficacy, on glycemia control. 82 randomized controlled trials after 2008 with glycemic control and weight loss as primary end-points were included. Both DPP-4i and GLP-1Ra reduced HbA1c, but only GLP-1Ra caused weight loss when compared to either active comparator drugs or placebo. GLP-1Ra were more effective than DPP-4i in glycemia lowering. Long acting GLP-1Ra were more effective in HbA1c lowering than short-acting agents but with similar weight loss effect. The effect of DPP-4i incretin glycemic efficacy was not modified by background therapy used in the study. Copyright © 2016. Published by Elsevier Inc.

Perfluoroalkyl substances and changes in body weight and resting metabolic rate in response to weight-loss diets: A prospective study.

PubMed

Liu, Gang; Dhana, Klodian; Furtado, Jeremy D; Rood, Jennifer; Zong, Geng; Liang, Liming; Qi, Lu; Bray, George A; DeJonge, Lilian; Coull, Brent; Grandjean, Philippe; Sun, Qi

2018-02-01

The potential endocrine-disrupting effects of perfluoroalkyl substances (PFASs) have been demonstrated in animal studies, but whether PFASs may interfere with body weight regulation in humans is largely unknown. This study aimed to examine the associations of PFAS exposure with changes in body weight and resting metabolic rate (RMR) in a diet-induced weight-loss setting. In the 2-year POUNDS Lost randomized clinical trial based in Boston, Massachusetts, and Baton Rouge, Louisiana, that examined the effects of energy-restricted diets on weight changes, baseline plasma concentrations of major PFASs were measured among 621 overweight and obese participants aged 30-70 years. Body weight was measured at baseline and 6, 12, 18, and 24 months. RMR and other metabolic parameters, including glucose, lipids, thyroid hormones, and leptin, were measured at baseline and 6 and 24 months. Participants lost an average of 6.4 kg of body weight during the first 6 months (weight-loss period) and subsequently regained an average of 2.7 kg of body weight during the period of 6-24 months (weight regain period). After multivariate adjustment, baseline PFAS concentrations were not significantly associated with concurrent body weight or weight loss during the first 6 months. In contrast, higher baseline levels of PFASs were significantly associated with a greater weight regain, primarily in women. In women, comparing the highest to the lowest tertiles of PFAS concentrations, the multivariate-adjusted mean weight regain (SE) was 4.0 (0.8) versus 2.1 (0.9) kg for perfluorooctanesulfonic acid (PFOS) (Ptrend = 0.01); 4.3 (0.9) versus 2.2 (0.8) kg for perfluorooctanoic acid (PFOA) (Ptrend = 0.007); 4.7 (0.9) versus 2.5 (0.9) kg for perfluorononanoic acid (PFNA) (Ptrend = 0.006); 4.9 (0.9) versus 2.7 (0.8) kg for perfluorohexanesulfonic acid (PFHxS) (Ptrend = 0.009); and 4.2 (0.8) versus 2.5 (0.9) kg for perfluorodecanoic acid (PFDA) (Ptrend = 0.03). When further adjusted for changes in body weight or thyroid hormones during the first 6 months, results remained similar. Moreover, higher baseline plasma PFAS concentrations, especially for PFOS and PFNA, were significantly associated with greater decline in RMR during the weight-loss period and less increase in RMR during the weight regain period in both men and women. Limitations of the study include the possibility of unmeasured or residual confounding by socioeconomic and psychosocial factors, as well as possible relapse to the usual diet prior to randomization, which could have been rich in foods contaminated by PFASs through food packaging and also dense in energy. In this diet-induced weight-loss trial, higher baseline plasma PFAS concentrations were associated with a greater weight regain, especially in women, possibly explained by a slower regression of RMR levels. These data illustrate a potential novel pathway through which PFASs interfere with human body weight regulation and metabolism. The possible impact of environmental chemicals on the obesity epidemic therefore deserves attention. ClinicalTrials.gov NCT00072995.

Sleeping Well Trial: Increasing the effectiveness of treatment with continuous positive airway pressure using a weight management program in overweight adults with obstructive sleep apnoea-A stepped wedge randomised trial protocol.

PubMed

Truby, Helen; Edwards, Bradley A; O'Driscoll, Denise M; Young, Alan; Ghazi, Ladan; Bristow, Claire; Roem, Kerryn; Bonham, Maxine P; Murgia, Chiara; Day, Kaitlin; Haines, Terry P; Hamilton, Garun S

2018-05-24

The majority of adults diagnosed with obstructive sleep apnoea (OSA) are overweight or obese. Continuous positive airway pressure (CPAP) is the most common effective therapy for OSA. However, adherence declines over time with only 50% of patients prescribed CPAP continuing to use it long term. Furthermore, a recent prospective analysis indicated that those more adherent with CPAP therapy have enhanced weight gain trajectories which in turn may negatively impact their OSA. The Sleeping Well Trial aims to establish whether the timing of starting a lifestyle weight loss intervention impacts on weight trajectory in those with moderate-severe OSA treated at home with CPAP, while testing the potential for smart phone technology to improve adherence with lifestyle interventions. A stepped wedge design with randomisation of individuals from 1 to 6 months post-enrolment, with 5 months of additional prospective follow up after completion of the stepped wedge. This design will investigate the effect of the 6-month lifestyle intervention on people undergoing CPAP on body weight, body composition and health-related quality of life. This trial tests whether the timing of supporting the patient through a weight loss intervention is important in obtaining the maximum benefit of a lifestyle change and CPAP usage, and identify how best to support patients through this critical period. The protocol (v1) is registered prospectively with the International Clinical Trials Registry (CTR) ACTRN12616000203459 (public access). Any amendments to protocol will be documented via the CTR. Recruitment commenced in March 2016 with data collection scheduled to finish by May 2018. © 2018 Dietitians Association of Australia.

Randomized Controlled Trial Examining the Ripple Effect of a Nationally Available Weight Management Program on Untreated Spouses.

PubMed

Gorin, Amy A; Lenz, Erin M; Cornelius, Talea; Huedo-Medina, Tania; Wojtanowski, Alexis C; Foster, Gary D

2018-03-01

For married couples, when one spouse participates in weight loss treatment, the untreated spouse can also experience weight loss. This study examined this ripple effect in a nationally available weight management program. One hundred thirty dyads were randomized to Weight Watchers (WW; n = 65) or to a self-guided control group (SG; n = 65) and assessed at 0, 3, and 6 months. Inclusion criteria were age ≥ 25 years, BMI 27 to 40 kg/m 2 (≥ 25 kg/m 2 for untreated spouses), and no weight loss contraindications. WW participants received 6 months of free access to in-person meetings and online tools. SG participants received a weight loss handout. Spouses did not receive treatment. Untreated spouses lost weight at 3 months (WW = -1.5 ± 2.9 kg; SG = -1.1 ± 3.3 kg) and 6 months (WW = -2.2 ± 4.2 kg; SG = -1.9 ± 3.6 kg), but weight losses did not differ by condition. Overall, 32.0% of untreated spouses lost ≥ 3% of initial body weight by 6 months. Baseline weight was significantly correlated within couples (r = 0.26; P < 0.01) as were weight loss trajectories (r = 0.52; P < 0.001). Evidence of a ripple effect was found in untreated spouses in both formal and self-guided weight management approaches. These data suggest that weight loss can spread within couples, and that widely available lifestyle programs have weight loss effects beyond the treated individual. © 2018 The Authors. Obesity published by Wiley Periodicals, Inc. on behalf of The Obesity Society (TOS).

Comparison of two self-directed weight loss interventions: Limited weekly support vs. no outside support.

PubMed

Smith, Bryan K; Van Walleghen, Emily L; Cook-Wiens, Galen; Martin, Rachael N; Curry, Chelsea R; Sullivan, Debra K; Gibson, Cheryl A; Donnelly, Joseph E

2009-08-01

The purpose of this study was to compare the efficacy of two home-based weight loss interventions that differ only in the amount of outside support provided. This was a 12-week, randomized, controlled trial. One group received limited support (LWS, n = 35) via a single 10 min phone call each week while another group received no weekly support (NWS, n = 28). Both the LWS and NWS received pre-packaged meals (PM) and shakes. A third group served as control (CON, n = 30) and received no components of the intervention. Weight loss at 12 weeks was the primary outcome. Diet (PM, shake, and fruit/vegetable (F/V) intake) and physical activity (PA) were self-monitored, recorded daily and reported weekly. An exit survey was completed by participants in the intervention groups upon completion of the study. Weight loss and percent weight loss in the LWS, NWS, and CON groups were 7.7 ± 4.4 kg (8.5 ± 4.2%), 5.9 ± 4.1 kg (6.0 ± 4.2%), and 0.3 ± 1.9 kg (0.4 ± 1.2%), respectively. The decrease in body weight and percent weight loss was significantly greater in the LWS and NWS groups when compared to the CON group and the percent weight loss was significantly greater in the LWS when compared to both the NWS and CON groups. A home-based weight loss program utilizing PM and shakes results in clinically significant percent weight loss and the addition of a brief weekly call promotes additional percent weight loss. © 2009 Asian Oceanian Association for the Study of Obesity . Published by Elsevier Ltd. All rights reserved.

Comparison of weight-loss diets with different compositions of fat, protein, and carbohydrates.

PubMed

Sacks, Frank M; Bray, George A; Carey, Vincent J; Smith, Steven R; Ryan, Donna H; Anton, Stephen D; McManus, Katherine; Champagne, Catherine M; Bishop, Louise M; Laranjo, Nancy; Leboff, Meryl S; Rood, Jennifer C; de Jonge, Lilian; Greenway, Frank L; Loria, Catherine M; Obarzanek, Eva; Williamson, Donald A

2009-02-26

The possible advantage for weight loss of a diet that emphasizes protein, fat, or carbohydrates has not been established, and there are few studies that extend beyond 1 year. We randomly assigned 811 overweight adults to one of four diets; the targeted percentages of energy derived from fat, protein, and carbohydrates in the four diets were 20, 15, and 65%; 20, 25, and 55%; 40, 15, and 45%; and 40, 25, and 35%. The diets consisted of similar foods and met guidelines for cardiovascular health. The participants were offered group and individual instructional sessions for 2 years. The primary outcome was the change in body weight after 2 years in two-by-two factorial comparisons of low fat versus high fat and average protein versus high protein and in the comparison of highest and lowest carbohydrate content. At 6 months, participants assigned to each diet had lost an average of 6 kg, which represented 7% of their initial weight; they began to regain weight after 12 months. By 2 years, weight loss remained similar in those who were assigned to a diet with 15% protein and those assigned to a diet with 25% protein (3.0 and 3.6 kg, respectively); in those assigned to a diet with 20% fat and those assigned to a diet with 40% fat (3.3 kg for both groups); and in those assigned to a diet with 65% carbohydrates and those assigned to a diet with 35% carbohydrates (2.9 and 3.4 kg, respectively) (P>0.20 for all comparisons). Among the 80% of participants who completed the trial, the average weight loss was 4 kg; 14 to 15% of the participants had a reduction of at least 10% of their initial body weight. Satiety, hunger, satisfaction with the diet, and attendance at group sessions were similar for all diets; attendance was strongly associated with weight loss (0.2 kg per session attended). The diets improved lipid-related risk factors and fasting insulin levels. Reduced-calorie diets result in clinically meaningful weight loss regardless of which macronutrients they emphasize. (ClinicalTrials.gov number, NCT00072995.) 2009 Massachusetts Medical Society

Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss at 5 Years Among Patients With Morbid Obesity: The SLEEVEPASS Randomized Clinical Trial.

PubMed

Salminen, Paulina; Helmiö, Mika; Ovaska, Jari; Juuti, Anne; Leivonen, Marja; Peromaa-Haavisto, Pipsa; Hurme, Saija; Soinio, Minna; Nuutila, Pirjo; Victorzon, Mikael

2018-01-16

Laparoscopic sleeve gastrectomy for treatment of morbid obesity has increased substantially despite the lack of long-term results compared with laparoscopic Roux-en-Y gastric bypass. To determine whether laparoscopic sleeve gastrectomy and laparoscopic Roux-en-Y gastric bypass are equivalent for weight loss at 5 years in patients with morbid obesity. The Sleeve vs Bypass (SLEEVEPASS) multicenter, multisurgeon, open-label, randomized clinical equivalence trial was conducted from March 2008 until June 2010 in Finland. The trial enrolled 240 morbidly obese patients aged 18 to 60 years, who were randomly assigned to sleeve gastrectomy or gastric bypass with a 5-year follow-up period (last follow-up, October 14, 2015). Laparoscopic sleeve gastrectomy (n = 121) or laparoscopic Roux-en-Y gastric bypass (n = 119). The primary end point was weight loss evaluated by percentage excess weight loss. Prespecified equivalence margins for the clinical significance of weight loss differences between gastric bypass and sleeve gastrectomy were -9% to +9% excess weight loss. Secondary end points included resolution of comorbidities, improvement of quality of life (QOL), all adverse events (overall morbidity), and mortality. Among 240 patients randomized (mean age, 48 [SD, 9] years; mean baseline body mass index, 45.9, [SD, 6.0]; 69.6% women), 80.4% completed the 5-year follow-up. At baseline, 42.1% had type 2 diabetes, 34.6% dyslipidemia, and 70.8% hypertension. The estimated mean percentage excess weight loss at 5 years was 49% (95% CI, 45%-52%) after sleeve gastrectomy and 57% (95% CI, 53%-61%) after gastric bypass (difference, 8.2 percentage units [95% CI, 3.2%-13.2%], higher in the gastric bypass group) and did not meet criteria for equivalence. Complete or partial remission of type 2 diabetes was seen in 37% (n = 15/41) after sleeve gastrectomy and in 45% (n = 18/40) after gastric bypass (P > .99). Medication for dyslipidemia was discontinued in 47% (n = 14/30) after sleeve gastrectomy and 60% (n = 24/40) after gastric bypass (P = .15) and for hypertension in 29% (n = 20/68) and 51% (n = 37/73) (P = .02), respectively. There was no statistically significant difference in QOL between groups (P = .85) and no treatment-related mortality. At 5 years the overall morbidity rate was 19% (n = 23) for sleeve gastrectomy and 26% (n = 31) for gastric bypass (P = .19). Among patients with morbid obesity, use of laparoscopic sleeve gastrectomy compared with use of laparoscopic Roux-en-Y gastric bypass did not meet criteria for equivalence in terms of percentage excess weight loss at 5 years. Although gastric bypass compared with sleeve gastrectomy was associated with greater percentage excess weight loss at 5 years, the difference was not statistically significant, based on the prespecified equivalence margins. clinicaltrials.gov Identifier: NCT00793143.

Weight change among people randomized to minimal intervention control groups in weight loss trials.

PubMed

Johns, David J; Hartmann-Boyce, Jamie; Jebb, Susan A; Aveyard, Paul

2016-04-01

Evidence on the effectiveness of behavioral weight management programs often comes from uncontrolled program evaluations. These frequently make the assumption that, without intervention, people will gain weight. The aim of this study was to use data from minimal intervention control groups in randomized controlled trials to examine the evidence for this assumption and the effect of frequency of weighing on weight change. Data were extracted from minimal intervention control arms in a systematic review of multicomponent behavioral weight management programs. Two reviewers classified control arms into three categories based on intensity of minimal intervention and calculated 12-month mean weight change using baseline observation carried forward. Meta-regression was conducted in STATA v12. Thirty studies met the inclusion criteria, twenty-nine of which had usable data, representing 5,963 participants allocated to control arms. Control arms were categorized according to intensity, as offering leaflets only, a single session of advice, or more than one session of advice from someone without specialist skills in supporting weight loss. Mean weight change at 12 months across all categories was -0.8 kg (95% CI -1.1 to -0.4). In an unadjusted model, increasing intensity by moving up a category was associated with an additional weight loss of -0.53 kg (95% CI -0.96 to -0.09). Also in an unadjusted model, each additional weigh-in was associated with a weight change of -0.42 kg (95% CI -0.81 to -0.03). However, when both variables were placed in the same model, neither intervention category nor number of weigh-ins was associated with weight change. Uncontrolled evaluations of weight loss programs should assume that, in the absence of intervention, their population would weigh up to a kilogram on average less than baseline at the end of the first year of follow-up. © 2016 The Authors Obesity published by Wiley Periodicals, Inc. on behalf of The Obesity Society (TOS).

Prevention of type 2 diabetes through lifestyle modification: is there a role for higher-protein diets?

PubMed

Liu, Amy Y; Silvestre, Marta P; Poppitt, Sally D

2015-11-01

Type 2 diabetes (T2D) incidence is increasing worldwide, driven by a rapidly changing environment and lifestyle and increasing rates of overweight and obesity. Prevention of diabetes is key and is most likely achieved through prevention of weight gain and/or successful long-term weight loss maintenance. Weight loss is readily achievable but there is considerable challenge in maintaining that weight loss over the long term. Lower-fat carbohydrate-based diets are widely used for T2D prevention. This is supported primarily by 3 successful long-term interventions, the US Diabetes Prevention Program, the Finnish Diabetes Prevention Study, and the Chinese Da Qing Study, but evidence is building in support of novel higher-protein (>20% of energy) diets for successful weight loss maintenance and prevention of T2D. Higher-protein diets have the advantage of having relatively low energy density, aiding longer-term appetite suppression, and preserving lean body mass, all central to successful weight loss and prevention of weight regain. Here, we review the carbohydrate-based intervention trials and present mechanistic evidence in support of increased dietary protein for weight loss maintenance and a possible novel role in prevention of dysglycemia and T2D. © 2015 American Society for Nutrition.

Mammary tumorigenesis causes bone loss and dietary selenium supplementation does not affect such bone loss in male MMTV-PyMT mice

USDA-ARS?s Scientific Manuscript database

Cancer progression is accompanied by wasting that eventually results in cachexia characterized by significant weight loss and multi-organ functional failures. Limited clinical trials indicate that bone is adversely affected by cancer-associated wasting. To determine the effects of breast cancer on...

The look AHEAD trial: bone loss at four-year follow-up in type 2 diabetes

USDA-ARS?s Scientific Manuscript database

OBJECTIVE: To determine whether an intensive lifestyle intervention (ILI) designed to sustain weight loss and improve physical fitness in overweight or obese persons with type 2 diabetes was associated with bone loss after 4 years of follow-up. RESEARCH DESIGN AND METHODS: This randomized controlled...

Impact of sleep, screen time, depression and stress on weight change in the intensive weight loss phase of the LIFE study.

PubMed

Elder, C R; Gullion, C M; Funk, K L; Debar, L L; Lindberg, N M; Stevens, V J

2012-01-01

The LIFE study is a two-phase randomized clinical trial comparing two approaches to maintaining weight loss following guided weight loss. Phase I provided a nonrandomized intensive 6-month behavioral weight loss intervention to 472 obese (body mass index 30-50) adult participants. Phase II is the randomized weight loss maintenance portion of the study. This paper focuses on Phase I measures of sleep, screen time, depression and stress. The Phase I intervention consisted of 22 group sessions led over 26 weeks by behavioral counselors. Recommendations included reducing dietary intake by 500 calories per day, adopting the Dietary Approaches to Stop Hypertension (DASH) dietary pattern and increasing physical exercise to at least 180 min per week. Measures reported here are sleep time, insomnia, screen time, depression and stress at entry and post-weight loss intervention follow-up. The mean weight loss for all participants over the intensive Phase I weight loss intervention was 6.3 kg (s.d. 7.1). Sixty percent (N=285) of participants lost at least 4.5 kg (10 lbs) and were randomized into Phase II. Participants (N=472) attended a mean of 73.1% (s.d. 26.7) of sessions, completed 5.1 (s.d. 1.9) daily food records/week, and reported 195.1 min (s.d. 123.1) of exercise per week. Using logistic regression, sleep time (quadratic trend, P=0.030) and lower stress (P=0.024) at entry predicted success in the weight loss program, and lower stress predicted greater weight loss during Phase I (P=0.021). In addition, weight loss was significantly correlated with declines in stress (P=0.048) and depression (P=0.035). Results suggest that clinicians and investigators might consider targeting sleep, depression and stress as part of a behavioral weight loss intervention.

Restricted versus liberal water intake for preventing morbidity and mortality in preterm infants.

PubMed

Bell, E F; Acarregui, M J

2008-01-23

Most premature infants are not sufficiently mature physiologically to ingest all of their required water and nutrients orally. Therefore, premature infants rely on their caregivers to regulate their volume of water intake. Thus, the caregiver must determine the amount of water to be given each day to such infants. The objective of this review is to examine the effects of water intake on postnatal weight loss and on the risks of dehydration, patent ductus arteriosus, necrotizing enterocolitis, bronchopulmonary dysplasia, intracranial hemorrhage, and death in premature infants. Randomized clinical trials identified in previous versions of this review were re-examined and, in each case, retained. Additional trials were sought that compared the outcomes of interest in groups of premature infants who were given different levels of water intake according to experimental protocol. Such trials were sought in a list of trials provided by the Cochrane Neonatal Review Group, with a PubMed search, and in the authors' personal files. Only randomized clinical trials of varying water intake in premature infants are included. The review was limited to trials that included infants whose water intake was provided mainly or entirely by intravascular infusion. Included studies reported at least one of the following outcomes: postnatal weight loss, dehydration, patent ductus arteriosus, necrotizing enterocolitis, bronchopulmonary dysplasia, intracranial hemorrhage, and death. Standard methods of the Cochrane Collaboration were used. The studies to be included were selected by two reviewers, each of whom also assessed the methodological quality of each trial. Data were independently extracted by the reviewers, who agreed on the key details. The data were then entered into tables using RevMan 4.3.1. The adverse event rates were calculated for the restricted and liberal water intake groups for each dichotomous outcome, and the relative risk and risk difference were computed. In addition, the maximal weight loss results were recorded, and the weighted mean difference was computed. The analyses - including calculation of relative risk, risk difference, and weighted mean difference - and tests of heterogeneity were accomplished using RevMan 4.3.1 software. The analysis of the five studies taken together indicates that restricted water intake significantly increases postnatal weight loss and significantly reduces the risks of patent ductus arteriosus and necrotizing enterocolitis. With restricted water intake, there are trends toward increased risk of dehydration and reduced risks of bronchopulmonary dysplasia, intracranial hemorrhage, and death, but these trends are not statistically significant. Based on this analysis, the most prudent prescription for water intake to premature infants would seem to be careful restriction of water intake so that physiological needs are met without allowing significant dehydration. This practice could be expected to decrease the risks of patent ductus arteriosus and necrotizing enterocolitis without significantly increasing the risk of adverse consequences.

A Commercially Available Portion-Controlled Diet Program Is More Effective for Weight Loss than a Self-Directed Diet: Results from a Randomized Clinical Trial.

PubMed

Cook, Chad M; McCormick, Courtney N; Knowles, Mandi; Kaden, Valerie N

2017-01-01

To examine changes in weight and related outcomes in response to a commercial weight loss program compared to a self-directed diet in adults with overweight or obesity. Participants were randomly assigned [stratified by body mass index (BMI) and age] to a commercial weight loss program ( n  = 38) or to a self-directed Dietary Approaches to Stop Hypertension (DASH) diet ( n  = 40) for a 16-week period. Daily energy intake goals were 1,500 kcal/d for men and 1,200 kcal/d for women, except for the first week of the commercial program (1,000 kcal/d). This study was registered at http://ClinicalTrials.gov (NCT03017443). Primarily Caucasian (71%) women ( n  = 61) and men ( n  = 17) from the greater metropolitan area of the city of Chicago, IL, USA. with a mean baseline BMI of 34.4 kg/m 2 , body weight of 95.7 kg, and age of 50.4 years. Data = mean (95% CI). At week 16, the commercial program group lost significantly more body weight [-5.9 (-7.5, -4.3) kg vs. -1.8 (-2.9, -0.8) kg; or -6.4 vs. -1.8% of initial body weight, respectively], fat mass [-4.4 (-5.7, -3.1) kg vs. -1.2 (-2.1, -0.4) kg] and total body circumference (chest + waist + hip + upper arm + thigh) [-16.9 (-21.5, -12.3) cm vs. -5.8 (-9.0, -2.6) cm] ( p  < 0.01 for all). Additionally, more participants in the commercial program group lost a clinically meaningful amount of weight, defined as ≥5% of initial body weight, at week 16 (58% vs. 13%, p  < 0.001). The commercial program resulted in greater weight loss and improvements in body composition/anthropometric parameters compared to a self-directed DASH diet over a 16-week period. Some important limitations were that no objective measurements of dietary intake or physical activity were collected to potentially ascertain the independent or combined effects of these components on weight loss (or lack thereof). Additionally, future research is warranted in order to understand the effects of this program, and similar programs, on longer term changes in body weight, in particular weight loss maintenance, as weight regain is common following the cessation of a structured weight loss intervention.

Mail and phone interventions for weight loss in a managed-care setting: Weigh-To-Be one-year outcomes.

PubMed

Jeffery, R W; Sherwood, N E; Brelje, K; Pronk, N P; Boyle, R; Boucher, J L; Hase, K

2003-12-01

To describe methods, recruitment success, and 1-y results of a study evaluating the effectiveness of phone- and mail-based weight-loss interventions in a managed care setting. Randomized clinical trial with three groups, that is, usual care, mail intervention, and phone intervention. In total, 1801 overweight members of a managed-care organization (MCO). Height, weight, medical status, and weight-loss history were measured at baseline. Participation in intervention activities was monitored for 12 months in the two active treatment groups. Self-reported weight was obtained at 6 and 12 months. More individuals assigned to mail treatment started it (88%) than did those assigned to phone treatment (69%). However, program completion rates were higher in the phone (36%) than mail (7%) intervention. The mean weight losses were 1.93, 2.38, and 1.47 kg at 6 months in the mail, phone, and usual care groups, respectively. The differences between the phone and usual care groups were statistically significant. The mean weight losses at 12 months did not differ by treatment group (2.28 kg mail, 2.29 kg phone, and 1.92 kg usual care). Greater weight loss was seen in men, older participants, and those with no prior experience in a weight-loss program. Heavier participants and those who reported current treatment for depression lost less weight. Although mail- and phone-based weight-loss programs can be delivered to large numbers of people in an MCO setting, additional work is needed to enhance their clinical efficacy as well as to assess their costs.

Weight loss prevents urinary incontinence in women with type 2 diabetes: results from the Look AHEAD trial.

PubMed

Phelan, Suzanne; Kanaya, Alka M; Subak, Leslee L; Hogan, Patricia E; Espeland, Mark A; Wing, Rena R; Burgio, Kathryn L; DiLillo, Vicki; Gorin, Amy A; West, Delia S; Brown, Jeanette S

2012-03-01

We determined the effect of weight loss on the prevalence, incidence and resolution of weekly or more frequent urinary incontinence in overweight/obese women with type 2 diabetes after 1 year of intervention in the Look AHEAD (Action for Health in Diabetes) trial. Women in this substudy (2,739, mean ± SD age 57.9 ± 6.8 years, body mass index 36.5 ± 6.1 kg/m(2)) were randomized into an intensive lifestyle weight loss intervention or a diabetes support and education control condition. At baseline 27% of participants reported urinary incontinence on a validated questionnaire (no significant difference by intensive lifestyle intervention vs diabetes support and education). After 1 year of intervention the intensive lifestyle intervention group in this substudy lost 7.7 ± 7.0 vs 0.7 ± 5.0 kg in the diabetes support and education group. At 1 year fewer women in the intensive lifestyle intervention group reported urinary incontinence (25.3% vs 28.6% in the diabetes support and education group, p = 0.05). Among participants without urinary incontinence at baseline 10.5% of intensive lifestyle intervention and 14.0% of diabetes support and education participants experienced urinary incontinence after 1 year (p = 0.02). There were no significant group differences in the resolution of urinary incontinence (p >0.17). Each kg of weight lost was associated with a 3% reduction in the odds of urinary incontinence developing (p = 0.01), and weight losses of 5% to 10% reduced these odds by 47% (p = 0.002). Moderate weight loss reduced the incidence but did not improve the resolution rates of urinary incontinence at 1 year among overweight/obese women with type 2 diabetes. Weight loss interventions should be considered for the prevention of urinary incontinence in overweight/obese women with diabetes. Copyright © 2012 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Presurgical weight loss affects tumour traits and circulating biomarkers in men with prostate cancer

PubMed Central

Demark-Wahnefried, Wendy; Rais-Bahrami, Soroush; Desmond, Renee A; Gordetsky, Jennifer B; Hunter, Gary R; Yang, Eddy S; Azrad, Maria; Frugé, Andrew D; Tsuruta, Yuko; Norian, Lyse A; Segal, Roanne; Grizzle, William E

2017-01-01

Background: Obesity is associated with aggressive prostate cancer. To explore whether weight loss favourably affects tumour biology and other outcomes, we undertook a presurgical trial among overweight and obese men with prostate cancer. Methods: This single-blinded, two-arm randomised controlled trial explored outcomes of a presurgical weight loss intervention (WLI) that promoted ∼1 kg per week loss via caloric restriction and increased physical activity (PA). Forty overweight/obese men with clinically confirmed prostate cancer were randomised to the WLI presurgery or to a control arm; changes in weight, body composition, quality-of-life, circulating biomarkers, gene expression, and immunohistochemical markers in tumour and benign prostatic tissue were evaluated. Results: The study period averaged 50 days. Mean (s.d.) change scores for the WLI vs control arms were as follows: weight: −4.7 (3.1) kg vs −2.2 (4.4) kg (P=0.0508); caloric intake: −500 (636) vs −159 (600) kcal per day (P=0.0034); PA: +0.9 (3.1) vs +1.7 (4.6) MET-hours per day (NS); vitality: +5.3 (7.l4) vs −1.8 (8.1) (P=0.0491); testosterone: +55.1 (86.0) vs −48.3 (203.7) ng dl−1 (P=0.0418); sex hormone-binding globulin: +14.0 (14.6) vs +1.8 (7.6) nmol l−1 (P=0.0023); and leptin: −2.16 (2.6) vs −0.03 (3.75) (P=0.0355). Follow-up Ki67 was significantly higher in WLI vs control arms; median (interquartile range): 5.0 (2.5,10.0) vs 0.0 (0.0,2.5) (P=0.0061) and several genes were upregulated, for example, CTSL, GSK3B, MED12, and LAMC2. Conclusions: Intentional weight loss shows mixed effects on circulating biomarkers, tumour gene expression, and proliferative markers. More study is needed before recommending weight loss, in particular rapid weight loss, among men with prostate cancer. PMID:28881355

Effects of an Abbreviated Obesity Intervention Supported by Mobile Technology: The ENGAGED Randomized Clinical Trial

PubMed Central

Spring, Bonnie; Pellegrini, Christine A.; Pfammatter, Angela; Duncan, Jennifer M.; Pictor, Alex; McFadden, H. Gene; Siddique, Juned; Hedeker, Donald

2017-01-01

Objectives To determine the effects on weight loss of three abbreviated behavioral weight loss interventions with and without coaching and mobile technology. Methods Randomized controlled efficacy study of three six-month weight loss treatments delivered to 96 adults with obesity: 1) self-guided [SELF], 2) standard [STND], or 3) technology-supported [TECH]. STND and TECH received 8 in-person group treatment sessions. SELF and STND used paper diaries to self-monitor diet, activity, and weight; TECH used a smartphone application with social networking features and wireless accelerometer. Results Weight loss was greater for TECH and STND than SELF at 6 months [−5.7kg (95% CI: −7.2, −4.1) vs. −2.7kg (95% CI: −5.1, −0.3), p<.05]), but not 12 months. TECH and STND did not differ except that more STND (59%) than TECH (34%) achieved ≥5% weight loss at 6 months (P < 0.05). Self-monitoring adherence was greater in TECH than STND (P <0.001), greater in both interventions than SELF (P <0.001), and covaried with weight loss (r(84) = 0.36 − 0.51, P<.001). Conclusions Abbreviated behavioral counseling can produce clinically meaningful weight loss regardless of whether self-monitoring is performed on paper or smartphone, but long-term superiority over standard of care self-guided treatment is challenging to maintain. PMID:28494136

Effect of Weight Loss with or without Exercise on Inflammatory Markers and Adipokines in Postmenopausal Women: The SHAPE-2 Trial, A Randomized Controlled Trial.

PubMed

van Gemert, Willemijn A; May, Anne M; Schuit, Albertine J; Oosterhof, Blanche Y M; Peeters, Petra H; Monninkhof, Evelyn M

2016-05-01

We investigated the effect of equivalent weight loss, by a hypocaloric diet or mainly exercise, on inflammatory markers and adipokines in overweight postmenopausal women. Women were randomized to a diet (n = 97), mainly exercise (n = 98), or control group (n = 48). Goal of both interventions was to lose 5 to 6 kg bodyweight by a hypocaloric diet or an exercise program (4 hours/week) combined with a small caloric intake restriction. Outcomes after 16 weeks included serum high-sensitive C-reactive protein (hsCRP), IL6, adiponectin, and leptin. Both intervention groups achieved the target weight loss. Controls remained weight stable. Compared with control, hsCRP decreased with mainly exercise [treatment effect ratio (TER) = 0.64] and borderline statistically significant with diet (TER = 0.77). There was a suggestively larger effect of exercise, directly compared with diet (TER = 0.83). Leptin decreased with both interventions: mainly exercise (TER = 0.55) and diet (TER = 0.59), versus control. Effects attenuated and lost significance after adjusting for change in body fat percentage, and to a lesser extent when adjusting for fitness. No effects were seen on IL6 and adiponectin. A 16-week randomized intervention inducing comparable weight loss by a hypocaloric diet or mainly exercise, resulted in favorable effects on serum hsCRP and leptin. We found a possible more beneficial effect on hsCRP with mainly exercise versus diet. These effects of exercise were established by changes in body fat percentage and physical fitness. A modest amount of weight loss in postmenopausal women reduces hsCRP and leptin levels which might be associated with a lower breast cancer risk. Cancer Epidemiol Biomarkers Prev; 25(5); 799-806. ©2016 AACR. ©2016 American Association for Cancer Research.

Protocol and recruitment results from a randomized controlled trial comparing group phone-based versus newsletter interventions for weight loss maintenance among rural breast cancer survivors.

PubMed

Befort, Christie A; Klemp, Jennifer R; Fabian, Carol; Perri, Michael G; Sullivan, Debra K; Schmitz, Kathryn H; Diaz, Francisco J; Shireman, Theresa

2014-03-01

Obesity is a risk factor for breast cancer recurrence and death. Women who reside in rural areas have higher obesity prevalence and suffer from breast cancer treatment-related disparities compared to urban women. The objective of this 5-year randomized controlled trial is to compare methods for delivering extended care for weight loss maintenance among rural breast cancer survivors. Group phone-based counseling via conference calls addresses access barriers, is more cost-effective than individual phone counseling, and provides group support which may be ideal for rural breast cancer survivors who are more likely to have unmet support needs. Women (n=210) diagnosed with Stage 0 to III breast cancer in the past 10 years who are ≥ 3 months out from initial cancer treatments, have a BMI 27-45 kg/m(2), and have physician clearance were enrolled from multiple cancer centers. During Phase I (months 0 to 6), all women receive a behavioral weight loss intervention delivered through group phone sessions. Women who successfully lose 5% of weight enter Phase II (months 6 to 18) and are randomized to one of two extended care arms: continued group phone-based treatment or a mail-based newsletter. During Phase III, no contact is made (months 18 to 24). The primary outcome is weight loss maintenance from 6 to 18 months. Secondary outcomes include quality of life, serum biomarkers, and cost-effectiveness. This study will provide essential information on how to reach rural survivors in future efforts to establish weight loss support for breast cancer survivors as a standard of care. Copyright © 2014 Elsevier Inc. All rights reserved.

Meal replacement with a low-calorie diet formula in weight loss maintenance after weight loss induction with diet alone.

PubMed

Vázquez, C; Montagna, C; Alcaraz, F; Balsa, J A; Zamarrón, I; Arrieta, F; Botella-Carretero, J I

2009-10-01

Weight loss in obesity can reduce morbidity and mortality and benefits persist as long as weight loss is maintained. Weight maintenance is difficult in the long term and new strategies need to be developed to achieve this goal. We aimed to evaluate the efficacy of substituting a low-calorie diet formula for a meal in a weight loss program during the maintenance phase. Randomized paralleled clinical trial including 62 adult patients with at least a 5% weight loss with diet alone for 6 months, randomized to two groups: daily replacement of one meal with a low-calorie diet formula, or dieting alone for another 6 months (weight maintenance phase). Weight maintenance or further weight loss occurred in 83.9% of patients in the intervention group, whereas only in 58.1% in the control group (P=0.025). As a whole, patients in the intervention group lost a further 3.2+/-3.7% of initial weight compared with a 1.3+/-3.6% in the control group (P=0.030). Body fat mass diminished in both groups, with no differences between them (1.6+/-3.5 vs 1.0+/-9.3 kg, respectively, P=0.239), and the same happened with free fat mass (0.9+/-3.3 vs 0.4+/-6.7 kg, respectively, P=0.471). A multivariate logistic regression analysis (R (2)=0.114, P=0.023) retained only the intervention as a predictor of the achievement of weight maintenance with an odds ratio (95% confidence interval) of 3.756 (1.138-12.391). Substitution of a low-calorie diet formula for a meal is an effective measure for weight loss maintenance compared with dieting alone.

Treatment of clozapine-associated obesity and diabetes with exenatide in adults with schizophrenia: A randomized controlled trial (CODEX).

PubMed

Siskind, Dan J; Russell, Anthony W; Gamble, Clare; Winckel, Karl; Mayfield, Karla; Hollingworth, Sam; Hickman, Ingrid; Siskind, Victor; Kisely, Steve

2018-04-01

Clozapine causes obesity and type 2 diabetes (T2DM). Glucagon-like peptide-1 (GLP-1) receptor agonists (e.g. exenatide) can counter clozapine-associated GLP-1 dysregulation in animals, and may be beneficial in people on clozapine. This randomized, controlled, open-label, pilot trial evaluated weekly exenatide for weight loss among clozapine-treated obese adults with schizophrenia, with or without T2DM. A total of 28 outpatients were randomized to once-weekly extended-release subcutaneous exenatide or usual care for 24 weeks. The primary outcome was proportion of participants with >5% weight loss. All 28 participants completed the study; 3/14 in the exenatide group and 2/14 in the usual care group had T2DM. Six people on exenatide achieved >5% weight loss vs one receiving usual care (P = .029). Compared with usual care, participants on exenatide had greater mean weight loss (-5.29 vs -1.12 kg; P = .015) and body mass index reduction (-1.78 vs -0.39 kg/m 2 ; P = .019), and reduced fasting glucose (-0.34 vs 0.39 mmol/L; P = .036) and glycated haemoglobin levels (-0.21% vs 0.03%; P = .004). There were no significant differences in other metabolic syndrome components. Exenatide may be a promising therapeutic agent for glycaemic control and weight loss in clozapine-treated people with obesity, and could assist in reducing clozapine-associated cardio-metabolic morbidity and mortality. © 2017 John Wiley & Sons Ltd.

Comparative effectiveness of plant-based diets for weight loss: a randomized controlled trial of five different diets.

PubMed

Turner-McGrievy, Gabrielle M; Davidson, Charis R; Wingard, Ellen E; Wilcox, Sara; Frongillo, Edward A

2015-02-01

The aim of this study was to determine the effect of plant-based diets on weight loss. Participants were enrolled in a 6-mo, five-arm, randomized controlled trial in 2013 in South Carolina. Participants attended weekly group meetings, with the exception of the omnivorous group, which served as the control and attended monthly meetings augmented with weekly e-mail lessons. All groups attended monthly meetings for the last 4 mo of the study. Diets did not emphasize caloric restriction. Overweight adults (body mass index 25-49.9 kg/m(2); age 18-65 y, 19% non-white, and 27% men) were randomized to a low-fat, low-glycemic index diet: vegan (n = 12), vegetarian (n = 13), pesco-vegetarian (n = 13), semi-vegetarian (n = 13), or omnivorous (n = 12). Fifty (79%) participants completed the study. In intention-to-treat analysis, the linear trend for weight loss across the five groups was significant at both 2 (P < 0.01) and 6 mo (P < 0.01). At 6 mo, the weight loss in the vegan group (-7.5% ± 4.5%) was significantly different from the omnivorous (-3.1% ± 3.6%; P = 0.03), semi-vegetarian (-3.2% ± 3.8%; P = 0.03), and pesco-vegetarian (-3.2% ± 3.4%; P = 0.03) groups. Vegan participants decreased their fat and saturated fat more than the pesco-vegetarian, semi-vegetarian, and omnivorous groups at both 2 and 6 mo (P < 0.05). Vegan diets may result in greater weight loss than more modest recommendations. Copyright © 2015 Elsevier Inc. All rights reserved.

PreDictor Research in Obesity during Medical care - weight Loss in children and adolescents during an INpatient rehabilitation: rationale and design of the DROMLIN study

PubMed Central

2014-01-01

Background Obesity in adults and children is increasing worldwide at alarming rates. Obese children and adolescents are likely to become obese adults with increased risk of a number of comorbidities. In addition to preventing the development of obesity at young age, it is necessary to individualize the therapy of already obese children and adolescents in order to increase the likelihood of weight loss and maintenance. Therefore, the aim of this study is to identify predictors which play a significant role in successful weight loss and weight loss maintenance in children and adolescents. Methods/Design Over a one year period, 60 obese children and adolescents between 9 to 17 years of age shall be recruited at an inpatient children rehabilitation facility in Germany. They will be investigated twice within a few days following admission and prior to discharge. The study will be an integrated component of an established inpatient weight-loss and in part psychosomatic therapy. The collected data can be grouped into four clusters: 1) demographic, sociometric and psychometric data, 2) objective and subjective parameters of body condition, 3) autonomic nervous system regulated functions and 4) objective and subjective parameters for eating behavior. Primary outcome is the change of the body mass index standard deviation score (BMI-SDS). In order to evaluate the data appropriately, all examinations will be also conducted in a normal-weight reference group, matched for age and gender. Discussion For some of the collected parameters the time span between measures may be too short. Therefore, a 6 months, 1 year and 2 year follow-up will be performed for evaluating the different predictors and their influence in regard to a successful intervention. Further middle- and long-term follow-up studies are planned. Trial Registration The study protocol was approved by the Ethics Committee of the University Hospital Tübingen, Germany. This study is registered at the German Clinical Trials Register (DRKS) with the clinical trial number DRKS00005122. PMID:24764531

Adherence and success in long-term weight loss diets: the dietary intervention randomized controlled trial (DIRECT).

PubMed

Greenberg, Ilana; Stampfer, Meir J; Schwarzfuchs, Dan; Shai, Iris

2009-04-01

Data are limited as to whether participants in diet trials truly adhere to their assigned diet and the factors that affect their adherence. We evaluated success and adherence in a two-year dietary intervention randomized controlled trial (DIRECT) in which 322 moderately obese participants (mean age 52 yrs, mean body-mass-index (BMI) 31 kg/m(2), 86% men) were randomized to one of three groups: low-fat, Mediterranean, or low-carbohydrate diets. Overall compliance at month-24 was 85%, with 90% in low-fat, 85% in Mediterranean, and 78% in low-carbohydrate diet (p = .042 between groups). Attrition was higher in women (29% vs. 14% men, p = .001) and current smokers (25% vs. 14% among maintainers, p = 0.04). In a multivariate model, independent predictors of dropping-out were: higher baseline BMI (OR = 1.11; CI: 1.03-1.21) and less weight loss at month-6 (OR = 1.20; CI: 1.1-1.3). In a multivariate model, greater weight loss achieved at month-6 was the main predictor associated with success in weight loss (> 5%) over 2 years (OR = 1.5; CI: 1.35-1.67). Self-reported complete adherence score to diet was greater on low-carbohydrate diet (p < .05 compared to low-fat) until month-6, but dropped overall from 81% at month-1 to 57% at month-24. Holidays were a trigger to a significant decrease in adherence followed by a partial rebound. Changes in diet composition from month-1 to month-12 were more pronounced in the multi-stage low-carbohydrate diet-group (p < .05). Generally, the most irresistible restricted food items were cookies (45% of dieters) and fruits (30%). Among the physically active (n = 107), 44% reported a tendency to eat less after exercising compared to 10% who tended to eat more. Initial 6-month reduction in weight is the main predictor of both long-term retention and success in weight loss. Special attention is needed for women, current smokers, and during holidays. Physical activity is associated with subsequent reduction in energy intake.

Meal-based enhancement of protein quality and quantity during weight loss in obese older adults with mobility limitations: rationale and design for the MEASUR-UP trial.

PubMed

McDonald, Shelley R; Porter Starr, Kathryn N; Mauceri, Luisa; Orenduff, Melissa; Granville, Esther; Ocampo, Christine; Payne, Martha E; Pieper, Carl F; Bales, Connie W

2015-01-01

Obese older adults with even modest functional limitations are at a disadvantage for maintaining their independence into late life. However, there is no established intervention for obesity in older individuals. The Measuring Eating, Activity, and Strength: Understanding the Response - Using Protein (MEASUR-UP) trial is a randomized controlled pilot study of obese women and men aged ≥60 years with mild to moderate functional impairments. Changes in body composition (lean and fat mass) and function (Short Physical Performance Battery) in an enhanced protein weight reduction (Protein) arm will be compared to those in a traditional weight loss (Control) arm. The Protein intervention is based on evidence that older adults achieve optimal rates of muscle protein synthesis when consuming about 25-30 g of high quality protein per meal; these participants will consume ~30 g of animal protein at each meal via a combination of provided protein (beef) servings and diet counseling. This trial will provide information on the feasibility and efficacy of enhancing protein quantity and quality in the context of a weight reduction regimen and determine the impact of this intervention on body weight, functional status, and lean muscle mass. We hypothesize that the enhancement of protein quantity and quality in the Protein arm will result in better outcomes for function and/or lean muscle mass than in the Control arm. Ultimately, we hope our findings will help identify a safe weight loss approach that can delay or prevent late life disability by changing the trajectory of age-associated functional impairment associated with obesity. Copyright © 2014 Elsevier Inc. All rights reserved.

A losing battle: weight regain does not restore weight loss-induced bone loss in postmenopausal women.

PubMed

Villalon, Karen L; Gozansky, Wendolyn S; Van Pelt, Rachael E; Wolfe, Pam; Jankowski, Catherine M; Schwartz, Robert S; Kohrt, Wendy M

2011-12-01

Previously, we reported significant bone mineral density (BMD) loss in postmenopausal women after modest weight loss. It remains unclear whether the magnitude of BMD change in response to weight loss is appropriate (i.e., proportional to weight loss) and whether BMD is recovered with weight regain. We now report changes in BMD after a 1-year follow-up. Subjects (n = 23) in this secondary analysis were postmenopausal women randomized to placebo as part of a larger trial. They completed a 6-month exercise-based weight loss program and returned for follow-up at 18 months. Dual-energy X-ray absorptiometry (DXA) was performed at baseline, 6, and 18 months. At baseline, subjects were aged 56.8 ± 5.4 years (mean ± s.d.), 10.0 ± 9.2 years postmenopausal, and BMI was 29.6 ± 4.0 kg/m(2). They lost 3.9 ± 3.5 kg during the weight loss intervention. During follow-up, they regained 2.9 ± 3.9 kg. Six months of weight loss resulted in a significant decrease in lumbar spine (LS) (-1.7 ± 3.5%; P = 0.002) and hip (-0.04 ± 3.5%; P = 0.03) BMD that was accompanied by an increase in a biomarker of bone resorption (serum C-terminal telopeptide of type I collagen, CTX: 34 ± 54%; P = 0.08). However, weight regain was not associated with LS (0.05 ± 3.8%; P = 0.15) or hip (-0.6 ± 3.0%; P = 0.81) bone regain or decreased bone resorption (CTX: -3 ± 37%; P = 0.73). The findings suggest that BMD lost during weight reduction may not be fully recovered with weight regain in hormone-deficient, postmenopausal women. Future studies are needed to identify effective strategies to prevent bone loss during periods of weight loss.

Evaluation of the Human/Extreme Environment Interaction: Implications for Enhancing Operational Performance and Recovery

DTIC Science & Technology

2011-10-01

healthy conditions such as exercise (6) and weight loss (22,48) while fission (degradation, dysfunction) is associated with obesity and disease (3,4...before each trial. Following an overnight 12 hour fast , participants arrived at the laboratory in the early morning to complete testing. Upon...type 2 diabetes, obesity , weight loss, and the regulatory role of tumor necrosis factor alpha and interleukin-6. Diabetes 54: 2685-2693, 2005. 4

Habit-based interventions for weight loss maintenance in adults with overweight and obesity: a randomized controlled trial.

PubMed

Cleo, Gina; Glasziou, Paul; Beller, Elaine; Isenring, Elisabeth; Thomas, Rae

2018-04-23

The objective of this study was to determine whether habit-based interventions are clinically beneficial in achieving long-term (12-month) weight loss maintenance and explore whether making new habits or breaking old habits is more effective. Volunteer community members aged 18-75 years who had overweight or obesity (BMI ≥ 25 kg/m 2 ) were randomized in a single-blind, three-arm, randomized controlled trial. Ten Top Tips (TTT), Do Something Different (DSD), and the attention-only waitlist (WL) control groups were conducted for 12 weeks from July to October 2015. Participants were followed up post-intervention (all groups) and at 6 and 12-month post-intervention (Ten Top Tips and Do Something Different only). The primary outcome was weight-loss maintenance at 12-month follow-up. Secondary outcomes included weight loss at all time points, fruit and vegetable consumption, exercise, wellbeing, depression, anxiety, habit strength, and openness to change. Of the 130 participants assessed for eligibility, 75 adults (mean BMI 34.5 kg/m 2 [SD 6.2]), with a mean age of 51 years were recruited. Assessments were completed post-intervention by 66/75 (88%) of participants and by 43/50 (86%) at 12 months. At post-intervention, participants in the Ten Top Tips (-3.3 kg; 95% CI -5.2, -1.4) and Do Something Different (-2.9 kg; 95% CI -4.3, -1.4) interventions lost significantly more weight (P = < .001) than those on the waitlist control (-0.4 kg; 95% CI -1.2, 0.3). Both intervention groups continued to lose further weight to the 12-month follow-up; TTT lost an additional -2.4 kg (95% CI -5.1, 0.4) and DSD lost -1.7 kg (95% CI -3.4, -0.1). At 12-month post-intervention, 28/43 (65%) of participants in both intervention groups had reduced their total body weight by ≥5%, a clinically important change. Habit-based weight-loss interventions-forming new habits (TTT) and breaking old habits (DSD), resulted in clinically important weight-loss maintenance at 12-month follow-up.

Do intermittent diets provide physiological benefits over continuous diets for weight loss? A systematic review of clinical trials.

PubMed

Seimon, Radhika V; Roekenes, Jessica A; Zibellini, Jessica; Zhu, Benjamin; Gibson, Alice A; Hills, Andrew P; Wood, Rachel E; King, Neil A; Byrne, Nuala M; Sainsbury, Amanda

2015-12-15

Energy restriction induces physiological effects that hinder further weight loss. Thus, deliberate periods of energy balance during weight loss interventions may attenuate these adaptive responses to energy restriction and thereby increase the efficiency of weight loss (i.e. the amount of weight or fat lost per unit of energy deficit). To address this possibility, we systematically searched MEDLINE, PreMEDLINE, PubMed and Cinahl and reviewed adaptive responses to energy restriction in 40 publications involving humans of any age or body mass index that had undergone a diet involving intermittent energy restriction, 12 with direct comparison to continuous energy restriction. Included publications needed to measure one or more of body weight, body mass index, or body composition before and at the end of energy restriction. 31 of the 40 publications involved 'intermittent fasting' of 1-7-day periods of severe energy restriction. While intermittent fasting appears to produce similar effects to continuous energy restriction to reduce body weight, fat mass, fat-free mass and improve glucose homeostasis, and may reduce appetite, it does not appear to attenuate other adaptive responses to energy restriction or improve weight loss efficiency, albeit most of the reviewed publications were not powered to assess these outcomes. Intermittent fasting thus represents a valid--albeit apparently not superior--option to continuous energy restriction for weight loss. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Habitual physical activity and plasma metabolomic patterns distinguish individuals with low vs. high weight loss during controlled energy restriction.

PubMed

Piccolo, Brian D; Keim, Nancy L; Fiehn, Oliver; Adams, Sean H; Van Loan, Marta D; Newman, John W

2015-04-01

Total weight loss induced by energy restriction is highly variable even under tightly controlled conditions. Identifying weight-loss discriminants would provide a valuable weight management tool and insights into body weight regulation. This study characterized responsiveness to energy restriction in adults from variables including the plasma metabolome, endocrine and inflammatory markers, clinical indices, body composition, diet, and physical activity. Data were derived from a controlled feeding trial investigating the effect of 3-4 dairy product servings in an energy-restricted diet (2092 kJ/d reduction) over 12 wk. Partial least squares regression was used to identify weight-loss discriminants in 67 overweight and obese adults. Linear mixed models were developed to identify discriminant variable differences in high- vs. low-weight-loss responders. Both pre- and postintervention variables (n = 127) were identified as weight-loss discriminants (root mean squared error of prediction = 1.85 kg; Q(2) = 0.43). Compared with low-responders (LR), high-responders (HR) had greater decreases in body weight (LR: 2.7 ± 1.6 kg; HR: 9.4 ± 1.8 kg, P < 0.01), BMI (in kg/m(2); LR: 1.0 ± 0.6; HR: 3.3 ± 0.5, P < 0.01), and total fat (LR: 2.2 ± 1.1 kg; HR: 8.0 ± 2.1 kg, P < 0.01). Significant group effects unaffected by the intervention were determined for the respiratory exchange ratio (LR: 0.86 ± 0.05; HR: 0.82 ± 0.03, P < 0.01), moderate physical activity (LR: 127 ± 52 min; HR: 167 ± 68 min, P = 0.02), sedentary activity (LR: 1090 ± 99 min; HR: 1017 ± 110 min, P = 0.02), and plasma stearate [LR: 102,000 ± 21,000 quantifier ion peak height (QIPH); HR: 116,000 ± 24,000 QIPH, P = 0.01]. Overweight and obese individuals highly responsive to energy restriction had accelerated reductions in adiposity, likely supported in part by higher lipid mobilization and combustion. A novel observation was that person-to-person differences in habitual physical activity and magnitude of weight loss were accompanied by unique blood metabolite signatures. This trial was registered at clinicaltrials.gov as NCT00858312. © 2015 American Society for Nutrition.

Long-Term Effects of Weight Loss and Exercise on Biomarkers Associated with Angiogenesis.

PubMed

Duggan, Catherine; Tapsoba, Jean de Dieu; Wang, Ching-Yun; Schubert, Karen E Foster; McTiernan, Anne

2017-12-01

Background: We tested the effect of weight loss on circulating levels of the angiogenic factors VEGF and pigment epithelium-derived factor (PEDF) in postmenopausal overweight/obese women, 18 months after completing a year-long 4-arm randomized controlled trial of behavioral weight loss and/or exercise versus control (i.e., 30 months postrandomization). Methods: The 439 overweight/obese, postmenopausal women, ages 50 to 75 years, were randomized to: diet (goal: 10% weight loss, N = 118), exercise (225 min/wk moderate-to-vigorous activity, N = 117), diet + exercise ( N = 117), or control ( N = 87). At 12 months, 399 women gave a blood sample; 156 returned at 30 months. Biomarkers were measured by immunoassay. Changes were compared using generalized estimating equations, adjusting for baseline BMI, age, and race/ethnicity. Results: Participants randomized to diet, exercise, and diet + exercise arms had greater reductions in VEGF at 30 months (-14.1% P = 0.02; -19.7% P = 0.003; -14.5% P = 0.002, respectively) versus controls (-4.5%). There were no statistically significant changes in PEDF in any intervention arm. Participants maintaining ≥10% of baseline weight loss at 30 months had greater reductions in VEGF versus those who gained weight/had no weight change (-22.3% vs. -10.2% respectively, P = 0.002). Participants maintaining any weight loss had significantly lower levels of PEDF at 30 months versus those who gained weight/no weight change. Conclusions: Sustained weight loss via diet and/or exercise results in reductions in angiogenic factors, and can be maintained up to 30-month follow-up. Limitations include relatively small numbers, and possible bias toward more successful weight loss among women who returned at 30 months. Impact: Maintaining weight loss can achieve long-term reductions in biomarkers of angiogenesis that can persist up to 18 months after completion of a weight loss intervention. Cancer Epidemiol Biomarkers Prev; 26(12); 1788-94. ©2017 AACR . ©2017 American Association for Cancer Research.

The effects of mindfulness training on weight-loss and health-related behaviours in adults with overweight and obesity: A systematic review and meta-analysis.

PubMed

Ruffault, Alexis; Czernichow, Sébastien; Hagger, Martin S; Ferrand, Margot; Erichot, Nelly; Carette, Claire; Boujut, Emilie; Flahault, Cécile

The aim of this study was to conduct a comprehensive quantitative synthesis of the effects of mindfulness training interventions on weight-loss and health behaviours in adults with overweight and obesity using meta-analytic techniques. Studies included in the analysis (k=12) were randomised controlled trials investigating the effects of any form of mindfulness training on weight loss, impulsive eating, binge eating, or physical activity participation in adults with overweight and obesity. Random effects meta-analysis revealed that mindfulness training had no significant effect on weight loss, but an overall negative effect on impulsive eating (d=-1.13) and binge eating (d=-.90), and a positive effect on physical activity levels (d=.42). Meta-regression analysis showed that methodological features of included studies accounted for 100% of statistical heterogeneity of the effects of mindfulness training on weight loss (R 2 =1,00). Among methodological features, the only significant predictor of weight loss was follow-up distance from post-intervention (β=1.18; p<.05), suggesting that the longer follow-up distances were associated with greater weight loss. Results suggest that mindfulness training has short-term benefits on health-related behaviours. Future studies should explore the effectiveness of mindfulness training on long-term post-intervention weight loss in adults with overweight and obesity. Copyright © 2016 Asia Oceania Association for the Study of Obesity. Published by Elsevier Ltd. All rights reserved.

Family PArtners in Lifestyle Support (PALS): Family-Based Weight Loss for African American Adults with Type 2 Diabetes

PubMed Central

Samuel-Hodge, Carmen D.; Holder-Cooper, Judith C.; Gizlice, Ziya; Davis, Gwendolyn; Steele, Sonia P.; Keyserling, Thomas C.; Kumanyika, Shiriki K.; Brantley, Phillip J.; Svetkey, Laura P.

2016-01-01

Objective To develop and test a family-centered behavioral weight loss intervention for African American adults with type 2 diabetes. Methods In this randomized trial, dyads consisting of African American adult with overweight or obesity and type 2 diabetes (index participant) paired with a family partner with overweight or obesity, but not diagnosed with diabetes, were assigned in a 2:1 ratio to a 20-week special intervention (SI) or delayed intervention (DI) control group. The primary outcome was weight loss among index participants at 20 weeks follow-up. Results One hundred-eight participants (54 dyads – 36 (SI) and 18 (DI) dyads) were enrolled: 81% females; mean age, 51 years; mean weight,103 kg; and mean BMI, 37 kg/m2. At post-intervention, 96 participants (89%) returned for follow-up measures. Among index participants, mean difference in weight loss between groups was −5.0 kg, p<.0001 (−3.6 kg loss among SI; 1.4 kg gain in DI). SI index participants showed significantly greater improvements in hemoglobin A1c, depressive symptoms, family interactions, and dietary, physical activity, and diabetes self-care behaviors. SI family partners also had significant weight loss (−3.9 kg (SI) vs. −1.0 kg (DI) p=0.02). Conclusions A family-centered, behavioral weight loss intervention led to clinically significant short-term weight loss among family dyads. PMID:27911049

Preoperative weight loss program targeting women with overweight and hypertrophy of the breast - a pilot study.

PubMed

Geiker, N R W; Horn, J; Astrup, A

2017-04-01

Among women with hypertrophic breasts, the clear majority are overweight or obese. Owing to increased risk of complications, women with a body mass index (BMI) above 25 kg m -2 are precluded from reduction mammaplasty. The primary aim was to investigate if intensive weight loss could ready women with overweight for breast reduction surgery. Six women, all overweight [BMI 30.9 {28.5; 35.8} kg m -2 ] with symptomatic hypertrophy of the breast, were included a 12-week weight loss program. All women desired reduction mammaplasty and were motivated for preoperational weight loss. The first 8 weeks consisted of a formula-based diet supplying 800 kcal daily, in the subsequent 4 weeks regular foods were reintroduced increasing the intake to 1200 kcal daily. Five women completed the trial, and achieved a median (range) weight loss of 10.2 (6.5; 19) kg. Initial breast volume was 1100-2500 mL per breast, this was reduced by 300 (200; 500) mL after the intervention; equivalent to approximately 19%. Waist, hip, upper arm and thorax circumference were significantly reduced following weight loss. At end of study, all the women still suffered from symptomatic breast hypertrophy to substantiate reduction mammaplasty. Surgeries were performed 2 months thereafter. A 12-week intensive preoperative weight loss program enabled women with obesity for breast reduction surgery. Breast size was reduced proportionally more than total weight loss among women with hypertrophy. © 2017 World Obesity Federation.

Effects of canagliflozin on body weight and body composition in patients with type 2 diabetes over 104 weeks.

PubMed

Blonde, Lawrence; Stenlöf, Kaj; Fung, Albert; Xie, John; Canovatchel, William; Meininger, Gary

2016-05-01

Canagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, has been associated with weight loss in a broad range of patients with type 2 diabetes mellitus (T2DM). This analysis further evaluated changes in body weight and composition with canagliflozin in two 104-week, Phase 3 studies. In Study 1, patients aged 18-80 years (N = 1,450) received canagliflozin 100 or 300 mg or glimepiride as add-on to metformin for a 52-week core treatment period, followed by a 52-week extension period. In Study 2, patients aged 55-80 years (N = 714) received canagliflozin 100 or 300 mg or placebo added to stable background antihyperglycemic agents for a 26-week core treatment period, followed by a 78-week extension period. Percent change from baseline in body weight; proportion of patients with any weight loss, ≥5% weight loss, and ≥10% weight loss; change in body mass index (BMI) and waist circumference; change in body weight across weight-loss quartiles; and changes in body composition were evaluated in both studies. Canagliflozin 100 and 300 mg provided sustained weight loss versus either glimepiride or placebo over 104 weeks. More patients experienced any weight loss and ≥5% weight loss with canagliflozin versus comparator. Across the 3 highest weight-loss quartiles, canagliflozin provided greater weight loss versus glimepiride or placebo. BMI and waist circumference reductions were observed with canagliflozin 100 and 300 mg versus either glimepiride or placebo over 104 weeks; more patients had BMI or waist circumference reductions with canagliflozin versus comparator. Body composition analysis indicated that the majority of weight loss was due to loss of fat mass. Canagliflozin was generally well tolerated, with increased incidence of adverse events related to the SGLT2 inhibition mechanism. Canagliflozin 100 and 300 mg provided sustained reductions in body weight, BMI, and waist circumference in a greater proportion of patients with T2DM versus glimepiride or placebo over 104 weeks. ClinicalTrials.gov NCT00968812, NCT01106651.

Weight management for adolescents with intellectual and developmental disabilities: Rationale and design for an 18month randomized trial.

PubMed

Donnelly, J E; Ptomey, L T; Goetz, J R; Sullivan, D K; Gibson, C A; Greene, J L; Lee, R H; Mayo, M S; Honas, J J; Washburn, R A

2016-11-01

Adolescents with intellectual and developmental disabilities (IDD) are an underserved group in need of weight management. However, information regarding effective weight management for this group is limited, and is based primarily on results from small, non-powered, non-randomized trials that were not conducted in accordance with current weight management guidelines. Additionally, the comparative effectiveness of emerging dietary approaches, such as portion-controlled meals (PCMs) or program delivery strategies such as video chat using tablet computers have not been evaluated. Therefore, we will conduct an 18month trial to compare weight loss (6months) and maintenance (7-18months) in 123 overweight/obese adolescents with mild to moderate IDD, and a parent, randomized to a weight management intervention delivered remotely using FaceTime™ on an iPad using either a conventional meal plan diet (RD/CD) or a Stop Light diet enhanced with PCMs (RD/eSLD), or conventional diet delivered during face-to-face home visits (FTF/CD). This design will provide an adequately powered comparison of both diet (CD vs. eSLD) and delivery strategy (FTF vs. RD). Exploratory analyses will examine the influence of behavioral session attendance, compliance with recommendations for diet (energy intake), physical activity (min/day), self-monitoring of diet and physical activity, medications, and parental variables including diet quality, physical activity, baseline weight, weight change, and beliefs and attitudes regarding diet and physical activity on both weight loss and maintenance. We will also complete a cost and contingent valuation analysis to compare costs between RD and FTF delivery. Copyright © 2016. Published by Elsevier Inc.

A randomized controlled trial to prevent excessive gestational weight gain and promote postpartum weight loss in overweight and obese women: Health In Pregnancy and Postpartum (HIPP).

PubMed

Wilcox, Sara; Liu, Jihong; Addy, Cheryl L; Turner-McGrievy, Gabrielle; Burgis, Judith T; Wingard, Ellen; Dahl, Alicia A; Whitaker, Kara M; Schneider, Lara; Boutté, Alycia K

2018-03-01

Interventions to prevent excessive gestational weight gain and promote postpartum weight loss have yielded modest results, particularly in overweight and obese women. To examine the impact of a theory-based lifestyle intervention on gestational weight gain, postpartum weight loss, and related maternal and child outcomes and to examine race differences in these outcomes. A randomized controlled trial (target N=400; 200 intervention, 200 standard care; 200 African American, 200 white). Overweight and obese African American and white women ≤16weeks gestation are recruited from obstetrics and gynecology clinics in South Carolina. Intervention participants receive two in-depth counseling sessions (early pregnancy and postpartum), telephone counseling, behavioral podcasts, and social media support that target weight self-monitoring and increasing physical activity and healthy dietary behavior practices, guided by Social Cognitive Theory. Standard care participants receive monthly mailings and a matched number of podcasts on non-weight related topics. All intervention activities last from ≤18weeks gestation to 6months after delivery. Gestational weight gain is the primary outcome. Secondary outcomes are meeting gestational weight gain guidelines (inadequate, adequate, excessive), weekly rate of gestational weight gain, postpartum weight retention, physical activity and dietary behaviors, health-related quality of life, and offspring adiposity. Participants are assessed at baseline (≤16weeks gestation), 32weeks gestation, and 6 and 12months postpartum, and offspring are assessed at 6 and 12months. HIPP is an innovative study that addresses significant gaps in the literature. Primary outcome results are expected in 2019. Copyright © 2018 Elsevier Inc. All rights reserved.

No effect of weight loss on LINE-1 methylation levels in peripheral blood leukocytes from postmenopausal overweight women.

PubMed

Duggan, Catherine; Xiao, Liren; Terry, Mary Beth; McTiernan, Anne

2014-09-01

Obesity and weight-loss are associated with methylation patterns in specific genes, but their effect on Long Interspersed Nuclear Elements (LINE-1) methylation, a measure of global methylation is largely unknown. Three hundred overweight/obese post-menopausal women (50-75 years) were part of a completed, 1-year randomized controlled trial, comparing independent and combined effects of a reduced-calorie weight-loss diet, and exercise program, versus control. DNA was extracted from peripheral blood leukocytes collected at baseline and 12-months, and LINE-1 methylation analyzed by pyrosequencing. Mean changes between groups using generalized estimating equations and examined effects of weight-loss on LINE-1 methylation using stratified analyses (gained weight/no weight-loss [N = 84]; <5% [N = 45]; 5%-10% [N = 45]; >10% of baseline weight-loss [N = 126]) within each arm, adjusted by blood cell counts were compared. Associations between LINE-1 methylation and previously measured biomarkers, and anthropometrics were also examined. No significant difference in LINE-1 methylation levels was detected in any intervention group versus controls. The magnitude of weight-loss was not associated with LINE-1 methylation at 12-months. There were no associations between baseline characteristics of participants, or previously measured biomarkers, and LINE-1 methylation. Our results suggest that lifestyle changes sufficient to significantly reduce weight over 12-months may not change LINE-1 DNA methylation levels. © 2014 The Obesity Society.

A meta-analysis of overall effects of weight loss interventions delivered via mobile phones and effect size differences according to delivery mode, personal contact, and intervention intensity and duration.

PubMed

Schippers, M; Adam, P C G; Smolenski, D J; Wong, H T H; de Wit, J B F

2017-04-01

Weight loss interventions are delivered through various mediums including, increasingly, mobile phones. This systematic review and meta-analysis assesses whether interventions delivered via mobile phones reduce body weight and which intervention characteristics are associated with efficacy. The study included randomised controlled trials assessing the efficacy of weight loss interventions delivered via mobile phones. A meta-analysis to test intervention efficacy was performed, and subgroup analyses were conducted to determine whether interventions' delivery mode(s), inclusion of personal contact, duration and interaction frequency improve efficacy. Pooled body weight reduction (d = -0.23; 95% confidence interval = -0.38, -0.08) was significant. Interventions delivered via other modes in addition to the mobile phone were associated with weight reduction. Personal contact and more frequent interactions in interventions were also associated with greater weight reduction. In conclusion, the current body of evidence shows that interventions delivered via mobile phones produce a modest reduction in body weight when combined with other delivery modes. Delivering interventions with frequent and personal interactions may in particular benefit weight loss results. © 2017 World Obesity Federation.

Feasibility and effectiveness of an automated bilingual text message intervention for weight loss: pilot study.

PubMed

Kolodziejczyk, Julia K; Norman, Gregory J; Barrera-Ng, Angelica; Dillon, Lindsay; Marshall, Simon; Arredondo, Elva; Rock, Cheryl L; Raab, Fred; Griswold, William G; Sullivan, Mark; Patrick, Kevin

2013-11-06

Little is known about the feasibility and acceptability of tailored text message based weight loss programs for English and Spanish-language speakers. This pilot study evaluated the feasibility, acceptability, and estimated impact of a tailored text message based weight loss program for English and Spanish-language speakers. The purpose of this pilot study was to inform the development of a full-scale randomized trial. There were 20 overweight or obese participants (mean age 40.10, SD 8.05; 8/20, 40% male; 9/20, 45% Spanish-speakers) that were recruited in San Diego, California, from March to May 2011 and evaluated in a one-group pre/post clinical trial. For 8 weeks, participants received and responded to 3-5 text messages daily sent from a fully automated text messaging system. They also received printed weight loss materials and brief 10-15 minute weekly counseling calls. To estimate the impact of the program, the primary outcome was weight (kg) measured during face-to-face measurement visits by trained research staff. Pre and post differences in weight were analyzed with a one-way repeated measures analysis of variance. Differences by language preference at both time points were analyzed with t tests. Body mass index and weight management behaviors also were examined. Feasibility and acceptability were determined by recruitment success, adherence (ie, percentage of replies to interactive text messages and attrition), and participant satisfaction. Participants who completed the final assessment (N=18) decreased body weight by 1.85 kg (F1,17=10.80, P=.004, CI∆ 0.66-3.03, η(2)=0.39). At both time points, there were no differences in weight by language preference. Participants responded to 88.04% (986/1120) of interactive text messages, attrition rate was 10% (2/20), and 94% (19/20) of participants reported satisfaction with the program. This fully automated text message based weight program was feasible with English and Spanish-speakers and may have promoted modest weight loss over an 8-week period. Clinicaltrials.gov NCT01171586; http://clinicaltrials.gov/ct2/show/NCT01171586 (Archived by WebCite at http://www.webcitation.org/6Ksr6dl7n).

Adherence to Hunger Training over 6 Months and the Effect on Weight and Eating Behaviour: Secondary Analysis of a Randomised Controlled Trial

PubMed Central

Taylor, Rachael W.; Athens, Josie; Brown, Rachel C.

2017-01-01

Monitoring blood glucose prior to eating can teach individuals to eat only when truly hungry, but how adherence to ‘hunger training’ influences weight loss and eating behaviour is uncertain. This exploratory, secondary analysis from a larger randomized controlled trial examined five indices of adherence to ‘hunger training’, chosen a priori, to examine which adherence measure best predicted weight loss over 6 months. We subsequently explored how the best measure of adherence influenced eating behavior in terms of intuitive and emotional eating. Retention was 72% (n = 36/50) at 6 months. Frequency of hunger training booklet entry most strongly predicted weight loss, followed by frequency of blood glucose measurements. Participants who completed at least 60 days of booklet entry (of recommended 63 days) lost 6.8 kg (95% CI: 2.6, 11.0; p < 0.001) more weight than those who completed fewer days. They also had significantly higher intuitive eating scores than those who completed 30 days or less of booklet entry; a difference (95% CI) of 0.73 (0.12, 1.35) in body-food choice congruence and 0.79 (0.06, 1.51) for eating for physical rather than emotional reasons. Adherent participants also reported significantly lower scores for emotional eating of −0.70 (−1.13, −0.27). Following hunger training and focusing on simply recording ratings of hunger on a regular basis can produce clinically significant weight loss and clinically relevant improvements in eating behaviour. PMID:29149038

Determining optimal approaches for weight maintenance: a randomized controlled trial

PubMed Central

Dale, Kelly S.; McAuley, Kirsten A.; Taylor, Rachael W.; Williams, Sheila M.; Farmer, Victoria L.; Hansen, Paul; Vorgers, Sue M.; Chisholm, Alexandra W.; Mann, Jim I.

2009-01-01

Background Weight regain often occurs after weight loss in overweight individuals. We aimed to compare the effectiveness of 2 support programs and 2 diets of different macronutrient compositions intended to facilitate long-term weight maintenance. Methods Using a 2 × 2 factorial design, we randomly assigned 200 women who had lost 5% or more of their initial body weight to an intensive support program (implemented by nutrition and activity specialists) or to an inexpensive nurse-led program (involving “weigh-ins” and encouragement) that included advice about high-carbohydrate diets or relatively high-monounsaturated-fat diets. Results In total, 174 (87%) participants were followed-up for 2 years. The average weight loss (about 2 kg) did not differ between those in the support programs (0.1 kg, 95% confidence interval [CI] −1.8 to 1.9, p = 0.95) or diets (0.7 kg, 95% CI −1.1 to 2.4, p = 0.46). Total and low-density lipoprotein (LDL) cholesterol levels were significantly higher among those on the high-monounsaturated-fat diet (total cholesterol: 0.17 mmol/L, 95% CI 0.01 to 0.33; p = 0.040; LDL cholesterol: 0.16 mmol/L, 95% CI 0.01 to 0.31; p = 0.039) than among those on the high-carbohydrate diet. Those on the high-monounsaturated-fat diet also had significantly higher intakes of total fat (5% total energy, 95% CI 3% to 6%, p < 0.001) and saturated fat (2% total energy, 95% CI 1% to 2%, p < 0.001). All of the other clinical and laboratory measures were similar among those in the support programs and diets. Interpretation A relatively inexpensive program involving nurse support is as effective as a more resource-intensive program for weight maintenance over a 2-year period. Diets of different macronutrient composition produced comparable beneficial effects in terms of weight loss maintenance. ClinicalTrials.gov trial register no. NCT00128336. PMID:19433812

Weight loss and retention in a commercial weight-loss program and the effect of corporate partnership.

PubMed

Martin, C K; Talamini, L; Johnson, A; Hymel, A M; Khavjou, O

2010-04-01

No studies report whether improvements to commercial weight-loss programs affect retention and weight loss. Similarly, no studies report whether enrolling in a program through work (with a corporate partner) affects retention and weight loss. To determine whether: (1) adding evidence-based improvements to a commercial weight-loss program increased retention and weight loss, (2) enrolling in a program through work increased retention and weight loss and (3) whether increased weight loss was because of longer retention. Data were collected on 60 164 adults who enrolled in Jenny Craig's Platinum Program over 1 year in 2001-2002. The program was subsequently renamed the Rewards Program and improved by increasing treatment personalization and including motivational interviewing. Data were then collected on 81 505 participants of the Rewards Program who enrolled during 2005 (2418 of these participants enrolled through their employer, but paid out-of-pocket). Retention (participants were considered active until >or=42 consecutive days were missed) and weight loss (percent of original body weight) from baseline to the last visit (data were evaluated through week 52) were determined. Alpha was set at 0.001. Mean (95% confidence interval (CI)) retention (weeks) was significantly higher among Rewards (19.5 (19.4-19.6)) compared with Platinum (16.3 (16.2-16.4)) participants, and Rewards Corporate (25.9 (25.0-26.8)) compared with Noncorporate (21.9 (21.7-22.1)) participants. Modified intent-to-treat analyses indicated that mean (95% CI) percent weight loss was significantly larger among Rewards (6.36 (6.32-6.40)) compared with Platinum (5.45 (5.41-5.49)) participants, and Rewards Corporate (7.16 (6.92-7.40)) compared with Noncorporate (6.20 (6.16-6.24)) participants, with and without adjustment for baseline participant characteristics. In all cases, greater weight loss was secondary to longer retention. The study was not a randomized controlled trial, rather, a translational effectiveness study. Improvements to a commercial program and enrolling through a corporate partner are associated with greater weight loss that is because of improved retention.

A systematic review and meta-analysis of changes in body weight in clinical trials of vegetarian diets.

PubMed

Barnard, Neal D; Levin, Susan M; Yokoyama, Yoko

2015-06-01

In observational studies, vegetarians generally have lower body weights compared with omnivores. However, weight changes that occur when vegetarian diets are prescribed have not been well quantified. We estimated the effect on body weight when vegetarian diets are prescribed. We searched PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials for articles through December 31, 2013. Additional articles were identified from reference lists. We included intervention trials in which participants were adults, interventions included vegetarian diets of ≥4 weeks' duration without energy intake limitations, and effects on body weight were reported. Two investigators independently extracted data using predetermined fields. Estimates of body weight change, comparing intervention groups to untreated control groups, were derived using a random effects model to estimate the weighted mean difference. To quantify effects on body weight of baseline weight, sex, age, study duration, study goals, type of diet, and study authorship, additional analyses examined within-group changes for all studies reporting variance data. We identified 15 trials (17 intervention groups), of which 4 included untreated controls. Prescription of vegetarian diets was associated with a mean weight change of -3.4 kg (95% CI -4.4 to -2.4; P<0.001) in an intention-to-treat analysis and -4.6 kg (95% CI -5.4 to -3.8; P<0.001) in a completer analysis (omitting missing post-intervention values). Greater weight loss was reported in studies with higher baseline weights, smaller proportions of female participants, older participants, or longer durations, and in studies in which weight loss was a goal. Using baseline data for missing values, I(2) equaled 52.3 (P=0.10), indicating moderate heterogeneity. When missing data were omitted, I(2) equaled 0 (P=0.65), indicating low heterogeneity. Studies are relatively few, with variable quality. The prescription of vegetarian diets reduces mean body weight, suggesting potential value for prevention and management of weight-related conditions. Copyright © 2015 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.

Hydrazine Sulfate (PDQ®)—Patient Version

Cancer.gov

Hydrazine sulfate has shown no anticancer activity in randomized clinical trials. It was reported in some clinical trials to be helpful in treating poor appetite and weight loss due to cancer. Learn more about hydrazine sulfate as a treatment for people with cancer in this expert-reviewed summary.

Effect of Alternate-Day Fasting on Weight Loss, Weight Maintenance, and Cardioprotection Among Metabolically Healthy Obese Adults: A Randomized Clinical Trial.

PubMed

Trepanowski, John F; Kroeger, Cynthia M; Barnosky, Adrienne; Klempel, Monica C; Bhutani, Surabhi; Hoddy, Kristin K; Gabel, Kelsey; Freels, Sally; Rigdon, Joseph; Rood, Jennifer; Ravussin, Eric; Varady, Krista A

2017-07-01

Alternate-day fasting has become increasingly popular, yet, to date, no long-term randomized clinical trials have evaluated its efficacy. To compare the effects of alternate-day fasting vs daily calorie restriction on weight loss, weight maintenance, and risk indicators for cardiovascular disease. A single-center randomized clinical trial of obese adults (18 to 64 years of age; mean body mass index, 34) was conducted between October 1, 2011, and January 15, 2015, at an academic institution in Chicago, Illinois. Participants were randomized to 1 of 3 groups for 1 year: alternate-day fasting (25% of energy needs on fast days; 125% of energy needs on alternating "feast days"), calorie restriction (75% of energy needs every day), or a no-intervention control. The trial involved a 6-month weight-loss phase followed by a 6-month weight-maintenance phase. The primary outcome was change in body weight. Secondary outcomes were adherence to the dietary intervention and risk indicators for cardiovascular disease. Among the 100 participants (86 women and 14 men; mean [SD] age, 44 [11] years), the dropout rate was highest in the alternate-day fasting group (13 of 34 [38%]), vs the daily calorie restriction group (10 of 35 [29%]) and control group (8 of 31 [26%]). Mean weight loss was similar for participants in the alternate-day fasting group and those in the daily calorie restriction group at month 6 (-6.8% [95% CI, -9.1% to -4.5%] vs -6.8% [95% CI, -9.1% to -4.6%]) and month 12 (-6.0% [95% CI, -8.5% to -3.6%] vs -5.3% [95% CI, -7.6% to -3.0%]) relative to those in the control group. Participants in the alternate-day fasting group ate more than prescribed on fast days, and less than prescribed on feast days, while those in the daily calorie restriction group generally met their prescribed energy goals. There were no significant differences between the intervention groups in blood pressure, heart rate, triglycerides, fasting glucose, fasting insulin, insulin resistance, C-reactive protein, or homocysteine concentrations at month 6 or 12. Mean high-density lipoprotein cholesterol levels at month 6 significantly increased among the participants in the alternate-day fasting group (6.2 mg/dL [95% CI, 0.1-12.4 mg/dL]), but not at month 12 (1.0 mg/dL [95% CI, -5.9 to 7.8 mg/dL]), relative to those in the daily calorie restriction group. Mean low-density lipoprotein cholesterol levels were significantly elevated by month 12 among the participants in the alternate-day fasting group (11.5 mg/dL [95% CI, 1.9-21.1 mg/dL]) compared with those in the daily calorie restriction group. Alternate-day fasting did not produce superior adherence, weight loss, weight maintenance, or cardioprotection vs daily calorie restriction. clinicaltrials.gov Identifier: NCT00960505.

Effectiveness of Web-Based Self-Disclosure Peer-to-Peer Support for Weight Loss: Randomized Controlled Trial

PubMed Central

Imanaka, Mie; Kitamura, Tetsuhisa; Kawamura, Takashi

2013-01-01

Background Obesity is one of the most common public health problems in the industrialized world as a cause of noncommunicable diseases. Although primarily used for one-on-one communication, email is available for uninterrupted support for weight loss, but little is known about the effects of dietitian group counseling for weight control via the Internet. Objective We developed a Web-based self-disclosure health support (WSHS) system for weight loss. This study aims to compare the effect of weight change between those using the WSHS and those using the email health support (EHS). Methods This study was designed as an open prospective individual randomized controlled trial. Eligible participants were aged 35 to 65 years with a body mass index (BMI) of ≥25.0 in their latest health examination. Participants were randomly assigned to either the WSHS group or the EHS group. Thirteen registered dietitians under the direction of a principal dietitian each instructed 6 to 8 participants from the respective groups. All participants in the WSHS group could receive nutritional advice and calculate their nutritive intake from a photograph of a meal on their computer screen from the Internet sent to them by their dietitian, receive supervision from the registered dietitian, and view fellow participants’ weight changes and lifestyle modifications. In the EHS group, a participant could receive one-on-one nutritional advice and calculate his/her nutritive intake from the photograph of a meal on computer screen sent by email from his/her dietitian, without being able to view fellow participants’ status. The follow-up period was 12 weeks for both groups. The primary outcome measure was change in body weight. The secondary outcome measure included changes in BMI and waist circumference. The intergroup comparison of the changes before and after intervention was evaluated using analysis of covariance. Results A total of 193 participants were randomly assigned to either the WSHS group (n=97) or the EHS group (n=96). Ten from the WSHS group and 8 from the EHS group dropped out during the study period, and the remaining 87 in the WSHS group and 88 in the EHS group were followed up completely. Weight loss was significantly greater in the WSHS group than in the EHS group (–1.6 kg vs –0.7 kg; adjusted P=.04). However, there were few differences in waist circumference between the 2 groups. (–3.3 cm vs –3.0 cm; adjusted P=.71). Conclusions Our newly developed WSHS system using forced self-disclosure had better short-term weight loss results. Further study in a longer-term trial is necessary to determine what effects this type of intervention might have on long-term cardiovascular disease. Trial Registration University Hospital Medical Information Network Clinical Trial Registration (UMIN-CTR): UMIN000009147; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000010719&language=E (Archived by WebCite at http://www.webcitation.org/6HTCkhb1p). PMID:23838533

A randomised controlled intervention study investigating the efficacy of carotenoid-rich fruits and vegetables and extra-virgin olive oil on attenuating sarcopenic symptomology in overweight and obese older adults during energy intake restriction: protocol paper.

PubMed

Villani, Anthony; Wright, Hattie; Slater, Gary; Buckley, Jonathan

2018-01-05

Weight loss interventions have not been advocated for overweight/obese older adults due to potential loss of skeletal muscle and strength impacting on physical function with potential loss of independence. Carotenoids and polyphenols are inversely associated with sarcopenic symptomology. This paper reports the protocol of a study evaluating the efficacy of a high-protein, energy restricted diet rich in carotenoids and polyphenols on body composition, muscle strength, physical performance and quality of life in overweight and obese older adults. This randomised controlled clinical trial will recruit community-dwelling, healthy overweight and obese older adults (≥60 years) for a 12-week weight loss intervention. Seventy-three participants will be recruited and randomized to an energy restricted (~30% restriction), isocaloric diet (30% protein; 30% carbohydrate; 40% fat) enriched with either: a) 375 g/d of high carotenoid vegetables, 300 g/d high carotenoid fruit, and 40-60 ml extra-virgin olive oil (EVOO); or b) 375 g/d of lower carotenoid vegetables, 300 g/d lower carotenoid fruit, and 40-60 ml Polyunsaturated fatty acid (PUFA) based oil. All participants will receive individual dietary counselling each fortnight for the duration of the study and will be asked to maintain their habitual level of physical activity throughout the study. The primary outcome will be appendicular skeletal muscle (ASM) assessed by dual energy X-ray absorptiometry (DXA). Secondary outcomes will include body weight, fat-free mass (FFM), fat mass (FM), muscle strength (Isometric hand-grip strength), physical performance (Short Physical Performance Battery), physical activity (International Physical Activity Questionnaire) and health related quality of life (SF-36). Outcomes will be measured at baseline and at week 12. The results of this study will provide a novel insight relating to the potential influence of high carotenoid and polyphenol intakes on attenuation of ASM during dietary energy-restricted weight loss in overweight and obese older adults. The trial was registered on the Australia New Zealand Clinical Trials Register ( ACTRN12616001400459 ); Trial registration date: 10th October, 2016.

EVIDENT 3 Study: A randomized, controlled clinical trial to reduce inactivity and caloric intake in sedentary and overweight or obese people using a smartphone application

PubMed Central

Recio-Rodriguez, José I.; Gómez-Marcos, Manuel A.; Agudo-Conde, Cristina; Ramirez, Ignasi; Gonzalez-Viejo, Natividad; Gomez-Arranz, Amparo; Salcedo-Aguilar, Fernando; Rodriguez-Sanchez, Emiliano; Alonso-Domínguez, Rosario; Sánchez-Aguadero, Natalia; Gonzalez-Sanchez, Jesus; Garcia-Ortiz, Luis

2018-01-01

Abstract Introduction: Mobile technology, when included within multicomponent interventions, could contribute to more effective weight loss. The objective of this project is to assess the impact of adding the use of the EVIDENT 3 application, designed to promote healthy living habits, to traditional modification strategies employed for weight loss. Other targeted behaviors (walking, caloric-intake, sitting time) and outcomes (quality of life, inflammatory markers, measurements of arterial aging) will also be evaluated. Methods: Randomized, multicentre clinical trial with 2 parallel groups. The study will be conducted in the primary care setting and will include 700 subjects 20 to 65 years, with a body mass index (27.5–40 kg/m2), who are clinically classified as sedentary. The primary outcome will be weight loss. Secondary outcomes will include change in walking (steps/d), sitting time (min/wk), caloric intake (kcal/d), quality of life, arterial aging (augmentation index), and pro-inflammatory marker levels. Outcomes will be measured at baseline, after 3 months, and after 1 year. Participants will be randomly assigned to either the intervention group (IG) or the control group (CG). Both groups will receive the traditional primary care lifestyle counseling prior to randomization. The subjects in the IG will be lent a smartphone and a smartband for a 3-month period, corresponding to the length of the intervention. The EVIDENT 3 application integrates the information collected by the smartband on physical activity and the self-reported information by participants on daily food intake. Using this information, the application generates recommendations and personalized goals for weight loss. Discussion: There is a great diversity in the applications used obtaining different results on lifestyle improvement and weight loss. The populations studied are not homogeneous and generate different results. The results of this study will help our understanding of the efficacy of new technologies, combined with traditional counseling, towards reducing obesity and enabling healthier lifestyles. Ethics and dissemination: The study was approved by the Clinical Research Ethics Committee of the Health Area of Salamanca (“CREC of Health Area of Salamanca”) on April 2016. A SPIRIT checklist is available for this protocol. The trial was registered in ClinicalTrials.gov provided by the US National Library of Medicine-number NCT03175614. PMID:29480874

Two-Year Outcomes of Vagal Nerve Blocking (vBloc) for the Treatment of Obesity in the ReCharge Trial.

PubMed

Apovian, Caroline M; Shah, Sajani N; Wolfe, Bruce M; Ikramuddin, Sayeed; Miller, Christopher J; Tweden, Katherine S; Billington, Charles J; Shikora, Scott A

2017-01-01

The ReCharge Trial demonstrated that a vagal blocking device (vBloc) is a safe and effective treatment for moderate to severe obesity. This report summarizes 24-month outcomes. Participants with body mass index (BMI) 40 to 45 kg/m 2 , or 35 to 40 kg/m 2 with at least one comorbid condition were randomized to either vBloc therapy or sham intervention for 12 months. After 12 months, participants randomized to vBloc continued open-label vBloc therapy and are the focus of this report. Weight loss, adverse events, comorbid risk factors, and quality of life (QOL) will be assessed for 5 years. At 24 months, 123 (76 %) vBloc participants remained in the trial. Participants who presented at 24 months (n = 103) had a mean excess weight loss (EWL) of 21 % (8 % total weight loss [TWL]); 58 % of participants had ≥5 % TWL and 34 % had ≥10 % TWL. Among the subset of participants with abnormal preoperative values, significant improvements were observed in mean LDL (-16 mg/dL) and HDL cholesterol (+4 mg/dL), triglycerides (-46 mg/dL), HbA1c (-0.3 %), and systolic (-11 mmHg) and diastolic blood pressures (-10 mmHg). QOL measures were significantly improved. Heartburn/dyspepsia and implant site pain were the most frequently reported adverse events. The primary related serious adverse event rate was 4.3 %. vBloc therapy continues to result in medically meaningful weight loss with a favorable safety profile through 2 years. https://clinicaltrials.gov/ct2/show/NCT01327976.

Does diet intervention in line with nutrition recommendations affect dietary carbon footprint? Results from a weight loss trial among lactating women.

PubMed

Huseinovic, E; Ohlin, M; Winkvist, A; Bertz, F; Sonesson, U; Brekke, H K

2017-10-01

Results from studies evaluating the sustainability of diets combining environmental and nutritional aspects have been diverse; thus, greenhouse gas emissions (that is, carbon footprint (CF)) of diets in line with dietary recommendations in free-living individuals warrants further examination. Here, changes in dietary CF related to changes in food choice during a weight loss trial among lactating women who received a 12-week diet intervention based on the Nordic Nutrition Recommendations (NNR) 2004 were analyzed. The objective of this study was to examine if a diet intervention based on NNR 2004 results in reduced dietary CF. Changes in dietary CF were analyzed among 61 lactating women participating in a weight loss trial. Food intake data from 4-day weighed diet records and results from life cycle analyses were used to examine changes in dietary CF across eight food groups during the intervention, specified in the unit carbon dioxide equivalent (CO 2 eq/day). Differences in changes in dietary CF between women receiving diet treatment (D-group) and women not receiving it (ND-group) were compared. There was no difference in change in dietary CF of the overall diet between D- and ND-group (P>0.05). As for the eight food groups, D-group increased their dietary CF from fruit and vegetables (+0.06±0.13 kg CO 2 eq/day) compared with a decrease in ND-group (-0.01±0.01 kg CO 2 eq/day) during the intervention, P=0.01. A diet intervention in line with NNR 2004 produced clinically relevant weight loss, but did not reduce dietary CF among lactating women with overweight and obesity. Dietary interventions especially designed to decrease dietary CF and their coherence with dietary recommendations need further exploration.

Dietary Intervention for Overweight and Obese Adults: Comparison of Low-Carbohydrate and Low-Fat Diets. A Meta-Analysis

PubMed Central

Sackner-Bernstein, Jonathan; Kanter, David; Kaul, Sanjay

2015-01-01

Background Reduced calorie, low fat diet is currently recommended diet for overweight and obese adults. Prior data suggest that low carbohydrate diets may also be a viable option for those who are overweight and obese. Purpose Compare the effects of low carbohydrate versus low fats diet on weight and atherosclerotic cardiovascular disease risk in overweight and obese patients. Data Sources Systematic literature review via PubMed (1966–2014). Study Selection Randomized controlled trials with ≥8 weeks follow up, comparing low carbohydrate (≤120gm carbohydrates/day) and low fat diet (≤30% energy from fat/day). Data Extraction Data were extracted and prepared for analysis using double data entry. Prior to identification of candidate publications, the outcomes of change in weight and metabolic factors were selected as defined by Cochrane Collaboration. Assessment of the effects of diets on predicted risk of atherosclerotic cardiovascular disease risk was added during the data collection phase. Data Synthesis 1797 patients were included from 17 trials with <1 year follow up in 12. Compared with low fat diet, low carbohydrate was associated with significantly greater reduction in weight (Δ = -2.0 kg, 95% CI: -3.1, -0.9) and significantly lower predicted risk of atherosclerotic cardiovascular disease events (p<0.03). Frequentist and Bayesian results were concordant. The probability of greater weight loss associated with low carbohydrate was >99% while the reduction in predicted risk favoring low carbohydrate was >98%. Limitations Lack of patient-level data and heterogeneity in dropout rates and outcomes reported. Conclusions This trial-level meta-analysis of randomized controlled trials comparing LoCHO diets with LoFAT diets in strictly adherent populations demonstrates that each diet was associated with significant weight loss and reduction in predicted risk of ASCVD events. However, LoCHO diet was associated with modest but significantly greater improvements in weight loss and predicted ASCVD risk in studies from 8 weeks to 24 months in duration. These results suggest that future evaluations of dietary guidelines should consider low carbohydrate diets as effective and safe intervention for weight management in the overweight and obese, although long-term effects require further investigation. PMID:26485706

The Diabetes Remission Clinical Trial (DiRECT): protocol for a cluster randomised trial.

PubMed

Leslie, Wilma S; Ford, Ian; Sattar, Naveed; Hollingsworth, Kieren G; Adamson, Ashley; Sniehotta, Falko F; McCombie, Louise; Brosnahan, Naomi; Ross, Hazel; Mathers, John C; Peters, Carl; Thom, George; Barnes, Alison; Kean, Sharon; McIlvenna, Yvonne; Rodrigues, Angela; Rehackova, Lucia; Zhyzhneuskaya, Sviatlana; Taylor, Roy; Lean, Mike E J

2016-02-16

Despite improving evidence-based practice following clinical guidelines to optimise drug therapy, Type 2 diabetes (T2DM) still exerts a devastating toll from vascular complications and premature death. Biochemical remission of T2DM has been demonstrated with weight loss around 15kg following bariatric surgery and in several small studies of non-surgical energy-restriction treatments. The non-surgical Counterweight-Plus programme, running in Primary Care where obesity and T2DM are routinely managed, produces >15 kg weight loss in 33% of all enrolled patients. The Diabetes UK-funded Counterpoint study suggested that this should be sufficient to reverse T2DM by removing ectopic fat in liver and pancreas, restoring first-phase insulin secretion. The Diabetes Remission Clinical Trial (DiRECT) was designed to determine whether a structured, intensive, weight management programme, delivered in a routine Primary Care setting, is a viable treatment for achieving durable normoglycaemia. Other aims are to understand the mechanistic basis of remission and to identify psychological predictors of response. Cluster-randomised design with GP practice as the unit of randomisation: 280 participants from around 30 practices in Scotland and England will be allocated either to continue usual guideline-based care or to add the Counterweight-Plus weight management programme, which includes primary care nurse or dietitian delivery of 12-20weeks low calorie diet replacement, food reintroduction, and long-term weight loss maintenance. Main inclusion criteria: men and women aged 20-65 years, all ethnicities, T2DM 0-6years duration, BMI 27-45 kg/m(2). Tyneside participants will undergo Magnetic Resonance (MR) studies of pancreatic and hepatic fat, and metabolic studies to determine mechanisms underlying T2DM remission. Co-primary endpoints: weight reduction ≥ 15 kg and HbA1c <48 mmol/mol at one year. Further follow-up at 2 years. This study will establish whether a structured weight management programme, delivered in Primary Care by practice nurses or dietitians, is a viable treatment to achieve T2DM remission. Results, available from 2018 onwards, will inform future service strategy. Current Controlled Trials ISRCTN03267836 . Date of Registration 20/12/2013.

Weight Loss Strategies Associated With BMI in Overweight Adults With Type 2 Diabetes at Entry Into the Look AHEAD (Action for Health in Diabetes) Trial

PubMed Central

Raynor, Hollie A.; Jeffery, Robert W.; Ruggiero, Andrea M.; Clark, Jeanne M.; Delahanty, Linda M.

2008-01-01

OBJECTIVE—Intentional weight loss is recommended for those with type 2 diabetes, but the strategies patients attempt and their effectiveness for weight management are unknown. In this investigation we describe intentional weight loss strategies used and those related to BMI in a diverse sample of overweight participants with type 2 diabetes at enrollment in the Look AHEAD (Action for Health in Diabetes) clinical trial. RESEARCH DESIGN AND METHODS—This was a cross-sectional study of baseline weight loss strategies, including self-weighing frequency, eating patterns, and weight control practices, reported in 3,063 women and 2,082 men aged 45–74 years with BMI ≥25 kg/m2. RESULTS—Less than half (41.4%) of participants self-weighed ≥1/week. Participants ate breakfast 6.0 ± 1.8 days/week, ate 5.0 ± 3.1 meals/snacks per day, and ate 1.9 ± 2.7 fast food meals/week. The three most common weight control practices (increasing fruits and vegetables, cutting out sweets, and eating less high-carbohydrate foods) were reported by ∼60% of participants for ≥20 weeks over the previous year. Adjusted models showed that self-weighing less than once per week (B = 0.83), more fast food meals consumed per week (B = 0.14), and fewer breakfast meals consumed per week (B = −0.19) were associated (P < 0.05) with a higher BMI (R2 = 0.24). CONCLUSIONS—Regular self-weighing and breakfast consumption, along with infrequent consumption of fast food, were related to lower BMI in the Look AHEAD study population. PMID:18375417

Weight loss with a modified Mediterranean-type diet using fat modification: a randomized controlled trial.

PubMed

Austel, A; Ranke, C; Wagner, N; Görge, J; Ellrott, T

2015-08-01

There is evidence that Mediterranean diets with a high proportion of olive oil and nuts can be effective for weight management and prevention of cardiovascular disease. It might be difficult for populations with other eating habits to follow such diets. Therefore, a modified Mediterranean-type diet using fat modification through neutral and butter-flavored canola oil, walnuts and walnut oil with two portion-controlled sweet daily snacks was tested in Germany. Randomized waiting-list control study with overweight/grade 1 obese subjects: 12-week self-help modified Mediterranean-type diet, 6 weeks of diet plans and 6 weeks of weight loss maintenance training. Trial duration was 12 months. Intervention group (IG) included 100 participants (average age of 52.4 years, weight 85.1 kg and body mass index (BMI) 30.1 kg/m(2)), waiting-list control group (CG) included 112 participants (52.6 years, 84.1 kg and 30.1 kg/m(2)). Per-protocol weight loss after 12 weeks was 5.2 kg in IG vs 0.4 kg in CG (P ⩽ 0.0001), BMI -1.8 vs -0.1 kg/m(2) (P ⩽ 0.0001), waist circumference -4.7 vs -0.9 cm (P ⩽ 0.0001). Triglycerides, total cholesterol and LDL cholesterol improved significantly in IG but not in CG. One-year dropouts: 44% in IG and 53% in CG. Weight loss after 12 months: 4.2 kg (pooled data). A five-meal modified Mediterranean-type diet with two daily portion-controlled sweet snacks was effective for weight management in a self-help setting for overweight and grade 1 obese subjects. Fat modification through canola oil, walnuts and walnut oil improved blood lipids even at 12 months.

Association of the magnitude of weight loss and changes in physical fitness with long-term cardiovascular disease outcomes in overweight or obese people with type 2 diabetes: a post-hoc analysis of the Look AHEAD randomised clinical trial.

PubMed

Gregg, Edward; Jakicic, John; Blackburn, George; Bloomquist, Paul; Bray, George; Clark, Jeanne; Coday, Mace; Curtis, Jeffrey; Egan, Caitlin; Evans, Mary; Foreyt, John; Foster, Gary; Hazuda, Helen; Hill, James; Horton, Edward; Hubbard, Van; Jeffery, Robert; Johnson, Karen; Kitabchi, Abbas; Knowler, William; Kriska, Andrea; Lang, Wei; Lewis, Cora; Montez, Maria; Nathan, David; Neiberg, Rebecca; Patricio, Jennifer; Peters, Anne; Pi-Sunyer, Xavier; Pownall, Henry; Redmon, Bruce; Regensteiner, Judith; Rejeski, Jack; Ribisl, Paul; Safford, Monika; Stewart, Kerry; Trence, Dace; Wadden, Thomas; Wing, Rena; Yanovski, Susan

2016-11-01

Findings from the Look AHEAD trial showed no significant reductions in the primary outcome of cardiovascular disease incidence in adults with type 2 diabetes randomly assigned to an intensive lifestyle intervention for weight loss compared with those randomly assigned to diabetes support and education (control). We examined whether the incidence of cardiovascular disease in Look AHEAD varied by changes in weight or fitness. Look AHEAD was a randomised clinical trial done at 16 clinical sites in the USA, recruiting patients from Aug 22, 2001, to April 30, 2004. In the trial, 5145 overweight or obese adults aged 45-76 years with type 2 diabetes were assigned (1:1) to an intensive lifestyle intervention or diabetes support and education. In this observational, post-hoc analysis, we examined the association of magnitude of weight loss and fitness change over the first year with incidence of cardiovascular disease. The primary outcome of the trial and of this analysis was a composite of death from cardiovascular causes, non-fatal acute myocardial infarction, non-fatal stroke, or admission to hospital for angina. The secondary outcome included the same indices plus coronary artery bypass grafting, carotid endartectomy, percutaneous coronary intervention, hospitalisation for congestive heart failure, peripheral vascular disease, or total mortality. We adjusted analyses for baseline differences in weight or fitness, demographic characteristics, and risk factors for cardiovascular disease. The Look AHEAD trial is registered with ClinicalTrials.gov, number NCT00017953. For the analyses related to weight change, we excluded 311 ineligible participants, leaving a population of 4834; for the analyses related to fitness change, we excluded 739 participants, leaving a population of 4406. In analyses of the full cohort (ie, combining both study groups), over a median 10·2 years of follow-up (IQR 9·5-10·7), individuals who lost at least 10% of their bodyweight in the first year of the study had a 21% lower risk of the primary outcome (adjusted hazard ratio [HR] 0·79, 95% CI 0·64-0·98; p=0·034) and a 24% reduced risk of the secondary outcome (adjusted HR 0·76, 95% CI 0·63-0·91; p=0·003) compared with individuals with stable weight or weight gain. Achieving an increase of at least 2 metabolic equivalents in fitness change was associated with a significant reduction in the secondary outcome (adjusted HR 0·77, 95% CI 0·61-0·96; p=0·023) but not the primary outcome (adjusted HR 0·78, 0·60-1·03; p=0·079). In analyses treating the control group as the reference group, participants in the intensive lifestyle intervention group who lost at least 10% of their bodyweight had a 20% lower risk of the primary outcome (adjusted HR 0·80, 95% CI 0·65-0·99; p=0·039), and a 21% lower risk of the secondary outcome (adjusted HR 0·79, 95% CI 0·66-0·95; p=0·011); however, change in fitness was not significantly associated with a change in the primary outcome. The results of this post-hoc analysis of Look AHEAD suggest an association between the magnitude of weight loss and incidence of cardiovascular disease in people with type 2 diabetes. These findings suggest a need to continue to refine approaches to identify individuals who are most likely to benefit from lifestyle interventions and to develop strategies to improve the magnitude of sustained weight loss with lifestyle interventions. US National Institute of Diabetes and Digestive and Kidney Diseases. Copyright © 2016 Elsevier Ltd. All rights reserved.

Why are some people more successful at lifestyle change than others? Factors associated with successful weight loss in the BeWEL randomised controlled trial of adults at risk of colorectal cancer.

PubMed

Stead, Martine; Craigie, Angela M; Macleod, Maureen; McKell, Jennifer; Caswell, Stephen; Steele, Robert J C; Anderson, Annie S

2015-06-26

The BeWEL (BodyWEight and physicaL activity) randomised controlled trial demonstrated that a weight management programme offered in the colorectal cancer screening setting was effective. However, the differential responses of participants to the programme were notable. This study aimed to explore the factors associated with success and to identify implications for future programme design. Analyses were conducted of quantitative data (n = 148) from the BeWEL intervention group to compare demographic and psychosocial characteristics and lifestyle changes in those who met and exceeded the target 7% weight loss ('super-achievers') with those who achieved only 'moderate' or 'low' amounts of weight loss (2-7% loss, or <2% loss, respectively). In-depth qualitative interviews (n = 24) explored in detail the motivations, actions, pathways to weight loss and circumstances of study participants. Over the 12 month intervention period, mean percentage weight loss of super-achievers (n = 33) was 11.5%, compared with moderate-achievers (n = 58) who lost 4.2%, and low-achievers (n = 57) who gained 0.8%. Compared to other groups, super- achievers increased their fruit and vegetable intake (p < 0.01) and physical activity (step count, p < 0.01). 'Super-achievers' did not differ in baseline demographic characteristics from other participants. However, significantly fewer reported that their activities were limited by physical and emotional health and they were more likely to perceive their current diet as harmful. Qualitative analyses found no consistent patterns among super-achievers in relation to some factors identified as important in previous studies, such as social support. However, super-achievers shared several characteristics such as determination and consistency in their engagement with the intervention, receptivity to new information and prompts, previous positive experience of changing health behaviours, being motivated by early success, making changes routine, and an ability to devise and apply strategies for dealing with setback and 'relapse' triggers. Successful lifestyle change depends on active engagement as well as effective intervention ingredients. Weight loss interventions are likely to be more effective where they can adapt to participants' differing characteristics and needs, while also providing core elements likely to build success.

Weight Loss Can Lead to Resolution of Gastroesophageal Reflux Disease Symptoms: A Prospective Intervention Trial

PubMed Central

Singh, Mandeep; Lee, Jaehoon; Gupta, Neil; Gaddam, Srinivas; Smith, Bryan K.; Wani, Sachin B.; Sullivan, Debra K.; Rastogi, Amit; Bansal, Ajay; Donnelly, Joseph E.; Sharma, Prateek

2013-01-01

Objective Weight gain is an important risk factor for gastroesophageal reflux disease (GERD); however, whether weight loss can lead to resolution of GERD symptoms is not clear. Our aim was to measure the impact of weight loss on GERD symptoms. Design and Methods In a prospective cohort study at a tertiary referral center, overweight/obese subjects (BMI 25-39.9 kg/m2) were enrolled in a structured weight loss program. Weight loss strategies included dietary modifications, increased physical activity and behavioral changes. At baseline and at 6 months, BMI and waist circumference were measured and all participants completed a validated reflux disease questionnaire. Results A total of 332 adult subjects, mean age 46 years and 66% women were prospectively enrolled. At baseline, the mean body weight, BMI, and waist circumference were 101 (±18) kg, 35 (±5) kg/m2 and 103 (±13) cm. At 6 months, majority of the subjects (97%) lost weight (average weight loss: 13 ± 7.7 kg) and as compared with baseline, there was a significant decrease in the overall prevalence of GERD (15 vs. 37%; P < 0.01) and the mean GERD symptom score (1.8 vs. 5.5; P < 0.01). Overall, 81% of the subjects had reduction in GERD symptom scores; 65% had complete resolution and 15% had partial resolution of reflux symptoms. There was a significant correlation between % body weight loss and reduction in GERD symptom scores (r = 0.17, P < 0.05). Conclusions In conclusion, the overall prevalence of GERD symptoms is high (37%) in overweight and obese subjects. A structured weight loss program can lead to complete resolution of GERD symptoms in the majority of these subjects. PMID:23532991

Behavioral Weight Loss Treatment in Antipsychotic Treated Youth.

PubMed

Nicol, Ginger E; Kolko, Rachel P; Mills, Monica; Gunnarsdottir, Thrudur; Yingling, Michael D; Schweiger, Julia A; Lenze, Eric J; Newcomer, John W; Wilfley, Denise

2016-05-01

Antipsychotic-treated youth have increased risk for the development of obesity and type 2 diabetes. Behavioral weight loss treatments show promise in reducing obesity and diabetes risk in antipsychotic treated adults, but have received no study in antipsychotic treated youth. We describe a rationale for behavioral weight loss interventions in high-weight antipsychotic treated youth, and report behavioral, anthropomorphic, and metabolic findings from a case series of obese antipsychotic-treated adolescents participating in a short-term, family-based behavioral weight loss intervention. We adapted the Traffic Light Plan, a 16-week family-based weight loss intervention that promotes healthy energy balance using the colors of the traffic light to categorize the nutritional value of foods and intensity of physical activity, adapting a social ecological framework to address health behavior change in multiple social contexts. The intervention was administered to three obese adolescents with long-term antipsychotic medication exposure. Efficacy of the intervention was evaluated with a battery of anthropomorphic and metabolic assessments including weight, body mass index percentile, whole body adiposity, liver fat content, and fasting plasma glucose and lipids. Participants and their parents also filled out a treatment satisfaction questionnaire upon study completion. Two males and 1 female (all aged 14 years) participated. All 3 participants attended all 16 sessions, and experienced beneficial changes in adiposity, fasting lipids and liver fat content associated with weight stabilization or weight loss. Adolescents and their parents all reported a high level of satisfaction with the treatment. Family-based behavioral weight loss treatment can be feasibly delivered and is acceptable to antipsychotic-treated youth and their families. Randomized controlled trials are needed to fully evaluate the effectiveness and acceptability of behavioral weight loss interventions in antipsychotic treated youth and their families.

A randomized trial of energy-restricted high-protein versus high-carbohydrate, low-fat diet in morbid obesity.

PubMed

Dalle Grave, Riccardo; Calugi, Simona; Gavasso, Ilaria; El Ghoch, Marwan; Marchesini, Giulio

2013-09-01

Conflicting evidence exists as to weight loss produced by diets with different carbohydrate/protein ratio. The aim was to compare the long-term effects of high-protein vs. high-carbohydrate diet (HPD, HCD), combined with cognitive behavior therapy (CBT). In a randomized trial, 88 obese participants (mean age, 46.7; mean BMI, 45.6 kg m(-2) ) were enrolled in a 3-week inpatient and 48-week outpatient treatment, with continuous CBT during the study period. All subjects consumed a restricted diet (1,200 kcal day(-1) for women, 1,500 for men; 20% energy from fat, <10% saturated fat). HPD derived 34% energy from proteins, 46% from carbohydrates; HCD 17% from proteins, 64% from carbohydrates. The primary outcome was 1-year percent weight loss. Secondary outcomes were attrition rates and changes in cardiovascular risk factors and psychological profile. Attrition rates were similar between groups (25.6%). In the intention-to-treat analysis, weight loss averaged 15.0% in HPD and 13.3% in HCD at 1 year, without any difference throughout the study period. Both diets produced a similar improvement in secondary outcomes. The relative carbohydrate and protein content of the diet, when combined with intensive CBT, does not significantly affect attrition rate, weight loss and psychosocial outcome in patients with severe obesity. Copyright © 2013 The Obesity Society.

Effects of medium-chain triglycerides on weight loss and body composition: a meta-analysis of randomized controlled trials.

PubMed

Mumme, Karen; Stonehouse, Welma

2015-02-01

Medium-chain triglycerides (MCTs) may result in negative energy balance and weight loss through increased energy expenditure and lipid oxidation. However, results from human intervention studies investigating the weight reducing potential of MCTs, have been mixed. To conduct a systematic review and meta-analysis of randomized controlled trials comparing the effects of MCTs, specifically C8:0 and C10:0, to long-chain triglycerides (LCTs) on weight loss and body composition in adults. Changes in blood lipid levels were secondary outcomes. Randomized controlled trials >3 weeks' duration conducted in healthy adults were identified searching Web of Knowledge, Discover, PubMed, Scopus, New Zealand Science, and Cochrane CENTRAL until March 2014 with no language restriction. Identified trials were assessed for bias. Mean differences were pooled and analyzed using inverse variance models with fixed effects. Heterogeneity between studies was calculated using I(2) statistic. An I(2)>50% or P<0.10 indicated heterogeneity. Thirteen trials (n=749) were identified. Compared with LCTs, MCTs decreased body weight (-0.51 kg [95% CI-0.80 to -0.23 kg]; P<0.001; I(2)=35%); waist circumference (-1.46 cm [95% CI -2.04 to -0.87 cm]; P<0.001; I(2)=0%), hip circumference (-0.79 cm [95% CI -1.27 to -0.30 cm]; P=0.002; I(2)=0%), total body fat (standard mean difference -0.39 [95% CI -0.57 to -0.22]; P<0.001; I(2)=0%), total subcutaneous fat (standard mean difference -0.46 [95% CI -0.64 to -0.27]; P<0.001; I(2)=20%), and visceral fat (standard mean difference -0.55 [95% CI -0.75 to -0.34]; P<0.001; I(2)=0%). No differences were seen in blood lipid levels. Many trials lacked sufficient information for a complete quality assessment, and commercial bias was detected. Although heterogeneity was absent, study designs varied with regard to duration, dose, and control of energy intake. Replacement of LCTs with MCTs in the diet could potentially induce modest reductions in body weight and composition without adversely affecting lipid profiles. However, further research is required by independent research groups using large, well-designed studies to confirm the efficacy of MCT and to determine the dosage needed for the management of a healthy body weight and composition. Copyright © 2015 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.

Increasing the effectiveness of the Diabetes Prevention Program through if-then plans: study protocol for the randomized controlled trial of the McGill CHIP Healthy Weight Program.

PubMed

Knäuper, Bärbel; Ivanova, Elena; Xu, Zhen; Chamandy, Melodie; Lowensteyn, Ilka; Joseph, Lawrence; Luszczynska, Aleksandra; Grover, Steven

2014-05-18

The Diabetes Prevention Program (DPP) is highly effective in promoting weight loss in overweight and obese individuals. However, one-on-one DPP sessions are costly. As a cost-saving alternative, a group version of the DPP, called Group Lifestyle Balance program (GLB), has been developed but has been shown to be less effective. The aim of this two-arm parallel randomized controlled trial is to increase the effectiveness of the GLB by integrating habit formation techniques, namely if-then plans and their mental practice, into the program. A total of 154 participants will be randomized to a standard or enriched GLB program. For the enriched GLB program, if-then plans and their mental practice will be integrated into the standard GLB program. Participants will be overweight or obese men and women (BMI of 28 to 45 kg/m2, waist circumference ≥ 88 for women, ≥ 102 for men, 18 to 75 years of age) who do less than 200 minutes of self-reported moderate or vigorous exercise per week. Measures will be completed at baseline, 3 months, post-intervention (12 months), and 12 months post-intervention (24 months). The primary outcome measure is weight loss at 3, 12, and 24 months. Secondary outcomes include percent reaching weight loss goal, physical activity at 3, 12, and 24 months, and weight-related risk factors (waist circumference, hemoglobin A1c, systolic/diastolic blood pressure, total cholesterol/HDL ratio). Standardized training of the life-style coaches, use of standardized manuals, and audio taping and reviewing of the sessions will ensure intervention fidelity. The study will provide evidence-based data on the effectiveness of an enhanced GLB intervention in promoting weight loss and in reducing weight-related risk factors for chronic health problems. Ethical clearance has been received from the Research Ethics and Compliance Board of the Faculty of Medicine Research and Graduate Studies Office at McGill University (Montreal, Canada). ClinicalTrials.gov Identifier: NCT02008435. Registered 6 December 2013.

Weight loss for overweight and obese individuals with gout: a systematic review of longitudinal studies.

PubMed

Nielsen, Sabrina M; Bartels, Else M; Henriksen, Marius; Wæhrens, Eva E; Gudbergsen, Henrik; Bliddal, Henning; Astrup, Arne; Knop, Filip K; Carmona, Loreto; Taylor, William J; Singh, Jasvinder A; Perez-Ruiz, Fernando; Kristensen, Lars E; Christensen, Robin

2017-11-01

Weight loss is commonly recommended for gout, but the magnitude of the effect has not been evaluated in a systematic review. The aim of this systematic review was to determine benefits and harms associated with weight loss in overweight and obese patients with gout. We searched six databases for longitudinal studies, reporting the effect of weight loss in overweight/obese gout patients. Risk of bias was assessed using the tool Risk of Bias in Non-Randomised Studies of Interventions. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation. From 3991 potentially eligible studies, 10 were included (including one randomised trial). Interventions included diet with/without physical activity, bariatric surgery, diuretics, metformin or no intervention. Mean weight losses ranged from 3 kg to 34 kg. Clinical heterogeneity in study characteristics precluded meta-analysis. The effect on serum uric acid (sUA) ranged from -168 to 30 μmol/L, and 0%-60% patients achieving sUA target (<360 μmol/L). Six out of eight studies (75%) showed beneficial effects on gout attacks. Two studies indicated dose-response relationship for sUA, achieving sUA target and gout attacks. At short term, temporary increased sUA and gout attacks tended to occur after bariatric surgery. The available evidence is in favour of weight loss for overweight/obese gout patients, with low, moderate and low quality of evidence for effects on sUA, achieving sUA target and gout attacks, respectively. At short term, unfavourable effects may occur. Since the current evidence consists of a few studies (mostly observational) of low methodological quality, there is an urgent need to initiate rigorous prospective studies (preferably randomised controlled trials). PROSPERO, CRD42016037937. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Impact of Diet and/or Exercise Intervention on Infrapatellar Fat Pad Morphology: Secondary Analysis from the Intensive Diet and Exercise for Arthritis (IDEA) Trial.

PubMed

Pogacnik Murillo, Aarón Leonardo; Eckstein, Felix; Wirth, Wolfgang; Beavers, Daniel; Loeser, Richard F; Nicklas, Barbara J; Mihalko, Shannon L; Miller, Gary D; Hunter, David J; Messier, Stephen P

2017-01-01

The infrapatellar fat pad (IPFP) represents intra-articular adipose tissue that may contribute to intra-articular inflammation and pain by secretion of proinflammatory cytokines. Here we examined the impact of weight loss by diet and/or exercise interventions on the IPFP volume. Intensive Diet and Exercise for Arthritis (IDEA) was a single-blinded, single-center, 18-month, prospective, randomized controlled trial that enrolled 454 overweight and obese older adults with knee pain and radiographic osteoarthritis. Participants were randomized to 1 of 3 groups: exercise-only control (E), diet-induced weight loss (D), and diet-induced weight loss + exercise (D+E). In a subsample (n = 106; E: n = 36, D: n = 35, and D+E: n = 35), magnetic resonance images were acquired at baseline and at the 18-month follow-up, from which we analyzed IPFP volume, surface areas, and thickness in this secondary analysis. The average weight loss amounted to 1.0% in the E group, 10.5% in the D group, and 13.0% in the D+E group. A significant (p < 0.01) reduction in IPFP volume was observed in the E (2.1%), D (4.0%), and D+E (5.2%) groups. The IPFP volume loss in the D+E group was significantly greater than that in the E group (p < 0.05) when not adjusting for parallel comparisons. Across intervention groups, there were significant correlations between IPFP volume change, individual weight loss (r = 0.40), and change in total body fat mass (dual-energy X-ray absorptiometry; r = 0.44, n = 88) and in subcutaneous thigh fat area (computed tomography; r = 0.32, n = 82). As a potential link between obesity and knee osteoarthritis, the IPFP was sensitive to intervention by diet and/or exercise, and its reduction was correlated with changes in weight and body fat. © 2017 S. Karger AG, Basel.

IMPACT OF DIET AND/OR EXERCISE INTERVENTION ON INFRAPATELLAR FAT PAD MORPHOLOGY - SECONDARY ANALYSIS FROM THE INTENSIVE DIET AND EXERCISE FOR ARTHRITIS (IDEA) TRIAL

PubMed Central

Murillo, A. Pogacnik; Eckstein, F.; Wirth, W.; Beavers, D.; Loeser, R. F.; Nicklas, B. J.; Mihalko, S.L.; Miller, G.D.; Hunter, D.J.; Messier, S. P.

2017-01-01

Objectives The infrapatellar fat pad (IPFP) represents intra-articular adipose tissue that may contribute to intra-articular inflammation and pain by secretion of pro-inflammatory cytokines. Here we examined the impact of weight loss by diet and/or exercise interventions on IPFP volume. Methods Intensive Diet and Exercise for Arthritis (IDEA) was a single-blinded, single-center, 18-month, prospective, randomized controlled trial that enrolled 454 overweight and obese older adults with knee pain and radiographic osteoarthritis. Participants were randomized to 1 of 3 groups: exercise only control (E), diet-induced weight loss (D), and diet-induced weight loss + exercise (D+E). In a subsample (n=106; E: n=36; D: n=35; D+E: n=35), magnetic resonance images were acquired at baseline and 18-month follow-up, from which we analyzed IPFP volume, surface areas and thickness in this secondary analysis. Results Average weight loss in each group amounted to 1.0% in E, 10.5% in D, and 13.0% in D+E. A significant (p< 0.01) reduction in IPFP volume was observed in E (2.1%), D (4.0%) and D+E (5.2%). The IPFP volume loss in D+E was significantly greater than that in E (p<0.05) when not adjusting for parallel comparisons. Across intervention groups, there were significant correlations between IPFP volume change, individual weight loss (r=0.40), and change in total body fat mass (DXA; r=0.44; n=88) and in subcutaneous thigh fat area (CT; r=0.32; n=82). Conclusions As a potential link between obesity and knee OA, the IPFP was sensitive to intervention by diet and/or exercise, and its reduction was correlated with change in weight and body fat. PMID:28222422

Diet and Physical Activity Behaviors in Primary Care Patients with Recent Intentional Weight Loss.

PubMed

Gibbs, Bethany Barone; Tudorascu, Dana; Bryce, Cindy L; Comer, Diane; Fischer, Gary S; Hess, Rachel; Huber, Kimberly A; McTigue, Kathleen M; Simkin-Silverman, Laurey R; Conroy, Molly B

2017-01-01

Lifestyle habits of primary care patients with recent, intentional weight loss are unclear and need to be better understood to aid in translational health promotion efforts. We aimed to characterize diet and exercise habits in primary care patients with recent, intentional weight loss, comparing those with greater (≥10%) vs. lesser (5 to <10%) weight loss. This was a cross-sectional analysis of baseline data from a randomized trial comparing weight loss maintenance interventions. The study included primary care patients, 18-75 years old, with ≥5% intentional weight loss via lifestyle change in the past 2 years. Participants (74% female, 87% white) had mean age 53 (12) years, body mass index 30.4 (5.9) kg/m 2 , and recent weight loss of 11 (8)%. Dietary habits were measured by the Diet Habits Survey. Physical activity and sedentary behavior were measured by self-report and objectively by pedometer. On average, participants reported high fruits and vegetables intake (5 servings/day), and low intake of fried foods (1 serving/week), desserts (1 serving/week) and sugar-sweetened beverages (0 servings/week). Those with greater vs. lesser weight loss had higher intake of fruits and vegetables (p=0.037) and low fat foods or recipes (p=0.019). Average self-reported moderate-vigorous physical activity was 319 (281) minutes/week, with significant differences between greater (374 (328) minutes/week) vs. lesser (276 (230) minutes/week) weight loss groups (p=0.017). By pedometer, 30% had ≥7,500 steps/day; the proportion was higher in greater (43%) vs. lesser (19%) weight loss groups (p=0.005). For weight loss, clinical patients typically employ simple strategies such as 5+ fruits and vegetables per day, fried foods and desserts ≤1 per week, elimination of sugary drinks, choosing low fat foods/recipes, and physical activity 45-60 min/day.

Pancreatic beta cell function following liraglutide-augmented weight loss in individuals with prediabetes: analysis of a randomised, placebo-controlled study

PubMed Central

Liu, Alice; Ariel, Danit; Abbasi, Fahim; Lamendola, Cindy; Grove, Kaylene; Tomasso, Vanessa; Reaven, Gerald

2016-01-01

Aims/hypothesis Liraglutide can modulate insulin secretion by directly stimulating beta cells or indirectly through weight loss and enhanced insulin sensitivity. Recently, we showed that liraglutide treatment in overweight individuals with prediabetes (impaired fasting glucose and/or impaired glucose tolerance) led to greater weight loss (−7.7% vs −3.9%) and improvement in insulin resistance compared with placebo. The current study evaluates the effects on beta cell function of weight loss augmented by liraglutide compared with weight loss alone. Methods This was a parallel, randomised study conducted in a single academic centre. Both participants and study administrators were blinded to treatment assignment. Individuals who were 40–70 years old, overweight (BMI 27–40 kg/m2) and with prediabetes were randomised (via a computerised system) to receive liraglutide (n = 35) or matching placebo (n = 33), and 49 participants were analysed. All were instructed to follow an energy-restricted diet. Primary outcome was insulin secretory function, which was evaluated in response to graded infusions of glucose and day-long mixed meals. Results Liraglutide treatment (n = 24) significantly (p ≤0.03) increased the insulin secretion rate (% mean change [95% CI]; 21% [12, 31] vs −4% [−11, 3]) and pancreatic beta cell sensitivity to intravenous glucose (229% [161, 276] vs −0.5% (−15, 14]), and decreased insulin clearance rate (−3.5% [−11, 4] vs 8.2 [0.2, 16]) as compared with placebo (n = 25). The liraglutide-treated group also had significantly (p ≤0.03) lower day-long glucose (−8.2% [−11, −6] vs −0.1 [−3, 2]) and NEFA concentrations (−14 [−20, −8] vs −2.1 [−10, 6]) following mixed meals, whereas day-long insulin concentrations did not significantly differ as compared with placebo. In a multivariate regression analysis, weight loss was associated with a decrease in insulin secretion rate and day-long glucose and insulin concentrations in the placebo group (p ≤0.05), but there was no association with weight loss in the liraglutide group. The most common side effect of liraglutide was nausea. Conclusions/interpretation A direct stimulatory effect on beta cell function was the predominant change in liraglutide-augmented weight loss. These changes appear to be independent of weight loss. Trial registration ClinicalTrials.gov NCT01784965 PMID:24326527

Persistent weight loss with a non-invasive novel medical device to change eating behaviour in obese individuals with high-risk cardiovascular risk profile.

PubMed

von Seck, Peter; Sander, F Martin; Lanzendorf, Leon; von Seck, Sabine; Schmidt-Lucke, André; Zielonka, Mirja; Schmidt-Lucke, Caroline

2017-01-01

In evidence-based weight-loss programs weight regain is common after an initial weight reduction. Eating slowly significantly lowers meal energy intake and hunger ratings. Despite this knowledge, obese individuals do not implement this behaviour. We, thus tested the hypothesis of changing eating behaviour with an intra-oral medical device leading to constant weight reduction in overweight and obesity. Six obese patients (6 men, age 56 ± 14, BMI 29 ± 2 kg / m2) with increased CVRF profile were included in this prospective study. All patients had been treated for obesity during the last 10 years in a single centre and had at least 3 frustrate evidence-based diets. Patients received a novel non-invasive intra-oral medical device to slow eating time. Further advice included not to count calories, to avoid any other form of diet, to take their time with their meals, and to eat whatever they liked. This device was used only during meals for the first 4 to 8 weeks for a total of 88 [20-160] hours. Follow-up period was 23 [15-38] months. During this period, patients lost 11% [5-20%] (p<0.001) of their initial weight. At 12 months, all patients had lost >5%, and 67% (4/6) achieved a >10% bodyweight loss. In the course of the study, altered eating patterns were observed. There were no complications with the medical device. Of note, all patients continued to lose weight after the initial intervention period (p<0.001) and none of them had weight regain. With this medical device, overweight and obese patients with a history of previously frustrating attempts to lose weight achieved a significant and sustained weight loss over two years. These results warrant the ongoing prospective randomised controlled trial to prove concept and mechanism of action. German Clinical Trials Register DRKS00011357.

Effect of macronutrient composition on short-term food intake and weight loss.

PubMed

Bellissimo, Nick; Akhavan, Tina

2015-05-01

The purpose of this review is to describe the role of macronutrient composition on the suppression of short-term food intake (FI) and weight loss. The effects of macronutrient composition on short-term FI will be reviewed first, followed by a brief examination of longer-term clinical trials that vary in effects of dietary macronutrient composition on weight loss. The objectives were: 1) to examine the effect of macronutrient composition on the suppression of short-term FI, 2) to determine whether some macronutrient sources suppress FI beyond their provision of energy, 3) to assess the combined effects of macronutrients on FI and glycemic response, and 4) to determine whether knowledge of the effect of macronutrients on short-term FI has led to greater success in spontaneous weight loss, adherence to energy-restricted diets, and better weight maintenance after weight loss. Although knowledge of macronutrient composition on short-term FI regulation has advanced our understanding of the role of diet composition on energy balance, it has yet to lead to greater success in long-term weight loss and weight maintenance. It is clear from this review that many approaches based on manipulating dietary macronutrient composition can help people lose weight as long as they follow the diets. However, only by evaluating the interaction between the physiologic systems that govern FI and body weight may the benefits of dietary macronutrient composition be fully realized. © 2015 American Society for Nutrition.

Does bone loss begin after weight loss ends? Results two years after weight loss or regain in postmenopausal women

PubMed Central

Von Thun, Nancy L.; Sukumar, Deeptha; Heymsfield, Steven B.; Shapses, Sue A.

2016-01-01

Objective Short-term weight loss is accompanied by bone loss in postmenopausal women. The longer-term impact on bone in the reduced overweight/obese woman compared to those who regain their weight was examined in this study using a case-control design. Methods Postmenopausal women (n = 42, body mass index of 28.3 ± 2.8 kg/m2; 60.7 ± 5.5 y) were recruited 2 years after the start of a 6 month weight loss trial and those who maintained their weight (WL-M) were matched to a cohort who regained weight (WL-R). Serum hormones and bone markers were measured in a subset. Bone mineral density (BMD) at the femoral neck (FN), trochanter, spine, radius, and total body and soft tissue composition were taken at baseline, 0.5 and 2 years. Results During WL, both groups lost 9.3 ± 3.4% body weight with no significant difference between groups. After weight loss, weight change was −0.1 ± 2.7 % and 6.0 ± 3.3% in the WL-M (n=22) and WL-R (n=20) groups, respectively. After 2 years, both groups lost BMD at the FN and trochanter (p ≤ 0.01), whereas only the WL-M group reduced BMD at the 1/3 radius (p < 0.001). There was a greater BMD loss at the trochanter (−6.8 ± 5.7%) and the 1/3 radius (−4.5 ± 3.3%) in the WL-M compared to the WL-R group after 2 years. Multiple linear regression showed that change in leg fat mass (but not trunk fat) contributed to trochanter BMD loss (p <0.05). Conclusions After 2 years, there is no BMD recovery of weight reduction-induced bone loss, irrespective of weight-regain. These data suggest that the period after weight loss may be an important point in time to prevent bone loss for both those who maintain or regain weight. PMID:24149920

Living Well with Diabetes: a randomized controlled trial of a telephone-delivered intervention for maintenance of weight loss, physical activity and glycaemic control in adults with type 2 diabetes.

PubMed

Eakin, Elizabeth G; Reeves, Marina M; Marshall, Alison L; Dunstan, David W; Graves, Nicholas; Healy, Genevieve N; Bleier, Jonathan; Barnett, Adrian G; O'Moore-Sullivan, Trisha; Russell, Anthony; Wilkie, Ken

2010-08-03

By 2025, it is estimated that approximately 1.8 million Australian adults (approximately 8.4% of the adult population) will have diabetes, with the majority having type 2 diabetes. Weight management via improved physical activity and diet is the cornerstone of type 2 diabetes management. However, the majority of weight loss trials in diabetes have evaluated short-term, intensive clinic-based interventions that, while producing short-term outcomes, have failed to address issues of maintenance and broad population reach. Telephone-delivered interventions have the potential to address these gaps. Using a two-arm randomised controlled design, this study will evaluate an 18-month, telephone-delivered, behavioural weight loss intervention focussing on physical activity, diet and behavioural therapy, versus usual care, with follow-up at 24 months. Three-hundred adult participants, aged 20-75 years, with type 2 diabetes, will be recruited from 10 general practices via electronic medical records search. The Social-Cognitive Theory driven intervention involves a six-month intensive phase (4 weekly calls and 11 fortnightly calls) and a 12-month maintenance phase (one call per month). Primary outcomes, assessed at 6, 18 and 24 months, are: weight loss, physical activity, and glycaemic control (HbA1c), with weight loss and physical activity also measured at 12 months. Incremental cost-effectiveness will also be examined. Study recruitment began in February 2009, with final data collection expected by February 2013. This is the first study to evaluate the telephone as the primary method of delivering a behavioural weight loss intervention in type 2 diabetes. The evaluation of maintenance outcomes (6 months following the end of intervention), the use of accelerometers to objectively measure physical activity, and the inclusion of a cost-effectiveness analysis will advance the science of broad reach approaches to weight control and health behaviour change, and will build the evidence base needed to advocate for the translation of this work into population health practice. ACTRN12608000203358.

Consumers' salient beliefs regarding dairy products in the functional food era: a qualitative study using concepts from the theory of planned behaviour

PubMed Central

2011-01-01

Background Inadequate consumption of dairy products without appropriate dietary substitution may have deleterious health consequences. Social research reveals the factors that may impede compliance with dietary recommendations. This is particularly important given the recent introduction of functional dairy products. One of the challenges for public health professionals is to demonstrate the efficacy of nutrition education in improving attitudes toward nutrient rich foods. The aim of this study was to explore the salient beliefs of adult weight loss trial participants regarding both traditional and functional dairy products and to compare these with a control group not exposed to nutrition education. Methods Six focus groups were conducted, three with weight loss trial completers (n = 15) that had received nutrition education and three with individuals from the same region (n = 14) to act as controls. Transcribed focus groups were coded using the Theory of Planned Behaviour theoretical framework. Results Non-trial participants perceived dairy foods as weight inducing and were sceptical of functional dairy products. A lack of time/ability to decipher dairy food labels was also discussed by these individuals. In contrast trial participants discussed several health benefits related to dairy foods, practised label reading and were confident in their ability to incorporate dairy foods into their diet. Normative beliefs expressed were similar for both groups indicating that these were more static and less amenable to change through nutrition education than control and behavioural beliefs. Conclusions Nutrition education provided as a result of weight loss trial participation influenced behavioural and control beliefs relating to dairy products. This study provides a proof of concept indication that nutrition education may improve attitudes towards dairy products and may thus be an important target for public health campaigns seeking to increase intake of this food group. PMID:22047610

Using new technologies to promote weight management: a randomised controlled trial study protocol.

PubMed

Jane, Monica; Foster, Jonathan; Hagger, Martin; Pal, Sebely

2015-05-27

Over the last three decades, overweight and obesity and the associated health consequences have become global public health priorities. Methods that have been tried to address this problem have not had the desired impact, suggesting that other approaches need to be considered. One of the lessons learned throughout these attempts is that permanent weight loss requires sustained dietary and lifestyle changes, yet adherence to weight management programs has often been noted as one of the biggest challenges. This trial aims to address this issue by examining whether social media, as a potential health promotion tool, will improve adherence to a weight management program. To test the effectiveness of this measure, the designated program will be delivered via the popular social networking site Facebook, and compared to a standard delivery method that provides exactly the same content but which is communicated through a pamphlet. The trial will be conducted over a period of twelve weeks, with a twelve week follow-up. Although weight loss is expected, this study will specifically investigate the effectiveness of social media as a program delivery method. The program utilised will be one that has already been proven to achieve weight loss, namely The CSIRO Total Wellbeing Diet. This project will be conducted as a 3-arm randomised controlled trial. One hundred and twenty participants will be recruited from the Perth community, and will be randomly assigned to one of the following three groups: the Facebook group, the pamphlet group, or a control group. The Facebook Group will receive the weight management program delivered via a closed group in Facebook, the Pamphlet Group will be given the same weight management program presented in a booklet, and the Control Group will follow the Australian Dietary Guidelines and the National Physical Activity Guidelines for Adults as usual care. Change in weight, body composition and waist circumference will be initial indicators of adherence to the program. Secondary outcome measures will be blood glucose, insulin, blood pressure, arterial stiffness, physical activity, eating behaviour, mental well-being (stress, anxiety, and depression), social support, self-control, self-efficacy, Facebook activity, and program evaluation. It is expected that this trial will support the use of social media - a source of social support and information sharing - as a delivery method for weight management programs, enhancing the reduction in weight expected from dietary and physical activity changes. Facebook is a popular, easy to access and cost-effective online platform that can be used to assist the formation of social groups, and could be translated into health promotion practice relatively easily. It is anticipated in the context of the predicted findings that social media will provide an invaluable resource for health professionals and patients alike. Australian New Zealand Clinical Trials Register (ANZCTR): ACTRN12614000536662. Date registered: 21 May 2014.

Daughters and Mothers Against Breast Cancer (DAMES): Main outcomes of a randomized controlled trial of weight loss in overweight mothers with breast cancer and their overweight daughters

PubMed Central

Demark-Wahnefried, Wendy; Jones, Lee W; Snyder, Denise C; Sloane, Richard J; Kimmick, Gretchen G; Hughes, Daniel C; Badr, Hoda J; Miller, Paige E; Burke, Lora E; Lipkus, Isaac M

2014-01-01

BACKGROUND Few studies to date have used the cancer diagnosis as a teachable moment to promote healthy behavior changes in survivors of cancer and their family members. Given the role of obesity in the primary and tertiary prevention of breast cancer, the authors explored the feasibility of a mother-daughter weight loss intervention. METHODS A randomized controlled trial of a mailed weight loss intervention was undertaken among 68 mother-daughter dyads (n = 136), each comprised of a survivor of breast cancer (AJCC stage 0-III) and her adult biological daughter. All women had body mass indices ≥ 25 kg/m2 and underwent in-person assessments at baseline, 6 months, and 12 months, with accelerometry and exercise capacity performed on a subset of individuals. All women received a personalized workbook and 6 newsletters over a 1-year period that promoted weight loss; exercise; and a nutrient-rich, low-energy density diet. A total of 25 dyads received individually tailored instruction (INDIVIDUAL), 25 dyads received team-tailored instruction (TEAM), and 18 dyads received standardized brochures (CONTROL). RESULTS The trial met its accrual target, experienced 90% retention, and caused no serious adverse events. Significant differences in baseline to 12-month changes were observed between INDIVIDUAL versus CONTROL mothers for body mass index, weight, and waist circumference (WC); significant differences also were observed in the WC of corresponding daughters (P < .05). Significant differences were found between INDIVIDUAL versus CONTROL and TEAM versus CONTROL dyads for WC (P = .0002 and .018, respectively), minutes per week of physical activity (P = .031 and .036, respectively), and exercise capacity (P = .047 for both). CONCLUSIONS Significant improvements in lifestyle behaviors and health outcomes are possible with tailored print interventions directed toward survivors of cancer and their family members. For greater impact, more research is needed to expand this work beyond the mother-daughter dyad. Cancer 2014;120:2522–2534. © 2014 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society. Obesity is a major risk factor for the incidence and mortality of several cancers. The results of this randomized controlled trial of weight loss among 136 women diagnosed with breast cancer and their biological daughters suggests that the diagnosis of cancer can be used to motivate healthy diet and exercise behaviors among survivors of cancer and their family members using mailed print interventions. PMID:24804802

Energy-restricted, high-protein diets more effectively impact cardiometabolic profile in overweight and obese women than lower-protein diets.

PubMed

Mateo-Gallego, Rocío; Marco-Benedí, Victoria; Perez-Calahorra, Sofía; Bea, Ana M; Baila-Rueda, Lucía; Lamiquiz-Moneo, Itziar; de Castro-Orós, Isabel; Cenarro, Ana; Civeira, Fernando

2017-04-01

High-protein energy-restricted diets have demonstrated efficacy in promoting weight loss in overweight and obesity. However, the protein percentage that achieves optimal efficacy and acceptability remains unknown. We sought to assess the effects of three energy-reduced diets with different percentages of calories from protein (20%, 27%, and 35%) on weight loss and lipids. Secondary outcomes included diet acceptability and compliance. Six-month, randomized study included women aged 18-80 years with BMI of 27.5-45 kg/m 2 and who were not taking lipid-lowering drugs. We randomly assigned 91 women to one of three calorie-reduced diets with: protein, 20%, 27%, or 35% (80% from animal protein); carbohydrates, 50%, 43%, or 35%; fat, 30%. Dietary intervention involved individual visits with a nutritionist every 2 weeks during the first 3 months. We performed a follow-up visit at 6 months. Eighty women aged 44.0 ± 9.08 years with BMI of 37.7 ± 3.39 kg/m 2 completed the study. At 3 months, weight loss was -8.16 ± 4.18 kg, -9.66 ± 5.28 kg, and -10.7 ± 4.28 kg in the 20%, 27%, and 35%-protein groups, respectively (P = 0.16). These figures slightly and homogeneously increased at 6 months. Around 65% of women following 35%-protein diet lost ≥10% of body weight vs. ∼33% in 20%-protein group (P = 0.023). Significant decreases occurred in fat mass, lipids and insulin resistance, especially in the 35%-protein group (P < 0.05 vs. 20% protein). This improvement was not fully explained by weight loss. Triglyceride change was negatively correlated with animal-protein intake. All groups provided similar responses to an acceptance, palatability, and satisfaction questionnaire. An energy-restricted diet with 35% protein, mostly of animal origin, more effectively impacts cardiometabolic profile than an energy-restricted diet with lower protein content although no clear benefit between diets in terms of overall weight loss was observed. The high-protein diet displayed an excellent safety profile and acceptability. This trial was registered in ClinicalTrials.gov as NCT02160496. The clinical trial has been registered in ClinicalTrials.gov (Identifier: NCT02160496). Copyright © 2016 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Green tea for weight loss and weight maintenance in overweight or obese adults.

PubMed

Jurgens, Tannis M; Whelan, Anne Marie; Killian, Lara; Doucette, Steve; Kirk, Sara; Foy, Elizabeth

2012-12-12

Preparations of green tea are used as aids in weight loss and weight maintenance. Catechins and caffeine, both contained in green tea, are each believed to have a role in increasing energy metabolism, which may lead to weight loss. A number of randomised controlled trials (RCTs) evaluating the role of green tea in weight loss have been published; however, the efficacy of green tea preparations in weight loss remains unclear. To assess the efficacy and safety of green tea preparations for weight loss and weight maintenance in overweight or obese adults. We searched the following databases from inception to specified date as well as reference lists of relevant articles: The Cochrane Library (Issue 12, 2011), MEDLINE (December 2011), EMBASE (December 2011), CINAHL (January 2012), AMED (January 2012), Biological Abstracts (January 2012), IBIDS (August 2010), Obesity+ (January 2012), IPA (January 2012) and Web of Science (December 2011). Current Controlled Trials with links to other databases of ongoing trials was also searched. RCTs of at least 12 weeks' duration comparing green tea preparations to a control in overweight or obese adults. Three authors independently extracted data, assessed studies for risk of bias and quality, with differences resolved by consensus. Heterogeneity of included studies was assessed visually using forest plots and quantified using the I(2) statistic. We synthesised data using meta-analysis and descriptive analysis as appropriate; subgroup and sensitivity analyses were conducted. Adverse effects reported in studies were recorded. Due to the level of heterogeneity among studies, studies were divided into two groups; those conducted in Japan and those conducted outside Japan. Study length ranged between 12 and 13 weeks. Meta-analysis of six studies conducted outside Japan showed a mean difference (MD) in weight loss of -0.04 kg (95% CI -0.5 to 0.4; P = 0.88; I(2) = 18%; 532 participants). The eight studies conducted in Japan were not similar enough to allow pooling of results and MD in weight loss ranged from -0.2 kg to -3.5 kg (1030 participants) in favour of green tea preparations. Meta-analysis of studies measuring change in body mass index (BMI) conducted outside Japan showed a MD in BMI of -0.2 kg/m(2) (95% CI -0.5 to 0.1; P = 0.21; I(2) = 38%; 222 participants). Differences among the eight studies conducted in Japan did not allow pooling of results and showed a reduction in BMI ranging from no effect to -1.3 kg/m(2) (1030 participants), in favour of green tea preparations over control. Meta-analysis of five studies conducted outside Japan and measuring waist circumference reported a MD of -0.2 cm (95% CI -1.4 to 0.9; P = 0.70; I(2) = 58%; 404 participants). Differences among the eight studies conducted in Japan did not allow pooling of results and showed effects on waist circumference ranging from a gain of 1 cm to a loss of 3.3 cm (1030 participants). Meta-analysis for three weight loss studies, conducted outside Japan, with waist-to-hip ratio data (144 participants) yielded no significant change (MD 0; 95% CI -0.02 to 0.01). Analysis of two studies conducted to determine if green tea could help to maintain weight after a period of weight loss (184 participants) showed a change in weight loss of 0.6 to -1.6 kg, a change in BMI from 0.2 to -0.5 kg/m(2) and a change in waist circumference from 0.3 to -1.7 cm. In the eight studies that recorded adverse events, four reported adverse events that were mild to moderate, with the exception of two (green tea preparations group) that required hospitalisation (reported as not associated with the intervention). Nine studies reported on compliance/adherence, one study assessed attitude towards eating as part of the health-related quality of life outcome. No studies reported on patient satisfaction, morbidity or cost. Green tea preparations appear to induce a small, statistically non-significant weight loss in overweight or obese adults. Because the amount of weight loss is small, it is not likely to be clinically important. Green tea had no significant effect on the maintenance of weight loss. Of those studies recording information on adverse events, only two identified an adverse event requiring hospitalisation. The remaining adverse events were judged to be mild to moderate.

Formulary management of 2 new agents: lorcaserin and phentermine/topiramate for weight loss.

PubMed

Kelly, Elizabeth M; Tungol, Alexandra A; Wesolowicz, Laurie A

2013-10-01

Obesity may lead to the development of multiple chronic disease states, including hypertension, dyslipidemia, and type 2 diabetes mellitus. Over a half billion adults worldwide are affected by obesity, and more than two-thirds of adults are either obese or overweight in the United States. Diet and exercise have been the mainstays of treatment in this population; however, once failed, noninvasive, long-term effective treatment modality is lacking, and medications may potentially fill the void. Lorcaserin and phentermine/topiramate were approved by the FDA in June 2012 and July 2012, respectively, as adjuncts to diet and exercise for chronic weight management of obese (body mass index [BMI] ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2) individuals with comorbidities. To review the phase 3 trials of lorcaserin and phentermine/topiramate and provide managed care considerations that may be taken into account as a result. A MEDLINE review was performed for articles published and available through September 17, 2012, using keywords "lorcaserin" or "phentermine/topiramate" with an emphasis on phase 3 trials. The literature search was limited to randomized controlled trials in humans published in the English language. Additional information on lorcaserin from its FDA review was obtained from the FDA website. 5 pivotal phase 3 trials were identified: 3 for lorcaserin and 2 for phentermine/topiramate. Both agents demonstrated a statistically significant higher proportion of individuals who lost ≥ 5% of body weight, as well as higher mean weight loss when compared with placebo. Safety concerns for lorcaserin include cardiac valvulopathy and increased risk of psychiatric, cognitive, and serotonergic adverse effects. Teratogenicity and increased heart rate are major safety concerns regarding phentermine/topiramate. Health care decision makers have many factors to consider when developing strategies to fight obesity. Despite a great need for new therapies to treat obesity, medications used for weight loss have significant side-effect profiles and contraindications that may limit therapy. An appropriate utilization management strategy is needed.

Effects of an abbreviated obesity intervention supported by mobile technology: The ENGAGED randomized clinical trial.

PubMed

Spring, Bonnie; Pellegrini, Christine A; Pfammatter, Angela; Duncan, Jennifer M; Pictor, Alex; McFadden, H Gene; Siddique, Juned; Hedeker, Donald

2017-07-01

To determine the effects on weight loss of three abbreviated behavioral weight loss interventions with and without coaching and mobile technology. A randomized controlled efficacy study of three 6-month weight loss treatments was conducted in 96 adults with obesity: 1) self-guided (SELF), 2) standard (STND), or 3) technology-supported (TECH). STND and TECH received eight in-person group treatment sessions. SELF and STND used paper diaries to self-monitor diet, activity, and weight; TECH used a smartphone application with social networking features and wireless accelerometer. Weight loss was greater for TECH and STND than SELF at 6 months (-5.7 kg [95% confidence interval: -7.2 to -4.1] vs. -2.7 kg [95% confidence interval: -5.1 to -0.3], P < 0.05) but not 12 months. TECH and STND did not differ except that more STND (59%) than TECH (34%) achieved ≥ 5% weight loss at 6 months (P < 0.05). Self-monitoring adherence was greater in TECH than STND (P < 0.001), greater in both interventions than SELF (P < 0.001), and covaried with weight loss (r(84) = 0.36-0.51, P < 0.001). Abbreviated behavioral counseling can produce clinically meaningful weight loss regardless of whether self-monitoring is performed on paper or smartphone, but long-term superiority over standard of care self-guided treatment is challenging to maintain. © 2017 The Obesity Society.

Weight loss treatment influences untreated spouses and the home environment: Evidence of a ripple effect

PubMed Central

Gorin, Amy A.; Wing, Rena R.; Fava, Joseph L.; Jakicic, John M.; Jeffery, Robert; West, Delia Smith; Brelje, Kerrin; DiLillo, Vicki G.

2009-01-01

Objectives To examine whether a weight loss program delivered to one spouse has beneficial effects on the untreated spouse and the home environment. Methods We assessed untreated spouses of participants in 3 sites of Look AHEAD, a multi-center randomized controlled trial evaluating the impact of intentional weight loss on cardiovascular outcomes in overweight individuals with type 2 diabetes. Participants and spouses (n=357 pairs) were weighed and completed measures of diet and physical activity at 0 and 12 months. Spouses completed household food and exercise environment inventories. We examined differences between spouses of participants assigned to the Intensive Lifestyle Intervention (ILI) or to enhanced usual care (DSE). Results Spouses of ILI participants lost -2.2±4.5 kg vs. -0.2±3.3 kg in spouses of DSE participants (p<.001). In addition, more ILI spouses lost ≥ 5% of their body weight than DSE spouses (26% vs. 9%, p<.001). Spouses of ILI participants also had greater reductions in reported energy intake (p=.007) and percentage of energy from fat (p=.012) than DSE spouses. Spouse weight loss was associated with participant weight loss (p<.001) and decreases in high-fat foods in the home (p=.05). Conclusion The reach of behavioral weight loss treatment can extend to a spouse, suggesting that social networks can be utilized to promote the spread of weight loss thus creating a ripple effect. PMID:18762804

Relationships between depression, gender, and unhealthy weight loss practices among overweight or obese college students.

PubMed

Davila, E P; Kolodziejczyk, J K; Norman, G J; Calfas, K; Huang, J S; Rock, C L; Griswold, W; Fowler, J H; Marshall, S J; Gupta, A; Patrick, K

2014-04-01

Unhealthy weight loss practices are common among female college students. It is unknown if these practices are also most common among women in the subset of overweight or obese college students or if these practices are related to depression. We examined the relationship between gender, depression, and unhealthy weight loss practices among overweight or obese college students. Students (body mass index between 25.0 and 34.9 kg/m(2)) from three Southern California universities (M(age) = 22 years, SD = 4; 70% women) were recruited from May 2011 to May 2012 for participation in a weight loss clinical trial (N = 404). Logistic regressions were performed with baseline data to assess the cross-sectional relationship between self-reported unhealthy weight loss practices and gender and depression as measured by the Center for Epidemiologic Studies Depression short form. Twenty-nine percent of participants reported engaging in at least one unhealthy weight loss behavior (e.g., fasting, purging) over the last 30 days, with no differences by gender. Self-report of at least one unhealthy weight loss behavior was associated with report of symptoms of depression (e(B) = 1.14 [confidence interval, CI: 1.08-1.20]), adjusting for potential confounders. Interactions between gender and depression were not significant (e(B) = 1.04 [CI: 0.93-1.16]). Among an overweight or obese sample of college students, unhealthy weight loss practices were equally common in both genders, and students with depressive symptomatology were at greatest risk. Obesity interventions targeting overweight or obese college students should educate both men and women about the dangers of unhealthy weight loss practices. In addition, screening for depression can help identify students who would benefit from additional supportive and coping strategies and resources. Copyright © 2014 Elsevier Ltd. All rights reserved.

Long-term persistence of hormonal adaptations to weight loss.

PubMed

Sumithran, Priya; Prendergast, Luke A; Delbridge, Elizabeth; Purcell, Katrina; Shulkes, Arthur; Kriketos, Adamandia; Proietto, Joseph

2011-10-27

After weight loss, changes in the circulating levels of several peripheral hormones involved in the homeostatic regulation of body weight occur. Whether these changes are transient or persist over time may be important for an understanding of the reasons behind the high rate of weight regain after diet-induced weight loss. We enrolled 50 overweight or obese patients without diabetes in a 10-week weight-loss program for which a very-low-energy diet was prescribed. At baseline (before weight loss), at 10 weeks (after program completion), and at 62 weeks, we examined circulating levels of leptin, ghrelin, peptide YY, gastric inhibitory polypeptide, glucagon-like peptide 1, amylin, pancreatic polypeptide, cholecystokinin, and insulin and subjective ratings of appetite. Weight loss (mean [±SE], 13.5±0.5 kg) led to significant reductions in levels of leptin, peptide YY, cholecystokinin, insulin (P<0.001 for all comparisons), and amylin (P=0.002) and to increases in levels of ghrelin (P<0.001), gastric inhibitory polypeptide (P=0.004), and pancreatic polypeptide (P=0.008). There was also a significant increase in subjective appetite (P<0.001). One year after the initial weight loss, there were still significant differences from baseline in the mean levels of leptin (P<0.001), peptide YY (P<0.001), cholecystokinin (P=0.04), insulin (P=0.01), ghrelin (P<0.001), gastric inhibitory polypeptide (P<0.001), and pancreatic polypeptide (P=0.002), as well as hunger (P<0.001). One year after initial weight reduction, levels of the circulating mediators of appetite that encourage weight regain after diet-induced weight loss do not revert to the levels recorded before weight loss. Long-term strategies to counteract this change may be needed to prevent obesity relapse. (Funded by the National Health and Medical Research Council and others; ClinicalTrials.gov number, NCT00870259.).

Impact of weight loss with or without exercise on abdominal fat and insulin resistance in obese individuals: a randomised clinical trial.

PubMed

Trussardi Fayh, Ana Paula; Lopes, André Luiz; Fernandes, Pablo Rober; Reischak-Oliveira, Alvaro; Friedman, Rogério

2013-08-28

Evidence supports an important contribution of abdominal obesity and inflammation to the development of insulin resistance (IR) and CVD. Weight loss in obese individuals can reduce inflammation and, consequently, IR, but the role of training remains unclear. The aim of this study was to evaluate the effects of body weight reduction with and without exercise over abdominal fat tissue (primary outcome) and IR. In this randomised clinical trial, forty-eight obese individuals (age 31·8 (SD 6·0) years, BMI 34·8 (SD 2·7) kg/m2) were randomised to either a diet-only group (DI) or a diet and exercise group (DI þ EXE). Treatment was maintained until 5% of the initial body weight was lost. At baseline and upon completion, the following parameters were analysed: biochemical parameters such as glycaemia and insulin for the determination of homeostasis model assessment of insulin resistance (HOMA-IR), high-sensitivity C-reactive protein (hs-CRP) and abdominal computed tomography for the determination of visceral and subcutaneous adipose tissue. A total of thirteen individuals dropped out before completing the weight-loss intervention and did not repeat the tests. In both the DI (n 18) and DI þ EXE (n 17) groups, we observed significant and similar decreases of visceral adipose tissue (difference between means: 7·9 (95% CI 29·5, 25·2) cm2, P¼0·36), hs-CRP (difference between means: 20·06 (95% CI 20·19, 0·03) mg/l, P¼0·39) and HOMA (difference between means: 20·04 (95% CI 20·17, 0·08), P¼0·53). In the present study, 5% weight loss reduced abdominal fat and IR in obese individuals and exercise did not add to the effect of weight loss on the outcome variables.

The Dietary Intervention to Enhance Tracking with Mobile Devices (DIET Mobile) Study: A 6-Month Randomized Weight Loss Trial.

PubMed

Turner-McGrievy, Gabrielle M; Wilcox, Sara; Boutté, Alycia; Hutto, Brent E; Singletary, Camelia; Muth, Eric R; Hoover, Adam W

2017-08-01

To examine the use of two different mobile dietary self-monitoring methods for weight loss. Adults with overweight (n = 81; mean BMI 34.7 ± 5.6 kg/m 2 ) were randomized to self-monitor their diet with a mobile app (App, n = 42) or wearable Bite Counter device (Bite, n = 39). Both groups received the same behavioral weight loss information via twice-weekly podcasts. Weight, physical activity (International Physical Activity Questionnaire), and energy intake (two dietary recalls) were assessed at 0, 3, and 6 months. At 6 months, 75% of participants completed the trial. The App group lost significantly more weight (-6.8 ± 0.8 kg) than the Bite group (-3.0 ± 0.8 kg; group × time interaction: P < 0.001). Changes in energy intake (kcal/d) (-621 ± 157 App, -456 ± 167 Bite; P = 0.47) or number of days diet was tracked (90.7 ± 9.1 App, 68.4 ± 9.8 Bite; P = 0.09) did not differ between groups, but the Bite group had significant increases in physical activity metabolic equivalents (+2015.4 ± 684.6 min/wk; P = 0.02) compared to little change in the App group (-136.5 ± 630.6; P = 0.02). Total weight loss was significantly correlated with number of podcasts downloaded (r = -0.33, P < 0.01) and number of days diet was tracked (r = -0.33, P < 0.01). While frequency of diet tracking was similar between the App and Bite groups, there was greater weight loss observed in the App group. © 2017 The Obesity Society.

Early improvement in food cravings are associated with long-term weight loss success in a large clinical sample

PubMed Central

Dalton, M; Finlayson, G; Walsh, B; Halseth, A E; Duarte, C; Blundell, J E

2017-01-01

Background: Food cravings are associated with dysregulated eating behaviour and obesity, and may impede successful weight loss attempts. Gaining control over food craving is therefore a component in the management of obesity. The current paper examined whether early changes in control over food craving (assessed using the Craving Control subscale on the Control of Eating Questionnaire (CoEQ)) was predictive of weight loss in four phase 3 clinical trials investigating a sustained-release combination of naltrexone/bupropion (NB) in obese adults. The underlying component structure of the CoEQ was also examined. Method: In an integrated analysis of four 56-week phase 3 clinical trials, subjects completed the CoEQ and had their body weight measured at baseline and at weeks 8, 16, 28 and 56. All analyses were conducted on subjects who had complete weight and CoEQ measurements at baseline and week 56, and had completed 56 weeks of NB (n=1310) or placebo (n=736). A latent growth curve model was used to examine whether early changes in the CoEQ subscales were associated with decreases in weight loss over time. Confirmatory factor analysis (CFA) was used to determine the psychometric properties of the CoEQ. Results: The factor structure of the CoEQ was consistent with previous findings with a four-factor solution being confirmed: Craving Control, Positive Mood, Craving for Sweet and Craving for Savoury with good internal consistency (Cronbach’s α=0.72–0.92). Subjects with the greatest improvement in Craving Control at week 8 exhibited a greater weight loss at week 56. Conclusions: These findings highlight the importance of the experience of food cravings in the treatment of obesity and support the use of the CoEQ as a psychometric tool for the measurement of food cravings in research and the pharmacological management of obesity. PMID:28373674

Web Support for Weight-Loss Interventions: PREDIRCAM2 Clinical Trial Baseline Characteristics and Preliminary Results.

PubMed

Alcántara-Aragón, Valeria; Rodrigo-Cano, Susana; Lupianez-Barbero, Ascension; Martinez, María José; Martinez, Carmen; Tapia, José; Iniesta, José Manuel; Tenes, Susana; Urgell, Eulalia; Navarro, Gemma; Hernando, M Elena; Merino-Torres, Juan Francisco; de Leiva, Alberto; Gonzalez, Cintia

2018-05-01

An ongoing clinical trial is testing the efficacy of web telematic support in a structured program for obesity treatment and diabetes prevention. Participants were recruited from two tertiary-care hospitals and randomized to receive either a telematic intervention (TI) supported by PREDIRCAM2 web platform or a non-telematic intervention (NTI). All receive 1-year follow-up. Both interventions consist of tailored dietary and exercise prescriptions, based on a Mediterranean dietary pattern and general WHO exercise recommendations for adults. At 6 months, both groups have received 7 contacts, 3 exclusively telematic for the TI group. This is a preliminary result intention-to-treat analysis. One hundred eighty-three participants were recruited, with a mean body mass index of 34.75 ± 2.75 kg/m 2 . General dropout rate at 6 months was 26.8%. Weight changes were statistically significant at months 3 and 6 compared to baseline, -2.915 ± 0.24 kg, -3.29 ± 0.36 kg, respectively (P < 0.001), but not statistically significant between the 3- and 6-month time points -0.37 ± 0.21 kg (P = 0.24). Mean group differences showed that the TI group lost 1.61 ± 1.88 kg more than the NTI group (P = 0.39). Waist, waist/hip ratio, resting heart rate, blood pressure, HbA1c, and low-density lipoprotein cholesterol also showed statistically significant changes at 6 months, with no significant differences between groups. Weight loss in the TI group shows similar results as the usual care NTI group for weight loss and control of obesity comorbidities. At completion of the clinical trial, these results will be reevaluated to assess the potential role of web support in weight-loss maintenance and its cost-effectiveness.

Quality of life outcomes from the Exercise and Nutrition Enhance Recovery and Good Health for You (ENERGY)-randomized weight loss trial among breast cancer survivors

PubMed Central

Colditz, Graham A.; Rock, Cheryl L.; Sedjo, Rebecca L.; Liu, Jingxia; Wolin, Kathleen Y.; Krontiras, Helen; Byers, Tim; Pakiz, Bilgé; Parker, Barbara A.; Naughton, Michael; Elias, Anthony; Ganz, Patricia A.

2015-01-01

Obesity is a poor prognostic factor and is negatively related to quality of life (QOL) in breast cancer survivors. Exercise and Nutrition to Enhance Recovery and Good Health for You is the largest weight loss trial completed among cancer survivors. Percent losses in body weight with an intensive group-based intervention versus an attention control were 6.0 versus 1.5 % (p < 0.0001) and 3.7 versus 1.3 % (p<0.0001) at 12 and 24 months, respectively. ENERGY also was designed to answer the research question: Does weight loss significantly improve vitality and physical function (key components of QOL)? 692 breast cancer survivors (BMI: 25–45 kg/m2) at 4 US sites were randomized to a year-long intensive intervention of 52 group sessions and telephone counseling contacts versus a non-intensive (control) of two in-person counseling sessions. Weight, self-reported QOL, and symptoms were measured semi-annually for two years. Significant decreases in physical function and increases in symptoms were observed among controls from baseline to 6 months, but not in the intervention arm, −3.45 (95 % Confidence Interval [CI] −6.10, –0.79, p = 0.0109) and 0.10 (95 %CI 0.04, 0.16, p = 0.0021), respectively. Improvements in vitality were seen in both arms but trended toward greater improvement in the intervention arm −2.72 (95 % CI −5.45, 0.01, p = 0.0508). These differences diminished over time; however, depressive symptoms increased in the intervention versus control arms and became significant at 24 months, −1.64 (95 % CI −3.13, –0.15, p = 0.0308). Increased QOL has been reported in shorter term diet and exercise trials among cancer survivors. These longer term data suggest that diet and exercise interventions improve some aspects of QOL, but these benefits may diminish over time. PMID:26518022

Local recruitment experience in a study comparing the effectiveness of a low glycaemic index diet with a low calorie healthy eating approach at achieving weight loss and reducing the risk of endometrial cancer in women with polycystic ovary syndrome (PCOS).

PubMed

Atiomo, William; Read, Anna; Golding, Mary; Silcocks, Paul; Razali, Nuguelis; Sarkar, Sabitabrata; Hardiman, Paul; Thornton, Jim

2009-09-01

Feasibility of a clinical-trial comparing a low-glycaemic diet with a low-calorie healthy eating approach at achieving weight loss and reducing the risk of endometrial cancer in women with PCOS. A pilot Randomised-Controlled-Trial using different recruitment strategies. A University Hospital in the United Kingdom. Women seen at specialist gynaecology clinics over a 12 month period in one University Hospital, and women self identified through a website and posters. Potential recruits were assessed for eligibility, gave informed consent, randomised, treated and assessed as in the definitive trial. Eligibility and recruitment rates, compliance with the allocated diet for 6 months and with clinical assessments, blood tests, pelvic ultrasound scans and endometrial biopsies. 1433 new and 2598 follow up patients were seen in 153 gynaecology clinics for over 12 months. 441 (11%) potentially eligible women were identified, 19 (0.4%) of whom met the trial entry criteria. Eleven consented to take part, of which 8 (73%) completed the study. Planned future trials on over-weight women with PCOS should be multicentre and should incorporate primary care. This data will help other researchers plan and calculate the sample size and potential recruitment rates in future clinical trials in PCOS. The results will also be useful for inclusion in future meta-analyses.

Orlistat with behavioral weight loss for obesity with versus without binge eating disorder: randomized placebo-controlled trial at a community mental health center serving educationally and economically disadvantaged Latino/as.

PubMed

Grilo, Carlos M; White, Marney A

2013-03-01

This study was a randomized placebo-controlled trial testing the addition of orlistat to behavioral weight loss for obesity in Spanish-speaking-only Latino/as with versus without binge eating disorder (BED) performed at a community mental health center serving educationally- and economically-disadvantaged patients. Latino/as have high rates of obesity but are under-represented in obesity treatment studies and despite comparable-to-or-higher rates of BED than Whites, Latino/as are under-represented in BED treatment studies. BED is associated with obesity but whether it predicts/moderates treatment outcomes remains uncertain. Thus, this study also tested whether BED prospectively predicts/moderates outcomes. Seventy-nine obese Spanish-speaking-only Latino/as with BED (N=40) versus without BED (N=39) at a community mental health center were randomly assigned to four-months of orlistat-plus-BWL or placebo-plus-BWL. BWL was culturally-enhanced modification of Diabetes-Prevention-Program delivered in weekly sessions in Spanish. Orlistat (120 mg tid) and matching-placebo delivered with standard clinical-management. Participants were assessed independently throughout treatment, post-treatment, and six-month follow-up. 78% completed treatments; completion rates did not differ significantly by medication or BED. Intent-to-treat mixed-models analyses revealed significant improvements in binge eating, eating-psychopathology, and depression, and significant--albeit modest--weight-loss. Overall, the addition of orlistat to BWL was not associated with greater improvements; however, BED moderated weight-loss: orlistat-plus-BWL produced significantly greater weight-loss in non-BED group but not in BED. Improvements were maintained through 6-month follow-up; BED significantly predicted/moderated increases in eating concerns and depression following treatment. Within BED-group, binge-eating remission rates were 65% (post-treatment) and 50% (follow-up). In this controlled trial performed at community mental health center serving educationally- and economically-disadvantaged Spanish-speaking-only Latino/as with co-morbid psychiatric needs, we observed outcomes for the BWL plus orlistat/placebo medication that approximate or are slightly dampened relative to the literature for efficacy trials with much more restrictive obese and BED samples. In this complex patient group, adding orlistat to BWL produced greater weight-loss than adding placebo among obese patients without BED but not among those with BED. Although 50% of BED patients maintained abstinence from binge-eating following these specific obesity treatments (BWL plus orlistat/placebo), BED was a negative prognostic indicator for some outcome variables. clinicaltrials.gov Identifier: NCT00516919. Copyright © 2013 Elsevier Ltd. All rights reserved.

Calcium plus vitamin D3 supplementation facilitated fat loss in overweight and obese college students with very-low calcium consumption: a randomized controlled trial.

PubMed

Zhu, Wei; Cai, Donglian; Wang, Ying; Lin, Ning; Hu, Qingqing; Qi, Yang; Ma, Shuangshuang; Amarasekara, Sidath

2013-01-08

Recent evidence suggests that higher calcium and/or vitamin D intake may be associated with lower body weight and better metabolic health. Due to contradictory findings from intervention trials, we investigated the effect of calcium plus vitamin D3 (calcium+D) supplementation on anthropometric and metabolic profiles during energy restriction in healthy, overweight and obese adults with very-low calcium consumption. Fifty-three subjects were randomly assigned in an open-label, randomized controlled trial to receive either an energy-restricted diet (-500 kcal/d) supplemented with 600 mg elemental calcium and 125 IU vitamin D3 or energy restriction alone for 12 weeks. Repeated measurements of variance were performed to evaluate the differences between groups for changes in body weight, BMI, body composition, waist circumference, and blood pressures, as well as in plasma TG, TC, HDL, LDL, glucose and insulin concentrations. Eighty-one percent of participants completed the trial (85% from the calcium + D group; 78% from the control group). A significantly greater decrease in fat mass loss was observed in the calcium + D group (-2.8±1.3 vs.-1.8±1.3 kg; P=0.02) than in the control group, although there was no significant difference in body weight change (P>0.05) between groups. The calcium + D group also exhibited greater decrease in visceral fat mass and visceral fat area (P<0.05 for both). No significant difference was detected for changes in metabolic variables (P>0.05). Calcium plus vitamin D3 supplementation for 12 weeks augmented body fat and visceral fat loss in very-low calcium consumers during energy restriction. ClinicalTrials.gov (NCT01447433, http://clinicaltrials.gov/).

Multilevel Approach of a 1-Year Program of Dietary and Exercise Interventions on Bone Mineral Content and Density in Metabolic Syndrome--the RESOLVE Randomized Controlled Trial.

PubMed

Courteix, Daniel; Valente-dos-Santos, João; Ferry, Béatrice; Lac, Gérard; Lesourd, Bruno; Chapier, Robert; Naughton, Geraldine; Marceau, Geoffroy; João Coelho-e-Silva, Manuel; Vinet, Agnès; Walther, Guillaume; Obert, Philippe; Dutheil, Frédéric

2015-01-01

Weight loss is a public health concern in obesity-related diseases such as metabolic syndrome (MetS). However, restrictive diets might induce bone loss. The nature of exercise and whether exercise with weight loss programs can protect against potential bone mass deficits remains unclear. Moreover, compliance is essential in intervention programs. Thus, we aimed to investigate the effects that modality and exercise compliance have on bone mineral content (BMC) and density (BMD). We investigated 90 individuals with MetS who were recruited for the 1-year RESOLVE trial. Community-dwelling seniors with MetS were randomly assigned into three different modalities of exercise (intensive resistance, intensive endurance, moderate mixed) combined with a restrictive diet. They were compared to 44 healthy controls who did not undergo the intervention. This intensive lifestyle intervention (15-20 hours of training/week + restrictive diet) resulted in weight loss, body composition changes and health improvements. Baseline BMC and BMD for total body, lumbar spine and femoral neck did not differ between MetS groups and between MetS and controls. Despite changes over time, BMC or BMD did not differ between the three modalities of exercise and when compared with the controls. However, independent of exercise modality, compliant participants increased their BMC and BMD compared with their less compliant peers. Decreases in total body lean mass and negative energy balance significantly and independently contributed to decreases in lumbar spine BMC. After the one year intervention, differences relating to exercise modalities were not evident. However, compliance with an intensive exercise program resulted in a significantly higher bone mass during energy restriction than non-compliance. Exercise is therefore beneficial to bone in the context of a weight loss program. ClinicalTrials.gov NCT00917917.

Is lost lean mass from intentional weight loss recovered during weight regain in postmenopausal women?

PubMed

Beavers, Kristen M; Lyles, Mary F; Davis, Cralen C; Wang, Xuewen; Beavers, Daniel P; Nicklas, Barbara J

2011-09-01

Despite the well-known recidivism of obesity, surprisingly little is known about the composition of body weight during weight regain. The objective of this study was to determine whether the composition of body weight regained after intentional weight loss is similar to the composition of body weight lost. The design was a follow-up to a randomized controlled trial of weight loss in which body composition was analyzed and compared in 78 postmenopausal women before the intervention, immediately after the intervention, and 6 and 12 mo after the intervention. All body mass and composition variables were lower immediately after weight loss than at baseline (all P < 0.05). More fat than lean mass was lost with weight loss, which resulted in body-composition changes favoring a lower percentage of body fat and a higher lean-to-fat mass ratio (P < 0.001). Considerable interindividual variability in weight regain was noted (CV = 1.07). In women who regained ≥2 kg body weight, a decreasing trend in the lean-to-fat mass ratio was observed, which indicated greater fat mass accretion than lean mass accretion (P < 0.001). Specifically, for every 1 kg fat lost during the weight-loss intervention, 0.26 kg lean tissue was lost; for every 1 kg fat regained over the following year, only 0.12 kg lean tissue was regained. Although not all postmenopausal women who intentionally lose weight will regain it within 1 y, the data suggest that fat mass is regained to a greater degree than is lean mass in those who do experience some weight regain. The health ramifications of our findings remain to be seen.

Rationale and design of REWARD (revving-up exercise for sustained weight loss by altering neurological reward and drive): a randomized trial in obese endometrial cancer survivors.

PubMed

Nock, Nora L; Dimitropoulos, Anastasia; Rao, Stephen M; Flask, Chris A; Schluchter, Mark; Zanotti, Kristine M; Rose, Peter G; Kirwan, John P; Alberts, Jay

2014-11-01

Obesity is a leading risk factor for endometrial cancer (EC), particularly Type I forms, which are increasing in the U.S. Although death rates from most cancers have been decreasing, overall mortality in EC is increasing in the U.S. EC survivors' poor fitness combined with their surgical treatments may make weight loss particularly challenging. High intensity exercise increases neurotrophins and neurological reward via altered striatal dopamine in animals, and, in humans, chronic high intensity exercise enhances meal-induced satiety and may reduce hedonic eating. "Assisted" exercise, a mode of exercise whereby a patient's voluntary exercise rate is augmented mechanically, may modulate brain dopamine levels in Parkinson's Disease patients but has not been previously evaluated as a treatment for obesity. We describe the rationale and design of the REWARD trial, which has the overarching goal of randomizing 120 obese EC survivors to "assisted" or voluntary rate cycling to evaluate the efficacy of "assisted" exercise in enhancing and sustaining weight loss. Patients in both arms will receive 3 days/week of supervised exercise and 1 day/week of a group dietary behavioral intervention for 16 weeks and, then, will be followed for 6 months. The primary outcome is weight loss. Secondary outcomes include measures for body composition, fitness, eating behavior, exercise motivation and, quality of life as well as cognition and food reward and motivation as assessed by functional magnetic resonance imaging (fMRI) tasks. If successful, the REWARD program could be extended to help sustain weight loss in obese cancer and non-cancer patients. Copyright © 2014 Elsevier Inc. All rights reserved.

Low-fat dietary pattern and risk of treated diabetes mellitus in postmenopausal women: the Women's Health Initiative randomized controlled dietary modification trial.

PubMed

Tinker, Lesley F; Bonds, Denise E; Margolis, Karen L; Manson, JoAnn E; Howard, Barbara V; Larson, Joseph; Perri, Michael G; Beresford, Shirley A A; Robinson, Jennifer G; Rodríguez, Beatriz; Safford, Monika M; Wenger, Nanette K; Stevens, Victor J; Parker, Linda M

2008-07-28

Decreased fat intake with weight loss and increased exercise may reduce the risk of diabetes mellitus in persons with impaired glucose tolerance. This study was undertaken to assess the effects of a low-fat dietary pattern on incidence of treated diabetes among generally healthy postmenopausal women. A randomized controlled trial was conducted at 40 US clinical centers from 1993 to 2005, including 48,835 postmenopausal women aged 50 to 79 years. Women were randomly assigned to a usual-diet comparison group (n = 29,294 [60.0%]) or an intervention group with a 20% low-fat dietary pattern with increased vegetables, fruits, and grains (n = 19,541 [40.0%]). Self-reported incident diabetes treated with oral agents or insulin was assessed. Incident treated diabetes was reported by 1303 intervention participants (7.1%) and 2039 comparison participants (7.4%) (hazard ratio, 0.96; 95% confidence interval, 0.90-1.03; P = .25). Weight loss occurred in the intervention group, with a difference between intervention and comparison groups of 1.9 kg after 7.5 years (P < .001). Subgroup analysis suggested that greater decreases in percentage of energy from total fat reduced diabetes risk (P for trend = .04), which was not statistically significant after adjusting for weight loss. A low-fat dietary pattern among generally healthy postmenopausal women showed no evidence of reducing diabetes risk after 8.1 years. Trends toward reduced incidence were greater with greater decreases in total fat intake and weight loss. Weight loss, rather than macronutrient composition, may be the dominant predictor of reduced risk of diabetes.

Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes.

PubMed

Wing, Rena R; Bolin, Paula; Brancati, Frederick L; Bray, George A; Clark, Jeanne M; Coday, Mace; Crow, Richard S; Curtis, Jeffrey M; Egan, Caitlin M; Espeland, Mark A; Evans, Mary; Foreyt, John P; Ghazarian, Siran; Gregg, Edward W; Harrison, Barbara; Hazuda, Helen P; Hill, James O; Horton, Edward S; Hubbard, Van S; Jakicic, John M; Jeffery, Robert W; Johnson, Karen C; Kahn, Steven E; Kitabchi, Abbas E; Knowler, William C; Lewis, Cora E; Maschak-Carey, Barbara J; Montez, Maria G; Murillo, Anne; Nathan, David M; Patricio, Jennifer; Peters, Anne; Pi-Sunyer, Xavier; Pownall, Henry; Reboussin, David; Regensteiner, Judith G; Rickman, Amy D; Ryan, Donna H; Safford, Monika; Wadden, Thomas A; Wagenknecht, Lynne E; West, Delia S; Williamson, David F; Yanovski, Susan Z

2013-07-11

Weight loss is recommended for overweight or obese patients with type 2 diabetes on the basis of short-term studies, but long-term effects on cardiovascular disease remain unknown. We examined whether an intensive lifestyle intervention for weight loss would decrease cardiovascular morbidity and mortality among such patients. In 16 study centers in the United States, we randomly assigned 5145 overweight or obese patients with type 2 diabetes to participate in an intensive lifestyle intervention that promoted weight loss through decreased caloric intake and increased physical activity (intervention group) or to receive diabetes support and education (control group). The primary outcome was a composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for angina during a maximum follow-up of 13.5 years. The trial was stopped early on the basis of a futility analysis when the median follow-up was 9.6 years. Weight loss was greater in the intervention group than in the control group throughout the study (8.6% vs. 0.7% at 1 year; 6.0% vs. 3.5% at study end). The intensive lifestyle intervention also produced greater reductions in glycated hemoglobin and greater initial improvements in fitness and all cardiovascular risk factors, except for low-density-lipoprotein cholesterol levels. The primary outcome occurred in 403 patients in the intervention group and in 418 in the control group (1.83 and 1.92 events per 100 person-years, respectively; hazard ratio in the intervention group, 0.95; 95% confidence interval, 0.83 to 1.09; P=0.51). An intensive lifestyle intervention focusing on weight loss did not reduce the rate of cardiovascular events in overweight or obese adults with type 2 diabetes. (Funded by the National Institutes of Health and others; Look AHEAD ClinicalTrials.gov number, NCT00017953.).

Success of a weight loss plan for overweight dogs: The results of an international weight loss study

PubMed Central

Flanagan, John; Bissot, Thomas; Hours, Marie-Anne; Moreno, Bernabe; Feugier, Alexandre

2017-01-01

Introduction Obesity is a global concern in dogs with an increasing prevalence, and effective weight loss solutions are required that work in different geographical regions. The main objective was to conduct an international, multi-centre, weight loss trial to determine the efficacy of a dietary weight loss intervention in obese pet dogs. Methods A 3-month prospective observational cohort study of weight loss in 926 overweight dogs was conducted at 340 veterinary practices in 27 countries. Commercially available dry or wet weight loss diets were used, with the initial energy allocation being 250–335 kJ/kg target body weight0.75/day (60–80 kcal/kg target body weight0.75/day) depending on sex and neuter status. The primary outcome measure was percentage weight loss; the main secondary outcomes were changes in activity, quality of life, and food-seeking behaviour, which were subjectively determined from owner descriptions. Results At baseline, median (range) age was 74 (12 to 193) months and median body condition score was 8 (range 7–9). 896 of the 926 dogs (97%) lost weight, with mean weight loss being 11.4 ±5.84%. Sexually intact dogs lost more weight than neutered dogs (P = 0.001), whilst female dogs lost more weight than male dogs (P = 0.007), with the difference being more pronounced in North and South American dogs (median [Q1, Q3]: female: 11.5% [8.5%, 14.5%]; male: 9.1% [6.3%, 12.1%], P = 0.053) compared with those from Europe (female: 12.3% [8.9%, 14.9%]; male: 10.9% [8.6%, 15.4%]). Finally, subjective scores for activity (P<0.001) and quality of life (P<0.001) increased sequentially, whilst scores for food-seeking behaviour decreased sequentially (P<0.001) during the study. Conclusion This is the largest international multi-centre weight loss study conducted to date in obese dogs. Most dogs lost a clinically significant amount of weight, although there were notable differences between dogs of different sex, neuter status and in different geographical locations. PMID:28886096

Effectiveness of web-based self-disclosure peer-to-peer support for weight loss: randomized controlled trial.

PubMed

Imanaka, Mie; Ando, Masahiko; Kitamura, Tetsuhisa; Kawamura, Takashi

2013-07-09

Obesity is one of the most common public health problems in the industrialized world as a cause of noncommunicable diseases. Although primarily used for one-on-one communication, email is available for uninterrupted support for weight loss, but little is known about the effects of dietitian group counseling for weight control via the Internet. We developed a Web-based self-disclosure health support (WSHS) system for weight loss. This study aims to compare the effect of weight change between those using the WSHS and those using the email health support (EHS). This study was designed as an open prospective individual randomized controlled trial. Eligible participants were aged 35 to 65 years with a body mass index (BMI) of ≥25.0 in their latest health examination. Participants were randomly assigned to either the WSHS group or the EHS group. Thirteen registered dietitians under the direction of a principal dietitian each instructed 6 to 8 participants from the respective groups. All participants in the WSHS group could receive nutritional advice and calculate their nutritive intake from a photograph of a meal on their computer screen from the Internet sent to them by their dietitian, receive supervision from the registered dietitian, and view fellow participants' weight changes and lifestyle modifications. In the EHS group, a participant could receive one-on-one nutritional advice and calculate his/her nutritive intake from the photograph of a meal on computer screen sent by email from his/her dietitian, without being able to view fellow participants' status. The follow-up period was 12 weeks for both groups. The primary outcome measure was change in body weight. The secondary outcome measure included changes in BMI and waist circumference. The intergroup comparison of the changes before and after intervention was evaluated using analysis of covariance. A total of 193 participants were randomly assigned to either the WSHS group (n=97) or the EHS group (n=96). Ten from the WSHS group and 8 from the EHS group dropped out during the study period, and the remaining 87 in the WSHS group and 88 in the EHS group were followed up completely. Weight loss was significantly greater in the WSHS group than in the EHS group (-1.6 kg vs -0.7 kg; adjusted P=.04). However, there were few differences in waist circumference between the 2 groups. (-3.3 cm vs -3.0 cm; adjusted P=.71). Our newly developed WSHS system using forced self-disclosure had better short-term weight loss results. Further study in a longer-term trial is necessary to determine what effects this type of intervention might have on long-term cardiovascular disease. University Hospital Medical Information Network Clinical Trial Registration (UMIN-CTR): UMIN000009147; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000010719&language=E (Archived by WebCite at http://www.webcitation.org/6HTCkhb1p).

Early weight loss while on lorcaserin, diet and exercise as a predictor of week 52 weight-loss outcomes.

PubMed

Smith, Steven R; O'Neil, Patrick M; Astrup, Arne; Finer, Nicholas; Sanchez-Kam, Matilde; Fraher, Kyle; Fain, Randi; Shanahan, William R

2014-10-01

To identify an early treatment milestone that optimizes sensitivity and specificity for predicting ≥5% weight loss at Week (W) 52 in patients with and without type 2 diabetes on lorcaserin or placebo. Post hoc area under the curve for receiver operating characteristic analyses of data from three phase 3 trials comparing lifestyle modification+placebo with lifestyle modification+lorcaserin. A total of 6897 patients (18-65 years; BMI, 30-45 or 27-29.9 kg/m(2) with ≥1 comorbidity) were randomized to placebo or lorcaserin 10 mg bid. Changes (baseline to W52) in cardiometabolic parameters were assessed. Response (≥5% weight loss from baseline) at W12 was a strong predictor of W52 response. Lorcaserin patients with a W12 response achieved mean W52 weight losses of 10.6 kg (without diabetes) and 9.3 kg (with diabetes). Proportions achieving ≥5% and ≥10% weight loss at W52 were 85.5% and 49.8% (without diabetes), and 70.5% and 35.9% (with diabetes). Lorcaserin patients who did not achieve a W12 response lost 3.2 kg (without diabetes) and 2.8 kg (with diabetes) at W52. Responders had greater improvements in cardiometabolic risk factors than the modified intent-to-treat (MITT) population, consistent with greater weight loss. ≥5% weight loss by W12 predicts robust response to lorcaserin at 1 year. Copyright © 2014 The Authors Obesity published by Wiley Periodicals, Inc. on behalf of The Obesity Society (TOS).

Together We STRIDE: A quasi-experimental trial testing the effectiveness of a multi-level obesity intervention for Hispanic children in rural communities.

PubMed

Ko, Linda K; Rillamas-Sun, Eileen; Bishop, Sonia; Cisneros, Oralia; Holte, Sarah; Thompson, Beti

2018-04-01

Hispanic children are disproportionally overweight and obese compared to their non-Hispanic white counterparts in the US. Community-wide, multi-level interventions have been successful to promote healthier nutrition, increased physical activity (PA), and weight loss. Using community-based participatory approach (CBPR) that engages community members in rural Hispanic communities is a promising way to promote behavior change, and ultimately weight loss among Hispanic children. Led by a community-academic partnership, the Together We STRIDE (Strategizing Together Relevant Interventions for Diet and Exercise) aims to test the effectiveness of a community-wide, multi-level intervention to promote healthier diets, increased PA, and weight loss among Hispanic children. The Together We STRIDE is a parallel quasi-experimental trial with a goal of recruiting 900 children aged 8-12 years nested within two communities (one intervention and one comparison). Children will be recruited from their respective elementary schools. Components of the 2-year multi-level intervention include comic books (individual-level), multi-generational nutrition and PA classes (family-level), teacher-led PA breaks and media literacy education (school-level), family nights, a farmer's market and a community PA event (known as ciclovia) at the community-level. Children from the comparison community will receive two newsletters. Height and weight measures will be collected from children in both communities at three time points (baseline, 6-months, and 18-months). The Together We STRIDE study aims to promote healthier diet and increased PA to produce healthy weight among Hispanic children. The use of CBPR approach and the engagement of the community will springboard strategies for intervention' sustainability. Clinical Trials Registration Number: NCT02982759 Retrospectively registered. Copyright © 2018 Elsevier Inc. All rights reserved.

Long-term weight loss maintenance for obesity: a multidisciplinary approach

PubMed Central

Montesi, Luca; El Ghoch, Marwan; Brodosi, Lucia; Calugi, Simona; Marchesini, Giulio; Dalle Grave, Riccardo

2016-01-01

The long-term weight management of obesity remains a very difficult task, associated with a high risk of failure and weight regain. However, many people report that they have successfully managed weight loss maintenance in the long term. Several factors have been associated with better weight loss maintenance in long-term observational and randomized studies. A few pertain to the behavioral area (eg, high levels of physical activity, eating a low-calorie, low-fat diet; frequent self-monitoring of weight), a few to the cognitive component (eg, reduced disinhibition, satisfaction with results achieved, confidence in being able to lose weight without professional help), and a few to personality traits (eg, low novelty seeking) and patient–therapist interaction. Trials based on the most recent protocols of lifestyle modification, with a prolonged extended treatment after the weight loss phase, have also shown promising long-term weight loss results. These data should stimulate the adoption of a lifestyle modification-based approach for the management of obesity, featuring a nonphysician lifestyle counselor (also called “lifestyle trainer” or “healthy lifestyle practitioner”) as a pivotal component of the multidisciplinary team. The obesity physicians maintain a primary role in engaging patients, in team coordination and supervision, in managing the complications associated with obesity and, in selected cases, in the decision for drug treatment or bariatric surgery, as possible more intensive, add-on interventions to lifestyle treatment. PMID:27013897

Effect of beta-adrenergic blockade with carvedilol on cachexia in severe chronic heart failure: results from the COPERNICUS trial.

PubMed

Clark, Andrew L; Coats, Andrew J S; Krum, Henry; Katus, Hugo A; Mohacsi, Paul; Salekin, Damien; Schultz, Melissa K; Packer, Milton; Anker, Stefan D

2017-08-01

Cardiac cachexia frequently accompanies the progression of heart failure despite the use of effective therapies for left ventricular dysfunction. Activation of the sympathetic nervous system has been implicated in the pathogenesis of weight loss, but the effects of sympathetic antagonism on cachexia are not well defined. We prospectively evaluated changes in body weight in 2289 patients with heart failure who had dyspnoea at rest or on minimal exertion and a left ventricular ejection fraction <25%. Patients were randomly assigned (double-blind) to receive either placebo (n = 1133) or carvedilol (n = 1156) and were followed for the occurrence of major clinical events for up to 29 months (COPERNICUS trial). Patients were not enrolled if they had signs of clinically significant fluid retention due to heart failure. Patients in the carvedilol group were 33% less likely than patients in the placebo group to experience a further significant loss of weight (>6%) (95% confidence interval: 14-48%, P = 0.002) and were 37% more likely to experience a significant gain in weight (≥5%) (95% confidence interval: 12-66%, P = 0.002). Carvedilol's ability to prevent weight loss was most marked in patients with increased body mass index at baseline, whereas its ability to promote weight gain was most marked in patients with decreased body mass index at baseline. Increases in weight were not accompanied by evidence of fluid retention. Baseline values for body mass index and change in body weight were significant predictors of survival regardless of treatment. Carvedilol attenuated the development and promoted a partial reversal of cachexia in patients with severe chronic heart failure, supporting a role for prolonged sympathetic activation in the genesis of weight loss. © 2017 The Authors. Journal of Cachexia, Sarcopenia and Muscle published by John Wiley & Sons Ltd on behalf of the Society on Sarcopenia, Cachexia and Wasting Disorders.

Genetic determinant for amino acid metabolites and changes in body weight and insulin resistance in response to weight-loss diets: the Preventing Overweight Using Novel Dietary Strategies (POUNDS LOST) trial.

PubMed

Xu, Min; Qi, Qibin; Liang, Jun; Bray, George A; Hu, Frank B; Sacks, Frank M; Qi, Lu

2013-03-26

Circulating branched-chain amino acids and aromatic amino acids were recently related to insulin resistance and diabetes mellitus in prospective cohorts. We tested the effects of a genetic determinant of branched-chain amino acid/aromatic amino acid ratio on changes in body weight and insulin resistance in a 2-year diet intervention trial. We genotyped the branched-chain amino acid/aromatic amino acid ratio-associated variant rs1440581 near the PPM1K gene in 734 overweight or obese adults who were assigned to 1 of 4 diets varying in macronutrient content. At 6 months, dietary fat significantly modified genetic effects on changes in weight, fasting insulin, and homeostasis model assessment of insulin resistance (HOMA-IR) after adjustment for the confounders (all P for interaction ≤0.006). Further adjustment for weight change did not appreciably change the interactions for fasting insulin and HOMA-IR. In the high-fat diet group, the C allele was related to less weight loss and smaller decreases in serum insulin and HOMA-IR (all P ≤ 0.02 in an additive pattern), whereas an opposite genotype effect on changes in insulin and HOMA-IR was observed in the low-fat diet group (P=0.02 and P=0.04, respectively). At 2 years, the gene-diet interactions remained significant for weight loss (P=0.008) but became null for changes in serum insulin and HOMA-IR resulting from weight regain. Individuals carrying the C allele of the branched-chain amino acid/aromatic amino acid ratio-associated variant rs1440581 may benefit less in weight loss and improvement of insulin sensitivity than those without this allele when undertaking an energy-restricted high-fat diet. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00072995.

The Impact of the 6:3 Polyunsaturated Fatty Acid Ratio on Intermediate Markers of Breast Cancer

DTIC Science & Technology

2008-05-01

randomized clinical trial of a standard versus vegetarian diet for weight loss: the impact of treatment preference. Int J Obes. 2008; 32: 166-76. o...Burke L, Hudson A, Styn M, Warziski M, Ulci O, Sereika S. Effects of a vegetarian diet and treatment preference on biological and dietary variables in...a standard versus vegetarian diet for weight loss: the impact of treatment preference. Int J Obes. 2008; 32: 166-76. Burke L, Hudson A, Styn M

eHealth interventions for the prevention and treatment of overweight and obesity in adults: a systematic review with meta-analysis.

PubMed

Hutchesson, M J; Rollo, M E; Krukowski, R; Ells, L; Harvey, J; Morgan, P J; Callister, R; Plotnikoff, R; Collins, C E

2015-05-01

A systematic review of randomized controlled trials was conducted to evaluate the effectiveness of eHealth interventions for the prevention and treatment of overweight and obesity in adults. Eight databases were searched for studies published in English from 1995 to 17 September 2014. Eighty-four studies were included, with 183 intervention arms, of which 76% (n = 139) included an eHealth component. Sixty-one studies had the primary aim of weight loss, 10 weight loss maintenance, eight weight gain prevention, and five weight loss and maintenance. eHealth interventions were predominantly delivered using the Internet, but also email, text messages, monitoring devices, mobile applications, computer programs, podcasts and personal digital assistants. Forty percent (n = 55) of interventions used more than one type of technology, and 43.2% (n = 60) were delivered solely using eHealth technologies. Meta-analyses demonstrated significantly greater weight loss (kg) in eHealth weight loss interventions compared with control (MD -2.70 [-3.33,-2.08], P < 0.001) or minimal interventions (MD -1.40 [-1.98,-0.82], P < 0.001), and in eHealth weight loss interventions with extra components or technologies (MD 1.46 [0.80, 2.13], P < 0.001) compared with standard eHealth programmes. The findings support the use of eHealth interventions as a treatment option for obesity, but there is insufficient evidence for the effectiveness of eHealth interventions for weight loss maintenance or weight gain prevention. © 2015 World Obesity.

Weight and metabolic effects of dietary weight loss and exercise interventions in postmenopausal antidepressant medication users and non-users: a randomized controlled trial.

PubMed

Imayama, Ikuyo; Alfano, Catherine M; Mason, Caitlin; Wang, Chiachi; Duggan, Catherine; Campbell, Kristin L; Kong, Angela; Foster-Schubert, Karen E; Blackburn, George L; Wang, Ching-Yun; McTiernan, Anne

2013-11-01

Antidepressants may attenuate the effects of diet and exercise programs. We compared adherence and changes in body measures and biomarkers of glucose metabolism and inflammation between antidepressant users and non-users in a 12-month randomized controlled trial. Overweight or obese, postmenopausal women were assigned to: diet (10% weight loss goal, N=118); moderate-to-vigorous aerobic exercise (225 min/week, N=117); diet+exercise (N=117); and control (N=87) in Seattle, WA 2005-2009. Women using antidepressants at baseline were classified as users (N=109). ANCOVA and generalized estimating equation approaches, respectively, were used to compare adherence (exercise amount, diet session attendance, and changes in percent calorie intake from fat, cardiopulmonary fitness, and pedometer steps) and changes in body measures (weight, waist and percent body fat) and serum biomarkers (glucose, insulin, homeostasis assessment-insulin resistance, and high-sensitivity C-reactive protein) between users and non-users. An interaction term (intervention×antidepressant use) tested effect modification. There were no differences in adherence except that diet session attendance was lower among users in the diet+exercise group (P<0.05 vs. non-users). Changes in body measures and serum biomarkers did not differ by antidepressant use (Pinteraction>0.05). Dietary weight loss and exercise improved body measures and biomarkers of glucose metabolism and inflammation independent of antidepressant use. © 2013.

Promoting weight maintenance with electronic health record tools in a primary care setting: Baseline results from the MAINTAIN-pc trial.

PubMed

Conroy, Molly B; Bryce, Cindy L; McTigue, Kathleen M; Tudorascu, Dana; Gibbs, Bethany Barone; Comer, Diane; Hess, Rachel; Huber, Kimberly; Simkin-Silverman, Laurey R; Fischer, Gary S

2017-03-01

Maintaining weight loss is a significant challenge in combating obesity. The goal of Maintaining Activity and Nutrition through Technology-Assisted Innovation in Primary Care (MAINTAIN-pc) is to evaluate the use of tools delivered through an electronic health record (EHR) and patient portal, with or without health coach support, to help primary care patients maintain weight loss. EHR tools include flowsheets, standardized surveys, and secure patient messaging. Inclusion criteria were age 18-75years, voluntary 5% weight loss in the past 2years with prior BMI≥25kg/m 2 , and no bariatric procedures in past 5years. Participants were randomized 1:1 to tailored online coaching with EHR tracking tools (CC) or EHR tracking tools alone (TO). We screened 721 individuals between October 2013 and February 2015; 194 participants enrolled (98 CC; 96 TO). The most common reasons for not enrolling included lack of interest (56%), not meeting age or weight loss criteria (17%), and no verified prior weight loss (10%). At baseline, participants were 53.4 (SD 12.2) years old, 74% female, and 88% White; 95% reported moderate physical activity. Average weight and BMI at baseline were 189.1 (SD 42.1) lbs and 30.4 (5.9) kg/m 2 , respectively. Pre-weight loss BMI was 34.4 (SD 6.5) kg/m 2 . Participants lost an average of 11.3% (SD 6.6) of their body weight before enrolling. Demographic and clinical characteristics did not differ by randomized group. The study successfully identified and recruited primary care patients with recent voluntary weight loss for participation in a weight maintenance program that uses EHR-based tools. Copyright © 2017 Elsevier Inc. All rights reserved.

An Economic Evaluation of a Weight Loss Intervention Program for People with Serious Mental Illnesses Taking Antipsychotic Medications.

PubMed

Meenan, Richard T; Stumbo, Scott P; Yarborough, Micah T; Leo, Michael C; Yarborough, Bobbi Jo H; Green, Carla A

2016-07-01

Individuals with serious mental illnesses suffer from obesity and cardiometabolic diseases at high rates, and antipsychotic medications exacerbate these conditions. While studies have shown weight loss and lifestyle interventions can be effective in this population, few have assessed intervention cost-effectiveness. We present results from a 12-month randomized controlled trial that reduced weight, fasting glucose, and medical hospitalizations in intervention participants. Costs per participant ranged from $4365 to $5687. Costs to reduce weight by one kilogram ranged from $1623 to $2114; costs to reduce fasting glucose by 1 mg/dL ranged from $467 to $608. Medical hospitalization costs were reduced by $137,500.

Systematic review of the clinical efficacy of sibutramine and orlistat in weigth loss, quality of life and its adverse effects in obese adolescents.

PubMed

García Díaz, E; Martín Folgueras, T

2011-01-01

The prevalence of obesity, a serious public health problem, is increasing among teenagers and thus also increases cardiovascular morbidity and mortality in adulthood. To provide a systematic review of the best evidence about the effect of sibutramine and orlistat in weight loss, quality of life and its adverse effects in adolescents diagnosed with obesity. We searched electronic databases and bibliographies of selected articles were inspected for any further reference. We included only randomized controlled trials that met a set of predefined criteria. The studies were reviewed by a narrative synthesis. We included 6 randomized controlled trials of sibutramine and 3 of orlistat. The majority reached a moderate to high methodological quality. Sibutramine and orlistat showed a reduction in body mass index (BMI) that was significantly higher compared with the placebo group. We also found a variation of weight with these drugs significantly better than placebo. Only one trial evaluated the quality of life. The incidence of adverse effects was similar for sibutramine and placebo, except for tachycardia. The most common adverse reactions associated with orlistat were gastrointestinal, mild to moderate. Sibutramine and orlistat in combination with a hypocaloric diet and changes in lifestyle in obese adolescents achieve a short-term loss of weight greater than that achieved through the dietary-behavioral therapy alone.

Zonisamide for weight reduction in obese adults: a 1-year randomized controlled trial.

PubMed

Gadde, Kishore M; Kopping, Mariko F; Wagner, H Ryan; Yonish, Gretchen M; Allison, David B; Bray, George A

2012-11-12

Obese individuals who have failed to achieve adequate weight loss with lifestyle changes have limited nonsurgical therapeutic options. We evaluated the efficacy and tolerability of zonisamide, an antiepileptic drug, for enhancing weight loss in obese patients receiving diet and lifestyle guidance. This was a 1-year, randomized, double-blind, placebo-controlled trial conducted from January 9, 2006, through September 20, 2011, at Duke University Medical Center. A total of 225 obese (mean [SD] body mass index, 37.6 [4.9]) participants included 134 women (59.6%) and 91 men (40.4%) without diabetes mellitus. (Body mass index is calculated as weight in kilograms divided by height in meters squared.) Interventions were daily dosing with placebo (n = 74), 200 mg of zonisamide (n = 76), or 400 mg of zonisamide (n = 75), in addition to diet and lifestyle counseling by a dietitian for 1 year. Primary outcome was change in body weight at 1 year. Of the 225 randomized patients, 218 (96.9%) provided 1-year follow-up assessments. Change in body weight was -4.0 kg (95% CI, -5.8 to -2.3 kg; least squares mean, -3.7%) for placebo, -4.4 kg (-6.1 to -2.6 kg; -3.9%; P = .79 vs placebo) for 200 mg of zonisamide, and -7.3 kg (-9.0 to -5.6 kg; -6.8%; P = .009 vs placebo) for 400 mg of zonisamide. In the categorical analysis, 23 (31.1%) assigned to placebo, 26 (34.2%; P = .72) assigned to 200 mg of zonisamide, and 41 (54.7%; P = .007) assigned to 400 mg of zonisamide achieved 5% or greater weight loss; for 10% or greater weight loss, the corresponding numbers were 6 (8.1%), 17 (22.4%; P = .02), and 24 (32.0%; P < .001). Gastrointestinal, nervous system, and psychiatric adverse events occurred at a higher incidence with zonisamide than with placebo. Zonisamide at the daily dose of 400 mg moderately enhanced weight loss achieved with diet and lifestyle counseling but had a high incidence of adverse events. clinicaltrials.gov Identifier: NCT00275834

Improvement in Body Image, Perceived Health, and Health-Related Self-Efficacy Among People With Serious Mental Illness: The STRIDE Study.

PubMed

Yarborough, Bobbi Jo H; Leo, Michael C; Yarborough, Micah T; Stumbo, Scott; Janoff, Shannon L; Perrin, Nancy A; Green, Carla A

2016-03-01

The authors examined secondary outcomes of STRIDE, a randomized controlled trial that tested a weight-loss and lifestyle intervention for individuals taking antipsychotic medications. Hierarchical linear regression was used to explore the effects of the intervention and weight change at follow-up (six, 12, and 24 months) on body image, perceived health, and health-related self-efficacy. Participants were 200 adults who were overweight and taking antipsychotic agents. Weight change × study arm interaction was associated with significant improvement in body image from baseline to six months. From baseline to 12 months, body image scores of intervention participants improved by 1.7 points more compared with scores of control participants; greater weight loss was associated with more improvement. Between baseline and 24 months, greater weight loss was associated with improvements in body image, perceived health, and health-related self-efficacy. Participation in STRIDE improved body image, and losing weight improved perceived health and health-related self-efficacy.

Design and Implementation of an Interactive Website to Support Long-Term Maintenance of Weight Loss

PubMed Central

Stevens, Victor J; Brantley, Phillip J; Erlinger, Thomas P; Myers, Valerie H; Champagne, Catherine M; Bauck, Alan; Samuel-Hodge, Carmen D; Hollis, Jack F

2008-01-01

Background For most individuals, long-term maintenance of weight loss requires long-term, supportive intervention. Internet-based weight loss maintenance programs offer considerable potential for meeting this need. Careful design processes are required to maximize adherence and minimize attrition. Objective This paper describes the development, implementation and use of a Web-based intervention program designed to help those who have recently lost weight sustain their weight loss over 1 year. Methods The weight loss maintenance website was developed over a 1-year period by an interdisciplinary team of public health researchers, behavior change intervention experts, applications developers, and interface designers. Key interactive features of the final site include social support, self-monitoring, written guidelines for diet and physical activity, links to appropriate websites, supportive tools for behavior change, check-in accountability, tailored reinforcement messages, and problem solving and relapse prevention training. The weight loss maintenance program included a reminder system (automated email and telephone messages) that prompted participants to return to the website if they missed their check-in date. If there was no log-in response to the email and telephone automated prompts, a staff member called the participant. We tracked the proportion of participants with at least one log-in per month, and analyzed log-ins as a result of automated prompts. Results The mean age of the 348 participants enrolled in an ongoing randomized trial and assigned to use the website was 56 years; 63% were female, and 38% were African American. While weight loss data will not be available until mid-2008, website use remained high during the first year with over 80% of the participants still using the website during month 12. During the first 52 weeks, participants averaged 35 weeks with at least one log-in. Email and telephone prompts appear to be very effective at helping participants sustain ongoing website use. Conclusions Developing interactive websites is expensive, complex, and time consuming. We found that extensive paper prototyping well in advance of programming and a versatile product manager who could work with project staff at all levels of detail were essential to keeping the development process efficient. Trial Registration clinicaltrials.gov NCT00054925 PMID:18244892

Effects of dairy intake on weight maintenance

PubMed Central

Zemel, Michael B; Donnelly, Joseph E; Smith, Bryan K; Sullivan, Debra K; Richards, Joanna; Morgan-Hanusa, Danielle; Mayo, Matthew S; Sun, Xiaocun; Cook-Wiens, Galen; Bailey, Bruce W; Van Walleghen, Emily L; Washburn, Richard A

2008-01-01

Background To compare the effects of low versus recommended levels of dairy intake on weight maintenance and body composition subsequent to weight loss. Design and Methods Two site (University of Kansas-KU; University of Tennessee-UT), 9 month, randomized trial. Weight loss was baseline to 3 months, weight maintenance was 4 to 9 months. Participants were maintained randomly assigned to low dairy (< 1 dairy serving/d) or recommended dairy (> 3 servings/d) diets for the maintenance phase. Three hundred thirty eight men and women, age: 40.3 ± 7.0 years and BMI: 34.5 ± 3.1, were randomized; Change in weight and body composition (total fat, trunk fat) from 4 to 9 months were the primary outcomes. Blood chemistry, blood pressure, resting metabolism, and respiratory quotient were secondary outcomes. Energy intake, calcium intake, dairy intake, and physical activity were measured as process evaluation. Results During weight maintenance, there were no overall significant differences for weight or body composition between the low and recommended dairy groups. A significant site interaction occurred with the low dairy group at KU maintaining weight and body composition and the low dairy group at UT increasing weight and body fat. The recommended dairy group exhibited reductions in plasma 1,25-(OH)2-D while no change was observed in the low dairy group. No other differences were found for blood chemistry, blood pressure or physical activity between low and recommended dairy groups. The recommended dairy group showed significantly greater energy intake and lower respiratory quotient compared to the low dairy group. Conclusion Weight maintenance was similar for low and recommended dairy groups. The recommended dairy group exhibited evidence of greater fat oxidation and was able to consume greater energy without greater weight gain compared to the low dairy group. Recommended levels of dairy products may be used during weight maintenance without contributing to weight gain compared to diets low in dairy products. Trial Registration ClinicalTrials.gov NCT00686426 PMID:18950508

Effect of Wearable Technology Combined With a Lifestyle Intervention on Long-term Weight Loss: The IDEA Randomized Clinical Trial.

PubMed

Jakicic, John M; Davis, Kelliann K; Rogers, Renee J; King, Wendy C; Marcus, Marsha D; Helsel, Diane; Rickman, Amy D; Wahed, Abdus S; Belle, Steven H

2016-09-20

Effective long-term treatments are needed to address the obesity epidemic. Numerous wearable technologies specific to physical activity and diet are available, but it is unclear if these are effective at improving weight loss. To test the hypothesis that, compared with a standard behavioral weight loss intervention (standard intervention), a technology-enhanced weight loss intervention (enhanced intervention) would result in greater weight loss. Randomized clinical trial conducted at the University of Pittsburgh and enrolling 471 adult participants between October 2010 and October 2012, with data collection completed by December 2014. Participants were placed on a low-calorie diet, prescribed increases in physical activity, and had group counseling sessions. At 6 months, the interventions added telephone counseling sessions, text message prompts, and access to study materials on a website. At 6 months, participants randomized to the standard intervention group initiated self-monitoring of diet and physical activity using a website, and those randomized to the enhanced intervention group were provided with a wearable device and accompanying web interface to monitor diet and physical activity. The primary outcome of weight was measured over 24 months at 6-month intervals, and the primary hypothesis tested the change in weight between 2 groups at 24 months. Secondary outcomes included body composition, fitness, physical activity, and dietary intake. Among the 471 participants randomized (body mass index [BMI], 25 to <40; age range, 18-35 years; 28.9% nonwhite, 77.2% women), 470 (233 in the standard intervention group, 237 in the enhanced intervention group) initiated the interventions as randomized, and 74.5% completed the study. For the enhanced intervention group, mean base line weight was 96.3 kg (95% CI, 94.2-98.5) and 24-month weight 92.8 kg (95% CI, 90.6- 95.0) [corrected]. For the standard intervention group, mean baseline weight was 95.2kg (95%CI,93.0-97.3)and24-month weight was 89.3 kg (95%CI, 87.1-91.5) [corrected]. Weight change at 24 months differed significantly by intervention group (estimated mean weight loss, 3.5 kg [95% CI, 2.6-4.5} in the enhanced intervention group and 5.9 kg [95% CI, 5.0-6.8] in the standard intervention group; difference, 2.4 kg [95% CI, 1.0-3.7]; P = .002). Both groups had significant improvements in body composition, fitness, physical activity, and diet, with no significant difference between groups. Among young adults with a BMI between 25 and less than 40, the addition of a wearable technology device to a standard behavioral intervention resulted in less weight loss over 24 months. Devices that monitor and provide feedback on physical activity may not offer an advantage over standard behavioral weight loss approaches. clinicaltrials.gov Identifier: NCT01131871.

How strongly does appetite counter weight loss? Quantification of the feedback control of human energy intake

PubMed Central

Polidori, David; Sanghvi, Arjun; Seeley, Randy; Hall, Kevin D.

2016-01-01

Objective To quantify the feedback control of energy intake in response to long-term covert manipulation of energy balance in free-living humans. Methods We used a validated mathematical method to calculate energy intake changes during a 52 week placebo-controlled trial in 153 patients treated with canagliflozin, a sodium glucose co-transporter inhibitor that increases urinary glucose excretion thereby resulting in weight loss without patients being directly aware of the energy deficit. We analyzed the relationship between the body weight time course and the calculated energy intake changes using principles from engineering control theory. Results We discovered that weight loss leads to a proportional increase in appetite resulting in eating above baseline by ~100 kcal/day per kg of lost weight – an amount more than 3-fold larger than the corresponding energy expenditure adaptations. Conclusions While energy expenditure adaptations are often thought to be the main reason for slowing of weight loss and subsequent regain, feedback control of energy intake plays an even larger role and helps explain why long-term maintenance of a reduced body weight is so difficult. PMID:27804272

Effectiveness of a Smartphone application and wearable device for weight loss in overweight or obese primary care patients: protocol for a randomised controlled trial.

PubMed

Granado-Font, Esther; Flores-Mateo, Gemma; Sorlí-Aguilar, Mar; Montaña-Carreras, Xavier; Ferre-Grau, Carme; Barrera-Uriarte, Maria-Luisa; Oriol-Colominas, Eulàlia; Rey-Reñones, Cristina; Caules, Iolanda; Satué-Gracia, Eva-María

2015-06-04

To evaluate the effectiveness of an experimental intervention based on standard diet recommendations plus free Smartphone application (app) and wearable device for weight loss, compared with the standard diet intervention alone, in primary care patients aged 18 years or older who are overweight or obese. Multicentre randomized, controlled clinical trial. Primary health care centres in the city of Tarragona and surrounding areas. 70 primary care patients, aged 18 years or older, with body mass index of 25 g/m2 or greater who wish to lose weight. Description of the intervention: 12 months of standard diet recommendations without (n = 35) or with (n = 35) assistance of a free Smartphone app that allows the participant to maintain a record of dietary intake and a bracelet monitor that records physical activity. The outcomes will be weight loss at 12 months (primary outcome), changes in physical activity and cardiometabolic risk factors, frequency of app use, and participant satisfaction after 12 months. The results of our study will offer evidence of the effectiveness of an intervention using one of the most popular free apps and wearable devices in achieving weight loss among patients who are overweight or obese. If these new technologies are proven effective in our population, they could be readily incorporated into primary care interventions promoting healthy weight. The open design and study characteristics make it impossible for the participants and researchers to be blinded to study group assignment. Researchers responsible for data analysis will be blinded to participant allocation. Clinical Register: NCT02417623. Registered 26 March 2015.

An intensive behavioral weight loss intervention and hot flushes in women.

PubMed

Huang, Alison J; Subak, Leslee L; Wing, Rena; West, Delia Smith; Hernandez, Alexandra L; Macer, Judy; Grady, Deborah

2010-07-12

Higher body mass index is associated with worse hot flushes during menopause but the effect of weight loss on flushing is unclear. Self-administered questionnaires were used to assess bothersome hot flushes in a 6-month randomized controlled trial of an intensive behavioral weight loss program (intervention) vs a structured health education program (control) in 338 women who were overweight or obese and had urinary incontinence. Weight, body mass index, abdominal circumference, physical activity, calorie intake, blood pressure, and physical and mental functioning were assessed at baseline and at 6 months. Repeated-measures proportional odds models examined intervention effects on bothersome hot flushes and potential mediating factors. Approximately half of participants (n = 154) were at least slightly bothered by hot flushes at baseline. Among these women, the intervention was associated with greater improvement in bothersome flushes vs control (odds ratio [OR] for improvement by 1 Likert category, 2.25; 95% confidence interval [CI], 1.20-4.21). Reductions in weight (OR, 1.32; 95% CI, 1.08-1.61; per 5-kg decrease), body mass index (1.17; 1.05-1.30; per 1-point decrease), and abdominal circumference (1.32; 1.07-1.64; per 5-cm decrease) were each associated with improvement in flushing, but changes in physical activity, calorie intake, blood pressure, and physical and mental functioning were not related. The effect of the intervention on flushing was modestly diminished after adjustment for multiple potential mediators (OR, 1.92; 95% CI, 0.95-3.89). Among women who were overweight or obese and had bothersome hot flushes, an intensive behavioral weight loss intervention resulted in improvement in flushing relative to control. Trial Registration clinicaltrials.gov Identifier: NCT00091988.