Clinical trial registration and reporting: a survey of academic organizations in the United States.

PubMed

Mayo-Wilson, Evan; Heyward, James; Keyes, Anthony; Reynolds, Jesse; White, Sarah; Atri, Nidhi; Alexander, G Caleb; Omar, Audrey; Ford, Daniel E

2018-05-02

Many clinical trials conducted by academic organizations are not published, or are not published completely. Following the US Food and Drug Administration Amendments Act of 2007, "The Final Rule" (compliance date April 18, 2017) and a National Institutes of Health policy clarified and expanded trial registration and results reporting requirements. We sought to identify policies, procedures, and resources to support trial registration and reporting at academic organizations. We conducted an online survey from November 21, 2016 to March 1, 2017, before organizations were expected to comply with The Final Rule. We included active Protocol Registration and Results System (PRS) accounts classified by ClinicalTrials.gov as a "University/Organization" in the USA. PRS administrators manage information on ClinicalTrials.gov. We invited one PRS administrator to complete the survey for each organization account, which was the unit of analysis. Eligible organization accounts (N = 783) included 47,701 records (e.g., studies) in August 2016. Participating organizations (366/783; 47%) included 40,351/47,701 (85%) records. Compared with other organizations, Clinical and Translational Science Award (CTSA) holders, cancer centers, and large organizations were more likely to participate. A minority of accounts have a registration (156/366; 43%) or results reporting policy (129/366; 35%). Of those with policies, 15/156 (11%) and 49/156 (35%) reported that trials must be registered before institutional review board approval is granted or before beginning enrollment, respectively. Few organizations use computer software to monitor compliance (68/366; 19%). One organization had penalized an investigator for non-compliance. Among the 287/366 (78%) accounts reporting that they allocate staff to fulfill ClinicalTrials.gov registration and reporting requirements, the median number of full-time equivalent staff is 0.08 (interquartile range = 0.02-0.25). Because of non-response and

The web of clinical trial registration obligations: have foreign clinical trials been caught?

PubMed

Hathaway, Carolyne R; Manthei, John R; Haas, J Ben; Meltzer, Elizabeth D

2009-01-01

The web of overlapping requirements, standards, recommendations and policies governing the conduct of clinical trials highlights the intense scrutiny of the ethical, data quality and public access issues raised by human trials that are conducted to demonstrate the safety and efficacy of medical products marketed in the United States. One relatively recent development is the requirement that sponsors register and make public information about their clinical trials and clinical trial results. These clinical trial registration requirements illustrate the interests of patients, providers and researchers in increased visibility, transparency and accessibility of clinical trials and the data they generate. These requirements, however, pose regulatory, logistical and practical hurdles for companies sponsoring clinical trials of drugs and medical devices.

Improving transparency and reproducibility through registration: The status of intervention trials published in clinical psychology journals.

PubMed

Cybulski, Lukasz; Mayo-Wilson, Evan; Grant, Sean

2016-09-01

Prospective registration increases the validity of randomized controlled trials (RCTs). In the United States, registration is a legal requirement for drugs and devices regulated by the Food and Drug Administration (FDA), and many biomedical journals refuse to publish trials that are not registered. Trials in clinical psychology have not been subject to these requirements; it is unknown to what extent they are registered. We searched the 25 highest-impact clinical psychology journals that published at least 1 RCT of a health-related psychological intervention in 2013. For included trials, we evaluated their registration status (prospective, retrospective, not registered) and the completeness of their outcome definitions. We identified 163 articles that reported 165 RCTs; 73 (44%) RCTs were registered, of which only 25 (15%) were registered prospectively. Of registered RCTs, only 42 (58%) indicated their registration status in the publication. Only 2 (1% of all trials) were registered prospectively and defined their primary outcomes completely. For the primary outcome(s), 72 (99%) of all registrations defined the domain, 67 (92%) the time frame, and 48 (66%) the specific measurements. Only 19 (26%) and 5 (7%) defined the specific metric and method of aggregation, respectively, for all primary outcomes. Very few reports of RCTs published in clinical psychology journals were registered prospectively and completely. Clinical psychology journals could improve transparency and reproducibility, as well as reduce bias, by requiring complete prospective trial registration for publication and by including trial registration numbers in all reports of RCTs. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Prospective registration trends, reasons for retrospective registration and mechanisms to increase prospective registration compliance: descriptive analysis and survey.

PubMed

Hunter, Kylie Elizabeth; Seidler, Anna Lene; Askie, Lisa M

2018-03-01

To analyse prospective versus retrospective trial registration trends on the Australian New Zealand Clinical Trials Registry (ANZCTR) and to evaluate the reasons for non-compliance with prospective registration. Part 1: Descriptive analysis of trial registration trends from 2006 to 2015. Part 2: Online registrant survey. Part 1: All interventional trials registered on ANZCTR from 2006 to 2015. Part 2: Random sample of those who had retrospectively registered a trial on ANZCTR between 2010 and 2015. Part 1: Proportion of prospective versus retrospective clinical trial registrations (ie, registration before versus after enrolment of the first participant) on the ANZCTR overall and by various key metrics, such as sponsor, funder, recruitment country and sample size. Part 2: Reasons for non-compliance with prospective registration and perceived usefulness of various proposed mechanisms to improve prospective registration compliance. Part 1: Analysis of the complete dataset of 9450 trials revealed that compliance with prospective registration increased from 48% (216 out of 446 trials) in 2006 to 63% (723/1148) in 2012 and has since plateaued at around 64%. Patterns of compliance were relatively consistent across sponsor and funder types (industry vs non-industry), type of intervention (drug vs non-drug) and size of trial (n<100, 100-500, >500). However, primary sponsors from Australia/New Zealand were almost twice as likely to register prospectively (62%; 4613/7452) compared with sponsors from other countries with a WHO Network Registry (35%; 377/1084) or sponsors from countries without a WHO Registry (29%; 230/781). Part 2: The majority (56%; 84/149) of survey respondents cited lack of awareness as a reason for not registering their study prospectively. Seventy-four per cent (111/149) stated that linking registration to ethics approval would facilitate prospective registration. Despite some progress, compliance with prospective registration remains suboptimal. Linking

Prospective registration trends, reasons for retrospective registration and mechanisms to increase prospective registration compliance: descriptive analysis and survey

PubMed Central

Seidler, Anna Lene; Askie, Lisa M

2018-01-01

Objectives To analyse prospective versus retrospective trial registration trends on the Australian New Zealand Clinical Trials Registry (ANZCTR) and to evaluate the reasons for non-compliance with prospective registration. Design Part 1: Descriptive analysis of trial registration trends from 2006 to 2015. Part 2: Online registrant survey. Participants Part 1: All interventional trials registered on ANZCTR from 2006 to 2015. Part 2: Random sample of those who had retrospectively registered a trial on ANZCTR between 2010 and 2015. Main outcome measures Part 1: Proportion of prospective versus retrospective clinical trial registrations (ie, registration before versus after enrolment of the first participant) on the ANZCTR overall and by various key metrics, such as sponsor, funder, recruitment country and sample size. Part 2: Reasons for non-compliance with prospective registration and perceived usefulness of various proposed mechanisms to improve prospective registration compliance. Results Part 1: Analysis of the complete dataset of 9450 trials revealed that compliance with prospective registration increased from 48% (216 out of 446 trials) in 2006 to 63% (723/1148) in 2012 and has since plateaued at around 64%. Patterns of compliance were relatively consistent across sponsor and funder types (industry vs non-industry), type of intervention (drug vs non-drug) and size of trial (n<100, 100–500, >500). However, primary sponsors from Australia/New Zealand were almost twice as likely to register prospectively (62%; 4613/7452) compared with sponsors from other countries with a WHO Network Registry (35%; 377/1084) or sponsors from countries without a WHO Registry (29%; 230/781). Part 2: The majority (56%; 84/149) of survey respondents cited lack of awareness as a reason for not registering their study prospectively. Seventy-four per cent (111/149) stated that linking registration to ethics approval would facilitate prospective registration. Conclusions Despite some

Review of the registration of clinical trials in UMIN-CTR from 2 June 2005 to 1 June 2010 - focus on Japan domestic, academic clinical trials

PubMed Central

2013-01-01

Background Established on 1 June 2005, the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) is the largest clinical trial registry in Japan, and joined the World Health Organization (WHO) registry network in October 2008. Our aim was to understand the registration trend and overall characteristics of Japan domestic, academic (non-industry-funded) clinical trials, which constitute the main body of registrations in UMIN-CTR. In addition, we aimed to investigate the accessibility of clinical trials in UMIN-CTR to people worldwide, as well as the accessibility of clinical trials conducted in Japan but registered abroad to Japanese people in the Japanese language. Methods We obtained the data for registrations in UMIN-CTR from the UMIN Center, and extracted Japan domestic, academic clinical trials to analyze their registration trend and overall characteristics. We also investigated how many of the trials registered in UMIN-CTR could be accessed from the International Clinical Trials Registry Platform (ICTRP). Finally, we searched ClinicalTrials.gov for all clinical trials conducted in Japan and investigated how many of them were also registered in Japanese registries. All of the above analyses included clinical trials registered from 2 June 2005 to 1 June 2010. Results During the period examined, the registration trend showed an obvious peak around September 2005 and rapid growth from April 2009. Of the registered trials, 46.4% adopted a single-arm design, 34.5% used an active control, only 10.9% were disclosed before trial commencement, and 90.0% did not publish any results. Overall, 3,063 of 3,064 clinical trials registered in UMIN-CTR could be accessed from ICTRP. Only 8.7% of all clinical trials conducted in Japan and registered in ClinicalTrials.gov were also registered in Japanese registries. Conclusions The International Committee of Medical Journal Editors (ICMJE) announcements about clinical trial registration and the Ethical

Clinical trial transparency: a reassessment of industry compliance with clinical trial registration and reporting requirements in the United States

PubMed Central

Lassman, Scott M; Shopshear, Olivia M; Jazic, Ina; Ulrich, Jocelyn; Francer, Jeffrey

2017-01-01

Objective To evaluate the accuracy of a 2015 cross-sectional analysis published in the BMJ Open which reported that pharmaceutical industry compliance with clinical trial registration and results reporting requirements under US law was suboptimal and varied widely among companies. Design We performed a reassessment of the data reported in Miller et al to evaluate whether statutory compliance analyses and conclusions were valid. Data sources Information from the Dryad Digital Repository, ClinicalTrials.gov, Drugs@FDA and direct communications with sponsors. Main outcome measures Compliance with the clinical trial registration and results reporting requirements under the Food and Drug Administration Amendments Act (FDAAA). Results Industry compliance with FDAAA disclosure requirements was notably higher than reported by Miller et al. Among trials subject to FDAAA, Miller et al reported that, per drug, a median of 67% (middle 50% range: 0%–100%) of trials fully complied with registration and results reporting requirements. On reanalysis of the data, we found that a median of 100% (middle 50% range: 93%–100%) of clinical trials for a particular drug fully complied with the law. When looking at overall compliance at the trial level, our reassessment yields 94% timely registration and 90% timely results reporting among the 49 eligible trials, and an overall FDAAA compliance rate of 86%. Conclusions The claim by Miller et al that industry compliance is below legal standards is based on an analysis that relies on an incomplete dataset and an interpretation of FDAAA that requires disclosure of study results for drugs that have not yet been approved for any indication. On reanalysis using a different interpretation of FDAAA that focuses on whether results were disclosed within 30 days of drug approval, we found that industry compliance with US statutory disclosure requirements for the 15 reviewed drugs was consistently high. PMID:28942418

Association of the FDA Amendment Act with trial registration, publication, and outcome reporting.

PubMed

Phillips, Adam T; Desai, Nihar R; Krumholz, Harlan M; Zou, Constance X; Miller, Jennifer E; Ross, Joseph S

2017-07-18

Selective clinical trial publication and outcome reporting has the potential to bias the medical literature. The 2007 Food and Drug Administration (FDA) Amendment Act (FDAAA) mandated clinical trial registration and outcome reporting on ClinicalTrials.gov, a publicly accessible trial registry. Using publicly available data from ClinicalTrials.gov, FDA documents, and PubMed, we determined registration, publication, and reporting of findings for all efficacy trials supporting FDA approval of new drugs for cardiovascular disease and diabetes between 2005 and 2014, before and after the FDAAA. For published trials, we compared the published interpretation of the findings (positive, equivocal, or negative) with the FDA reviewer's interpretation. Between 2005 and 2014, the FDA approved 30 drugs for 32 indications of cardiovascular disease (n = 17) and diabetes (n = 15) on the basis of 183 trials (median per indication 5.7 (IQR, 3-8)). Compared with pre FDAAA, post-FDAAA studies were more likely to be registered (78 of 78 (100%) vs 73 of 105 (70%); p < 0.001), to be published (76 of 78 (97%) vs 93 of 105 (89%); p = 0.03), and to present findings concordant with the FDA reviewer's interpretation (74 of 76 (97%) vs 78 of 93 (84%); p = 0.004). Pre FDAAA, the FDA reviewer interpreted 80 (76%) trials as positive and 91 (98%) were published as positive. Post FDAAA, the FDA reviewer interpreted 71 (91%) trials as positive and 71 (93%) were published as positive. FDAAA was associated with increased registration, publication, and FDA-concordant outcome reporting for trials supporting FDA approval of new drugs for cardiovascular disease and diabetes.

Multi-system verification of registrations for image-guided radiotherapy in clinical trials.

PubMed

Cui, Yunfeng; Galvin, James M; Straube, William L; Bosch, Walter R; Purdy, James A; Li, X Allen; Xiao, Ying

2011-09-01

To provide quantitative information on the image registration differences from multiple systems for image-guided radiotherapy (IGRT) credentialing and margin reduction in clinical trials. Images and IGRT shift results from three different treatment systems (Tomotherapy Hi-Art, Elekta Synergy, Varian Trilogy) have been sent from various institutions to the Image-Guided Therapy QA Center (ITC) for evaluation for the Radiation Therapy Oncology Group (RTOG) trials. Nine patient datasets (five head-and-neck and four prostate) were included in the comparison, with each patient having 1-4 daily individual IGRT studies. In all cases, daily shifts were re-calculated by re-registration of the planning CT with the daily IGRT data using three independent software systems (MIMvista, FocalSim, VelocityAI). Automatic fusion was used in all calculations. The results were compared with those submitted from institutions. Similar regions of interest (ROIs) and same initial positions were used in registrations for inter-system comparison. Different slice spacings for CBCT sampling and different ROIs for registration were used in some cases to observe the variation of registration due to these factors. For the 54 comparisons with head-and-neck datasets, the absolute values of differences of the registration results between different systems were 2.6±2.1 mm (mean±SD; range 0.1-8.6 mm, left-right [LR]), 1.7±1.3 mm (0.0-4.9 mm, superior-inferior [SI]), and 1.8±1.1 mm (0.1-4.0 mm, anterior-posterior [AP]). For the 66 comparisons in prostate cases, the differences were 1.1±1.0 mm (0.0-4.6 mm, LR), 2.1±1.7 mm (0.0-6.6 mm, SI), and 2.0±1.8 mm (0.1-6.9 mm, AP). The differences caused by the slice spacing variation were relatively small, and the different ROI selections in FocalSim and MIMvista also had limited impact. The extent of differences was reported when different systems were used for image registration. Careful examination and quality assurance of the image registration process

Unreported links between trial registrations and published articles were identified using document similarity measures in a cross-sectional analysis of ClinicalTrials.gov.

PubMed

Dunn, Adam G; Coiera, Enrico; Bourgeois, Florence T

2018-03-01

Trial registries can be used to measure reporting biases and support systematic reviews, but 45% of registrations do not provide a link to the article reporting on the trial. We evaluated the use of document similarity methods to identify unreported links between ClinicalTrials.gov and PubMed. We extracted terms and concepts from a data set of 72,469 ClinicalTrials.gov registrations and 276,307 PubMed articles and tested methods for ranking articles across 16,005 reported links and 90 manually identified unreported links. Performance was measured by the median rank of matching articles and the proportion of unreported links that could be found by screening ranked candidate articles in order. The best-performing concept-based representation produced a median rank of 3 (interquartile range [IQR] 1-21) for reported links and 3 (IQR 1-19) for the manually identified unreported links, and term-based representations produced a median rank of 2 (1-20) for reported links and 2 (IQR 1-12) in unreported links. The matching article was ranked first for 40% of registrations, and screening 50 candidate articles per registration identified 86% of the unreported links. Leveraging the growth in the corpus of reported links between ClinicalTrials.gov and PubMed, we found that document similarity methods can assist in the identification of unreported links between trial registrations and corresponding articles. Copyright © 2017 Elsevier Inc. All rights reserved.

Impact of registration on clinical trials on infection risk in pediatric acute myeloid leukemia.

PubMed

Dix, David; Aplenc, Richard; Bowes, Lynette; Cellot, Sonia; Ethier, Marie-Chantal; Feusner, Jim; Gillmeister, Biljana; Johnston, Donna L; Lewis, Victor; Michon, Bruno; Mitchell, David; Portwine, Carol; Price, Victoria; Silva, Mariana; Stobart, Kent; Yanofsky, Rochelle; Zelcer, Shayna; Beyene, Joseph; Sung, Lillian

2016-04-01

Little is known about the impact of enrollment on therapeutic clinical trials on adverse event rates. Primary objective was to describe the impact of clinical trial registration on sterile site microbiologically documented infection for children with newly diagnosed acute myeloid leukemia (AML). We conducted a multicenter cohort study that included children aged ≤18 years with de novo AML. Primary outcome was microbiologically documented sterile site infection. Infection rates were compared between those registered and not registered on clinical trials. Five hundred seventy-four children with AML were included of which 198 (34.5%) were registered on a therapeutic clinical trial. Overall, 400 (69.7%) had at least one sterile site microbiologically documented infection. In multiple regression, registration on clinical trials was independently associated with a higher risk of microbiologically documented sterile site infection [adjusted odds ratio (OR) 1.24, 95% confidence interval (CI) 1.01-1.53; p = 0.040] and viridans group streptococcal infection (OR 1.46, 95% CI 1.08-1.98; p = 0.015). Registration on trials was not associated with Gram-negative or invasive fungal infections. Children with newly diagnosed AML enrolled on clinical trials have a higher risk of microbiologically documented sterile site infection. This information may impact on supportive care practices in pediatric AML. © 2015 UICC.

Gender differences in clinical registration trials: is there a real problem?

PubMed Central

Labots, Geert; Jones, Aubrey; de Visser, Saco J.; Burggraaf, Jacobus

2018-01-01

Aims Several studies have reported the under‐representation of women in clinical trials, thereby challenging the external validity of the benefit/risk assessments of launched drugs. Our aim was to determine the extent to which women have been included in clinical trials used for drug registration and to analyse the fraction of women participating in phases I, II and III. Methods We conducted cross‐sectional, structured research into publicly available registration dossiers of Food and Drug Administration (FDA)‐approved drugs that are prescribed frequently. Furthermore, we analysed compounds with high hepatic clearance and a known gender‐related difference in drug response. In a sensitivity analysis, we compared figures with US disease prevalence data. Results For 38 of the initial 137 drugs (28%), sufficient data were reported and publicly available. For these drugs, 185 479 trial participants were included, of whom 47% were female and 44% were male; gender was not reported for 9% of participants. However, the number of female participants varied with the phase of the trial, with 22% females in phase I trials vs. 48% and 49%, respectively, in phase II and III trials. When compared with US disease prevalence data, 10 drugs (26%) had a greater than 20% difference between the proportion of females affected with the disease compared with representation in clinical trials. Conclusions From these publicly available data, there was no evidence of any systematic under‐representation of women in clinical trials. PMID:29293280

PAAPPAS community trial protocol: a randomized study of obesity prevention for adolescents combining school with household intervention.

PubMed

Sgambato, Michele R; Cunha, Diana B; Henriques, Viviana T; Estima, Camilla C P; Souza, Bárbara S N; Pereira, Rosangela A; Yokoo, Edna M; Paravidino, Vitor B; Sichieri, Rosely

2016-08-17

The prevalence of childhood obesity is increasing at a high rate in Brazil, making prevention a health priority. Schools are the central focus of interventions aiming the prevention and treatment of childhood obesity, however, randomized trials and cohort studies have not yet provided clear evidence of strategies to reduce prevalence of obesity. The aim of this study is to present a protocol to evaluate the efficacy of combining school and household level interventions to reduce excessive weight gain among students. The intervention target fifth and sixth graders from 18 public schools (9 interventions and 9 controls) in the municipality of Duque de Caxias, metropolitan area of Rio de Janeiro, Brazil. A sample size of 2500 students will be evaluated at school for their weight status and those from the intervention group who are overweight or obese will be followed monthly at home by community health agents. Demographic, socioeconomic, anthropometric, eating behavior and food consumption data will be collected at school using a standardized questionnaire programmed in personal digital assistant. At school, all students from the intervention group will be encouraged to change eating habits and food consumption and to increase physical activity and reducing sedentary behavior. This study will provide evidence whether integration of school with primary health care can prevent excessive weight gain among adolescents. Positive results will inform a sustainable strategy to be disseminated in the health care system in Brazil. ClinicalTrials.gov, NCT02711488 . Date of registration: March 11, 2016.

Effects of exercise intensity and nutrition advice on myocardial function in obese children and adolescents: a multicentre randomised controlled trial study protocol

PubMed Central

Dias, Katrin A; Coombes, Jeff S; Green, Daniel J; Gomersall, Sjaan R; Keating, Shelley E; Tjonna, Arnt Erik; Hollekim-Strand, Siri Marte; Hosseini, Mansoureh Sadat; Ro, Torstein Baade; Haram, Margrete; Huuse, Else Marie; Davies, Peter S W; Cain, Peter A; Leong, Gary M; Ingul, Charlotte B

2016-01-01

Introduction The prevalence of paediatric obesity is increasing, and with it, lifestyle-related diseases in children and adolescents. High-intensity interval training (HIIT) has recently been explored as an alternate to traditional moderate-intensity continuous training (MICT) in adults with chronic disease and has been shown to induce a rapid reversal of subclinical disease markers in obese children and adolescents. The primary aim of this study is to compare the effects of HIIT with MICT on myocardial function in obese children and adolescents. Methods and analysis Multicentre randomised controlled trial of 100 obese children and adolescents in the cities of Trondheim (Norway) and Brisbane (Australia). The trial will examine the efficacy of HIIT to improve cardiometabolic outcomes in obese children and adolescents. Participants will be randomised to (1) HIIT and nutrition advice, (2) MICT and nutrition advice or (3) nutrition advice. Participants will partake in supervised exercise training and/or nutrition sessions for 3 months. Measurements for study end points will occur at baseline, 3 months (postintervention) and 12 months (follow-up). The primary end point is myocardial function (peak systolic tissue velocity). Secondary end points include vascular function (flow-mediated dilation assessment), quantity of visceral and subcutaneous adipose tissue, myocardial structure and function, body composition, cardiorespiratory fitness, autonomic function, blood biochemistry, physical activity and nutrition. Lean, healthy children and adolescents will complete measurements for all study end points at one time point for comparative cross-sectional analyses. Ethics and dissemination This randomised controlled trial will generate substantial information regarding the effects of exercise intensity on paediatric obesity, specifically the cardiometabolic health of this at-risk population. It is expected that communication of results will allow for the development of

The effect of family-based multidisciplinary cognitive behavioral treatment in children with obesity: study protocol for a randomized controlled trial

PubMed Central

2011-01-01

impact on the individual as well as on society, prevention and treatment of obesity in children is of great importance. For evaluation of short- and long-term effects of the treatment, measurements are taken before and after 3 months of treatment, and after 12 and 24 months follow-up. During these visits clinical and biochemical data are determined, cardiovascular fitness tests are performed and quality of life questionnaires are completed. Trial registration International Standard Randomised Controlled Trial Number Register ISRCTN36146436 PMID:21548919

ClinicalTrials.gov registration can supplement information in abstracts for systematic reviews: a comparison study.

PubMed

Scherer, Roberta W; Huynh, Lynn; Ervin, Ann-Margret; Taylor, Jakeisha; Dickersin, Kay

2013-06-18

The inclusion of randomized controlled trials (RCTs) reported in conference abstracts in systematic reviews is controversial, partly because study design information and risk of bias is often not fully reported in the abstract. The Association for Research in Vision and Ophthalmology (ARVO) requires trial registration of abstracts submitted for their annual conference as of 2007. Our goal was to assess the feasibility of obtaining study design information critical to systematic reviews, but not typically included in conference abstracts, from the trial registration record. We reviewed all conference abstracts presented at the ARVO meetings from 2007 through 2009, and identified 496 RCTs; 154 had a single matching registration record in ClinicalTrials.gov. Two individuals independently extracted information from the abstract and the ClinicalTrials.gov record, including study design, sample size, inclusion criteria, masking, interventions, outcomes, funder, and investigator name and contact information. Discrepancies were resolved by consensus. We assessed the frequencies of reporting variables appearing in the abstract and the trial register and assessed agreement of information reported in both sources. We found a substantial amount of study design information in the ClinicalTrials.gov record that was unavailable in the corresponding conference abstract, including eligibility criteria associated with gender (83%; 128/154); masking or blinding of study participants (53%, 82/154), persons administering treatment (30%, 46/154), and persons measuring the outcomes (40%, 61/154)); and number of study centers (58%; 90/154). Only 34% (52/154) of abstracts explicitly described a primary outcome, but a primary outcome was included in the "Primary Outcome" field in the ClinicalTrials.gov record for 82% (126/154) of studies. One or more study interventions were reported in each abstract, but agreed exactly with those reported in ClinicalTrials.gov only slightly more than half

ClinicalTrials.gov registration can supplement information in abstracts for systematic reviews: a comparison study

PubMed Central

2013-01-01

Background The inclusion of randomized controlled trials (RCTs) reported in conference abstracts in systematic reviews is controversial, partly because study design information and risk of bias is often not fully reported in the abstract. The Association for Research in Vision and Ophthalmology (ARVO) requires trial registration of abstracts submitted for their annual conference as of 2007. Our goal was to assess the feasibility of obtaining study design information critical to systematic reviews, but not typically included in conference abstracts, from the trial registration record. Methods We reviewed all conference abstracts presented at the ARVO meetings from 2007 through 2009, and identified 496 RCTs; 154 had a single matching registration record in ClinicalTrials.gov. Two individuals independently extracted information from the abstract and the ClinicalTrials.gov record, including study design, sample size, inclusion criteria, masking, interventions, outcomes, funder, and investigator name and contact information. Discrepancies were resolved by consensus. We assessed the frequencies of reporting variables appearing in the abstract and the trial register and assessed agreement of information reported in both sources. Results We found a substantial amount of study design information in the ClinicalTrials.gov record that was unavailable in the corresponding conference abstract, including eligibility criteria associated with gender (83%; 128/154); masking or blinding of study participants (53%, 82/154), persons administering treatment (30%, 46/154), and persons measuring the outcomes (40%, 61/154)); and number of study centers (58%; 90/154). Only 34% (52/154) of abstracts explicitly described a primary outcome, but a primary outcome was included in the “Primary Outcome” field in the ClinicalTrials.gov record for 82% (126/154) of studies. One or more study interventions were reported in each abstract, but agreed exactly with those reported in ClinicalTrials

Evaluation of active and passive recruitment methods used in randomized controlled trials targeting pediatric obesity

PubMed Central

RAYNOR, HOLLIE A.; OSTERHOLT, KATHRIN M.; HART, CHANTELLE N.; JELALIAN, ELISSA; VIVIER, PATRICK; WING, RENA R.

2016-01-01

Objective Evaluate enrollment numbers, randomization rates, costs, and cost-effectiveness of active versus passive recruitment methods for parent-child dyads into two pediatric obesity intervention trials. Methods Recruitment methods were categorized into active (pediatrician referral and targeted mailings, with participants identified by researcher/health care provider) versus passive methods (newspaper, bus, internet, television, and earning statements; fairs/community centers/schools; and word of mouth; with participants self-identified). Numbers of enrolled and randomized families and costs/recruitment method were monitored throughout the 22-month recruitment period. Costs (in USD) per recruitment method included staff time, mileage, and targeted costs of each method. Results A total of 940 families were referred or made contact, with 164 families randomized (child: 7.2±1.6 years, 2.27±0.61 standardized body mass index [zBMI], 86.6% obese, 61.7% female, 83.5% white; parent: 38.0±5.8 years, 32.9±8.4 BMI, 55.2% obese, 92.7% female, 89.6% white). Pediatrician referral, followed by targeted mailings, produced the largest number of enrolled and randomized families (both methods combined producing 87.2% of randomized families). Passive recruitment methods yielded better retention from enrollment to randomization (p <0.05), but produced few families (21 in total). Approximately $91 000 was spent on recruitment, with cost per randomized family at $554.77. Pediatrician referral was the most cost-effective method, $145.95/randomized family, but yielded only 91 randomized families over 22-months of continuous recruitment. Conclusion Pediatrician referral and targeted mailings, which are active recruitment methods, were the most successful strategies. However, recruitment demanded significant resources. Successful recruitment for pediatric trials should use several strategies. Clinical Trials Registration: NCT00259324, NCT00200265 PMID:19922036

Effectiveness of a Multi-Component Intervention for Overweight and Obese Children (Nereu Program): A Randomized Controlled Trial

PubMed Central

Serra-Paya, Noemi; Ensenyat, Assumpta; Castro-Viñuales, Iván; Real, Jordi; Sinfreu-Bergués, Xènia; Zapata, Amalia; Mur, Jose María; Galindo-Ortego, Gisela; Solé-Mir, Eduard; Teixido, Concepció

2015-01-01

Introduction Treatment of childhood obesity is a complex challenge for primary health care professionals. Objectives To evaluate the effectiveness of the Nereu Program in improving anthropometric parameters, physical activity and sedentary behaviours, and dietary intake. Methods Randomized, controlled, multicentre clinical trial comparing Nereu Program and usual counselling group interventions in primary care settings. The 8-month study recruited 113 children aged 6 to 12 years with overweight/obesity. Before recruitment, eligible participants were randomly allocated to an intensive, family-based multi-component behavioural intervention (Nereu Program group) or usual advice from their paediatrician on healthy eating and physical activity. Anthropometric parameters, objectively measured sedentary and physical activity behaviours, and dietary intake were evaluated pre- and post-intervention. Results At the end of the study period, both groups achieved a similar decrease in body mass index (BMIsd) compared to baseline. Nereu Program participants (n = 54) showed greater increases in moderate-intense physical activity (+6.27% vs. -0.61%, p<0.001) and daily fruit servings (+0.62 vs. +0.13, p<0.026), and decreased daily soft drinks consumption (-0.26 vs. -0.02, p<0.047), respectively, compared to the counselling group (n = 59). Conclusions At the end of the 8-month intervention, participants in the Nereu Program group showed improvement in physical activity and dietary behaviours, compared to the counselling group. Trial Registration ClinicalTrials.gov NCT01878994 PMID:26658988

Obstructive sleep apnea and pulmonary function in patients with severe obesity before and after bariatric surgery: a randomized clinical trial

PubMed Central

2014-01-01

architecture and reduces respiratory sleep disorders, specifically obstructive sleep apnea, in patients with severe obesity. Trial registration The protocol for this study was registered with the World Health Organization (Universal Trial Number: U1111-1121-8873) and Brazilian Registry of Clinical Trials – ReBEC (RBR-9k9hhv). PMID:25136444

Associations between overweight, obesity, health measures and need for recovery in office employees: a cross-sectional analysis

PubMed Central

2013-01-01

Background With both a high need for recovery (NFR) and overweight and obesity being a potential burden for organizations (e.g. productivity loss and sickness absence), the aim of this paper was to examine the associations between overweight and obesity and several other health measures and NFR in office workers. Methods Baseline data of 412 office employees participating in a randomised controlled trial aimed at improving NFR in office workers were used. Associations between self-reported BMI categories (normal body weight, overweight, obesity) and several other health measures (general health, mental health, sleep quality, stress and vitality) with NFR were examined. Unadjusted and adjusted linear regression analyses were performed and adjusted for age, education and job demands. In addition, we adjusted for general health in the association between overweight and obesity and NFR. Results A significant positive association was observed between stress and NFR (B = 18.04, 95%CI:14.53-21.56). General health, mental health, sleep quality and vitality were negatively associated with NFR (p < 0.001). Analyses also showed a significant positive association between obesity and NFR (B = 8.77, 95%CI:0.01-17.56), but not between overweight and NFR. Conclusions The findings suggest that self-reported stress is, and obesity may be, associated with a higher NFR. Additionally, the results imply that health measures that indicate a better health are associated with a lower NFR. Trial registration The trial is registered at the Dutch Trial Register (NTR) under trial registration number: NTR2553. PMID:24359267

Limiting weight gain in overweight and obese women during pregnancy to improve health outcomes: the LIMIT randomised controlled trial

PubMed Central

2011-01-01

Background Obesity is a significant global health problem, with the proportion of women entering pregnancy with a body mass index greater than or equal to 25 kg/m2 approaching 50%. Obesity during pregnancy is associated with a well-recognised increased risk of adverse health outcomes both for the woman and her infant, however there is more limited information available regarding effective interventions to improve health outcomes. The aims of this randomised controlled trial are to assess whether the implementation of a package of dietary and lifestyle advice to overweight and obese women during pregnancy to limit gestational weight gain is effective in improving maternal, fetal and infant health outcomes. Methods/Design Design: Multicentred randomised, controlled trial. Inclusion Criteria: Women with a singleton, live gestation between 10+0-20+0 weeks who are obese or overweight (defined as body mass index greater than or equal to 25 kg/m2), at the first antenatal visit. Trial Entry & Randomisation: Eligible, consenting women will be randomised between 10+0 and 20+0 weeks gestation using a central telephone randomisation service, and randomisation schedule prepared by non-clinical research staff with balanced variable blocks. Stratification will be according to maternal BMI at trial entry, parity, and centre where planned to give birth. Treatment Schedules: Women randomised to the Dietary and Lifestyle Advice Group will receive a series of inputs from research assistants and research dietician to limit gestational weight gain, and will include a combination of dietary, exercise and behavioural strategies. Women randomised to the Standard Care Group will continue to receive their pregnancy care according to local hospital guidelines, which does not currently include routine provision of dietary, lifestyle and behavioural advice. Outcome assessors will be blinded to the allocated treatment group. Primary Study Outcome: infant large for gestational age (defined as

Effect of rimonabant on carotid intima-media thickness (CIMT) progression in patients with abdominal obesity and metabolic syndrome: the AUDITOR Trial.

PubMed

O'Leary, Daniel H; Reuwer, Anne Q; Nissen, Steven E; Després, Jean-Pierre; Deanfield, John E; Brown, Michael W; Zhou, Rong; Zabbatino, Salvatore M; Job, Bernard; Kastelein, John J P; Visseren, Frank L J

2011-07-01

The aim of this trial was to determine whether obese patients benefit from treatment with rimonabant in terms of progression of carotid atherosclerosis. Rimonabant, a selective cannabinoid-1 receptor blocker, reduces body weight and improves cardiometabolic risk factors in patients who are obese. A prospective, double-blind, placebo-controlled trial (Atherosclerosis Underlying Development assessed by Intima-media Thickness in patients On Rimonabant (AUDITOR)) randomised 661 patients with abdominal obesity and metabolic syndrome to rimonabant or placebo for 30 months of treatment. The absolute change in the average value for six segments of far wall carotid intima-media thickness from baseline to month 30 was 0.010 ± 0.095 mm in the rimonabant group and 0.012 ± 0.091 mm in the placebo group (p=0.67). The annualised change was an increase of 0.005 ± 0.042 mm for the rimonabant-treated group and 0.007 ± 0.043 mm for the placebo-treated group (p=0.45). There was no difference in atherosclerosis progression between patients receiving rimonabant for 30 months and those receiving placebo for the primary efficacy measure (absolute change in carotid intima-media thickness). These findings are consistent with a similar study using coronary intravascular ultrasound and another study evaluating the occurrence of cardiovascular events. Our findings suggest that a 5% loss of body weight over a 30-month period with rimonabant is insufficient to modify atherosclerosis progression in the carotid artery in obese patients with metabolic syndrome. Clinical trial registration information clinicaltrials.gov Identifier: NCT00228176.

Protocol for: Sheffield Obesity Trial (SHOT): a randomised controlled trial of exercise therapy and mental health outcomes in obese adolescents [ISRCNT83888112].

PubMed

Daley, Amanda J; Copeland, Robert J; Wright, Neil P; Wales, Jerry K H

2005-10-31

While obesity is known to have many physiological consequences, the psychopathology of this condition has not featured prominently in the literature. Cross-sectional studies have indicated that obese children have increased odds of experiencing poor quality of life and mental health. However, very limited trial evidence has examined the efficacy of exercise therapy for enhancing mental health outcomes in obese children, and the Sheffield Obesity Trial (SHOT) will provide evidence of the efficacy of supervised exercise therapy in obese young people aged 11-16 years versus usual care and an attention-control intervention. SHOT is a randomised controlled trial where obese young people are randomised to receive; (1) exercise therapy, (2) attention-control intervention (involving body-conditioning exercises and games that do not involve aerobic activity), or (3) usual care. The exercise therapy and attention-control sessions will take place three times per week for eight weeks and a six-week home programme will follow this. Ninety adolescents aged between 11-16 years referred from a children's hospital for evaluation of obesity or via community advertisements will need to complete the study. Participants will be recruited according to the following criteria: (1) clinically obese and aged 11-16 years (Body Mass Index Centile > 98th UK standard) (2) no medical condition that would restrict ability to be active three times per week for eight weeks and (3) not diagnosed with insulin dependent diabetes or receiving oral steroids. Assessments of outcomes will take place at baseline, as well as four (intervention midpoint) and eight weeks (end of intervention) from baseline. Participants will be reassessed on outcome measures five and seven months from baseline. The primary endpoint is physical self-perceptions. Secondary outcomes include physical activity, self-perceptions, depression, affect, aerobic fitness and BMI.

Do emergency medicine journals promote trial registration and adherence to reporting guidelines? A survey of "Instructions for Authors".

PubMed

Sims, Matthew T; Henning, Nolan M; Wayant, C Cole; Vassar, Matt

2016-11-24

The aim of this study was to evaluate the current state of two publication practices, reporting guidelines requirements and clinical trial registration requirements, by analyzing the "Instructions for Authors" of emergency medicine journals. We performed a web-based data abstraction from the "Instructions for Authors" of the 27 Emergency Medicine journals catalogued in the Expanded Science Citation Index of the 2014 Journal Citation Reports and Google Scholar Metrics h5-index to identify whether each journal required, recommended, or made no mention of the following reporting guidelines: EQUATOR Network, ICMJE, ARRIVE, CARE, CONSORT, STARD, TRIPOD, CHEERS, MOOSE, STROBE, COREQ, SRQR, SQUIRE, PRISMA-P, SPIRIT, PRISMA, and QUOROM. We also extracted whether journals required or recommended trial registration. Authors were blinded to one another's ratings until completion of the data validation. Cross-tabulations and descriptive statistics were calculated using IBM SPSS 22. Of the 27 emergency medicine journals, 11 (11/27, 40.7%) did not mention a single guideline within their "Instructions for Authors," while the remaining 16 (16/27, 59.3%) mentioned one or more guidelines. The QUOROM statement and SRQR were not mentioned by any journals whereas the ICMJE guidelines (18/27, 66.7%) and CONSORT statement (15/27, 55.6%) were mentioned most often. Of the 27 emergency medicine journals, 15 (15/27, 55.6%) did not mention trial or review registration, while the remaining 12 (12/27, 44.4%) at least mentioned one of the two. Trial registration through ClinicalTrials.gov was mentioned by seven (7/27, 25.9%) journals while the WHO registry was mentioned by four (4/27, 14.8%). Twelve (12/27, 44.4%) journals mentioned trial registration through any registry platform. The aim of this study was to evaluate the current state of two publication practices, reporting guidelines requirements and clinical trial registration requirements, by analyzing the "Instructions for Authors" of

A randomised controlled trial for overweight and obese parents to prevent childhood obesity--Early STOPP (STockholm Obesity Prevention Program).

PubMed

Sobko, Tanja; Svensson, Viktoria; Ek, Anna; Ekstedt, Mirjam; Karlsson, Håkan; Johansson, Elin; Cao, Yingting; Hagströmer, Maria; Marcus, Claude

2011-05-18

Overweight and obesity have a dramatic negative impact on children's health not only during the childhood but also throughout the adult life. Preventing the development of obesity in children is therefore a world-wide health priority. There is an obvious urge for sustainable and evidenced-based interventions that are suitable for families with young children, especially for families with overweight or obese parents. We have developed a prevention program, Early STOPP, combating multiple obesity-promoting behaviors such unbalanced diet, physical inactivity and disturbed sleeping patterns. We also aim to evaluate the effectiveness of the early childhood obesity prevention in a well-characterized population of overweight or obese parents. This protocol outlines methods for the recruitment phase of the study. This randomized controlled trial (RCT) targets overweight and/or obese parents with infants, recruited from the Child Health Care Centers (CHCC) within the Stockholm area. The intervention starts when infants are one year of age and continues until they are six and is regularly delivered by a trained coach (dietitian, physiotherapist or a nurse). The key aspects of Early STOPP family intervention are based on Swedish recommendations for CHCC, which include advices on healthy food choices and eating patterns, increasing physical activity/reducing sedentary behavior and regulating sleeping patterns. The Early STOPP trial design addresses weaknesses of previous research by recruiting from a well-characterized population, defining a feasible, theory-based intervention and assessing multiple measurements to validate and interpret the program effectiveness. The early years hold promise as a time in which obesity prevention may be most effective. To our knowledge, this longitudinal RCT is the first attempt to demonstrate whether an early, long-term, targeted health promotion program focusing on healthy eating, physical activity/reduced sedentary behaviors and normalizing

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

Whole of Systems Trial of Prevention Strategies for Childhood Obesity: WHO STOPS Childhood Obesity.

PubMed

Allender, Steven; Millar, Lynne; Hovmand, Peter; Bell, Colin; Moodie, Marj; Carter, Rob; Swinburn, Boyd; Strugnell, Claudia; Lowe, Janette; de la Haye, Kayla; Orellana, Liliana; Morgan, Sue

2016-11-16

Background : Community-based initiatives show promise for preventing childhood obesity. They are characterized by community leaders and members working together to address complex local drivers of energy balance. Objectives : To present a protocol for a stepped wedge cluster randomized trial in ten communities in the Great South Coast Region of Victoria, Australia to test whether it is possible to: (1) strengthen community action for childhood obesity prevention, and (2) measure the impact of increased action on risk factors for childhood obesity. Methods: The WHO STOPS intervention involves a facilitated community engagement process that: creates an agreed systems map of childhood obesity causes for a community; identifies intervention opportunities through leveraging the dynamic aspects of the system; and, converts these understandings into community-built, systems-oriented action plans. Ten communities will be randomized (1:1) to intervention or control in year one and all communities will be included by year three. The primary outcome is childhood obesity prevalence among grade two (ages 7-8 y), grade four (9-10 y) and grade six (11-12 y) students measured using our established community-led monitoring system (69% school and 93% student participation rate in government and independent schools). An additional group of 13 external communities from other regions of Victoria with no specific interventions will provide an external comparison. These communities will also allow us to assess diffusion of the intervention to control communities during the first three years of the trial. Conclusion : This trial will test effectiveness, over a five-year period, of community-owned, -supported and -led strategies designed to address complex and dynamic causes of childhood obesity.

Whole of Systems Trial of Prevention Strategies for Childhood Obesity: WHO STOPS Childhood Obesity

PubMed Central

Allender, Steven; Millar, Lynne; Hovmand, Peter; Bell, Colin; Moodie, Marj; Carter, Rob; Swinburn, Boyd; Strugnell, Claudia; Lowe, Janette; de la Haye, Kayla; Orellana, Liliana; Morgan, Sue

2016-01-01

Background: Community-based initiatives show promise for preventing childhood obesity. They are characterized by community leaders and members working together to address complex local drivers of energy balance. Objectives: To present a protocol for a stepped wedge cluster randomized trial in ten communities in the Great South Coast Region of Victoria, Australia to test whether it is possible to: (1) strengthen community action for childhood obesity prevention, and (2) measure the impact of increased action on risk factors for childhood obesity. Methods: The WHO STOPS intervention involves a facilitated community engagement process that: creates an agreed systems map of childhood obesity causes for a community; identifies intervention opportunities through leveraging the dynamic aspects of the system; and, converts these understandings into community-built, systems-oriented action plans. Ten communities will be randomized (1:1) to intervention or control in year one and all communities will be included by year three. The primary outcome is childhood obesity prevalence among grade two (ages 7–8 y), grade four (9–10 y) and grade six (11–12 y) students measured using our established community-led monitoring system (69% school and 93% student participation rate in government and independent schools). An additional group of 13 external communities from other regions of Victoria with no specific interventions will provide an external comparison. These communities will also allow us to assess diffusion of the intervention to control communities during the first three years of the trial. Conclusion: This trial will test effectiveness, over a five-year period, of community-owned, -supported and -led strategies designed to address complex and dynamic causes of childhood obesity. PMID:27854354

Serious adverse events and compensation in registration trials: a review of data from a Japanese university hospital

PubMed Central

2014-01-01

Background Clinical trials leading to regulatory approval, or registration trials, play a central role in the development of drugs and medical devices. The contribution of support staff, such as the clinical research coordinator (CRC) and administrative officers, in registration trials is now widely recognized. Attending to serious adverse events is an important duty of the CRC and investigators alike, and managing these complications and compensation constitutes a key responsibility. We retrospectively examined the frequency of serious adverse events and compensation events reported from 2007 through 2011 at Tokushima University Hospital, an academic hospital in rural Japan. We present herein the results of our analysis. Results Over the five-year period, 284 subjects participating in 106 registration trials experienced a total of 43 serious adverse events, and eight compensation events were documented. Among the serious adverse events, 35 (81.4%) were considered not related to the investigational drug, and 17 (39.5%) resulted in withdrawal of the study drug. Patients with malignant diseases experienced serious adverse events significantly more frequently compared to those with non-malignant diseases (28.3% versus 8.2%, respectively; P < 0.01). Conclusions The CRC should be vigilant for serious adverse events in oncology clinical trials due to the generally higher frequency of these complications in subjects with malignancy. However, on an individual basis, the CRC may be seldom involved in the process for compensating serious adverse events. Therefore, the CRC’s ability to share such experiences may serve as an opportunity for educating clinical trial support staff at the study site as well as those at other sites. However, further study is warranted to determine the role of the clinical trial support staff in optimizing methods for managing adverse events requiring compensation in registration trials. PMID:24742228

The Malaysian Childhood Obesity Treatment Trial (MASCOT).

PubMed

Sharifah, W W; Nur, Hana H; Ruzita, A T; Roslee, R; Reilly, J J

2011-08-01

The present study describes a randomised controlled trial (RCT) based on a novel, generalisable intervention for childhood obesity, comparing the intervention with a no-treatment control group. The Malaysian Childhood Obesity Treatment Trial (MASCOT) was a single-blind RCT of a dietetic treatment for childhood obesity in children of primary school age (7 to 11 years old) in Kuala Lumpur, Malaysia. The MASCOT comprising eight sessions, of an 8-hour family-centred group treatment programme is described, based on behavioural change techniques. The study sample was characterised by BMI z-score, health related quality of life reported by participants and their parents (PedsQL questionnaire), objectively measured habitual physical activity and sedentary behaviour (Actigraph accelerometry) The MASCOT sample of 107 children was characterised by a low quality of life, mean total score on PedsQL 67.7 (4.5) as reported by the children, and 66.0 (16.4) as reported by their parents. The children spent, on average, 89% of their waking day on sedentary activity, and 1% of the day in moderate-vigorous intensity physical activity, equivalent to only around 8 minutes/day. Obese children in the MASCOT study had an impaired quality of life, high levels of sedentary behaviour and very low levels of physical activity.

Compliance with prospective trial registration guidance remained low in high-impact journals and has implications for primary end point reporting.

PubMed

Dal-Ré, Rafael; Ross, Joseph S; Marušić, Ana

2016-07-01

To examine compliance with International Committee of Medical Journal Editors' (ICMJE) policy on prospective trial registration along with predictors of compliance. Cross-sectional analysis of all articles reporting trial results published in the six highest-impact general medicine journals in January-June 2014 that were registered in a public trial registry. The main outcome measure was compliance with ICMJE policy. The time frame for trial primary end point ascertainment was used to assess whether retrospective registration could have allowed changing of primary end points following an interim analysis. Forty of 144 (28%) articles did not comply with the ICMJE policy. Trials of non-FDA-regulated interventions were less compliant than trials of FDA-regulated interventions (i.e., medicines, medical devices) (42% vs. 21%; P = 0.016). Twenty-nine of these 40 (72%; 20% overall) were registered before any interim analysis of primary end points could have been conducted; 11 (28%; 8% overall) were registered after primary end point ascertainment, such that investigators could have had the opportunity to conduct an interim analysis before trial registration. Twenty-eight percent of trials published in high-impact journals were retrospectively registered including nearly 10% that were registered after primary end point ascertainment could have had taken place. Prospective registration should be prompted and enforced to ensure transparency and accountability in clinical research. Copyright © 2016 Elsevier Inc. All rights reserved.

Promoting weight loss through diet and exercise in overweight or obese breast cancer survivors (InForma): study protocol for a randomized controlled trial.

PubMed

Gnagnarella, Patrizia; Dragà, Daniele; Baggi, Federica; Simoncini, Maria Claudia; Sabbatini, Annarita; Mazzocco, Ketti; Bassi, Fabio Domenico; Pravettoni, Gabriella; Maisonneuve, Patrick

2016-07-28

identifying changes of fat and fat-free mass. Women allocated to the less intensive intervention arm will be considered as the control group. While there is a rising concern about the role of obesity in cancer recurrence and survival, this trial with its multi-arm design, motivational approach and use of a pedometer device will provide important insights regarding the most effective approach in promoting weight control in breast cancer survivors. ISRCTN53325751 (registration date: 16 October 2015); ClinicalTrials.gov NCT02622711 (registration date: 2 December 2015).

Mechanisms Regulating Insulin Response to Intragastric Glucose in Lean and Non-Diabetic Obese Subjects: A Randomized, Double-Blind, Parallel-Group Trial

PubMed Central

Meyer-Gerspach, Anne Christin; Cajacob, Lucian; Riva, Daniele; Herzog, Raphael; Drewe, Juergen; Beglinger, Christoph; Wölnerhanssen, Bettina K.

2016-01-01

Background/Objectives The changes in blood glucose concentrations that result from an oral glucose challenge are dependent on the rate of gastric emptying, the rate of glucose absorption and the rate of insulin-driven metabolism that include the incretins, glucose-dependent insulinotropic peptide (GIP) and glucagon-like peptide-1 (GLP-1). The rate of insulin-driven metabolism is clearly altered in obese subjects, but it is controversial which of these factors is predominant. We aimed to quantify gastric emptying, plasma insulin, C-peptide, glucagon and glucose responses, as well as incretin hormone secretions in obese subjects and healthy controls during increasing glucose loads. Subjects/Methods The study was conducted as a randomized, double-blind, parallel-group trial in a hospital research unit. A total of 12 normal weight (6 men and 6 women) and 12 non-diabetic obese (BMI > 30, 6 men and 6 women) participants took part in the study. Subjects received intragastric loads of 10 g, 25 g and 75 g glucose dissolved in 300 ml tap water. Results Main outcome measures were plasma GLP-1 and GIP, plasma glucagon, glucose, insulin, C-peptide and gastric emptying. The primary findings are: i) insulin resistance (P < 0.001) and hyperinsulinemia (P < 0.001); ii) decreased insulin disposal (P < 0.001); iii) trend for reduced GLP-1 responses at 75 g glucose; and iv) increased fasting glucagon levels (P < 0.001) in obese subjects. Conclusions It seems that, rather than changes in incretin secretion, fasting hyperglucagonemia and consequent hyperglycemia play a role in reduced disposal of insulin, contributing to hyperinsulinemia and insulin resistance. Trial Registration ClinicalTrials.gov NCT01875575 PMID:26942445

Transparency of outcome reporting and trial registration of randomized controlled trials in top psychosomatic and behavioral health journals: A systematic review.

PubMed

Milette, Katherine; Roseman, Michelle; Thombs, Brett D

2011-03-01

The most reliable evidence for evaluating healthcare interventions comes from well-designed and conducted randomized controlled trials (RCTs). The extent to which published RCTs reflect the efficacy of interventions, however, depends on the completeness and accuracy of published results. The Consolidated Standards of Reporting Trials statement, initially developed in 1996, provides guidelines intended to improve the transparency of published RCT reports. A policy of the International Committee of Medical Journal Editors, initiated in 2005, requires clinical trials published in member journals to be registered in publicly accessible registries prior to patient enrollment. The objective of this study was to assess the clarity of outcome reporting, proportion of registered trials, and adequacy of outcome registration in RCTs published in top behavioral health journals. Eligible studies were primary or secondary reports of RCTs published in Annals of Behavioral Medicine, Health Psychology, Journal of Psychosomatic Research, and Psychosomatic Medicine from January 2008 to September 2009. Data were extracted for each study on adequacy of outcome reporting and registration. Of 63 articles reviewed, only 25 (39.7%) had adequately declared primary or secondary outcomes, whereas 38 (60.3%) had multiple primary outcomes or did not define outcomes. Only 13 studies (20.6%) were registered. Only 1 study registered sufficiently precise outcome information to compare with published outcomes, and registered and published outcomes were discrepant in that study. Greater attention to outcome reporting and trial registration by researchers, peer reviewers, and journal editors will increase the likelihood that effective behavioral health interventions are readily identified and made available to patients. Copyright © 2011 Elsevier Inc. All rights reserved.

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

Land-based versus aquatic resistance therapeutic exercises for older women with sarcopenic obesity: study protocol for a randomised controlled trial

PubMed Central

2013-01-01

trial designed to evaluate resistance exercises in older patients with sarcopenic obesity. If our hypothesis proves correct, both intervention programmes will be effective, with the land-based exercises conferring better results in muscle performance. Trial registration Registro Brasileiro de Ensaios Clínicos: RBR-9p5q67 PMID:24041219

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

Exercise Training and Weight Gain in Obese Pregnant Women: A Randomized Controlled Trial (ETIP Trial)

PubMed Central

Garnæs, Kirsti Krohn; Mørkved, Siv; Salvesen, Øyvind; Moholdt, Trine

2016-01-01

of 0.1 (95% CI 0.02, 0.95; p = 0.04). Systolic blood pressure was significantly lower in the exercise group (mean 120.4 mm Hg) compared to the control group (mean 128.1 mm Hg), with a mean difference of −7.73 mm Hg (95% CI −13.23, −2.22; p = 0.006). No significant between-group differences were seen in diastolic blood pressure, blood measurements, skinfold thickness, or body composition in late pregnancy. In per protocol analyses, late pregnancy systolic blood pressure was 115.7 (95% CI 110.0, 121.5) mm Hg in the exercise group (significant between-group difference, p = 0.001), and diastolic blood pressure was 75.1 (95% CI 71.6, 78.7) mm Hg (significant between-group difference, p = 0.02). We had planned to recruit 150 women into the trial; hence, under-recruitment represents a major limitation of our results. Another limitation to our study was the low adherence to the exercise program, with only 50% of the women included in the intention-to-treat analysis adhering as described in the study protocol. Conclusions In this trial we did not observe a reduction in GWG among overweight/obese women who received a supervised exercise training program during their pregnancy. The incidence of GDM in late pregnancy seemed to be lower in the women randomized to exercise training than in the women receiving standard maternity care only. Systolic blood pressure in late pregnancy was also apparently lower in the exercise group than in the control group. These results indicate that supervised exercise training might be beneficial as a part of standard pregnancy care for overweight/obese women. Trial Registration ClinicalTrials.gov NCT01243554 PMID:27459375

Implementation and evaluation of the 5As framework of obesity management in primary care: design of the 5As Team (5AsT) randomized control trial

PubMed Central

2014-01-01

obesity management in primary practice. The use of existing resources, collaborative design, practice facilitation, and integrated feedback loops cultivate an applicable, adaptable and sustainable approach to increasing the quantity and quality of weight management visits in primary care. Trial registration NCT01967797. PMID:24947045

Pediatric obesity pharmacotherapy: current state of the field, review of the literature and clinical trial considerations.

PubMed

Kelly, A S; Fox, C K; Rudser, K D; Gross, A C; Ryder, J R

2016-07-01

Despite the increasing number of medications recently approved to treat obesity among adults, few agents have been formally evaluated in children or adolescents for this indication. Moreover, there is a paucity of guidance in the literature addressing best practices with regard to pediatric obesity pharmacotherapy clinical trial design, and only general recommendations have been offered by regulatory agencies on this topic. The purposes of this article are to (1) offer a background of the current state of the field of pediatric obesity medicine, (2) provide a brief review of the literature summarizing pediatric obesity pharmacotherapy clinical trials, and (3) highlight and discuss some of the unique aspects that should be considered when designing and conducting high-quality clinical trials evaluating the safety and efficacy of obesity medications in children and adolescents. Suggestions are offered in the areas of target population and eligibility criteria, clinical trial end-point selection, trial duration, implementation of lifestyle modification therapy and recruitment and retention of participants. Efforts should be made to design and conduct trials appropriately to ensure that high-quality evidence is generated on the safety and efficacy of various medications used to treat pediatric obesity.

Pediatric Obesity Pharmacotherapy: Current State of the Field, Review of the Literature, and Clinical Trial Considerations

PubMed Central

Kelly, Aaron S.; Fox, Claudia K.; Rudser, Kyle D.; Gross, Amy C.; Ryder, Justin R.

2017-01-01

Despite the increasing number of medications recently approved to treat obesity among adults, few agents have been formally evaluated in children or adolescents for this indication. Moreover, there is a paucity of guidance in the literature addressing best practices in regard to pediatric obesity pharmacotherapy clinical trial design, and only general recommendations have been offered by regulatory agencies on this topic. The purposes of this article are to: 1) offer a background of the current state of the field of pediatric obesity medicine; 2) provide a brief review of the literature summarizing pediatric obesity pharmacotherapy clinical trials; and 3) highlight and discuss some of the unique aspects that should be considered when designing and conducting high-quality clinical trials evaluating the safety and efficacy of obesity medications in children and adolescents. Suggestions are offered in the areas of target population and eligibility criteria, clinical trial endpoint selection, trial duration, implementation of lifestyle modification therapy, and recruitment and retention of participants. Efforts should be made to design and conduct trials appropriately to ensure that high-quality evidence is generated on the safety and efficacy of various medications used to treat pediatric obesity. PMID:27113643

A randomized controlled trial to investigate the impact of a low glycemic index (GI) diet on body mass index in obese adolescents

PubMed Central

2014-01-01

Background The role of a low glycemic index (GI) diet in the management of adolescent obesity remains controversial. In this study, we aim to evaluate the impact of low GI diet versus a conventional Chinese diet on the body mass index (BMI) and other obesity indices of obese adolescents. Methods Obese adolescents aged 15–18 years were identified from population-recruited, territory-wide surveys. Obesity was defined as BMI ≥95th percentile of Hong Kong local age- and sex-specific references. Eligible subjects were randomized to either an intervention with low GI diet (consisting of 45-50% carbohydrate, 30-35% fat and 15-20% protein) or conventional Chinese diet as control (consisting of 55-60% carbohydrate, 25-30% fat and 10-15% protein). We used random intercept mixed effects model to compare the differential changes across the time points from baseline to month 6 between the 2 groups. Results 104 obese adolescents were recruited (52 in low GI group and 52 in control group; 43.3% boys). Mean age was 16.7 ± 1.0 years and 16.8 ±1.0 years in low GI and control group respectively. 58.7% subjects completed the study at 6 months (65.4% in low GI group and 51.9% in control group). After adjustment for age and sex, subjects in the low GI group had a significantly greater reduction in obesity indices including BMI, body weight and waist circumference (WC) compared to subjects in the control group (all p <0.05). After further adjustment for physical activity levels, WC was found to be significantly lower in the low GI group compared to the conventional group (p = 0.018). Conclusion Low GI diet in the context of a comprehensive lifestyle modification program may be an alternative to conventional diet in the management of obese adolescents. Trial registration number ClinicalTrials.gov Ref. No: NCT01278563 PMID:24552366

Evaluation of a family intervention programme for the treatment of overweight and obese children (Nereu Programme): a randomized clinical trial study protocol

PubMed Central

2013-01-01

end of the intervention (8 months later), 6 and 12 months after the intervention. We have considered necessary to recruit 100 children and divide them in 2 groups of 50 to detect the differences between the groups. Discussion This trial will provide new evidence for the long-term effects of childhood obesity management, as well as help to know the impact of the present intervention as a health intervention tool for healthcare centres. Trial registration ClinicalTrials.gov, NCT01878994 PMID:24153001

PRALIMAP: study protocol for a high school-based, factorial cluster randomised interventional trial of three overweight and obesity prevention strategies

PubMed Central

2010-01-01

Background Given the increase in overweight and obesity prevalence in adolescents in the last decade, effective prevention strategies for these conditions in adolescents are urgently needed. The PRALIMAP (Promotion de l'ALImentation et de l'Activité Physique) trial aims to evaluate the effectiveness for these conditions of 3 health promotion strategies -- educational, screening and environmental -- applied singly or in combination in high schools over a 2-year intervention period. Methods PRALIMAP is a stratified 2 × 2 × 2 factorial cluster randomised controlled trial including 24 state high schools in Lorraine, northeastern France, in 2 waves: 8 schools in 2006 (wave 1) and 16 in 2007 (wave 2). Students entering the selected high schools in the 4 academic years from 2006 to 2009 are eligible for data collection. Interventional strategies are organized over 2 academic years. The follow-up consists of 3 visits: at the entry of grade 10 (T0), grade 11 (T1) and grade 12 (T2). At T0, 5,458 (85.7%) adolescents participated. The educational strategy consists of nutritional lessons, working groups and a final party. The screening strategy consists in detecting overweight/obesity and eating disorders in adolescents and proposing, if necessary, an adapted care management program of 7 group educational sessions. The environmental strategy consists in improving dietary and physical activity offerings in high schools and facilities, especially catering. The main outcomes are body size evolution over time, nutritional behaviour and knowledge, health and quality of life. An evaluation process documents how each intervention strategy is implemented in the schools and estimates the dose of the intervention, allowing for a per protocol analysis after the main intention-to-treat analysis. Discussion PRALIMAP aims at improving the prevention and management of overweight and obesity in adolescents by translating current evidence into public health practice. Particular attention is

Effect of vitamin C on inflammation and metabolic markers in hypertensive and/or diabetic obese adults: a randomized controlled trial

PubMed Central

Ellulu, Mohammed S; Rahmat, Asmah; Patimah, Ismail; Khaza’ai, Huzwah; Abed, Yehia

2015-01-01

Background Obesity is well associated as being an interfering factor in metabolic diseases such as hypertension and diabetes by increasing the secretion of proinflammatory markers from adipose tissue. Having healthy effects, vitamin C could work as an anti-inflammatory agent through its antioxidant capacity. Registration Registration number: FPSK_Mac [13]04. Objective The aim of the study reported here was to identify the effect of vitamin C on reducing the levels of inflammatory markers in hypertensive and/or diabetic obese adults. Subjects and methods Sixty-four obese patients, who were hypertensive and/or diabetic and had high levels of inflammatory markers, from primary health care centers in Gaza City, Palestine, were enrolled into one of two groups in an open-label, parallel, randomized controlled trial. A total of 33 patients were randomized into a control group and 31 patients were randomized into an experimental group. The experimental group was treated with 500 mg vitamin C twice a day. Results In the experimental group, vitamin C significantly reduced the levels of high-sensitivity C-reactive protein (hs-CRP), interleukin 6 (IL-6), fasting blood glucose (FBG), and triglyceride (TG) after 8 weeks of treatment (overall: P<0.001); no changes appeared in total cholesterol (TC). In the control group, there were significant reductions in FBG and TG (P=0.001 and P=0.026, respectively), and no changes in hs-CRP, IL-6, or TC. On comparing the changes in the experimental group with those in the control group at the endpoint, vitamin C was found to have achieved clinical significance in treating effectiveness for reducing hs-CRP, IL-6, and FBG levels (P=0.01, P=0.001, and P<0.001, respectively), but no significant changes in TC or TG were found. Conclusion Vitamin C (500 mg twice daily) has potential effects in alleviating inflammatory status by reducing hs-CRP, IL-6, and FBG in hypertensive and/or diabetic obese patients. PMID:26170625

Changes to registration elements and results in a cohort of Clinicaltrials.gov trials were not reflected in published articles.

PubMed

Pranić, Shelly; Marušić, Ana

2016-02-01

To assess effectiveness of legislative initiatives to stimulate public registration of trial results, we assessed adherence to protocol and results reporting, changes to registry, and publication data for randomized controlled trials (RCTs) after introduction of Food and Drug Administration Amendment Act (FDAAA). Observational study of a cohort of ClinicalTrials.gov registered FDAAA-covered RCTs found through ClinicalTrials.gov between 2009 and 2012 and data from corresponding publications. WHO Minimum Data Set items were abstracted by one author and verified by the other author. Among 81 eligible trials, most were industry-funded, with a drug intervention in parallel assignment. Secondary outcomes at the initial and last registration were omitted for 17% and 19.7% of RCTs, respectively. RCT registration changes mostly involved scientific title (18.8%). Inclusion criteria omission was most common (88%) in publications. Inferential statistical methods for primary and secondary outcomes matched between registry and publication for 53.4% and 28.6% of RCTs, respectively. Serious and other adverse events (AEs) that were absent for 23.8% and 4.8% of RCTs, respectively, were published as nonoccurring. Discrepancies remain relatively high between registered and published outcomes, particularly regarding registered omissions in publications and concomitant reporting, nature of statistical method used, and reporting of AEs. This seriously undermines transparency of clinical trials and needs immediate attention of all stakeholders in health research. Copyright © 2016 Elsevier Inc. All rights reserved.

Participant Recruitment and Engagement in Automated eHealth Trial Registration: Challenges and Opportunities for Recruiting Women Who Experience Violence.

PubMed

Koziol-McLain, Jane; McLean, Christine; Rohan, Maheswaran; Sisk, Rose; Dobbs, Terry; Nada-Raja, Shyamala; Wilson, Denise; Vandal, Alain C

2016-10-25

Automated eHealth Web-based research trials offer people an accessible, confidential opportunity to engage in research that matters to them. eHealth trials may be particularly useful for sensitive issues when seeking health care may be accompanied by shame and mistrust. Yet little is known about people's early engagement with eHealth trials, from recruitment to preintervention autoregistration processes. A recent randomized controlled trial that tested the effectiveness of an eHealth safety decision aid for New Zealand women in the general population who experienced intimate partner violence (isafe) provided the opportunity to examine recruitment and preintervention participant engagement with a fully automated Web-based registration process. The trial aimed to recruit 340 women within 24 months. The objective of our study was to examine participant preintervention engagement and recruitment efficiency for the isafe trial, and to analyze dropout through the registration pathway, from recruitment to eligibility screening and consent, to completion of baseline measures. In this case study, data collection sources included the trial recruitment log, Google Analytics reports, registration and program metadata, and costs. Analysis included a qualitative narrative of the recruitment experience and descriptive statistics of preintervention participant engagement and dropout rates. A Koyck model investigated the relationship between Web-based online marketing website advertisements (ads) and participant accrual. The isafe trial was launched on September 17, 2012. Placement of ads in an online classified advertising platform increased the average number of recruited participants per month from 2 to 25. Over the 23-month recruitment period, the registration website recorded 4176 unique visitors. Among 1003 women meeting eligibility criteria, 51.55% (517) consented to participate; among the 501 women who enrolled (consented, validated, and randomized), 412 (82.2%) were

The assessment of field trials in GMO research around the world and their possible integration in field trials for variety registration.

PubMed

Slot, M M; van de Wiel, C C M; Kleter, G A; Visser, R G F; Kok, E J

2018-05-04

Most regulations worldwide stipulate that a new genetically modified (GM) crop event has to be compared to its closest non-GM counterpart as a corner stone of the pre-market risk assessment. To this end the GM crop and its comparator should be grown in field trials for a phenotypic comparison as well as for subsequent detailed analysis of the composition of the two crop varieties. A more in-depth globally harmonised approach for the conduct of these field trials is lacking. Only a few countries have formulated detailed protocols for the set-up of GM field trials. In some countries, commercial non-GM reference varieties need to be included in a field study to compile reliable data that indicate the range of natural variation for the compounds tested at the specific location. Detailed analysis of pre-market assessment reports have so far not shown the added value of including these reference varieties in the field trials. In all cases where specific values were found to be outside of the range of the reference varieties, it proved possible to draw conclusions on the part of the pre-market risk assessment that relates to the compositional analysis, on the basis of already available compositional data. With the increasing quality of several databases on compositional data of a growing number of crop species, it seems unlikely that reference varieties will become more important on future occasions. It was furthermore investigated whether this part of the risk assessment can be related to field trial requirements for variety registration with the explicit intention of reducing the data burden on producers of new GM plant varieties. Field trials for variety registration so far include an assessment of phenotypic characteristics that do not cover safety aspects, with the exception of establishment of the glycoalkaloid content in potatoes in the Netherlands and Sweden. It may, however, under certain conditions be relatively easy to exchange data from compositional

Children’s Healthy Living (CHL) Program for remote underserved minority populations in the Pacific region: rationale and design of a community randomized trial to prevent early childhood obesity

PubMed Central

2013-01-01

) framework. Discussion The Children’s Healthy Living Program environmental trial is designed to focus on capacity building and to maximize the likelihood of sustainable impact on childhood obesity-related behaviors and outcomes. The multiple measures at the individual, community, and environment levels are designed to maximize the likelihood of detecting change. This approach enhances the likelihood for identifying and promoting the best methods to promote health and well-being of the children in the underserved US Affiliated Pacific Region. Trial registration NIH clinical trial # NCT01881373 PMID:24107083

Design and methods for evaluating an early childhood obesity prevention program in the childcare center setting

PubMed Central

2013-01-01

attempts have been made to prevent obesity during the first years of life, this period may represent the best opportunity for obesity prevention. Findings from this investigation will inform both the fields of childhood obesity prevention and early childhood research about the effects of an obesity prevention program housed in the childcare setting. Trial registration Trial registration number: NCT01722032 PMID:23356862

Participant Recruitment and Engagement in Automated eHealth Trial Registration: Challenges and Opportunities for Recruiting Women Who Experience Violence

PubMed Central

McLean, Christine; Rohan, Maheswaran; Sisk, Rose; Dobbs, Terry; Nada-Raja, Shyamala; Wilson, Denise; Vandal, Alain C

2016-01-01

Background Automated eHealth Web-based research trials offer people an accessible, confidential opportunity to engage in research that matters to them. eHealth trials may be particularly useful for sensitive issues when seeking health care may be accompanied by shame and mistrust. Yet little is known about people’s early engagement with eHealth trials, from recruitment to preintervention autoregistration processes. A recent randomized controlled trial that tested the effectiveness of an eHealth safety decision aid for New Zealand women in the general population who experienced intimate partner violence (isafe) provided the opportunity to examine recruitment and preintervention participant engagement with a fully automated Web-based registration process. The trial aimed to recruit 340 women within 24 months. Objective The objective of our study was to examine participant preintervention engagement and recruitment efficiency for the isafe trial, and to analyze dropout through the registration pathway, from recruitment to eligibility screening and consent, to completion of baseline measures. Methods In this case study, data collection sources included the trial recruitment log, Google Analytics reports, registration and program metadata, and costs. Analysis included a qualitative narrative of the recruitment experience and descriptive statistics of preintervention participant engagement and dropout rates. A Koyck model investigated the relationship between Web-based online marketing website advertisements (ads) and participant accrual. Results The isafe trial was launched on September 17, 2012. Placement of ads in an online classified advertising platform increased the average number of recruited participants per month from 2 to 25. Over the 23-month recruitment period, the registration website recorded 4176 unique visitors. Among 1003 women meeting eligibility criteria, 51.55% (517) consented to participate; among the 501 women who enrolled (consented, validated

Exclusion of patients with concomitant chronic conditions in ongoing randomised controlled trials targeting 10 common chronic conditions and registered at ClinicalTrials.gov: a systematic review of registration details.

PubMed

Buffel du Vaure, Céline; Dechartres, Agnès; Battin, Constance; Ravaud, Philippe; Boutron, Isabelle

2016-09-27

To systematically assess registration details of ongoing randomised controlled trials (RCTs) targeting 10 common chronic conditions and registered at ClinicalTrials.gov and to determine the prevalence of (1) trial records excluding patients with concomitant chronic condition(s) and (2) those specifically targeting patients with concomitant chronic conditions. Systematic review of trial registration records. ClinicalTrials.gov register. All ongoing RCTs registered from 1 January 2014 to 31 January 2015 that assessed an intervention targeting adults with coronary heart disease (CHD), hypertension, heart failure, stroke/transient ischaemic attack, atrial fibrillation, type 2 diabetes, chronic obstructive pulmonary disease, painful condition, depression and dementia with a target sample size ≥100. From the trial registration records, 2 researchers independently recorded the trial characteristics and the number of exclusion criteria and determined whether patients with concomitant chronic conditions were excluded or specifically targeted. Among 319 ongoing RCTs, despite the high prevalence of the concomitant chronic conditions, patients with these conditions were excluded in 251 trials (79%). For example, although 91% of patients with CHD had a concomitant chronic condition, 69% of trials targeting such patients excluded patients with concomitant chronic condition(s). When considering the co-occurrence of 2 chronic conditions, 31% of patients with chronic pain also had depression, but 58% of the trials targeting patients with chronic pain excluded patients with depression. Only 37 trials (12%) assessed interventions specifically targeting patients with concomitant chronic conditions; 31 (84%) excluded patients with concomitant chronic condition(s). Despite widespread multimorbidity, more than three-quarters of ongoing trials assessing interventions for patients with chronic conditions excluded patients with concomitant chronic conditions. Published by the BMJ

Euiiyin-tang in the treatment of obesity: study protocol for a randomised controlled trial.

PubMed

Cheon, Chunhoo; Jang, Soobin; Park, Jeong-Su; Ko, Youme; Kim, Doh Sun; Lee, Byung Hoon; Song, Hyun Jong; Song, Yun-Kyung; Jang, Bo-Hyoung; Shin, Yong-Cheol; Ko, Seong-Gyu

2017-06-21

Obesity is a public health concern in many countries due to its increasing prevalence. Euiiyin-tang is an herbal medicine formula often used as a clinical treatment for obesity. It acts to eliminate humidity and purify the blood, the causes of obesity identified by the theoretical framework of Korean medicine. The purpose of this study is to evaluate the efficacy and safety of Euiiyin-tang in treating obesity. This study is a randomised, double-blinded and placebo-controlled, multicentre trial. It has two parallel arms: the Euiiyin-tang group and the placebo group. A total of 160 obese adult women will be enrolled in the trial. The participants will be randomly divided at a 1:1 ratio at visit 2 (baseline). The participants will be administered Euiiyin-tang or placebo for 12 weeks. The primary endpoint is the change in weight occurring between baseline and post-treatment. The secondary outcomes include average weight reduction, changes in body fat, waist and hip circumferences, body mass index, and lipid profile, and the results of questionnaires such as the Korean version of Obesity-related Quality of Life, the Korean version of Eating Attitudes Test, the Social Readjustment Rating Scale, and the Stress Reaction Inventory. The present study will provide research methodologies for evaluating the efficacy and safety of Euiiyin-tang in patients with obesity. In addition, it will provide evidence of correlation between obesity and Sasang constitutional medicine. ClinicalTrials.gov, NCT01724099 . Registered on 2 November 2012.

Ultrasound-guided percutaneous tracheostomy in critically ill obese patients

PubMed Central

2012-01-01

Introduction The purpose of this study was to evaluate the feasibility of ultrasound (US)-guided percutaneous tracheostomy (PCT) and the incidence of complications in critically ill, obese patients. Methods Fifty consecutive patients were included in a prospective study in two surgical and critical care medicine departments. Obesity was defined as a body mass index (BMI) of at least 30 kg/m2. The feasibility of PCT and the incidence of complications were compared in obese patients (n = 26) and non-obese patients (n = 24). Results are expressed as the median (25th-75th percentile) or number (percentage). Results The median BMIs were 34 kg/m2 (32-38) in the obese patient group and 25 kg/m2 (24-28) in the non-obese group (p < 0.001). The median times for tracheostomy were 10 min (8-14) in non-obese patients and 9 min (5-10) in obese-patients (p = 0.1). The overall complication rate was similar in obese and non-obese patient groups (35% vs. 33%, p = 0.92). Most complications were minor (hypotension, desaturation, tracheal cuff puncture and minor bleeding), with no differences between obese and non-obese groups. Bronchoscopic inspection revealed two cases of granuloma (8%) in obese patients. One non-obese patient developed a peristomal skin infection, which was treated with intravenous antibiotics. Ultrasound-guided PCT was possible in all enrolled patients and there were no surgical conversions or deaths. Conclusions This study demonstrated that US-guided PCT is feasible in obese patients with a low complication rate. Obesity may not constitute a contra-indication for US-guided PCT. A US examination provides information on cervical anatomy and hence modifies and guides choice of the PCT puncture site. Trial registration ClinicalTrials.gov: NCT01502657. PMID:22390815

Pharmacy Students' Knowledge and Attitude toward Registration Trials and Clinical Research: A Survey in a Japanese University Hospital.

PubMed

Ise, Natsuko; Takechi, Kenshi; Miyamoto, Toshiko; Ishizawa, Keisuke; Yanagawa, Hiroaki

2017-12-11

Clinical research plays a fundamental role in establishing new treatments. Clinical research coordinators are considered essential in clinical research, and medical professionals such as pharmacists often take on this role. Pharmacy students can be considered future candidates for this task. We used questionnaires to survey the knowledge of and attitudes toward registration trials and clinical research of pharmacy students at Tokushima University Hospital. All pharmacy students (103) to whom questionnaires were sent responded. Almost all respondents were aware of registration trials and clinical research. More than 90% were aware of the existence of clinical research coordinators, and about half (48.6%) understood their role. In clinical research terminology, most respondents were aware of informed consent and related issues, but fewer than 20% were aware of more practical things. In total, 29.1% and 40.8% of the respondents were willing to carry out and coordinate research. These findings suggest that pharmacy students have basic knowledge of clinical research and that many students are willing to carry out and coordinate clinical research. More practical exposure to clinical research may help to strengthen their future contribution. Further studies may help to determine how to provide education on registration trials and clinical research to pharmacy students.

Short-term role of the dietary total antioxidant capacity in two hypocaloric regimes on obese with metabolic syndrome symptoms: the RESMENA randomized controlled trial

PubMed Central

2013-01-01

Background Dietary strategies seem to be the most prescribed therapy in order to counteract obesity regarding not only calorie restriction, but also bioactive ingredients and the composition of the consumed foods. Dietary total antioxidant capacity (TAC) is gaining importance in order to assess the quality of the diet. Methods Ninety-six obese adults presenting metabolic syndrome (MetS) symptoms completed an 8-week intervention trial to evaluate the effects of a novel dietary program with changes in the nutrient distribution and meal frequency and to compare it with a dietary pattern based on the American Heart Association (AHA) guidelines. Anthropometric and biochemical parameters were assessed at baseline and at the endpoint of the study, in addition to 48-hours food dietary records. Results Both diets equally (p > 0.05) improved MetS manifestations. Dietary TAC was the component which showed the major influence on body weight (p = 0.034), body mass index (p = 0.026), waist circumference (p = 0.083) and fat mass (p = 0.015) reductions. Transaminases (ALT and AST) levels (p = 0.062 and p = 0.004, respectively) were associated with lower TAC values. Conclusion RESMENA diet was as effective as AHA pattern for reducing MetS features. Dietary TAC was the most contributing factor involved in body weight and obesity related markers reduction. Trial registration http://www.clinicaltrials.gov; NCT01087086 PMID:23406163

Feasibility, design and conduct of a pragmatic randomized controlled trial to reduce overweight and obesity in children: The electronic games to aid motivation to exercise (eGAME) study

PubMed Central

Maddison, Ralph; Foley, Louise; Ni Mhurchu, Cliona; Jull, Andrew; Jiang, Yannan; Prapavessis, Harry; Rodgers, Anthony; Vander Hoorn, Stephen; Hohepa, Maea; Schaaf, David

2009-01-01

Background Childhood obesity has reached epidemic proportions in developed countries. Sedentary screen-based activities such as video gaming are thought to displace active behaviors and are independently associated with obesity. Active video games, where players physically interact with images onscreen, may have utility as a novel intervention to increase physical activity and improve body composition in children. The aim of the Electronic Games to Aid Motivation to Exercise (eGAME) study is to determine the effects of an active video game intervention over 6 months on: body mass index (BMI), percent body fat, waist circumference, cardio-respiratory fitness, and physical activity levels in overweight children. Methods/Design Three hundred and thirty participants aged 10–14 years will be randomized to receive either an active video game upgrade package or to a control group (no intervention). Discussion An overview of the eGAME study is presented, providing an example of a large, pragmatic randomized controlled trial in a community setting. Reflection is offered on key issues encountered during the course of the study. In particular, investigation into the feasibility of the proposed intervention, as well as robust testing of proposed study procedures is a critical step prior to implementation of a large-scale trial. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12607000632493 PMID:19450288

Effectiveness of a Group Support Lifestyle Modification (GSLiM) Programme among Obese Adults in Workplace: A Randomised Controlled Trial

PubMed Central

Azmi Mohamed, Mohd Nahar; Mukhtar, Firdaus

2016-01-01

targeted weight loss, improving weight self-efficacy, friend social support, and quality of life compared to dietary counseling. Trial Registration Iranian Registry of Clinical Trials IRCT201104056127N1 PMID:27537687

Published intimate partner violence studies often differ from their trial registration records.

PubMed

Madden, Kim; Tai, Kerry; Ali, Zak; Schneider, Patricia; Singh, Mahip; Ghert, Michelle; Bhandari, Mohit

2017-12-27

Registering study protocols in a trial registry is important for methodologic transparency and reducing selective reporting bias. The objective of this investigation was to determine whether published studies of intimate partner violence (IPV) that had been registered matched the registration record on key study design elements. We systematically searched three trial registries to identify registered IPV studies and the published literature for the associated publication. Two authors independently determined for each study whether key study elements in the registry matched those in the published paper. We included 66 studies published between 2006 and 2017. Nearly half (29/66, 44%) were registered after study completion. Many (26/66, 39%) had discrepancies regarding the primary outcome, and nearly two-thirds (42/66, 64%) had discrepancies in secondary outcomes. Discrepancies in study design were less frequent (13/66, 20%). However, large changes in sample size (26/66, 39%) and discrepancies in funding source (28/66, 42%) were frequently observed. Trial registries are important tools for research transparency and identifying and preventing outcome switching and selective outcome reporting bias. Published IPV studies often differ from their records in trial registries. Researchers should pay close attention to the accuracy of trial registry records.

New medications for treatment of obesity: metabolic and cardiovascular effects.

PubMed

Pucci, Andrea; Finer, Nicholas

2015-02-01

The management of obesity remains a major challenge. Dietary therapy often fails, whereas bariatric surgery, although successful, is demanding and applicable to a limited number of patients. Drug therapy has had many setbacks over the past 20 years because of serious adverse effects; however, several new drugs for the treatment of obesity are either licensed in some parts of the world, submitted for registration, or completing phase III trials. These include combinations (at low dose) of existing drugs, e.g., bupropion + naltrexone (Contrave), phentermine + topiramate (Qsymia), higher doses of existing drugs licensed for other indications (liraglutide, 3 mg), and new entities (lorcaserin). We discuss the challenges and opportunities for obesity pharmacotherapy and review in detail the efficacy of the new drugs regarding weight loss and both desirable and potential undesirable cardiovascular (CV) and metabolic risk factors. Substantial barriers remain, even if the drugs are approved, in successfully integrating these agents into weight management practice, largely related to cost, patient acceptability, and clinician willingness to be engaged in obesity treatment. Although hard clinical outcome benefit (at least for CV outcomes) has yet to be established, obesity pharmacotherapy may soon address many of the challenges in the clinical management of obesity, although newer and better drug combinations and more evidence of benefit from appropriately designed outcome trials is needed. Copyright © 2015 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

High Intensity Interval- vs Moderate Intensity- Training for Improving Cardiometabolic Health in Overweight or Obese Males: A Randomized Controlled Trial

PubMed Central

Fisher, Gordon; Brown, Andrew W.; Bohan Brown, Michelle M.; Alcorn, Amy; Noles, Corey; Winwood, Leah; Resuehr, Holly; George, Brandon; Jeansonne, Madeline M.; Allison, David B.

2015-01-01

previously sedentary overweight or obese young men, with no clear advantage between these two specific regimes (Clinical Trial Registry number NCT01935323). Trial Registration ClinicalTrials.gov NCT01935323 PMID:26489022

Assessment of Registration Information on Methodological Design of Acupuncture RCTs: A Review of 453 Registration Records Retrieved from WHO International Clinical Trials Registry Platform

PubMed Central

Gu, Jing; Wang, Qi; Wang, Xiaogang; Li, Hailong; Gu, Mei; Ming, Haixia; Dong, Xiaoli; Yang, Kehu; Wu, Hongyan

2014-01-01

Background. This review provides the first methodological information assessment of protocol of acupuncture RCTs registered in WHO International Clinical Trials Registry Platform (ICTRP). Methods. All records of acupuncture RCTs registered in the ICTRP have been collected. The methodological design assessment involved whether the randomization methods, allocation concealment, and blinding were adequate or not based on the information of registration records (protocols of acupuncture RCTs). Results. A total of 453 records, found in 11 registries, were examined. Methodological details were insufficient in registration records; there were 76.4%, 89.0%, and 21.4% records that did not provide information on randomization methods, allocation concealment, and blinding respectively. The proportions of adequate randomization methods, allocation concealment, and blinding were only 107 (23.6%), 48 (10.6%), and 210 (46.4%), respectively. The methodological design improved year by year, especially after 2007. Additionally, methodology of RCTs with ethics approval was clearly superior to those without ethics approval and different among registries. Conclusions. The overall methodological design based on registration records of acupuncture RCTs is not very well but improved year by year. The insufficient information on randomization methods, allocation concealment, and blinding maybe due to the relevant description is not taken seriously in acupuncture RCTs' registration. PMID:24688591

Assessment of Registration Information on Methodological Design of Acupuncture RCTs: A Review of 453 Registration Records Retrieved from WHO International Clinical Trials Registry Platform.

PubMed

Gu, Jing; Wang, Qi; Wang, Xiaogang; Li, Hailong; Gu, Mei; Ming, Haixia; Dong, Xiaoli; Yang, Kehu; Wu, Hongyan

2014-01-01

Background. This review provides the first methodological information assessment of protocol of acupuncture RCTs registered in WHO International Clinical Trials Registry Platform (ICTRP). Methods. All records of acupuncture RCTs registered in the ICTRP have been collected. The methodological design assessment involved whether the randomization methods, allocation concealment, and blinding were adequate or not based on the information of registration records (protocols of acupuncture RCTs). Results. A total of 453 records, found in 11 registries, were examined. Methodological details were insufficient in registration records; there were 76.4%, 89.0%, and 21.4% records that did not provide information on randomization methods, allocation concealment, and blinding respectively. The proportions of adequate randomization methods, allocation concealment, and blinding were only 107 (23.6%), 48 (10.6%), and 210 (46.4%), respectively. The methodological design improved year by year, especially after 2007. Additionally, methodology of RCTs with ethics approval was clearly superior to those without ethics approval and different among registries. Conclusions. The overall methodological design based on registration records of acupuncture RCTs is not very well but improved year by year. The insufficient information on randomization methods, allocation concealment, and blinding maybe due to the relevant description is not taken seriously in acupuncture RCTs' registration.

Intake of Sweets, Snacks and Soft Drinks Predicts Weight Gain in Obese Pregnant Women: Detailed Analysis of the Results of a Randomised Controlled Trial

PubMed Central

Renault, Kristina M.; Carlsen, Emma M.; Nørgaard, Kirsten; Nilas, Lisbeth; Pryds, Ole; Secher, Niels J.; Olsen, Sjurdur F.; Halldorsson, Thorhallur I.

2015-01-01

Background Lifestyle interventions targeting obese pregnant women often result in modest reduction in gestational weight gain, pregnancy complications and related risk factors. Examining adherence to the intervention can, however, provide valuable information on the importance of the different factors targeted. Objective To evaluate improvements and relevance of different dietary factors targeted with respect to gestational weight gain in a 3-arm Randomised Controlled Trial (n=342) among obese pregnant women with BMI≥30 kg/m2. Methods Randomisation 1:1:1 to either hypocaloric Mediterranean type of diet and physical activity intervention (D+PA); physical activity intervention alone (PA); or control (C). Diet was assessed at baseline (weeks 11–14) and endpoint (weeks 36–37) using a validated food frequency questionnaire. Results During the intervention women in the D+PA group significantly lowered their intakes of added sugars and saturated fat and increased their protein intake by ~1% of total energy compared to controls. Of these dietary variables only intakes of added sugar appeared to be related to GWG, while no association was observed for saturated fat or protein. Further analyses revealed that foods that contributed to intake of added sugars, including sweets, snacks, cakes, and soft drinks were strongly associated with weight gain, with women consuming sweets ≥2/day having 5.4 kg (95% CI 2.1-8.7) greater weight gain than those with a low (<1wk) intake. The results for soft drinks were more conflicting, as women with high weight gain tended to favour artificially sweetened soft drinks. Conclusion In our sample of obese pregnant women, craving for sweets, snacks, and soft drinks strongly predicts GWG. Emphasis on reducing intakes of these foods may be more relevant for limiting gestational weight gain than encouraging strict compliance to more specific diets. Trial Registration ClinicalTrials.gov NCT01345149 PMID:26192183

Effect of a prescriptive dietary intervention on psychological dimensions of eating behavior in obese adolescents

PubMed Central

2013-01-01

intervention approach is a well-accepted and suitable option for obese adolescents with clinical features of insulin resistance. It may reduce external and emotional eating, led to modest weight loss and did not cause any adverse effect on dietary restraint. Trial registration Australian New Zealand Clinical Trial Registration Number (ACTRN) 12608000416392 https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=83071 PMID:24156290

Associations between overweight, obesity, health measures and need for recovery in office employees: a cross-sectional analysis.

PubMed

van der Starre, Robine E; Coffeng, Jennifer K; Hendriksen, Ingrid J M; van Mechelen, Willem; Boot, Cécile R L

2013-12-20

With both a high need for recovery (NFR) and overweight and obesity being a potential burden for organizations (e.g. productivity loss and sickness absence), the aim of this paper was to examine the associations between overweight and obesity and several other health measures and NFR in office workers. Baseline data of 412 office employees participating in a randomised controlled trial aimed at improving NFR in office workers were used. Associations between self-reported BMI categories (normal body weight, overweight, obesity) and several other health measures (general health, mental health, sleep quality, stress and vitality) with NFR were examined. Unadjusted and adjusted linear regression analyses were performed and adjusted for age, education and job demands. In addition, we adjusted for general health in the association between overweight and obesity and NFR. A significant positive association was observed between stress and NFR (B= 18.04, 95%CI:14.53-21.56). General health, mental health, sleep quality and vitality were negatively associated with NFR (p<0.001). Analyses also showed a significant positive association between obesity and NFR (B=8.77, 95%CI:0.01-17.56), but not between overweight and NFR. The findings suggest that self-reported stress is, and obesity may be, associated with a higher NFR. Additionally, the results imply that health measures that indicate a better health are associated with a lower NFR. The trial is registered at the Dutch Trial Register (NTR) under trial registration number: NTR2553.

Lifestyle Triple P: a parenting intervention for childhood obesity

PubMed Central

2012-01-01

Background Reversing the obesity epidemic requires the development and evaluation of childhood obesity intervention programs. Lifestyle Triple P is a parent-focused group program that addresses three topics: nutrition, physical activity, and positive parenting. Australian research has established the efficacy of Lifestyle Triple P, which aims to prevent excessive weight gain in overweight and obese children. The aim of the current randomized controlled trial is to assess the effectiveness of the Lifestyle Triple P intervention when applied to Dutch parents of overweight and obese children aged 4–8 years. This effectiveness study is called GO4fit. Methods/Design Parents of overweight and obese children are being randomized to either the intervention or the control group. Those assigned to the intervention condition receive the 14-week Lifestyle Triple P intervention, in which they learn a range of nutritional, physical activity and positive parenting strategies. Parents in the control group receive two brochures, web-based tailored advice, and suggestions for exercises to increase active playing at home. Measurements are taken at baseline, directly after the intervention, and at one year follow-up. Primary outcome measure is the children’s body composition, operationalized as BMI z-score, waist circumference, and fat mass (biceps and triceps skinfolds). Secondary outcome measures are children’s dietary behavior and physical activity level, parenting practices, parental feeding style, parenting style, parental self-efficacy, and body composition of family members (parents and siblings). Discussion Our intervention is characterized by a focus on changing general parenting styles, in addition to focusing on changing specific parenting practices, as obesity interventions typically do. Strengths of the current study are the randomized design, the long-term follow-up, and the broad range of both self-reported and objectively measured outcomes. Trial Registration

Intervention on whole grain with healthy balanced diet to manage childhood obesity (GReat-Child™trial): study protocol for a quasi-experimental trial.

PubMed

Koo, H C; Poh, B K; Ruzita, Abd Talib

2016-01-01

The rapid increase in childhood obesity is a serious public health problem, and has led to the development of many interventions. However, no intervention has emphasized whole grains as a strategy to manage childhood obesity. Therefore, this article describes the protocol of a 12-week multi-component, family-based intervention on whole grain, using a healthy balanced diet for managing childhood obesity. The GReat-Child trial utilize a quasi-experimental method in which two schools in Kuala Lumpur are assigned to intervention and control groups. The eligibility criteria are overweight/obese children, aged 9 through 11 years, who has no serious co-morbidities. The children who report consuming whole-grain foods in their 3-day diet-recall during the screening will be excluded. The study sample is characterized by anthropometric measurements (weight, height, percentage of body fat and waist circumference), whole grain and nutrient intakes (3-day 24-h diet recalls), and their knowledge, attitudes and practices towards whole grain. The 12-week intervention is comprised of three components addressing behaviour, personal and environmental factors, based on social cognitive theory: (1) individual diet counselling for the parents; (2) six 30-min nutrition education classes and (3) school delivery of whole-grain foods; The control school does not receive any interventions, however, for ethical purposes, a health talk is conducted after the entire GReat-Child Trial is completed. The GReat-Child trial represents a novel approach to examining the effectiveness of the intervention of whole grain in a healthy balanced diet on managing childhood obesity. We anticipate that this trial will reveal not only whether whole grain intervention will be effective in managing childhood obesity, but also provide greater insights into the acceptance of whole grain among Malaysian children.

Efficacy of nanocurcumin supplementation on insulin resistance, lipids, inflammatory factors and nesfatin among obese patients with non-alcoholic fatty liver disease (NAFLD): a trial protocol

PubMed Central

Jazayeri-Tehrani, Seyed Ali; Rezayat, Seyed Mahdi; Mansouri, Siavash; Qorbani, Mostafa; Alavian, Seyed Moayed; Daneshi-Maskooni, Milad; Hosseinzadeh-Attar, Mohammad-Javad

2017-01-01

Objectives Different studies have been conducted on the role of curcumin in health since having multiple properties, including antioxidant and anti-inflammatory effects. Due to the lack of studies regarding curcumin effects on obese patients with non-alcoholic fatty liver disease (NAFLD), our protocol was designed to assess nanocurcumin impacts on blood sugar, lipids, inflammatory indices, insulin resistance and liver function, especially by nesfatin. Setting This trial will be conducted in the Oil Company central hospital of Tehran, Iran with a primary level of care. Participants 84 obese patients with NAFLD diagnosed using ultrasonography will be employed according to the eligibility criteria‎. Interventions The patients will be randomly divided into two equal groups (nanocurcumin and placebo, two 40 mg capsules per day with meals for 3 months, follow-up monthly). Also, lifestyle changes (low-calorie diet and physical activity) will be advised. Measures of the primary and secondary outcomes A general questionnaire, 24 hours food recall (at the beginning, middle and end) and short-form International Physical Activity Questionnaire will be completed. Blood pressure, anthropometrics, serum sugar indices (fasting blood sugar and insulin, insulin resistance and sensitivity and glycosylated haemoglobin), lipids (triglyceride, total cholesterol and low-density and high-density lipoprotein-cholesterol, inflammatory profiles (interleukin-6, high-sensitivity C-reactive protein, and tumour necrosis factor-alpha), liver function (alanine and aspartate transaminase) and nesfatin will be measured at the beginning and end of the study. Conclusion This trial would be the first experiment to determine nanocurcumin efficacy on certain blood factors among obese patients with NAFLD. Nevertheless, studying the potential consequences of curcumin in various diseases, especially NAFLD, is required for clinical use. Trial registration number IRCT2016071915536N3; pre-results. PMID

Niños Sanos, Familia Sana: Mexican immigrant study protocol for a multifaceted CBPR intervention to combat childhood obesity in two rural California towns

PubMed Central

2013-01-01

Background Overweight and obese children are likely to develop serious health problems. Among children in the U.S., Latino children are affected disproportionally by the obesity epidemic. Niños Sanos, Familia Sana (Healthy Children, Healthy Family) is a five-year, multi-faceted intervention study to decrease the rate of BMI growth in Mexican origin children in California’s Central Valley. This paper describes the methodology applied to develop and launch the study. Methods/Design Investigators use a community-based participatory research approach to develop a quasi-experimental intervention consisting of four main components including nutrition, physical activity, economic and art-community engagement. Each component’s definition, method of delivery, data collection and evaluation are described. Strategies to maintain engagement of the comparison community are reported as well. Discussion We present a study methodology for an obesity prevention intervention in communities with unique environmental conditions due to rural and isolated location, limited infrastructure capacity and limited resources. This combined with numerous cultural considerations and an unstable population with limited exposure to researcher expectations necessitates reassessment and adaptation of recruitment strategies, intervention delivery and data collection methods. Trial registration # NCT01900613. Trial registration NCT01900613. PMID:24172250

Effects of the Healthy Start randomized intervention trial on physical activity among normal weight preschool children predisposed to overweight and obesity

PubMed Central

Larsen, Sofus Christian; Rohde, Jeanett Friis; Stougaard, Maria; Olsen, Nanna Julie; Heitmann, Berit Lilienthal

2017-01-01

Background There is limited evidence to support the effectiveness of primary interventions aiming to prevent excess weight gain among young children. Evaluating behavioral changes, such as physical activity (PA), may add to future development of efficient interventions. The objective was to evaluate the effect on PA outcomes of the 15 month Healthy Start intervention that focused on changing diet, PA, sleep and stress management among normal weight but obesity-prone preschool children. Children were defined as obesity-prone if they had a birth weight > 4,000 g, mothers with a pre-pregnancy body mass index of > 28 kg/m2, or mothers with ≤ 10 years of schooling. Method From a baseline study population of 635 normal weight 2–6 year old preschool children from the greater Copenhagen area, parents of 307 children had given information on PA at both the baseline and follow-up examinations. PA was obtained from a 7 days recording in the Children’s Physical Activity Questionnaire. Time used for sport activities were combined with outdoor playing time to achieve a proxy of total PA level of moderate to vigorous intensity. Results Linear regression analyses revealed that at follow-up the intervention group spent more time on sports and outdoor activities combined per week than the control group (ITT analyses: intervention: 400 min/week; 95% confidence interval (CI): 341, 459 versus control: 321 min/week; 95% CI: 277, 366; p = 0.02), although no significant intervention effects were seen for each of the subcategories, e.g. sports participation, outdoor activities, screen time, or commuting frequency. Conclusion Our results suggest that the overall time spent on sports and outdoor activities combined was increased at follow-up among normal weight obesity-prone children, as a result of the Healthy Start intervention. Trial registration ClinicalTrials.gov NCT01583335 PMID:28991907

The IDEFICS intervention trial to prevent childhood obesity: design and study methods.

PubMed

Pigeot, I; Baranowski, T; De Henauw, S

2015-12-01

One of the major research dimensions of the Identification and prevention of Dietary- and lifestyle-induced health EFfects In Children and infantS (IDEFICS) study involved the development, implementation and evaluation of a setting-based community-oriented intervention programme for primary prevention of childhood obesity. In this supplement of Obesity Reviews, a compilation of key results of the IDEFICS intervention is packaged in a series of complementary papers. This paper describes the overall design and methods of the IDEFICS intervention in order to facilitate a comprehensive reading of the supplement. In addition, some 'best practice' examples are described. The IDEFICS intervention trial was conducted to assess whether the IDEFICS intervention prevented obesity in young children aged 2 to 9.9 years. The study was a non-randomized, quasi-experimental trial with one intervention matched to one control region in each of eight participating countries. The intervention was designed following the intervention mapping framework, using a socio-ecological theoretical approach. The intervention was designed to address several key obesity-related behaviours in children, parents, schools and community actors; the primary outcome was the prevalence of overweight/obesity according to the IOTF criteria based on body mass index. The aim was to achieve a reduction of overweight/obesity prevalence in the intervention regions. The intervention was delivered in school and community settings over a 2-year period. Data were collected in the intervention and control cohort regions at baseline and 2 years later. This paper offers an introductory framework for a comprehensive reading of this supplement on IDEFICS intervention key results. © 2015 World Obesity.

The By-Band study: gastric bypass or adjustable gastric band surgery to treat morbid obesity: study protocol for a multi-centre randomised controlled trial with an internal pilot phase

PubMed Central

2014-01-01

Background The prevalence of severe and complex obesity is increasing worldwide and surgery may offer an effective and lasting treatment. Laparoscopic adjustable gastric band and Roux-en-Y gastric bypass surgery are the two main surgical procedures performed. Design This open parallel-group randomised controlled trial will compare the effectiveness, cost-effectiveness and acceptability of gastric band (Band) versus gastric bypass (Bypass) in adults with severe and complex obesity. It has an internal pilot phase (in two centres) with integrated qualitative research to establish effective and optimal methods for recruitment. Adults with a body mass index (BMI) of 40 kg/m2 or more, or a BMI of 35 kg/m2 or more and other co-morbidities will be recruited. At the end of the internal pilot the study will expand into more centres if the pre-set progression criteria of numbers and rates of eligible patients screened and randomised are met and if the expected rates of retention and adherence to treatment allocation are achieved. The trial will test the joint hypotheses that Bypass is non-inferior to Band with respect to more than 50% excess weight loss and that Bypass is superior to Band with respect to health related quality of life (HRQOL, EQ-5D) at three years. Secondary outcomes include other weight loss measures, waist circumference and remission/resolution of co-morbidities; generic and symptom-specific HRQOL; nutritional blood test results; resource use; eating behaviours and adverse events. A core outcome set for reporting the results of obesity surgery will be developed and a systematic review of the evidence for sleeve gastrectomy undertaken to inform the main study design. Discussion By-Band is the first pragmatic study to compare the two most commonly performed bariatric surgical procedures for severe and complex obesity. The design will enable and empower surgeons to learn to recruit and participate in a randomised study. Early evidence shows that timely

The Walking Interventions Through Texting (WalkIT) Trial: Rationale, Design, and Protocol for a Factorial Randomized Controlled Trial of Adaptive Interventions for Overweight and Obese, Inactive Adults

PubMed Central

Hurley, Jane C; Hollingshead, Kevin E; Todd, Michael; Jarrett, Catherine L; Tucker, Wesley J; Angadi, Siddhartha S

2015-01-01

active and are overweight or obese. WalkIT is one of the first studies focusing on the individual components of combined goal setting and reward structures in a factorial design to increase walking. The trial is expected to produce results useful to future research interventions and perhaps industry initiatives, primarily focused on mHealth, goal setting, and those looking to promote behavior change through performance-based incentives. Trial Registration ClinicalTrials.gov NCT02053259; https://clinicaltrials.gov/ct2/show/NCT02053259 (Archived by WebCite at http://www.webcitation.org/6b65xLvmg). PMID:26362511

Early-Life Obesity Prevention: Critique of Intervention Trials During the First One Thousand Days.

PubMed

Reilly, John J; Martin, Anne; Hughes, Adrienne R

2017-06-01

To critique the evidence from recent and ongoing obesity prevention interventions in the first 1000 days in order to identify evidence gaps and weaknesses, and to make suggestions for more informative future intervention trials. Completed and ongoing intervention trials have had fairly modest effects, have been limited largely to high-income countries, and have used relatively short-term interventions and outcomes. Comparison of the evidence from completed prevention trials with the evidence from systematic reviews of behavioral risk factors shows that some life-course stages have been neglected (pre-conception and toddlerhood), and that interventions have neglected to target some important behavioral risk factors (maternal smoking during pregnancy, infant and child sleep). Finally, while obesity prevention interventions aim to modify body composition, few intervention trials have used body composition measures as outcomes, and this has limited their sensitivity to detect intervention effects. The new WHO Healthy Lifestyles Trajectory (HeLTI) initiative should address some of these weaknesses. Future early obesity prevention trials should be much more ambitious. They should, ideally: extend their interventions over the first 1000 days; have longer-term (childhood) outcomes, and improved outcome measures (body composition measures in addition to proxies for body composition such as the BMI for age); have greater emphasis on maternal smoking and child sleep; be global.

Effects of zinc supplementation on obesity: study protocol for a randomized controlled clinical trial.

PubMed

Rathnayake, Kumari M; Silva, Kdrr; Jayawardena, Ranil

2016-11-04

The prevalence of obesity is escalating alarmingly worldwide, and it is now becoming a rapidly growing epidemic in developing countries. Recent studies have reported that zinc has been implicated in altered lipid markers, insulin resistance and some obesity markers. There is a lack of evidence on zinc as a potential therapeutic agent to reduce weight and improve metabolic parameters in obese adults. The present study is designed to evaluate the effects of zinc supplementation on obese adults in Sri Lanka. Furthermore, we aim to evaluate the effects of zinc supplementation on metabolic parameters in this population. This study will be conducted as a randomized, double-blind, placebo-controlled clinical trial for a period of 3 months at the clinical laboratory, Department of Applied Nutrition, Wayamba University of Sri Lanka to assess the efficacy of daily zinc 20 mg supplementation in obese subjects. There will be a total of 80 subjects, aged between 18-60 years, of both genders, who are obese (body mass index (BMI) ≥25). Subjects will be stratified according to age, gender and BMI and randomly assigned into the test and placebo groups in a 1:1 ratio. The treatment drug is a capsule containing elemental zinc 20 mg as the active ingredient (as zinc sulphate). The placebo capsule will contain lactose monohydrate. The subjects will receive either zinc capsules or placebo daily for 3 months. The study treatments will be double blinded to both investigator and subject. The visits and the evaluations will be as follows: screening (visit 0), baseline (visit 1) and 3 month (visit 2). The primary outcome will be weight reduction among the obese subjects. Secondary outcome measures include glycaemic status (fasting blood glucose), lipid parameters (total cholesterol, triglyceride levels, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol) and blood pressure. The trial protocol will aim to establish the effects of zinc supplementation on weight

Promoting deceased organ and tissue donation registration in family physician waiting rooms (RegisterNow-1 trial): study protocol for a pragmatic, stepped-wedge, cluster randomized controlled registry.

PubMed

Li, Alvin H; Garg, Amit X; Prakash, Versha; Grimshaw, Jeremy M; Taljaard, Monica; Mitchell, Joanna; Matti, Danny; Linklater, Stefanie; Naylor, Kyla L; Dixon, Stephanie; Faulds, Cathy; Bevan, Rachel; Getchell, Leah; Knoll, Greg; Kim, S Joseph; Sontrop, Jessica; Bjerre, Lise M; Tong, Allison; Presseau, Justin

2017-12-21

There is a worldwide shortage of organs available for transplant, leading to preventable mortality associated with end-stage organ disease. While most citizens in many countries with an intent-to-donate "opt-in" system support organ donation, registration rates remain low. In Canada, most Canadians support organ donation but less than 25% in most provinces have registered their desire to donate their organs when they die. The family physician office is a promising yet underused setting in which to promote organ donor registration and address known barriers and enablers to registering for deceased organ and tissue donation. We developed a protocol to evaluate an intervention to promote registration for organ and tissue donation in family physician waiting rooms. This protocol describes a planned, stepped-wedge, cluster randomized registry trial in six family physician offices in Ontario, Canada to evaluate the effectiveness of reception staff providing patients with a pamphlet that addresses barriers and enablers to registration including a description of how to register for organ donation. An Internet-enabled tablet will also be provided in waiting rooms so that interested patients can register while waiting for their appointments. Family physicians and reception staff will be provided with training and/or materials to support any conversations about organ donation with their patients. Following a 2-week control period, the six offices will cross sequentially into the intervention arm in randomized sequence at 2-week intervals until all offices deliver the intervention. The primary outcome will be the proportion of patients visiting the office who are registered organ donors 7 days following their office visit. We will evaluate this outcome using routinely collected registry data from provincial administrative databases. A post-trial qualitative evaluation process will assess the experiences of reception staff and family physicians with the intervention and the

Individualized Exercise Training at Maximal Fat Oxidation Combined with Fruit and Vegetable-Rich Diet in Overweight or Obese Women: The LIPOXmax-Réunion Randomized Controlled Trial

PubMed Central

Besnier, Florent; Lenclume, Victorine; Gérardin, Patrick; Fianu, Adrian; Martinez, Jérémy; Naty, Nadège; Porcherat, Sylvaine; Boussaid, Karim; Schneebeli, Stéphane; Jarlet, Eric; Hatia, Sarah; Dalleau, Georges; Verkindt, Chantal; Brun, Jean-Frédéric; Gonthier, Marie-Paule; Favier, François

2015-01-01

LIPOXmax training for the prevention of T2DM in overweight or obese women. Trial Registration ClincialTrials.gov NCT01464073 PMID:26555595

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

Latino Families, Primary Care, and Childhood Obesity

PubMed Central

Arauz Boudreau, Alexy D.; Kurowski, Daniel S.; Gonzalez, Wanda I.; Dimond, Melissa A.; Oreskovic, Nicolas M.

2017-01-01

necessary for primary care to partner with community initiatives to address childhood obesity in a more intense manner. Trial registration This study is registered at Clinicaltrials.partners.org 2009P001721. PMID:23415190

A shared-care model of obesity treatment for 3-10 year old children: protocol for the HopSCOTCH randomised controlled trial.

PubMed

Wake, Melissa; Lycett, Kate; Sabin, Matthew A; Gunn, Jane; Gibbons, Kay; Hutton, Cathy; McCallum, Zoe; York, Elissa; Stringer, Michael; Wittert, Gary

2012-03-28

Despite record rates of childhood obesity, effective evidence-based treatments remain elusive. While prolonged tertiary specialist clinical input has some individual impact, these services are only available to very few children. Effective treatments that are easily accessible for all overweight and obese children in the community are urgently required. General practitioners are logical care providers for obese children but high-quality trials indicate that, even with substantial training and support, general practitioner care alone will not suffice to improve body mass index (BMI) trajectories. HopSCOTCH (the Shared Care Obesity Trial in Children) will determine whether a shared-care model, in which paediatric obesity specialists co-manage obesity with general practitioners, can improve adiposity in obese children. Randomised controlled trial nested within a cross-sectional BMI survey conducted across 22 general practices in Melbourne, Australia. Children aged 3-10 years identified as obese by Centers for Disease Control criteria at their family practice, and randomised to either a shared-care intervention or usual care. A single multidisciplinary obesity clinic appointment at Melbourne's Royal Children's Hospital, followed by regular appointments with the child's general practitioner over a 12 month period. To support both specialist and general practice consultations, web-based shared-care software was developed to record assessment, set goals and actions, provide information to caregivers, facilitate communication between the two professional groups, and jointly track progress. Primary - change in BMI z-score. Secondary - change in percentage fat and waist circumference; health status, body satisfaction and global self-worth. This will be the first efficacy trial of a general-practitioner based, shared-care model of childhood obesity management. If effective, it could greatly improve access to care for obese children. Australian New Zealand Clinical Trials

Is laser acupuncture an effective complementary therapy for obesity management? A systematic review of clinical trials.

PubMed

Namazi, Nazli; Khodamoradi, Kajal; Larijani, Bagher; Ayati, Mohammad Hossein

2017-12-01

Complementary therapies may increase the success rate of weight loss via a calorie-restricted diet. Acupuncture is a popular complementary therapy for obesity management. To our knowledge, no studies have summarised the effects of laser acupuncture (LA) on obesity. To evaluate the efficacy of LA, in particular with respect to its impact on anthropometric features and appetite in obese adults, by conducting a systematic review of previous clinical trials. We searched PubMed/Medline, Scopus, Web of Science, the Cochrane Library, Embase and Google Scholar electronic databases for papers published through October 2016. All clinical trials in English containing either anthropometric indices or appetite parameters were included. Two reviewers independently examined studies based on a predefined form for data extraction and the Jadad scale for quality assessment in order to minimise bias throughout the evaluation. After screening the papers, seven clinical trials met the criteria and were included in the systematic review. Positive effects of LA therapy were seen in body weight (n=3), body mass index (n=5), waist circumference (n=4), hip circumference (n=3), waist to hip ratio (n=4) and % fat mass (n=3). Appetite parameters were reported in one study, which showed that LA can reduce appetite and increase the sensation of feeling full. Although some studies have indicated beneficial effects for LA on obesity, the lack of evidence with high methodological quality made it impossible to reach a definitive conclusion about the efficacy of LA for obesity management. Further high-quality, randomised, sham-controlled clinical trials with a larger sample size are needed to shed light on the efficacy of LA for obesity management and weight maintenance. © 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.

The Healthy Lifestyles Programme (HeLP), a novel school-based intervention to prevent obesity in school children: study protocol for a randomised controlled trial

PubMed Central

2013-01-01

Background Over the last three decades there has been a substantial increase in the proportion of children who are overweight or obese. The Healthy Lifestyles Programme (HeLP) is a novel school-based intervention, using highly interactive and creative delivery methods to prevent obesity in children. Methods/Design We describe a cluster randomised controlled trial to evaluate the effectiveness and cost effectiveness of HeLP. The intervention has been developed using intervention mapping (involving extensive stakeholder involvement) and has been guided by the Information, Motivation, Behavioural Skills model. HeLP includes creating a receptive environment, drama activities, goal setting and reinforcement activities and runs over three school terms. Piloting showed that 9 to 10 year olds were the most receptive and participative. This study aims to recruit 1,300 children from 32 schools (over half of which will have ≥19% of pupils eligible for free school meals) from the southwest of England. Participating schools will be randomised to intervention or control groups with baseline measures taken prior to randomisation. The primary outcome is change in body mass index standard deviation score (BMI SDS) at 24 months post baseline. Secondary outcomes include, waist circumference and percent body fat SDS and proportion of children classified as overweight or obese at 18 and 24 months and objectively measured physical activity and food intake at 18 months. Between-group comparisons will be made using random effects regression analysis taking into account the hierarchical nature of the study design. An economic evaluation will estimate the incremental cost-effectiveness of HeLP, compared to control, from the perspective of the National Health Service (NHS)/third party payer. An in-depth process evaluation will provide insight into how HeLP works, and whether there is any differential uptake or engagement with the programme. Discussion The results of the trial will provide

A primary-school-based study to reduce the prevalence of childhood obesity – the EdAl (Educació en Alimentació) study: a randomized controlled trial

PubMed Central

2014-01-01

Background Obesity is one of the main determinants of avoidable disease burden. To implement a program by university students acting as “health promoting agents” (HPAs) and to evaluate the effects on obesity prevalence of the primary-school-based program that promotes healthy lifestyle, including dietary and physical activity recommendations over 28 months. Methods Two school clusters were randomly assigned to intervention (24 schools, 1,222 pupils) or control (14 schools, 717 pupils); 78% of pupils were Western European. Mean age (±SD) was 8.4 ± 0.6 years (49.9% females) at baseline. Generalized linear mixed models were used to analyze differences in primary outcome between both groups. Data collected included body mass index (BMI) every year. Dietary habits and lifestyle questionnaires were filled in by the parents at baseline and at the end of the study. The interventions focused on eight lifestyle topics covered in 12 activities (1 hour/activity/session) implemented by HPAs over 3 school academic years. Results At 28 months, obesity prevalence in boys was decreased −2.36% in the intervention group (from 9.59% to 7.23%) and increased 2.03% (from 7.40% to 9.43%) in the control group; the difference was 4.39% (95% CI 3.48 to 5.30; P = 0.01). The boys in the intervention group had an effective reduction of −0.24 units in the change of BMI z-score (from 0.01 to −0.04), compared to control (from −0.10 to 0.09); 5.1% more intervention pupils undertook physical activity >5 hours/week than control pupils (P = 0.02). Fish consumption was a protector (odds ratio 0.39; 95% CI 0.23 to 0.67) while “fast-food” consumption was a risk factor for childhood obesity (odds ratio: 2.27; 95% CI 1.08 to 4.77). Conclusions Our school-based program, conducted by HPA students, successfully reduced childhood obesity prevalence in boys. Trial registration International Standard Randomized Controlled Trial Number: ISRCTN29247645. PMID:24529258

Controlling on-demand gastric acidity in obese subjects: a randomized, controlled trial comparing a single dose of 20 mg rabeprazole and 20 mg omeprazole

PubMed Central

2014-01-01

Background Obesity is associated with a risk of gastroesophageal reflux disease. The pharmacodynamic efficacy of proton pump inhibitors has not been specifically evaluated in obese subjects. The aim of this study was to compare the antisecretory response to a single oral dose of 20 mg rabeprazole, 20 mg omeprazole and placebo in obese subjects. Methods Gastric pH was monitored for 24 hours on three separate occasions in eighteen H. pylori-negative, asymptomatic obese subjects. Subjects were given omeprazole, rabeprazole or placebo in a randomized order and in a double-blind fashion. The main analysis criterion was 24-h percent of time post dose with intragastric pH above 3; secondary criteria were percentage of time above pH 4, median pH, [H+] concentrations and nocturnal acid breakthrough (NAB). Results were analyzed using linear mixed models and Wilks test comparing variances. Results 24-h median [IQ] percentages of time with gastric pH above 3 and 4 were higher with rabeprazole than omeprazole (46 [37–55] vs. 30 [15–55] %, 9 [5-11] % for placebo) but the differences did not reach statistical significance (p = 0.11 and 0.24, respectively). Median acid concentrations were significantly lower with rabeprazole than with omeprazole and placebo (22 [14–53] vs. 54 [19–130] and 95 [73–170] mmoles/l, p < 0.01) for all periods. The number of NAB was significantly lower with rabeprazole than with omeprazole (median 1 [1,2] vs. 2 [1-3], p = 0.04). Variances of 24-h data (pH above 3 and 4, median pH, [H+] concentrations) were significantly lower with rabeprazole than with omeprazole (p < 0.0001). Conclusions In asymptomatic obese subjects the gastric antisecretory response to a single dose of rabeprazole and omeprazole was strong and not significantly different between drugs despite a significantly more homogeneous response with rabeprazole. Trial registration ClinicalTrial.gov: NCT01136317 PMID:25027286

Effective Obesity Treatments

ERIC Educational Resources Information Center

Powell, Lynda H.; Calvin, James E., III; Calvin, James E., Jr.

2007-01-01

To curb the epidemic of obesity in the United States, revised Medicare policy allows support for efficacious obesity treatments. This review summarizes the evidence from rigorous randomized trials (9 lifestyle trials, 5 drug trials, and 2 surgical trials) on the efficacy and risk-benefit profile of lifestyle, drug, and surgical interventions aimed…

Combining insulin with metformin or an insulin secretagogue in non-obese patients with type 2 diabetes: 12 month, randomised, double blind trial

PubMed Central

Tarnow, Lise; Frandsen, Merete; Nielsen, Bente B; Hansen, Birgitte V; Pedersen, Oluf; Parving, Hans-Henrik; Vaag, Allan A

2009-01-01

Objectives To study the effect of insulin treatment in combination with metformin or an insulin secretagogue, repaglinide, on glycaemic regulation in non-obese patients with type 2 diabetes. Design Randomised, double blind, double dummy, parallel trial. Setting Secondary care in Denmark between 2003 and 2006. Participants Non-obese patients (BMI ≤27) with preserved beta cell function. Interventions After a four month run-in period with repaglinide plus metformin combination therapy, patients with a glycated haemoglobin (HbA1c) concentration of 6.5% or more were randomised to repaglinide 6 mg or metformin 2000 mg. All patients also received biphasic insulin aspart 70/30 (30% soluble insulin aspart and 70% intermediate acting insulin aspart) 6 units once a day before dinner for 12 months. Insulin dose was adjusted aiming for a fasting plasma glucose concentration of 4.0-6.0 mmol/l. The target of HbA1c concentration was less than 6.5%. Treatment was intensified to two or three insulin injections a day if glycaemic targets were not reached. Main outcome measure HbA1c concentration. Results Of the 459 patients who were eligible, 102 were randomised, and 97 completed the trial. Patients had had type 2 diabetes for approximately 10 years. At the end of treatment, HbA1c concentration was reduced by a similar amount in the two treatment groups (insulin plus metformin: mean (standard deviation) HbA1c 8.15% (1.32) v 6.72% (0.66); insulin plus repaglinide: 8.07% (1.49) v 6.90% (0.68); P=0.177). Total daily insulin dose and risk of hypoglycaemia were also similar in the two treatment groups. Weight gain was less with metformin plus biphasic insulin aspart 70/30 than with repaglinide plus biphasic insulin aspart 70/30 (difference in mean body weight between treatments −2.51 kg, 95% confidence interval −4.07 to −0.95). Conclusions In non-obese patients with type 2 diabetes and poor glycaemic regulation on oral hypoglycaemic agents, overall glycaemic regulation with

Comparing cognitive behavioural therapy for eating disorders integrated with behavioural weight loss therapy to cognitive behavioural therapy-enhanced alone in overweight or obese people with bulimia nervosa or binge eating disorder: study protocol for a randomised controlled trial.

PubMed

Palavras, Marly Amorim; Hay, Phillipa; Touyz, Stephen; Sainsbury, Amanda; da Luz, Felipe; Swinbourne, Jessica; Estella, Nara Mendes; Claudino, Angélica

2015-12-18

that aims to assist weight management in people with co-morbid overweight or obesity bulimia nervosa as well as with binge eating disorder. It will have the potential to improve health outcomes for the rapidly increasing number of adults with co-morbid obesity and binge eating disorder or bulimia nervosa. US National Institutes of Health clinical trial registration number NCT02464345 , date of registration 1 June 2015.

Can early weight loss, eating behaviors and socioeconomic factors predict successful weight loss at 12- and 24-months in adolescents with obesity and insulin resistance participating in a randomised controlled trial?

PubMed

Gow, Megan L; Baur, Louise A; Ho, Mandy; Chisholm, Kerryn; Noakes, Manny; Cowell, Chris T; Garnett, Sarah P

2016-04-01

Lifestyle interventions in adolescents with obesity can result in weight loss following active intervention but individual responses vary widely. This study aimed to identify predictors of weight loss at 12- and 24-months in adolescents with obesity and clinical features of insulin resistance. Adolescents (n = 111, 66 girls, aged 10-17 years) were participants in a randomised controlled trial, the RESIST study, examining the effects of two diets differing in macronutrient content on insulin sensitivity. Eighty-five completed the 12-month program and 24-month follow-up data were available for 42 adolescents. Change in weight was determined by BMI expressed as a percentage of the 95th percentile (BMI95). The study physician collected socioeconomic data at baseline. Physical activity and screen time, and psychological dimensions of eating behavior were self-reported using the validated CLASS and EPI-C questionnaires, respectively. Stepwise multiple regressions were conducted to identify models that best predicted change in BMI95 at 12- and 24-months. Mean BMI95 was reduced at 12-months compared with baseline (mean difference [MD] ± SE: -6.9 ± 1.0, P < 0.001) but adolescents had significant re-gain from 12- to 24-months (MD ± SE: 3.7 ± 1.5, P = 0.017). Participants who achieved greater 12-month weight loss had: greater 3-month weight loss, a father with a higher education, lower baseline external eating and parental pressure to eat scores and two parents living at home. Participants who achieved greater 24-month weight loss had: greater 12-month weight loss and a lower baseline emotional eating score. Early weight loss is consistently identified as a strong predictor of long-term weight loss. This could be because early weight loss identifies those more motivated and engaged individuals. Patients who have baseline factors predictive of long-term weight loss failure may benefit from additional support during the intervention. Additionally

Beating-heart registration for organ-mounted robots.

PubMed

Wood, Nathan A; Schwartzman, David; Passineau, Michael J; Moraca, Robert J; Zenati, Marco A; Riviere, Cameron N

2018-03-06

Organ-mounted robots address the problem of beating-heart surgery by adhering to the heart, passively providing a platform that approaches zero relative motion. Because of the quasi-periodic deformation of the heart due to heartbeat and respiration, registration must address not only spatial registration but also temporal registration. Motion data were collected in the porcine model in vivo (N = 6). Fourier series models of heart motion were developed. By comparing registrations generated using an iterative closest-point approach at different phases of respiration, the phase corresponding to minimum registration distance is identified. The spatiotemporal registration technique presented here reduces registration error by an average of 4.2 mm over the 6 trials, in comparison with a more simplistic static registration that merely averages out the physiological motion. An empirical metric for spatiotemporal registration of organ-mounted robots is defined and demonstrated using data from animal models in vivo. Copyright © 2018 John Wiley & Sons, Ltd.

Optimizing image registration and infarct definition in stroke research.

PubMed

Harston, George W J; Minks, David; Sheerin, Fintan; Payne, Stephen J; Chappell, Michael; Jezzard, Peter; Jenkinson, Mark; Kennedy, James

2017-03-01

Accurate representation of final infarct volume is essential for assessing the efficacy of stroke interventions in imaging-based studies. This study defines the impact of image registration methods used at different timepoints following stroke, and the implications for infarct definition in stroke research. Patients presenting with acute ischemic stroke were imaged serially using magnetic resonance imaging. Infarct volume was defined manually using four metrics: 24-h b1000 imaging; 1-week and 1-month T2-weighted FLAIR; and automatically using predefined thresholds of ADC at 24 h. Infarct overlap statistics and volumes were compared across timepoints following both rigid body and nonlinear image registration to the presenting MRI. The effect of nonlinear registration on a hypothetical trial sample size was calculated. Thirty-seven patients were included. Nonlinear registration improved infarct overlap statistics and consistency of total infarct volumes across timepoints, and reduced infarct volumes by 4.0 mL (13.1%) and 7.1 mL (18.2%) at 24 h and 1 week, respectively, compared to rigid body registration. Infarct volume at 24 h, defined using a predetermined ADC threshold, was less sensitive to infarction than b1000 imaging. 1-week T2-weighted FLAIR imaging was the most accurate representation of final infarct volume. Nonlinear registration reduced hypothetical trial sample size, independent of infarct volume, by an average of 13%. Nonlinear image registration may offer the opportunity of improving the accuracy of infarct definition in serial imaging studies compared to rigid body registration, helping to overcome the challenges of anatomical distortions at subacute timepoints, and reducing sample size for imaging-based clinical trials.

Randomized trial of an obesity prevention intervention that embeds weight-related messages within a general parenting program

PubMed Central

Haines, Jess; Rifas-Shiman, Sheryl L.; Gross, Deborah; McDonald, Julia; Kleinman, Ken; Gillman, Matthew W.

2016-01-01

Objective To assess the extent to which an obesity prevention intervention that embeds obesity-related messages within a parenting program, compared with controls who received weekly mailings, resulted in a smaller increase in children’s BMI (primary outcome) and improvements in weight-related behaviors from baseline to 9-month follow-up. Methods We randomized 56 families to the intervention and 56 to control. Children were primarily Hispanic (58%) or Black/African American (23%). Intervention included 9, weekly: 1) group parenting sessions, 2) children’s program, and 3) homework assignments. At baseline, post-intervention, and 9-month follow-up, staff assessed children’s weight and height. Parents completed surveys assessing parenting skills, feeding behaviors, and children’s weight-related behaviors. Results From baseline to 9-month follow-up, BMI decreased by a mean of 0.13 kg/m2 among children in the intervention and increased by 0.21 kg/m2 among children in the control, resulting in a non-significant difference (multivariate adjusted difference =−0.36; 95% confidence interval [CI] −1.23, 0.51; P=0.41). Parents in the intervention decreased restrictive feeding practices relative to control (−0.30; 95% CI −0.53,−0.07; P=0.01). Intervention and control arms showed similar changes in children’s weight-related behaviors. Conclusions The intervention improved restrictive feeding, but did not influence children’s BMI or weight-related behaviors compared to controls who received weekly mailings. Trial Registration NCT02222766 PMID:26638185

Study protocol: effects of the THAO-child health intervention program on the prevention of childhood obesity - The POIBC study

PubMed Central

2014-01-01

Background The speeding increase and the high prevalence of childhood obesity is a serious problem for Public Health. Community Based Interventions has been developed to combat against the childhood obesity epidemic. However little is known on the efficacy of these programs. Therefore, there is an urgent need to determine the effect of community based intervention on changes in lifestyle and surrogate measures of adiposity. Methods/design Parallel intervention study including two thousand 2249 children aged 8 to 10 years ( 4th and 5th grade of elementary school) from 4 Spanish towns. The THAO-Child Health Program, a community based intervention, were implemented in 2 towns. Body weight, height, and waist circumferences were measured. Children recorded their dietary intake on a computer-based 24h recall. All children also completed validated computer based questionnaires to estimate physical activity, diet quality, eating behaviors, and quality of life and sleep. Additionally, parental diet quality and physical activity were assessed by validated questionnaires. Discussion This study will provide insight in the efficacy of the THAO-Child Health Program to promote a healthy lifestyle. Additionally it will evaluate if lifestyle changes are accompanied by favorable weight management. Trial registration Trial Registration Number ISRCTN68403446 PMID:25174356

Micronutrient deficiency in obese subjects undergoing low calorie diet

PubMed Central

2012-01-01

and unbalanced dispersal of lipophilic compounds in the body. Trial registration The study was registered at ClinicalTrials.gov (NCT01344525). The study protocol comprises only a part of the approved trial protocol. PMID:22657586

Effects of a Worksite Weight-Control Programme in Obese Male Workers: A Randomized Controlled Crossover Trial

ERIC Educational Resources Information Center

Iriyama, Yae; Murayama, Nobuko

2014-01-01

Objective: We conducted a randomized controlled crossover trial to evaluate the effects of a new worksite weight-control programme designed for men with or at risk of obesity using a combination of nutrition education and nutrition environmental interventions. Subjects and methods: Male workers with or at risk of obesity were recruited for this…

Hip-Hop to Health Jr. Obesity Prevention Effectiveness Trial: postintervention results.

PubMed

Fitzgibbon, Marian L; Stolley, Melinda R; Schiffer, Linda A; Braunschweig, Carol L; Gomez, Sandra L; Van Horn, Linda; Dyer, Alan R

2011-05-01

The preschool years offer an opportunity to interrupt the trajectory toward obesity in black children. The Hip-Hop to Health Jr. Obesity Prevention Effectiveness Trial was a group-randomized controlled trial assessing the feasibility and effectiveness of a teacher-delivered weight control intervention for black preschool children. The 618 participating children were enrolled in 18 schools administered by the Chicago Public Schools. Children enrolled in the nine schools randomized to the intervention group received a 14-week weight control intervention delivered by their classroom teachers. Children in the nine control schools received a general health intervention. Height and weight, physical activity, screen time, and diet data were collected at baseline and postintervention. At postintervention, children in the intervention schools engaged in more moderate-to-vigorous physical activity (MVPA) than children in the control schools (difference between adjusted group means = 7.46 min/day, P = 0.02). Also, children in the intervention group had less total screen time (-27.8 min/day, P = 0.05). There were no significant differences in BMI, BMI Z score, or dietary intake. It is feasible to adapt an obesity prevention program to be taught by classroom teachers. The intervention showed positive influences on physical activity and screen time, but not on diet. Measuring diet and physical activity in preschool children remains a challenge, and interventions delivered by classroom teachers require both intensive initial training and ongoing individualized supervision.

A pivotal registration phase III, multicenter, randomized tuberculosis controlled trial: design issues and lessons learnt from the Gatifloxacin for TB (OFLOTUB) project.

PubMed

Merle, Corinne S C; Sismanidis, Charalambos; Sow, Oumou Bah; Gninafon, Martin; Horton, John; Lapujade, Olivier; Lo, Mame Bocar; Mitchinson, Denis A; Perronne, Christian; Portaels, Francoise; Odhiambo, Joseph; Olliaro, Piero; Rustomjee, Roxana; Lienhardt, Christian; Fielding, Katherine

2012-05-18

There have been no major advances in tuberculosis (TB) drug development since the first East African/British Medical Research Council short course chemotherapy trial 35 years ago. Since then, the landscape for conducting TB clinical trials has profoundly changed with the emergence of HIV infection, the spread of resistant TB bacilli strains, recent advances in mycobacteriological capacity, and drug discovery. As a consequence questions have arisen on the most appropriate approach to design and conduct current TB trials. To highlight key issues discussed: Is a superiority, equivalence, or non-inferiority design most appropriate? What should be the primary efficacy outcome? How to consider re-infections in the definition of the outcome? What is the optimal length of patient follow-up? Is blinding appropriate when treatment duration in test arm is shorter? What are the appropriate assumptions for sample size calculation? Various drugs are currently in the development pipeline. We are presenting in this paper the design of the most recently completed phase III TB trial, the OFLOTUB project, which is the pivotal trial of a registration portfolio for a gatifloxacin-containing TB regimen. It is a randomized, open-label, multicenter, controlled trial aiming to evaluate the efficacy and safety of a gatifloxacin-containing 4-month regimen (trial registration: ClinicalTrial.gov database: NCT00216385). In the light of the recent scientific and regulatory discussions, we discuss some of the design issues in TB clinical trials and more specifically the reasons that guided our choices, in order to best answer the trial objectives, while at the same time satisfying regulatory authority requirements. When shortening TB treatment, we are advocating for a non-inferiority, non-blinded design, with a composite unfavorable endpoint assessed 12 months post treatment completion, and added trial procedures specifically aiming to: (1) minimize endpoint unavailability; and (2) distinguish

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

Educational interventions in childhood obesity: a systematic review with meta-analysis of randomized clinical trials.

PubMed

Sbruzzi, Graciele; Eibel, Bruna; Barbiero, Sandra M; Petkowicz, Rosemary O; Ribeiro, Rodrigo A; Cesa, Claudia C; Martins, Carla C; Marobin, Roberta; Schaan, Camila W; Souza, Willian B; Schaan, Beatriz D; Pellanda, Lucia C

2013-05-01

To assess the effectiveness of educational interventions including behavioral modification, nutrition and physical activity to prevent or treat childhood obesity through a systematic review and meta-analysis of randomized trials. A search of databases (PubMed, EMBASE and Cochrane CENTRAL) and references of published studies (from inception until May 2012) was conducted. Eligible studies were randomized trials enrolling children 6 to 12 years old and assessing the impact of educational interventions during 6 months or longer on waist circumference, body mass index (BMI), blood pressure and lipid profile to prevent or treat childhood obesity. Calculations were performed using a random effects method and pooled-effect estimates were obtained using the final values. Of 22.852 articles retrieved, 26 trials (23.617 participants) were included. There were no differences in outcomes assessed in prevention studies. However, in treatment studies, educational interventions were associated with a significant reduction in waist circumference [-3.21 cm (95%CI -6.34, -0.07)], BMI [-0.86 kg/m(2) (95%CI -1.59, -0.14)] and diastolic blood pressure [-3.68 mmHg (95%CI -5.48, -1.88)]. Educational interventions are effective in treatment, but not prevention, of childhood obesity and its consequences. Copyright © 2013 Elsevier Inc. All rights reserved.

Childhood obesity prevention in rural settings: background, rationale, and study design of ‘4-Health,’ a parent-only intervention

PubMed Central

2012-01-01

Background Childhood obesity in rural communities is a serious but understudied problem. The current experiment aims to assess a wide range of obesity risk factors among rural youth and to offer an 8-month intervention program for parents to reduce obesity risk in their preteen child. Methods/Design A two-group, repeated measures design is used to assess the effectiveness of the 4-Health intervention program. Assessments include anthropometric measures, child self-evaluations, parent self-evaluations, and parent evaluations of child. County Extension agents from 21 rural Montana counties recruit approximately 150 parent–child dyads and counties are semi-randomly assigned to the active intervention group (4-Health Educational Program) or a “best-practices” (Healthy Living Information) control group. Discussion This study will shed light on the effectiveness of this parent-only intervention strategy in reducing obesity risk factors among rural preteens. The 4-Health program is designed to provide information and skills development for busy rural parents that will increase healthy lifestyles of their preteen children and improve the parents’ ability to intervene effectively in the lives of their families during this critical developmental period. Trial registration ClinicalTrials.gov ID: NCT01510587 PMID:22471650

The effectiveness of nutrition education for overweight/obese mothers with stunted children (NEO-MOM) in reducing the double burden of malnutrition in Indonesia: study protocol for a randomized controlled trial.

PubMed

Mahmudiono, Trias; Nindya, Triska Susila; Andrias, Dini Ririn; Megatsari, Hario; Rosenkranz, Richard R

2016-06-08

Nutrition transition in developing countries were induced by rapid changes in food patterns and nutrient intake when populations adopt modern lifestyles during economic and social development, urbanization and acculturation. Consequently, these countries suffer from the double burden of malnutrition, consisting of unresolved undernutrition and the rise of overweight/obesity. The prevalence of the double burden of malnutrition tends to be highest for moderate levels (third quintile) of socioeconomic status. Evidence suggests that modifiable factors such as intra-household food distribution and dietary diversity are associated with the double burden of malnutrition, given household food security. This article describes the study protocol of a behaviorally based nutrition education intervention for overweight/obese mothers with stunted children (NEO-MOM) in reducing the double burden of malnutrition. NEO-MOM is a randomized controlled trial with a three-month behavioral intervention for households involving pairs of 72 stunted children aged 2-5 years old and overweight/obese mothers (SCOWT) in urban Indonesia. The SCOWT pairs were randomly assigned to either an intervention group or to a comparison group that received usual care plus printed educational materials. The intervention consisted of six classroom sessions on nutrition education and home visits performed by trained community health workers using a motivational interviewing approach. The primary outcomes of this study are the prevalence of double burden of malnutrition as measured in SCOWT, child's height-for-age z-score (HAZ) and maternal body mass index (BMI). Because previous studies are mainly observational in nature, this study advances understanding of the double burden of malnutrition through a fully powered randomized controlled trial. The intervention assists participants in self-administered goal setting to improve diet and child feeding behaviors by improving self-efficacy. Maternal self

Effectiveness of a childhood obesity prevention programme delivered through schools, targeting 6 and 7 year olds: cluster randomised controlled trial (WAVES study)

PubMed Central

Pallan, Miranda J; Lancashire, Emma R; Hemming, Karla; Frew, Emma; Barrett, Tim; Bhopal, Raj; Cade, Janet E; Canaway, Alastair; Clarke, Joanne L; Daley, Amanda; Deeks, Jonathan J; Duda, Joan L; Ekelund, Ulf; Gill, Paramjit; Griffin, Tania; McGee, Eleanor; Hurley, Kiya; Martin, James; Parry, Jayne; Passmore, Sandra; Cheng, K K

2018-01-01

z score was non-significantly lower in the intervention arm compared with the control arm at 15 months (mean difference −0.075 (95% confidence interval −0.183 to 0.033, P=0.18) in the baseline adjusted models. At 30 months the mean difference was −0.027 (−0.137 to 0.083, P=0.63). There was no statistically significant difference between groups for other anthropometric, dietary, physical activity, or psychological measurements (including assessment of harm). Conclusions The primary analyses suggest that this experiential focused intervention had no statistically significant effect on BMI z score or on preventing childhood obesity. Schools are unlikely to impact on the childhood obesity epidemic by incorporating such interventions without wider support across multiple sectors and environments. Trial registration Current Controlled Trials ISRCTN97000586. PMID:29437667

Obesity susceptibility loci and dietary intake in the Look AHEAD Trial.

PubMed

McCaffery, Jeanne M; Papandonatos, George D; Peter, Inga; Huggins, Gordon S; Raynor, Hollie A; Delahanty, Linda M; Cheskin, Lawrence J; Balasubramanyam, Ashok; Wagenknecht, Lynne E; Wing, Rena R

2012-06-01

Genome-wide association studies (GWAS) have identified consistent associations with obesity. However, the mechanisms remain unclear. The objective was to determine the association between obesity susceptibility loci and dietary intake. The association of GWAS-identified obesity risk alleles (FTO, MC4R, SH2B1, BDNF, INSIG2, TNNI3K, NISCH-STAB1, MTIF3, MAP2K5, QPCTL/GIPR, and PPARG) with dietary intake, measured through food-frequency questionnaires, was investigated in 2075 participants from the Look AHEAD (Action for Health in Diabetes) clinical trial. We adjusted for age, sex, population stratification, and study site. Obesity risk alleles at FTO rs1421085 significantly predicted more eating episodes per day (P = 0.001)-an effect that persisted after adjustment for body weight (P = 0.004). Risk variants within BDNF were significantly associated with more servings from the dairy product and the meat, eggs, nuts, and beans food groups (P ≤ 0.004). The risk allele at SH2B1 rs4788099 was significantly associated with more servings of dairy products (P = 0.001), whereas the risk allele at TNNI3K rs1514176 was significantly associated with a lower percentage of energy from protein (P = 0.002). These findings suggest that obesity risk loci may affect the pattern and content of food consumption among overweight or obese individuals with type 2 diabetes. The Look AHEAD Genetic Ancillary Study was registered at clinicaltrials.gov as NCT01270763 and the Look AHEAD study as NCT00017953.

[Clinical trials registry].

PubMed

Ryder, Elena

2004-12-01

Authors and journals are more enthusiastic about the publication of trials with positive results than those negative or inconclusive trials. The International Committee of Medical Journal Editors proposed comprehensive trials registration as a solution to the problem of selective awareness and announces that the ICMJE member journals will adopt a trial-registration policy to promote this goal. They establish as a condition of consideration for publication, registration in a public trials registry. They recommend registries that meet certain criteria as www.clinicaltrials.com. Among those criteria is that the registry must be supported by a non-profit organization. On the other hand, people from Current Controlled Trials Ltd. being a commercial company, but meeting all the other criteria established by the ICMJE, feel that is being put aside. We wonder if clinical trials in our country are being registered in some of these International Registries. If not, would it be time to do so?

Randomized controlled trial of a good practice approach to treatment of childhood obesity in Malaysia: Malaysian Childhood Obesity Treatment Trial (MASCOT).

PubMed

Wafa, Sharifah W; Talib, Ruzita A; Hamzaid, Nur H; McColl, John H; Rajikan, Roslee; Ng, Lai O; Ramli, Ayiesah H; Reilly, John J

2011-06-01

Few randomized controlled trials (RCTs) of interventions for the treatment of childhood obesity have taken place outside the Western world. To test whether a good practice intervention for the treatment of childhood obesity would have a greater impact on weight status and other outcomes than a control condition in Kuala Lumpur, Malaysia. Assessor-blinded RCT of a treatment intervention in 107 obese 7- to 11-year olds. The intervention was relatively low intensity (8 hours contact over 26 weeks, group based), aiming to change child sedentary behavior, physical activity, and diet using behavior change counselling. Outcomes were measured at baseline and six months after the start of the intervention. Primary outcome was BMI z-score, other outcomes were weight change, health-related quality of life (Peds QL), objectively measured physical activity and sedentary behavior (Actigraph accelerometry over 5 days). The intervention had no significant effect on BMI z score relative to control. Weight gain was reduced significantly in the intervention group compared to the control group (+1.5 kg vs. +3.5 kg, respectively, t-test p < 0.01). Changes in health-related quality of life and objectively measured physical activity and sedentary behavior favored the intervention group. Treatment was associated with reduced rate of weight gain, and improvements in physical activity and quality of life. More substantial benefits may require longer term and more intensive interventions which aim for more substantive lifestyle changes.

Effectiveness of a primary care-based intervention to reduce sitting time in overweight and obese patients (SEDESTACTIV): a randomized controlled trial; rationale and study design

PubMed Central

2014-01-01

intention to treat principle. Discussion If the SEDESTACTIV intervention shows its effectiveness in reducing sitting time, health professionals would have a low-cost intervention tool for sedentary overweight and obese patients management. Trial registration A service of the U.S. National Institutes of Health. Developed by the National Library of Medicine. ClinicalTrials.gov NCT01729936 PMID:24597534

Impact of the 5As Team study on clinical practice in primary care obesity management: a qualitative study

PubMed Central

Asselin, Jodie; Salami, Eniola; Osunlana, Adedayo M.; Ogunleye, Ayodele A.; Cave, Andrew; Johnson, Jeffrey A.; Sharma, Arya M.; Campbell-Scherer, Denise L.

2017-01-01

Background: The 5As [Ask, Assess, Advise, Agree, Assist] of Obesity Management Team study was a randomized controlled trial of an intervention that was implemented and evaluated to help primary care providers improve clinical practice for obesity management. This paper presents health care provider perspectives of the impacts of the intervention on individual provider and team practices. Methods: This study reports a thematic network analysis of qualitative data collected during the 5As Team study, which involved 24 chronic disease teams affiliated with family practices in a Primary Care Network in Alberta. Qualitative data from 28 primary care providers (registered nurses/nurse practitioners [n = 14], dietitians [n = 7] and mental health workers [n = 7]) in the intervention arm were collected through semistructured interviews, field notes, practice facilitator diaries and 2 evaluation workshop questionnaires. Results: Providers internalized 5As Team intervention concepts, deepening self-evaluation and changing clinical reasoning around obesity. Providers perceived that this internalization changed the provider-patient relationship positively. The intervention changed relations between providers, increasing interdisciplinary understanding, collaboration and discovery of areas for improvement. This personal and interpersonal evolution effected change to the entire Primary Care Network. Interpretation: The 5As Team intervention had multiple impacts on providers and teams to improve obesity management in primary care. Improved provider confidence and capability is a precondition of developing effective patient interventions. Trial registration: ClinicalTrials.gov, no.: NCT01967797. PMID:28450428

Integrating a family-focused approach into child obesity prevention: Rationale and design for the My Parenting SOS study randomized control trial

PubMed Central

2011-01-01

Background More than 20% of US children ages 2-5 yrs are classified as overweight or obese. Parents greatly influence the behaviors their children adopt, including those which impact weight (e.g., diet and physical activity). Unfortunately, parents often fail to recognize the risk for excess weight gain in young children, and may not be motivated to modify behavior. Research is needed to explore intervention strategies that engage families with young children and motivate parents to adopt behaviors that will foster healthy weight development. Methods This study tests the efficacy of the 35-week My Parenting SOS intervention. The intervention consists of 12 sessions: initial sessions focus on general parenting skills (stress management, effective parenting styles, child behavior management, coparenting, and time management) and later sessions apply these skills to promote healthier eating and physical activity habits. The primary outcome is change in child percent body fat. Secondary measures assess parent and child dietary intake (three 24-hr recalls) and physical activity (accelerometry), general parenting style and practices, nutrition- and activity-related parenting practices, and parent motivation to adopt healthier practices. Discussion Testing of these new approaches contributes to our understanding of how general and weight-specific parenting practices influence child weight, and whether or not they can be changed to promote healthy weight trajectories. Trial Registration ClinicalTrials.gov: NCT00998348 PMID:21639940

Adaptation and dissemination of an evidence-based obesity prevention intervention: design of a comparative effectiveness trial.

PubMed

Buscemi, Joanna; Odoms-Young, Angela; Stolley, Melinda L; Blumstein, Lara; Schiffer, Linda; Berbaum, Michael L; McCaffrey, Jennifer; Montoya, Anastasia McGee; Braunschweig, Carol; Fitzgibbon, Marian L

2014-07-01

Low-income youth are at increased risk for excess weight gain. Although evidence-based prevention programs exist, successful adaptation to provide wide dissemination presents a challenge. Hip-Hop to Health (HH) is a school-based obesity prevention intervention that targets primarily preschool children of low-income families. In a large randomized controlled trial, HH was found to be efficacious for prevention of excessive weight gain. The Expanded Food and Nutrition Education Program (EFNEP) and the Supplemental Nutrition Assistance Program-Education (SNAP-Ed) are USDA-funded nutrition education programs offered to low-income families, and may provide an ideal platform for the wide dissemination of evidence-based obesity prevention programs. A research-practice partnership was established in order to conduct formative research to guide the adaptation and implementation of HH through EFNEP and SNAP-Ed. We present the design and method of a comparative effectiveness trial that will determine the efficacy of HH when delivered by peer educators through these programs compared to the standard EFNEP and SNAP-Ed nutrition education (NE) curriculum. Results from this trial will inform larger scale dissemination. The dissemination of HH through government programs has the potential to increase the reach of efficacious obesity prevention programs that target low-income children and families. Copyright © 2014 Elsevier Inc. All rights reserved.

Adaptation and Dissemination of an Evidence-Based Obesity Prevention Intervention: Design of a Comparative Effectiveness Trial

PubMed Central

Buscemi, Joanna; Odoms-Young, Angela; Stolley, Melinda L.; Blumstein, Lara; Schiffer, Linda; Berbaum, Michael L.; McCaffrey, Jennifer; Montoya, Anastasia McGee; Braunschweig, Carol; Fitzgibbon, Marian L.

2014-01-01

Low-income youth are at increased risk for excess weight gain. Although evidence-based prevention programs exist, successful adaptation to provide wide dissemination presents a challenge. Hip-Hop to Health (HH) is a school-based obesity prevention intervention that targets primarily preschool children of low-income families. In a large randomized controlled trial, HH was found to be efficacious for prevention of excessive weight gain. The Expanded Food and Nutrition Education Program (EFNEP) and the Supplemental Nutrition Assistance Program--Education (SNAP-Ed) are USDA-funded nutrition education programs offered to low-income families, and may provide an ideal platform for the wide dissemination of evidence-based obesity prevention programs. A research-practice partnership was established in order to conduct formative research to guide the adaptation and implementation of HH through EFNEP and SNAP-Ed. We present the design and method of a comparative effectiveness trial that will determine the efficacy of HH when delivered by peer educators through these programs compared to the standard EFNEP and SNAP-Ed nutrition education (NE) curriculum. Results from this trial will inform larger scale dissemination. The dissemination of HH through government programs has the potential to increase the reach of efficacious obesity prevention programs that target low-income children and families. PMID:24952282

Recommendations for Obesity Clinical Trials in Cancer Survivors: American Society of Clinical Oncology Statement.

PubMed

Ligibel, Jennifer A; Alfano, Catherine M; Hershman, Dawn; Ballard, Rachel M; Bruinooge, Suanna S; Courneya, Kerry S; Daniels, Elvan C; Demark-Wahnefried, Wendy; Frank, Elizabeth S; Goodwin, Pamela J; Irwin, Melinda L; Levit, Laura A; McCaskill-Stevens, Worta; Minasian, Lori M; O'Rourke, Mark A; Pierce, John P; Stein, Kevin D; Thomson, Cynthia A; Hudis, Clifford A

2015-11-20

Observational evidence has established a relationship between obesity and cancer risk and outcomes. Interventional studies have demonstrated the feasibility and benefits of lifestyle change after cancer diagnosis, and guidelines recommend weight management and regular physical activity in cancer survivors; however, lifestyle interventions are not a routine part of cancer care. The ASCO Research Summit on Advancing Obesity Clinical Trials in Cancer Survivors sought to identify the knowledge gaps that clinical trials addressing energy balance factors in cancer survivors have not answered and to develop a roadmap for the design and implementation of studies with the potential to generate data that could lead to the evidence-based incorporation of weight management and physical activity programs into standard oncology practice. Recommendations highlight the need for large-scale trials evaluating the impact of energy balance interventions on cancer outcomes, as well as the concurrent conduct of studies focused on dissemination and implementation of interventions in diverse populations of cancer survivors, including answering critical questions about the degree of benefit in key subgroups of survivors. Other considerations include the importance of incorporating economic metrics into energy balance intervention trials, the need to establish intermediate biomarkers, and the importance of integrating traditional and nontraditional funding sources. Establishing lifestyle change after cancer diagnosis as a routine part of cancer care will require a multipronged effort to overcome barriers related to study development, funding, and stakeholder engagement. Given the prevalence of obesity and inactivity in cancer survivors in the United States and elsewhere, energy balance interventions hold the potential to reduce cancer morbidity and mortality in millions of patients, and it is essential that we move forward in determining their role in cancer care with the same care and

Hip-Hop to Health Jr. Obesity Prevention Effectiveness Trial: Post-Intervention Results

PubMed Central

Fitzgibbon, M. L.; Stolley, M. R.; Schiffer, L.; Braunschweig, C. L.; Gomez, S. L.; Van Horn, L.; Dyer, A.

2013-01-01

The preschool years offer an opportunity to interrupt the trajectory toward obesity in black children. The Hip-Hop to Health Jr. Obesity Prevention Effectiveness Trial was a group-randomized controlled trial assessing the feasibility and effectiveness of a teacher-delivered weight control intervention for black preschool children. The 618 participating children were enrolled in 18 schools administered by the Chicago Public Schools. Children enrolled in the 9 schools randomized to the intervention group received a 14-week weight control intervention delivered by their classroom teachers. Children in the 9 control schools received a general health intervention. Height and weight, physical activity, screen time, and diet data were collected at baseline and post-intervention. At post-intervention, children in the intervention schools engaged in more moderate-to vigorous physical activity than children in the control schools (difference between adjusted group means=7.46 min/day, p=.02). Also, children in the intervention group had less total screen time (−27.8 min/day, p=.05). There were no significant differences in BMI, BMI Z score, or dietary intake. It is feasible to adapt an obesity prevention program to be taught by classroom teachers. The intervention showed positive influences on physical activity and screen time, but not diet. Measuring diet and physical activity in preschool children remains a challenge, and interventions delivered by classroom teachers require both intensive initial training and ongoing individualized supervision. PMID:21193852

High-intensity interval training or continuous training, combined or not with fasting, in obese or overweight women with cardiometabolic risk factors: study protocol for a randomised clinical trial

PubMed Central

Van Bavel, Diogo; de Moraes, Roger; Tibiriça, Eduardo V

2018-01-01

Introduction Physical inactivity and increased caloric intake play important roles in the pathophysiology of obesity. Increasing physical activity and modifying eating behaviours are first-line interventions, frequently hampered by lack of time to exercise and difficulties in coping with different diets. High-intensity interval training (HIIT) may be a time-efficient method compared with moderate-intensity continuous training (CT). Conversely, diets with a fasting component may be more effective than other complex and restrictive diets, as it essentially limits caloric intake to a specified period without major diet composition changes. Therefore, the combination of HIIT and fasting may provide incremental benefits in terms of effectiveness and time efficiency in obese and sedentary populations. The aim of this study is to determine the effect of HIIT versus CT, combined or not with fasting, on microcirculatory function, cardiometabolic parameters, anthropometric indices, cardiorespiratory fitness and quality of life in a population of sedentary overweight or obese women with cardiometabolic risk factors. Methods and analysis Sedentary women aged 30–50 years, with a body mass index ≥25 kg/m2 and cardiometabolic risk factors, will be randomised to HIIT performed in the fasting state, HIIT performed in the fed state, CT in the fasting state or CT in the fed state. Cardiometabolic parameters, anthropometric indices, cardiorespiratory fitness, quality of life and microvascular function (cutaneous capillary density and microvascular reactivity evaluated by laser speckle contrast imaging) will be evaluated before initiation of the interventions and 16 weeks thereafter. Ethics and dissemination The trial complies with the Declaration of Helsinki and has been approved by the local ethics committee (Instituto Nacional de Cardiologia, Rio de Janeiro, Brazil). All patients provide written informed consent before enrolment and randomisation. The study’s results will be

Improving Self-Regulation for Obesity Prevention in Head Start: A Randomized Controlled Trial.

PubMed

Lumeng, Julie C; Miller, Alison L; Horodynski, Mildred A; Brophy-Herb, Holly E; Contreras, Dawn; Lee, Hannah; Sturza, Julie; Kaciroti, Niko; Peterson, Karen E

2017-05-01

To determine the effect of an intervention to improve emotional and behavioral self-regulation in combination with an obesity-prevention program on the prevalence of obesity and obesity-related behaviors in preschoolers. This was a cluster-randomized intervention trial in Head Start (HS) classrooms conducted in each of 4 academic years from 2011 to 2015. Participants (697 children; 49% boys; mean age: 4.1 ± 0.5 years; 48% white, 30% African American, 12% Hispanic) were randomly assigned by classroom to 1 of 3 intervention arms: (1) HS + Preschool Obesity Prevention Series (POPS) + Incredible Years Series (IYS) (HS enhanced by the POPS [program targeting evidence-based obesity-prevention behaviors] and the IYS [program to improve children's self-regulation]), (2) HS+POPS, or (3) HS. Primary outcomes were changes in prevalence of obesity, overweight/obesity, BMI z score, and teacher-reported child emotional and behavioral self-regulation; secondary outcomes were dietary intake, outdoor play, screen time, and parent nutrition knowledge and nutrition self-efficacy. HS+POPS+IYS improved teacher-reported self-regulation compared with HS+POPS ( P < .001) and HS ( P < .001), but there was no effect on the prevalence of obesity (16.4% preintervention to 14.3% postintervention in HS+POPS+IYS versus 17.3% to 14.4% in HS+POPS [ P = .54] versus 12.2% to 13.0% in HS [ P = .33]). There was no effect of HS+POPS compared with HS alone ( P = .16). There was no effect on other outcomes except for sugar-sweetened beverage intake (HS+POPS+IYS resulted in a greater decline than HS; P = .005). An intervention for parents and children to improve HS preschoolers' emotional and behavioral self-regulation in combination with an obesity-prevention curriculum did not reduce obesity prevalence or most obesity-related behaviors. Copyright © 2017 by the American Academy of Pediatrics.

Clinical trial registration, reporting, publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012

PubMed Central

Miller, Jennifer E; Korn, David; Ross, Joseph S

2015-01-01

Objective To evaluate clinical trial registration, reporting and publication rates for new drugs by: (1) legal requirements and (2) the ethical standard that all human subjects research should be publicly accessible to contribute to generalisable knowledge. Design Cross-sectional analysis of all clinical trials submitted to the Food and Drug Administration (FDA) for drugs approved in 2012, sponsored by large biopharmaceutical companies. Data sources Information from Drugs@FDA, ClinicalTrials.gov, MEDLINE-indexed journals and drug company communications. Main outcome measures Clinical trial registration and results reporting in ClinicalTrials.gov, publication in the medical literature, and compliance with the 2007 FDA Amendments Acts (FDAAA), analysed on the drug level. Results The FDA approved 15 drugs sponsored by 10 large companies in 2012. We identified 318 relevant trials involving 99 599 research participants. Per drug, a median of 57% (IQR 32–83%) of trials were registered, 20% (IQR 12–28%) reported results in ClinicalTrials.gov, 56% (IQR 41–83%) were published, and 65% (IQR 41–83%) were either published or reported results. Almost half of all reviewed drugs had at least one undisclosed phase II or III trial. Per drug, a median of 17% (IQR 8–20%) of trials supporting FDA approvals were subject to FDAAA mandated public disclosure; of these, a median of 67% (IQR 0–100%) were FDAAA-compliant. 68% of research participants (67 629 of 99 599) participated in FDAAA-subject trials, with 51% (33 405 of 67 629) enrolled in non-compliant trials. Transparency varied widely among companies. Conclusions Trial disclosures for new drugs remain below legal and ethics standards, with wide variation in practices among drugs and their sponsors. Best practices are emerging. 2 of our 10 reviewed companies disclosed all trials and complied with legal disclosure requirements for their 2012 approved drugs. Ranking new drugs on transparency criteria may improve

A pivotal registration phase III, multicenter, randomized tuberculosis controlled trial: design issues and lessons learnt from the Gatifloxacin for TB (OFLOTUB) project

PubMed Central

2012-01-01

Background There have been no major advances in tuberculosis (TB) drug development since the first East African/British Medical Research Council short course chemotherapy trial 35 years ago. Since then, the landscape for conducting TB clinical trials has profoundly changed with the emergence of HIV infection, the spread of resistant TB bacilli strains, recent advances in mycobacteriological capacity, and drug discovery. As a consequence questions have arisen on the most appropriate approach to design and conduct current TB trials. To highlight key issues discussed: Is a superiority, equivalence, or non-inferiority design most appropriate? What should be the primary efficacy outcome? How to consider re-infections in the definition of the outcome? What is the optimal length of patient follow-up? Is blinding appropriate when treatment duration in test arm is shorter? What are the appropriate assumptions for sample size calculation? Methods Various drugs are currently in the development pipeline. We are presenting in this paper the design of the most recently completed phase III TB trial, the OFLOTUB project, which is the pivotal trial of a registration portfolio for a gatifloxacin-containing TB regimen. It is a randomized, open-label, multicenter, controlled trial aiming to evaluate the efficacy and safety of a gatifloxacin-containing 4-month regimen (trial registration: ClinicalTrial.gov database: NCT00216385). Results In the light of the recent scientific and regulatory discussions, we discuss some of the design issues in TB clinical trials and more specifically the reasons that guided our choices, in order to best answer the trial objectives, while at the same time satisfying regulatory authority requirements. Conclusion When shortening TB treatment, we are advocating for a non-inferiority, non-blinded design, with a composite unfavorable endpoint assessed 12 months post treatment completion, and added trial procedures specifically aiming to: (1) minimize

Double-blind randomised controlled trial of the independent and synergistic effect of Spirulina maxima with exercise (ISESE) on general fitness, lipid profile and redox status in overweight and obese subjects: study protocol

PubMed Central

Hernández-Lepe, Marco Antonio; López-Díaz, José Alberto; de la Rosa, Laura Alejandra; Hernández-Torres, Rosa Patricia; Wall-Medrano, Abraham; Juarez-Oropeza, Marco Antonio; Pedraza-Chaverri, José; Urquidez-Romero, Rene; Ramos-Jiménez, Arnulfo

2017-01-01

Introduction In order to reduce cardiovascular disease risk factors, a healthy diet must include dietary antioxidants from different sources (eg, Spirulina maxima) and regular practice of exercise should be promoted. There is some evidence from animal studies that S. maxima and exercise decrease cardiovascular disease risks factors. However, very few studies have proved the independent or synergistic effect of S. maxima plus exercise in humans. This study attempts to address the independent and synergistic effects in overweight and obese subjects participating in a systematic physical exercise programme at moderate intensity on general fitness, plasma lipid profile and antioxidant capacity. Methods and analysis Using a randomised, double-blind, placebo-controlled, counterbalanced crossover study design, 80 healthy overweight and obese subjects will be evaluated during a 12-week isoenergetic diet accompanied by 4.5 g/day S. maxima intake and/or a physical systematic exercise programme at moderate intensity. Body composition, oxygen uptake, heart rate, capillary blood lactate, plasma concentrations of triacylglycerols, total, low-density and high-density lipoprotein cholesterol, antioxidant status, lipid oxidation, protein carbonyls, superoxide dismutase, catalase, glutathione, glutathione peroxidase, glutathione reductase and paraoxonase will be assessed. Ethics and dissemination This study and all the procedures have been approved by the Universidad Autonoma de Ciudad Juarez Bioethics Committee. Findings will be disseminated through peer-reviewed journals, national and international conferences. Trial registration number ClinicalTrials.gov: NCT02837666. PMID:28645949

Cost-effectiveness of Recruitment Methods in an Obesity Prevention Trial for Young Children

PubMed Central

Robinson, Jodie L.; Fuerch, Janene H.; Winiewicz, Dana D.; Salvy, Sarah J.; Roemmich, James N.; Epstein, Leonard H.

2007-01-01

Background Recruitment of participants for clinical trials requires considerable effort and cost. There is no research on the cost-effectiveness of recruitment methods for an obesity prevention trial of young children. Methods This study determined the cost-effectiveness of recruiting 70 families with a child aged 4 to 7 (5.9 ± 1.3) years in Western New York from February, 2003 to November, 2004, for a two year randomized obesity prevention trial to reduce television watching in the home. Results Of the 70 randomized families, 65.7% (n = 46) were obtained through direct mailings, 24.3% (n = 17) were acquired through newspaper advertisements, 7.1 % (n = 5) from other sources (e.g. word of mouth), and 2.9% (n = 2) through posters and brochures. Costs of each recruitment method were computed by adding the cost of materials, staff time, and media expenses. Cost-effectiveness (money spent per randomized participant) was US $0 for other sources, US $227.76 for direct mailing, US $546.95 for newspaper ads, and US $3,020.84 for posters and brochures. Conclusion Of the methods with associated costs, direct mailing was the most cost effective in recruiting families with young children, which supports the growing literature of the effectiveness of direct mailing. PMID:17475318

Cost effectiveness of recruitment methods in an obesity prevention trial for young children.

PubMed

Robinson, Jodie L; Fuerch, Janene H; Winiewicz, Dana D; Salvy, Sarah J; Roemmich, James N; Epstein, Leonard H

2007-06-01

Recruitment of participants for clinical trials requires considerable effort and cost. There is no research on the cost effectiveness of recruitment methods for an obesity prevention trial of young children. This study determined the cost effectiveness of recruiting 70 families with a child aged 4 to 7 (5.9+/-1.3) years in Western New York from February 2003 to November 2004, for a 2-year randomized obesity prevention trial to reduce television watching in the home. Of the 70 randomized families, 65.7% (n=46) were obtained through direct mailings, 24.3% (n=17) were acquired through newspaper advertisements, 7.1% (n=5) from other sources (e.g., word of mouth), and 2.9% (n=2) through posters and brochures. Costs of each recruitment method were computed by adding the cost of materials, staff time, and media expenses. Cost effectiveness (money spent per randomized participant) was US $0 for other sources, US $227.76 for direct mailing, US $546.95 for newspaper ads, and US $3,020.84 for posters and brochures. Of the methods with associated costs, direct mailing was the most cost effective in recruiting families with young children, which supports the growing literature of the effectiveness of direct mailing.

The Effects of Industry Sponsorship on Comparator Selection in Trial Registrations for Neuropsychiatric Conditions in Children

PubMed Central

Dunn, Adam G.; Mandl, Kenneth D.; Coiera, Enrico; Bourgeois, Florence T.

2013-01-01

Pediatric populations continue to be understudied in clinical drug trials despite the increasing use of pharmacotherapy in children, particularly with psychotropic drugs. Most pertinent to the clinical selection of drug interventions are trials directly comparing drugs against other drugs. The aim was to measure the prevalence of active drug comparators in neuropsychiatric drug trials in children and identify the effects of funding source on comparator selection. We analyzed the selection of drugs and drug comparisons in clinical trials registered between January 2006 and May 2012. Completed and ongoing interventional trials examining treatments for six neuropsychiatric conditions in children were included. Networks of drug comparisons for each condition were constructed using information about the trial study arms. Of 421 eligible trial registrations, 228 (63,699 participants) were drug trials addressing ADHD (106 trials), autism spectrum disorders (47), unipolar depression (16), seizure disorders (38), migraines and other headaches (15), or schizophrenia (11). Active drug comparators were used in only 11.0% of drug trials while 44.7% used a placebo control and 44.3% no drug or placebo comparator. Even among conditions with well-established pharmacotherapeutic options, almost all drug interventions were compared to a placebo. Active comparisons were more common among trials without industry funding (17% vs. 8%, p=0.04). Trials with industry funding differed from non-industry trials in terms of the drugs studied and the comparators selected. For 73% (61/84) of drugs and 90% (19/21) of unique comparisons, trials were funded exclusively by either industry or non-industry. We found that industry and non-industry differed when choosing comparators and active drug comparators were rare for both groups. This gap in pediatric research activity limits the evidence available to clinicians treating children and suggests a need to reassess the design and funding of pediatric

The effects of industry sponsorship on comparator selection in trial registrations for neuropsychiatric conditions in children.

PubMed

Dunn, Adam G; Mandl, Kenneth D; Coiera, Enrico; Bourgeois, Florence T

2013-01-01

Pediatric populations continue to be understudied in clinical drug trials despite the increasing use of pharmacotherapy in children, particularly with psychotropic drugs. Most pertinent to the clinical selection of drug interventions are trials directly comparing drugs against other drugs. The aim was to measure the prevalence of active drug comparators in neuropsychiatric drug trials in children and identify the effects of funding source on comparator selection. We analyzed the selection of drugs and drug comparisons in clinical trials registered between January 2006 and May 2012. Completed and ongoing interventional trials examining treatments for six neuropsychiatric conditions in children were included. Networks of drug comparisons for each condition were constructed using information about the trial study arms. Of 421 eligible trial registrations, 228 (63,699 participants) were drug trials addressing ADHD (106 trials), autism spectrum disorders (47), unipolar depression (16), seizure disorders (38), migraines and other headaches (15), or schizophrenia (11). Active drug comparators were used in only 11.0% of drug trials while 44.7% used a placebo control and 44.3% no drug or placebo comparator. Even among conditions with well-established pharmacotherapeutic options, almost all drug interventions were compared to a placebo. Active comparisons were more common among trials without industry funding (17% vs. 8%, p=0.04). Trials with industry funding differed from non-industry trials in terms of the drugs studied and the comparators selected. For 73% (61/84) of drugs and 90% (19/21) of unique comparisons, trials were funded exclusively by either industry or non-industry. We found that industry and non-industry differed when choosing comparators and active drug comparators were rare for both groups. This gap in pediatric research activity limits the evidence available to clinicians treating children and suggests a need to reassess the design and funding of pediatric

The risk of adverse pregnancy outcomes in women who are overweight or obese

PubMed Central

2010-01-01

Background The prevalence of obesity amongst women bearing children in Australia is rising and has important implications for obstetric care. The aim of this study was to assess the prevalence and impact of mothers being overweight and obese in early to mid-pregnancy on maternal, peripartum and neonatal outcomes. Methods A secondary analysis was performed on data collected from nulliparous women with a singleton pregnancy enrolled in the Australian Collaborative Trial of Supplements with antioxidants Vitamin C and Vitamin E to pregnant women for the prevention of pre-eclampsia (ACTS). Women were categorized into three groups according to their body mass index (BMI): normal (BMI 18.5-24.9 kg/m2); overweight (BMI 25-29.9 kg/m2) and; obese (BMI 30-34.9 kg/m2). Obstetric and perinatal outcomes were compared by univariate and multivariate analyses. Results Of the 1661 women included, 43% were overweight or obese. Obese women were at increased risk of pre-eclampsia (relative risk (RR) 2.99 [95% confidence intervals (CI) 1.88, 4.73], p < 0.0001) and gestational diabetes (RR 2.10 [95%CI 1.17, 3.79], p = 0.01) compared with women with a normal BMI. Obese and overweight women were more likely to be induced and require a caesarean section compared with women of normal BMI (induction - RR 1.33 [95%CI 1.13, 1.57], p = 0.001 and 1.78 [95%CI 1.51, 2.09], p < 0.0001, caesarean section - RR 1.42 [95%CI 1.18, 1.70], p = 0.0002 and 1.63 [95%CI 1.34, 1.99], p < 0.0001). Babies of women who were obese were more likely to be large for gestational age (LFGA) (RR 2.08 [95%CI 1.47, 2.93], p < 0.0001) and macrosomic (RR 4.54 [95%CI 2.01, 10.24], p = 0.0003) compared with those of women with a normal BMI. Conclusion The rate of overweight and obesity is increasing amongst the Australian obstetric population. Women who are overweight and obese have an increased risk of adverse pregnancy outcomes. In particular, obese women are at increased risk of gestational diabetes, pregnancy induced

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

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

Anthropometrics and Body Composition by Dual Energy X-Ray in Children of Obese Women: A Follow-Up of a Randomized Controlled Trial (the Lifestyle in Pregnancy and Offspring [LiPO] Study)

PubMed Central

Tanvig, Mette; Vinter, Christina A.; Jørgensen, Jan S.; Wehberg, Sonja; Ovesen, Per G.; Lamont, Ronald F.; Beck-Nielsen, Henning

2014-01-01

Objective In obese women, 1) to assess whether lower gestational weight gain (GWG) during pregnancy in the lifestyle intervention group of a randomized controlled trial (RCT) resulted in differences in offspring anthropometrics and body composition, and 2) to compare offspring outcomes to a reference group of children born to women with a normal Body Mass Index (BMI). Research design and methods The LiPO (Lifestyle in Pregnancy and Offspring) study was an offspring follow-up of a RCT with 360 obese pregnant women with a lifestyle intervention during pregnancy including dietary advice, coaching and exercise. The trial was completed by 301 women who were eligible for follow-up. In addition, to the children from the RCT, a group of children born to women with a normal BMI were included as a reference group. At 2.8 (range 2.5–3.2) years, anthropometrics were measured in 157 children of the RCT mothers and in 97 reference group children with Body Mass Index (BMI) Z-score as a primary outcome. Body composition was estimated by Dual Energy X-ray (DEXA) in 123 successful scans out of 147 (84%). Results No differences between randomized groups were seen in mean (95% C.I.) BMI Z-score (intervention group 0.06 [−0.17; 0.29] vs. controls −0.18 [−0.43; 0.05]), in the percentage of overweight or obese children (10.9% vs. 6.7%), in other anthropometrics, or in body composition values by DEXA. Outcomes between children from the RCT and the reference group children were not significantly different. Conclusions The RCT with lifestyle intervention in obese pregnant women did not result in any detectable effect on offspring anthropometrics or body composition by DEXA at 2.8 years of age. This may reflect the limited difference in GWG between intervention and control groups. Offspring of obese mothers from the RCT were comparable to offspring of mothers with a normal BMI. Trial registration clinicaltrials.gov NCT00530439, NCT01918319 and NCT01918423. URL: NCT00530439&quest

Using Intervention Mapping to develop the Parents as Agents of Change (PAC©) intervention for managing pediatric obesity.

PubMed

Ball, Geoff D C; Mushquash, Aislin R; Keaschuk, Rachel A; Ambler, Kathryn A; Newton, Amanda S

2017-01-13

evaluated within a randomized clinical trial. Trial registration NCT01267097; clinicaltrials.gov.

Antiobesity Effect of Caraway Extract on Overweight and Obese Women: A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial

PubMed Central

Radzi, Che Wan Jasimah Bt wan Mohamed; Hajifaraji, Majid; Haerian, Batoul Sadat; Mosaddegh, Mohammad Hossein; Cordell, Geoffrey A.

2013-01-01

Caraway (Carum carvi L.), a potent medicinal plant, is traditionally used for treating obesity. This study investigates the weight-lowering effects of caraway extract (CE) on physically active, overweight and obese women through a randomized, triple-blind, placebo-controlled clinical trial. Seventy overweight and obese, healthy, aerobic-trained, adult females were randomly assigned to two groups (n = 35 per group). Participants received either 30 mL/day of CE or placebo without changing their diet or physical activity. Subjects were examined at baseline and after 90 days for changes in body composition, anthropometric indices, and clinical and paraclinical variables. The treatment group, compared with placebo, showed a significant reduction of weight, body mass index, body fat percentage, and waist-to-hip ratio. No changes were observed in lipid profile, urine-specific gravity, and blood pressure of subjects. The results suggest that a dietary CE with no restriction in food intake, when combined with exercise, is of value in the management of obesity in women wishing to lower their weight, BMI, body fat percentage, and body size, with no clinical side effects. In conclusion, results of this study suggest a possible phytotherapeutic approach for caraway extract in the management of obesity. This trial is registered with NCT01833377. PMID:24319489

Developing a complex intervention for diet and activity behaviour change in obese pregnant women (the UPBEAT trial); assessment of behavioural change and process evaluation in a pilot randomised controlled trial.

PubMed

Poston, Lucilla; Briley, Annette L; Barr, Suzanne; Bell, Ruth; Croker, Helen; Coxon, Kirstie; Essex, Holly N; Hunt, Claire; Hayes, Louise; Howard, Louise M; Khazaezadeh, Nina; Kinnunen, Tarja; Nelson, Scott M; Oteng-Ntim, Eugene; Robson, Stephen C; Sattar, Naveed; Seed, Paul T; Wardle, Jane; Sanders, Thomas A B; Sandall, Jane

2013-07-15

Complex interventions in obese pregnant women should be theoretically based, feasible and shown to demonstrate anticipated behavioural change prior to inception of large randomised controlled trials (RCTs). The aim was to determine if a) a complex intervention in obese pregnant women leads to anticipated changes in diet and physical activity behaviours, and b) to refine the intervention protocol through process evaluation of intervention fidelity. We undertook a pilot RCT of a complex intervention in obese pregnant women, comparing routine antenatal care with an intervention to reduce dietary glycaemic load and saturated fat intake, and increase physical activity. Subjects included 183 obese pregnant women (mean BMI 36.3 kg/m2). Compared to women in the control arm, women in the intervention arm had a significant reduction in dietary glycaemic load (33 points, 95% CI -47 to -20), (p < 0.001) and saturated fat intake (-1.6% energy, 95% CI -2.8 to -0. 3) at 28 weeks' gestation. Objectively measured physical activity did not change. Physical discomfort and sustained barriers to physical activity were common at 28 weeks' gestation. Process evaluation identified barriers to recruitment, group attendance and compliance, leading to modification of intervention delivery. This pilot trial of a complex intervention in obese pregnant women suggests greater potential for change in dietary intake than for change in physical activity, and through process evaluation illustrates the considerable advantage of performing an exploratory trial of a complex intervention in obese pregnant women before undertaking a large RCT. ISRCTN89971375.

Effects of a Family-Based Childhood Obesity Treatment Program on Parental Weight Status

PubMed Central

Trier, Cæcilie; Dahl, Maria; Stjernholm, Theresa; Nielsen, Tenna R. H.; Bøjsøe, Christine; Fonvig, Cilius E.; Pedersen, Oluf; Hansen, Torben; Holm, Jens-Christian

2016-01-01

Objective The aim of this study was to investigate the prevalence of overweight/obesity among parents of children entering childhood obesity treatment and to evaluate changes in the parents’ weight statuses during their child’s treatment. Methods The study included parents of 1,125 children and adolescents aged 3–22 years, who were enrolled in a multidisciplinary childhood obesity treatment program. At baseline, weight and height of the parents were obtained by self-reported information and parental body mass index (BMI) was calculated. Weight and height of the children were measured in the clinic and BMI standard deviation scores were calculated. Furthermore, anthropometric data from parents of 664 children were obtained by telephone interview after a mean of 2.5 years of treatment (ranging 16 days to 7 years), and changes in parental BMI were analyzed. Results Data on changes in BMI were available in 606 mothers and 479 fathers. At baseline, the median BMI of the mothers was 28.1 kg/m2 (range: 16.9–66.6), and the median BMI of the fathers was 28.9 kg/m2 (range: 17.2–48.1). Seventy percent of the mothers and 80% of the fathers were overweight or obese at the time of their child’s treatment initiation. Both the mothers and fathers lost weight during their child’s treatment with a mean decrease in BMI in the mothers of 0.5 (95% CI: 0.2–0.8, p = 0.0006) and in the fathers of 0.4 (95% CI: 0.2–0.6, p = 0.0007). Of the overweight/obese parents, 60% of the mothers and 58% of the fathers lost weight during their child’s treatment. Conclusion There is a high prevalence of overweight/obesity among parents of children entering childhood obesity treatment. Family-based childhood obesity treatment with a focus on the child has a positive effect on parental BMI with both mothers and fathers losing weight. Trial Registration ClinicalTrials.gov NCT00928473 PMID:27560141

Antenatal exercise in overweight and obese women and its effects on offspring and maternal health: design and rationale of the IMPROVE (Improving Maternal and Progeny Obesity Via Exercise) randomised controlled trial.

PubMed

Seneviratne, Sumudu N; Parry, Graham K; McCowan, Lesley Me; Ekeroma, Alec; Jiang, Yannan; Gusso, Silmara; Peres, Geovana; Rodrigues, Raquel O; Craigie, Susan; Cutfield, Wayne S; Hofman, Paul L

2014-04-26

Obesity during pregnancy is associated with adverse outcomes for the offspring and mother. Lifestyle interventions in pregnancy such as antenatal exercise, are proposed to improve both short- and long-term health of mother and child. We hypothesise that regular moderate-intensity exercise during the second half of pregnancy will result in improved maternal and offspring outcomes, including a reduction in birth weight and adiposity in the offspring, which may be protective against obesity in later life. The IMPROVE (Improving Maternal and Progeny Risks of Obesity Via Exercise) study is a two-arm parallel randomised controlled clinical trial being conducted in Auckland, New Zealand. Overweight and obese women (BMI ≥25 kg/m2) aged 18-40 years, with a singleton pregnancy of <20 weeks of gestation, from the Auckland region, are eligible for the trial. Exclusion criteria are ongoing smoking or medical contra-indications to antenatal exercise.Participants are randomised with 1:1 allocation ratio to either intervention or control group, using computer-generated randomisation sequences in variable block sizes, stratified on ethnicity and parity, after completion of baseline assessments. The intervention consists of a 16-week structured home-based moderate-intensity exercise programme utilising stationary cycles and heart rate monitors, commencing at 20 weeks of gestation. The control group do not receive any exercise intervention. Both groups undergo regular fetal ultrasonography and receive standard antenatal care. Due to the nature of the intervention, participants are un-blinded to group assignment during the trial.The primary outcome is offspring birth weight. Secondary offspring outcomes include fetal and neonatal body composition and anthropometry, neonatal complications and cord blood metabolic markers. Maternal outcomes include weight gain, pregnancy and delivery complications, aerobic fitness, quality of life, metabolic markers and post-partum body composition

Rationale and methods of a randomised cross-over cluster trial to assess the effectiveness of MOVI-KIDS on preventing obesity in pre-schoolers.

PubMed

Martínez-Vizcaino, Vicente; Mota, Jorge; Solera-Martínez, Montserrat; Notario-Pacheco, Blanca; Arias-Palencia, Natalia; García-Prieto, Jorge Cañete; González-García, Alberto; Álvarez-Bueno, Celia; Sánchez-López, Mairena

2015-02-22

points were physical activity, fitness, and carotid intima-media thickness. This paper reports the design of a randomised cross-over cluster trial aimed at assessing the effectiveness of the multidimensional physical activity intervention (MOVI-KIDS) during two years in pre-school children. Clinical trials.gov: NCT01971840 . (Date of registration: Initial Release: 10/07/2013; Record Verification: 23/10/2013).

Worksite Environmental Interventions for Obesity Prevention and Control: Evidence from Group Randomized Trials.

PubMed

Fernandez, Isabel Diana; Becerra, Adan; Chin, Nancy P

2014-06-01

Worksites provide multiple advantages to prevent and treat obesity and to test environmental interventions to tackle its multiple causal factors. We present a literature review of group-randomized and non-randomized trials that tested worksite environmental, multiple component interventions for obesity prevention and control paying particular attention to the conduct of formative research prior to intervention development. The evidence on environmental interventions on measures of obesity appears to be strong since most of the studies have a low (4/8) and unclear (2/8) risk of bias. Among the studies reviewed whose potential risk of bias was low, the magnitude of the effect was modest and sometimes in the unexpected direction. None of the four studies describing an explicit formative research stage with clear integration of findings into the intervention was able to demonstrate an effect on the main outcome of interest. We present alternative explanation for the findings and recommendations for future research.

Treatment of antipsychotic-associated obesity with a GLP-1 receptor agonist—protocol for an investigator-initiated prospective, randomised, placebo-controlled, double-blinded intervention study: the TAO study protocol

PubMed Central

Ishøy, Pelle L; Knop, Filip K; Broberg, Brian V; Baandrup, Lone; Fagerlund, Birgitte; Jørgensen, Niklas R; Andersen, Ulrik B; Rostrup, Egill; Glenthøj, Birte Y; Ebdrup, Bjørn H

2014-01-01

Introduction Antipsychotic medication is widely associated with dysmetabolism including obesity and type 2 diabetes, cardiovascular-related diseases and early death. Obesity is considered the single most important risk factor for cardiovascular morbidity and mortality. Interventions against antipsychotic-associated obesity are limited and insufficient. Glucagon-like peptide-1 (GLP-1) receptor agonists are approved for the treatment of type 2 diabetes, but their bodyweight-lowering effects have also been recognised in patients with non-diabetes. The primary endpoint of this trial is weight loss after 3 months of treatment with a GLP-1 receptor agonist (exenatide once weekly) in patients with non-diabetic schizophrenia with antipsychotic-associated obesity. Secondary endpoints include physiological and metabolic measurements, various psychopathological and cognitive measures, and structural and functional brain MRI. Methods and analysis 40 obese patients with schizophrenia or schizoaffective disorder treated with antipsychotic drugs will be randomised to subcutaneous injection of exenatide once weekly (2 mg) or placebo for 3 months, adjunctive to their antipsychotic treatment. Ethics and dissemination The trial has been approved by the Danish Health and Medicines Authority, the National Committee on Health Research Ethics and the Danish Data Protection Agency. Trial participation presupposes theoral and written patient informed consent. An external, independent monitoring committee (Good Clinical Practice Unit at Copenhagen University Hospital) will monitor the study according to the GCP Guidelines. Trial data, including positive, negative and inconclusive results, will be presented at national and international scientific meetings and conferences. Papers will be submitted to peer-reviewed journals. Trial registration ClinicalTrials.gov identifier: NCT01794429; National Committee on Health Research Ethics project number: 36378; EudraCT nr: 2012-005404-17; The

Kansas Primary Care Weighs In: A Pilot Randomized Trial of a Chronic Care Model Program for Obesity in 3 Rural Kansas Primary Care Practices

ERIC Educational Resources Information Center

Ely, Andrea C.; Banitt, Angela; Befort, Christie; Hou, Qing; Rhode, Paula C.; Grund, Chrysanne; Greiner, Allen; Jeffries, Shawn; Ellerbeck, Edward

2008-01-01

Context: Obesity is a chronic disease of epidemic proportions in the United States. Primary care providers are critical to timely diagnosis and treatment of obesity, and need better tools to deliver effective obesity care. Purpose: To conduct a pilot randomized trial of a chronic care model (CCM) program for obesity care in rural Kansas primary…

The cost of a primary care-based childhood obesity prevention intervention

PubMed Central

2014-01-01

Background United States pediatric guidelines recommend that childhood obesity counseling be conducted in the primary care setting. Primary care-based interventions can be effective in improving health behaviors, but also costly. The purpose of this study was to evaluate the cost of a primary care-based obesity prevention intervention targeting children between the ages of two and six years who are at elevated risk for obesity, measured against usual care. Methods High Five for Kids was a cluster-randomized controlled clinical trial that aimed to modify children’s nutrition and TV viewing habits through a motivational interviewing intervention. We assessed visit-related costs from a societal perspective, including provider-incurred direct medical costs, provider-incurred equipment costs, parent time costs and parent out-of-pocket costs, in 2011 dollars for the intervention (n = 253) and usual care (n = 192) groups. We conducted a net cost analysis using both societal and health plan costing perspectives and conducted one-way sensitivity and uncertainty analyses on results. Results The total costs for the intervention group and usual care groups in the first year of the intervention were $65,643 (95% CI [$64,522, $66,842]) and $12,192 (95% CI [$11,393, $13,174]). The mean costs for the intervention and usual care groups were $259 (95% CI [$255, $264]) and $63 (95% CI [$59, $69]) per child, respectively, for a incremental difference of $196 (95% CI [$191, $202]) per child. Children in the intervention group attended a mean of 2.4 of a possible 4 in-person visits and received 0.45 of a possible 2 counseling phone calls. Provider-incurred costs were the primary driver of cost estimates in sensitivity analyses. Conclusions High Five for Kids was a resource-intensive intervention. Further studies are needed to assess the cost-effectiveness of the intervention relative to other pediatric obesity interventions. Trial registration ClinicalTrials.gov Identifier

Effect of Internet-based Intervention on Obesity among Adolescents in Kuala Lumpur: A School-based Cluster Randomised Trial

PubMed Central

Mohammed Nawi, AZMAWATI; Che Jamaludin, FARRAH ILYANI

2015-01-01

Background: Co-morbidities in adulthood is a significant problem and is associated with obesity during adolescent. Methods: This 3-months randomised controlled trial was aimed at determining the effectiveness of having internet-based intervention (obeseGO!) toward obesity among adolescents in Kuala Lumpur. Forty seven students were assigned randomly to the obeseGO! (intervention) group for internet-based intervention i.e., information on healthy lifestyle and diet were provided via the internet. Fifty students were assigned to the control group, where pamphlets containing health education were provided to these students. The measurement of body mass index (BMI), waist circumference, and the body fat percentage was taken at baseline and after 12 weeks of intervention. Results: The multivariate analysis of variance (MANOVA) analysis found that obeseGO! had a small effect in reducing BMI, waist circumference and body fat percentage. Conclusion: The internet-based obesity intervention program may be an effective medium for promoting healthy diet and physical activity among the obese adolescents. PMID:26715908

Can a trial of motivational lifestyle counseling be effective for controlling childhood obesity and the associated cardiometabolic risk factors?

PubMed

Kelishadi, Roya; Malekahmadi, Mohammad; Hashemipour, Mahin; Soghrati, Mehrnaz; Soghrati, Mojgan; Mirmoghtadaee, Parisa; Ghatrehsamani, Shohreh; Poursafa, Parinaz; Khavarian, Noushin

2012-04-01

This study was conducted to assess the effectiveness of a simple office-based program for encouraging healthy lifestyle on controlling childhood obesity and associated cardiometabolic risk factors. This non-randomized 24-week lifestyle modification trial was conducted among 457 obese children and adolescents, aged 2-18 years, who had at least one cardiometabolic risk factor in addition to obesity. This trial included three components of exercise, diet education and behavior modification, with all recommendations provided by a pediatrician, two general physicians and a nurse. Instead of strict inhibitory recommendations, healthier lifestyle was encouraged. Overall 448 (98.04%) of enrolled children completed the trial with a mean age of 9.6 ± 2.9 years. After the trial, the mean of anthropometric measures and cardiometabolic risk factors decreased significantly, the mean high-density lipoprotein cholesterol (HDL-C) increased significantly, and the prevalence of the metabolic syndrome decreased from 20.8% to 1.8%. Triglycerides, LDL-C, diastolic blood pressure and WC had the highest decrease in all age groups, with the most prominent changes in the 14-18-year age group. By each -1SD decline in BMI and WC, risk factors had significant improvement. Motivational office-based counseling can be effective in treatment of childhood obesity and its associated cardio-metabolic risk factors. Such approach can be implemented in the primary health care system; and can be of special concern in low- and middle-income countries with limited human and financial resources. We suggest that expanding the roles of non-physician clinicians such as nurse practitioners can help to increase the amount of time available for such services. Copyright © 2012. Published by Elsevier B.V.

Evaluation of recruitment methods for a trial targeting childhood obesity: Families for Health randomised controlled trial.

PubMed

Fleming, J; Kamal, A; Harrison, E; Hamborg, T; Stewart-Brown, S; Thorogood, M; Griffiths, F; Robertson, W

2015-11-25

Recruitment to trials evaluating the effectiveness of childhood obesity management interventions is challenging. We report our experience of recruitment to the Families for Health study, a randomised controlled trial evaluating the effectiveness of a family-based community programme for children aged 6-11 years, versus usual care. We evaluated the effectiveness of active recruitment (contacting eligible families directly) versus passive recruitment (informing the community through flyers, public events, media). Initial approaches included passive recruitment via the media (newspapers and radio) and two active recruitment methods: National Child Measurement Programme (letters to families with overweight children) and referrals from health-care professionals. With slow initial recruitment, further strategies were employed, including active (e.g. targeted letters from general practices) and passive (e.g. flyers, posters and public events) methods. At first enquiry from a potential participant, families were asked where they heard about the study. Further quantitative (questionnaire) and qualitative data (one-to-one interviews with parents/carers), were collected from recruited families at baseline and 3-month follow-up and included questions about recruitment. In total, 194 families enquired about Families for Health, and 115 (59.3 %) were recruited and randomised. Active recruitment yielded 85 enquiries, with 43 families recruited (50.6 %); passive recruitment yielded 99 enquiries with 72 families recruited (72.7 %). Information seen at schools or GP surgeries accounted for over a quarter of enquiries (28.4 %) and over a third (37.4 %) of final recruitment. Eight out of ten families who enquired this way were recruited. Media-led enquiries were low (5 %), but all were recruited. Children of families recruited actively were more likely to be Asian or mixed race. Despite extensive recruitment methods, the trial did not recruit as planned, and was awarded a no

The evolution in registration of clinical trials: a chronicle of the historical calls and current initiatives promoting transparency.

PubMed

Pansieri, Claudia; Pandolfini, Chiara; Bonati, Maurizio

2015-10-01

Quality of care is strongly influenced by evidence-based medicine, a large part of which is based on results obtained from clinical trials. If trials are conducted in secret, patient safety is at risk. Several mandates-legal, editorial, financial, and ethical-have tried to influence the disclosure of clinical trials, first by encouraging registration in publicly accessible registers and, second, by calling for the publication of results. Not all these initiatives have reached high rates of compliance, but the succession of national and international events over a few years gave an important boost to information disclosure. This article provides a chronicle of the succession of the events, from the historical calls to the recent EMA policy and WHO statement, and public consultations requested by the NIH, and the HHS, which will inevitably change the international panorama. The path of these new policies is moving towards more supervised clinical research. Individual scientific institutions can also contribute, at the local level, to such an ethical endeavor as is improving research transparency, by disclosing information on the trials coordinated by their own researchers. The way is long and complex, but, if everyone contributes there could be a prompt, worldwide diffusion of the findings of clinical trials, and therefore a more possible evidenced-based medicine.

Effects of advice to drink 8 cups of water per day in adolescents with overweight or obesity: a randomized trial

PubMed Central

Wong, Julia MW; Ebbeling, Cara B; Robinson, Lisa; Feldman, Henry A; Ludwig, David S

2017-01-01

Importance Healthcare professionals commonly recommend increased water consumption, typically to 8 cups/d, as part of a weight-reducing diet. However, this recommendation is based on limited evidence and virtually no experimental data in the pediatric age range. Objective The aim of this study was to compare two standard weight-loss diets, either with (Water) or without (Control) additional advice and behavioral support to increase habitual water intake to 8 cups/d. Design 6-month randomized controlled parallel-group design. Setting The trial was conducted at Boston Children’s Hospital, Boston, Massachusetts, between February 2011 and June 2014. Participants 38 overweight and obese adolescents who reported drinking ≤4 cups of water/d. Intervention Both groups received similar weight-reducing interventions, differentiated by water messages but controlled for other dietary recommendations and treatment intensity. The interventions included dietary counseling, daily text messages, and a cookbook with health guides. To support adherence to 8 cups water/d, the Water group received well-defined water messages through counseling and daily text messages, a water bottle, and a water pitcher with filters. The Control group received no specific advice on water consumption. Main Outcome and Measures Primary outcome was 6-month change in body mass index (BMI) z-score. Results All randomized participants completed the study. Both groups reported drinking ~2 cups/d water at baseline. Self-reported change in water intake was greater in the Water Group compared to the Control Group (difference between groups, 1.6; 95% CI, 0.2 to 3.0 cups/d; P=0.03). The 6-month change in BMI z-score did not differ between groups (−0.0; 95% CI, −0.1 to 0.1; P=0.88). Conclusions and Relevance Contrary to hypothesis, advice and behavioral supports to consume 8 cups water/d in the context of a weight-reducing diet did not affect body weight among overweight and obese adolescents. Despite

Three controlled trials of interventions to increase recruitment to a randomized controlled trial of mobile phone based smoking cessation support.

PubMed

Free, Caroline; Hoile, Elizabeth; Robertson, Steven; Knight, Rosemary

2010-06-01

Recruitment is a major challenge for trials but there is little evidence regarding interventions to increase trial recruitment. We report three controlled trials of interventions to increase recruitment to the Txt2stop trial. To evaluate: Trial 1. The impact on registrations of a text message regarding an online registration facility; Trial 2. The impact on randomizations of sending pound5 with a covering letter to those eligible to join the trial; Trial 3. The impact on randomizations of text messages containing quotes from existing participants. Single blind controlled trials with allocation concealment. Trial 1: A text message regarding our new online registration facility; Trial 2: A letter with pound5 enclosed; Trial 3: A series of four text messages containing quotes from participants. The control group in each trial received standard Txt2stop procedures. Trial 1: 3.6% (17/470) of the intervention group and 1.1% (5/467) of the control group registered for the trial, risk difference 2.5% (95% CI 0.6-4.5). 0% (0/ 470) of the intervention group and 0.2% (1/467) of the control group registered successfully online, risk difference -0.2 (95% CI -0.6-0.2); Trial 2: 4.5% (11/246) of the intervention group and 0.4% (1/245) of the control group were randomized into the Txt2stop trial, risk difference 4.0% (95% CI 1.4-6.7); Trial 3: 3.5% (14/405) of the intervention group and 0% (0/406) of the control group were randomized into the Txt2stop trial, risk difference 3.5 (95% CI 1.7-5.2). There were no baseline data available for trial 1. Allocation of participant IDs in trials 2 and 3 were systematic. Sending a text message about an online registration facility increased registrations to Txt2stop, but did not increase online registrations. Sending a pound5 reimbursement for participants' time and sending text messages containing quotes from existing participants increased randomizations into the Txt2stop trial. Clinical Trials 2010; 7: 265-273. http://ctj.sagepub.com.

Effectiveness of social marketing strategies to reduce youth obesity in European school-based interventions: a systematic review and meta-analysis

PubMed Central

Aceves-Martins, Magaly; Llauradó, Elisabet; Tarro, Lucia; Moreno-García, Carlos Francisco; Trujillo Escobar, Tamy Goretty; Giralt, Montse

2016-01-01

Context: The use of social marketing to modify lifestyle choices could be helpful in reducing youth obesity. Some or all of the 8 domains of the National Social Marketing Centre’s social marketing benchmark criteria (SMBC) are often used but not always defined in intervention studies. Objective: The aim of this review is to assess the effectiveness of European school-based interventions to prevent obesity relative to the inclusion of SMBC domains in the intervention. Data Sources: The PubMed, Cochrane, and ERIC databases were used. Study Selection: Nonrandomized and randomized controlled trials conducted from 1990 to April 2014 in participants aged 5 to 17 years were included. Data Extraction: After the study selection, the 8 domains of the SMBC were assessed in each included study. Results: Thirty-eight publications were included in the systematic review. For the meta-analysis, randomized controlled trials (RCTs) reporting body mass index or prevalence of overweight and obesity were considered. Eighteen RCTs with a total of 8681 participants included at least 5 SMBC. The meta-analysis showed a small standardized mean difference in body mass index of −0.25 (95%CI, −0.45 to −0.04) and a prevalence of overweight and obesity odds ratio of 0.72 (95%CI, 0.5–0.97). Conclusion: Current evidence indicates that the inclusion of at least 5 SMBC domains in school-based interventions could benefit efforts to prevent obesity in young people. PROSPERO registration number: CRD42014007297. PMID:27018054

Healthy eating and lifestyle in pregnancy (HELP): a protocol for a cluster randomised trial to evaluate the effectiveness of a weight management intervention in pregnancy

PubMed Central

2014-01-01

Background Approximately 1 in 5 pregnant women in the United Kingdom are obese. In addition to being associated generally with poor health, obesity is known to be a contributing factor to pregnancy and birth complications and the retention of gestational weight can lead to long term obesity. This paper describes the protocol for a cluster randomised trial to evaluate whether a weight management intervention for obese pregnant women is effective in reducing women’s Body Mass Index at 12 months following birth. Methods/design The study is a cluster randomised controlled trial involving 20 maternity units across England and Wales. The units will be randomised, 10 to the intervention group and 10 to the control group. 570 pregnant women aged 18 years or over, with a Body Mass Index of +/=30 (kg/m2) and between 12 and 20 weeks gestation will be recruited. Women allocated to the control group will receive usual care and two leaflets giving advice on diet and physical activity. In addition to their usual care and the leaflets, women allocated to the intervention group will be offered to attend a weekly 1.5 hour weight management group, which combines expertise from Slimming World with clinical advice and supervision from National Health Service midwives, until 6 weeks postpartum. Participants will be followed up at 36 weeks gestation and at 6 weeks, 6 months and 12 months postpartum. Body Mass Index at 12 months postpartum is the primary outcome. Secondary outcomes include pregnancy weight gain, quality of life, mental health, waist-hip ratio, child weight centile, admission to neonatal unit, diet, physical activity levels, pregnancy and birth complications, social support, self-regulation and self-efficacy. A cost effectiveness analysis and process evaluation will also be conducted. Discussion This study will evaluate the effectiveness of a theory-based intervention developed for obese pregnant women. If successful the intervention will equip women with the

Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE): study protocol for a randomized controlled trial.

PubMed

Bluth, T; Teichmann, R; Kiss, T; Bobek, I; Canet, J; Cinnella, G; De Baerdemaeker, L; Gregoretti, C; Hedenstierna, G; Hemmes, S N; Hiesmayr, M; Hollmann, M W; Jaber, S; Laffey, J G; Licker, M J; Markstaller, K; Matot, I; Müller, G; Mills, G H; Mulier, J P; Putensen, C; Rossaint, R; Schmitt, J; Senturk, M; Serpa Neto, A; Severgnini, P; Sprung, J; Vidal Melo, M F; Wrigge, H; Schultz, M J; Pelosi, P; Gama de Abreu, M

2017-04-28

Postoperative pulmonary complications (PPCs) increase the morbidity and mortality of surgery in obese patients. High levels of positive end-expiratory pressure (PEEP) with lung recruitment maneuvers may improve intraoperative respiratory function, but they can also compromise hemodynamics, and the effects on PPCs are uncertain. We hypothesized that intraoperative mechanical ventilation using high PEEP with periodic recruitment maneuvers, as compared with low PEEP without recruitment maneuvers, prevents PPCs in obese patients. The PRotective Ventilation with Higher versus Lower PEEP during General Anesthesia for Surgery in OBESE Patients (PROBESE) study is a multicenter, two-arm, international randomized controlled trial. In total, 2013 obese patients with body mass index ≥35 kg/m 2 scheduled for at least 2 h of surgery under general anesthesia and at intermediate to high risk for PPCs will be included. Patients are ventilated intraoperatively with a low tidal volume of 7 ml/kg (predicted body weight) and randomly assigned to PEEP of 12 cmH 2 O with lung recruitment maneuvers (high PEEP) or PEEP of 4 cmH 2 O without recruitment maneuvers (low PEEP). The occurrence of PPCs will be recorded as collapsed composite of single adverse pulmonary events and represents the primary endpoint. To our knowledge, the PROBESE trial is the first multicenter, international randomized controlled trial to compare the effects of two different levels of intraoperative PEEP during protective low tidal volume ventilation on PPCs in obese patients. The results of the PROBESE trial will support anesthesiologists in their decision to choose a certain PEEP level during general anesthesia for surgery in obese patients in an attempt to prevent PPCs. ClinicalTrials.gov identifier: NCT02148692. Registered on 23 May 2014; last updated 7 June 2016.

A Randomized Clinical Trial of the Effects of Parent Mentors on Early Childhood Obesity: Study Design and Baseline Data

PubMed Central

Foster, Byron A.; Aquino, Christian; Gil, Mario; Flores, Glenn; Hale, Daniel

2015-01-01

Background Few effective community-based interventions exist for early childhood obesity. Parent mentors have been successful as an intervention for other conditions, but have not been used for childhood obesity. We designed an intervention for early childhood obesity using parent mentors and a positive outlier approach to assess potential efficacy, feasibility, and acceptability. Methods This trial enrolled obese (≥95th BMI percentile for age and gender) 2-5-year-old children in a Head Start program and their parents, with allocation to either parent mentors trained in positively deviant behaviors regarding childhood obesity, or community health workers delivering health education on obesity-related behaviors. The primary outcome is body mass index z-score change at the six-month follow-up assessment. Secondary outcomes include feeding behaviors and practices, health-related quality of life, dietary intake, and participation levels. Results We enrolled three parent mentors and 60 parent-child dyads. The population is 100% Hispanic; 44% of parents speak Spanish as their primary language and 45% were not high-school graduates. Children had a reported median vegetable and fruit intake of 0.3 and 1.1 cups per day, respectively, at baseline, and a median daily screen time of three hours. There was no intergroup difference in quality-of-life scores at baseline. Retention has been high, at 90% at three months. Conclusions In this randomized trial of the effects of parent mentors on early childhood obesity, parent-child dyads from an underserved, Hispanic population were successfully enrolled through a partnership with a Head Start organization, with a high retention rate. PMID:26343746

Effectiveness of an implementation optimisation intervention aimed at increasing parent engagement in HENRY, a childhood obesity prevention programme - the Optimising Family Engagement in HENRY (OFTEN) trial: study protocol for a randomised controlled trial.

PubMed

Bryant, Maria; Burton, Wendy; Cundill, Bonnie; Farrin, Amanda J; Nixon, Jane; Stevens, June; Roberts, Kim; Foy, Robbie; Rutter, Harry; Hartley, Suzanne; Tubeuf, Sandy; Collinson, Michelle; Brown, Julia

2017-01-24

Family-based interventions to prevent childhood obesity depend upon parents' taking action to improve diet and other lifestyle behaviours in their families. Programmes that attract and retain high numbers of parents provide an enhanced opportunity to improve public health and are also likely to be more cost-effective than those that do not. We have developed a theory-informed optimisation intervention to promote parent engagement within an existing childhood obesity prevention group programme, HENRY (Health Exercise Nutrition for the Really Young). Here, we describe a proposal to evaluate the effectiveness of this optimisation intervention in regard to the engagement of parents and cost-effectiveness. The Optimising Family Engagement in HENRY (OFTEN) trial is a cluster randomised controlled trial being conducted across 24 local authorities (approximately 144 children's centres) which currently deliver HENRY programmes. The primary outcome will be parental enrolment and attendance at the HENRY programme, assessed using routinely collected process data. Cost-effectiveness will be presented in terms of primary outcomes using acceptability curves and through eliciting the willingness to pay for the optimisation from HENRY commissioners. Secondary outcomes include the longitudinal impact of the optimisation, parent-reported infant intake of fruits and vegetables (as a proxy to compliance) and other parent-reported family habits and lifestyle. This innovative trial will provide evidence on the implementation of a theory-informed optimisation intervention to promote parent engagement in HENRY, a community-based childhood obesity prevention programme. The findings will be generalisable to other interventions delivered to parents in other community-based environments. This research meets the expressed needs of commissioners, children's centres and parents to optimise the potential impact that HENRY has on obesity prevention. A subsequent cluster randomised controlled pilot

Effect of Hibiscus sabdariffa Calices on Dyslipidemia in Obese Adolescents: A Triple-masked Randomized Controlled Trial

PubMed Central

Sabzghabaee, Ali Mohammad; Ataei, Ehsan; Kelishadi, Roya; Ghannadi, Alireza; Soltani, Rasool; Badri, Shirinsadat; Shirani, Shahin

2013-01-01

Conflict of interest: none declared. Objective We aimed to evaluate the effects of Hibiscus sabdariffa (HS) calices on controlling dyslipidemia in obese adolescents. Methodology In this triple blind randomized placebo-controlled clinical trial which was registered in the Iranian registry for clinical trials (IRCT201109122306N2), 90 obese adolescents aged 12-18 years with documented dyslipidemia were randomly assigned in two groups of cases who received 2 grams of fine powdered calices of Hibiscus sabdariffa per day for one month and controls who received placebo powder with the same dietary and physical activity recommendations and duration of exposure. Full lipid profile and fasting blood sugar measured before and after the trial. Data were analyzed using multivariate general linear model. Findings Overall, 72 participants (mean age of 14.21±1.6, 35 boys) completed the trial. The two arms of the study (cases and controls) were not statistically different in terms of age, gender, weight, body mass index (BMI) and lipid profile before the trial. Serum total cholesterol, low density lipoprotein cholesterol and serum triglyceride showed a significant decrease in cases group but high density lipoprotein cholesterol level was not changed significantly. Conclusion It is concluded that Hibiscus sabdariffa calyces powder may have significant positive effects on lipid profile of adolescents which maybe attributed to its polyphenolic and antioxidant content. Further studies are needed on dose-response and formulation optimization. PMID:24082826

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.

Exercise, adipokines and pediatric obesity: a meta-analysis of randomized controlled trials.

PubMed

García-Hermoso, A; Ceballos-Ceballos, R J M; Poblete-Aro, C E; Hackney, A C; Mota, J; Ramírez-Vélez, R

2017-04-01

Adipokines are involved in the etiology of diabetes, insulin resistance, and the development of atherosclerosis and other latent-onset complications. The objective of this meta-analysis was to determine the effectiveness of exercise interventions on adipokines in pediatric obesity. A computerized search was made using three databases. The analysis was restricted to studies that examined the effect of exercise interventions on adipokines (adiponectin, leptin, resistin and visfatin) in pediatric obesity (6-18 years old). Fourteen randomized controlled trials (347 youths) were included. Weighted mean difference (WMD) and 95% confidence intervals were calculated. Exercise was associated with a significant increase in adiponectin (WMD=0.882 μg ml -1 , 95% CI, 0.271-1.493) but did not alter leptin and resistin level. Likewise, exercise intensity and change in body fat; as well as total exercise program duration, duration of the sessions, and change in body fat all significantly influenced the effect of exercise on adiponectin and leptin, respectively. Exercise seems to increase adiponectin levels in childhood obesity. Our results also suggested that exercise on its own, without the concomitant presence of changes in body composition levels, does not affect leptin levels.

Effect of L-Tryptophan and L-Leucine on Gut Hormone Secretion, Appetite Feelings and Gastric Emptying Rates in Lean and Non-Diabetic Obese Participants: A Randomized, Double-Blind, Parallel-Group Trial

PubMed Central

Meyer-Gerspach, Anne Christin; Häfliger, Simon; Meili, Julian; Doody, Alison; Rehfeld, Jens F; Drewe, Jürgen; Beglinger, Christoph; Wölnerhanssen, Bettina

2016-01-01

Background/Objectives Gut hormones such as cholecystokinin (CCK) and glucagon-like peptide-1 (GLP-1) play a role as satiation factors. Strategies to enhance satiation peptide secretion could provide a therapeutic approach for obesity. Carbohydrates and lipids have been extensively investigated in relation to peptide release. In contrast, the role of proteins or amino acids is less clear. Our aim was to compare the effects of the amino acids L-tryptophan (L-trp) and L-leucine (L-leu) separately on gastric emptying and gut peptide secretion. Participants/Methods The study was conducted as a randomized (balanced), double-blind, parallel-group trial. A total of 10 lean and 10 non-diabetic obese participants were included. Participants received intragastric loads of L-trp (0.52 g and 1.56 g) and L-leu (1.56 g), dissolved in 300 mL tap water; 75 g glucose and 300 mL tap water served as control treatments. Results Results of the study are: i) L-trp at the higher dose stimulates CCK release (p = 0.0018), and induces a significant retardation in gastric emptying (p = 0.0033); ii) L-trp at the higher dose induced a small increase in GLP-1 secretion (p = 0.0257); iii) neither of the amino acids modulated subjective appetite feelings; and iv) the two amino acids did not alter insulin or glucose concentrations. Conclusions L-trp is a luminal regulator of CCK release with effects on gastric emptying, an effect that could be mediated by CCK. L-trp’s effect on GLP-1 secretion is only minor. At the doses given, the two amino acids did not affect subjective appetite feelings. Trial Registration ClinicalTrials.gov NCT02563847 PMID:27875537

The Impact of Curtin University's Activity, Food and Attitudes Program on Physical Activity, Sedentary Time and Fruit, Vegetable and Junk Food Consumption among Overweight and Obese Adolescents: A Waitlist Controlled Trial

PubMed Central

Straker, Leon M.; Howie, Erin K.; Smith, Kyla L.; Fenner, Ashley A.; Kerr, Deborah A.; Olds, Tim S.; Abbott, Rebecca A.; Smith, Anne J.

2014-01-01

Background To determine the effects of participation in Curtin University's Activity, Food and Attitudes Program (CAFAP), a community-based, family-centered behavioural intervention, on the physical activity, sedentary time, and healthy eating behaviours of overweight and obese adolescents. Methods In this waitlist controlled clinical trial in Western Australia, adolescents (n = 69, 71% female, mean age 14.1 (SD 1.6) years) and parents completed an 8-week intervention followed by 12 months of telephone and text message support. Assessments were completed at baseline, before beginning the intervention, immediately following the intervention, and at 3-, 6-, and 12- months follow-up. The primary outcomes were physical activity and sedentary time assessed by accelerometers and servings of fruit, vegetables and junk food assessed by 3-day food records. Results During the intensive 8-week intervention sedentary time decreased by −5.1 min/day/month (95% CI: −11.0, 0.8) which was significantly greater than the rate of change during the waitlist period (p = .014). Moderate physical activity increased by 1.8 min/day/month (95% CI: −0.04, 3.6) during the intervention period, which was significantly greater than the rate of change during the waitlist period (p = .041). Fruit consumption increased during the intervention period (monthly incidence rate ratio (IRR) 1.3, 95% CI: 1.10, 1.56) and junk food consumption decreased (monthly IRR 0.8, 95% CI: 0.74, 0.94) and these changes were different to those seen during the waitlist period (p = .004 and p = .020 respectively). Conclusions Participating in CAFAP appeared to have a positive influence on the physical activity, sedentary and healthy eating behaviours of overweight and obese adolescents and many of these changes were maintained for one year following the intensive intervention. Trial Registration Australia and New Zealand Clinical Trials Registry ACTRN12611001187932 PMID:25375109

76 FR 4940 - Algirdas J. Krisciunas, M.D.; Revocation of Registration

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-27

... substances and the visit. Id. at 5-6. On January 7, 2010, a Federal Grand Jury indicted Registrant. United..., 2010, a Federal Grand Jury issued a superseding indictment. United States v. Algirdas Krisciunas and... went to trial. On July 6, 2010, a jury found Registrant guilty on all six counts. U.S. v. Algirdas...

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.

A Preschool Obesity Treatment Clinical Trial: Reasons Primary Care Providers Declined Referrals.

PubMed

Robson, Shannon M; Bolling, Christopher; McCullough, Mary Beth; Stough, Cathleen Odar; Stark, Lori J

2016-10-01

To examine referral by primary care providers (PCPs) of preschool children with obesity (≥95th percentile for body mass index [BMI]) to a weight management intervention when offered through a randomized clinical trial (RCT), and identify reasons for not referring children. In phase I, 3 experts in obesity, psychology, and nutrition completed an open card sort and classified PCPs' reasons for declining referral into groups based on similarity of reasons. Categories were then defined and labeled. In phase II, 2 independent sorters placed each decline into 1 of the categories defined in phase I. PCPs referred 78% of eligible children to the RCT. Compared with children declined for referral, referred children had a significantly higher weight (48.4 lb vs 46.1 lb; P < .001) and BMI percentile (97.6 vs 97.0; P < .001). Eleven categories for decline were identified in phase I. In phase II, excellent reliability was obtained between each independent sorter and the phase I categories, and also between the 2 independent sorters (κ values, 0.72-1.0). The most common reason for declining was "family not a good fit" (23.6%), followed by "doesn't believe weight is a problem" (13.9%), "family would not be interested" (12%), and "doesn't believe measurement is accurate" (11.5%). Appropriately, exclusionary criteria of the RCT was a reason as well (11.8%). The availability of weight management for preschoolers through RCTs appeared to overcome barriers of resources, time, and credible treatment cited in previous studies. However, concerns about the family's response or interest in a weight management program remained barriers, as did PCPs' perceptions about obesity in young children. ClinicalTrials.gov:NCT01546727. Copyright © 2016 Elsevier Inc. All rights reserved.

Association between obesity and periodontal disease. A systematic review of epidemiological studies and controlled clinical trials

PubMed Central

Martinez-Herrera, Mayte; Silvestre-Rangil, Javier

2017-01-01

Background Obesity is a very prevalent chronic disease worldwide and has been suggested to increase susceptibility of periodontitis. The aim of this paper was to provide a systematic review of the association between obesity and periodontal disease, and to determine the possible mechanisms underlying in this relationship. Material and Methods A literature search was carried out in the databases PubMed-Medline and Embase. Controlled clinical trials and observational studies identifying periodontal and body composition parameters were selected. Each article was subjected to data extraction and quality assessment. Results A total of 284 articles were identified, of which 64 were preselected and 28 were finally included in the review. All the studies described an association between obesity and periodontal disease, except two articles that reported no such association. Obesity is characterized by a chronic subclinical inflammation that could exacerbate other chronic inflammatory disorders like as periodontitis. Conclusions The association between obesity and periodontitis was consistent with a compelling pattern of increased risk of periodontitis in overweight or obese individuals. Although the underlying pathophysiological mechanism remains unclear, it has been pointed out that the development of insulin resistance as a consequence of a chronic inflammatory state and oxidative stress could be implicated in the association between obesity and periodontitis. Further prospective longitudinal studies are needed to define the magnitude of this association and to elucidate the causal biological mechanisms. Key words:Periodontal disease, periodontitis, periodontal infection, obesity, abdominal obesity. PMID:29053651

Preventing childhood obesity by reducing consumption of carbonated drinks: cluster randomised controlled trial

PubMed Central

James, Janet; Thomas, Peter; Cavan, David; Kerr, David

2004-01-01

Objective To determine if a school based educational programme aimed at reducing consumption of carbonated drinks can prevent excessive weight gain in children. Design Cluster randomised controlled trial. Setting Six primary schools in southwest England. Participants 644 children aged 7-11 years. Intervention Focused educational programme on nutrition over one school year. Main outcome measures Drink consumption and number of overweight and obese children. Results Consumption of carbonated drinks over three days decreased by 0.6 glasses (average glass size 250 ml) in the intervention group but increased by 0.2 glasses in the control group (mean difference 0.7, 95% confidence interval 0.1 to 1.3). At 12 months the percentage of overweight and obese children increased in the control group by 7.5%, compared with a decrease in the intervention group of 0.2% (mean difference 7.7%, 2.2% to 13.1%). Conclusion A targeted, school based education programme produced a modest reduction in the number of carbonated drinks consumed, which was associated with a reduction in the number of overweight and obese children. PMID:15107313

The impact of metformin, oral contraceptives, and lifestyle modification on polycystic ovary syndrome in obese adolescent women in two randomized, placebo-controlled clinical trials.

PubMed

Hoeger, Kathleen; Davidson, Kristen; Kochman, Lynda; Cherry, Tracy; Kopin, Laurie; Guzick, David S

2008-11-01

Polycystic ovary syndrome (PCOS) presents in adolescence, and obesity is a common finding. The benefits and risks of alternate approaches to the management of PCOS in obese adolescent women are not clear. We investigated the effects of metformin, oral contraceptives (OCs), and/or lifestyle modification in obese adolescent women with PCOS. Two small, randomized, placebo-controlled clinical trials were performed. A total of 79 obese adolescent women with PCOS participated. In the single treatment trial, subjects were randomized to metformin, placebo, a lifestyle modification program, or OC. In the combined treatment trial, all subjects received lifestyle modification and OC and were randomized to metformin or placebo. Serum concentrations of androgens and lipids were measured. Lifestyle modification alone resulted in a 59% reduction in free androgen index with a 122% increase in SHBG. OC resulted in a significant decrease in total testosterone (44%) and free androgen index (86%) but also resulted in an increase in C-reactive protein (39.7%) and cholesterol (14%). The combination of lifestyle modification, OC, and metformin resulted in a 55% decrease in total testosterone, as compared to 33% with combined treatment and placebo, a 4% reduction in waist circumference, and a significant increase in HDL (46%). In these preliminary trials, both lifestyle modification and OCs significantly reduce androgens and increase SHBG in obese adolescents with PCOS. Metformin, in combination with lifestyle modification and OC, reduces central adiposity, reduces total testosterone, and increases HDL, but does not enhance overall weight reduction.

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.

Preventing childhood obesity, phase II feasibility study focusing on South Asians: BEACHeS

PubMed Central

Adab, Peymané; Pallan, Miranda J; Cade, Janet; Ekelund, Ulf; Barrett, Timothy; Daley, Amanda; Deeks, Jonathan; Duda, Joan; Gill, Paramjit; Parry, Jayne; Bhopal, Raj; Cheng, K K

2014-01-01

Objective To assess feasibility and acceptability of a multifaceted, culturally appropriate intervention for preventing obesity in South Asian children, and to obtain data to inform sample size for a definitive trial. Design Phase II feasibility study of a complex intervention. Setting 8 primary schools in inner city Birmingham, UK, within populations that are predominantly South Asian. Participants 1090 children aged 6–8 years took part in the intervention. 571 (85.9% from South Asian background) underwent baseline measures. 85.5% (n=488) were followed up 2 years later. Interventions The 1-year intervention consisted of school-based and family-based activities, targeting dietary and physical activity behaviours. The intervention was modified and refined throughout the period of delivery. Main outcome measures Acceptability and feasibility of the intervention and of measurements required to assess outcomes in a definitive trial. The difference in body mass index (BMI) z-score between arms was used to inform sample size calculations for a definitive trial. Results Some intervention components (increasing school physical activity opportunities, family cooking skills workshops, signposting of local leisure facilities and attending day event at a football club) were feasible and acceptable. Other components were acceptable, but not feasible. Promoting walking groups was neither acceptable nor feasible. At follow-up, children in the intervention compared with the control group were less likely to be obese (OR 0.41; 0.19 to 0.89), and had lower adjusted BMI z-score (−0.15 kg/m2; 95% CI −0.27 to −0.03). Conclusions The feasibility study informed components for an intervention programme. The favourable direction of outcome for weight status in the intervention group supports the need for a definitive trial. A cluster randomised controlled trial is now underway to assess the clinical and cost-effectiveness of the intervention. Trial registration number ISRCTN

Modifying Alcohol Consumption to Reduce Obesity (MACRO): development and feasibility trial of a complex community-based intervention for men.

PubMed Central

Crombie, Iain K; Cunningham, Kathryn B; Irvine, Linda; Williams, Brian; Sniehotta, Falko F; Norrie, John; Melson, Ambrose; Jones, Claire; Briggs, Andrew; Rice, Peter M; Achison, Marcus; McKenzie, Andrew; Dimova, Elena; Slane, Peter W

2017-01-01

randomised in 3 months. Of the 69 men randomised, 35 were allocated to the intervention group and 34 to the control group. The analysis was conducted on 31 participants from the intervention group and 30 from the control group. The participants covered a wide range of ages and socioeconomic statuses. The average alcohol consumption of the men recruited was 47.2 units per week, more than twice that of the entry criterion (> 21 units per week). Most (78%) engaged in binge drinking (> 8 units in a session) at least weekly. Almost all (95%) exceeded the threshold for a 19-fold increase in the risk of dying from liver disease (BMI of > 30 kg/m(2) and > 14 units of alcohol per week). Despite this, they believed that they were at low risk of harm from alcohol, possibly because they seldom suffered acute harms (e.g. hangovers) and made few visits to a general practitioner or hospital. INTERVENTION The intervention was delivered with high fidelity. A high follow-up rate was achieved (98%) and the outcomes for the full RCT were measured. A process evaluation showed that participants engaged with the main components of the intervention. The acceptability of the study methods was high. CONCLUSIONS This feasibility study developed a novel intervention and evaluated all of the stages of a RCT that would test the effectiveness of the intervention. The main stages of a trial were completed successfully: recruitment, randomisation, intervention delivery, follow-up and measurement of study outcomes. Most of the men recruited drank very heavily and were also obese. This places them at a very high risk of liver disease, making them a priority for intervention. FUTURE WORK A RCT to test the effectiveness and cost-effectiveness of the intervention. TRIAL REGISTRATION Current Controlled Trials ISRCTN55309164. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology

Lorcaserin. In obesity: unacceptable risks.

PubMed

2014-05-01

Treatment of obesity and overweight is based primarily on dietary measures and physical exercise.There are still no drugs with a favourable harm-benefit balance in this setting. Lorcaserin, a "selective" 5HT2C serotonin receptor agonist, has been refused marketing authorisation in the European Union despite approval in the United States. Clinical evaluation of lorcaserin is based on three placebo-controlled trials, each lasting one year, in a total of about 6000 patients. Two trials involved obese patients, and one obese patients with type 2 diabetes. The results of these trials are undermined by the large proportion (40% to 50%) of patients who were lost to follow-up before the end of the trial. None of the trials examined the impact of lorcaserin on the clinical complications of obesity. From an average initial weight of about 100 kg, patients taking lorcaserin lost only about 3 kg more than those in the placebo groups.The patients put on weight again after lorcaserin was discontinued. Adverse effects observed in clinical trials were mainly gastrointestinal (dry mouth, nausea) and neuropsychiatric (dizziness, fatigue, headache, euphoria). The incidence of cardiac valve disorders was higher with lorcaserin than with placebo. These trials were too short in duration to exclude a risk of cancer (breast cancer and astrocytoma) that was reported in experimental animals. This serotonin agonist is metabolised by the liver, creating a risk of multiple drug interactions. In practice, lorcaserin has not been shown to prevent complications of obesity or even lead to substantial weight loss.There is therefore no justification for exposing patients to the risk of adverse effects.

[Developing a harmonised system for the recognition of clinical trials for veterinary product registration].

PubMed

Maliandi, F S

2008-12-01

The increase of commerce between developing countries requires a harmonised system for accepting the results of clinical trials (CT) of veterinary products, similar to those that exist in developed countries. The objective of this paper is to propose a basis for the creation of a system that harmonises CTs for approving veterinary products (VP) for registration. Such a system would be a step towards unifying the CTs of different countries, while maintaining country-specific variations that are compatible with the scientific method, international standards, and the principles of objectivity, transparency and confidentiality. Basic requirements to be fulfilled by both private institutions and public offices are described, as are professional responsibilities and possible administrative procedures that could be adapted in each country. The conclusion reached is that a harmonised system is feasible, as has been demonstrated in numerous countries throughout the world. A harmonised system will result in a more efficient product approval process, a reduction in costs, greater transparency in controls, an improvement in the reliability of the health system, and a reduction in the time the process takes. It will also contribute to animal welfare by avoiding the need to repeat trials. The author acknowledges that there are cultural, technological and economic limitations and that these problems, and others, have yet to be overcome.

Effectiveness of a motivational intervention on overweight/obese patients in the primary healthcare: a cluster randomized trial.

PubMed

Rodriguez-Cristobal, Juan Jose; Alonso-Villaverde, Carlos; Panisello, Jose Ma; Travé-Mercade, Pere; Rodriguez-Cortés, Francisca; Marsal, Josep Ramon; Peña, Esther

2017-06-20

Overweight and obesity are common health problems which increase the risk of developing several serious health conditions. The main difficulty in the management of weight-loss lies in its maintenance, once it is achieved. The aim of this study was to investigate whether a motivational intervention, together with current clinical practice, was more efficient than a traditional intervention, in the treatment of overweight and obesity and whether this intervention reduces cardiovascular risk factors associated with overweight and obesity. Multi-centre cluster randomized trial with a 24-month follow-up included 864 overweight/obese patients randomly assigned. Motivational intervention group (400 patients), delivered by a nurse trained by an expert psychologist, in 32 sessions, 1 to 12 fortnightly, and 13 to 32, monthly, on top of their standard programmed diet and exercise. The control group (446 patients), received the usual follow-up. Weight reduction was statistically significant in the second year with a mean reduction of 1.0 Kg in the control group and 2.5 Kg in the intervention group (p = 0. 02). While 18.1% of patients in the control group reduced their weight by more than 5%, this percentage rose to 26.9% in the intervention group, which is statistically significant (p = 0.04). Patients in the motivational intervention group had significantly greater improvements in triglycerides and APOB/APOA1ratio. The results highlight the importance of the group motivational interview in the treatment of overweight /obese patients in primary care, and in the improvement of their associated cardiovascular risks factors. ClinicalTrials.gov Identifier: NCT01006213 October 30, 2009.

Sugars, obesity, and cardiovascular disease: results from recent randomized control trials.

PubMed

Rippe, James M; Angelopoulos, Theodore J

2016-11-01

The relationship between sugar consumption and various health-related sequelas is controversial. Some investigators have argued that excessive sugar consumption is associated with increased risk of obesity, coronary heart disease, diabetes (T2D), metabolic syndrome, non-alcoholic fatty liver disease, and stimulation of reward pathways in the brain potentially causing excessive caloric consumption. These concerns have influenced organizations such as the World Health Organization, the Scientific Advisory Committee on Nutrition in England not to exceed 5 % of total energy and the Dietary Guidelines for Americans Advisory Committee 2015 to recommend upper limits of sugar consumption not to exceed 10 % of calories. Data from many randomized control trials (RCTs) do not support linkages between sugar consumption at normal levels within the human diet and various adverse metabolic and health-related effects. Fructose and glucose are typically consumed together in roughly equal proportions from high-fructose corn syrup (also known as isoglucose in Europe) or sucrose. The purpose of this review is to present data from recent RCTs and findings from recent systematic reviews and meta-analyses related to sugar consumption and its putative health effects. This review evaluates findings from recent randomized controlled trials, systematic reviews and meta-analyses into the relationship of sugar consumption and a range of health-related issues including energy-regulating hormones, obesity, cardiovascular disease, diabetes, and accumulation of liver fat and neurologic responses. Data from these sources do not support linkages between sugar consumption at normal levels within the human diet and various adverse metabolic and health-related effects.

Health-related quality of life in randomized controlled trials of lorcaserin for obesity management: what mediates improvement?

PubMed

Kolotkin, R L; Crosby, R D; Wang, Z

2017-12-01

Lorcaserin, plus diet and exercise, has demonstrated significant weight loss and improved cardiometabolic parameters vs. placebo in patients with overweight/obesity in three randomized, placebo-controlled trials. We examined whether lorcaserin is also associated with greater improvements in health-related quality of life (HRQOL) and whether these improvements are wholly attributable to weight loss. Pooled data from Behavioral Modification and Lorcaserin for Overweight and Obesity Management (BLOOM), Behavioral Modification and Lorcaserin Second Study for Obesity Management (BLOSSOM) and BLOOM-Diabetes Mellitus (BLOOM-DM) trials were analysed (n = 5624). HRQOL was assessed at baseline and 52 weeks using the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire. Multiple mediation analyses were conducted to evaluate the mechanisms underlying improved HRQOL. Greater HRQOL improvements were observed at 52 weeks in lorcaserin vs. placebo (P < 0.0001). A greater percentage of lorcaserin patients (54.1%) experienced meaningful improvements in IWQOL-Lite total score than placebo patients (48.2%) (P < 0.001). Body mass index (BMI) reduction was the primary driver of improved HRQOL (P < 0.0001), with depressive symptoms and total cholesterol also playing a role (P < 0.05). Improved HRQOL varied by gender, age, race and presence of diabetes and other comorbidities. Lorcaserin treatment significantly improves HRQOL compared with placebo. Although BMI reduction accounts for the majority of these improvements, improvement in depressive symptoms and total cholesterol are contributing factors. © 2017 World Obesity Federation.

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.

Effectiveness of social marketing strategies to reduce youth obesity in European school-based interventions: a systematic review and meta-analysis.

PubMed

Aceves-Martins, Magaly; Llauradó, Elisabet; Tarro, Lucia; Moreno-García, Carlos Francisco; Trujillo Escobar, Tamy Goretty; Solà, Rosa; Giralt, Montse

2016-05-01

The use of social marketing to modify lifestyle choices could be helpful in reducing youth obesity. Some or all of the 8 domains of the National Social Marketing Centre's social marketing benchmark criteria (SMBC) are often used but not always defined in intervention studies. The aim of this review is to assess the effectiveness of European school-based interventions to prevent obesity relative to the inclusion of SMBC domains in the intervention. The PubMed, Cochrane, and ERIC databases were used. Nonrandomized and randomized controlled trials conducted from 1990 to April 2014 in participants aged 5 to 17 years were included. After the study selection, the 8 domains of the SMBC were assessed in each included study. Thirty-eight publications were included in the systematic review. For the meta-analysis, randomized controlled trials (RCTs) reporting body mass index or prevalence of overweight and obesity were considered. Eighteen RCTs with a total of 8681 participants included at least 5 SMBC. The meta-analysis showed a small standardized mean difference in body mass index of -0.25 (95%CI, -0.45 to -0.04) and a prevalence of overweight and obesity odds ratio of 0.72 (95%CI, 0.5-0.97). Current evidence indicates that the inclusion of at least 5 SMBC domains in school-based interventions could benefit efforts to prevent obesity in young people. PROSPERO registration number: CRD42014007297. © The Author(s) 2016. Published by Oxford University Press on behalf of the International Life Sciences Institute.

Assessing parental self-efficacy for obesity prevention related behaviors

PubMed Central

2014-01-01

Background Reliable, valid and theoretically consistent measures that assess a parent’s self-efficacy for helping a child with obesity prevention behaviors are lacking. Objectives To develop measures of parental self-efficacy for four behaviors: 1) helping their child get at least 60 minutes of moderate intensity physical activity every day, 2) helping one’s child consume five servings of fruits and vegetables each day, 3) limiting sugary drinks to once a week, and 4) limiting consumption of fruit juice to 6 ounces every day. Methods Sequential methods of scale development were used. An item pool was generated based on theory and qualitative interviews, and reviewed by content experts. Scales were administered to parents or legal guardians of children 4–10 years old. The item pool was reduced using principal component analysis. Confirmatory factor analysis tested the resulting models in a separate sample. Subjects 304 parents, majority were women (88%), low-income (61%) and single parents (61%). Ethnic distribution was 40% Black and 37% white. Results All scales had excellent fit indices: Comparative fit index > .98 and chi-squares (Pediatrics 120 Suppl 4:S229-253, 2007) = .85 – 7.82. Alphas and one-week test-retest ICC’s were ≥ .80. Significant correlations between self-efficacy scale scores and their corresponding behaviors ranged from .13-.29 (all p < .03). Conclusions We developed four, four-item self-efficacy scales with excellent psychometric properties and construct validity using diverse samples of parents. Trial registration Clinical trial registration: NCT01768533. PMID:24750693

Infant adiposity following a randomised controlled trial of a behavioural intervention in obese pregnancy

PubMed Central

Patel, Nashita; Godfrey, Keith M.; Pasupathy, Dharmintra; Levin, Julia; Flynn, Angela C; Hayes, Louise; Briley, Annette L; Bell, Ruth; Lawlor, Debbie A; Oteng-Ntim, Eugene; Nelson, Scott M.; Robson, Stephen C.; Sattar, Naveed; Singh, Claire; Wardle, Jane; White, Sara; Seed, Paul T; Poston, Lucilla

2017-01-01

Objective Randomised controlled trials are required to address causality in the reported associations between maternal influences and offspring adiposity. The aim of this study was to determine whether an antenatal lifestyle intervention in obese pregnant women associated with improved maternal diet and reduced gestational weight gain leads to a reduction in infant adiposity and sustained improvements in maternal lifestyle behaviours at 6 months postpartum. Subjects and Methods We conducted a planned postnatal follow up of a randomised controlled trial (UPBEAT) of a complex behavioural intervention targeting maternal diet (glycemic load and saturated fat intake) and physical activity in 1555 obese pregnant women. The main outcome measure was infant adiposity, assessed by subscapular and triceps skinfold thicknesses. Maternal diet and physical activity, indices of the familial lifestyle environment, were assessed by questionnaire. Results 698 (45.9%) infants (342 intervention, 356 standard antenatal care) were followed up at mean age 5.92 months. There was no difference in triceps skinfold thickness z-scores between the intervention vs. standard care arms (difference -0.14 SD, 95% CI -0.38 to 0.10, p=0.246), but subscapular skinfold thickness z-score was 0.26 SD (-0.49 to -0.02; p=0.03) lower in the intervention arm. Maternal dietary glycemic load (-35.34; -48.0 to -22.67; p<0.001) and saturated fat intake (-1.93% energy; -2.64 to -1.22; p<0.001) were reduced in the intervention arm at 6 months postpartum. Causal mediation analysis suggested that lower infant subscapular skinfold thickness was mediated by changes in antenatal maternal diet and gestational weight gain rather than postnatal diet. Conclusion This study provides evidence from follow-up of a randomised controlled trial that a maternal behavioural intervention in obese pregnant women has the potential to reduce infant adiposity and to produce a sustained improvement in maternal diet at 6 months postpartum

The First 500 Registrations to the Research Registry®: Advancing Registration of Under-Registered Study Types.

PubMed

Agha, Riaz; Fowler, Alexander J; Limb, Christopher; Al Omran, Yasser; Sagoo, Harkiran; Koshy, Kiron; Jafree, Daniyal J; Anwar, Mohammed Omer; McCullogh, Peter; Orgill, Dennis Paul

2016-01-01

The Declaration of Helsinki 2013 encourages the registration of all research studies involving human participants. However, emphasis has been placed on prospective clinical trials, and it is estimated that only 10% of observational studies are registered. In response, Research Registry ® was launched in February 2015; a retrospectively curated registry that is free and easy to use. Research Registry ® enables prospective or retrospective registration of studies, including those study types that cannot be registered on existing registries. In this study, we describe the first 500 registrations on Research Registry ® . Since the launch of Research Registry ® in February 2015, data of registrations have been collected, including type of studies registered, country of origin, and data curation activity. Inappropriate registrations, such as duplicates, were identified by the data curation process. These were removed from the database or modified as required. A quality score was assigned for each registration, based on Sir Austin Bradford Hill's criteria on what research studies should convey. Changes in quality scores over time were assessed. A total of 500 studies were registered on Research Registry ® from February 2015 to October 2015, with a total of 1.7 million patients enrolled. The most common study types were retrospective cohort studies (37.2%), case series (14.8%), and first-in-man case reports (10.4%). Registrations were received from 57 different countries; the most submissions were received from Turkey, followed by China and the United Kingdom. Retrospective data curation identified 80 studies that were initially registered as the incorrect study type, and were subsequently correct. The Kruskal-Wallis test identified a significant improvement in quality scores for registrations from February 2015 to October 2015 ( p  < 0.0001). Since its conception in February 2015, Research Registry ® has established itself as a new registry that is free, easy to

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.

Efficacy of prophylactic antibiotic administration for breast cancer surgery in overweight or obese patients: a randomized controlled trial.

PubMed

Gulluoglu, Bahadir M; Guler, Sertac Ata; Ugurlu, M Umit; Culha, Gulcan

2013-01-01

To assess the impact of prophylactic antibiotics on the prevention of surgical site infection (SSI) and the cost-effectiveness of this prophylaxis for breast cancer surgery in overweight or obese women. SSI is higher than expected after breast surgery. Obesity was found to be one of the risk factors. The trial was designed as a phase IV randomized, controlled, parallel-group efficacy trial. It was conducted at a tertiary university hospital. Overweight or obese women with clinically early-stage breast cancer who had been assigned to undergo surgery were eligible. Patients were randomly allocated to either a prophylaxis or a control group by using a computer-generated list. The prophylaxis group received 1 g ampicillin-sulbactam intravenously at anesthesia. The control group received no intervention. Patients and observers were blinded to the assignments. The primary outcome was the comparison of SSI incidences of the 2 groups. Patients were monitored for 30 days. A total of 369 patients were included in final analysis, out of which 187 were allocated for prophylaxis and 182 were randomly assigned to the control group. Analysis was done according to the intention-to-treat principle. Prophylaxis significantly reduced the SSI rate (4.8%) in the prophylaxis group when compared with that in the control group [13.7%; relative risk (RR) 0.35; 95% CI: 0.17-0.73]. No adverse reaction was observed. The mean SSI-related cost (20.26 USD) was found to be significantly higher in the control group when compared with that (8.48 USD) in the prophylaxis group. Antibiotic prophylaxis significantly decreased SSI incidence after elective surgery and was shown to be cost-effective in obese breast cancer patients. ClinicalTrials.gov Identifier: NCT00356148.

A randomized trial Examining The Impact Of Communicating Genetic And Lifestyle Risks For Obesity.

PubMed

Wang, Catharine; Gordon, Erynn S; Norkunas, Tricia; Wawak, Lisa; Liu, Ching-Ti; Winter, Michael; Kasper, Rachel S; Christman, Michael F; Green, Robert C; Bowen, Deborah J

2016-12-01

Genetic testing for obesity is available directly to consumers, yet little is understood about its behavioral impact and its added value to nongenetic risk communication efforts based on lifestyle factors. A randomized trial examined the short-term impact of providing personalized obesity risk information, using a 2 × 2 factorial design. Participants were recruited from the Coriell Personalized Medicine Collaborative (CPMC) and randomized to receive (1) no risk information (control), (2) genetic risk, (3) lifestyle risk, or (4) combined genetic/lifestyle risks. Baseline and 3-month follow-up survey data were collected. Analyses examined the impact of risk feedback on intentions to lose weight and self-reported weight. A total of 696 participants completed the study. A significant interaction effect was observed for genetic and lifestyle information on intent to lose weight (P = 0.0150). Those who received genetic risk alone had greater intentions at follow-up, compared with controls (P = 0.0034). The impact of receiving elevated risk information on intentions varied by source and combination of risks presented. Non-elevated genetic risk did not lower intentions. No group differences were observed for self-reported weight. Genetic risk information for obesity may add value to lifestyle risk information depending on the context in which it is presented. © 2016 The Obesity Society.

SWITCH: rationale, design, and implementation of a community, school, and family-based intervention to modify behaviors related to childhood obesity

PubMed Central

Eisenmann, Joey C; Gentile, Douglas A; Welk, Gregory J; Callahan, Randi; Strickland, Sarah; Walsh, Monica; Walsh, David A

2008-01-01

Background Although several previous projects have attempted to address the issue of child obesity through school-based interventions, the overall effectiveness of school-based programs on health-related outcomes in youth has been poor. Thus, it has been suggested that multi-level interventions that aim to influence healthy lifestyle behaviors at the community, school and family levels may prove more successful in the prevention of childhood obesity. Methods/Design This paper describes the rationale, design, and implementation of a community-, school-, and family-based intervention aimed at modifying key behaviors (physical activity, screen time (Internet, television, video games), and nutrition) related to childhood obesity among third through fifth graders in two mid-western cities. The intervention involves a randomized study of 10 schools (5 intervention and 5 control schools). The intervention is being conducted during the duration of the academic year – approximately 9 months – and includes baseline and post-intervention measurements of physical activity, dietary intake, screen time and body composition. Discussion We hope this report will be useful to researchers, public health professionals, and school administrators and health professionals (nurses and physical/health educators) seeking to develop similar prevention programs. It is obvious that more collaborative, inter-disciplinary, multi-level work is needed before a proven, effective intervention package to modify behaviors related to childhood obesity can be generally recommended. It is our hope that SWITCH is a step in that direction. Trial Registration ClinicalTrials.gov NCT00685555 PMID:18588706

The effect of family-based multidisciplinary cognitive behavioral treatment in children with obesity: study protocol for a randomized controlled trial.

PubMed

Vos, Rimke C; Wit, Jan M; Pijl, Hanno; Kruyff, Carolien C; Houdijk, Euphemia C A M

2011-05-06

The prevalence of childhood obesity has increased rapidly during the last three decades in the Netherlands. It is assumed that mainly environmental factors have contributed to this trend. Parental overweight and low social economic status are risk factors for childhood obesity. Childhood obesity affects self-esteem and has negative consequences on cognitive and social development. Obese children tend to become obese adults, which increases the risk for developing cardiovascular complications, type 2 diabetes mellitus, and psychosocial problems. Additionally, the secretion of several gastrointestinal hormones, responsible for appetite and food intake, is impaired in obese subjects. Weight reduction through lifestyle changes in order to change health risks is, until now, suggested as the preferred treatment for childhood obesity.The objective of this study is the effect evaluation of a family-based cognitive behavioral multidisciplinary lifestyle treatment. The intervention aims to establish long-term weight reduction and stabilization, reduction of obesity-related health consequences and improvement of self-image by change of lifestyle and learning cognitive behavioral techniques. In this randomized clinical trial newly presented children with obesity (8-17 years old) are divided, by randomization, in an intervention and control group, both consisting of 40 obese children. The intervention is carried out in groups of 8-11 children, and consists of respectively 7 and 5 separate group meetings for the children and their parents and 1 joint group meeting of 2 ½ hours. Main topics are education on nutrition, self-control techniques, social skills, physical activity and improvement of self-esteem. The control group is given advice on physical activity and nutrition. For normal data comparison, data were collected of 40 normal-weight children, 8-17 years old. Because of the increasing prevalence of childhood obesity and the impact on the individual as well as on society

Effects of Proximity to Supermarkets on a Randomized Trial Studying Interventions for Obesity

PubMed Central

Kleinman, Ken; Melly, Steven J.; Sharifi, Mona; Marshall, Richard; Block, Jason; Cheng, Erika R.; Taveras, Elsie M.

2016-01-01

Objectives. To determine whether proximity to a supermarket modified the effects of an obesity intervention. Methods. We examined 498 children aged 6 to 12 years with a body mass index (BMI) at or above the 95th percentile participating in an obesity trial in Massachusetts in 2011 to 2013. The practice-based interventions included computerized clinician decision support plus family self-guided behavior change or health coaching. Outcomes were 1-year change in BMI z-score, sugar-sweetened beverage intake, and fruit and vegetable intake. We examined distance to the closest supermarket as an effect modifier. Results. Distance to supermarkets was an effect modifier of 1-year change in BMI z-score and fruit and vegetable intake but not sugar-sweetened beverage intake. With each 1-mile shorter distance to a supermarket, intervention participants increased their fruit and vegetable intake by 0.29 servings per day and decreased their BMI z-score by −0.04 units relative to controls. Conclusions. Living closer to a supermarket is associated with greater improvements in fruit and vegetable intake and weight status in an obesity intervention. PMID:26794159

Parent-only interventions in the treatment of childhood obesity: a systematic review of randomized controlled trials.

PubMed

Ewald, H; Kirby, J; Rees, K; Robertson, W

2014-09-01

An effective and cost-effective treatment is required for the treatment of childhood obesity. Comparing parent-only interventions with interventions including the child may help determine this. A systematic review of published and ongoing studies until 2013, using electronic database and manual searches. randomized controlled trials, overweight/obese children aged 5-12 years, parent-only intervention compared with an intervention that included the child, 6 months or more follow-up. Outcomes included measures of overweight. Ten papers from 6 completed studies, and 2 protocols for ongoing studies, were identified. Parent-only groups are either more effective than or similarly effective as child-only or parent-child interventions, in the change in degree of overweight. Most studies were at unclear risk of bias for randomization, allocation concealment and blinding of outcome assessors. Two trials were at high risk of bias for incomplete outcome data. Four studies showed higher dropout from parent-only interventions. One study examined programme costs and found parent-only interventions to be cheaper. Parent-only interventions appear to be as effective as parent-child interventions in the treatment of childhood overweight/obesity, and may be less expensive. Reasons for higher attrition rates in parent-only interventions need further investigation. © 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.

Obesity is associated with fatal coronary heart disease independently of traditional risk factors and deprivation.

PubMed

Logue, Jennifer; Murray, Heather M; Welsh, Paul; Shepherd, James; Packard, Chris; Macfarlane, Peter; Cobbe, Stuart; Ford, Ian; Sattar, Naveed

2011-04-01

The effect of body mass index (BMI) on coronary heart disease (CHD) risk is attenuated when mediators of this risk (such as diabetes, hypertension and hyperlipidaemia) are accounted for. However, there is now evidence of a differential effect of risk factors on fatal and non-fatal CHD events, with markers of inflammation more strongly associated with fatal than non-fatal events. To describe the association with BMI separately for both fatal and non-fatal CHD risk after accounting for classical risk factors and to assess any independent effects of obesity on CHD risk. In the West of Scotland Coronary Prevention Study BMI in 6082 men (mean age 55 years) with hypercholesterolaemia, but no history of diabetes or CVD, was related to the risk of fatal and non-fatal CHD events. After excluding participants with any event in the first 2 years, 1027 non-fatal and 214 fatal CHD events occurred during 14.7 years of follow-up. A minimally adjusted model (age, sex, statin treatment) and a maximally adjusted model (including known CVD risk factors and deprivation) were compared, with BMI 25-27.4 kg/m² as referent. The risk of non-fatal events was similar across all BMI categories in both models. The risk of fatal CHD events was increased in men with BMI 30.0-39.9 kg/m² in both the minimally adjusted model (HR = 1.75 (95% CI 1.12 to 2.74)) and the maximally adjusted model (HR = 1.60 (95% CI 1.02 to 2.53)). These hypothesis generating data suggest that obesity is associated with fatal, but not non-fatal, CHD after accounting for known cardiovascular risk factors and deprivation. Clinical trial registration WOSCOPS was carried out and completed before the requirement for clinical trial registration.

Effects of exercise amount and intensity on abdominal obesity and glucose tolerance in obese adults: a randomized trial.

PubMed

Ross, Robert; Hudson, Robert; Stotz, Paula J; Lam, Miu

2015-03-03

Exercise reduces obesity and related glucose tolerance, but whether increasing exercise intensity offers additional benefit at fixed exercise amounts is unknown. To determine the separate effects of exercise amount and intensity on abdominal obesity and glucose tolerance. 24-week, single-center, parallel-group trial from 2009 to 2013. (ClinicalTrials.gov: NCT00955071). Kingston, Ontario, Canada. 300 abdominally obese adults. Control (no exercise) (n = 75) or 5 weekly sessions of low-amount, low-intensity exercise (LALI) (180 and 300 kcal/session for women and men, respectively, at 50% of maximum oxygen consumption [V̇o2peak]) (n = 73); high-amount, low-intensity exercise (HALI) (360 and 600 kcal/session, respectively, at 50% of V̇o2peak) (n = 76); or high-amount, high-intensity exercise (HAHI) (360 and 600 kcal/session, respectively, at 75% of V̇o2peak) (n = 76). Daily unsupervised physical activity and sedentary time were measured by accelerometer. Waist circumference and 2-hour glucose level (primary outcomes) and cardiorespiratory fitness and measures of insulin action (secondary measurements). 217 participants (72.3%) completed the intervention. Mean exercise time in minutes per session was 31 (SD, 4.4) for LALI, 58 (SD, 7.6) for HALI, and 40 (SD, 6.2) for HAHI. Daily unsupervised physical activity and sedentary time did not change in any exercise group versus control (P > 0.33). After adjustment for age and sex in a linear mixed model, reductions in waist circumference were greater in the LALI (-3.9 cm [95% CI, -5.6 to -2.3 cm]; P < 0.001), HALI (-4.6 cm [CI, -6.2 to -3.0 cm]; P < 0.001), and HAHI (-4.6 cm [CI, -6.3 to -2.9 cm]; P < 0.001) groups than the control group but did not differ among the exercise groups (P > 0.43). After adjustment for covariates, reductions in 2-hour glucose level were greater in the HAHI group (-0.7 mmol/L [-12.5 mg/dL] [CI, -1.3 to -0.1 mmol/L {-23.5 to -1.5 mg/dL}]; P = 0.027) than the control group but did not differ for the

Preventing Obesity in the Military Community (POMC): The Development of a Clinical Trials Research Network

PubMed Central

Spieker, Elena A.; Sbrocco, Tracy; Theim, Kelly R.; Maurer, Douglas; Johnson, Dawn; Bryant, Edny; Bakalar, Jennifer L.; Schvey, Natasha A.; Ress, Rachel; Seehusen, Dean; Klein, David A.; Stice, Eric; Yanovski, Jack A.; Chan, Linda; Gentry, Shari; Ellsworth, Carol; Hill, Joanne W.; Tanofsky-Kraff, Marian; Stephens, Mark B.

2015-01-01

Obesity impacts the U.S. military by affecting the health and readiness of active duty service members and their families. Preventing Obesity in Military Communities (POMC) is a comprehensive research program within Patient Centered Medical Homes (PCMHs) in three Military Training Facilities. This paper describes three pilot randomized controlled trials that target critical high risk periods for unhealthy weight gain from birth to young adulthood: (1) pregnancy and early infancy (POMC-Mother-Baby), (2) adolescence (POMC-Adolescent), and (3) the first tour of duty after boot camp (POMC-Early Career). Each study employs a two-group randomized treatment or prevention program with follow up. POMC offers a unique opportunity to bring together research and clinical expertise in obesity prevention to develop state-of-the-art programs within PCMHs in Military Training Facilities. This research builds on existing infrastructure that is expected to have immediate clinical benefits to DoD and far-reaching potential for ongoing collaborative work. POMC may offer an economical approach for widespread obesity prevention, from conception to young adulthood, in the U.S. military as well as in civilian communities. PMID:25648176

A Dietary Supplement Containing Cinnamon, Chromium and Carnosine Decreases Fasting Plasma Glucose and Increases Lean Mass in Overweight or Obese Pre-Diabetic Subjects: A Randomized, Placebo-Controlled Trial

PubMed Central

Liu, Yuejun; Cotillard, Aurélie; Vatier, Camille; Bastard, Jean-Philippe; Fellahi, Soraya; Stévant, Marie; Allatif, Omran; Langlois, Clotilde; Bieuvelet, Séverine; Brochot, Amandine; Guilbot, Angèle; Clément, Karine; Rizkalla, Salwa W.

2015-01-01

Background Preventing or slowing the progression of prediabetes to diabetes is a major therapeutic issue. Objectives Our aim was to evaluate the effects of 4-month treatment with a dietary supplement containing cinnamon, chromium and carnosine in moderately obese or overweight pre-diabetic subjects, the primary outcome being change in fasting plasma glucose (FPG) level. Other parameters of plasma glucose homeostasis, lipid profile, adiposity and inflammatory markers were also assessed. Methods In a randomized, double-blind, placebo-controlled study, 62 subjects with a FPG level ranging from 5.55 to 7 mmol/L and a body mass index ≥25 kg/m2, unwilling to change their dietary and physical activity habits, were allocated to receive a 4-month treatment with either 1.2 g/day of the dietary supplement or placebo. Patients were followed up until 6 months post-randomization. Results Four-month treatment with the dietary supplement decreased FPG compared to placebo (-0.24±0.50 vs +0.12±0.59 mmol/L, respectively, p = 0.02), without detectable significant changes in HbA1c. Insulin sensitivity markers, plasma insulin, plasma lipids and inflammatory markers did not differ between the treatment groups. Although there were no significant differences in changes in body weight and energy or macronutrient intakes between the two groups, fat-free mass (%) increased with the dietary supplement compared to placebo (p = 0.02). Subjects with a higher FPG level and a milder inflammatory state at baseline benefited most from the dietary supplement. Conclusions Four-month treatment with a dietary supplement containing cinnamon, chromium and carnosine decreased FPG and increased fat-free mass in overweight or obese pre-diabetic subjects. These beneficial effects might open up new avenues in the prevention of diabetes. Trial Registration ClinicalTrials.gov NCT01530685 PMID:26406981

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.

Reducing pediatric caries and obesity risk in South Asian immigrants: randomized controlled trial of common health/risk factor approach.

PubMed

Karasz, Alison; Bonuck, Karen

2018-05-31

This paper describes the design and methods of a multi-phase study to reduce early childhood caries and obesity in vulnerable South Asian (SA) immigrants in the United States. Early childhood caries and obesity are the most common diseases of early childhood. Risk factors for both diseases are rooted in early childhood feeding practices such as bottle feeding and intake of sweets and sweetened beverages. The Common Health/Risk Factor Approach to addressing oral health is widely promoted by the WHO and other policy makers. This approach recognizes links between oral health and other diseases of modernity. Our CHALO! ("Child Health Action to Lower Obesity and Oral health risk"--from a Hindi word meaning "Let's go!") study targets SA families at high risk for early childhood caries and obesity. CHALO! addresses common risk factors associated with these two common diseases of childhood. This two part project includes a randomized controlled trial, and a Knowledge Translation campaign. A randomized controlled trial will enroll n =  360 families from pediatric practices serving South Asians in the New York metro area. The intervention group will receive home visits by SA community health workers at 6, 8, 10, 12, 14, and 16 months of age. Controls will receive culturally tailored educational material. Primary outcomes-- cariogenic and obesogenic feeding practices at 6, 12, and 18 months-- will be assessed with the MySmileBuddy iPad based tool. Secondary outcomes include: oral hygiene practices, anthropometrics, and caries incidence at 18 months. A public education campaign will focus on both families and health care providers. There are few Common Health/Risk Factor Approach published studies on obesity and oral health risk in children, despite health morbidity and costs associated with both conditions. CHALO! comprises a multi-level interventions designed to promote culturally competent, sustainable change. ClinicalTrials.gov NCT03077425 .

Economic evaluation of a primary care trial to reduce weight gain in overweight/obese children: the LEAP trial.

PubMed

Wake, Melissa; Gold, Lisa; McCallum, Zoë; Gerner, Bibi; Waters, Elizabeth

2008-01-01

A common policy response to the childhood obesity epidemic is to recommend that primary care physicians screen for and offer counseling to the overweight/obese. As the literature suggests, this approach may be ineffective; it is important to document the opportunity costs incurred by brief primary care obesity interventions that ultimately may not alter body mass index (BMI) trajectory. Live, Eat and Play (LEAP) was a randomized controlled trial of a brief secondary prevention intervention delivered by family physicians in 2002-2003 that targeted overweight/mildly obese children aged 5 to 9 years. Primary care utilization was prospectively audited via medical records, and parents reported family resource use by written questionnaire. Outcome measures were BMI (primary) and parent-reported physical activity and dietary habits (secondary) in intervention compared with control children. The cost of LEAP per intervention family was AU $4094 greater than for control families, mainly due to increased family resources devoted to child physical activity. Total health sector costs were AU $873 per intervention family and AU $64 per control, a difference of AU $809 (P < .001). At 15 months, intervention children did not differ significantly in adjusted BMI or daily physical activity scores compared with the control group, but dietary habits had improved. This brief intervention resulted in higher costs to families and the health care sector, which could have been devoted to other uses that do create benefits to health and/or family well-being. This has implications for countries such as the United States, the United Kingdom, and Australia, whose current guidelines recommend routine surveillance and counseling for high child BMI in the primary care sector.

Dietary interventions in overweight and obese pregnant women: a systematic review of the content, delivery, and outcomes of randomized controlled trials.

PubMed

Flynn, Angela C; Dalrymple, Kathryn; Barr, Suzanne; Poston, Lucilla; Goff, Louise M; Rogozińska, Ewelina; van Poppel, Mireille N M; Rayanagoudar, Girish; Yeo, SeonAe; Barakat Carballo, Ruben; Perales, Maria; Bogaerts, Annick; Cecatti, Jose G; Dodd, Jodie; Owens, Julie; Devlieger, Roland; Teede, Helena; Haakstad, Lene; Motahari-Tabari, Narges; Tonstad, Serena; Luoto, Riitta; Guelfi, Kym; Petrella, Elisabetta; Phelan, Suzanne; Scudeller, Tânia T; Hauner, Hans; Renault, Kristina; Sagedal, Linda Reme; Stafne, Signe N; Vinter, Christina; Astrup, Arne; Geiker, Nina R W; McAuliffe, Fionnuala M; Mol, Ben W; Thangaratinam, Shakila

2016-05-01

Interventions targeting maternal obesity are a healthcare and public health priority. The objective of this review was to evaluate the adequacy and effectiveness of the methodological designs implemented in dietary intervention trials for obesity in pregnancy. A systematic review of the literature, consistent with PRISMA guidelines, was performed as part of the International Weight Management in Pregnancy collaboration. Thirteen randomized controlled trials, which aimed to modify diet and physical activity in overweight and obese pregnant women, were identified. There was significant variability in the content, delivery, and dietary assessment methods of the dietary interventions examined. A number of studies demonstrated improved dietary behavior in response to diet and/or lifestyle interventions. Nine studies reduced gestational weight gain. This review reveals large methodological variability in dietary interventions to control gestational weight gain and improve clinical outcomes in overweight and obese pregnant women. This lack of consensus limits the ability to develop clinical guidelines and apply the evidence in clinical practice. © The Author(s) 2016. Published by Oxford University Press on behalf of the International Life Sciences Institute. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

A randomized, double blind, cross-over, placebo-controlled clinical trial to assess the effects of Candesartan on the insulin sensitivity on non diabetic, non hypertense subjects with dysglyce mia and abdominal obesity. "ARAMIA"

PubMed Central

López-Jaramillo, Patricio; Pradilla, Lina P; Lahera, Vicente; Sieger, Federico A Silva; Rueda-Clausen, Christian F; Márquez, Gustavo A

2006-01-01

Candesartan, could improve the HOMA index, the response to the oral glucose tolerance test and reduce the plasma levels of adipoquines, oxidative stress and prothrombotic markers, in non diabetic, non hypertense subjects with dysglycemia and abdominal obesity, recruited from a population at high risk of developing insulin resistance. These effects are independent of the changes in arterial blood pressure. Trial registration: NCT00319202 PMID:16959033

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.

Intensive lifestyle intervention improves physical function among obese adults with knee pain: Findings from the Look AHEAD Trial

USDA-ARS?s Scientific Manuscript database

Lifestyle interventions have resulted in weight loss or improved physical fitness among individuals with obesity, which may lead to improved physical function. This prospective investigation involved participants in the Action for Health in Diabetes (Look AHEAD) trial who reported knee pain at basel...

Lower protein content in infant formula reduces BMI and obesity risk at school age: follow-up of a randomized trial.

PubMed

Weber, Martina; Grote, Veit; Closa-Monasterolo, Ricardo; Escribano, Joaquín; Langhendries, Jean-Paul; Dain, Elena; Giovannini, Marcello; Verduci, Elvira; Gruszfeld, Dariusz; Socha, Piotr; Koletzko, Berthold

2014-05-01

Early nutrition is recognized as a target for the effective prevention of childhood obesity. Protein intake was associated with more rapid weight gain during infancy-a known risk factor for later obesity. We tested whether the reduction of protein in infant formula reduces body mass index (BMI; in kg/m(2)) and the prevalence of obesity at 6 y of age. The Childhood Obesity Project was conducted as a European multicenter, double-blind, randomized clinical trial that enrolled healthy infants born between October 2002 and July 2004. Formula-fed infants (n = 1090) were randomly assigned to receive higher protein (HP)- or lower protein (LP)-content formula (within recommended amounts) in the first year of life; breastfed infants (n = 588) were enrolled as an observational reference group. We measured the weight and height of 448 (41%) formula-fed children at 6 y of age. BMI was the primary outcome. HP children had a significantly higher BMI (by 0.51; 95% CI: 0.13, 0.90; P = 0.009) at 6 y of age. The risk of becoming obese in the HP group was 2.43 (95% CI: 1.12, 5.27; P = 0.024) times that in the LP group. There was a tendency for a higher weight in HP children (0.67 kg; 95% CI: -0.04, 1.39 kg; P = 0.064) but no difference in height between the intervention groups. Anthropometric measurements were similar in the LP and breastfed groups. Infant formula with a lower protein content reduces BMI and obesity risk at school age. Avoidance of infant foods that provide excessive protein intakes could contribute to a reduction in childhood obesity. This trial was registered at clinicaltrials.gov as NCT00338689.

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

Optimizing Implementation of Obesity Prevention Programs: A Qualitative Investigation Within a Large-Scale Randomized Controlled Trial.

PubMed

Kozica, Samantha L; Teede, Helena J; Harrison, Cheryce L; Klein, Ruth; Lombard, Catherine B

2016-01-01

The prevalence of obesity in rural and remote areas is elevated in comparison to urban populations, highlighting the need for interventions targeting obesity prevention in these settings. Implementing evidence-based obesity prevention programs is challenging. This study aimed to investigate factors influencing the implementation of obesity prevention programs, including adoption, program delivery, community uptake, and continuation, specifically within rural settings. Nested within a large-scale randomized controlled trial, a qualitative exploratory approach was adopted, with purposive sampling techniques utilized, to recruit stakeholders from 41 small rural towns in Australia. In-depth semistructured interviews were conducted with clinical health professionals, health service managers, and local government employees. Open coding was completed independently by 2 investigators and thematic analysis undertaken. In-depth interviews revealed that obesity prevention programs were valued by the rural workforce. Program implementation is influenced by interrelated factors across: (1) contextual factors and (2) organizational capacity. Key recommendations to manage the challenges of implementing evidence-based programs focused on reducing program delivery costs, aided by the provision of a suite of implementation and evaluation resources. Informing the scale-up of future prevention programs, stakeholders highlighted the need to build local rural capacity through developing supportive university partnerships, generating local program ownership and promoting active feedback to all program partners. We demonstrate that the rural workforce places a high value on obesity prevention programs. Our results inform the future scale-up of obesity prevention programs, providing an improved understanding of strategies to optimize implementation of evidence-based prevention programs. © 2015 National Rural Health Association.

Healthy Homes/Healthy Kids: A Randomized Trial of a Pediatric Primary Care Based Obesity Prevention Intervention for At-Risk 5-10 Year Olds

PubMed Central

Sherwood, Nancy E.; Levy, Rona L.; Langer, Shelby L.; Senso, Meghan M.; Crain, A. Lauren; Hayes, Marcia G.; Anderson, Julie D.; Seburg, Elisabeth M.; Jeffery, Robert W.

2014-01-01

Pediatric primary care is an important setting in which to address obesity prevention, yet relatively few interventions have been evaluated and even fewer have been shown to be effective. The development and evaluation of cost-effective approaches to obesity prevention that leverage opportunities of direct access to families in the pediatric primary care setting, overcome barriers to implementation in busy practice settings, and facilitate sustained involvement of parents is an important public health priority. The goal of the Healthy Homes/Healthy Kids (HHHK 5-10) randomized controlled trial is to evaluate the efficacy of a relatively low-cost primary care-based obesity prevention intervention aimed at 5 to 10 year old children who are at risk for obesity. Four hundred twenty one parent/child dyads were recruited and randomized to either the obesity prevention arm or a contact control condition that focuses on safety and injury prevention. The HHHK 5-10 obesity prevention intervention combines brief counseling with a pediatric primary care provider during routine well-child visits and follow-up telephone coaching that supports parents in making home environmental changes to support healthful eating, activity patterns, and body weight. The contact control condition combines the same provider counseling with telephone coaching focused on safety and injury prevention messages. This manuscript describes the study design and baseline characteristics of participants enrolled in the HHHK 5-10 trial. PMID:23816490

Improvement of registration accuracy in accelerated partial breast irradiation using the point-based rigid-body registration algorithm for patients with implanted fiducial markers

DOE Office of Scientific and Technical Information (OSTI.GOV)

Inoue, Minoru; Yoshimura, Michio, E-mail: myossy@kuhp.kyoto-u.ac.jp; Sato, Sayaka

2015-04-15

Purpose: To investigate image-registration errors when using fiducial markers with a manual method and the point-based rigid-body registration (PRBR) algorithm in accelerated partial breast irradiation (APBI) patients, with accompanying fiducial deviations. Methods: Twenty-two consecutive patients were enrolled in a prospective trial examining 10-fraction APBI. Titanium clips were implanted intraoperatively around the seroma in all patients. For image-registration, the positions of the clips in daily kV x-ray images were matched to those in the planning digitally reconstructed radiographs. Fiducial and gravity registration errors (FREs and GREs, respectively), representing resulting misalignments of the edge and center of the target, respectively, were comparedmore » between the manual and algorithm-based methods. Results: In total, 218 fractions were evaluated. Although the mean FRE/GRE values for the manual and algorithm-based methods were within 3 mm (2.3/1.7 and 1.3/0.4 mm, respectively), the percentages of fractions where FRE/GRE exceeded 3 mm using the manual and algorithm-based methods were 18.8%/7.3% and 0%/0%, respectively. Manual registration resulted in 18.6% of patients with fractions of FRE/GRE exceeding 5 mm. The patients with larger clip deviation had significantly more fractions showing large FRE/GRE using manual registration. Conclusions: For image-registration using fiducial markers in APBI, the manual registration results in more fractions with considerable registration error due to loss of fiducial objectivity resulting from their deviation. The authors recommend the PRBR algorithm as a safe and effective strategy for accurate, image-guided registration and PTV margin reduction.« less

Recent advancements in drug treatment of obesity.

PubMed

Carter, Rebeca; Mouralidarane, Angelina; Ray, Shuvra; Soeda, Junpei; Oben, Jude

2012-10-01

The prevalence of obesity is rising worldwide, with the U.K. having the highest prevalence in Europe. Obesity is associated with significant morbidity and has substantial healthcare implications, with current projections estimating that by 2030 obesity will cost the NHS approximately pounds 2 billion each year. Lifestyle modification remains the cornerstone of anti-obesity treatment, but drugs can be introduced as adjuncts to assist and maintain weight loss. Some 1.45 million obesity-related prescriptions were dispensed in 2009, highlighting the high demand for obesity pharmacotherapy. At present, the lipase inhibitor orlistat (Xenical) is the only UK-approved long-term medical therapy for obesity. Double-blind clinical trials have shown that orlistat significantly increases weight loss compared to placebo, but the array of adverse side effects associated with orlistat limits its tolerability. The need for more effective and better-tolerated anti-obesity medications is clear and six therapies have reached phase-III trials.

Postoperative recovery after anesthesia in morbidly obese patients: a systematic review and meta-analysis of randomized controlled trials.

PubMed

Liu, Feng-Lin; Cherng, Yih-Giun; Chen, Shin-Yan; Su, Yen-Hao; Huang, Shih-Yu; Lo, Po-Han; Lee, Yen-Ying; Tam, Ka-Wai

2015-08-01

Obese patients present a challenge to safe general anesthesia because of impaired cardiopulmonary physiology and increased risks of aspiration and acute upper airway obstruction. Since studies are lacking regarding the postoperative effects on recovery from general anesthesia in morbidly obese patients, we conducted a systematic review and meta-analysis of recovery outcomes in morbidly obese patients who had undergone general anesthesia. We systematically searched the PubMed, EMBASE™, Cochrane, and Scopus™ databases for randomized controlled trials that evaluated the outcome of anesthesia with desflurane, sevoflurane, isoflurane, or propofol in morbidly obese patients. Using a random effects model, we conducted meta-analyses to assess recovery times (eye opening, hand squeezing, tracheal extubation, and stating name or birth date), time to discharge from the postanesthesia care unit (PACU), and the incidence and severity of postoperative nausea and vomiting (PONV). We reviewed results for 11 trials and found that patients given desflurane took less time: to respond to commands to open their eyes (weighted mean difference [WMD] -3.10 min; 95% confidence interval (CI): -5.13 to -1.08), to squeeze the investigator's hand (WMD -7.83 min; 95% CI: -8.81 to -6.84), to be prepared for tracheal extubation (WMD -3.88 min; 95% CI: -7.42 to -0.34), and to state their name (WMD -7.15 min; 95% CI: -11.00 to -3.30). We did not find significant differences in PACU discharge times, PONV, or the PACU analgesic requirement. Postoperative recovery was significantly faster after desflurane than after sevoflurane, isoflurane, or propofol anesthesia in obese patients. No clinically relevant differences were observed regarding PACU discharge time, incidence of PONV, or postoperative pain scores. The systematic review was registered with PROSPERO (CRD42014009480).

Healthy together Victoria and childhood obesity-a methodology for measuring changes in childhood obesity in response to a community-based, whole of system cluster randomized control trial.

PubMed

Strugnell, Claudia; Millar, Lynne; Churchill, Andrew; Jacka, Felice; Bell, Colin; Malakellis, Mary; Swinburn, Boyd; Allender, Steve

2016-01-01

Healthy Together Victoria (HTV) - a complex 'whole of system' intervention, including an embedded cluster randomized control trial, to reduce chronic disease by addressing risk factors (physical inactivity, poor diet quality, smoking and harmful alcohol use) among children and adults in selected communities in Victoria, Australia (Healthy Together Communities). To describe the methodology for: 1) assessing changes in the prevalence of measured childhood obesity and associated risks between primary and secondary school students in HTV communities, compared with comparison communities; and 2) assessing community-level system changes that influence childhood obesity in HTC and comparison communities. Twenty-four geographically bounded areas were randomized to either prevention or comparison (2012). A repeat cross-sectional study utilising opt-out consent will collect objectively measured height, weight, waist and self-reported behavioral data among primary [Grade 4 (aged 9-10y) and Grade 6 (aged 11-12y)] and secondary [Grade 8 (aged 13-14y) and Grade 10 (aged 15-16y)] school students (2014 to 2018). Relationships between measured childhood obesity and system causes, as defined in the Foresight obesity systems map, will be assessed using a range of routine and customised data. This research methodology describes the beginnings of a state-wide childhood obesity monitoring system that can evolve to regularly inform progress on reducing obesity, and situate these changes in the context of broader community-level system change.

Work, Weight, and Wellness: the 3W Program: a worksite obesity prevention and intervention trial.

PubMed

Williams, Andrew E; Vogt, Thomas M; Stevens, Victor J; Albright, Cheryl A; Nigg, Claudio R; Meenan, Richard T; Finucane, Melissa L

2007-11-01

In this paper, we describe the aims, intervention, and design of the Work, Weight, and Wellness program, a group-randomized worksite obesity prevention and intervention trial being conducted at 31 hotels with 11,559 employees on the island of Oahu in Hawaii. We report baseline prevalence of overweight and obesity, and the distribution of BMI (kilograms per meter squared) across sex, race, and job categories. We also describe factors that have influenced intervention adoption and employee participation. The study's primary outcome is change in BMI among hotel employees over a 2-year intervention period. The intervention includes environmental and group components that target diet, physical activity, and weight management. Men, Pacific Islanders, and individuals employed in managerial or facility maintenance roles had higher prevalence of obesity and higher mean BMI than women and individuals from other races or in other occupational categories. These results may be helpful in guiding choices about the adoption or design of future worksite and community interventions addressing at-risk ethnically diverse populations and are especially relevant to the hotel industry and similar industries.

Intensive lifestyle intervention improves physical function among obese adults with knee pain: Findings from the Look AHEAD trial

USDA-ARS?s Scientific Manuscript database

Lifestyle interventions causing weight loss or improved physical fitness in obese individuals may lead to improved physical function. This study involved participants in the Action for Health in Diabetes (Look AHEAD) trial who reported knee pain at baseline (n = 2,203). The purposes of this study we...

Involvement of Fathers in Pediatric Obesity Treatment and Prevention Trials: A Systematic Review.

PubMed

Morgan, Philip J; Young, Myles D; Lloyd, Adam B; Wang, Monica L; Eather, Narelle; Miller, Andrew; Murtagh, Elaine M; Barnes, Alyce T; Pagoto, Sherry L

2017-02-01

Despite their important influence on child health, it is assumed that fathers are less likely than mothers to participate in pediatric obesity treatment and prevention research. This review investigated the involvement of fathers in obesity treatment and prevention programs targeting children and adolescents (0-18 years). A systematic review of English, peer-reviewed articles across 7 databases. Retrieved records included at least 1 search term from 2 groups: "participants" (eg, child*, parent*) and "outcomes": (eg, obes*, diet*). Randomized controlled trials (RCTs) assessing behavioral interventions to prevent or treat obesity in pediatric samples were eligible. Parents must have "actively participated" in the study. Two authors independently extracted data using a predefined template. The search retrieved 213 eligible RCTs. Of the RCTs that limited participation to 1 parent only (n = 80), fathers represented only 6% of parents. In RCTs in which participation was open to both parents (n = 133), 92% did not report objective data on father involvement. No study characteristics moderated the level of father involvement, with fathers underrepresented across all study types. Only 4 studies (2%) suggested that a lack of fathers was a possible limitation. Two studies (1%) reported explicit attempts to increase father involvement. The review was limited to RCTs published in English peer-reviewed journals over a 10-year period. Existing pediatric obesity treatment or prevention programs with parent involvement have not engaged fathers. Innovative strategies are needed to make participation more accessible and engaging for fathers. Copyright © 2017 by the American Academy of Pediatrics.

Prebiotic supplementation improves appetite control in children with overweight and obesity: a randomized controlled trial.

PubMed

Hume, Megan P; Nicolucci, Alissa C; Reimer, Raylene A

2017-04-01

Background: Prebiotics have been shown to improve satiety in adults with overweight and obesity; however, studies in children are limited. Objective: We examined the effects of prebiotic supplementation on appetite control and energy intake in children with overweight and obesity. Design: This study was a randomized, double-blind, placebo-controlled trial. Forty-two boys and girls, ages 7-12 y, with a body mass index (BMI) of ≥85th percentile were randomly assigned to 8 g oligofructose-enriched inulin/d or placebo (maltodextrin) for 16 wk. Objective measures of appetite included energy intake at an ad libitum breakfast buffet, 3-d food records, and fasting satiety hormone concentrations. Subjective appetite ratings were obtained from visual analog scales before and after the breakfast. Children's Eating Behavior Questionnaires were also completed by caregivers. Results: Compared with placebo, prebiotic intake resulted in significantly higher feelings of fullness ( P = 0.04) and lower prospective food consumption ( P = 0.03) at the breakfast buffet at 16 wk compared with baseline. Compared with placebo, prebiotic supplementation significantly reduced energy intake at the week 16 breakfast buffet in 11- and 12-y-olds ( P = 0.04) but not in 7- to 10-y-olds. Fasting adiponectin ( P = 0.04) and ghrelin ( P = 0.03) increased at 16 wk with the prebiotic compared with placebo. In intent-to-treat analysis, there was a trend for prebiotic supplementation to reduce BMI z score to a greater extent than placebo (-3.4%; P = 0.09) and a significant -3.8% reduction in per-protocol analysis ( P = 0.043). Conclusions: Independent of other lifestyle changes, prebiotic supplementation in children with overweight and obesity improved subjective appetite ratings. This translated into reduced energy intake in a breakfast buffet in older but not in younger children. This simple dietary change has the potential to help with appetite regulation in children with obesity. This trial was

The effects of Spirulina Platensis on anthropometric indices, appetite, lipid profile and serum vascular endothelial growth factor (VEGF) in obese individuals: a randomized double blinded placebo controlled trial.

PubMed

Zeinalian, Reihaneh; Farhangi, Mahdieh Abbasalizad; Shariat, Atefeh; Saghafi-Asl, Maryam

2017-04-21

In recent years, a great attention has been focused on Spirulina platensis as a source of potential valuable nutrients for prevention and treatment of chronic diseases. The objectives of the current study were to determine the effects of Spirulina platensis on anthropometric parameters, serum lipids, appetite and serum Vascular Endothelial Growth Factor (VEGF) in obese individuals. In the current study sixty four obese individuals aged 20-50 years were enrolled and randomly allocated into two groups of intervention and placebo. Intervention group (n = 29) received each 500 mg of the Spirulina platensis a twice-daily dosage while the control group (n = 27) received two pills daily starch for 12 weeks. Anthropometric parameters and serum VEGF and lipid profile were measured in fasting blood samples at the beginning and end of the study period. Dietary intakes were assessed by a 24-h recall method and appetite was measured using standard visual analogue scale (VAS). Body weight and body mass index (BMI) were decreased in intervention and placebo treated groups although the mean reduction in Spirulina platensis-treated group was significantly higher (P < 0.05). Serum total cholesterol (TC) significantly reduced in intervention group (P < 0.05). Also, treatment with Spirulina platensis significantly reduced appetite (P = 0.008). Mean serum VEGF, low density lipoprotein-cholesterol, and triglycerides did not change significantly after intervention. Serum high density lipoprotein-cholesterol concentrations (HDL-c) significantly increased in both groups while no difference in mean difference of this change has been observed. Spirulina supplementation at a dose of 1 g/d for 12 weeks is effective in modulating body weight and appetite and partly modifies serum lipids. This can further confirm the efficacy of this herbal supplement in control and prevention of obesity and obesity- related disorders. Iranian registry of clinical trials (IRCT registration number

Tackling inequalities in obesity: a protocol for a systematic review of the effectiveness of public health interventions at reducing socioeconomic inequalities in obesity among adults.

PubMed

Bambra, Clare L; Hillier, Frances C; Moore, Helen J; Cairns-Nagi, Joanne-Marie; Summerbell, Carolyn D

2013-05-10

Socioeconomic inequalities in obesity and associated risk factors for obesity are widening throughout developed countries worldwide. Tackling obesity is high on the public health agenda both in the United Kingdom and internationally. However, what works in terms of interventions that are able to reduce inequalities in obesity is lacking. The review will examine public health interventions at the individual, community and societal level that might reduce inequalities in obesity among adults aged 18 years and over, in any setting and in any country. The following electronic databases will be searched: MEDLINE, EMBASE, CINAHL, PsycINFO, Social Science Citation Index, ASSIA, IBSS, Sociological Abstracts, and the NHS Economic Evaluation Database. Database searches will be supplemented with website and gray literature searches. No studies will be excluded based on language, country or publication date. Randomized and non-randomized controlled trials, prospective and retrospective cohort studies (with/without control groups) and prospective repeat cross-sectional studies (with/without control groups) that have a primary outcome that is a proxy for body fatness and have examined differential effects with regard to socioeconomic status (education, income, occupation, social class, deprivation, poverty) or where the intervention has been targeted specifically at disadvantaged groups or deprived areas will be included. Study inclusion, data extraction and quality appraisal will be conducted by two reviewers. Meta-analysis and narrative synthesis will be conducted. The main analysis will examine the effects of 1) individual, 2) community and 3) societal level public health interventions on socioeconomic inequalities in adult obesity. Interventions will be characterized by their level of action and their approach to tackling inequalities. Contextual information on how such public health interventions are organized, implemented and delivered will also be examined. The review

Adding value to clinical trial registries: insights from Australian Cancer Trials Online, a website for consumers.

PubMed

Dear, Rachel; Barratt, Alexandra; Askie, Lisa; McGeechan, Kevin; Arora, Sheena; Crossing, Sally; Currow, David; Tattersall, Martin

2011-02-01

Clinical trials registries are now operating in the USA, Europe, Australia, China, and India and more are planned. Trial registries could be an excellent source of information about clinical trials for patients and others affected by cancer as well as health care professionals, but may be difficult for patients to navigate and use. An opportunity arose in Australia to develop a consumer friendly cancer clinical trials website (Australian Cancer Trials Online (ACTO), www.australiancancertrials.gov.au) using an automated data feed from two large clinical trial registries. In this article, we describe aspects of this new website, and explore ways in which such a website may add value to clinical trial data which are already collected and held by trial registries. The development of ACTO was completed by a Web company working in close association with staff at the Australian New Zealand Clinical Trials Registry (ANZCTR), and with consumer representatives. Data for the website were sourced directly and only from clinical trial registries, thus avoiding the creation of an additional trials database. It receives an automated, daily data feed of newly registered cancer clinical trials from both the ANZCTR and Clinical Trials.gov. The development of ACTO exemplifies the advantage of a local clinical trial registry working with consumers to provide accessible information about cancer clinical trials to meet consumers' information needs. We found that the inclusion of a lay summary added substantial value for consumers, and recommend that consideration be given to adding a lay summary to the mandatory data items collected by all trial registries. Furthermore, improved navigation, decision support tools, and consistency in data collection between clinical trial registries will also enable consumer websites to provide additional value for users. Clinical trial registration is not compulsory in Australia. If the additional cancer items (including a lay summary) are not provided

The Pregnancy in Polycystic Ovary Syndrome Study II: Baseline Characteristics and Effects of Obesity from a Multi-Center Randomized Clinical Trial

PubMed Central

Legro, Richard S.; Brzyski, Robert G.; Diamond, Michael P.; Coutifaris, Christos; Schlaff, William D.; Alvero, Ruben; Casson, Peter; Christman, Gregory M.; Huang, Hao; Yan, Qingshang; Haisenleder, Daniel J.; Barnhart, Kurt T.; Bates, G. Wright; Usadi, Rebecca; Lucidi, Richard; Baker, Valerie; Trussell, J.C.; Krawetz, Stephen A.; Snyder, Peter; Ohl, Dana; Santoro, Nanette; Eisenberg, Esther; Zhang, Heping

2014-01-01

Objective To summarize baseline characteristics from a large multi-center infertility clinical trial. Design Cross-sectional baseline data from a double-blind randomized trial of 2 treatment regimens (letrozole vs. clomiphene). Setting Academic Health Centers throughout the U.S. Interventions None Main Outcome Measure(s) Historical, biometric, biochemical and questionnaire parameters. Participants 750 women with PCOS and their male partners took part in the study. Results Females averaged ~30 years old and were obese (BMI 35) with ~20% from a racial/ethnic minority. Most (87%) were hirsute and nulligravid (63%). . Most of the females had an elevated antral follicle count and enlarged ovarian volume on ultrasound. Women had elevated mean circulating androgens, LH:FSH ratio (~2), and AMH levels (8.0 ng/mL). Additionally, women had evidence for metabolic dysfunction with elevated mean fasting insulin and dyslipidemia. Increasing obesity was associated with decreased LH:FSH levels, AMH levels and antral follicle counts but increasing cardiovascular risk factors, including prevalence of the metabolic syndrome. Males were obese (BMI 30) and had normal mean semen parameters. Conclusions The treatment groups were well-matched at baseline. Obesity exacerbates select female reproductive and most metabolic parameters. We have also established a database and sample repository that will eventually be accessible to investigators. PMID:24156957

Rapid Evidence Review of Bariatric Surgery in Super Obesity (BMI ≥ 50 kg/m2).

PubMed

Peterson, Kim; Anderson, Johanna; Boundy, Erin; Ferguson, Lauren; Erickson, Katherine

2017-04-01

Despite accumulating evidence of the important health benefits of bariatric surgery in morbidly obese patients in general, bariatric surgery outcomes are less clear in higher-risk, high-priority populations of patients with BMI ≥ 50 kg/m 2 . To help the Department of Veterans Affairs (VA) Health Services Research & Development Service (HSR&D) develop a research agenda, we conducted a rapid evidence review to better understand bariatric surgery outcomes in adults with BMI ≥ 50 kg/m 2 . We searched MEDLINE ® , the Cochrane Database of Systematic Reviews, the Cochrane Central Registry of Controlled Trials, and ClinicalTrials.gov through June 2016. We included trials and observational studies. We used pre-specified criteria to select studies, abstract data, and rate internal validity and strength of the evidence (PROSPERO registration number CRD42015025348). All decisions were completed by one reviewer and checked by another. Among 1892 citations, we included 23 studies in this rapid review. Compared with usual care, one large retrospective VA study provided limited evidence that bariatric surgery can lead to increased mortality in the first year, but decreased mortality long-term among super obese veterans. Studies that compared different bariatric surgical approaches suggested some differences in weight loss and complications. Laparoscopic gastric bypass generally resulted in greater short-term proportion of excess weight loss than did other procedures. Duodenal switch led to greater long-term weight loss than did gastric bypass, but with more complications. The published literature that separates the super obese is insufficient for determining the precise balance of benefits and harms of bariatric surgery in this high-risk subgroup. Future studies should evaluate a more complete set of key outcomes with longer follow-up in larger samples of more broadly representative adults.

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.

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

Effect of plant-based diets on obesity-related inflammatory profiles: a systematic review and meta-analysis of intervention trials.

PubMed

Eichelmann, F; Schwingshackl, L; Fedirko, V; Aleksandrova, K

2016-11-01

Plant-based dietary interventions have been proposed to reduce obesity induced chronic low-grade inflammation and hence prevent chronic disease risk; however, human evidence remains unclear. This systematic review and meta-analysis of intervention trials aimed to assess the effect of plant-based diets on obesity-related inflammatory biomarker profiles. Medline, EMBASE and Cochrane Central Register of Controlled Trials (CENTRAL) were searched for articles published until January 2016 and mean differences in biomarkers of inflammatory status were assessed for: C-reactive protein (CRP), interleukin-6 (IL-6), tumour necrosis factor-alpha (TNF-ɑ), soluble intercellular adhesion molecule 1 (sICAM), leptin, adiponectin and resistin. Of initially identified 2,583 publications, 29 met the meta-analysis inclusion criteria [a total of 2,689 participants]. Consumption of plant-based diets was associated with a reduction in the mean concentrations of the following biomarkers: CRP [effect size, -0.55 mg/l, 95% confidence intervals (CI): -0.78; -0.32, I 2  = 94.4%], IL-6 [effect size, -0.25 ng/l, 95% CI: -0.56; 0.06, I 2  = 74%], and, to some degree, sICAM (-25.07 ng/ml [95% CI: -52.32; 2.17, I 2  = 93.2%]). No substantial effects were revealed for TNF-ɑ, resistin, adiponectin and leptin. Plant-based diets are associated with an improvement in obesity-related inflammatory profiles and could provide means for therapy and prevention of chronic disease risk. © 2016 World Obesity.

Effects of exercise intensity and nutrition advice on myocardial function in obese children and adolescents: a multicentre randomised controlled trial study protocol.

PubMed

Dias, Katrin A; Coombes, Jeff S; Green, Daniel J; Gomersall, Sjaan R; Keating, Shelley E; Tjonna, Arnt Erik; Hollekim-Strand, Siri Marte; Hosseini, Mansoureh Sadat; Ro, Torstein Baade; Haram, Margrete; Huuse, Else Marie; Davies, Peter S W; Cain, Peter A; Leong, Gary M; Ingul, Charlotte B

2016-04-04

The prevalence of paediatric obesity is increasing, and with it, lifestyle-related diseases in children and adolescents. High-intensity interval training (HIIT) has recently been explored as an alternate to traditional moderate-intensity continuous training (MICT) in adults with chronic disease and has been shown to induce a rapid reversal of subclinical disease markers in obese children and adolescents. The primary aim of this study is to compare the effects of HIIT with MICT on myocardial function in obese children and adolescents. Multicentre randomised controlled trial of 100 obese children and adolescents in the cities of Trondheim (Norway) and Brisbane (Australia). The trial will examine the efficacy of HIIT to improve cardiometabolic outcomes in obese children and adolescents. Participants will be randomised to (1) HIIT and nutrition advice, (2) MICT and nutrition advice or (3) nutrition advice. Participants will partake in supervised exercise training and/or nutrition sessions for 3 months. Measurements for study end points will occur at baseline, 3 months (postintervention) and 12 months (follow-up). The primary end point is myocardial function (peak systolic tissue velocity). Secondary end points include vascular function (flow-mediated dilation assessment), quantity of visceral and subcutaneous adipose tissue, myocardial structure and function, body composition, cardiorespiratory fitness, autonomic function, blood biochemistry, physical activity and nutrition. Lean, healthy children and adolescents will complete measurements for all study end points at one time point for comparative cross-sectional analyses. This randomised controlled trial will generate substantial information regarding the effects of exercise intensity on paediatric obesity, specifically the cardiometabolic health of this at-risk population. It is expected that communication of results will allow for the development of more effective evidence-based exercise prescription

Evaluation of active and passive recruitment methods used in randomized controlled trials targeting pediatric obesity.

PubMed

Raynor, Hollie A; Osterholt, Kathrin M; Hart, Chantelle N; Jelalian, Elissa; Vivier, Patrick; Wing, Rena R

2009-01-01

Evaluate enrollment numbers, randomization rates, costs, and cost-effectiveness of active versus passive recruitment methods for parent-child dyads into two pediatric obesity intervention trials. Recruitment methods were categorized into active (pediatrician referral and targeted mailings, with participants identified by researcher/health care provider) versus passive methods (newspaper, bus, internet, television, and earning statements; fairs/community centers/schools; and word of mouth; with participants self-identified). Numbers of enrolled and randomized families and costs/recruitment method were monitored throughout the 22-month recruitment period. Costs (in USD) per recruitment method included staff time, mileage, and targeted costs of each method. A total of 940 families were referred or made contact, with 164 families randomized (child: 7.2+/-1.6 years, 2.27+/-0.61 standardized body mass index [zBMI], 86.6% obese, 61.7% female, 83.5% Caucasian; parent: 38.0+/-5.8 years, 32.9+/-8.4 BMI, 55.2% obese, 92.7% female, 89.6% caucasian). Pediatrician referral, followed by targeted mailings, produced the largest number of enrolled and randomized families (both methods combined producing 87.2% of randomized families). Passive recruitment methods yielded better retention from enrollment to randomization (p<0.05), but produced few families (21 in total). Approximately $91,000 was spent on recruitment, with cost per randomized family at $554.77. Pediatrician referral was the most cost-effective method, $145.95/randomized family, but yielded only 91 randomized families over 22-months of continuous recruitment. Pediatrician referral and targeted mailings, which are active recruitment methods, were the most successful strategies. However, recruitment demanded significant resources. Successful recruitment for pediatric trials should use several strategies. NCT00259324, NCT00200265.

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

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

Long-Term Effects of a Randomised Controlled Trial Comparing High Protein or High Carbohydrate Weight Loss Diets on Testosterone, SHBG, Erectile and Urinary Function in Overweight and Obese Men

PubMed Central

Moran, Lisa J.; Brinkworth, Grant D.; Martin, Sean; Wycherley, Thomas P.; Stuckey, Bronwyn; Lutze, Janna; Clifton, Peter M.; Wittert, Gary A.; Noakes, Manny

2016-01-01

sexual function. Trial Registration Anzctr.org.au ACTRN12606000002583 PMID:27584019

Metabolically normal obese people are protected from adverse effects following weight gain

PubMed Central

Fabbrini, Elisa; Yoshino, Jun; Yoshino, Mihoko; Magkos, Faidon; Tiemann Luecking, Courtney; Samovski, Dmitri; Fraterrigo, Gemma; Okunade, Adewole L.; Patterson, Bruce W.; Klein, Samuel

2015-01-01

BACKGROUND. Obesity is associated with insulin resistance and increased intrahepatic triglyceride (IHTG) content, both of which are key risk factors for diabetes and cardiovascular disease. However, a subset of obese people does not develop these metabolic complications. Here, we tested the hypothesis that people defined by IHTG content and insulin sensitivity as “metabolically normal obese” (MNO), but not those defined as “metabolically abnormal obese” (MAO), are protected from the adverse metabolic effects of weight gain. METHODS. Body composition, multiorgan insulin sensitivity, VLDL apolipoprotein B100 (apoB100) kinetics, and global transcriptional profile in adipose tissue were evaluated before and after moderate (~6%) weight gain in MNO (n = 12) and MAO (n = 8) subjects with a mean BMI of 36 ± 4 kg/m2 who were matched for BMI and fat mass. RESULTS. Although the increase in body weight and fat mass was the same in both groups, hepatic, skeletal muscle, and adipose tissue insulin sensitivity deteriorated, and VLDL apoB100 concentrations and secretion rates increased in MAO, but not MNO, subjects. Moreover, biological pathways and genes associated with adipose tissue lipogenesis increased in MNO, but not MAO, subjects. CONCLUSIONS. These data demonstrate that MNO people are resistant, whereas MAO people are predisposed, to the adverse metabolic effects of moderate weight gain and that increased adipose tissue capacity for lipogenesis might help protect MNO people from weight gain–induced metabolic dysfunction. TRIAL REGISTRATION. ClinicalTrials.gov NCT01184170. FUNDING. This work was supported by NIH grants UL1 RR024992 (Clinical Translational Science Award), DK 56341 (Nutrition and Obesity Research Center), DK 37948 and DK 20579 (Diabetes Center Grant), and UL1 TR000450 (KL2 Award); a Central Society for Clinical and Translational Research Early Career Development Award; and by grants from the Longer Life Foundation and the Kilo Foundation. PMID

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

The effects of a strength and neuromuscular exercise programme for the lower extremity on knee load, pain and function in obese children and adolescents: study protocol for a randomised controlled trial.

PubMed

Horsak, Brian; Artner, David; Baca, Arnold; Pobatschnig, Barbara; Greber-Platzer, Susanne; Nehrer, Stefan; Wondrasch, Barbara

2015-12-23

including the following analyses: cardiopulmonary testing to quantify aerobic fitness effects, anthropometric measures, nutritional status and psychological status to characterise the study sample. The findings will help to determine whether a neuromuscular and strength training exercise programme for the obese children population can reduce joint loading during locomotion, and thereby decrease the possible risk of developing degenerative joint diseases later in adulthood. ClinicalTrials NCT02545764 , Date of registration: 24 September 2015.

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

Required friction during overground walking is lower among obese compared to non-obese older men, but does not differ with obesity among women.

PubMed

Arena, Sara L; Garman, Christina R; Nussbaum, Maury A; Madigan, Michael L

2017-07-01

Obesity and aging have been independently associated with altered required friction during walking, but it is unclear how these factors interact to influence the likelihood of slipping. Therefore, the purpose of this study was to determine whether there are differences related to obesity and aging on required friction during overground walking. Fourteen older non-obese, 11 older obese, 20 younger non-obese, and 20 younger obese adults completed walking trials at both a self-selected and hurried speed. When walking at a hurried speed, older obese men walked at a slower gait speed and exhibited lower frictional demands compared both to older non-obese men and to younger obese men. No differences in required friction were found between non-obese and obese younger adults. These results suggest that the increased rate of falls among obese or older adults is not likely due to a higher risk of slip initiation. Copyright © 2017 Elsevier Ltd. All rights reserved.

Methodological issues in negative symptom trials.

PubMed

Marder, Stephen R; Daniel, David G; Alphs, Larry; Awad, A George; Keefe, Richard S E

2011-03-01

Individuals from academia, the pharmaceutical industry, and the US Food and Drug Administration used a workshop format to discuss important methodological issues in the design of trials of pharmacological agents for improving negative symptoms in schizophrenia. The issues addressed included the need for a coprimary functional measure for registration trials; the characteristics of individuals who should enter negative symptom trials; the optimal duration for a proof-of-concept or registration trial; the optimal design of a study of a broad-spectrum agent that treats both positive and negative symptoms or a co-medication that is added to an antipsychotic; the relative strengths and weaknesses of available instruments for measuring negative symptoms; the definition of clinically meaningful improvement for these trials; and whether drugs can be approved for a subdomain of negative symptoms.

Methodological Issues in Negative Symptom Trials

PubMed Central

Marder, Stephen R.; Daniel, David G.; Alphs, Larry; Awad, A. George; Keefe, Richard S. E.

2011-01-01

Individuals from academia, the pharmaceutical industry, and the US Food and Drug Administration used a workshop format to discuss important methodological issues in the design of trials of pharmacological agents for improving negative symptoms in schizophrenia. The issues addressed included the need for a coprimary functional measure for registration trials; the characteristics of individuals who should enter negative symptom trials; the optimal duration for a proof-of-concept or registration trial; the optimal design of a study of a broad-spectrum agent that treats both positive and negative symptoms or a co-medication that is added to an antipsychotic; the relative strengths and weaknesses of available instruments for measuring negative symptoms; the definition of clinically meaningful improvement for these trials; and whether drugs can be approved for a subdomain of negative symptoms. PMID:21270473

Methods and baseline characteristics of a randomized trial treating early childhood obesity: the Positive Lifestyles for Active Youngsters (Team PLAY) trial.

PubMed

Hare, Marion E; Coday, Mace; Williams, Natalie A; Richey, Phyllis A; Tylavsky, Frances A; Bush, Andrew J

2012-05-01

There are few effective obesity interventions directed towards younger children, particularly young minority children. This paper describes the design, intervention, recruitment methods, and baseline data of the ongoing Positive Lifestyles for Active Youngsters (Team PLAY) study. This randomized controlled trial is designed to test the efficacy of a 6-month, moderately intense, primary care feasible, family-based behavioral intervention, targeting both young children and their parent, in promoting healthy weight change. Participants are 270 overweight and obese children (ages 4 to 7 years) and their parents, who were recruited from a primarily African American urban population. Parents and children were instructed in proven cognitive behavioral techniques (e.g. goal setting, self-talk, stimulus control and reinforcement) designed to encourage healthier food choices (more whole grains, fruits and vegetables, and less concentrated fats and sugar), reduce portion sizes, decrease sweetened beverages and increase moderate to vigorous physical activity engagement. The main outcome of this study is change in BMI at two year post enrollment. Recruitment using reactive methods (mailings, TV ads, pamphlets) was found to be more successful than using only a proactive approach (referral through physicians). At baseline, most children were very obese with an average BMI z-score of 2.6. Reported intake of fruits and vegetables and minutes of moderate to vigorous physical activity engagement did not meet national recommendations. If efficacious, Team PLAY would offer a model for obesity treatment directed at families with young children that could be tested and translated to both community and primary care settings. Copyright © 2012 Elsevier Inc. All rights reserved.

Implementation and evaluation of the 5As framework of obesity management in primary care: design of the 5As Team (5AsT) randomized control trial.

PubMed

Campbell-Scherer, Denise L; Asselin, Jodie; Osunlana, Adedayo M; Fielding, Sheri; Anderson, Robin; Rueda-Clausen, Christian F; Johnson, Jeffrey A; Ogunleye, Ayodele A; Cave, Andrew; Manca, Donna; Sharma, Arya M

2014-06-19

Obesity is a pressing public health concern, which frequently presents in primary care. With the explosive obesity epidemic, there is an urgent need to maximize effective management in primary care. The 5As of Obesity Management™ (5As) are a collection of knowledge tools developed by the Canadian Obesity Network. Low rates of obesity management visits in primary care suggest provider behaviour may be an important variable. The goal of the present study is to increase frequency and quality of obesity management in primary care using the 5As Team (5AsT) intervention to change provider behaviour. The 5AsT trial is a theoretically informed, pragmatic randomized controlled trial with mixed methods evaluation. Clinic-based multidisciplinary teams (RN/NP, mental health, dietitians) will be randomized to control or the 5AsT intervention group, to participate in biweekly learning collaborative sessions supported by internal and external practice facilitation. The learning collaborative content addresses provider-identified barriers to effective obesity management in primary care. Evidence-based shared decision making tools will be co-developed and iteratively tested by practitioners. Evaluation will be informed by the RE-AIM framework. The primary outcome measure, to which participants are blinded, is number of weight management visits/full-time equivalent (FTE) position. Patient-level outcomes will also be assessed, through a longitudinal cohort study of patients from randomized practices. Patient outcomes include clinical (e.g., body mass index [BMI], blood pressure), health-related quality of life (SF-12, EQ5D), and satisfaction with care. Qualitative data collected from providers and patients will be evaluated using thematic analysis to understand the context, implementation and effectiveness of the 5AsT program. The 5AsT trial will provide a wide range of insights into current practices, knowledge gaps and barriers that limit obesity management in primary practice

A 3-Arm randomised controlled trial of Communicating Healthy Beginnings Advice by Telephone (CHAT) to mothers with infants to prevent childhood obesity.

PubMed

Wen, Li Ming; Rissel, Chris; Baur, Louise A; Hayes, Alison J; Xu, Huilan; Whelan, Anna; Hua, Myna; Shaw, Miranda; Phongsavan, Philayrath

2017-01-14

With an increasing prevalence of obesity in young children globally, there is an urgent need for the development of effective early interventions. A previous Healthy Beginnings Trial using a nurse-led home visiting program has demonstrated that providing mothers with evidence-based advice can improve maternal practice regarding obesity prevention, and can reduce Body Mass Index (BMI) in the first few years of life. However, the costs for scale-up of home visiting limit its population reach. This trial aims to determine the efficacy of Communicating Healthy Beginnings Advice by Telephone (CHAT) to mothers with infants in improving infant feeding practices and preventing the early onset of childhood overweight and obesity. We propose a 3-arm randomised controlled trial (RCT) with a consecutive sample of 1056 mothers with their newborn children in New South Wales (NSW) Australia. Pregnant women who are between weeks 28 and 34 of their pregnancy will be invited to participate in the CHAT trial. Informed consent will be obtained, and after baseline data collection, participants will be randomly allocated to the telephone intervention, text messaging intervention, or the control group. The intervention comprises telephone consultations or text messages, together with 6 intervention packages being mailed at specific times from the third trimester of pregnancy until 12 months post birth. The main trial outcome measures include a) duration of breastfeeding, b) timing of introduction of solids, c) nutrition behaviours, physical activity and television viewing, and d) weight and BMI z-score at 12 and 24 months, e) cost-effectiveness, as well as f) feasibility and acceptability of the interventions. The results will ascertain whether early intervention using telephone consultation or text messaging together with staged mailed intervention resources can be feasible and effective in improving infant feeding practices, physical activity and reducing children's BMI in the early

Costs and effects of a state-wide health promotion program in primary schools in Germany – the Baden-Württemberg Study: A cluster-randomized, controlled trial

PubMed Central

Kesztyüs, Tibor; Kilian, Reinhold; Steinacker, Jürgen M

2017-01-01

Aim To evaluate the cost-effectiveness of the state-wide implementation of the health promotion program “Join the Healthy Boat” in primary schools in Germany. Methods Cluster-randomized intervention trial with wait-list control group. Anthropometric data of 1733 participating children (7.1 ± 0.6 years) were taken by trained staff before and after a one year intervention period in the academic year 2010/11. Parents provided information about the health status, and the health behaviour of their children and themselves, parental anthropometrics, and socio-economic background variables. Incidence of abdominal obesity, defined as waist-to-height ratio (WHtR) ≥ 0.5, was determined. Generalized linear models were applied to account for the clustering of data within schools, and to adjust for baseline-values. Losses to follow-up and missing data were analysed. From a societal perspective, the overall costs, costs per pupil, and incremental cost-effectiveness ratio (ICER) to identify the costs per case of averted abdominal obesity were calculated. Results The final regression model for the incidence of abdominal obesity shows lower odds for the intervention group after an adjustment for grade, gender, baseline WHtR, and breakfast habits (odds ratio = 0.48, 95% CI [0.25; 0.94]). The intervention costs per child/year were €25.04. The costs per incidental case of averted abdominal obesity varied between €1515 and €1993, depending on the different dimensions of the target group. Conclusion This study demonstrates the positive effects of state-wide, school-based health promotion on incidental abdominal obesity, at affordable costs and with proven cost-effectiveness. These results should support allocative decisions of policymakers. An early start to the prevention of abdominal obesity is of particular importance because of its close relationship to non-communicable diseases. Trial registration German Clinical Trials Register (DRKS), Freiburg University, Germany

A Multifactorial Weight Reduction Programme for Children with Overweight and Asthma: A Randomized Controlled Trial

PubMed Central

Willeboordse, Maartje; van de Kant, Kim D. G.; Tan, Frans E. S.; Mulkens, Sandra; Schellings, Julia; Crijns, Yvonne; van der Ploeg, Liesbeth; van Schayck, Constant P.; Dompeling, Edward

2016-01-01

Background There is increasing evidence that obesity is related to asthma development and severity. However, it is largely unknown whether weight reduction can influence asthma management, especially in children. Objective To determine the effects of a multifactorial weight reduction intervention on asthma management in overweight/obese children with (a high risk of developing) asthma. Methods An 18-month weight-reduction randomized controlled trial was conducted in 87 children with overweight/obesity and asthma. Every six months, measurements of anthropometry, lung function, lifestyle parameters and inflammatory markers were assessed. Analyses were performed with linear mixed models for longitudinal analyses. Results After 18 months, the body mass index-standard deviation score decreased by -0.14±0.29 points (p<0.01) in the intervention group and -0.12±0.34 points (p<0.01) in the control group. This change over time did not differ between groups (p>0.05). Asthma features (including asthma control and asthma-related quality of life) and lung function indices (static and dynamic) improved significantly over time in both groups. The FVC% predicted improved over time by 10.1 ± 8.7% in the intervention group (p<0.001), which was significantly greater than the 6.1 ± 8.4% in the control group (p<0.05). Conclusions & clinical relevance Clinically relevant improvements in body weight, lung function and asthma features were found in both the intervention and control group, although some effects were more pronounced in the intervention group (FVC, asthma control, and quality of life). This implies that a weight reduction intervention could be clinically beneficial for children with asthma. Trial Registration ClinicalTrials.gov NCT00998413 PMID:27294869

37 CFR 7.41 - Renewal of international registration and extension of protection.

Code of Federal Regulations, 2013 CFR

2013-07-01

... registration may be issued to 2.171 Not domiciled in U.S. 3.61 Right to take action when assignment is recorded... Trial and Appeal Board 2.145(d) Waiver of right to proceed by civil action in ex parte case 2.145(c)(2... Trial and Appeal Board) Ex parte matter disclosed but not tried in inter partes case 2.131 Express...

Comparison of range of commercial or primary care led weight reduction programmes with minimal intervention control for weight loss in obesity: lighten Up randomised controlled trial.

PubMed

Jolly, Kate; Lewis, Amanda; Beach, Jane; Denley, John; Adab, Peymane; Deeks, Jonathan J; Daley, Amanda; Aveyard, Paul

2011-11-03

To assess the effectiveness of a range of weight management programmes in terms of weight loss. Eight arm randomised controlled trial. Primary care trust in Birmingham, England. 740 obese or overweight men and women with a comorbid disorder identified from general practice records. Weight loss programmes of 12 weeks' duration: Weight Watchers; Slimming World; Rosemary Conley; group based, dietetics led programme; general practice one to one counselling; pharmacy led one to one counselling; choice of any of the six programmes. The comparator group was provided with 12 vouchers enabling free entrance to a local leisure (fitness) centre. The primary outcome was weight loss at programme end (12 weeks). Secondary outcomes were weight loss at one year, self reported physical activity, and percentage weight loss at programme end and one year. Follow-up data were available for 658 (88.9%) participants at programme end and 522 (70.5%) at one year. All programmes achieved significant weight loss from baseline to programme end (range 1.37 kg (general practice) to 4.43 kg (Weight Watchers)), and all except general practice and pharmacy provision resulted in significant weight loss at one year. At one year, only the Weight Watchers group had significantly greater weight loss than did the comparator group (2.5 (95% confidence interval 0.8 to 4.2) kg greater loss,). The commercial programmes achieved significantly greater weight loss than did the primary care programmes at programme end (mean difference 2.3 (1.3 to 3.4) kg). The primary care programmes were the most costly to provide. Participants allocated to the choice arm did not have better outcomes than those randomly allocated to a programme. Commercially provided weight management services are more effective and cheaper than primary care based services led by specially trained staff, which are ineffective. Trial registration Current Controlled Trials ISRCTN25072883.

Pharmacotherapy in the Management of Pediatric Obesity.

PubMed

Kelly, Aaron S; Fox, Claudia K

2017-08-01

This review provides a rationale for the use of pharmacotherapy in pediatric weight management, summarizes results of some of the key pediatric clinical trials of approved and "off-label" obesity medications, introduces new options in the pediatric pipeline, and offers a glimpse into the future of pediatric obesity medicine. Despite the need for adjunctive treatments to enhance the outcomes of lifestyle modification therapy among youth with obesity, none of the obesity medications evaluated to date have been shown to meaningfully reduce BMI or cardiometabolic risk factors. Promising medications recently approved for the treatment of obesity in adults will soon be tested in pediatric trials, offering hope that new therapeutic options will soon be available. As new medications are approved to treat pediatric obesity, it will be important to evaluate the safety and efficacy of combination pharmacotherapy and investigate predictors of response. Application of precision medicine approaches to the field of pediatric obesity management will improve the long-term outlook for the tens of millions of youth afflicted with this serious and recalcitrant disease.

Effect of lifestyle coaching versus care coordination versus treatment as usual in people with severe mental illness and overweight: Two-years follow-up of the randomized CHANGE trial.

PubMed

Jakobsen, Ane Storch; Speyer, Helene; Nørgaard, Hans Christian Brix; Karlsen, Mette; Birk, Merete; Hjorthøj, Carsten; Mors, Ole; Krogh, Jesper; Gluud, Christian; Pisinger, Charlotta; Nordentoft, Merete

2017-01-01

The objective of this trial was to assess the long-term effect of the CHANGE lifestyle coaching intervention for 428 people with abdominal obesity and schizophrenia spectrum disorders on cardiovascular risk. In this randomized, superiority, multi-center clinical trial, participants were randomized to 12 months of either lifestyle coaching plus care coordination (N = 138), care coordination alone, (N = 142) or treatment as usual (N = 148). There was no effect after 12 months, but we hypothesized that there might have been a delayed treatment effect. Our primary outcome at two-year follow-up was 10-year risk of cardiovascular disease standardized to 60 years of age. After two-years the mean 10-year cardiovascular-disease risk was 8.7% (95% confidence interval (CI) 7.6-9.9%) in the CHANGE group, 7.7% (95% CI 6.5-8.9%) in the care coordination group, and 8.9% (95% CI 6.9-9.2%) in the treatment as usual group (P = 0.24). Also, there were no intervention effects for any secondary or exploratory outcomes, including cardiorespiratory fitness, weight, physical activity, diet and smoking. No reported adverse events could be ascribed to the intervention. We conclude that there was neither any direct nor any long-term effect of individual lifestyle coaching or care coordination on cardiovascular risk factors in people with abdominal obesity and schizophrenia spectrum disorders. The trial was approved by the Ethics Committee of Capitol Region Copenhagen, Denmark (registration number: H-4-2012-051) and the Danish Data Protection Agency (registration number: 01689 RHP-2012-007). The trial was funded by the Mental Health Services of the Capital Region of Denmark, the Lundbeck Foundation, the Tryg Foundation, the Danish Ministry of Health, and the Dæhnfeldts Foundation.

Publication bias in obesity treatment trials?

PubMed

Allison, D B; Faith, M S; Gorman, B S

1996-10-01

The present investigation examined the extent of publication bias (namely the tendency to publish significant findings and file away non-significant findings) within the obesity treatment literature. Quantitative literature synthesis of four published meta-analyses from the obesity treatment literature. Interventions in these studies included pharmacological, educational, child, and couples treatments. To assess publication bias, several regression procedures (for example weighted least-squares, random-effects multi-level modeling, and robust regression methods) were used to regress effect sizes onto their standard errors, or proxies thereof, within each of the four meta-analysis. A significant positive beta weight in these analyses signified publication bias. There was evidence for publication bias within two of the four published meta-analyses, such that reviews of published studies were likely to overestimate clinical efficacy. The lack of evidence for publication bias within the two other meta-analyses might have been due to insufficient statistical power rather than the absence of selection bias. As in other disciplines, publication bias appears to exist in the obesity treatment literature. Suggestions are offered for managing publication bias once identified or reducing its likelihood in the first place.

Internet-based intervention programme for obese adolescents and their families (Next.Step): research protocol of a controlled trial.

PubMed

Sousa, Pedro; Fonseca, Helena; Gaspar, Pedro; Gaspar, Filomena

2014-04-01

This paper describes the design and rationale of a controlled trial that aims to determine the effectiveness of an intervention programme in which the internet is used. Adolescent obesity is a major health problem, there being urgency to find effective interventions that induce behavioural change. The inclusion of the internet in the intervention may improve adolescents' adherence to the weight management programme and lead to adoption of healthier lifestyles. A clinical trial with a control group (non-randomized). Participants are adolescents with appointments at a paediatric obesity clinic (Portugal). Sample size was calculated according to the power analysis. The experimental group will follow the standard treatment protocol and receive free access to the e-therapeutic platform. The control group will follow the standard treatment protocol and join a waiting list. Intervention length will be 36 weeks (24 weeks of direct intervention with a follow-up for 12 weeks). This study was approved by the Ethical Committee for Health (Lisbon, Portugal) in January 2012 and funded by the Foundation for Science and Technology (Portugal) in December 2012. The results of this research will promote reflection on new approaches directed to treat adolescent obesity and on the promotion of healthy behaviours. We expect to gather empirical evidence of the intervention programme effectiveness. The expectations lie on the population health gains, empowerment in decision-making and adoption of healthier lifestyles. © 2013 John Wiley & Sons Ltd.

Endocrinology and Adolescence: aerobic exercise reduces insulin resistance markers in obese youth: a meta-analysis of randomized controlled trials.

PubMed

García-Hermoso, Antonio; Saavedra, Jose M; Escalante, Yolanda; Sánchez-López, Mairena; Martínez-Vizcaíno, Vicente

2014-10-01

The purpose of this meta-analysis was to examine the evidence for the effectiveness of aerobic exercise interventions on reducing insulin resistance markers in obese children and/or adolescents. A secondary outcome was change in percentage of body fat. A computerized search was made from seven databases: CINAHL, Cochrane Central Register of Controlled Trials, EMBASE, ERIC, MEDLINE, PsycINFO, and Science Citation Index. The analysis was restricted to randomized controlled trials that examined the effect of aerobic exercise on insulin resistance markers in obese youth. Two independent reviewers screened studies and extracted data. Effect sizes (ES) and 95% confidence interval (CI) were calculated, and the heterogeneity of the studies was estimated using Cochran's Q-statistic. Nine studies were selected for meta-analysis as they fulfilled the inclusion criteria (n=367). Aerobic exercise interventions resulted in decreases in fasting glucose (ES=-0.39; low heterogeneity) and insulin (ES=-0.40; low heterogeneity) and in percentage of body fat (ES=-0.35; low heterogeneity). These improvements were specifically accentuated in adolescents (only in fasting insulin), or through programs lasting more than 12 weeks, three sessions per week, and over 60 min of aerobic exercise per session. This meta-analysis provides insights into the effectiveness of aerobic exercise interventions on insulin resistance markers in the obese youth population. © 2014 European Society of Endocrinology.

The causal role of breakfast in energy balance and health: a randomized controlled trial in obese adults.

PubMed

Chowdhury, Enhad A; Richardson, Judith D; Holman, Geoffrey D; Tsintzas, Kostas; Thompson, Dylan; Betts, James A

2016-03-01

The causal nature of associations between breakfast and health remain unclear in obese individuals. We sought to conduct a randomized controlled trial to examine causal links between breakfast habits and components of energy balance in free-living obese humans. The Bath Breakfast Project is a randomized controlled trial with repeated measures at baseline and follow-up among a cohort in South West England aged 21-60 y with dual-energy X-ray absorptiometry-derived fat mass indexes of ≥13 kg/m(2) for women (n = 15) and ≥9 kg/m(2) for men (n = 8). Components of energy balance (resting metabolic rate, physical activity thermogenesis, diet-induced thermogenesis, and energy intake) were measured under free-living conditions with random allocation to daily breakfast (≥700 kcal before 1100) or extended fasting (0 kcal until 1200) for 6 wk, with baseline and follow-up measures of health markers (e.g., hematology/adipose biopsies). Breakfast resulted in greater physical activity thermogenesis during the morning than when fasting during that period (difference: 188 kcal/d; 95% CI: 40, 335) but without any consistent effect on 24-h physical activity thermogenesis (difference: 272 kcal/d; 95% CI: -254, 798). Energy intake was not significantly greater with breakfast than fasting (difference: 338 kcal/d; 95% CI: -313, 988). Body mass increased across both groups over time but with no treatment effects on body composition or any change in resting metabolic rate (stable within 8 kcal/d). Metabolic/cardiovascular health also did not respond to treatments, except for a reduced insulinemic response to an oral-glucose-tolerance test over time with daily breakfast relative to an increase with daily fasting (P = 0.05). In obese adults, daily breakfast leads to greater physical activity during the morning, whereas morning fasting results in partial dietary compensation (i.e., greater energy intake) later in the day. There were no differences between groups in weight change and most

Changing eating behaviours to treat childhood obesity in the community using Mandolean: the Community Mandolean randomised controlled trial (ComMando)--a pilot study.

PubMed

Hamilton-Shield, Julian; Goodred, Joanna; Powell, Lesley; Thorn, Joanna; Banks, Jon; Hollinghurst, Sandra; Montgomery, Alan; Turner, Katrina; Sharp, Debbie

2014-07-01

Around one in five children in England is obese when they leave primary school. Thus far, it has not been demonstrated that primary care interventions to manage childhood obesity can achieve significant weight reduction. Training obese children to eat more slowly as an adjunct to other healthy lifestyle behaviour change has been shown to increase weight reduction in a hospital setting. This pilot study aimed to test recruitment strategies, treatment adherence, clinic attendance and participants' experiences of using a device [Mandolean® (previously Mandometer®, Mikrodidakt AB, Lund, Sweden)] to slow down speed of eating as an adjunct to dietary and activity advice in treating obesity in primary school-aged children. A two-arm, parallel, randomised controlled trial with a qualitative study embedded within the pilot. Randomisation occurred after informed consent and baseline measures were collected. Participants were randomised by the Bristol Randomised Trials Collaboration randomisation service with allocation stratified by hub and minimised by age of the child, gender, and baseline body mass index (BMI) standard deviation score (BMI z-value) of the child, and by BMI of the study parent (obese/not obese). General practices across Bristol, North Somerset and South Gloucestershire primary care trusts. Children (BMI ≥ 95th percentile) aged 5-11 years and their families. Standard care comprised dietary and activity advice by trained practice nurses. Adjunctive Mandolean training (the intervention) educated participants to eat meals more slowly and to rate levels of fullness (satiety). Mandolean is a small computer device attached to a weighing scale that provides visual and oral feedback during meals while generating a visual representation of levels of satiety during the meal. Participants were encouraged to eat their main meal each day from the Mandolean. One parent was also given a Mandolean to use when eating with the child. Outcomes for the pilot were

Childhood obesity prevention: Changing the focus

USDA-ARS?s Scientific Manuscript database

Obesity in the United States and throughout the world remains highly prevalent, especially among children and adolescents. Innumerable child obesity prevention trials emphasizing diet, physical activity, sedentary behavior, and recently sleep have been designed, implemented, and evaluated with the b...

Family-based obesity prevention for infants: Design of the "Mothers & Others" randomized trial.

PubMed

Wasser, Heather M; Thompson, Amanda L; Suchindran, Chirayath M; Hodges, Eric A; Goldman, Barbara D; Perrin, Eliana M; Faith, Myles S; Bulik, Cynthia M; Heinig, M Jane; Bentley, Margaret E

2017-09-01

Our goal is to test the efficacy of a family-based, multi-component intervention focused on infants of African-American (AA) mothers and families, a minority population at elevated risk for pediatric obesity, versus a child safety attention-control group to promote healthy weight gain patterns during the first two years of life. The design is a two-group randomized controlled trial among 468 AA pregnant women in central North Carolina. Mothers and study partners in the intervention group receive anticipatory guidance on breastfeeding, responsive feeding, use of non-food soothing techniques for infant crying, appropriate timing and quality of complementary feeding, age-appropriate infant sleep, and minimization of TV/media. The primary delivery channel is 6 home visits by a peer educator, 4 interim newsletters and twice-weekly text messaging. Intervention families also receive 2 home visits from an International Board Certified Lactation Consultant. Assessments occur at 28 and 37weeks gestation and when infants are 1, 3, 6, 9, 12, and 15months of age. The primary outcome is infant/toddler growth and likelihood of overweight at 15months. Differences between groups are expected to be achieved through uptake of the targeted infant feeding and care behaviors (secondary outcomes) and change in caregivers' modifiable risk factors (mediators) underpinning the intervention. If successful in promoting healthy infant growth and enhancing caregiver behaviors, "Mothers and Others" will have high public health relevance for future obesity-prevention efforts aimed at children younger than 2years, including interventional research and federal, state, and community health programs. ClinicalTrials.gov, NCT01938118, August 9, 2013. Copyright © 2017 Elsevier Inc. All rights reserved.

Treatment of clozapine-associated obesity and diabetes with exenatide (CODEX) in adults with schizophrenia: study protocol for a pilot randomised controlled trial.

PubMed

Mayfield, Karla; Siskind, Dan; Winckel, Karl; Hollingworth, Samantha; Kisely, Steve; Russell, Anthony W

2015-06-01

Clozapine causes significant metabolic disturbances including obesity and type 2 diabetes. Recent evidence that reduced glucagon-like-peptide-1 (GLP-1) may contribute to aetiology of clozapine-associated metabolic dysregulation suggests a potential therapeutic role for GLP-1 agonists. This open-label, pilot randomised controlled trial evaluates the effect of exenatide in clozapine-treated obese adults who have schizophrenia, with or without poorly controlled diabetes. Sixty out-patients will be randomised to once weekly extended release exenatide or treatment as usual for 24 weeks. To evaluate the feasibility of larger studies regarding methodology, acceptability, tolerability and estimate efficacy for glycaemic control or weight loss. Secondary outcomes are psychosis severity and metabolic parameters. This is the first trial investigating GLP-1 agonists for glycaemic control and weight loss in clozapine-treated patients with either diabetes or obesity. Clozapine-associated obesity and diabetes with exenatide (CODEX) will provide proof-of-concept empirical evidence addressing whether this novel treatment is practical and worthy of further investigation. A.W.R. has received speaker honoraria and travel grants from AstraZeneca, BoehringerIngelheim, Eli Lilly, MSD, Novo Nordisk and Sanofi and has participated on advisory panels for MSD and Novo Nordisk. © The Royal College of Psychiatrists 2015. This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) licence.

Long-term supplementation of decaffeinated green tea extract does not modify body weight or abdominal obesity in a randomized trial of men at high risk for prostate cancer

PubMed Central

Kumar, Nagi B.; Patel, Roshni; Pow-Sang, Julio; Spiess, Philippe E.; Salup, Raoul; Williams, Christopher R.; Schell, Michael J.

2017-01-01

Background Evidence continues to demonstrate the role of obesity in prostate carcinogenesis and prognosis, underscoring the need to identify and continue to evaluate the effective interventions to reduce obesity in populations at high risk. The aim of the study was to determine the effect of daily consumption of decaffeinated green tea catechins (GTC) formulation (Polyphenon E® (PolyE)) for 1 year on biomarkers of obesity in men who are at high risk for prostate cancer. Materials and Methods A randomized, double-blinded trial was conducted targeting 97 men diagnosed with HGPIN or ASAP. Subjects were randomized to receive GTC (PolyE) (n = 49) or placebo (n = 48) for 1 year. Anthropometric data were collected at baseline, 6 and 12 months and data analyzed to observe change in weight, body mass index (indicator of obesity) and waist: hip ratio (indicator of abdominal obesity). Results Decaffeinated GTC containing 400 mgs of the bioactive catechin, EGCG administered for 1 year to men diagnosed with ASAP and HGPIN appears to be bioavailable, well tolerated but not effective in reducing biomarkers of obesity including body weight, body mass index and waist: hip ratio. Conclusions The results of our trial demonstrates that men who are obese and at high risk for prostate cancer should resort to effective weight management strategies to reduce obesity and not resort to ineffective measures such as taking supplements of green tea to reduce biomarkers of obesity. Changes in body mass index and abdominal obesity seen in other studies were potentially due to caffeine and not GTC. PMID:29228755

Clinical trials for drug registrations in Asian-Pacific countries: proposal for a new paradigm from a statistical perspective.

PubMed

Shih, W J

2001-08-01

The world has become more interdependent in the movement of free trade and global markets. The regulations for approval of new drugs in the Asian markets have always been an important issue in the free trade negotiation between the U.S.- and E.U.-based international manufacturers and the Asian-Pacific countries, since pharmaceuticals are of large trade value for them. In 1998 the University of Hong Kong and the Singapore National Medical Research Council jointly hosted the first Asian Clinical Trials Conference. The Society for Clinical Trials was invited as a collaborator for the event, which signified a milestone for interaction between the East and West in the discussion of clinical trials. Many have participated in the discussion of drug approval and registration issues for the Asian region based on the drug development experience in the United States. However, there are many interesting differences between the two regions, which lead to different approval processes for new drugs developed by the U.S.- and E.U.-based international manufacturers. This article highlights some regulatory dilemmas and some key statistical concepts pertinent to these differences. The purpose of this paper is to resolve the regional regulatory and scientific dilemma. A new paradigm of sample size design and data analysis for drug approval for countries in the Asian-Pacific region is proposed. The central premise is that substantial information from multicenter studies has already shown efficacy in the United States or the European Union when a drug manufacturer seeks marketing approval in an Asian country. This leads to the idea of a "consistency trial" using the method of Bayesian most plausible prediction. The method is illustrated with an example.

Effect of Integrated Approach of Yoga Therapy on Male Obesity and Psychological Parameters-A Randomised Controlled Trial

PubMed Central

Subramanya, Pailoor

2016-01-01

Introduction Obesity is a growing global epidemic and cause of non-communicable diseases. Yoga is one of the effective ways to reduce stress which is one of the causes of obesity. Aim To assess the effect of Integrated Approach of Yoga Therapy (IAYT) yoga module on adult male obesity in an urban setting. Materials and Methods RCT (Randomized Controlled Trial) was conducted for 14 weeks on obese male subjects with yoga and control groups. Total number of subjects were 72 and they were randomized into two groups (Yoga n=37, Control n=35). The subjects were from an urban setting of Mumbai and were doing yoga for the first time. Special yoga training of IAYT was given to yoga group for one and half hour for 5 days in a week for 14 weeks. The control group continued regular physical activities and no specific physical activity was given. The assessments were anthropometric parameters of weight, Body Mass Index (BMI), MAC (Mid Upper Arm Circumferences) of Left and Right Arm, Waist Circumference (WC), HC (Hip Circumference), WHR (Waist Hip Ratio), SKF(Skin Fold Thickness of Biceps, Triceps, Sub scapular, suprailiac and cumulative), Percentage body fat based on SKF and Psychological Questionnaires of Perceived Stress Scale (PSS) and AAQW (Acceptance and Action Questionnaire for Weight Related Difficulty). These were taken before and after intervention for both yoga and control groups. Within and between group analysis & correlation of differences from post to pre readings among the variables, were carried out using SPSS 21. Results The anthropometric and psychological parameters were improved in both the groups but changes were significant in yoga group. Conclusion Incorporating the IAYT for obese male in urban setting will be effective for obesity treatment and for reducing the obesity related problems. PMID:27891357

Children's Healthy Living (CHL) Program for remote underserved minority populations in the Pacific region: rationale and design of a community randomized trial to prevent early childhood obesity.

PubMed

Wilken, Lynne R; Novotny, Rachel; Fialkowski, Marie K; Boushey, Carol J; Nigg, Claudio; Paulino, Yvette; Leon Guerrero, Rachael; Bersamin, Andrea; Vargo, Don; Kim, Jang; Deenik, Jonathan

2013-10-09

Although surveillance data are limited in the US Affiliated Pacific, Alaska, and Hawaii, existing data suggest that the prevalence of childhood obesity is similar to or in excess of other minority groups in the contiguous US. Strategies for addressing the childhood obesity epidemic in the region support the use of community-based, environmentally targeted interventions. The Children's Healthy Living Program is a partnership formed across institutions in the US Affiliated Pacific, Alaska, and Hawaii to design a community randomized environmental intervention trial and a prevalence survey to address childhood obesity in the region through affecting the food and physical activity environment. The Children's Healthy Living Program community randomized trial is an environmental intervention trial in four matched-pair communities in American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, and Hawaii and two matched-pair communities in Alaska. A cross-sectional sample of children (goal n = 180) in each of the intervention trial communities is being assessed for outcomes at baseline and at 24 months (18 months post-intervention). In addition to the collection of the participant-based measures of anthropometry, diet, physical activity, sleep and acanthosis nigricans, community assessments are also being conducted in intervention trial communities. The Freely Associated States of Micronesia (Federated States of Micronesia, and Republics of Marshall Islands and Palau) is only conducting elements of the Children's Healthy Living Program sampling framework and similar measurements to provide prevalence data. In addition, anthropometry information will be collected for two additional communities in each of the 5 intervention jurisdictions to be included in the prevalence survey. The effectiveness of the environmental intervention trial is being assessed based on the RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework. The Children

75 FR 1813 - Manufacturer of Controlled Substances; Notice of Registration

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-13

... Parkinson's Disease and for manufacture in bulk for investigational new drug (IND) submission and clinical trials. No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a... to ensure that the company's registration is consistent with the public interest. The investigation...

[Establishing the acupuncture-moxibustion clinical trial registry and improving the transparence of clinical trials of acupuncture and moxibustion].

PubMed

Liu, Yali; He, Liyun; Liu, Jia; Yang, Xingyue; Yan, Dongning; Wang, Xin; Luo, Lin; Li, Hongjiao; Yan, Shiyan; Wen, Tiancai; Bai, Wenjing; Wu, Taixiang; Liu, Baoyan

2017-07-12

As a kind of intervention measures of traditional Chinese medicine, acupuncture-moxibustion is highly adopted on global clinical practice. Even though the global clinical trial registration system was established more than 10 years ago, the proportion of acupuncture-moxibustion clinical trial registration is still very low; and it is very problematic on the methodological quality and report quality in the published acupuncture-moxibustion clinical trials. In order to manage particularly the acupuncture-moxibustion clinical trials, China Academy of Chinese Medical Sciences, collaborated with China Association of Acupuncture and Moxibustion and World Federation of Acupuncture Societies, established the Acupuncture-Moxibustion Clinical Trail Registry (AMCTR). AMCTR is a secondary registry platform affiliated to the Chinese Clinical Trial Registry (ChiCTR) and WHO International Clinical Trials Registry Platform (ICTRP), specifically for the acceptance and management of clinical trials in the field of acupuncture and moxibustion. It is a nonprofit academic organization, located in China Academy of Chinese Medical Sciences.

Cluster-randomised controlled trial to assess the effectiveness and cost-effectiveness of an obesity prevention programme for Chinese primary school-aged children: the CHIRPY DRAGON study protocol

PubMed Central

Li, Bai; Liu, Wei Jia; Adab, Peymane; Pallan, Miranda; Hemming, Karla; Frew, Emma; Lin, Rong; Martin, James; Liu, Wei; Cheng, Kar Keung

2017-01-01

Introduction Childhood obesity in China has increased more rapidly and over a shorter time period than in other countries. However, there is a paucity of rigorously developed and evaluated prevention interventions. We aim to evaluate the clinical and cost-effectiveness as well as the implementation process of a complex multicomponent intervention developed using the UK Medical Research Council (MRC) framework. This study provides one of the first examples of rigorous development and evaluation of a childhood obesity prevention programme in a non-western population using the MRC methods. Methods and analysis A cluster-randomised controlled trial in 40 primary schools in Guangzhou, China, including children aged 6–7 years at baseline. Schools will be randomly allocated to either the usual practice (n=20) or intervention arm (n=20). The 12-month intervention consists of four components targeting diet and physical activity behaviours in and outside school, with family involvement. The primary objective is to compare the difference in mean body mass index (BMI) z-score between the intervention and control arms at the end of the intervention (starting March/April 2017). A sample size of 1640 pupils recruited from 40 schools is sufficient to detect a difference of 0.17 units in the mean BMI z-score with a power of 80% (ICC=0.01. ICC, intraclass correlation coefficient) and a significance level of 5%. Treatment effects will be tested using a mixed linear model in STATA adjusting for the child baseline BMI z-score and clustering by school. All analyses will be by intention to treat. Secondary analyses will additionally adjust for prespecified school-level and child-level covariates. The incremental cost-effectiveness ratio for the intervention versus usual practice will be ‘cost per quality-adjusted life year (QALY)’. Cost per change in BMI z-score will also be assessed. A range of methods will be used to evaluate intervention implementation, mechanisms of impact and

Adaptation of the By-Band randomized clinical trial to By-Band-Sleeve to include a new intervention and maintain relevance of the study to practice.

PubMed

Rogers, C A; Reeves, B C; Byrne, J; Donovan, J L; Mazza, G; Paramasivan, S; Andrews, R C; Wordsworth, S; Thompson, J; Blazeby, J M; Welbourn, R

2017-08-01

Recruitment into surgical RCTs can be threatened if new interventions available outside the trial compete with those being evaluated. Adapting the trial to include the new intervention may overcome this issue, yet this is not often done in surgery. This paper describes the challenges, rationale and methods for adapting an RCT to include a new intervention. The By-Band study was designed in the UK in 2009-2010 to compare the effectiveness of laparoscopic adjustable gastric band and Roux-en-Y gastric bypass for severe obesity. It contained a pilot phase to establish whether recruitment was possible, and the grant proposal specified that an adaptation to include sleeve gastrectomy would be considered if practice changed and recruitment was successful. Information on changing obesity surgery practice, updated evidence and expert opinion about trial design were used to inform the adaptation. The pilot phase recruited over 13 months in 2013-2014 and randomized 80 patients (79 anticipated). During this time, major changes in obesity practice in the UK were observed, with gastric band reducing from 32·6 to 15·8 per cent and sleeve gastrectomy increasing from 9·0 to 28·1 per cent. The evidence base had not changed markedly. The British Obesity and Metabolic Surgery Society and study oversight committees supported an adaptation to include sleeve gastrectomy, and a proposal to do so was approved by the funder. Adaptation of a two-group surgical RCT can allow evaluation of a third procedure and maintain relevance of the RCT to practice. It also optimizes the use of existing trial infrastructure to answer an additional important research question. Registration number: ISRCTN00786323 (http://www.isrctn.com/). © 2017 The Authors. BJS published by John Wiley & Sons Ltd on behalf of BJS Society Ltd.

Intensive gestational glycemic management and childhood obesity: a systematic review and meta-analysis.

PubMed

Guillemette, L; Durksen, A; Rabbani, R; Zarychanski, R; Abou-Setta, A M; Duhamel, T A; McGavock, J M; Wicklow, B

2017-07-01

Hyperglycemia in pregnancy is associated with increased risk of offspring childhood obesity. Treatment reduces macrosomia; however, it is unclear if this effect translates into a reduced risk of childhood obesity. We performed a systematic review and meta-analysis of randomized controlled trials to evaluate the efficacy and safety of intensive glycemic management in pregnancy in preventing childhood obesity. We searched MEDLINE, EMBASE, CENTRAL and ClinicalTrials.gov up to February 2016 and conference abstracts from 2010 to 2015. Two reviewers independently identified randomized controlled trials evaluating intensive glycemic management interventions for hyperglycemia in pregnancy and included four of the 383 citations initially identified. Two reviewers independently extracted study data and evaluated internal validity of the studies using the Cochrane Collaboration's Risk of Bias tool. Data were pooled using random-effects models. Statistical heterogeneity was quantified using the I 2 test. The primary outcome was age- and sex-adjusted childhood obesity. Secondary outcomes included childhood weight and waist circumference and maternal hypoglycemia during the trial (safety outcome). The four eligible trials (n=767 children) similarly used lifestyle and insulin to manage gestational hyperglycemia, but only two measured offspring obesity and waist circumference and could be pooled for these outcomes. We found no association between intensive gestational glucose management and childhood obesity at 7-10 years of age (relative risk 0.89, 95% confidence interval (CI) 0.65 to 1.22; two trials; n=568 children). Waist circumference also did not differ between treatment and control arms (mean difference, -2.68 cm; 95% CI, -8.17 to 2.81 cm; two trials; n=568 children). Intensive gestational glycemic management is not associated with reduced childhood obesity in offspring, but randomized data is scarce. Long-term follow-up of trials should be prioritized and comprehensive

A Social Media Peer Group Intervention for Mothers to Prevent Obesity and Promote Healthy Growth from Infancy: Development and Pilot Trial

PubMed Central

Gruver, Rachel S; Bishop-Gilyard, Chanelle T; Lieberman, Alexandra; Gerdes, Marsha; Virudachalam, Senbagam; Suh, Andrew W; Kalra, Gurpreet K; Magge, Sheela N; Shults, Justine; Schreiner, Mark S; Power, Thomas J; Berkowitz, Robert I

2016-01-01

Background Evidence increasingly indicates that childhood obesity prevention efforts should begin as early as infancy. However, few interventions meet the needs of families whose infants are at increased obesity risk due to factors including income and maternal body mass index (BMI). Social media peer groups may offer a promising new way to provide these families with the knowledge, strategies, and support they need to adopt obesity prevention behaviors. Objective The aim of this study is to develop and pilot test a Facebook-based peer group intervention for mothers, designed to prevent pediatric obesity and promote health beginning in infancy. Methods We conducted in-depth semi-structured interviews with 29 mothers of infants and focus groups with 30 pediatric clinicians, to inform the development of a theory-based intervention. We then conducted a single-group pilot trial with 8 mothers to assess its feasibility and acceptability. All participants were recruited offline at pediatric primary care practices. Participants in the pilot trial joined a private Facebook group, moderated by a psychologist, with a weekly video-based curriculum, and also had the option to meet at a face-to-face event. Within the Facebook group, mothers were encouraged to chat, ask questions, and share photos and videos of themselves and babies practicing healthy behaviors. Consistent with the literature on obesity prevention, the curriculum addressed infant feeding, sleep, activity, and maternal well-being. Feasibility was assessed using the frequency and content of group participation by mothers, and acceptability was measured using online surveys and phone interviews. Results Based on preferences of mothers interviewed (mean BMI 35 kg/m2, all Medicaid-insured, mean age 27, all Black), we designed the intervention to include frequent posts with new information, videos showing parents of infants demonstrating healthy behaviors, and an optional face-to-face meeting. We developed a privacy

Prepare, a randomized trial to promote and evaluate weight loss among overweight and obese women planning pregnancy: Study design and rationale

PubMed Central

Vesco, Kimberly K.; Funk, Kristine L.; Karanja, Njeri; Smith, Ning; Stevens, Victor J.

2017-01-01

Background Women who are overweight or have obesity at pregnancy onset, and those who gain excessive weight during pregnancy, are at increased risk of pregnancy-related complications and large for gestational age infants. Objective This report describes methodology for the Prepare study, a randomized, controlled clinical trial testing a preconception and pregnancy weight management program for women who are overweight or have obesity (BMI ≥ 27 kg/m2). Outcomes This trial examines multiple pregnancy and neonatal outcomes, with the primary outcome being gestational weight gain (GWG). Secondary outcomes include change in weight before conception, offspring birth weight adjusted for gestational age, offspring weight for length, and pregnancy diet quality and physical activity level. Methods Nonpregnant women who anticipate becoming pregnant in the next 2 years are randomly assigned to an intervention program or a usual care control condition. Intervention participants receive weight management counseling by telephone before and during pregnancy, with weekly contacts during the first 6 months and monthly contacts for the next 18 months. Intervention participants also have unlimited access to a study website that provides self-management tools. All participants who become pregnant are contacted at 20 weeks' gestation to assess physical activity levels and dietary habits. All other outcome data are obtained from medical records. Intervention satisfaction is assessed via questionnaire. Summary This clinical trial tests the efficacy of an intervention program designed to help overweight and obese women achieve healthy lifestyle changes that will result in a healthy weight prior to pregnancy and appropriate weight gain during pregnancy. PMID:27394386

The PICO project: aquatic exercise for knee osteoarthritis in overweight and obese individuals

PubMed Central

2013-01-01

Background Aquatic exercise is recommended by the Osteoarthritis Research Society (OARSI), by the American College of Rheumatology (ACR) and by the European League Against Rheumatism (EULAR) as a nonpharmacological method of controlling the knee osteoarthritis (KOA) symptoms. Moreover, given that weight loss results in a reduction of the load that is exerted upon the knee during daily activities, obesity is also considered to be a modifiable risk factor for the development and or exacerbation of KOA. The implementation of an exercise based weight loss program may, however, itself be limited by the symptoms of KOA. The aquatic program against osteoarthritis (termed “PICO” in Portuguese) prioritizes the control of symptoms and the recovery of functionality, with an attendant increase in the patient’s physical activity level and, consequently, metabolic rate. Our laboratory is assessing the effectiveness of 3 months of PICO on the symptoms of KOA, on physical function, on quality of life and on gait. In addition, PICO shall examine the effects of said exercise intervention on inflammatory biomarkers, psychological health, life style and body composition. Methods/Design The trial is a prospective, single-blinded, randomized controlled trial, and involves 50 overweight and obese adults (BMI = 28–43.5 kg/m2; age 40–65 yrs) with radiographic KOA. The participants are randomly allocated into either an educational attention (control) group or an aquatic (exercise program) group. This paper describes the experimental protocol that is used in the PICO project. Discussion The PICO program shall provide insight into the effectiveness of an aquatic exercise program in the control of KOA symptoms and in the improvement of the quality of life. As such, they are likely to prove a useful reference to health professionals who intend to implement any kind of therapeutic intervention based around aquatic exercise. Trial registration NCT01832545. PMID:24219758

A Behavioral Lifestyle Intervention Enhanced With Multiple-Behavior Self-Monitoring Using Mobile and Connected Tools for Underserved Individuals With Type 2 Diabetes and Comorbid Overweight or Obesity: Pilot Comparative Effectiveness Trial

PubMed Central

Cai, Chunyan; Padhye, Nikhil; Orlander, Philip; Zare, Mohammad

2018-01-01

Background Self-monitoring is a cornerstone of behavioral lifestyle interventions for obesity and type 2 diabetes mellitus. Mobile technology has the potential to improve adherence to self-monitoring and patient outcomes. However, no study has tested the use of a smartphone to facilitate self-monitoring in overweight or obese adults with type 2 diabetes mellitus living in the underserved community. Objective The aim of this study was to examine the feasibility of and compare preliminary efficacy of a behavioral lifestyle intervention using smartphone- or paper-based self-monitoring of multiple behaviors on weight loss and glycemic control in a sample of overweight or obese adults with type 2 diabetes mellitus living in underserved communities. Methods We conducted a randomized controlled trial to examine the feasibility and preliminary efficacy of a behavioral lifestyle intervention. Overweight or obese patients with type 2 diabetes mellitus were recruited from an underserved minority community health center in Houston, Texas. They were randomly assigned to one of the three groups: (1) behavior intervention with smartphone-based self-monitoring, (2) behavior intervention with paper diary-based self-monitoring, and (3) usual care group. Both the mobile and paper groups received a total of 11 face-to-face group sessions in a 6-month intervention. The mobile group received an Android-based smartphone with 2 apps loaded to help them record their diet, physical activity, weight, and blood glucose, along with a connected glucometer, whereas the paper group used paper diaries for these recordings. Primary outcomes of the study included percentage weight loss and glycated hemoglobin (HbA1c) changes over 6 months. Results A total of 26 patients were enrolled: 11 in the mobile group, 9 in the paper group, and 6 in the control group. We had 92% (24/26) retention rate at 6 months. The sample is predominantly African Americans with an average age of 56.4 years and body mass

Making a decision about trial participation: the feasibility of measuring deliberation during the informed consent process for clinical trials.

PubMed

Gillies, Katie; Elwyn, Glyn; Cook, Jonathan

2014-07-30

Informed consent of trial participants is both an ethical and a legal requirement. When facing a decision about trial participation, potential participants are provided with information about the trial and have the opportunity to have any questions answered before their degree of 'informed-ness' is assessed, usually subjectively, and before they are asked to sign a consent form. Currently, standardised methods for assessing informed consent have tended to be focused on aspects of understanding and associated outcomes, rather than on the process of consent and the steps associated with decision-making. Potential trial participants who were approached regarding participation in one of three randomised controlled trials were asked to complete a short questionnaire to measure their deliberation about trial participation. A total of 136 participants completed the 10-item questionnaire (DelibeRATE) before they made an explicit decision about trial participation (defined as signing the clinical trial consent form). Overall DelibeRATE scores were compared and investigated for differences between trial consenters and refusers. No differences in overall DelibeRATE scores were identified. In addition, there was no significant difference between overall score and the decision to participate, or not, in the parent trial. To our knowledge, this is the first study to prospectively measure the deliberation stage of the informed consent decision-making process of potential trial participants across different conditions and clinical areas. Although there were no differences detected in overall scores or scores of trial consenters and refusers, we did identify some interesting findings. These findings should be taken into consideration by those designing trials and others interested in developing and implementing measures of potential trial participants decision making during the informed consent process for research. International Standard Randomised Controlled Trial Number (ISRCTN

Childhood Obesity and Academic Performance: The Role of Working Memory.

PubMed

Wu, Nan; Chen, Yulu; Yang, Jinhua; Li, Fei

2017-01-01

The present study examined the role of working memory in the association between childhood obesity and academic performance, and further determined whether memory deficits in obese children are domain-specific to certain tasks or domain-general. A total of 227 primary school students aged 10-13 years were analyzed for weight and height, of which 159 children (44 "obese," 23 "overweight," and 92 "normal weight") filled out questionnaires on school performance and socioeconomic status. And then, all subjects finished three kinds of working memory tasks based on the digit memory task in 30 trials, which were image-generated with a series of numbers recall trial sets. After each trial set, subjects were given 5 s to recall and write down the numbers which hand appeared in the trial, in the inverse order in which they had appeared. The results showed there were significant academic performance differences among the three groups, with normal-weight children scoring higher than overweight and obese children after Bonferroni correction. A mediation model revealed a partial indirect effect of working memory in the relationship between obesity and academic performance. Although the performance of obese children in basic working memory tests was poorer than that of normal-weight children, they recalled more items than normal-weight children in working memory tasks involving with food/drink. Working memory deficits partially explain the poor academic performance of obese children. Those results indicated the obese children show domain-specific working memory deficits, whereas they recall more items than normal-weight children in working memory tasks associated with food/drink.

Preventing Obesity Among Adolescent Girls: One-Year Outcomes of the Nutrition and Enjoyable Activity for Teen Girls (NEAT Girls) Cluster Randomized Controlled Trial.

PubMed

Lubans, David R; Morgan, Philip J; Okely, Anthony D; Dewar, Deborah; Collins, Clare E; Batterham, Marijka; Callister, Robin; Plotnikoff, Ronald C

2012-09-01

OBJECTIVE To evaluate the impact of a 12-month multicomponent school-based obesity prevention program, Nutrition and Enjoyable Activity for Teen Girls among adolescent girls. DESIGN Group randomized controlled trial with 12-month follow-up. SETTING Twelve secondary schools in low-income communities in the Hunter and Central Coast regions of New South Wales, Australia. PARTICIPANTS Three hundred fifty-seven adolescent girls aged 12 to 14 years. INTERVENTION A multicomponent school-based intervention program tailored for adolescent girls. The intervention was based on social cognitive theory and included teacher professional development, enhanced school sport sessions, interactive seminars, nutrition workshops, lunch-time physical activity sessions, handbooks and pedometers for self-monitoring, parent newsletters, and text messaging for social support. MAIN OUTCOME MEASURES Body mass index (BMI, calculated as weight in kilograms divided by height in meters squared), BMI z score, body fat percentage, physical activity, screen time, dietary intake, and self-esteem. RESULTS After 12 months, changes in BMI (adjusted mean difference, -0.19; 95% CI, -0.70 to 0.33), BMI z score (mean, -0.08; 95% CI, -0.20 to 0.04), and body fat percentage (mean, -1.09; 95% CI, -2.88 to 0.70) were in favor of the intervention, but they were not statistically different from those in the control group. Changes in screen time were statistically significant (mean, -30.67 min/d; 95% CI, -62.43 to -1.06), but there were no group by time effects for physical activity, dietary behavior, or self-esteem. CONCLUSIONS A school-based intervention tailored for adolescent girls from schools located in low-income communities did not significantly reduce BMI gain. However, changes in body composition were of a magnitude similar to previous studies and may be associated with clinically important health outcomes. TRIAL REGISTRATION anzctr.org.au Identifier: 12610000330044.

A clinical carepath for obese pregnant women: A pragmatic pilot cluster randomized controlled trial.

PubMed

McDonald, Sarah D; Viaje, Kristen A; Rooney, Rebecca A; Jarde, Alexander; Giglia, Lucia; Maxwell, Cynthia V; Small, David; Kelly, Tracy Pearce; Midwifery, B H Sc; Sabatino, Lisa; Thabane, Lehana

2018-05-17

Obese women are at increased risks for complications during pregnancy, birth and in their infants. Although guidelines have been established for the clinical care of obese pregnant women, management is sometimes suboptimal. Our goal was to determine the feasibility of implementing and testing a clinical carepath for obese pregnant women compared to standard care, in a pilot cluster randomized controlled trial (RCT). A pragmatic pilot cluster RCT was conducted, randomly allocating eight clinics to the carepath or standard care for obese pregnant women. Women were eligible if they had a prepregnancy body mass index of ≥ 30 kg/m 2 and a viable singleton < 21 weeks. The primary outcomes were the feasibility of conducting a full-scale cluster RCT (defined as > 80%: randomization of clinics, use in eligible women, and completeness of follow-up) and of the intervention (defined as > 80%: compliance with each step in the carepath, and recommendation of the carepath by clinicians to a colleague). All eight approached clinics agreed to participate and were randomized. Half of the intervention clinics used the carepath, resulting in < 80% uptake of eligible women. High follow-up (99.5%) was achieved, in 188 of 189 women. The carepath was feasible for numerous guideline-directed recommendations for screening, but less so for counselling topics. When the carepath was used in the majority of women, all clinicians, most of whom were midwives, reported they would recommend it to a colleague. The intervention group had significantly higher overall adherence to the guideline recommendations compared to control (relative risk 1.71, 95% confidence interval 1.57-1.87). In this pragmatic pilot cluster RCT, a guideline-directed clinical carepath improved some aspects of care of obese pregnant women and was recommended by clinicians, particularly midwives. A cluster RCT may not be feasible in a mix of obstetric and midwifery clinics, but may be feasible in midwifery clinics. This

Effects of Aerobic and Resistance Exercise on Metabolic Syndrome, Sarcopenic Obesity, and Circulating Biomarkers in Overweight or Obese Survivors of Breast Cancer: A Randomized Controlled Trial.

PubMed

Dieli-Conwright, Christina M; Courneya, Kerry S; Demark-Wahnefried, Wendy; Sami, Nathalie; Lee, Kyuwan; Buchanan, Thomas A; Spicer, Darcy V; Tripathy, Debu; Bernstein, Leslie; Mortimer, Joanne E

2018-03-20

Purpose Metabolic syndrome is associated with an increased risk of cardiovascular disease, type 2 diabetes, and breast cancer recurrence in survivors of breast cancer. This randomized controlled trial assessed the effects of a 16-week combined aerobic and resistance exercise intervention on metabolic syndrome, sarcopenic obesity, and serum biomarkers among ethnically diverse, sedentary, overweight, or obese survivors of breast cancer. Methods Eligible survivors of breast cancer (N = 100) were randomly assigned to exercise (n = 50) or usual care (n = 50). The exercise group participated in supervised moderate-to-vigorous-65% to 85% of heart rate maximum-aerobic and resistance exercise three times per week for 16 weeks. Metabolic syndrome z-score (primary outcome), sarcopenic obesity, and serum biomarkers were measured at baseline, postintervention (4 months), and 3-month follow-up (exercise only). Results Participants were age 53 ± 10.4 years, 46% were obese, and 74% were ethnic minorities. Adherence to the intervention was 95%, and postintervention assessments were available in 91% of participants. Postintervention metabolic syndrome z-score was significantly improved in exercise versus usual care (between-group difference, -4.4; 95% CI, -5.9 to -2.7; P < .001). Sarcopenic obesity (appendicular skeletal mass index, P = .001; body mass index, P = .001) and circulating biomarkers, including insulin ( P = .002), IGF-1 ( P = .001), leptin ( P = .001), and adiponectin ( P = .001), were significantly improved postintervention compared with usual care. At 3-month follow-up, all metabolic syndrome variables remained significantly improved compared with baseline in the exercise group ( P < .01). Conclusion Combined resistance and aerobic exercise effectively attenuated metabolic syndrome, sarcopenic obesity, and relevant biomarkers in an ethnically diverse sample of sedentary, overweight, or obese survivors of breast cancer. Our findings suggest a targeted exercise

A randomized controlled trial to evaluate self-determination theory for exercise adherence and weight control: rationale and intervention description

PubMed Central

Silva, Marlene N; Markland, David; Minderico, Cláudia S; Vieira, Paulo N; Castro, Margarida M; Coutinho, Sílvia R; Santos, Teresa C; Matos, Margarida G; Sardinha, Luís B; Teixeira, Pedro J

2008-01-01

success, while exploring the utility of Self-Determination Theory for promoting health behavior change in the context of obesity. Trial Registration Clinical Trials Gov. Identifier NCT00513084 PMID:18613959

Process evaluation of the Enabling Mothers toPrevent Pediatric Obesity Through Web-Based Learning and Reciprocal Determinism (EMPOWER) randomized control trial.

PubMed

Knowlden, Adam P; Sharma, Manoj

2014-09-01

Family-and-home-based interventions are an important vehicle for preventing childhood obesity. Systematic process evaluations have not been routinely conducted in assessment of these interventions. The purpose of this study was to plan and conduct a process evaluation of the Enabling Mothers to Prevent Pediatric Obesity Through Web-Based Learning and Reciprocal Determinism (EMPOWER) randomized control trial. The trial was composed of two web-based, mother-centered interventions for prevention of obesity in children between 4 and 6 years of age. Process evaluation used the components of program fidelity, dose delivered, dose received, context, reach, and recruitment. Categorical process evaluation data (program fidelity, dose delivered, dose exposure, and context) were assessed using Program Implementation Index (PII) values. Continuous process evaluation variables (dose satisfaction and recruitment) were assessed using ANOVA tests to evaluate mean differences between groups (experimental and control) and sessions (sessions 1 through 5). Process evaluation results found that both groups (experimental and control) were equivalent, and interventions were administered as planned. Analysis of web-based intervention process objectives requires tailoring of process evaluation models for online delivery. Dissemination of process evaluation results can advance best practices for implementing effective online health promotion programs. © 2014 Society for Public Health Education.

Effect of physical exercise on spontaneous physical activity energy expenditure and energy intake in overweight adults (the EFECT study): a study protocol for a randomized controlled trial.

PubMed

Paravidino, Vitor Barreto; Mediano, Mauro Felippe Felix; Silva, Inácio Crochemore M; Wendt, Andrea; Del Vecchio, Fabrício Boscolo; Neves, Fabiana Alves; Terra, Bruno de Souza; Gomes, Erika Alvarenga Corrêa; Moura, Anibal Sanchez; Sichieri, Rosely

2018-03-07

, supporting the development of more effective interventions for prevention and treatment of obesity. Physical Exercise and Energy Balance trial registry, trial registration number: NCT 03138187 . Registered on 30 April 2017.

21 CFR 1301.35 - Certificate of registration; denial of registration.

Code of Federal Regulations, 2011 CFR

2011-04-01

... registration. (a) The Administrator shall issue a Certificate of Registration (DEA Form 223) to an applicant if... Federal Register. (c) The Certificate of Registration (DEA Form 223) shall contain the name, address, and...

21 CFR 1301.35 - Certificate of registration; denial of registration.

Code of Federal Regulations, 2010 CFR

2010-04-01

... registration. (a) The Administrator shall issue a Certificate of Registration (DEA Form 223) to an applicant if... Federal Register. (c) The Certificate of Registration (DEA Form 223) shall contain the name, address, and...

Rationale and design of the STAR randomized controlled trial to accelerate adoption of childhood obesity comparative effectiveness research.

PubMed

Taveras, Elsie M; Marshall, Richard; Horan, Christine M; Gillman, Matthew W; Hacker, Karen; Kleinman, Ken P; Koziol, Renata; Price, Sarah; Simon, Steven R

2013-01-01

Comparative effectiveness research (CER) evidence on childhood obesity provides the basis for effective screening and management strategies in pediatric primary care. The uses of health information technology including decision support tools in the electronic health records (EHRs), as well as remote and mobile support to families, offer the potential to accelerate the adoption of childhood obesity CER evidence. The Study of Technology to Accelerate Research (STAR) is a three-arm, cluster-randomized controlled trial being conducted in 14 pediatric offices in Massachusetts designed to enroll 800, 6 to 12 year old children with a body mass index (BMI)≥ 95th percentile seen in primary care at those practices. We will examine the extent to which computerized decision support tools in the EHR delivered to primary care providers at the point of care, with or without direct-to-parent support and coaching, will increase adoption of CER evidence for management of obese children. Direct-to-parent intervention components include telephone coaching and twice-weekly text messages. Point-of-care outcomes include obesity diagnosis, nutrition and physical activity counseling, and referral to weight management. One-year child-level outcomes include changes in BMI and improvements in diet, physical activity, screen time, and sleep behaviors, as well as cost and cost-effectiveness. STAR will determine the extent to which decision support tools in EHRs with or without direct-to-parent support will increase adoption of evidence-based obesity management strategies in pediatric practice and improve childhood obesity-related outcomes. Copyright © 2012 Elsevier Inc. All rights reserved.

New obesity agents: lorcaserin and phentermine/topiramate.

PubMed

Fleming, Joshua W; McClendon, Katie S; Riche, Daniel M

2013-01-01

To evaluate the evidence for lorcaserin and phentermine/topiramate in the treatment of obesity. Literature was accessed through PubMed (June 1975-March 2013) using the search terms lorcaserin, phentermine, topiramate, or phenter mine/topiramate. Additionally, reference citations from publications identified were reviewed. Additional information was obtained from the Food and Drug Administration (FDA)-approved prescribing information and FDA briefing documents. English-language articles focusing on Phase 3 clinical trials for obesity were critiqued. Data from preclinical and Phase 1 and/or 2 trials are reported when appropriate. Six prospective Phase 3 trials were reviewed. Obesity has reached epidemic proportions, affecting more than one third of adults in the US. Two medication products, lorcaserin and phenter mine/topiramate, have recently received FDA approval as adjuncts to a reduced-calorie diet and increased physical activity among individuals with a body mass index greater than or equal to 30 kg/m(2) or greater than or equal to 27 kg/m(2) with an obesity-related comorbidity, such as hypertension, dyslipidemia, or diabetes. Lorcaserin is a selective serotonin 5-HT2C agonist that regulates food intake, while the combination of phentermine/topiramate causes appetite suppression and enhanced satiety. Three Phase 3 randomized, placebo-controlled trials reported approximately 75% and 45% of patients achieved greater than or equal to 5% weight loss with phentermine/topiramate and lorcaserin, respectively. With lifestyle modification, phentermine/topiramate appears most effective in terms of weight loss. Lorcaserin demonstrates moderate efficacy. Long-term cardiovascular outcomes studies are needed to confirm the safety and benefit of these new obesity agents.

Cardio-metabolic and immunological impacts of extra virgin olive oil consumption in overweight and obese older adults: a randomized controlled trial.

PubMed

Rozati, Mitra; Barnett, Junaidah; Wu, Dayong; Handelman, Garry; Saltzman, Edward; Wilson, Thomas; Li, Lijun; Wang, Junpeng; Marcos, Ascensión; Ordovás, José M; Lee, Yu-Chi; Meydani, Mohsen; Meydani, Simin Nikbin

2015-01-01

Both aging and obesity are related to dysregulated immune function, which may be responsible for increased risk of infection and also chronic non-infectious diseases. Dietary lipids have been shown to impact immune and inflammatory responses and cardio-metabolic risk factors. No information on the impact of olive oil on immune responses of overweight and obese older adults is available. We aimed to determine the effect of replacing oils used in a typical American diet with extra virgin olive oil for 3 months on immune responses and cardio-metabolic risk factors in overweight and obese older adults. This was a randomized, single-blinded and placebo-controlled trial in 41 overweight or obese participants (aged ≥ 65) who consumed a typical American diet. Participants in the control (CON, n = 21) group were provided with a mixture of corn, soybean oil and butter, and those in the olive oil (OO, n = 20) group, with extra virgin olive oil, to replace substitutable oils in their diet. At baseline and 3 months, we measured blood pressure, biochemical and immunological parameters using fasting blood, and delayed-type hypersensitivity (DTH) skin response. Compared to the CON group, the OO group showed decreased systolic blood pressure (P < 0.05), a strong trend toward increased plasma HDL-C concentrations (P = 0.06), and increased anti-CD3/anti-CD28 -stimulated T cell proliferation (P < 0.05). No differences were found in T cell phenotype, cytokine production, and DTH response between the two groups. Our results indicate that substitution of oils used in a typical American diet with extra virgin olive oil in overweight and obese older adults may have cardio-metabolic and immunological health benefits. This trial was registered at clinicaltrials.gov as NCT01903304.

21 CFR 1309.42 - Certificate of registration; denial of registration.

Code of Federal Regulations, 2010 CFR

2010-04-01

...; denial of registration. (a) The Administrator shall issue a Certificate of Registration (DEA Form 511) to..., shall hold a hearing on the application pursuant to § 1309.51. (b) The Certificate of Registration (DEA...

21 CFR 1309.42 - Certificate of registration; denial of registration.

Code of Federal Regulations, 2011 CFR

2011-04-01

...; denial of registration. (a) The Administrator shall issue a Certificate of Registration (DEA Form 511) to..., shall hold a hearing on the application pursuant to § 1309.51. (b) The Certificate of Registration (DEA...

Parent-Focused Childhood and Adolescent Overweight and Obesity eHealth Interventions: A Systematic Review and Meta-Analysis

PubMed Central

Jones, Rachel A; Okely, Anthony D

2016-01-01

Background Effective broad-reach interventions to reduce childhood obesity are needed, but there is currently little consensus on the most effective approach. Parental involvement in interventions appears to be important. The use of eHealth modalities in interventions also seems to be promising. To our knowledge, there have been no previous reviews that have specifically investigated the effectiveness of parent-focused eHealth obesity interventions, a gap that this systematic review and meta-analysis intends to address. Objective The objective of this study was to review the evidence for body mass index (BMI)/BMI z-score improvements in eHealth overweight and obesity randomized controlled trials for children and adolescents, where parents or carers were an agent of change. Methods A systematic review and meta-analysis was conducted, which conforms to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement. Seven databases were searched for the period January 1995 to April 2015. Primary outcome measures were BMI and/or BMI z-score at baseline and post-intervention. Secondary outcomes included diet, physical activity, and screen time. Interventions were included if they targeted parents of children and adolescents aged 0-18 years of age and used an eHealth medium such as the Internet, interactive voice response (IVR), email, social media, telemedicine, or e-learning. Results Eight studies were included, involving 1487 parent and child or adolescent dyads. A total of 3 studies were obesity prevention trials, and 5 were obesity treatment trials. None of the studies found a statistically significant difference in BMI or BMI z-score between the intervention and control groups at post-intervention, and a meta-analysis demonstrated no significant difference in the effects of parent-focused eHealth obesity interventions compared with a control on BMI/BMI z-score (Standardized Mean Difference −0.15, 95% CI −0.45 to 0.16, Z=0.94, P=.35

Exercise and obesity in fibromyalgia: beneficial roles of IGF-1 and resistin?

PubMed Central

2013-01-01

obese patients (r = -0.815; P = 0.007). In obese patients, ∆FIQ fatigue after 30 weeks correlated negatively with ∆free IGF-1 (r = -0.711; P = 0.032). Conclusions Exercise reduced fatigue in all FM patients, this effect was achieved earlier in lean patients. Baseline levels of resistin in both serum and CSF associated negatively with fatigue. Resistin was increased after the exercise period which correlated with decreased fatigue. Changes in IGF-1 indicate similar long-term effects in obese patients. This study shows reduced fatigue after moderate exercise in FM and indicates the involvement of IGF-1 and resistin in these beneficial effects. Trial registration ClinicalTrials.gov: NCT00643006 PMID:23446104

Stanford GEMS phase 2 obesity prevention trial for low-income African-American girls: design and sample baseline characteristics.

PubMed

Robinson, Thomas N; Kraemer, Helena C; Matheson, Donna M; Obarzanek, Eva; Wilson, Darrell M; Haskell, William L; Pruitt, Leslie A; Thompson, Nikko S; Haydel, K Farish; Fujimoto, Michelle; Varady, Ann; McCarthy, Sally; Watanabe, Connie; Killen, Joel D

2008-01-01

African-American girls and women are at high risk of obesity and its associated morbidities. Few studies have tested obesity prevention strategies specifically designed for African-American girls. This report describes the design and baseline findings of the Stanford GEMS (Girls health Enrichment Multi-site Studies) trial to test the effect of a two-year community- and family-based intervention to reduce weight gain in low-income, pre-adolescent African-American girls. Randomized controlled trial with measurements scheduled in girls' homes at baseline, 6, 12, 18 and 24 month post-randomization. Low-income areas of Oakland, CA. Eight, nine and ten year old African-American girls and their parents/caregivers. Girls are randomized to a culturally-tailored after-school dance program and a home/family-based intervention to reduce screen media use versus an information-based community health education Active-Placebo Comparison intervention. Interventions last for 2 years for each participant. Change in body mass index over the two-year study. Recruitment and enrollment successfully produced a predominately low-socioeconomic status sample. Two-hundred sixty one (261) families were randomized. One girl per family is randomly chosen for the analysis sample. Randomization produced comparable experimental groups with only a few statistically significant differences. The sample had a mean body mass index (BMI) at the 74 th percentile on the 2000 CDC BMI reference, and one-third of the analysis sample had a BMI at the 95th percentile or above. Average fasting total cholesterol and LDL cholesterol were above NCEP thresholds for borderline high classifications. Girls averaged low levels of moderate to vigorous physical activity, more than 3 h per day of screen media use, and diets high in energy from fat. The Stanford GEMS trial is testing the benefits of culturally-tailored after-school dance and screen-time reduction interventions for obesity prevention in low-income, pre

Neuropeptide Y genotype, central obesity, and abdominal fat distribution: the POUNDS LOST trial1,2

PubMed Central

Lin, Xiaochen; Qi, Qibin; Zheng, Yan; Huang, Tao; Lathrop, Mark; Zelenika, Diana; Bray, George A; Sacks, Frank M; Liang, Liming; Qi, Lu

2015-01-01

Background: Neuropeptide Y is a key peptide affecting adiposity and has been related to obesity risk. However, little is known about the role of NPY variations in diet-induced change in adiposity. Objective: The objective was to examine the effects of NPY variant rs16147 on central obesity and abdominal fat distribution in response to dietary interventions. Design: We genotyped a functional NPY variant rs16147 among 723 participants in the Preventing Overweight Using Novel Dietary Strategies trial. Changes in waist circumference (WC), total abdominal adipose tissue, visceral adipose tissue, and subcutaneous adipose tissue (SAT) from baseline to 6 and 24 mo were evaluated with respect to the rs16147 genotypes. Genotype–dietary fat interaction was also examined. Results: The rs16147 C allele was associated with a greater reduction in WC at 6 mo (P < 0.001). In addition, the genotypes showed a statistically significant interaction with dietary fat in relation to WC and SAT (P-interaction = 0.01 and 0.04): the association was stronger in individuals with high-fat intake than in those with low-fat intake. At 24 mo, the association remained statistically significant for WC in the high-fat diet group (P = 0.02), although the gene–dietary fat interaction became nonsignificant (P = 0.30). In addition, we found statistically significant genotype–dietary fat interaction on the change in total abdominal adipose tissue, visceral adipose tissue, and SAT at 24 mo (P = 0.01, 0.05, and 0.04): the rs16147 T allele appeared to associate with more adverse change in the abdominal fat deposition in the high-fat diet group than in the low-fat diet group. Conclusion: Our data indicate that the NPY rs16147 genotypes affect the change in abdominal adiposity in response to dietary interventions, and the effects of the rs16147 single-nucleotide polymorphism on central obesity and abdominal fat distribution were modified by dietary fat. This trial was registered at clinicaltrials.gov as

A Community Resource Map to Support Clinical-Community Linkages in a Randomized Controlled Trial of Childhood Obesity, Eastern Massachusetts, 2014-2016.

PubMed

Fiechtner, Lauren; Puente, Gabriella C; Sharifi, Mona; Block, Jason P; Price, Sarah; Marshall, Richard; Blossom, Jeff; Gerber, Monica W; Taveras, Elsie M

2017-07-06

Novel approaches to health care delivery that leverage community resources could improve outcomes for children at high risk for obesity. We describe the process by which we created an online interactive community resources map for use in the Connect for Health randomized controlled trial. The trial was conducted in the 6 pediatric practices that cared for the highest percentage of children with overweight or obesity within a large multi-specialty group practice in eastern Massachusetts. By using semistructured interviews with parents and community partners and geographic information systems (GIS), we created and validated a community resource map for use in a randomized controlled trial for childhood obesity. We conducted semistructured interviews with 11 parents and received stakeholder feedback from 5 community partners, 2 pediatricians, and 3 obesity-built environment experts to identify community resources that could support behavior change. We used GIS databases to identify the location of resources. After the resources were validated, we created an online, interactive searchable map. We evaluated parent resource empowerment at baseline and follow-up, examined if the participant families went to new locations for physical activity and food shopping, and evaluated how satisfied the families were with the information they received. Parents, community partners, and experts identified several resources to be included in the map, including farmers markets, supermarkets, parks, and fitness centers. Parents expressed the need for affordable activities. Parent resource empowerment increased by 0.25 units (95% confidence interval, 0.21-0.30) over the 1-year intervention period; 76.2% of participants were physically active at new places, 57.1% of participant families shopped at new locations; and 71.8% reported they were very satisfied with the information they received. Parents and community partners identified several community resources that could help support

Development and evaluation of an articulated registration algorithm for human skeleton registration

NASA Astrophysics Data System (ADS)

Yip, Stephen; Perk, Timothy; Jeraj, Robert

2014-03-01

Accurate registration over multiple scans is necessary to assess treatment response of bone diseases (e.g. metastatic bone lesions). This study aimed to develop and evaluate an articulated registration algorithm for the whole-body skeleton registration in human patients. In articulated registration, whole-body skeletons are registered by auto-segmenting into individual bones using atlas-based segmentation, and then rigidly aligning them. Sixteen patients (weight = 80-117 kg, height = 168-191 cm) with advanced prostate cancer underwent the pre- and mid-treatment PET/CT scans over a course of cancer therapy. Skeletons were extracted from the CT images by thresholding (HU>150). Skeletons were registered using the articulated, rigid, and deformable registration algorithms to account for position and postural variability between scans. The inter-observers agreement in the atlas creation, the agreement between the manually and atlas-based segmented bones, and the registration performances of all three registration algorithms were all assessed using the Dice similarity index—DSIobserved, DSIatlas, and DSIregister. Hausdorff distance (dHausdorff) of the registered skeletons was also used for registration evaluation. Nearly negligible inter-observers variability was found in the bone atlases creation as the DSIobserver was 96 ± 2%. Atlas-based and manual segmented bones were in excellent agreement with DSIatlas of 90 ± 3%. Articulated (DSIregsiter = 75 ± 2%, dHausdorff = 0.37 ± 0.08 cm) and deformable registration algorithms (DSIregister = 77 ± 3%, dHausdorff = 0.34 ± 0.08 cm) considerably outperformed the rigid registration algorithm (DSIregsiter = 59 ± 9%, dHausdorff = 0.69 ± 0.20 cm) in the skeleton registration as the rigid registration algorithm failed to capture the skeleton flexibility in the joints. Despite superior skeleton registration performance, deformable registration algorithm failed to preserve the local rigidity of bones as over 60% of the

Growing Right Onto Wellness (GROW): A Family-Centered, Community-Based Obesity Prevention Randomized Controlled Trial for Preschool Child-Parent Pairs

PubMed Central

Po’e, Eli K.; Heerman, William J.; Mistry, Rishi S.; Barkin, Shari L.

2013-01-01

Growing Right Onto Wellness (GROW) is a randomized controlled trial that tests the efficacy of a family-centered, community-based, behavioral intervention to prevent childhood obesity among preschool-aged children. Focusing on parent-child pairs, GROW utilizes a multi-level framework, which accounts for macro (i.e., built-environment) and micro (i.e., genetics) level systems that contribute to the childhood obesity epidemic. Six hundred parent-child pairs will be randomized to a 3-year healthy lifestyle intervention or a 3-year school readiness program. Eligible children are enrolled between ages 3 and 5, are from minority communities, and are not obese. The principal site for the GROW intervention is local community recreation centers and libraries. The primary outcome is childhood Body Mass Index (BMI) trajectory at the end of the three-year study period. In addition to other anthropometric measurements, mediators and moderators of growth are considered, including genetics, accelerometry, and diet recall. GROW is a staged intensity intervention, consisting of intensive, maintenance, and sustainability phases. Throughout the study, parents build skills in nutrition, physical activity, and parenting, concurrently forming new social networks. Participants are taught goal-setting, self-monitoring, and problem solving techniques to facilitate sustainable behavior change. The GROW curriculum uses low health literacy communication and social media to communicate key health messages. The control arm is administered to both control and intervention participants. By conducting this trial in public community centers, and by implementing a family-centered approach to sustainable healthy childhood growth, we aim to develop an exportable community-based intervention to address the expanding public health crisis of pediatric obesity. PMID:24012890

A cluster randomised controlled trial evaluating the effectiveness and cost-effectiveness of the daily mile on childhood obesity and wellbeing; the Birmingham daily mile protocol.

PubMed

Breheny, Katie; Adab, Peymane; Passmore, Sandra; Martin, James; Lancashire, Emma; Hemming, Karla; Frew, Emma

2018-01-11

Childhood obesity prevention is a public health priority. Children spend a large proportion of their waking time in school; therefore this is an appropriate setting to implement obesity prevention initiatives. Anecdotal reports suggest that implementing The Daily Mile in schools has had positive effects on childhood obesity, academic attainment and wellbeing. This trial aims to measure the effectiveness of The Daily Mile for improving health and wellbeing. This protocol describes a cluster randomised controlled trial (RCT) in 40 primary schools located in Birmingham, UK. Eligible participants are children in years 3 (aged 7-8) and 5 (aged 9-10). The study compares The Daily Mile (intervention) to usual practice (control) in relation to health and wellbeing. The Daily Mile intervention involves an additional 15 min of running or walking integrated into the school day, throughout a 12 month study period. The primary clinical outcome is body mass index (BMI) z-scores at 12 months following introduction of the intervention. The cost per Quality Adjusted Life Year (QALY) is the primary outcome of the economic evaluation. Secondary outcomes include wellbeing, physical fitness and teacher reported academic attainment. This study is the first RCT investigating the clinical and cost-effectiveness of The Daily Mile. A range of outcomes will be measured to evaluate the broader wellbeing and academic benefits in addition to clinical outcomes typically measured in childhood obesity prevention trials. The intervention is simple and low-cost, therefore if the benefits are demonstrated it has enormous potential to influence future policy. ISRCTN: 12698269 . Date protocol registered 27th October 2016.

Effects of elastic resistance exercise on body composition and physical capacity in older women with sarcopenic obesity

PubMed Central

Liao, Chun-De; Tsauo, Jau-Yih; Lin, Li-Fong; Huang, Shih-Wei; Ku, Jan-Wen; Chou, Lin-Chuan; Liou, Tsan-Hon

2017-01-01

incorporating elastic RET should be used to attenuate muscle mass loss and prevent physical difficulty in obese older adults with sarcopenia on reconditioning therapy. Trial Registration: Chinese Clinical Trial Registry, ChiCTR-IPR-15006069. PMID:28591061

The comprehensive summary of surgical versus non-surgical treatment for obesity: a systematic review and meta-analysis of randomized controlled trials.

PubMed

Cheng, Ji; Gao, Jinbo; Shuai, Xiaoming; Wang, Guobin; Tao, Kaixiong

2016-06-28

Bariatric surgery has emerged as a competitive strategy for obese patients. However, its comparative efficacy against non-surgical treatments remains ill-defined, especially among nonseverely obese crowds. Therefore, we implemented a systematic review and meta-analysis in order for an academic addition to current literatures. Literatures were retrieved from databases of PubMed, Web of Science, EMBASE and Cochrane Library. Randomized trials comparing surgical with non-surgical therapies for obesity were included. A Revised Jadad's Scale and Risk of Bias Summary were employed for methodological assessment. Subgroups analysis, sensitivity analysis and publication bias assessment were respectively performed in order to find out the source of heterogeneity, detect the outcome stability and potential publication bias. 25 randomized trials were eligibly included, totally comprising of 1194 participants. Both groups displayed well comparability concerning baseline parameters (P > 0.05). The pooled results of primary endpoints (weight loss and diabetic remission) revealed a significant advantage among surgical patients rather than those receiving non-surgical treatments (P < 0.05). Furthermore, except for certain cardiovascular indicators, bariatric surgery was superior to conventional arms in terms of metabolic secondary parameters (P < 0.05). Additionally, the pooled outcomes were confirmed to be stable by sensitivity analysis. Although Egger's test (P < 0.01) and Begg's test (P<0.05) had reported the presence of publication bias among included studies, "Trim-and-Fill" method verified that the pooled outcomes remained stable. Bariatric surgery is a better therapeutic option for weight loss, irrespective of follow-up duration, surgical techniques and obesity levels.

Nutrition and physical activity programs for obesity treatment (PRONAF study): methodological approach of the project

PubMed Central

2012-01-01

obese subjects can benefit from the results. The aim is to transfer it to sports centres. Effectiveness on individual health-related parameter in order to determine the most effective training programme will be analysed in forthcoming publications. Trial registration ClinicalTrials.gov NCT01116856 PMID:23259716

Childhood Obesity and Academic Performance: The Role of Working Memory

PubMed Central

Wu, Nan; Chen, Yulu; Yang, Jinhua; Li, Fei

2017-01-01

The present study examined the role of working memory in the association between childhood obesity and academic performance, and further determined whether memory deficits in obese children are domain-specific to certain tasks or domain-general. A total of 227 primary school students aged 10–13 years were analyzed for weight and height, of which 159 children (44 “obese,” 23 “overweight,” and 92 “normal weight”) filled out questionnaires on school performance and socioeconomic status. And then, all subjects finished three kinds of working memory tasks based on the digit memory task in 30 trials, which were image-generated with a series of numbers recall trial sets. After each trial set, subjects were given 5 s to recall and write down the numbers which hand appeared in the trial, in the inverse order in which they had appeared. The results showed there were significant academic performance differences among the three groups, with normal-weight children scoring higher than overweight and obese children after Bonferroni correction. A mediation model revealed a partial indirect effect of working memory in the relationship between obesity and academic performance. Although the performance of obese children in basic working memory tests was poorer than that of normal-weight children, they recalled more items than normal-weight children in working memory tasks involving with food/drink. Working memory deficits partially explain the poor academic performance of obese children. Those results indicated the obese children show domain-specific working memory deficits, whereas they recall more items than normal-weight children in working memory tasks associated with food/drink. PMID:28469593

Adolescents Just Do Not Know What They Want: A Qualitative Study to Describe Obese Adolescents’ Experiences of Text Messaging to Support Behavior Change Maintenance Post Intervention

PubMed Central

Kerr, Deborah A; Fenner, Ashley A; Straker, Leon M

2014-01-01

actual experiences. Parent reports provided a useful secondary view of adolescent experience. Conclusions The conflicting views described in this study suggest that overweight and obese adolescents may not know or have the ability to articulate how they would best be supported with text messages during a healthy lifestyle maintenance phase. Further, supporting both engagement and behavior change simultaneously with text messaging may not be possible. Intervention texts should be personalized as much as possible and minimize feelings of guilt and shame in overweight and obese adolescents. Future research with text messaging for overweight and obese adolescents should incorporate clear intervention aims and evaluation methods specifically related to adolescent engagement or behavior change. Trial Registration Australian New Zealand Clinical Trials Registry: ACTRN12611001187932; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12611001187932 (Archived by WebCite at http://www.webcitation.org/6LGSbk8d9). PMID:24713407

Effect of Caloric Restriction or Aerobic Exercise Training on Peak Oxygen Consumption and Quality of Life in Obese Older Patients with Heart Failure and Preserved Ejection Fraction A Randomized, Controlled Trial

PubMed Central

Kitzman, Dalane W.; Brubaker, Peter; Morgan, Timothy; Haykowsky, Mark; Hundley, Gregory; Kraus, William E.; Eggebeen, Joel; Nicklas, Barbara J.

2016-01-01

.003) and the change in thigh muscle/intermuscular fat ratio (r=0.27; p=0.02). There were no study-related serious adverse events. Exercise attendance was 84±14%; Diet compliance was 99±1%. Body weight decreased by 7±1 kg (7%) in Diet, 4±1 kg (3%) in Exercise, 11±1 kg (10%) in Exercise+Diet, and 1±1 kg (1%) in Control. Conclusion and Relevance Among obese older patients with clinically stable heart failure and preserved ejection fraction, caloric restriction diet or aerobic exercise training increased peak oxygen consumption, and the effects may be additive. Neither intervention had a significant effect on quality of life as measured by the Minnesota Living with Heart Failure Questionnaire, Clinical Trial Registration Clinicaltrials.gov, NCT00959660; https://clinicaltrials.gov/ct2/show/NCT00959660 PMID:26746456

Evaluation of a family intervention programme for the treatment of overweight and obese children (Nereu Programme): a randomized clinical trial study protocol.

PubMed

Serra-Paya, Noemi; Ensenyat, Assumpta; Real, Jordi; Castro-Viñuales, Iván; Zapata, Amalia; Galindo, Gisela; Solé-Mir, Eduard; Bosch-Muñoz, Jordi; Mur, Jose Maria; Teixidó, Concepció

2013-10-23

Obesity is mainly attributed to environmental factors. In developed countries, the time spent on physical activity tasks is decreasing, whereas sedentary behaviour patterns are increasing.The purpose of the intervention is to evaluate the effectiveness of an intensive family-based behavioural multi-component intervention (Nereu programme) and compared it to counselling intervention such as a health centre intervention programme for the management of children's obesity. The study design is a randomized controlled multicenter clinical trial using two types of interventions: Nereu and Counselling. The Nereu programme is an 8-month intensive family-based multi-component behavioural intervention. This programme is based on a multidisciplinary intervention consisting of 4 components: physical activity sessions for children, family theoretical and practical sessions for parents, behaviour strategy sessions involving both, parents and children, and lastly, weekend extra activities for all. Counselling is offered to the family in the form of a monthly physical health and eating habits session. Participants will be recruited according the following criteria: 6 to 12 year-old-children, referred from their paediatricians due to overweight or obesity according the International Obesity Task Force criteria and with a sedentary profile (less than 2 hours per week of physical activity), they must live in or near the municipality of Lleida (Spain) and their healthcare paediatric unit must have previously accepted to cooperate with this study. The following variables will be evaluated: a) cardiovascular risk factors (anthropometric parameters, blood test and blood pressure), b) sedentary and physical activity behaviour and dietary intake, c) psychological aspects d) health related quality of life (HRQOL), e) cost-effectiveness of the intervention in relation to HRQOL. These variables will be then be evaluated 4 times longitudinally: at baseline, at the end of the intervention (8

Effect of Post-Cesarean Delivery Oral Cephalexin and Metronidazole on Surgical Site Infection Among Obese Women: A Randomized Clinical Trial.

PubMed

Valent, Amy M; DeArmond, Chris; Houston, Judy M; Reddy, Srinidhi; Masters, Heather R; Gold, Alison; Boldt, Michael; DeFranco, Emily; Evans, Arthur T; Warshak, Carri R

2017-09-19

The rate of obesity among US women has been increasing, and obesity is associated with increased risk of surgical site infection (SSI) following cesarean delivery. The optimal perioperative antibiotic prophylactic regimen in this high-risk population undergoing cesarean delivery is unknown. To determine rates of SSI among obese women who receive prophylactic oral cephalexin and metronidazole vs placebo for 48 hours following cesarean delivery. Randomized, double-blind clinical trial comparing oral cephalexin and metronidazole vs placebo for 48 hours following cesarean delivery for the prevention of SSI in obese women (prepregnancy BMI ≥30) who had received standard intravenous preoperative cephalosporin prophylaxis. Randomization was stratified by intact vs rupture of membranes prior to delivery. The study was conducted at the University of Cincinnati Medical Center, Cincinnati, Ohio, an academic and urban setting, between October 2010 and December 2015, with final follow-up through February 2016. Participants were randomly assigned to receive oral cephalexin, 500 mg, and metronidazole, 500 mg (n = 202 participants), vs identical-appearing placebo (n = 201 participants) every 8 hours for a total of 48 hours following cesarean delivery. The primary outcome was SSI, defined as any superficial incisional, deep incisional, or organ/space infections within 30 days after cesarean delivery. Among 403 randomized participants who were included (mean age, 28 [SD, 6] years; mean BMI, 39.7 [SD, 7.8]), 382 (94.6%) completed the trial. The overall rate of SSI was 10.9% (95% CI, 7.9%-14.0%). Surgical site infection was diagnosed in 13 women (6.4%) in the cephalexin-metronidazole group vs 31 women (15.4%) in the placebo group (difference, 9.0% [95% CI, 2.9%-15.0%]; relative risk, 0.41 [95% CI, 0.22-0.77]; P = .01). There were no serious adverse events, including allergic reaction, reported in either the antibiotic group or the placebo group. Among obese women

Registration and fusion quantification of augmented reality based nasal endoscopic surgery.

PubMed

Chu, Yakui; Yang, Jian; Ma, Shaodong; Ai, Danni; Li, Wenjie; Song, Hong; Li, Liang; Chen, Duanduan; Chen, Lei; Wang, Yongtian

2017-12-01

This paper quantifies the registration and fusion display errors of augmented reality-based nasal endoscopic surgery (ARNES). We comparatively investigated the spatial calibration process for front-end endoscopy and redefined the accuracy level of a calibrated endoscope by using a calibration tool with improved structural reliability. We also studied how registration accuracy was combined with the number and distribution of the deployed fiducial points (FPs) for positioning and the measured registration time. A physically integrated ARNES prototype was customarily configured for performance evaluation in skull base tumor resection surgery with an innovative approach of dynamic endoscopic vision expansion. As advised by surgical experts in otolaryngology, we proposed a hierarchical rendering scheme to properly adapt the fused images with the required visual sensation. By constraining the rendered sight in a known depth and radius, the visual focus of the surgeon can be induced only on the anticipated critical anatomies and vessel structures to avoid misguidance. Furthermore, error analysis was conducted to examine the feasibility of hybrid optical tracking based on point cloud, which was proposed in our previous work as an in-surgery registration solution. Measured results indicated that the error of target registration for ARNES can be reduced to 0.77 ± 0.07 mm. For initial registration, our results suggest that a trade-off for a new minimal time of registration can be reached when the distribution of five FPs is considered. For in-surgery registration, our findings reveal that the intrinsic registration error is a major cause of performance loss. Rigid model and cadaver experiments confirmed that the scenic integration and display fluency of ARNES are smooth, as demonstrated by three clinical trials that surpassed practicality. Copyright © 2017 Elsevier B.V. All rights reserved.

Effectiveness of lifestyle interventions for individuals with severe obesity and type 2 diabetes: results from the Look AHEAD trial.

PubMed

Unick, Jessica L; Beavers, Daniel; Jakicic, John M; Kitabchi, Abbas E; Knowler, William C; Wadden, Thomas A; Wing, Rena R

2011-10-01

Rates of severe obesity (BMI ≥40 kg/m(2)) are on the rise, and effective treatment options are needed. We examined the effect of an intensive lifestyle intervention (ILI) on weight loss, cardiovascular disease (CVD) risk, and program adherence in participants with type 2 diabetes who were severely obese compared with overweight (BMI 25 to <30 kg/m(2)), class I (BMI 30 to <35 kg/m(2)), and class II (BMI 35 to <40 kg/m(2)) obese participants. Participants in the Action for Health in Diabetes (Look AHEAD) trial were randomly assigned to ILI or diabetes support and education (DSE). DSE participants received a less intense educational intervention, whereas ILI participants received an intensive behavioral treatment to increase physical activity (PA) and reduce caloric intake. This article focuses on the 2,503 ILI participants (age 58.6 ± 6.8 years). At 1 year, severely obese participants in the ILI group lost -9.04 ± 7.6% of initial body weight, which was significantly greater (P < 0.05) than ILI participants who were overweight (-7.43 ± 5.6%) and comparable to class I (-8.72 ± 6.4%) and class II obese (-8.64 ± 7.4%) participants. All BMI groups had comparable improvements in fitness, PA, LDL cholesterol, triglycerides, blood pressure, fasting glucose, and HbA(1c) at 1 year. ILI treatment session attendance was excellent and did not differ among weight categories (severe obese 80% vs. others 83%; P = 0.43). Severely obese participants in the ILI group had similar adherence, percentage of weight loss, and improvement in CVD risk compared with less obese participants. Behavioral weight loss programs should be considered an effective option for this population.

Registration and Marking Requirements for UAS. Unmanned Aircraft System (UAS) Registration

NASA Technical Reports Server (NTRS)

2005-01-01

The registration of an aircraft is a prerequisite for issuance of a U.S. certificate of airworthiness by the FAA. The procedures and requirements for aircraft registration, and the subsequent issuance of registration numbers, are contained in FAR Part 47. However, the process/method(s) for applying the requirements of Parts 45 & 47 to Unmanned Aircraft Systems (UAS) has not been defined. This task resolved the application of 14 CFR Parts 45 and 47 to UAS. Key Findings: UAS are aircraft systems and as such the recommended approach to registration is to follow the same process for registration as manned aircraft. This will require manufacturers to comply with the requirements for 14 CFR 47, Aircraft Registration and 14 CFR 45, Identification and Registration Marking. In addition, only the UA should be identified with the N number registration markings. There should also be a documentation link showing the applicability of the control station and communication link to the UA. The documentation link can be in the form of a Type Certificate Data Sheet (TCDS) entry or a UAS logbook entry. The recommended process for the registration of UAS is similar to the manned aircraft process and is outlined in a 6-step process in the paper.

The Costs and Cost-Effectiveness of a School-Based Comprehensive Intervention Study on Childhood Obesity in China

PubMed Central

Meng, Liping; Xu, Haiquan; Liu, Ailing; van Raaij, Joop; Bemelmans, Wanda; Hu, Xiaoqi; Zhang, Qian; Du, Songming; Fang, Hongyun; Ma, Jun; Xu, Guifa; Li, Ying; Guo, Hongwei; Du, Lin; Ma, Guansheng

2013-01-01

Background The dramatic rise of overweight and obesity among Chinese children has greatly affected the social economic development. However, no information on the cost-effectiveness of interventions in China is available. The objective of this study is to evaluate the cost and the cost-effectiveness of a comprehensive intervention program for childhood obesity. We hypothesized the integrated intervention which combined nutrition education and physical activity (PA) is more cost-effective than the same intensity of single intervention. Methods And Findings: A multi-center randomized controlled trial conducted in six large cities during 2009-2010. A total of 8301 primary school students were categorized into five groups and followed one academic year. Nutrition intervention, PA intervention and their shared common control group were located in Beijing. The combined intervention and its’ control group were located in other 5 cities. In nutrition education group, ‘nutrition and health classes’ were given 6 times for the students, 2 times for the parents and 4 times for the teachers and health workers. "Happy 10" was carried out twice per day in PA group. The comprehensive intervention was a combination of nutrition and PA interventions. BMI and BAZ increment was 0.65 kg/m2 (SE 0.09) and 0.01 (SE 0.11) in the combined intervention, respectively, significantly lower than that in its’ control group (0.82±0.09 for BMI, 0.10±0.11 for BAZ). No significant difference were found neither in BMI nor in BAZ change between the PA intervention and its’ control, which is the same case in the nutrition intervention. The single intervention has a relative lower intervention costs compared with the combined intervention. Labor costs in Guangzhou, Shanghai and Jinan was higher compared to other cities. The cost-effectiveness ratio was $120.3 for BMI and $249.3 for BAZ in combined intervention, respectively. Conclusions The school-based integrated obesity intervention program

Clinical trial regulation in Argentina: overview and analysis of regulatory framework, use of existing tools, and researchers' perspectives to identify potential barriers.

PubMed

White, Lauren; Ortiz, Zulma; Cuervo, Luis G; Reveiz, Ludovic

2011-11-01

To review and analyze the regulatory framework of clinical trial registration, use of existing tools (publicly accessible national/international registration databases), and users' perspectives to identify possible barriers to registration compliance by sponsors and researchers in Argentina. Internationally registered trials recruiting patients in Argentina were found through clincialtrials.gov and the International Clinical Trial Registration Platform (ICTRP) and compared with publically available clinical trials registered through the National Administration of Drugs, Foods, and Medical Devices (ANMAT). A questionnaire addressing hypothesized attitudinal, knowledge-related, idiomatic, technical, economic, and regulatory barriers that could discourage or impede registration of clinical trials was developed, and semi-structured, in-depth interviews were conducted with a purposively selected sample of researchers (investigators, sponsors, and monitors) in Argentina. A response rate of 74.3% (n = 29) was achieved, and 27 interviews were ultimately used for analysis. Results suggested that the high proportion of foreign-sponsored or multinational trials (64.8% of all protocols approved by ANMAT from 1994-2006) may contribute to a communication gap between locally based investigators and foreign-based administrative officials. A lack of knowledge about available international registration tools and limited awareness of the importance of registration were also identified as limiting factors for local investigators and sponsors. To increase compliance and promote clinical trial registration in Argentina, national health authorities, sponsors, and local investigators could take the following steps: implement a grassroots educational campaign to improve clinical trial regulation, support local investigator-sponsor-initiated clinical trials, and/or encourage local and regional scientific journal compliance with standards from the International Committee of Medical Journal

Joint statement of the European Association for the Study of Obesity and the European Society of Hypertension: obesity and heart failure.

PubMed

Jordan, Jens; Toplak, Hermann; Grassi, Guido; Yumuk, Volkan; Kotsis, Vasilios; Engeli, Stefan; Cuspidi, Cesare; Nilsson, Peter M; Finer, Nick; Doehner, Wolfram

2016-09-01

Obese individuals are more likely to develop heart failure. Yet, once heart failure is established, the impact of overweight and obesity on prognosis and survival is unclear. The purpose of this joint scientific statement of the European Association for the Study of Obesity and the European Society of Hypertension is to provide an overview on the current scientific literature on obesity and heart failure in terms of prognosis, mechanisms, and clinical management implications. Moreover, the document identifies open questions that ought to be addressed. The need for more tailored weight management recommendations in heart failure will be emphasized and, in line with the emerging evidence, aims to distinguish between primary disease and secondary outcome prevention. In the primary prevention of heart failure, it appears prudent advising obese individuals to lose or achieve a healthy body weight, especially in those with risk factors such as hypertension or type 2 diabetes. However, there is no evidence from clinical trials to guide weight management in overweight or obese patients with established heart failure. Prospective clinical trials are strongly encouraged.

Effect of folic acid supplementation on plasma homocysteine in obese children: a randomized, double-blind, placebo-controlled trial.

PubMed

Iamopas, Orawan; Ratanachu-ek, Suntaree; Chomtho, Sirinuch

2014-06-01

Obese children tend to consume less dietary folate, which is an important cofactor in remethylation of homocysteine to methionine. The deficiency of folate can lead to hyperhomocysteinemia. To determine whether folic acid supplementation could reduce plasma homocysteine in obese children. Obese children, aged 9-15 years with body mass index > median plus 2 SD according to WHO reference, were randomly assigned to 2 groups: receiving either 5 mg folic acid or placebo for 2 months. Fasting homocysteine, creatinine, folate, vitamin B12, insulin, glucose and lipid profiles were taken at baseline and the end of the study. Dietary vitamin B12, folate intake and physical activity were assessed using validated questionnaires. Fifty obese children (31 boys and 19 girls) took part in the study. Their mean age was 10.9 ± 1.6 years and mean BMI Z-score was 3.41 ± 0.69. After the intervention, plasma homocysteine decreased by 15.75% and 6.99% in the folic acid and placebo group, respectively (mean difference 8.76%; 95% CI: 0.26%, 17.25%, p = 0.044). This divergence was more pronounced in boys and it remained significant after adjusting for baseline homocysteine and other confounders. Subgroup analysis showed a larger magnitude of plasma homocysteine reduction in the low folate group (mean difference 12.24%; 95% CI: 1.39%, 23.09%). The homocysteine lowering effect of folic acid supplementation was found in obese children, especially in boys and those with low serum folate. Further long-term interventional studies are needed to determine the effects of the lowered plasma homocysteine on the cardiovascular outcomes of obese children. This trial was registered on clinicaltrials.gov (NCT01766310).

Track: A randomized controlled trial of a digital health obesity treatment intervention for medically vulnerable primary care patients.

PubMed

Foley, Perry; Steinberg, Dori; Levine, Erica; Askew, Sandy; Batch, Bryan C; Puleo, Elaine M; Svetkey, Laura P; Bosworth, Hayden B; DeVries, Abigail; Miranda, Heather; Bennett, Gary G

2016-05-01

Obesity continues to disproportionately affect medically vulnerable populations. Digital health interventions may be effective for delivering obesity treatment in low-resource primary care settings. Track is a 12-month randomized controlled trial of a digital health weight loss intervention in a community health center system. Participants are 351 obese men and women aged 21 to 65years with an obesity-related comorbidity. Track participants are randomized to usual primary care or to a 12-month intervention consisting of algorithm-generated tailored behavior change goals, self-monitoring via mobile technologies, daily self-weighing using a network-connected scale, skills training materials, 18 counseling phone calls with a Track coach, and primary care provider counseling. Participants are followed over 12months, with study visits at baseline, 6, and 12months. Anthropometric data, blood pressure, fasting lipids, glucose and HbA1C and self-administered surveys are collected. Follow-up data will be collected from the medical record at 24months. Participants are 68% female and on average 50.7years old with a mean BMI of 35.9kg/m(2). Participants are mainly black (54%) or white (33%); 12.5% are Hispanic. Participants are mostly employed and low-income. Over 20% of the sample has hypertension, diabetes and hyperlipidemia. Almost 27% of participants currently smoke and almost 20% score above the clinical threshold for depression. Track utilizes an innovative, digital health approach to reduce obesity and chronic disease risk among medically vulnerable adults in the primary care setting. Baseline characteristics reflect a socioeconomically disadvantaged, high-risk patient population in need of evidence-based obesity treatment. Copyright © 2016 Elsevier Inc. All rights reserved.

Track: A randomized controlled trial of a digital health obesity treatment intervention for medically vulnerable primary care patients

PubMed Central

Foley, Perry; Steinberg, Dori; Levine, Erica; Askew, Sandy; Batch, Bryan C.; Puleo, Elaine M.; Svetkey, Laura P.; Bosworth, Hayden B.; DeVries, Abigail; Miranda, Heather; Bennett, Gary G.

2016-01-01

Introduction Obesity continues to disproportionately affect medically vulnerable populations. Digital health interventions may be effective for delivering obesity treatment in low-resource primary care settings. Methods Track is a 12-month randomized controlled trial of a digital health weight loss intervention in a community health center system. Participants are 351 obese men and women aged 21 to 65 years with an obesity-related comorbidity. Track participants are randomized to usual primary care or to a 12-month intervention consisting of algorithm-generated tailored behavior change goals, self-monitoring via mobile technologies, daily self-weighing using a network-connected scale, skills training materials, 18 counseling phone calls with a Track coach, and primary care provider counseling. Participants are followed over 12 months, with study visits at baseline, 6, and 12 months. Anthropometric data, blood pressure, fasting lipids, glucose and HbA1C and self-administered surveys are collected. Follow-up data will be collected from the medical record at 24 months. Results Participants are 68% female and on average 50.7 years old with a mean BMI of 35.9 kg/m2. Participants are mainly black (54%) or white (33%); 12.5% are Hispanic. Participants are mostly employed and low-income. Over 20% of the sample has hypertension, diabetes and hyperlipidemia. Almost 27% of participants currently smoke and almost 20% score above the clinical threshold for depression. Conclusions Track utilizes an innovative, digital health approach to reduce obesity and chronic disease risk among medically vulnerable adults in the primary care setting. Baseline characteristics reflect a socioeconomically disadvantaged, high-risk patient population in need of evidence-based obesity treatment. PMID:26995281

21 CFR 710.6 - Notification of registrant; cosmetic product establishment registration number.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Notification of registrant; cosmetic product... OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.6 Notification of registrant; cosmetic product establishment registration number. The...

21 CFR 710.6 - Notification of registrant; cosmetic product establishment registration number.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Notification of registrant; cosmetic product... OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.6 Notification of registrant; cosmetic product establishment registration number. The...

21 CFR 710.6 - Notification of registrant; cosmetic product establishment registration number.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Notification of registrant; cosmetic product... OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.6 Notification of registrant; cosmetic product establishment registration number. The...

21 CFR 710.6 - Notification of registrant; cosmetic product establishment registration number.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Notification of registrant; cosmetic product... OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.6 Notification of registrant; cosmetic product establishment registration number. The...

21 CFR 710.6 - Notification of registrant; cosmetic product establishment registration number.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Notification of registrant; cosmetic product... OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.6 Notification of registrant; cosmetic product establishment registration number. The...

Sleep Extension Improves Neurocognitive Functions in Chronically Sleep-Deprived Obese Individuals

PubMed Central

Lucassen, Eliane A.; Piaggi, Paolo; Dsurney, John; de Jonge, Lilian; Zhao, Xiong-ce; Mattingly, Megan S.; Ramer, Angela; Gershengorn, Janet; Csako, Gyorgy; Cizza, Giovanni

2014-01-01

findings have clinical implications for large segments of the US population. Trail registration www.ClinicalTrials.gov NCT00261898. NIDDK protocol 06-DK-0036 PMID:24482677

Effects of calcium supplementation on body weight and adiposity in overweight and obese adults: a randomized trial.

PubMed

Yanovski, Jack A; Parikh, Shamik J; Yanoff, Lisa B; Denkinger, Blakeley I; Calis, Karim A; Reynolds, James C; Sebring, Nancy G; McHugh, Teresa

2009-06-16

Some data suggest that increasing calcium intake may help prevent weight gain. To test the hypothesis that calcium supplementation can prevent weight gain in persons who are overweight or obese. Randomized, placebo-controlled trial. Randomization was computer-generated, and allocation was assigned by pharmacy personnel who prepared intervention and placebo capsules. Participants, providers, and those who assessed outcomes were blinded to study group assignment. Single research center. 340 overweight (body mass index [BMI], 25 to <30 kg/m(2)) and obese (BMI > or =30 kg/m(2)) adults (mean age, 38.8 years [SD, 10.5]). Calcium carbonate (elemental calcium, 1500 mg/d) (n = 170) or placebo (n = 170) with meals for 2 years. Changes in body weight and fat mass (primary outcomes). Seventy-five percent of participants completed the trial (78% received calcium; 73% received placebo). There were no statistically or clinically significant differences between the calcium and placebo groups in change in body weight (difference, 0.02 kg [95% CI, -1.64 to 1.69 kg]; P = 0.98), BMI (difference, 0.32 kg/m(2) [CI, -0.41 to 1.02 kg/m(2)]; P = 0.39), or body fat mass (difference, 0.39 kg [CI, -1.04 to 1.92 kg]; P = 0.55). Parathyroid hormone concentrations decreased in the calcium group compared with the placebo group (difference, -0.71 pmol/L [CI, -1.28 to -0.13 pmol/L]). The study took place at a research center, and its sample was mostly women. Dietary supplementation with elemental calcium, 1500 mg/d, for 2 years had no statistically or clinically significant effects on weight in overweight and obese adults. Calcium supplementation is unlikely to have clinically significant efficacy as a preventive measure against weight gain in such patients.

The Vicious Cycle of Myostatin Signaling in Sarcopenic Obesity: Myostatin Role in Skeletal Muscle Growth, Insulin Signaling and Implications for Clinical Trials.

PubMed

Consitt, L A; Clark, B C

2018-01-01

The age-related loss of skeletal muscle (sarcopenia) is a major health concern as it is associated with physical disability, metabolic impairments, and increased mortality. The coexistence of sarcopenia with obesity, termed 'sarcopenic obesity', contributes to skeletal muscle insulin resistance and the development of type 2 diabetes, a disease prevalent with advancing age. Despite this knowledge, the mechanisms contributing to sarcopenic obesity remain poorly understood, preventing the development of targeted therapeutics. This article will discuss the clinical and physiological consequences of sarcopenic obesity and propose myostatin as a potential candidate contributing to this condition. A special emphasis will be placed on examining the role of myostatin signaling in impairing both skeletal muscle growth and insulin signaling. In addition, the role of myostatin in regulating muscle-to fat cross talk, further exacerbating metabolic dysfunction in the elderly, will be highlighted. Lastly, we discuss how this knowledge has implications for the design of myostatin-inhibitor clinical trials.

Obesity in pregnancy.

PubMed

Davies, Gregory A L; Maxwell, Cynthia; McLeod, Lynne

2010-02-01

To review the evidence and provide recommendations for the counselling and management of obese parturients. Outcomes evaluated include the impact of maternal obesity on the provision of antenatal and intrapartum care, maternal morbidity and mortality, and perinatal morbidity and mortality. Literature was retrieved through searches of Statistics Canada, Medline, and The Cochrane Library on the impact of obesity in pregnancy on antepartum and intrapartum care, maternal morbidity and mortality, obstetrical anaesthesia, and perinatal morbidity and mortality. Results were restricted to systematic reviews, randomized controlled trials/controlled clinical trials, and observational studies. There were no date or language restrictions. Searches were updated on a regular basis and incorporated in the guideline to April 2009. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology assessment-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. The evidence obtained was reviewed and evaluated by the Maternal Fetal Medicine and Clinical Practice Obstetric Committees of the SOGC under the leadership of the principal authors, and recommendations were made according to guidelines developed by the Canadian Task Force on Preventive Health Care. Implementation of the recommendations in this guideline should increase recognition of the issues clinicians need to be aware of when managing obese women in pregnancy, improve communication and consultation amongst the obstetrical care team, and encourage federal and provincial agencies to educate Canadians about the values of entering pregnancy with as healthy a weight as possible. 1. Periodic health examinations and other appointments for gynaecologic care prior to pregnancy offer ideal opportunities to raise the issue of weight loss before conception. Women should be

21 CFR 710.8 - Misbranding by reference to registration or to registration number.

Code of Federal Regulations, 2012 CFR

2012-04-01

... HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.8 Misbranding by reference to registration or to registration number. Registration of a cosmetic product...

21 CFR 710.8 - Misbranding by reference to registration or to registration number.

Code of Federal Regulations, 2011 CFR

2011-04-01

... HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.8 Misbranding by reference to registration or to registration number. Registration of a cosmetic product...

21 CFR 710.8 - Misbranding by reference to registration or to registration number.

Code of Federal Regulations, 2014 CFR

2014-04-01

... HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.8 Misbranding by reference to registration or to registration number. Registration of a cosmetic product...

21 CFR 710.8 - Misbranding by reference to registration or to registration number.

Code of Federal Regulations, 2013 CFR

2013-04-01

... HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.8 Misbranding by reference to registration or to registration number. Registration of a cosmetic product...

21 CFR 710.8 - Misbranding by reference to registration or to registration number.

Code of Federal Regulations, 2010 CFR

2010-04-01

... HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.8 Misbranding by reference to registration or to registration number. Registration of a cosmetic product...

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

75 FR 41968 - Re-Registration and Renewal of Aircraft Registration

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-20

... the use of the second or ``Pink Copy'' of the application for registration for a reasonable period of... under ``Pink Copy'' temporary authority at any time if an application for registration is made. Due to... reference to the ``pink copy'' of the Aircraft Registration Application. V. Miscellaneous Comments A. Re...

Impact evaluation of Enabling Mothers to Prevent Pediatric Obesity through Web-Based Education and Reciprocal Determinism (EMPOWER) Randomized Control Trial.

PubMed

Knowlden, Adam P; Sharma, Manoj; Cottrell, Randall R; Wilson, Bradley R A; Johnson, Marcus Lee

2015-04-01

The family and home environment is an influential antecedent of childhood obesity. The purpose of this study was to pilot test The Enabling Mothers to Prevent Pediatric Obesity through Web-Based Education and Reciprocal Determinism (EMPOWER) intervention; a newly developed, theory-based, online program for prevention of childhood obesity. The two-arm, parallel group, randomized, participant-blinded trial targeted mothers with children between 4 and 6 years of age. Measures were collected at baseline, 4 weeks, and 8 weeks to evaluate programmatic effects on constructs of social cognitive theory (SCT) and obesity-related behaviors. Process evaluation transpired concurrently with each intervention session. Fifty-seven participants were randomly assigned to receive either experimental EMPOWER (n = 29) or active control Healthy Lifestyles (n = 28) intervention. Significant main effects were identified for child physical activity, sugar-free beverage consumption, and screen time, indicating that both groups improved in these behaviors. A significant group-by-time interaction was detected for child fruit and vegetable (FV) consumption as well as the SCT construct of environment in the EMPOWER cohort. An increase of 1.613 cups of FVs (95% confidence interval = [0.698, 2.529]) was found in the experimental group, relative to the active control group. Change score analysis found changes in the home environment accounted for 31.4% of the change in child FV intake for the experimental group. Child physical activity, sugar-free beverage consumption, and screen time improved in both groups over the course of the trial. Only the theory-based intervention was efficacious in increasing child FV consumption. The EMPOWER program was robust for inducing change in the home environment leading to an increase in child FV intake (Cohen's f = 0.160). © 2014 Society for Public Health Education.

Approach bias for food cues in obese individuals.

PubMed

Kemps, Eva; Tiggemann, Marika

2015-01-01

This study aimed to investigate the existence of an approach bias for food cues in obese individuals. A community sample of 56 obese women and 56 normal weight controls completed an approach-avoidance variant of the implicit association task. The obese participants were faster to respond to trials that paired food words with approach words, and trials that paired non-food words with avoid words, than the converse pairings, thus, demonstrating an approach bias for food. This bias was evident for both high caloric and low caloric food words, and was not attributable to a state of deprivation or feelings of hunger. By contrast, the normal weight controls did not show any such bias. The results are consistent with recent neurocognitive perspectives of obesity. At a practical level, approach biases for food may present a potential target for modifying (excessive) food intake.

A mixed methods protocol for developing and testing implementation strategies for evidence-based obesity prevention in childcare: a cluster randomized hybrid type III trial.

PubMed

Swindle, Taren; Johnson, Susan L; Whiteside-Mansell, Leanne; Curran, Geoffrey M

2017-07-18

Despite the potential to reach at-risk children in childcare, there is a significant gap between current practices and evidence-based obesity prevention in this setting. There are few investigations of the impact of implementation strategies on the uptake of evidence-based practices (EBPs) for obesity prevention and nutrition promotion. This study protocol describes a three-phase approach to developing and testing implementation strategies to support uptake of EBPs for obesity prevention practices in childcare (i.e., key components of the WISE intervention). Informed by the i-PARIHS framework, we will use a stakeholder-driven evidence-based quality improvement (EBQI) process to apply information gathered in qualitative interviews on barriers and facilitators to practice to inform the design of implementation strategies. Then, a Hybrid Type III cluster randomized trial will compare a basic implementation strategy (i.e., intervention as usual) with an enhanced implementation strategy informed by stakeholders. All Head Start centers (N = 12) within one agency in an urban area in a southern state in the USA will be randomized to receive the basic or enhanced implementation with approximately 20 classrooms per group (40 educators, 400 children per group). The educators involved in the study, the data collectors, and the biostastician will be blinded to the study condition. The basic and enhanced implementation strategies will be compared on outcomes specified by the RE-AIM model (e.g., Reach to families, Effectiveness of impact on child diet and health indicators, Adoption commitment of agency, Implementation fidelity and acceptability, and Maintenance after 6 months). Principles of formative evaluation will be used throughout the hybrid trial. This study will test a stakeholder-driven approach to improve implementation, fidelity, and maintenance of EBPs for obesity prevention in childcare. Further, this study provides an example of a systematic process to develop

Impact of a Water Intervention on Sugar-Sweetened Beverage Intake Substitution by Water: A Clinical Trial in Overweight and Obese Mexican Women.

PubMed

Hernández-Cordero, Sonia; Popkin, Barry M

2015-01-01

Intense marketing for sugar-sweetened beverages (SSB) along with the human innate preference for sweet taste contributes to the increase in consumption of SSB. It is important to understand the intricacies of dietary intake and global changes to the food supply to understand the complexities facing any intervention promoting water intake. We describe challenges to promote and achieve an increase in water intake and present key findings from a clinical trial examining the effects of substituting water for SSB on triglyceride levels, weight and other cardiometabolic factors in overweight/obese Mexican women. A randomized trial was conducted in Cuernavaca, Mexico selecting overweight/obese (BMI ≥25 and <39 kg/m(2)) women (18-45 years old), reporting an intake of SSB of at least 250 kcal/day. Women were randomly allocated to the water and education provision (WEP) group (n = 120) or to the education provision (EP) group (n = 120). Repeated 24 h dietary recall questionnaires, anthropometry, and fasting blood levels were collected at baseline and 3, 6, and 9 months following the intervention. There was no effect of the intervention on triglyceride concentration or on any of the studied outcomes. Post-hoc analyses according to weight at baseline show that triglyceride concentration decreased in obese women. Prevalence of metabolic syndrome after the intervention was lower in obese women from the WEP group. Water intake was increased but insufficient to achieve complete substitution of SSB, without effects on triglyceride concentration. Post-hoc analyses suggested that interventions lowered triglyceride concentration. Further studies are needed. © 2015 S. Karger AG, Basel.

Comparison of the performance of tracer kinetic model-driven registration for dynamic contrast enhanced MRI using different models of contrast enhancement.

PubMed

Buonaccorsi, Giovanni A; Roberts, Caleb; Cheung, Sue; Watson, Yvonne; O'Connor, James P B; Davies, Karen; Jackson, Alan; Jayson, Gordon C; Parker, Geoff J M

2006-09-01

The quantitative analysis of dynamic contrast-enhanced (DCE) magnetic resonance imaging (MRI) data is subject to model fitting errors caused by motion during the time-series data acquisition. However, the time-varying features that occur as a result of contrast enhancement can confound motion correction techniques based on conventional registration similarity measures. We have therefore developed a heuristic, locally controlled tracer kinetic model-driven registration procedure, in which the model accounts for contrast enhancement, and applied it to the registration of abdominal DCE-MRI data at high temporal resolution. Using severely motion-corrupted data sets that had been excluded from analysis in a clinical trial of an antiangiogenic agent, we compared the results obtained when using different models to drive the tracer kinetic model-driven registration with those obtained when using a conventional registration against the time series mean image volume. Using tracer kinetic model-driven registration, it was possible to improve model fitting by reducing the sum of squared errors but the improvement was only realized when using a model that adequately described the features of the time series data. The registration against the time series mean significantly distorted the time series data, as did tracer kinetic model-driven registration using a simpler model of contrast enhancement. When an appropriate model is used, tracer kinetic model-driven registration influences motion-corrupted model fit parameter estimates and provides significant improvements in localization in three-dimensional parameter maps. This has positive implications for the use of quantitative DCE-MRI for example in clinical trials of antiangiogenic or antivascular agents.

Improving cardiometabolic and mental health in women with gestational diabetes mellitus and their offspring: study protocol for MySweetHeart Trial, a randomised controlled trial

PubMed Central

Horsch, Antje; Gilbert, Leah; Lanzi, Stefano; Gross, Justine; Kayser, Bengt; Vial, Yvan; Simeoni, Umberto; Hans, Didier; Berney, Alexandre; Scholz, Urte; Barakat, Ruben; Puder, Jardena J

2018-01-01

Introduction Gestational diabetes mellitus (GDM) carries prenatal and perinatal risk for the mother and her offspring as well as longer-term risks for both the mother (obesity, diabetes, cardiovascular disease) and her child (obesity, type 2 diabetes). Compared with women without GDM, women with GDM are twice as likely to develop perinatal or postpartum depression. Lifestyle interventions for GDM are generally limited to physical activity and/or nutrition, often focus separately on the mother or the child and take place either during or after pregnancy, while their results are inconsistent. To increase efficacy of intervention, the multifactorial origins of GDM and the tight link between mental and metabolic as well as maternal and child health need to be heeded. This calls for an interdisciplinary transgenerational approach starting in, but continuing beyond pregnancy. Methods and analysis This randomised controlled trial will assess the effect of a multidimensional interdisciplinary lifestyle and psychosocial intervention aimed at improving the metabolic and mental health of 200 women with GDM and their offspring. Women with GDM at 24–32 weeks gestational age who understand French or English, and their offspring and partners can participate. The intervention components will be delivered on top of usual care during pregnancy and the first year postpartum. Metabolic and mental health outcomes will be measured at 24–32 weeks of pregnancy, shortly after birth and at 6–8 weeks and 1 year after childbirth. Data will be analysed using intention-to-treat analyses. The MySweetHeart Trial is linked to the MySweetHeart Cohort (clinicaltrials.gov/ct2/show/NCT02872974). Ethics and dissemination We will disseminate the findings through regional, national and international conferences and through peer-reviewed journals. Trial registration number NCT02890693; Pre-results. PMID:29487077

Decreased response to inhaled steroids in overweight and obese asthmatic children.

PubMed

Forno, Erick; Lescher, Rachel; Strunk, Robert; Weiss, Scott; Fuhlbrigge, Anne; Celedón, Juan C

2011-03-01

The mechanisms and consequences of the observed association between obesity and childhood asthma are unclear. We sought to determine the effect of obesity on treatment responses to inhaled corticosteroids in asthmatic children. We performed a post hoc analysis to evaluate the interaction between body mass index (BMI) and treatment with inhaled budesonide on lung function in the Childhood Asthma Management Program trial. Participants were then stratified into overweight/obese and nonoverweight groups, and their response to inhaled budesonide was analyzed longitudinally over the 4 years of the trial. There was a significant interaction between BMI and budesonide for prebronchodilator FEV(1)/forced vital capacity (FVC) ratio (P = .0007) and bronchodilator response (BDR; P = .049) and a nonsignificant trend for an interaction between BMI and budesonide on prebronchodilator FEV(1) (P = .15). Nonoverweight children showed significant improvement with inhaled budesonide in lung function (FEV(1), FEV(1)/FVC ratio, and BDR) during the early (years 1-2) and late (years 3-4) stages of the trial. Overweight/obese children had improved FEV(1) and BDR during the early but not the late stage of the trial and showed no improvement in FEV(1)/FVC ratio. When comparing time points at which both groups showed a significant response, the degree of improvement among nonoverweight children was significantly greater than in overweight/obese children at most visits. Nonoverweight children had a 44% reduction in the risk of emergency department visits or hospitalizations throughout the trial (P = .001); there was no reduction in risk among overweight/obese children (P = .97). Compared with children of normal weight, overweight/obese children in the Childhood Asthma Management Program showed a decreased response to inhaled budesonide on measures of lung function and emergency department visits/hospitalizations for asthma. Copyright © 2011 American Academy of Allergy, Asthma & Immunology

Undergraduate Cross Registration.

ERIC Educational Resources Information Center

Grupe, Fritz H.

This report discusses various aspects of undergraduate cross-registration procedures, including the dimensions, values, roles and functions, basic assumptions, and facilitating and encouragment of cross-registration. Dimensions of cross-registration encompass financial exchange, eligibility, program limitations, type of grade and credit; extent of…

Randomized Control Trial for Reduction of Body Weight, Body Fat Patterning, and Cardiometabolic Risk Factors in Overweight Worksite Employees in Delhi, India

PubMed Central

Shrivastava, Usha; Fatma, Mahrukh; Mohan, Smriti; Singh, Padam

2017-01-01

Background We studied the impact of the multicomponent interventions on body weight and cardiometabolic risk factors in overweight individuals working in corporate worksites. Methods Overweight (BMI ≥ 23 kg/m2) subjects were recruited from four randomised worksites [two active intervention (n, recruited, 180, completed 156) and two control (n, recruited 130, completed 111)]. Intensive intervention was given at intervention worksite. Results High prevalence (%) of obesity (90.9, 80.2), abdominal obesity (93.5, 84.3), excess skinfold thickness (70.3, 75.9), and low high-density lipoprotein cholesterol (HDL-c) levels (56.8, 63.7) were seen in the intervention and the control group, respectively. At the end of intervention, the following significant changes were observed in the intervention group: decrease in weight, BMI, waist circumference, serum triglycerides, and increase in HDL-c. Weight loss of more than 5% was seen in 12% and 4% individuals in the intervention and control groups, respectively. Most importantly, the sum of all the skinfold measurements (mm) in the intervention group decreased significantly more than the control group (12.51 ± 10.38 versus 3.50 ± 8.18, resp.). Conclusion This multicomponent worksite trial showed a reduction in weight, excess subcutaneous fat, and cardiometabolic risk factors after 6 months of active intervention in overweight Asian Indians. Trial Registration This trial is registered with NCT03249610. PMID:29318159

Oral administration of Bifidobacterium breve B-3 modifies metabolic functions in adults with obese tendencies in a randomised controlled trial.

PubMed

Minami, Jun-Ichi; Kondo, Shizuki; Yanagisawa, Naotake; Odamaki, Toshitaka; Xiao, Jin-Zhong; Abe, Fumiaki; Nakajima, Shigeru; Hamamoto, Yukie; Saitoh, Sanae; Shimoda, Taeko

2015-01-01

Accumulating evidence suggests an association between gut microbiota and the development of obesity, raising the possibility of probiotic administration as a therapeutic approach. Bifidobacterium breve B-3 was found to exhibit an anti-obesity effect on high-fat diet-induced obesity mice. In the present study, a randomised, double-blind, placebo-controlled trial was conducted to evaluate the effect of the consumption of B. breve B-3 on body compositions and blood parameters in adults with a tendency for obesity. After a 4-week run-in period, the participants were randomised to receive either placebo or a B-3 capsule (approximately 5 × 10(10) colony-forming units of B-3/d) daily for 12 weeks. A significantly lowered fat mass was observed in the B-3 group compared with the placebo group at week 12. Improvements were observed for some blood parameters related to liver functions and inflammation, such as γ-glutamyltranspeptidase and high-sensitivity C-reactive protein. Significant correlations were found between the changed values of some blood parameters and the changed fat mass in the B-3 group. These results suggest the beneficial potential of B. breve B-3 in improving metabolic disorders.

A Social Media Peer Group Intervention for Mothers to Prevent Obesity and Promote Healthy Growth from Infancy: Development and Pilot Trial.

PubMed

Gruver, Rachel S; Bishop-Gilyard, Chanelle T; Lieberman, Alexandra; Gerdes, Marsha; Virudachalam, Senbagam; Suh, Andrew W; Kalra, Gurpreet K; Magge, Sheela N; Shults, Justine; Schreiner, Mark S; Power, Thomas J; Berkowitz, Robert I; Fiks, Alexander G

2016-08-02

Evidence increasingly indicates that childhood obesity prevention efforts should begin as early as infancy. However, few interventions meet the needs of families whose infants are at increased obesity risk due to factors including income and maternal body mass index (BMI). Social media peer groups may offer a promising new way to provide these families with the knowledge, strategies, and support they need to adopt obesity prevention behaviors. The aim of this study is to develop and pilot test a Facebook-based peer group intervention for mothers, designed to prevent pediatric obesity and promote health beginning in infancy. We conducted in-depth semi-structured interviews with 29 mothers of infants and focus groups with 30 pediatric clinicians, to inform the development of a theory-based intervention. We then conducted a single-group pilot trial with 8 mothers to assess its feasibility and acceptability. All participants were recruited offline at pediatric primary care practices. Participants in the pilot trial joined a private Facebook group, moderated by a psychologist, with a weekly video-based curriculum, and also had the option to meet at a face-to-face event. Within the Facebook group, mothers were encouraged to chat, ask questions, and share photos and videos of themselves and babies practicing healthy behaviors. Consistent with the literature on obesity prevention, the curriculum addressed infant feeding, sleep, activity, and maternal well-being. Feasibility was assessed using the frequency and content of group participation by mothers, and acceptability was measured using online surveys and phone interviews. Based on preferences of mothers interviewed (mean BMI 35 kg/m(2), all Medicaid-insured, mean age 27, all Black), we designed the intervention to include frequent posts with new information, videos showing parents of infants demonstrating healthy behaviors, and an optional face-to-face meeting. We developed a privacy and safety plan that met the needs

The heart of the matter: Outcome reporting bias and registration status in cardio-thoracic surgery.

PubMed

Wiebe, Jordan; Detten, Grant; Scheckel, Caleb; Gearhart, David; Wheeler, Denna; Sanders, Donald; Vassar, Matt

2017-01-15

Our objective is to compare registered outcomes to published reports; to evaluate for discrepancies favoring statistically significant outcomes; to examine funding source and likelihood of outcome reporting bias; and to evaluate for any temporal trends in outcome reporting bias. PubMed was searched for randomized controlled trials published between 2008 and 2015 from 4 high impact cardio-thoracic journals: European Journal of Cardio-thoracic Surgery (EJCS), The Journal of Cardiothoracic Surgery (JCS), The Journal of Thoracic and Cardiovascular Surgery (JTCS), and Annals of Cardiothoracic Surgery (ACS). Data was collected using a standardized extraction form. We reviewed 287 articles, of which 214 (74.6%) did not meet registration criteria. Of those 214, 94 (43.9%) were published in the EJCS, 34 (15.9%) in JCS, 86 (40.2%) in JTCS, and 0 (0%) in the ACS. Of the remaining 73 articles, 34 (46.6%) had a discrepancy between the primary outcome registered and the published outcome, and 11 of the 34 reported p-values favoring the change. We also found that 12 of the 73 registrations had updated primary outcomes from the initial report to the final report. The timing of registration was an incidental finding showing 14 (19.1%) articles retrospectively registered, 29 (39.7%) registered during patient enrollment, and 30 (41.1%) registered prospectively. The results indicated that selective outcome reporting is prevalent in cardio-thoracic surgery journals. The more concerning issue, however, is the lack of registration or provision of registration number for randomized controlled trials within these journals. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Yoga Practice for Reducing the Male Obesity and Weight Related Psychological Difficulties-A Randomized Controlled Trial

PubMed Central

Subramanya, Pailoor; Nidhi, Ram

2016-01-01

Introduction Obesity is a health disorder and increasing all over the world. It is also a cause for many non-communicable diseases. Yoga practice reduces the stress level which may improve the eating habits and help in weight reduction. Aim To assess the final outcome of the effects after 3 months of the 14 weeks yoga training on obesity of adult male in an urban setting. Materials and Methods This was a randomized controlled trial with parallel groups (Yoga and Control groups) on male obese. Total 80 subjects with Body Mass Index (BMI) between 25 to 35 kg/cm2 were enrolled and randomized into two equal groups in which 72 subjects (yoga n = 37 and control n=35) completed the trial. Yoga group mean age ± SD was 40.03±8.74 and Control group mean age±SD was 42.20±12.06. A 14 weeks special IAYT (Integrated Approach of Yoga Therapy) yoga training was given to the Yoga group and no specific activity was given to Control group. The interim results of this study at 14 weeks were covered in another article which is under process. After the 14 weeks of yoga training the Yoga group was asked to continue the yoga practice for the next 3 months and the Control group was not given any physical activity. The final outcome is covered in this paper. The assessments were anthropometric parameters of body weight (Wt), BMI (Body Mass Index), MAC (Mid-upper Arm Circumferences of left and right arm), WC (Waist Circumference), HC (Hip Circumference), WHR (Waist Hip Ratio), SKF (Skin Fold Thickness) of biceps, triceps, sub scapular, suprailiac and cumulative skin fold thickness value), Percentage body fat based on SKF and Psychological questionnaires of PSS (Perceived Stress Scale) and AAQW (Acceptance and Action Questionnaire for Weight related difficulty). Assessments were taken after 3 months of yoga training, for both Yoga and Control groups. Within group, between group and correlation analyses were carried out using SPSS 21. Results Improvement in anthropometric and psychological

Reporting of Positive Results in Randomized Controlled Trials of Mindfulness-Based Mental Health Interventions.

PubMed

Coronado-Montoya, Stephanie; Levis, Alexander W; Kwakkenbos, Linda; Steele, Russell J; Turner, Erick H; Thombs, Brett D

2016-01-01

A large proportion of mindfulness-based therapy trials report statistically significant results, even in the context of very low statistical power. The objective of the present study was to characterize the reporting of "positive" results in randomized controlled trials of mindfulness-based therapy. We also assessed mindfulness-based therapy trial registrations for indications of possible reporting bias and reviewed recent systematic reviews and meta-analyses to determine whether reporting biases were identified. CINAHL, Cochrane CENTRAL, EMBASE, ISI, MEDLINE, PsycInfo, and SCOPUS databases were searched for randomized controlled trials of mindfulness-based therapy. The number of positive trials was described and compared to the number that might be expected if mindfulness-based therapy were similarly effective compared to individual therapy for depression. Trial registries were searched for mindfulness-based therapy registrations. CINAHL, Cochrane CENTRAL, EMBASE, ISI, MEDLINE, PsycInfo, and SCOPUS were also searched for mindfulness-based therapy systematic reviews and meta-analyses. 108 (87%) of 124 published trials reported ≥1 positive outcome in the abstract, and 109 (88%) concluded that mindfulness-based therapy was effective, 1.6 times greater than the expected number of positive trials based on effect size d = 0.55 (expected number positive trials = 65.7). Of 21 trial registrations, 13 (62%) remained unpublished 30 months post-trial completion. No trial registrations adequately specified a single primary outcome measure with time of assessment. None of 36 systematic reviews and meta-analyses concluded that effect estimates were overestimated due to reporting biases. The proportion of mindfulness-based therapy trials with statistically significant results may overstate what would occur in practice.

Registration of Space Objects

NASA Astrophysics Data System (ADS)

Schmidt-Tedd, Bernhard

2017-07-01

Space objects are subject to registration in order to allocate "jurisdiction and control" over those objects in the sovereign-free environment of outer space. This approach is similar to the registration of ships in view of the high sea and for aircrafts with respect to the international airspace. Registration is one of the basic principles of space law, starting with UN General Assembly Resolution 1721 B (XVI) of December 20, 1961, followed by Resolution 1962 (XVIII) of December 13, 1963, then formulated in Article VIII of the Outer Space Treaty of 1967 and as specified in the Registration Convention of 1975. Registration of space objects can be seen today as a principle of customary international law, relevant for each spacefaring state. Registration is divided into a national and an international level. The State Party establishes a national registry for its space objects, and those registrations have to be communicated via diplomatic channel to the UN Register of space objects. This UN Register is handled by the UN Office for Outer Space Affairs (UNOOSA) and is an open source of information for space objects worldwide. Registration is linked to the so-called launching state of the relevant space object. There might be more than one launching state for the specific launch event, but only one state actor can register a specific space object. The state of registry gains "jurisdiction and control" over the space object and therefore no double registration is permissible. Based on the established UN Space Law, registration practice was subject to some adaptions due to technical developments and legal challenges. After the privatization of the major international satellite organizations, a number of non-registrations had to be faced. The state actors reacted with the UN Registration Practice Resolution of 2007 as elaborated in the Legal Subcommittee of UNCOPUOS, the Committee for the Peaceful Use of Outer Space. In this context an UNOOSA Registration Information

Effects of Bariatric Surgery in Obese Patients With Hypertension

PubMed Central

Bersch-Ferreira, Angela Cristine; Santucci, Eliana Vieira; Oliveira, Juliana Dantas; Torreglosa, Camila Ragne; Bueno, Priscila Torres; Frayha, Julia Caldas; Santos, Renato Nakagawa; Damiani, Lucas Petri; Noujaim, Patricia Malvina; Halpern, Helio; Monteiro, Frederico L.J.; Cohen, Ricardo Vitor; Uchoa, Carlos H.; de Souza, Marcio Gonçalves; Amodeo, Celso; Bortolotto, Luiz; Ikeoka, Dimas; Drager, Luciano F.; Cavalcanti, Alexandre Biasi; Berwanger, Otavio

2018-01-01

cholesterol, triglycerides, high-sensitivity C-reactive protein, and 10-year Framingham risk score were lower in the gastric bypass than in the control group. Conclusions: Bariatric surgery represents an effective strategy for blood pressure control in a broad population of patients with obesity and hypertension. Clinical Trial Registration: URL: https://clinicaltrials.gov. Unique identifier: NCT01784848. PMID:29133606

Interventions for treating obesity in children.

PubMed

Summerbell, C D; Ashton, V; Campbell, K J; Edmunds, L; Kelly, S; Waters, E

2003-01-01

The prevalence of overweight and obesity is increasing in child populations throughout the world. Obesity in children has significant short and long term health consequences. To assess the effects of a range of lifestyle interventions designed to treat obesity in childhood. We searched CCTR, MEDLINE, EMBASE, CINAHL, PsychLIT, Science Citation Index, Social Science Citation Index. Each database was searched from 1985 to July 2001. We also contacted experts in child obesity treatment. We selected randomised controlled trials of lifestyle interventions for treating obesity in children with a minimum of six months duration. Examples of lifestyle interventions include dietary, physical activity and/or behavioural therapy interventions, with or without the support of associated family members. Interventions from any setting and delivered by any professional were considered. However, interventions that specifically dealt with the treatment of eating disorders were excluded. Two of our research team independently assessed trial quality and extracted data. Authors of the included studies were contacted for additional information where this was appropriate. We included 18 randomised controlled trials with 975 participants. Many studies were run from a specialist obesity clinic within a hospital setting. Five studies (n=245 participants) investigated changes in physical activity and sedentary behaviour. Two studies (n=107 participants) compared problem-solving with usual care or behavioural therapy. Nine studies (n=399 participants) compared behavioural therapy at varying degrees of family involvement with no treatment or usual care or mastery criteria and contingent reinforcement. Two studies (n=224 participants) compared cognitive behavioural therapy with relaxation.Most of the studies included in this review were too small to have the power to detect the effects of the treatment. We did not conduct a meta-analysis since so few of the trials included the same comparisons

One-Year Efficacy Testing of Enabling Mothers to Prevent Pediatric Obesity through Web-Based Education and Reciprocal Determinism (EMPOWER) Randomized Control Trial

ERIC Educational Resources Information Center

Knowlden, Adam; Sharma, Manoj

2016-01-01

Background: The purpose of this study was to evaluate the efficacy of the Enabling Mothers to Prevent Pediatric Obesity through Web-Based Education and Reciprocal Determinism (EMPOWER) intervention at 1-year, postintervention follow-up. Method: A mixed between-within subjects design was used to evaluate the trial. Independent variables included a…

The causal role of breakfast in energy balance and health: a randomized controlled trial in obese adults12

PubMed Central

Chowdhury, Enhad A; Richardson, Judith D; Holman, Geoffrey D; Tsintzas, Kostas; Thompson, Dylan; Betts, James A

2016-01-01

Background: The causal nature of associations between breakfast and health remain unclear in obese individuals. Objective: We sought to conduct a randomized controlled trial to examine causal links between breakfast habits and components of energy balance in free-living obese humans. Design: The Bath Breakfast Project is a randomized controlled trial with repeated measures at baseline and follow-up among a cohort in South West England aged 21–60 y with dual-energy X-ray absorptiometry–derived fat mass indexes of ≥13 kg/m2 for women (n = 15) and ≥9 kg/m2 for men (n = 8). Components of energy balance (resting metabolic rate, physical activity thermogenesis, diet-induced thermogenesis, and energy intake) were measured under free-living conditions with random allocation to daily breakfast (≥700 kcal before 1100) or extended fasting (0 kcal until 1200) for 6 wk, with baseline and follow-up measures of health markers (e.g., hematology/adipose biopsies). Results: Breakfast resulted in greater physical activity thermogenesis during the morning than when fasting during that period (difference: 188 kcal/d; 95% CI: 40, 335) but without any consistent effect on 24-h physical activity thermogenesis (difference: 272 kcal/d; 95% CI: −254, 798). Energy intake was not significantly greater with breakfast than fasting (difference: 338 kcal/d; 95% CI: −313, 988). Body mass increased across both groups over time but with no treatment effects on body composition or any change in resting metabolic rate (stable within 8 kcal/d). Metabolic/cardiovascular health also did not respond to treatments, except for a reduced insulinemic response to an oral-glucose-tolerance test over time with daily breakfast relative to an increase with daily fasting (P = 0.05). Conclusions: In obese adults, daily breakfast leads to greater physical activity during the morning, whereas morning fasting results in partial dietary compensation (i.e., greater energy intake) later in the day. There were

Lorcaserin Hcl for the treatment of obesity.

PubMed

Shukla, Alpana P; Kumar, Rekha B; Aronne, Louis J

2015-01-01

Obesity is a major health priority necessitating safe and effective strategies to address the obesity epidemic. Lorcaserin is a serotonergic agonist specific to the 5HT- 2C receptor approved for chronic management of obesity in patients with a BMI ≥ 30 kg/m(2) or a BMI ≥ 27 kg/m(2) with comorbidities related to obesity. In this paper, the pharmacodynamic and pharmacokinetic properties of lorcaserin are reviewed followed by a discussion of efficacy and safety data from major clinical trials. Lorcaserin is a unique highly selective serotonergic agonist designed to mitigate the risks associated with previous agents in this class. At therapeutic doses, it is well tolerated and produces modest but clinically meaningful weight loss with significant improvement in cardiometabolic parameters. Therapeutic efficacy should be assessed at 12 weeks (≥ 5% weight loss) to identify responders who will derive maximum weight loss and metabolic benefit from long-term therapy. The results of the ongoing cardiovascular outcomes trial (CAMELLIA TIMI 61) will determine the role of lorcaserin in primary prevention of diabetes in overweight/obese individuals and its use in the high-risk population of patients with established cardiovascular disease or multiple cardiovascular risk factors.

Obesity, insulin resistance and breast cancer outcomes.

PubMed

Goodwin, Pamela J

2015-11-01

There is growing evidence that obesity is associated with poor outcomes in early stage breast cancer. This paper addresses four current areas of focus: 1. Is obesity associated with poor outcomes in all biologic subtypes of breast cancer? 2. Does obesity effect AI efficacy or estrogen suppression in the adjuvant setting? 3. What are the potential biologic underpinnings of the obesity-breast cancer association? 4. Are intervention studies warranted? If so, which interventions in which populations? Research is needed to resolve these questions; intervention trials involving lifestyle interventions or targeting the biology postulated to link obesity and cancer are recommended. Copyright © 2015. Published by Elsevier Ltd.

The Obesity-Fertility Protocol: a randomized controlled trial assessing clinical outcomes and costs of a transferable interdisciplinary lifestyle intervention, before and during pregnancy, in obese infertile women.

PubMed

Duval, Karine; Langlois, Marie-France; Carranza-Mamane, Belina; Pesant, Marie-Hélène; Hivert, Marie-France; Poder, Thomas G; Lavoie, Hélène B; Ainmelk, Youssef; St-Cyr Tribble, Denise; Laredo, Sheila; Greenblatt, Ellen; Sagle, Margaret; Waddell, Guy; Belisle, Serge; Riverin, Daniel; Jean-Denis, Farrah; Belan, Matea; Baillargeon, Jean-Patrice

2015-01-01

Obesity in infertile women increases the costs of fertility treatments, reduces their effectiveness and increases significantly the risks of many complications of pregnancy and for the newborn. Studies suggest that even a modest loss of 5-10 % of body weight can restore ovulation. However, there are gaps in knowledge regarding the benefits and cost-effectiveness of a lifestyle modification program targeting obese infertile women and integrated into the fertility clinics. This study will evaluate clinical outcomes and costs of a transferable interdisciplinary lifestyle intervention, before and during pregnancy, in obese infertile women. We hypothesize that the intervention will: 1) improve fertility, efficacy of fertility treatments, and health of mothers and their children; and 2) reduce the cost per live birth, including costs of fertility treatments and pregnancy outcomes. Obese infertile women (age: 18-40 years; BMI ≥30 kg/m(2) or ≥27 kg/m(2) with polycystic ovary syndrome) will be randomised to either a lifestyle intervention followed by standard fertility treatments after 6 months if no conception has been achieved (intervention group) or standard fertility treatments only (control group). The intervention and/or follow-up will last for a maximum of 18 months or up to the end of pregnancy. Evaluation visits will be planned every 6 months where different outcome measures will be assessed. The primary outcome will be live-birth rates at 18 months. The secondary outcomes will be sub-divided into four categories: lifestyle and anthropometric, fertility, pregnancy complications, and neonatal outcomes. Outcomes and costs will be also compared to similar women seen in three fertility clinics across Canada. Qualitative data will also be collected from both professionals and obese infertile women. This study will generate new knowledge about the implementation, impacts and costs of a lifestyle management program in obese infertile women. This information

16 CFR 1130.8 - Requirements for Web site registration or alternative e-mail registration.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Requirements for Web site registration or... PRODUCTS § 1130.8 Requirements for Web site registration or alternative e-mail registration. (a) Link to registration page. The manufacturer's Web site, or other Web site established for the purpose of registration...

16 CFR 1130.8 - Requirements for Web site registration or alternative e-mail registration.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Requirements for Web site registration or... PRODUCTS § 1130.8 Requirements for Web site registration or alternative e-mail registration. (a) Link to registration page. The manufacturer's Web site, or other Web site established for the purpose of registration...

16 CFR 1130.7 - Requirements for Web site registration or alternative e-mail registration.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Requirements for Web site registration or... PRODUCTS § 1130.7 Requirements for Web site registration or alternative e-mail registration. (a) Link to registration page. The manufacturer's Web site, or other Web site established for the purpose of registration...

Phentermine and topiramate for the management of obesity: a review

PubMed Central

Cosentino, Gina; Conrad, Ariane O; Uwaifo, Gabriel I

2013-01-01

Obesity is now a major public health concern worldwide with increasing prevalence and a growing list of comorbidities and complications. The morbidity, mortality and reduced productivity associated with obesity and its complications result in a major burden to health care costs. Obesity is a complex chronic medical syndrome often with multiple different etiologic factors in individual patients. The long term successful management of obesity remains particularly challenging and invariably requires a multifaceted approach including lifestyle and behavioral modification, increased physical activity, and adjunctive pharmacotherapy. Bariatric surgery remains a last resort though at present it has the best results for achieving sustained robust weight loss. Obesity pharmacotherapy has been very limited in its role for long term obesity management because of the past history of several failed agents as well as the fact that presently available agents are few, and generally utilized as monotherapy. The recent FDA approval of the fixed drug combination of phentermine and extended release topiramate (topiramate-ER) (trade name Qsymia™) marks the first FDA approved combination pharmacotherapeutic agent for obesity since the Phen-Fen combination of the 1990s. This review details the history and clinical trial basis for the use of both phentermine and topiramate in obesity therapeutics as well as the results of clinical trials of their combination for obesity treatment in humans. The initial clinical approval trials offer evidence that this fixed drug combination offers synergistic potential for effective, robust and sustained weight loss with mean weight loss of at least 10% of baseline achieved and sustained for up to 2 years in over 50% of subjects treated. It is anticipated that this agent will be the first in a new trend of multi-agent combination therapy for the chronic adjunctive management of obesity. PMID:23630412

The nutrition-based comprehensive intervention study on childhood obesity in China (NISCOC): a randomised cluster controlled trial.

PubMed

Li, Yanping; Hu, Xiaoqi; Zhang, Qian; Liu, Ailing; Fang, Hongyun; Hao, Linan; Duan, Yifan; Xu, Haiquan; Shang, Xianwen; Ma, Jun; Xu, Guifa; Du, Lin; Li, Ying; Guo, Hongwei; Li, Tingyu; Ma, Guansheng

2010-05-02

Childhood obesity and its related metabolic and psychological abnormalities are becoming serious health problems in China. Effective, feasible and practical interventions should be developed in order to prevent the childhood obesity and its related early onset of clinical cardiovascular diseases. The objective of this paper is to describe the design of a multi-centred random controlled school-based clinical intervention for childhood obesity in China. The secondary objective is to compare the cost-effectiveness of the comprehensive intervention strategy with two other interventions, one only focuses on nutrition education, the other only focuses on physical activity. The study is designed as a multi-centred randomised controlled trial, which included 6 centres located in Beijing, Shanghai, Chongqing, Shandong province, Heilongjiang province and Guangdong province. Both nutrition education (special developed carton style nutrition education handbook) and physical activity intervention (Happy 10 program) will be applied in all intervention schools of 5 cities except Beijing. In Beijing, nutrition education intervention will be applied in 3 schools and physical activity intervention among another 3 schools. A total of 9750 primary students (grade 1 to grade 5, aged 7-13 years) will participate in baseline and intervention measurements, including weight, height, waist circumference, body composition (bioelectrical impendence device), physical fitness, 3 days dietary record, physical activity questionnaire, blood pressure, plasma glucose and plasma lipid profiles. Data concerning investments will be collected in our study, including costs in staff training, intervention materials, teachers and school input and supervising related expenditure. Present study is the first and biggest multi-center comprehensive childhood obesity intervention study in China. Should the study produce comprehensive results, the intervention strategies would justify a national school

Impact of non-surgical periodontal therapy on OHRQoL in an obese population, a randomised control trial.

PubMed

Basher, Samara S; Saub, R; Vaithilingam, R D; Safii, S H; Daher, Aqil M; Al-Bayaty, F H; Baharuddin, N A

2017-11-21

Oral Health Related Quality of Life (OHRQoL) is an important measure of disease and intervention outcomes. Chronic periodontitis (CP) is an inflammatory condition that is associated with obesity and adversely affects OHRQoL. Obese patients with CP incur a double burden of disease. In this article we aimed to explore the effect of Non-Surgical Periodontal Therapy (NSPT) on OHRQoL among obese participants with chronic periodontitis. This was a randomised control clinical trial at the Faculty of Dentistry, University of Malaya. A total of 66 obese patients with chronic periodontitis were randomly allocated into the treatment group (n=33) who received NSPT, while the control group (n=33) received no treatment. Four participants (2 from each group) were non-contactable 12 weeks post intervention. Therefore, their data were removed from the final analysis. The protocol involved questionnaires (characteristics and OHRQoL (Oral Health Impact Profile-14; OHIP-14)) and a clinical examination. The OHIP prevalence of impact (PI), overall mean OHIP severity score (SS) and mean OHIP Extent of Impact (EI) at baseline and at the 12-week follow up were almost similar between the two groups and statistically not significant at (p=0.618), (p=0.573), and (p=0.915), respectively. However, in a within-group comparison, OHIP PI, OHIP SS, and OHIP EI showed a significant improvement for both treatment and control groups and the p values were ((0.002), (0.008) for PI), ((0.006) and (0.004) for SS) and ((0.006) and (0.002) for EI) in-treatment and control groups, respectively. NSPT did not significantly affect the OHRQoL among those obese with CP. Regardless, NSPT, functional limitation and psychological discomfort domains had significantly improved. ( NCT02508415 ). Retrospectively registered on 2 nd of April 2015.

Antenatal lifestyle advice for women who are overweight or obese: LIMIT randomised trial.

PubMed

Dodd, Jodie M; Turnbull, Deborah; McPhee, Andrew J; Deussen, Andrea R; Grivell, Rosalie M; Yelland, Lisa N; Crowther, Caroline A; Wittert, Gary; Owens, Julie A; Robinson, Jeffrey S

2014-02-10

To determine the effect of antenatal dietary and lifestyle interventions on health outcomes in overweight and obese pregnant women. Multicentre randomised trial. We utilised a central telephone randomisation server, with computer generated schedule, balanced variable blocks, and stratification for parity, body mass index (BMI) category, and hospital. Three public maternity hospitals across South Australia. 2212 women with a singleton pregnancy, between 10+0 and 20+0 weeks' gestation, and BMI ≥ 25. 1108 women were randomised to a comprehensive dietary and lifestyle intervention delivered by research staff; 1104 were randomised to standard care and received pregnancy care according to local guidelines, which did not include such information. Incidence of infants born large for gestational age (birth weight ≥ 90th centile for gestation and sex). Prespecified secondary outcomes included birth weight >4000 g, hypertension, pre-eclampsia, and gestational diabetes. Analyses used intention to treat principles. 2152 women and 2142 liveborn infants were included in the analyses. The risk of the infant being large for gestational age was not significantly different in the two groups (lifestyle advice 203/1075 (19%) v standard care 224/1067 (21%); adjusted relative risk 0.90, 95% confidence interval 0.77 to 1.07; P=0.24). Infants born to women after lifestyle advice were significantly less likely to have birth weight above 4000 g (lifestyle advice 164/1075 (15%) v standard care 201/1067 (19%); 0.82, 0.68 to 0.99; number needed to treat (NNT) 28, 15 to 263; P=0.04). There were no differences in maternal pregnancy and birth outcomes between the two treatment groups. For women who were overweight or obese, the antenatal lifestyle advice used in this study did not reduce the risk delivering a baby weighing above the 90th centile for gestational age and sex or improve maternal pregnancy and birth outcomes. Australian and New Zealand Clinical Trials Registry (ACTRN12607000161426).

Chromium supplementation in non-obese non-diabetic subjects is associated with a decline in insulin sensitivity

PubMed Central

2012-01-01

Background The use of chromium supplements is widespread for the prevention and treatment of diabetes mellitus but there are conflicting reports on efficacy, possibly reflecting discrepant effects across different populations. In the present studies, we test the hypothesis that chromium supplementation raises serum chromium levels and correspondingly improves insulin sensitivity. Methods A double blind placebo-controlled randomized trial was conducted on 31 non-obese, normoglycemic subjects. After baseline studies, the subjects were randomized to placebo or chromium picolinate 500 μg twice a day. The primary endpoint was change in insulin sensitivity as measured by euglycemic hyperinsulinemic clamp. Pre-specified secondary endpoints included fasting lipids, blood pressure, weight, body composition measured by DXA scan. Results After 16 weeks of chromium picolinate therapy there was no significant change in insulin sensitivity between groups (p=0.83). There was, however, a strong association between serum chromium and change in insulin resistance (β = -0.83, p=0.01), where subjects with the highest serum chromium had a worsening of insulin sensitivity. This effect could not be explained by changes in physiological parameters such as body weight, truncal fat and serum lipids with chromium therapy. Conclusions Chromium therapy did not improve insulin sensitivity in non-obese normoglycemic individuals. Further, subjects who have high serum chromium levels paradoxically had a decline in insulin sensitivity. Caution therefore should be exercised in recommending the use of this supplement. Trial registration The study was registered on the NIH registry (clinicaltrials.gov) and the identifier is NCT00846248 PMID:23194380

The design and rationale of an interdisciplinary, non-prescriptive, and Health at Every Size®-based clinical trial: The "Health and Wellness in Obesity" study.

PubMed

Ulian, Mariana D; Gualano, Bruno; Benatti, Fabiana B; de Campos-Ferraz, Patricia Lopes; Coelho, Desire; Roble, Odilon J; Sabatini, Fernanda; Perez, Isabel; Aburad, Luiz; Pinto, Ana Jéssica; Vessoni, André; Victor, Jhessica Campos; Lima, Victoria Kupper; Unsain, Ramiro Fernandez; de Morais Sato, Priscila; Rogero, Marcelo Macedo; Toporcov, Tatiana Natasha; Scagliusi, Fernanda B

2017-12-01

This manuscript describes the design and rationale of a clinical trial that aims to investigate the multiple physiological, attitudinal, nutritional, and behavioral effects of a new interdisciplinary intervention based on the Health at Every Size® (HAES®) approach in obese women. This will be a prospective, 7-month, randomized (2:1), mixed-method clinical trial. Obese women will be recruited and randomly allocated into two groups. The intervention group (I-HAES®; proposed n = 40) will undertake a novel HAES®-based intervention. Participants will take part in an exercise program, nutrition counseling sessions, and philosophical workshops, all aligned with the principles of the HAES® approach. The control group (CTRL; proposed n = 20) will participate in a program using a traditional HAES®-based group format, characterized by bimonthly lectures about the same topics offered to the experimental group, encouraging the adoption of a healthy lifestyle. The following multiple quantitative outcomes will be assessed pre and post intervention: health-related quality of life, cardiovascular risk factors, anthropometric assessments, physical activity level, physical capacity and function, and psychological and behavioral assessments. Qualitative analysis will be used to evaluate the experiences of the participants throughout the intervention, as assessed by focus groups and semi-structured interviews. The interdisciplinary research team leading this study has varied and complementary expertise. The knowledge arising from this study will help to guide new interdisciplinary interventions with the potential to holistically improve the health of obese individuals. This trial is registered at Clinicaltrials.gov (NCT02102061).

14 CFR 47.15 - Registration number.

Code of Federal Regulations, 2011 CFR

2011-01-01

... REGISTRATION General § 47.15 Registration number. (a) Number required. An applicant for aircraft registration must place a U.S. registration number (registration mark) on the Aircraft Registration Application, AC... Dealer's Aircraft Registration Certificate, AC Form 8050-6, who applies for a temporary registration...

14 CFR 47.15 - Registration number.

Code of Federal Regulations, 2013 CFR

2013-01-01

... REGISTRATION General § 47.15 Registration number. (a) Number required. An applicant for aircraft registration must place a U.S. registration number (registration mark) on the Aircraft Registration Application, AC... Dealer's Aircraft Registration Certificate, AC Form 8050-6, who applies for a temporary registration...

14 CFR 47.15 - Registration number.

Code of Federal Regulations, 2014 CFR

2014-01-01

... REGISTRATION General § 47.15 Registration number. (a) Number required. An applicant for aircraft registration must place a U.S. registration number (registration mark) on the Aircraft Registration Application, AC... Dealer's Aircraft Registration Certificate, AC Form 8050-6, who applies for a temporary registration...

14 CFR 47.15 - Registration number.

Code of Federal Regulations, 2012 CFR

2012-01-01

... REGISTRATION General § 47.15 Registration number. (a) Number required. An applicant for aircraft registration must place a U.S. registration number (registration mark) on the Aircraft Registration Application, AC... Dealer's Aircraft Registration Certificate, AC Form 8050-6, who applies for a temporary registration...

Association of Maternal Obesity with Child Cerebral Palsy or Death.

PubMed

McPherson, Jessica A; Smid, Marcela C; Smiley, Sarah; Stamilio, David M

2017-05-01

Objective  The primary aim of this study was to determine if there is an association between maternal obesity and cerebral palsy or death in children. Study Design  This is a retrospective cohort analysis of a randomized controlled clinical trial previously performed by the Maternal-Fetal Medicine Units Network. Women in the original trial were included if at high risk for preterm delivery. The present study included singletons enrolled in the original study with complete data. Obese and nonobese women were compared. A secondary analysis comparing class 3 obese or classes 1 to 2 obese women to nonobese women was performed. The primary outcome was a composite of cerebral palsy or perinatal death. Results  In this study, 1,261 nonobese, 339 obese, and 69 morbidly obese women were included. When adjusted for gestational age at delivery and magnesium exposure, there was no association between maternal obesity and child cerebral palsy or death. In the analysis using obesity severity categories, excess risk for adverse outcome appeared confined to the class 3 obese group. Conclusion  In women at high risk of delivering preterm, maternal obesity was not independently associated with child cerebral palsy or death. The association in unadjusted analysis appears to be mediated by preterm birth among obese patients. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

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.

Imagine HEALTH: results from a randomized pilot lifestyle intervention for obese Latino adolescents using Interactive Guided ImagerySM

PubMed Central

2014-01-01

of intervention group and other relevant co-variates. Conclusions The improvements in physical activity and stress biomarkers following this pilot intervention support the role of guided imagery in promoting healthy lifestyle behavior change and reducing metabolic disease risk in obese Latino adolescent populations. Future investigations will be needed to determine the full effects of the Imagine HEALTH intervention on insulin resistance, stress, and stress biomarkers. Trial registration Clinicaltrials.gov Registry #: NCT01895595 PMID:24433565

The Walking Interventions Through Texting (WalkIT) Trial: Rationale, Design, and Protocol for a Factorial Randomized Controlled Trial of Adaptive Interventions for Overweight and Obese, Inactive Adults.

PubMed

Hurley, Jane C; Hollingshead, Kevin E; Todd, Michael; Jarrett, Catherine L; Tucker, Wesley J; Angadi, Siddhartha S; Adams, Marc A

2015-09-11

Walking is a widely accepted and frequently targeted health promotion approach to increase physical activity (PA). Interventions to increase PA have produced only small improvements. Stronger and more potent behavioral intervention components are needed to increase time spent in PA, improve cardiometabolic risk markers, and optimize health. Our aim is to present the rationale and methods from the WalkIT Trial, a 4-month factorial randomized controlled trial (RCT) in inactive, overweight/obese adults. The main purpose of the study was to evaluate whether intensive adaptive components result in greater improvements to adults' PA compared to the static intervention components. Participants enrolled in a 2x2 factorial RCT and were assigned to one of four semi-automated, text message-based walking interventions. Experimental components included adaptive versus static steps/day goals, and immediate versus delayed reinforcement. Principles of percentile shaping and behavioral economics were used to operationalize experimental components. A Fitbit Zip measured the main outcome: participants' daily physical activity (steps and cadence) over the 4-month duration of the study. Secondary outcomes included self-reported PA, psychosocial outcomes, aerobic fitness, and cardiorespiratory risk factors assessed pre/post in a laboratory setting. Participants were recruited through email listservs and websites affiliated with the university campus, community businesses and local government, social groups, and social media advertising. This study has completed data collection as of December 2014, but data cleaning and preliminary analyses are still in progress. We expect to complete analysis of the main outcomes in late 2015 to early 2016. The Walking Interventions through Texting (WalkIT) Trial will further the understanding of theory-based intervention components to increase the PA of men and women who are healthy, insufficiently active and are overweight or obese. WalkIT is one of

Childhood Obesity and Medical Neglect

PubMed Central

Varness, Todd; Allen, David B.; Carrel, Aaron L.; Fost, Norman

2011-01-01

The incidence of childhood obesity has increased dramatically, including severe childhood obesity and obesity-related comorbid conditions. Cases of severe childhood obesity have prompted the following question: does childhood obesity ever constitute medical neglect? In our opinion, removal of a child from the home is justified when all 3 of the following conditions are present: (1) a high likelihood that serious imminent harm will occur; (2) a reasonable likelihood that coercive state intervention will result in effective treatment; and (3) the absence of alternative options for addressing the problem. It is not the mere presence or degree of obesity but rather the presence of comorbid conditions that is critical for the determination of serious imminent harm. All 3 criteria are met in very limited cases, that is, the subset of obese children who have serious comorbid conditions and for whom all alternative options have been exhausted. In these limited cases, a trial of enforced treatment outside the home may be indicated, to protect the child from irreversible harm. PMID:19117907

Effectiveness of green tea on weight reduction in obese Thais: A randomized, controlled trial.

PubMed

Auvichayapat, Paradee; Prapochanung, Montira; Tunkamnerdthai, Oratai; Sripanidkulchai, Bung-orn; Auvichayapat, Narong; Thinkhamrop, Bandit; Kunhasura, Soontorn; Wongpratoom, Srisuda; Sinawat, Supat; Hongprapas, Pranithi

2008-02-27

This study was undertaken to investigate the effects of green tea on weight reduction in obese Thais. A randomized, controlled trial involving 60 obese subjects (body mass index, BMI > 25 kg/m2) was conducted. All subjects consumed a Thai diet containing 3 meals (8373.6 kJ/day) for 12 weeks, prepared by the Nutritional Unit at Srinagarind Hospital. The diet contained 65% carbohydrates, 15% protein, and 20% fat. Body weight, BMI, body composition, resting energy expenditure, and substrate oxidation were measured at baseline, and during weeks 4, 8, and 12 of the study. Serum levels of leptin and urine VMA were measured at baseline and during the 12th week. Differences over time and between the treatments (green tea or placebo) over time were determined using two-factor ANOVA with repeated measures. In comparing the two groups, differences in weight loss were 2.70, 5.10, and 3.3 kg during the 4th, 8th, and 12th weeks of the study, respectively. At the 8th and 12th weeks of the study, body weight loss was significantly different (P < 0.05). At the 8th week, the difference in resting energy expenditure was 183.38 kJ/day (P < 0.001), the difference in the respiratory quotient was 0.02 (P < 0.05), and no significant differences existed in satiety score, food intake, or physical activity. Urine VMA was significantly different in the 12th week of the study (P < 0.05). We conclude that green tea can reduce body weight in obese Thai subjects by increasing energy expenditure and fat oxidation.

Evaluating the Efficacy of the Feeding Exercise Randomized Trial in Overweight and Obese Adolescents.

PubMed

Patsopoulou, Anna; Tsimtsiou, Zoi; Katsioulis, Antonios; Malissiova, Eleni; Rachiotis, George; Hadjichristodoulou, Christos

2017-04-01

The Feeding Exercise Trial in Adolescents (FETA) aimed to evaluate whether a community-based, parents-involving, combined physical activity and nutritional education program was effective in improving adiposity profiles in overweight and obese adolescents. A total of 181 overweight and obese adolescents aged 13-15 years old were randomized in the three study groups ("Diet & Activity," "Activity," and Control). The Activity intervention included a 45-minute, 3-day per week supervised training program, while the Diet & Activity intervention included a supplementary 15 minutes of group-based sessions attended by the parents. The intervention lasted 3 months and the participants were followed for another 3 months after the intervention. The participants were assessed for anthropometric measures and activity and fulfilled the modified version of the questionnaire "Family Eating and Activity Habits Questionnaire" (FEAHQ). Both "Activity" only and "Diet & Activity" groups reduced significantly (p < 0.001) their mean body mass index (BMI) (-1.1, 95% CI -1.3, -0.8, and -1.4, 95% CI -1.7, -1.2, respectively), waist circumference, systolic and diastolic blood pressure, pulses per minute, and 50 m sprint run test at 3 months, while greater reductions in BMI were observed at 6 months (-2.3, 95% CI -2.6, -2.0, and -3.1, 95% CI -3.3, -2.8). Significant changes in the total FEAHQ score were achieved only in the "Diet & Activity" group both at 3 months and at 6 months. FETA resulted in significant effects on improving adiposity profiles in overweight and obese adolescents, as well as family activity and feeding habits, maintained at 3 months follow-up.

Registration performance on EUV masks using high-resolution registration metrology

NASA Astrophysics Data System (ADS)

Steinert, Steffen; Solowan, Hans-Michael; Park, Jinback; Han, Hakseung; Beyer, Dirk; Scherübl, Thomas

2016-10-01

Next-generation lithography based on EUV continues to move forward to high-volume manufacturing. Given the technical challenges and the throughput concerns a hybrid approach with 193 nm immersion lithography is expected, at least in the initial state. Due to the increasing complexity at smaller nodes a multitude of different masks, both DUV (193 nm) and EUV (13.5 nm) reticles, will then be required in the lithography process-flow. The individual registration of each mask and the resulting overlay error are of crucial importance in order to ensure proper functionality of the chips. While registration and overlay metrology on DUV masks has been the standard for decades, this has yet to be demonstrated on EUV masks. Past generations of mask registration tools were not necessarily limited in their tool stability, but in their resolution capabilities. The scope of this work is an image placement investigation of high-end EUV masks together with a registration and resolution performance qualification. For this we employ a new generation registration metrology system embedded in a production environment for full-spec EUV masks. This paper presents excellent registration performance not only on standard overlay markers but also on more sophisticated e-beam calibration patterns.

75 FR 52859 - Re-Registration and Renewal of Aircraft Registration; OMB Approval of Information Collection

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-30

... Aircraft Registration; OMB Approval of Information Collection AGENCY: Federal Aviation Administration, DOT... final rule, ``Re-Registration and Renewal of Aircraft Registration,'' which was published on July 20..., the FAA published the final rule, ``Re-Registration and Renewal of Aircraft Registration'' (75 FR...

Environmental Interventions for Obesity and Chronic Disease Prevention.

PubMed

Gittelsohn, Joel; Trude, Angela

2015-01-01

Innovative approaches are needed to impact obesity and other diet-related chronic diseases, including tested interventions at the environmental and policy levels. We have conducted multi-level community trials in low-income minority settings in the United States and other countries that test interventions to improve the food environment, support policy, and reduce the risk for developing obesity and other diet-related chronic diseases. All studies have examined change from pre- to post-study, comparing an intervention with a comparison group. Our results have shown consistent positive effects of these trials on consumer psychosocial factors, food purchasing, food preparation and diet, and, in some instances, obesity. We have recently implemented a systems science model to support programs and policies to improve urban food environments. Environmental interventions are a promising approach for addressing the global obesity epidemic due to their wide reach. Further work is needed to disseminate, expand and sustain these initiatives through policy at the city, state and federal levels.

Psychosocial Predictors of Physical Activity Change Among College Students in an Obesity Prevention Trial.

PubMed

Arigo, Danielle; Rohde, Paul; Shaw, Heather; Stice, Eric

2017-07-01

Moderate-to-vigorous physical activity (MVPA) is critical for maintaining a healthy weight, although little is known about psychological barriers to maintaining MVPA in at-risk groups. Identifying characteristics associated with poor MVPA maintenance in obesity prevention programs could improve participant outcomes. Toward this end, we examined predictors of MVPA in an obesity prevention trial for college students at risk for weight gain (n = 333; 72% female, mean BMI = 23.4 kg/m 2 ). Participants engaged in 1 of 3 weight control interventions and in 4 assessments over 12-month follow-up (ie, measured height/weight, self-reports of psychosocial characteristics, 4 days of accelerometer wear). Multilevel modeling analyses showed that across conditions, participants decreased total MVPA minutes per week over 12 months (B = -5.48, P < .01). Baseline self-report scores for both impulsiveness and cognitive dissonance regarding engaging in unhealthy behaviors negatively predicted MVPA over time. Participants higher (vs. lower) in baseline impulsiveness (B = -6.89, P = .03) and dissonance (B = -4.10, P = .04) began the study with more MVPA minutes, but showed sharper declines over time. Targeted MVPA-focused intervention for students who show elevated impulsiveness and cognitive dissonance may improve both MVPA and weight control outcomes for these individuals.

Clinical Safety of Bariatric Arterial Embolization: Preliminary Results of the BEAT Obesity Trial.

PubMed

Weiss, Clifford R; Akinwande, Olaguoke; Paudel, Kaylan; Cheskin, Lawrence J; Holly, Brian; Hong, Kelvin; Fischman, Aaron M; Patel, Rahul S; Shin, Eun J; Steele, Kimberley E; Moran, Timothy H; Kaiser, Kristen; Park, Amie; Shade, David M; Kraitchman, Dara L; Arepally, Aravind

2017-05-01

Purpose To conduct a pilot prospective clinical trial to evaluate the feasibility, safety, and short-term efficacy of bariatric embolization, a recently developed endovascular procedure for the treatment of obesity, in patients with severe obesity. Materials and Methods This is an institutional review board- and U.S. Food and Drug Administration-approved prospective physician-initiated investigational device exemption study. This phase of the study ran from June 2, 2014, to August 4, 2015. Five severely obese patients (four women, one man) who were 31-49 years of age and who had a mean body mass index of 43.8 kg/m 2 ± 2.9 with no clinically important comorbidities were enrolled in this study. Transarterial embolization of the gastric fundus with fluoroscopic guidance was performed with 300-500-μm Embosphere microspheres. The primary end point was 30-day adverse events (AEs). The secondary end points included short-term weight loss, serum obesity-related hormone levels, hunger and satiety assessments, and quality of life (QOL) surveys, reported up to 3 months. Simple statistics of central tendencies and variability were calculated. No hypothesis testing was performed. Results The left gastric artery, with or without the gastroepiploic artery, was embolized in five patients, with a technical success rate of 100%. There were no major AEs. There were two minor AEs-subclinical pancreatitis and a mucosal ulcer that had healed by the time of 3-month endoscopy. A hospital stay of less than 48 hours for routine supportive care was provided for three patients. Mean excess weight loss of 5.9% ± 2.4 and 9.0% ± 4.1 was noted at 1 month and at 3 months, respectively. Mean change in serum ghrelin was 8.7% ± 34.7 and -17.5% ± 29 at 1 month and 3 months, respectively. Mean changes in serum glucagon-like peptide 1 and peptide YY were 106.6% ± 208.5 and 17.8% ± 54.8 at 1 month. There was a trend toward improvement in QOL parameters. Hunger/appetite scores decreased in the

Clinical Safety of Bariatric Arterial Embolization: Preliminary Results of the BEAT Obesity Trial

PubMed Central

Akinwande, Olaguoke; Paudel, Kaylan; Cheskin, Lawrence J.; Holly, Brian; Hong, Kelvin; Fischman, Aaron M.; Patel, Rahul S.; Shin, Eun J.; Steele, Kimberley E.; Moran, Timothy H.; Kaiser, Kristen; Park, Amie; Shade, David M.; Kraitchman, Dara L.; Arepally, Aravind

2017-01-01

Purpose To conduct a pilot prospective clinical trial to evaluate the feasibility, safety, and short-term efficacy of bariatric embolization, a recently developed endovascular procedure for the treatment of obesity, in patients with severe obesity. Materials and Methods This is an institutional review board– and U.S. Food and Drug Administration–approved prospective physician-initiated investigational device exemption study. This phase of the study ran from June 2, 2014, to August 4, 2015. Five severely obese patients (four women, one man) who were 31–49 years of age and who had a mean body mass index of 43.8 kg/m2 ± 2.9 with no clinically important comorbidities were enrolled in this study. Transarterial embolization of the gastric fundus with fluoroscopic guidance was performed with 300–500-μm Embosphere microspheres. The primary end point was 30-day adverse events (AEs). The secondary end points included short-term weight loss, serum obesity-related hormone levels, hunger and satiety assessments, and quality of life (QOL) surveys, reported up to 3 months. Simple statistics of central tendencies and variability were calculated. No hypothesis testing was performed. Results The left gastric artery, with or without the gastroepiploic artery, was embolized in five patients, with a technical success rate of 100%. There were no major AEs. There were two minor AEs—subclinical pancreatitis and a mucosal ulcer that had healed by the time of 3-month endoscopy. A hospital stay of less than 48 hours for routine supportive care was provided for three patients. Mean excess weight loss of 5.9% ± 2.4 and 9.0% ± 4.1 was noted at 1 month and at 3 months, respectively. Mean change in serum ghrelin was 8.7% ± 34.7 and −17.5% ± 29 at 1 month and 3 months, respectively. Mean changes in serum glucagon-like peptide 1 and peptide YY were 106.6% ± 208.5 and 17.8% ± 54.8 at 1 month. There was a trend toward improvement in QOL parameters. Hunger/appetite scores decreased

Genetic polymorphisms and weight loss in obesity: a randomised trial of hypo-energetic high- versus low-fat diets.

PubMed

Sørensen, Thorkild I A; Boutin, Philippe; Taylor, Moira A; Larsen, Lesli H; Verdich, Camilla; Petersen, Liselotte; Holst, Claus; Echwald, Søren M; Dina, Christian; Toubro, Søren; Petersen, Martin; Polak, Jan; Clément, Karine; Martínez, J Alfredo; Langin, Dominique; Oppert, Jean-Michel; Stich, Vladimir; Macdonald, Ian; Arner, Peter; Saris, Wim H M; Pedersen, Oluf; Astrup, Arne; Froguel, Philippe

2006-06-01

To study if genes with common single nucleotide polymorphisms (SNPs) associated with obesity-related phenotypes influence weight loss (WL) in obese individuals treated by a hypo-energetic low-fat or high-fat diet. Randomised, parallel, two-arm, open-label multi-centre trial. Eight clinical centres in seven European countries. 771 obese adult individuals. 10-wk dietary intervention to hypo-energetic (-600 kcal/d) diets with a targeted fat energy of 20%-25% or 40%-45%, completed in 648 participants. WL during the 10 wk in relation to genotypes of 42 SNPs in 26 candidate genes, probably associated with hypothalamic regulation of appetite, efficiency of energy expenditure, regulation of adipocyte differentiation and function, lipid and glucose metabolism, or production of adipocytokines, determined in 642 participants. Compared with the noncarriers of each of the SNPs, and after adjusting for gender, age, baseline weight and centre, heterozygotes showed WL differences that ranged from -0.6 to 0.8 kg, and homozygotes, from -0.7 to 3.1 kg. Genotype-dependent additional WL on low-fat diet ranged from 1.9 to -1.6 kg in heterozygotes, and from 3.8 kg to -2.1 kg in homozygotes relative to the noncarriers. Considering the multiple testing conducted, none of the associations was statistically significant. Polymorphisms in a panel of obesity-related candidate genes play a minor role, if any, in modulating weight changes induced by a moderate hypo-energetic low-fat or high-fat diet.

Sleep Quality and Body Composition Variations in Obese Male Adults after 14 Weeks of Yoga Intervention: A Randomized Controlled Trial

PubMed Central

Rshikesan, PB; Subramanya, Pailoor; Singh, Deepeshwar

2017-01-01

Background: Obesity is a big challenge all over the world. It is associated with many noncommunicable diseases. Yoga known to be add-on treatment may be effective for obesity control. Aim: To assess the effect of integrated approach of yoga therapy (IAYT) for body composition and quality of sleep in adult obese male. Subjects and Methods: A randomized controlled trial was conducted for 14 weeks on obese male of urban setting. Eighty individuals were randomly divided into two groups, i.e., yoga group (n = 40; age; 40.03 ± 8.74 years, body mass index [BMI] 28.7 ± 2.35 kg/m2) and control group (age; 42.20 ± 12.06 years, BMI 27.70 ± 2.05 kg/m2). The IAYT was imparted to yoga group for 1½ hour for 5 days in a week for 14 weeks. The control group continued their regular activities. The body composition by InBody R20 and sleep quality by Pittsburgh Sleep Quality Index (PSQI) were assessed. Statistical analysis was done for within and between groups using SPSS version 21. The correlation analysis was done on the difference in pre-post values. Results: The results showed that weight (P = 0.004), BMI (P = 0.008), bone mass (P = 0.017), obesity degree (P = 0.005), and mineral mass (P = 0.046) were improved in yoga group and no change in control group (P > 0.05). The global score of PSQI improved (P = 0.017) in yoga group alone. Conclusion: The results indicate the beneficial effects of IAYT on body composition and sleep quality in obese males. The yoga practice may reduce obesity with the improvement in quality of life. PMID:29422743

75 FR 58292 - Re-Registration and Renewal of Aircraft Registration; OMB Approval of Information Collection...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-24

...-0188; Amdt. No. 47-29A] RIN 2120-AI89 Re-Registration and Renewal of Aircraft Registration; OMB... contained in the ``Re-Registration and Renewal of Aircraft Registration'' final rule. The final rule was... Renewal of Aircraft Registration'' (75 FR 41968). The final rule contained information collection...

Effectiveness of testosterone therapy in obese men with low testosterone levels, for losing weight, controlling obesity complications, and preventing cardiovascular events: Protocol of a systematic review of randomized controlled trials.

PubMed

Mangolim, Amanda S; Brito, Leonardo A R; Nunes-Nogueira, Vania S

2018-04-01

The use of testosterone replacement therapy in obese men with low testosterone levels has been controversial. This review aims to analyze the effectiveness of testosterone therapy for weight loss and preventing cardiovascular complications in obese men with low testosterone levels. We will perform a systematic review according to Cochrane Methodology of randomized studies, including crossover studies, wherein patients are allocated into one of the two groups: testosterone therapy and control (no treatment or placebo). The primary outcomes analyzed will be: weight loss, adverse events, quality of life, improvement of libido, control of obesity complications, frequency of cardiovascular events, and deaths. Four general and adaptive search strategies have been created for the following electronic health databases: Embase, Medline, LILACS, and CENTRAL. Two reviewers will independently select the eligible studies, assess the risk of bias, and extract the data from included studies. Similar outcomes measured in at least two trials will be plotted in the meta-analysis using Review Manager 5.3. The quality of evidence of the effect estimate of the intervention for the outcomes that could be plotted in the meta-analysis will be generated according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group. Although testosterone replacement seems to be an attractive treatment modality for obese men with low testosterone, its potential benefits has been refuted by some studies, whose results have not shown significant differences between treated and untreated patients. For obese men with low testosterone concentrations, the proposed systematic review aims to answer the following questions: When compared with no treatment or placebo: Is testosterone therapy safe? Is testosterone therapy effective in promoting weight loss, a sustained reduction in body weight and changes in body composition? Is testosterone effective in improving quality of

Effects of a nutrition plus exercise programme on physical function in sarcopenic obese elderly people: study protocol for a randomised controlled trial.

PubMed

Shen, Shan-Shan; Chu, Jiao-Jiao; Cheng, Lei; Zeng, Xing-Kun; He, Ting; Xu, Li-Yu; Li, Jiang-Ru; Chen, Xu-Jiao

2016-09-30

With a rapidly ageing population, sarcopenic obesity, defined as decreased muscle mass and function combined with increased body fat, is a complex health problem. Although sarcopenic obesity contributes to a decline in physical function and exacerbates frailty in older adults, evidence from clinical trials about the effect of exercise and nutrition on this complex syndrome in Chinese older adults is lacking. We devised a study protocol for a single-blind randomised controlled trial. Sarcopenia is described as age-related decline in muscle mass plus low muscle strength and/or low physical performance. Obesity is defined as a percentage of body fat above the 60th centile. Ninety-two eligible participants will be randomly assigned to a control group, nutrition group, exercise group and nutrition plus exercise group to receive an 8-week intervention and 12-week follow-up. The primary outcomes will be the change in short physical performance battery scores, grip strength and 6 m usual gait speed. The secondary outcomes will include basic activities of daily living scores, instrumental activity daily living scores, body composition and body anthropometric indexes. For all main analyses, the principle of intention-to-treat will be used. This study was approved by the medical ethics committee of Zhejiang Hospital on 25 November 2015. The study will present data targeting the clinical effects of nutrition and exercise on physical function and body composition in a Chinese older population with sarcopenic obesity. The results will help to provide important clinical evidence of the role of complex non-pharmaceutical interventions for sarcopenic obese older people. The findings of this study will be submitted to peer-reviewed medical journals for publication and presented at relevant academic conferences. ChiCTR-IOR-15007501; Pre-results. 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/.

Evaluation of a comprehensive intervention with a behavioural modification strategy for childhood obesity prevention: a nonrandomized cluster controlled trial.

PubMed

Wang, Jing-jing; Lau, Wing-chung Patrick; Wang, Hai-jun; Ma, Jun

2015-12-03

the biochemical lipid metabolism indicators. Positive but non-significant adjusted changes in body mass index and waist circumference were observed. Compared with the diet or PA only intervention groups, the current comprehensive program had superior positive effects on body fat percentage and blood pressure but not on the biochemical lipid metabolism indicators in Chinese overweight and obese children. Future randomized controlled trials and long-term follow-up studies are required to elaborate the findings of the current intervention. ClinicalTrials.gov identifier: NCT02228434.

28 CFR 12.3 - Prior registration with the Foreign Agents Registration Unit.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 28 Judicial Administration 1 2013-07-01 2013-07-01 false Prior registration with the Foreign Agents Registration Unit. 12.3 Section 12.3 Judicial Administration DEPARTMENT OF JUSTICE REGISTRATION OF CERTAIN PERSONS HAVING KNOWLEDGE OF FOREIGN ESPIONAGE, COUNTERESPIONAGE, OR SABOTAGE MATTERS UNDER THE ACT...

28 CFR 12.3 - Prior registration with the Foreign Agents Registration Unit.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 28 Judicial Administration 1 2014-07-01 2014-07-01 false Prior registration with the Foreign Agents Registration Unit. 12.3 Section 12.3 Judicial Administration DEPARTMENT OF JUSTICE REGISTRATION OF CERTAIN PERSONS HAVING KNOWLEDGE OF FOREIGN ESPIONAGE, COUNTERESPIONAGE, OR SABOTAGE MATTERS UNDER THE ACT...

28 CFR 12.3 - Prior registration with the Foreign Agents Registration Unit.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Prior registration with the Foreign Agents Registration Unit. 12.3 Section 12.3 Judicial Administration DEPARTMENT OF JUSTICE REGISTRATION OF CERTAIN PERSONS HAVING KNOWLEDGE OF FOREIGN ESPIONAGE, COUNTERESPIONAGE, OR SABOTAGE MATTERS UNDER THE ACT...

28 CFR 12.3 - Prior registration with the Foreign Agents Registration Unit.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 28 Judicial Administration 1 2011-07-01 2011-07-01 false Prior registration with the Foreign Agents Registration Unit. 12.3 Section 12.3 Judicial Administration DEPARTMENT OF JUSTICE REGISTRATION OF CERTAIN PERSONS HAVING KNOWLEDGE OF FOREIGN ESPIONAGE, COUNTERESPIONAGE, OR SABOTAGE MATTERS UNDER THE ACT...

28 CFR 12.3 - Prior registration with the Foreign Agents Registration Unit.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 28 Judicial Administration 1 2012-07-01 2012-07-01 false Prior registration with the Foreign Agents Registration Unit. 12.3 Section 12.3 Judicial Administration DEPARTMENT OF JUSTICE REGISTRATION OF CERTAIN PERSONS HAVING KNOWLEDGE OF FOREIGN ESPIONAGE, COUNTERESPIONAGE, OR SABOTAGE MATTERS UNDER THE ACT...

Metformin and dietary advice to improve insulin sensitivity and promote gestational restriction of weight among pregnant women who are overweight or obese: the GRoW Randomised Trial.

PubMed

Dodd, Jodie M; Grivell, Rosalie M; Deussen, Andrea R; Dekker, Gustaaf; Louise, Jennie; Hague, William

2016-11-21

Obesity is a significant global health problem, with approximately 50% of women entering pregnancy having a body mass index greater than or equal to 25 kg/m 2 . Obesity during pregnancy is associated with a well-recognised increased risk of adverse health outcomes both for the woman and her infant. Currently available data from large scale randomised trials and systematic reviews highlight only modest effects of antenatal dietary and lifestyle interventions in limiting gestational weight gain, with little impact on clinically relevant pregnancy outcomes. Further information evaluating alternative strategies is required. The aims of this randomised controlled trial are to assess whether the use of metformin as an adjunct therapy to dietary and lifestyle advice for overweight and obese women during pregnancy is effective in improving maternal, fetal and infant health outcomes. Design: Multicentre randomised, controlled trial. Women with a singleton, live gestation between 10 +0 -20 +0 weeks who are obese or overweight (defined as body mass index greater than or equal to 25 kg/m 2 ), at the first antenatal visit. Trial Entry & Randomisation: Eligible, consenting women will be randomised between 10 +0 and 20 +0 weeks gestation using an online computer randomisation system, and randomisation schedule prepared by non-clinical research staff with balanced variable blocks. Stratification will be according to maternal BMI at trial entry, parity, and centre where planned to give birth. Treatment Schedules: Women randomised to the Metformin Group will receive a supply of 500 mg oral metformin tablets. Women randomised to the Placebo Group will receive a supply of identical appearing and tasting placebo tablets. Women will be instructed to commence taking one tablet daily for a period of one week, increasing to a maximum of two tablets twice daily over four weeks and then continuing until birth. Women, clinicians, researchers and outcome assessors will be blinded to the

Effect of obesity on the effectiveness of hormonal contraceptives: an individual participant data meta-analysis.

PubMed

Yamazaki, Michiyo; Dwyer, Kate; Sobhan, Mahboob; Davis, Daniel; Kim, Myong-Jin; Soule, Lisa; Willett, Gerald; Yu, Chongwoo

2015-11-01

The objective of this investigation was to assess the potential effect of obesity on the effectiveness of hormonal contraceptives (HCs). A meta-analysis was conducted using individual participant data directly from the Phase 3 clinical trials of combination oral contraceptives (COCs) rather than extracting summary data from literature. Trials selected were reviewed by the US Food and Drug Administration (FDA) between 2000 and 2012, conducted in North America, had more than six 28-day cycle equivalents of exposure, and had readily retrievable participant-level data. Contraceptive effectiveness was measured by the Pearl Index (PI: the number of pregnancies per 100 woman-years) in women aged 18-35 at risk of unintended pregnancy. The incidence rate ratio (IRR), a ratio of PIs for obese women (defined as body mass index [BMI] ≥30 kg/m(2)) compared to non-obese women (BMI <30 kg/m(2)) was calculated. A Cox proportional-hazard regression model with fixed and random-effects were used to estimate hazard ratios (HRs) for unintended pregnancy in obese women compared to non-obese women. Seven clinical trials with COCs (N=14,024: 2707 obese and 11,317 non-obese women) met the inclusion criteria for the meta-analysis. The PI for each trial varied: 2.05-5.08 for obese and 1.84-3.80 for non-obese women. The pooled PI estimated using direct weighted average method was 3.14 (95% CI: 2.33-4.22) for obese and 2.53 (95% CI: 1.88-3.41) for non-obese women. The pooled IRRs estimated using direct weighted average and Mantel-Haenszel adjustment methods were comparable: 1.37 (95% CI: 1.02-1.84) and 1.43 (95% CI: 1.07-1.92), respectively. The overall HR of 1.44 (95% CI: 1.06-1.95; p=.018) in the meta-analysis suggested a 44% higher pregnancy rate during COC use for obese women after adjusting for age and race. Obesity may increase the risk of unintended pregnancy in women using COCs; more data on obese women from ongoing and future Phase 3 clinical trials are necessary to allow further

Robust non-rigid registration algorithm based on local affine registration

NASA Astrophysics Data System (ADS)

Wu, Liyang; Xiong, Lei; Du, Shaoyi; Bi, Duyan; Fang, Ting; Liu, Kun; Wu, Dongpeng

2018-04-01

Aiming at the problem that the traditional point set non-rigid registration algorithm has low precision and slow convergence speed for complex local deformation data, this paper proposes a robust non-rigid registration algorithm based on local affine registration. The algorithm uses a hierarchical iterative method to complete the point set non-rigid registration from coarse to fine. In each iteration, the sub data point sets and sub model point sets are divided and the shape control points of each sub point set are updated. Then we use the control point guided affine ICP algorithm to solve the local affine transformation between the corresponding sub point sets. Next, the local affine transformation obtained by the previous step is used to update the sub data point sets and their shape control point sets. When the algorithm reaches the maximum iteration layer K, the loop ends and outputs the updated sub data point sets. Experimental results demonstrate that the accuracy and convergence of our algorithm are greatly improved compared with the traditional point set non-rigid registration algorithms.

A prospective trial for laparoscopic adjustable gastric banding in morbidly obese adolescents: an interim report of weight loss, metabolic and quality of life outcomes.

USDA-ARS?s Scientific Manuscript database

The outcome of patients completing 12 months of follow-up in a prospective longitudinal trial of the safety/efficacy of laparoscopic adjustable gastric banding (LAGB), for morbidly obese adolescents aged 14 to 17 years using a Food and Drug Administration Institutional Device Exemption for the use o...

The influence of whole grain products and red meat on intestinal microbiota composition in normal weight adults: a randomized crossover intervention trial.

PubMed

Foerster, Jana; Maskarinec, Gertraud; Reichardt, Nicole; Tett, Adrian; Narbad, Arjan; Blaut, Michael; Boeing, Heiner

2014-01-01

Intestinal microbiota is related to obesity and serum lipid levels, both risk factors for chronic diseases constituting a challenge for public health. We investigated how a diet rich in whole grain (WG) products and red meat (RM) influences microbiota. During a 10-week crossover intervention study, 20 healthy adults consumed two isocaloric diets, one rich in WG products and one high in RM. Repeatedly data on microbiota were assessed by 16S rRNA based denaturing gradient gel electrophoresis (DGGE). A blood sample and anthropometric data were collected. Mixed models and logistic regression were used to investigate effects. Microbiota showed interindividual variability. However, dietary interventions modified microbiota appearance: 8 bands changed in at least 4 participants during the interventions. One of the bands appearing after WG and one increasing after RM remained significant in regression models and were identified as Collinsella aerofaciens and Clostridium sp. The WG intervention lowered obesity parameters, while the RM diet increased serum levels of uric acid and creatinine. The study showed that diet is a component of major relevance regarding its influence on intestinal microbiota and that WG has an important role for health. The results could guide investigations of diet and microbiota in observational prospective cohort studies. Trial registration: ClinicalTrials.gov NCT01449383.

The Influence of Whole Grain Products and Red Meat on Intestinal Microbiota Composition in Normal Weight Adults: A Randomized Crossover Intervention Trial

PubMed Central

Foerster, Jana; Maskarinec, Gertraud; Reichardt, Nicole; Tett, Adrian; Narbad, Arjan; Blaut, Michael; Boeing, Heiner

2014-01-01

Intestinal microbiota is related to obesity and serum lipid levels, both risk factors for chronic diseases constituting a challenge for public health. We investigated how a diet rich in whole grain (WG) products and red meat (RM) influences microbiota. During a 10-week crossover intervention study, 20 healthy adults consumed two isocaloric diets, one rich in WG products and one high in RM. Repeatedly data on microbiota were assessed by 16S rRNA based denaturing gradient gel electrophoresis (DGGE). A blood sample and anthropometric data were collected. Mixed models and logistic regression were used to investigate effects. Microbiota showed interindividual variability. However, dietary interventions modified microbiota appearance: 8 bands changed in at least 4 participants during the interventions. One of the bands appearing after WG and one increasing after RM remained significant in regression models and were identified as Collinsella aerofaciens and Clostridium sp. The WG intervention lowered obesity parameters, while the RM diet increased serum levels of uric acid and creatinine. The study showed that diet is a component of major relevance regarding its influence on intestinal microbiota and that WG has an important role for health. The results could guide investigations of diet and microbiota in observational prospective cohort studies. Trial registration ClinicalTrials.gov NCT01449383 PMID:25299601

Piloting a manualised weight management programme (Shape Up-LD) for overweight and obese persons with mild-moderate learning disabilities: study protocol for a pilot randomised controlled trial.