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Sample records for 12-week randomized intervention

  1. Efficacy of Olibra: A 12-Week Randomized Controlled Trial and a Review of Earlier Studies

    PubMed Central

    Rebello, Candida J; Martin, Corby K; Johnson, William D; O'Neil, Carol E; Greenway, Frank L

    2012-01-01

    Background Intervention strategies that harness the body's appetite and satiety regulating signals provide a means of countering excessive energy intake. Methods Eighty-two subjects were enrolled (18–60 years, body mass index: 25–40 kg/m2) in a randomized, placebo-controlled, double-blind, parallel trial. During a 12-week period, the effects of Olibra™ fat emulsion (2.1 g twice daily) on food intake, appetite, satiety, weight, and body composition were compared with those of a twice daily administered placebo (1.95 g milk fat). On days -7, 0, and 28, Olibra or the placebo added to 200 g of yogurt was served at breakfast and lunch. Food intake, appetite, and satiety were assessed after lunch and dinner. Body weight was measured on days -7, 0, 14, 28, 56, and 84. Body fat, waist circumference, and waist-hip ratio were determined on days 0 and 84. The Eating Inventory was administered at screening and on day 28. Data relating to 71 subjects were analyzed using analysis of covariance. Results At 12 weeks, body weight was reduced in the test group (2.17 ± 0.46 kg standard error of the mean, p < .0001) and the control group (1.68 ± 0.42 kg, p < .0001). Waist circumference decreased by 2.93 ± 0.85 cm in the test group (p = .001) and by 1.78 ± 0.74 cm in the control group (p = .02). Differential weight and waist circumference reductions were not significant. Hunger scores (Eating Inventory) decreased more in the test group (p = .0082). Differential group effects were not significant for body fat, waist-hip ratio, food intake, appetite, and satiety. Conclusions At this dose, Olibra did not exert a consistent effect on food intake, appetite regulation, body weight, or body composition. PMID:22768902

  2. Escitalopram for treatment of night eating syndrome: a 12-week, randomized, placebo-controlled trial.

    PubMed

    Vander Wal, Jillon S; Gang, Catherine H; Griffing, George T; Gadde, Kishore M

    2012-06-01

    The primary objective of this study was to examine the short-term effects of escitalopram on symptoms of night eating syndrome (NES) in a randomized controlled clinical trial. A total of 40 patients with NES were randomly assigned to double-blind treatment with escitalopram 20 mg (n = 20) or placebo (n = 20) for 12 weeks. Escitalopram was started at 10 mg/d with a dosage increase to 20 mg/d after 4 weeks; placebo dosing was identical. The primary end point was a mean change in total score of the Night Eating Questionnaire (NEQ). At 12 weeks, mean (SE) change in NEQ total score was -13.0 (1.6) and -10.6 (2.2) in the escitalopram and placebo groups, respectively (F(1,37) = 2.5, P = 0.124). There was a marginal interaction effect between response to escitalopram and race (F(1,34) = 4.0, P = 0.052), with a favorable effect for white patients (F(1,20) = 6.0, P = 0.024) but not for black patients (F(1,13) = 0.6, P = 0.453). Seven patients in the escitalopram group, compared with 6 patients in the placebo group, showed a 50% NEQ score reduction (P = 0.736). Sixteen patients in the escitalopram group and 12 patients in the placebo group no longer met NES criteria (P = 0.168). Twelve patients in the escitalopram group were classified as responders according to the Clinical Global Impression Improvement scale compared with 7 patients in the placebo group (P = 0.113). No significant between-group differences were found for weight, mood ratings, or adverse events. We conclude that escitalopram treatment for 12 weeks was not superior to placebo in reducing NES symptoms as measured by the NEQ.

  3. A 12-week Interdisciplinary Intervention Program for Children who are Obese

    PubMed Central

    Taylor, Laura; Williamson, Megan; Robinson, Chris

    2011-01-01

    Childhood obesity is a growing problem, for which multi-disciplinary interventions are needed. Purpose: This interdisciplinary intervention program was designed to improve the health of children who were obese. Methods: Twenty-five children, mean age 8.1 (1.5) years; body mass index (BMI)> 98th percentile, and their parents completed the 12-week (3 days/wk) intervention consisting of aerobic and resistance exercise appropriate to age and developmental levels. Baseline and posttest measures of blood values, fitness, and cardiovascular risk factors were performed. Data were analyzed using paired t-tests with significance accepted at P ≤ .05. Results: Significant differences between means (SD) for pre- and post-measurements were, respectively: BMI 30.31 (4.56), 27.80 (4.54), body-fat percent 43.7 (11.5), 40.7 (10.9), waist circumference 82.1 (7.1), 80.4(6.1) cm, calf circumference 34.2 (3.1), 35.2 (3.1) cm; step-test heart rate 137 (20), 126 (12) bpm, push-ups 1.0 (1.8), 5.6 (3.8), sit-ups 23.6 (12.7), 33.2 (13.8), sit-and-reach 35.1 (7.4), 41.2 (5.8) cm; systolic BP 102 (10), 108 (9) mmHg, glucose 4.9(0.3), 4.8 (0.4) mmol/L, total cholesterol 4.6 (1.0), 4.2 (0.8) mmol/L, ALT 41 (9), 35 (8) U/L, bilirubin 6.3 (2.4), 5.6 (2.1) μmol/L, and BUN 4.9 (1.1), 4.3 (0.9) mmol/L. Conclusions: This interdisciplinary intervention program positively affected the fitness and health status of children who were obese by involving the children and parents. PMID:22163176

  4. Exercise and quality of life in patients with cystic fibrosis: A 12-week intervention study.

    PubMed

    Schmidt, Anne Mette; Jacobsen, Ulla; Bregnballe, Vibeke; Olesen, Hanne Vebert; Ingemann-Hansen, Thorsten; Thastum, Mikael; Oluf Schiøtz, Peter

    2011-11-01

    It was hypothesised that increased exercise capacity is related to improved quality of life (QoL) in patients with cystic fibrosis (CF). A 12-week individually tailored unsupervised aerobic exercise programme was offered to 42 patients with CF. At the start and at the end of the exercise programme, data on QoL, current exercise habits and preferences, anthropometric data, exercise test, and lung function test were collected. Adherence was observed by a heart rate (HR) monitor. A total of 24 patients accepted to be enrolled in the exercise programme and 14 completed the programme. Another 14 patients declined to be enrolled in the exercise programme but completed the Cystic Fibrosis Questionnaire for Adolescents and Adults (CFQ-R 14+). Four patients did not want to participate at all. The 14 patients completing the exercise programme had a significantly increased VO(2max), but they showed no significant change in total QoL score. However, the scores in the domain of treatment burden and emotional functioning increased significantly. There was no significant difference in QoL and lung function between patients participating in the exercise programme (n = 24) and non-participants (n = 14). A 12-week individually tailored unsupervised aerobic exercise programme where HR monitors were used significantly affected VO(2max). Improvement in QoL could not be demonstrated in this study. PMID:21722067

  5. Magnesium Replacement Does Not Improve Insulin Resistance in Patients With Metabolic Syndrome: A 12-Week Randomized Double-Blind Study

    PubMed Central

    Lima de Souza e Silva, Maria de Lourdes; Cruz, Thomaz; Rodrigues, Luiz Erlon; Ladeia, Ana Marice; Bomfim, Olivia; Olivieri, Lucas; Melo, Juliana; Correia, Raquel; Porto, Mirna; Cedro, Alexandre

    2014-01-01

    Background To evaluate the effect of magnesium (Mg) replacement on insulin resistance and cardiovascular risk factors in women with metabolic syndrome (MS) without diabetes. Methods This 12-week clinical randomized double-blind study compared the effects of 400 mg/day of Mg with those of a placebo (n = 72) on fasting glucose, insulin, HOMA-IR, lipid profile and CRP. Mg was measured in serum (SMg) and in mononuclear cells (MMg). Results Hypomagnesemia (SMg < 1.7 mg/dL) was seen in 23.2% of patients and intracellular depletion in 36.1% of patients. The MMg means were lower in patients with obesity (0.94 ± 0.54 μg/mg vs. 1.19 ± 0.6 μg/mg, P = 0.04), and insulin resistance (0.84 ± 0.33 μg/mg vs. 1.14 ± 0.69 µg/mg, P < 0.05). Mg replacement did not alter SMg (1.82 ± 0.14 mg/dL vs. 1.81 ± 0.16 mg/dL, P = 0.877) and tended to increment MMg (0.90 ± 0.40 μg/mg vs. 1.21 ± 0.73 μg/mg, P = 0.089). HOMA-IR did not alter in interventions nor in placebo group (3.2 ± 2.0 to 2.8 ± 1.9, P = 0.368; 3.6 ± 1.9 to 3.2 ± 1.8, respectively), neither did other metabolic parameters. Conclusion Serum and intracellular Mg depletion is common in patients with MS; however, Mg replacement in recommended dosage did not increase significantly Mg levels, neither reduced insulin resistance or metabolic control. PMID:25247020

  6. A 12-week randomized double-blind parallel pilot trial of Sinetrol XPur on body weight, abdominal fat, waist circumference, and muscle metabolism in overweight men.

    PubMed

    Cases, Julien; Romain, Cindy; Dallas, Constantin; Gerbi, Alain; Rouanet, Jean Max

    2015-01-01

    Overweight and obesity are associated to increased risk of developing non-communicable diseases that might dramatically affect life expectancy according World Health Organization. Overweight, obesity, and decline in physical activity are correlated to a significant propensity to lose skeletal muscle mass as a result of prolonged inflammation and oxidative stress whereas cohort surveys and clinical investigations have demonstrated health benefits of Citrus-based polyphenols to reverse such regression. Overweight men were included in a double-blind, randomized, parallel pilot trial where they received daily for a 12-week period 900 mg of a Citrus-based polyphenol extract, Sinetrol® XPur. Body composition, anthropometric, and blood parameters were assessed before and at the end of the intervention period. After 12 weeks, while the silhouette slimmed down, metabolic parameters were significantly improved and skeletal muscle catabolism held back. These data suggest that over a 12-week period, the efficacy of the supplement improve both overweight process and correlated skeletal muscle mass metabolism. PMID:26037199

  7. Changes in physical activity levels following 12-week family intervention in Hispanic girls: Bounce study

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Pediatric obesity is a major health problem among Hispanic girls. Physical activity guidelines recommend that children engage in at least 60 min of moderate to vigorous activity daily. To examine the changes in physical activity level pre- and post-intervention. Hispanic girls in control (CG; N=26, ...

  8. Linagliptin monotherapy compared with voglibose monotherapy in patients with type 2 diabetes undergoing hemodialysis: a 12-week randomized trial

    PubMed Central

    Mori, Katsuhito; Emoto, Masanori; Shoji, Tetsuo; Inaba, Masaaki

    2016-01-01

    Objective Focusing on efficacy and tolerability, we compared linagliptin monotherapy with voglibose monotherapy in patients with type 2 diabetes undergoing hemodialysis (HD). Research design and methods In this multicenter, randomized, open-label, parallel-group, active-controlled study, 78 patients were randomized (1:1) to receive a 12-week treatment with 5 mg linagliptin once daily or 0.2 mg voglibose three times a day. To assess whether linagliptin was superior to voglibose, the primary efficacy end point was the change in glycated hemoglobin (HbA1c) level between baseline and week 12. Secondary efficacy end points included changes between baseline and week 12 in glycated albumin (GA) and casual plasma glucose (PG) levels. Results At week 12, the adjusted mean HbA1c levels had decreased by −0.60% after treatment with linagliptin and by −0.20% after treatment with voglibose (treatment difference: −0.40%, 95% CI −0.74% to −0.06%, p=0.022). A significant reduction in casual PG level was also observed after treatment with linagliptin compared with treatment with voglibose. Relative to voglibose, linagliptin tended to elicit reductions in GA, although without statistical significance. No hypoglycemic symptoms or severe hypoglycemia occurred during the study. Conclusions In patients with type 2 diabetes undergoing HD, linagliptin monotherapy provided significantly better glycemic control without severe hypoglycemia than voglibose monotherapy. Linagliptin represents a promising agent for glycemic management in patients with type 2 diabetes undergoing HD. Trial registration number UMIN000007635; results. PMID:27547421

  9. Effects of 12-week oral supplementation of Ecklonia cava polyphenols on anthropometric and blood lipid parameters in overweight Korean individuals: a double-blind randomized clinical trial.

    PubMed

    Shin, Hyeon-Cheol; Kim, Seong Ho; Park, Yongju; Lee, Bong Ho; Hwang, Hye Jeong

    2012-03-01

    The effects of 12-week supplementation with a polyphenol extract from Ecklonia cava (ECP) on anthropometry, serum biochemistry and hematology have been investigated. Ninety-seven overweight male and female adults (average age 40.5 ± 9.2 yr and body mass index (BMI) of 26.5 ± 1.6 kg/m²) were enrolled in a randomized, double-blind, placebo-controlled trial with parallel-group design. Subjects were randomly allocated into three groups designated as PC (placebo), LD (low-dose, 72 mg-ECP/day) and HD (high-dose, 144 mg-ECP/day). Both LD and HD groups showed significant decreases in BMI, body fat ratio, waist circumference, waist/hip ratio, total cholesterol, low-density lipoprotein (LDL) cholesterol, total cholesterol/high-density lipoprotein (HDL) cholesterol and atherogenic index (AI) after 12 weeks, as compared with the placebo group. The HD group also showed a significant increase in serum HDL cholesterol as compared with the placebo group. Only the HD group showed significant decreases in serum glucose and systolic blood pressure after 12 weeks. There was no significant adverse event related with ingestion of ECP, and serum biochemical and hematological parameters were maintained within normal range during the intervention period. In conclusion, these results demonstrated that ECP supplementation significantly contributed to lowering body fat and serum lipid parameters such as total and LDL cholesterols with dose dependence. Further studies using different populations, dosages or biological markers are highly recommended to better understand the physiological features of this polyphenol.

  10. Effect of a Brown Rice Based Vegan Diet and Conventional Diabetic Diet on Glycemic Control of Patients with Type 2 Diabetes: A 12-Week Randomized Clinical Trial

    PubMed Central

    Lee, Yu-Mi; Kim, Se-A; Lee, In-Kyu; Kim, Jung-Guk; Park, Keun-Gyu; Jeong, Ji-Yun; Jeon, Jae-Han; Shin, Ji-Yeon; Lee, Duk-Hee

    2016-01-01

    Objective Several intervention studies have suggested that vegetarian or vegan diets have clinical benefits, particularly in terms of glycemic control, in patients with type 2 diabetes (T2D); however, no randomized controlled trial has been conducted in Asians who more commonly depend on plant-based foods, as compared to Western populations. Here, we aimed to compare the effect of a vegan diet and conventional diabetic diet on glycemic control among Korean individuals. Materials and Methods Participants diagnosed with T2D were randomly assigned to follow either a vegan diet (excluding animal-based food including fish; n = 46) or a conventional diet recommended by the Korean Diabetes Association 2011 (n = 47) for 12 weeks. HbA1c levels were measured at weeks 0, 4, and 12, and the primary study endpoint was the change in HbA1c levels over 12 weeks. Results The mean HbA1c levels at weeks 0, 4, and 12 were 7.7%, 7.2%, and 7.1% in the vegan group, and 7.4%, 7.2%, and 7.2% in the conventional group, respectively. Although both groups showed significant reductions in HbA1C levels, the reductions were larger in the vegan group than in the conventional group (-0.5% vs. -0.2%; p-for-interaction = 0.017). When only considering participants with high compliance, the difference in HbA1c level reduction between the groups was found to be larger (-0.9% vs. -0.3%). The beneficial effect of vegan diets was noted even after adjusting for changes in total energy intake or waist circumference over the 12 weeks. Conclusion Both diets led to reductions in HbA1c levels; however, glycemic control was better with the vegan diet than with the conventional diet. Thus, the dietary guidelines for patients with T2D should include a vegan diet for the better management and treatment. However, further studies are needed to evaluate the long-term effects of a vegan diet, and to identify potential explanations of the underlying mechanisms. Trial Registration CRiS KCT0001771 PMID:27253526

  11. A 12-week medical exercise therapy program leads to significant improvement in knee function after degenerative meniscectomy: a randomized controlled trial with one year follow-up.

    PubMed

    Østerås, Håvard

    2014-07-01

    There is no consensus in the postoperative rehabilitation regimen for patients who have undergone surgery for medial meniscus damage. The aim of this study was to examine whether it is necessary to undergo postoperative physiotherapy treatment these patients. A prospective randomized controlled clinical trial was performed. 42 participants (26 males, 16 women) were randomly assigned into an exercise group (EG) (n = 22) or a control group (CG) (n = 20). Prognostic variables were similar between the groups at baseline. The EG achieved significantly better outcome effects than the CG at pain (VAS reduced 1.9 in TG and 0.6 in CG, p < 0.01) and function (KOOS decreased 18.0 in TG and only 6.5 in CG, p < 0.01) during the 12 week intervention period. The results after a 12-month follow-up indicated the same results as at posttest 3 months postoperatively. In patients with surgery for degenerative meniscus damage, postoperative medical exercise therapy - as a model of physiotherapy - is an efficient treatment alternative compared to no systematic rehabilitation.

  12. Effects of a 12-Week Hatha Yoga Intervention on Metabolic Risk and Quality of Life in Hong Kong Chinese Adults with and without Metabolic Syndrome

    PubMed Central

    Lau, Caren; Yu, Ruby; Woo, Jean

    2015-01-01

    Objective To determine the efficacy of a 12-week Hatha yoga intervention to improve metabolic risk profiles and health-related quality of life (HRQoL) in Chinese adults with and without metabolic syndrome (MetS). Methods We conducted a controlled trial within an university-affiliated hospital. 173 Chinese men and women aged 18 or above were assigned to either the yoga intervention group (n = 87) or the control group (n = 86). Primary outcomes included 12-week change in metabolic risk factors and MetS z score. Secondary outcome was HRQoL (Medical Outcomes Short Form Survey at 12 weeks). Results The mean age of participants was 52.0 (SD 7.4, range 31-71) years. Analysis involving the entire study population revealed that the yoga group achieved greater decline in waist circumference (p<0.001), fasting glucose (p<0.01), triglycerides (p<0.05), and MetS z score (p<0.01). Yoga training also improved general health perceptions (p<0.01), physical component score (p<0.01), and social functioning (p<0.01) domains score of HRQoL. However, no significant differences between groups were observed in the mean change of systolic/diastolic blood pressures or high-density lipid protein cholesterol (all p>0.05). There were no significant differences in the intervention effects on waist circumference and MetS z score between the MetS subgroups (both p>0.05). Conclusion A 12-week Hatha yoga intervention improves metabolic risk profiles and HRQoL in Chinese adults with and without MetS. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12613000816752 PMID:26111165

  13. Oral Microbiota Shift after 12-Week Supplementation with Lactobacillus reuteri DSM 17938 and PTA 5289; A Randomized Control Trial

    PubMed Central

    Romani Vestman, Nelly; Chen, Tsute; Lif Holgerson, Pernilla; Öhman, Carina; Johansson, Ingegerd

    2015-01-01

    Background Lactobacillus spp. potentially contribute to health by modulating bacterial biofilm formation, but their effects on the overall oral microbiota remain unclear. Methods and Findings Oral microbiota was characterized via 454-pyrosequencing of the 16S rDNA hypervariable region V3-V4 after 12 weeks of daily Lactobacillus reuteri DSM 17938 and PTA 5289 consumption. Forty-four adults were assigned to a test group (n = 22) that received lactobacilli lozenges (108 CFU of each strain/lozenge) or a control group that received placebo (n = 22). Presence of L. reuteri was confirmed by cultivation and species specific PCR. Tooth biofilm samples from 16 adults before, during, and after exposure were analyzed by pyrosequencing. A total of 1,310,292 sequences were quality filtered. After removing single reads, 257 species or phylotypes were identified at 98.5% identity in the Human Oral Microbiome Database. Firmicutes, Bacteroidetes, Fusobacteria, Proteobacteria, and Actinobacteria were the most abundant phyla. Streptococcus was the most common genus and the S. oralis/S. mitis/S. mitis bv2/S. infantis group comprised the dominant species. The number of observed species was unaffected by L. reuteri exposure. However, subjects who had consumed L. reuteri were clustered in a principal coordinates analysis relative to scattering at baseline, and multivariate modeling of pyrosequencing microbiota, and culture and PCR detected L. reuteri separated baseline from 12-week samples in test subjects. L. reuteri intake correlated with increased S. oralis/S. mitis/S. mitis bv2/S. infantis group and Campylobacter concisus, Granulicatella adiacens, Bergeyella sp. HOT322, Neisseria subflava, and SR1 [G-1] sp. HOT874 detection and reduced S. mutans, S. anginosus, N. mucosa, Fusobacterium periodicum, F. nucleatum ss vincentii, and Prevotella maculosa detection. This effect had disappeared 1 month after exposure was terminated. Conclusions L. reuteri consumption did not affect species

  14. Effects of a 12-week intervention period with football and running for habitually active men with mild hypertension.

    PubMed

    Knoepfli-Lenzin, C; Sennhauser, C; Toigo, M; Boutellier, U; Bangsbo, J; Krustrup, P; Junge, A; Dvorak, J

    2010-04-01

    The present study examined the effect of football (F, n=15) training on the health profile of habitually active 25-45-year-old men with mild hypertension and compared it with running (R, n=15) training and no additional activity (controls, C, n=17). The participants in F and R completed a 1-h training session 2.4 times/week for 12 weeks. Systolic and diastolic blood pressure decreased in all groups but the decrease in diastolic blood pressure in F (-9 +/- 5 (+/- SD) mmHg) was higher than that in C (-4 +/- 6 mmHg). F was as effective as R in decreasing body mass (-1.6 +/- 1.8 vs-1.5 +/- 2.1 kg) and total fat mass (-2.0 +/- 1.5 vs -1.6 +/- 1.5 kg) and in increasing supine heart rate variability, whereas no changes were detected for C. Maximal stroke volume improved in F (+13.1%) as well as in R (+10.1%) compared with C (-4.9%). Total cholesterol decreased in F (5.8 +/- 1.2 to 5.5 +/- 0.9 mmol/L) but was not altered in R and C. We conclude that football training, consisting of high-intensity intermittent exercise, results in positive effects on blood pressure, body composition, stroke volume and supine heart rate variability, and elicits at least the same cardiovascular health benefits as continuous running exercise in habitually active men with mild hypertension.

  15. Effect of an integrated community-based package for maternal and newborn care on feeding patterns during the first 12 weeks of life: a cluster-randomized trial in a South African township

    PubMed Central

    Ijumba, Petrida; Doherty, Tanya; Jackson, Debra; Tomlinson, Mark; Sanders, David; Swanevelder, Sonja; Persson, Lars-Åke

    2015-01-01

    Objective To analyse the effect of community-based counselling on feeding patterns during the first 12 weeks after birth, and to study whether the effect differs by maternal HIV status, educational level or household wealth. Design Cluster-randomized trial with fifteen clusters in each arm to evaluate an integrated package providing two pregnancy and five postnatal home visits delivered by community health workers. Infant feeding data were collected using 24 h recall of nineteen food and fluid items. Setting A township near Durban, South Africa. Subjects Pregnant women (1894 intervention and 2243 control) aged 17 yearsor more. Results Twelve weeks after birth, 1629 (intervention) and 1865 (control) mother–infant pairs were available for analysis. Socio-economic conditions differed slightly across intervention groups, which were considered in the analyses. There was no effect on early initiation of breast-feeding. At 12 weeks of age the intervention doubled exclusive breast-feeding (OR=2·29; 95 % CI 1·80, 2·92), increased exclusive formula-feeding (OR=1·70; 95 % CI 1·28, 2·27), increased predominant breast-feeding (OR=1·71; 95 % CI 1·34, 2·19), decreased mixed formula-feeding (OR=0·68; 95 % CI 0·55, 0·83) and decreased mixed breast-feeding (OR=0·54; 95 % CI 0·44, 0·67). The effect on exclusive breast-feeding at 12 weeks was stronger among HIV-negative mothers than HIV-positive mothers (P=0·01), while the effect on mixed formula feeding was significant only among HIV-positive mothers (P=0·03). The effect on exclusive feeding was not different by household wealth or maternal education levels. Conclusions A perinatal intervention package delivered by community health workers was effective in increasing exclusive breast-feeding, exclusive formula feeding and decreasing mixed feeding. PMID:25660465

  16. Effects of a 12-Week Hatha Yoga Intervention on Cardiorespiratory Endurance, Muscular Strength and Endurance, and Flexibility in Hong Kong Chinese Adults: A Controlled Clinical Trial

    PubMed Central

    Lau, Caren; Yu, Ruby; Woo, Jean

    2015-01-01

    Objective. To examine the effects of a 12-week Hatha yoga intervention on cardiorespiratory endurance, muscular strength and endurance, and flexibility in Chinese adults. Methods. 173 adults (aged 52.0 ± 7.5 years) were assigned to either the yoga intervention group (n = 87) or the waitlist control group (n = 86). 19 dropped out from the study. Primary outcomes were changes in cardiorespiratory endurance (resting heart rate (HR) and maximal oxygen uptake (VO2max)), muscular strength and endurance (curl-up and push-up tests), and lower back and hamstring flexibility (the modified back-saver sit-and-reach (MBS) test). Results. Compared to controls, the yoga group achieved significant improvements in VO2max (P < 0.01), curl-up (P < 0.05) and push-up (P < 0.001) tests, and the MBS left and right leg tests (both P < 0.001) in both genders. Significant change was also found for resting HR between groups in women (P < 0.05) but not in men. Further analysis comparing participants between younger and older subgroups yielded similar findings, except that the older participants in the yoga group failed to improve resting HR or the curl-up test versus control. Adherence (89%) and attendance (94%) were high. No serious adverse events occurred. Conclusion. A 12-week Hatha yoga intervention has favorable effects on cardiorespiratory endurance, muscular strength and endurance, and flexibility in Chinese adults. PMID:26167196

  17. Swahili 12 Weeks Course.

    ERIC Educational Resources Information Center

    Defense Language Inst., Washington, DC.

    This 12-weeks course in basic Swahili comprises 55 lesson units in five volumes. The general course format consists of (1) perception drills for comprehension, oral production, and association using "situational picture" illustrations; (2) dialogs in English and Swahili, with cartoon guides; (3) sequenced pattern and recombination drills, and (4)…

  18. Low-dose memantine attenuated methadone dose in opioid-dependent patients: a 12-week double-blind randomized controlled trial.

    PubMed

    Lee, Sheng-Yu; Chen, Shiou-Lan; Chang, Yun-Hsuan; Chen, Po See; Huang, San-Yuan; Tzeng, Nian-Sheng; Wang, Liang-Jen; Lee, I Hui; Wang, Tzu-Yun; Chen, Kao Chin; Yang, Yen Kuang; Hong, Jau-Shyong; Lu, Ru-Band

    2015-05-19

    Low-dose memantine might have anti-inflammatory and neurotrophic effects mechanistically remote from an NMDA receptor. We investigated whether add-on memantine reduced cytokine levels and benefitted patients with opioid dependence undergoing methadone maintenance therapy (MMT) in a randomized, double-blind, controlled 12-week study. Patients were randomly assigned to a group: Memantine (5 mg/day) (n = 53) or Placebo (n = 75). The methadone dose required and retention in treatment were monitored. Plasma tumor necrosis factor (TNF)-α, C-reactive protein (CRP), interleukin (IL)-6, IL-8, transforming growth factor (TGF)-β1, and brain-derived neurotrophic factor (BDNF) levels were examined during weeks 0, 1, 4, 8, and 12. General linear mixed models were used to examine therapeutic effect. After 12 weeks, Memantine-group required a somewhat lower methadone dose than did Placebo-group (P = 0.039). They also had significantly lower plasma TNF-α and significantly higher TGF-β1 levels. We provide evidence of the benefit of add-on memantine in opioid dependent patients undergoing MMT.

  19. Improvement in subjective and objective neurocognitive functions in patients with major depressive disorder: a 12-week, multicenter, randomized trial of tianeptine versus escitalopram, the CAMPION study.

    PubMed

    Jeon, Hong Jin; Woo, Jong-Min; Lee, Seung-Hwan; Kim, Eui-Joong; Chung, Seockhoon; Ha, Jee Hyun; Fava, Maurizio; Mischoulon, David; Kim, Ji-Hae; Heo, Jung-Yoon; Yu, Bum-Hee

    2014-04-01

    Although many patients with major depressive disorder (MDD) complain of neurocognitive impairment, the effects of antidepressant medications on neurocognitive functions remain unclear. This study compares neurocognitive effects of tianeptine and escitalopram in MDD. Patients with MDD (N = 164) were randomly assigned in a 1:1 ratio to either tianeptine (37.5 mg/d) or escitalopram (10 mg/d) for 12 weeks. Outcome measures included clinical improvement, subjective cognitive impairment on memory and concentration, the Mini-Mental State Examination, the Continuous Performance Test, the Verbal Learning Test, and the Raven Progressive Matrices, assessed every 4 weeks. After 12 weeks, the tianeptine group showed significant improvement in commission errors (P = 0.002), verbal immediate memory (P < 0.0001), Mini-Mental State Examination (P < 0.0001), delayed memory (P < 0.0001), and reasoning ability (P = 0.0010), whereas the escitalopram group improved in delayed memory and reasoning ability but not in the other measures. Both groups significantly improved in subjective cognitive impairment in memory (P < 0.0001) and concentration (P < 0.0001). Mixed effects model repeated measures analyses revealed that the tianeptine group had a significant improvement in scores of commission errors (F = 6.64, P = 0.011) and verbal immediate memory (F = 4.39, P = 0.038) from baseline to 12 weeks, compared with the escitalopram group, after controlling for age, sex, education years, baseline scores, and changes of depression severity. The treatment of MDD with tianeptine led to more improvements in neurocognitive functions, especially in commission errors and verbal immediate memory, compared with escitalopram, after controlling for changes in depression severity. Both drugs improved subjective cognitive impairment of memory and concentration.

  20. Improvement in subjective and objective neurocognitive functions in patients with major depressive disorder: a 12-week, multicenter, randomized trial of tianeptine versus escitalopram, the CAMPION study.

    PubMed

    Jeon, Hong Jin; Woo, Jong-Min; Lee, Seung-Hwan; Kim, Eui-Joong; Chung, Seockhoon; Ha, Jee Hyun; Fava, Maurizio; Mischoulon, David; Kim, Ji-Hae; Heo, Jung-Yoon; Yu, Bum-Hee

    2014-04-01

    Although many patients with major depressive disorder (MDD) complain of neurocognitive impairment, the effects of antidepressant medications on neurocognitive functions remain unclear. This study compares neurocognitive effects of tianeptine and escitalopram in MDD. Patients with MDD (N = 164) were randomly assigned in a 1:1 ratio to either tianeptine (37.5 mg/d) or escitalopram (10 mg/d) for 12 weeks. Outcome measures included clinical improvement, subjective cognitive impairment on memory and concentration, the Mini-Mental State Examination, the Continuous Performance Test, the Verbal Learning Test, and the Raven Progressive Matrices, assessed every 4 weeks. After 12 weeks, the tianeptine group showed significant improvement in commission errors (P = 0.002), verbal immediate memory (P < 0.0001), Mini-Mental State Examination (P < 0.0001), delayed memory (P < 0.0001), and reasoning ability (P = 0.0010), whereas the escitalopram group improved in delayed memory and reasoning ability but not in the other measures. Both groups significantly improved in subjective cognitive impairment in memory (P < 0.0001) and concentration (P < 0.0001). Mixed effects model repeated measures analyses revealed that the tianeptine group had a significant improvement in scores of commission errors (F = 6.64, P = 0.011) and verbal immediate memory (F = 4.39, P = 0.038) from baseline to 12 weeks, compared with the escitalopram group, after controlling for age, sex, education years, baseline scores, and changes of depression severity. The treatment of MDD with tianeptine led to more improvements in neurocognitive functions, especially in commission errors and verbal immediate memory, compared with escitalopram, after controlling for changes in depression severity. Both drugs improved subjective cognitive impairment of memory and concentration. PMID:24525660

  1. Bimatoprost 0.01% or 0.03% in patients with glaucoma or ocular hypertension previously treated with latanoprost: two randomized 12-week trials

    PubMed Central

    Myers, Jonathan S; Vold, Steven; Zaman, Fiaz; Williams, Julia M; Hollander, David A

    2014-01-01

    Background The purpose of this study was to evaluate the intraocular pressure (IOP)-lowering efficacy and safety of bimatoprost 0.01% or 0.03% as monotherapy in patients treated with latanoprost 0.005% monotherapy who require additional IOP lowering for their ocular hypertension or open-angle glaucoma. Methods Two prospective, investigator-masked, randomized, parallel-group, multicenter studies enrolled patients with baseline IOP ≥20 mmHg after ≥30 days of latanoprost 0.005% monotherapy. Patients were randomized to 12 weeks of study treatment (study 1, bimatoprost 0.01% once daily or bimatoprost 0.01% once daily plus brimonidine 0.1% three times daily; study 2, bimatoprost 0.03% once daily or bimatoprost 0.03% once daily plus fixed-combination brimonidine 0.2%/timolol 0.5% twice daily). Patient evaluations at weeks 4 and 12 included IOP at 8 am, 10 am, and 4 pm and safety assessments. Results in the monotherapy study arms (bimatoprost 0.01% or 0.03%) are presented. Results Latanoprost-treated baseline mean diurnal IOP (± standard error of the mean) was 22.2±0.3 mmHg and 22.1±0.4 mmHg in the bimatoprost 0.01% and bimatoprost 0.03% treatment arms, respectively (P=0.957). In both treatment arms, mean (± standard error of the mean) reduction in IOP from latanoprost-treated baseline was statistically significant at each time point at both follow-up visits (P<0.001), ranging from 3.7±0.4 (17.0%) mmHg to 4.4±0.4 (19.9%) mmHg with bimatoprost 0.01% and from 2.8±0.5 (12.8%) mmHg to 3.9±0.5 (16.7%) mmHg with bimatoprost 0.03%. Mean percentage IOP reduction from latanoprost-treated baseline was numerically greater with bimatoprost 0.01% than with bimatoprost 0.03% throughout follow-up. The incidence of conjunctival hyperemia of mild or greater severity increased from latanoprost baseline after 12 weeks of treatment only in the bimatoprost 0.03% treatment arm. Conclusion Many patients who do not reach their target IOP on latanoprost can achieve additional IOP

  2. Effectiveness and tissue compatibility of a 12-week treatment of chronic venous leg ulcers with an octenidine based antiseptic--a randomized, double-blind controlled study.

    PubMed

    Vanscheidt, Wolfgang; Harding, Keith; Téot, Luc; Siebert, Jörg

    2012-06-01

    The aim of this study was to evaluate the cytotoxic effect of octenidine dihydrochloride/phenoxyethanol (OHP) found in vitro by conducting a randomized, double-blind controlled clinical study focusing on its safe and effective use in chronic venous leg ulcers. In total, 126 male and female patients were treated with either OHP (n = 60) or Ringer solution (n = 66). The treatment lasted over a period of maximum 12 weeks. For the assessment of the wound-healing process, clinical outcome parameters were employed, that is, time span until 100% epithelization, wound status and the wound surface area were analysed. Side effects were recorded during the study period. The median time to complete ulcer healing was comparable between the OHP and Ringer solution groups (92 versus 87 days; P = 0·952), without being influenced by wound size or duration of the target ulcer (P-values: 0·947/0·978). In patients treated with OHP, fewer adverse events (AEs) were observed compared with the Ringer group (17% versus 29% of patients reported 20 versus 38 AEs). OHP is well suitable for the treatment of chronic wounds without cytotoxic effects. Furthermore, OHP does not impair the wound healing in chronic venous ulcers.

  3. The effect of 12 weeks Anethum graveolens (dill) on metabolic markers in patients with metabolic syndrome; a randomized double blind controlled trial

    PubMed Central

    2012-01-01

    Background The clustering of metabolic abnormalities defined as metabolic syndrome is now both a public health and a clinical problem .While interest in herbal medicine has greatly increased, lack of human evidence to support efficacies shown in animals does exist. This clinical trial study designed to investigate whether herbal medicine, Anethum graveolens (dill) extract, could improve metabolic components in patients with metabolic syndrome. Methods A double-blind, randomized, placebo-controlled trial using a parallel design was conducted. 24 subjects who had metabolic syndrome diagnostic criteria (update of ATP III) were randomly assigned to either dill extract (n = 12) or placebo (n = 12) for 3 months. Results Across lipid component of metabolic syndrome, no significant differences in triglyceride (TG) concentration and high density lipoprotein cholesterol were seen between the two groups. However TG improved significantly from baseline (257.0 vs. 201.5p = 0.01) with dill treatment but such a significant effect was not observed in placebo group. Moreover, no significant differences in waist circumference, blood pressure and fasting blood sugar were seen between two groups after 3 months follow up period. Conclusion In this small clinical trial in patients with metabolic syndrome, 12 weeks of dill extract treatment had a beneficial effect in terms of reducing TG from baseline. However dill treatment was not associated with a significant improvement in metabolic syndrome related markers compared to control group. Larger studies might be required to prove the efficacy and safety of long-term administration of dill to resolve metabolic syndrome components. PMID:23351341

  4. Onion peel extract reduces the percentage of body fat in overweight and obese subjects: a 12-week, randomized, double-blind, placebo-controlled study

    PubMed Central

    Lee, Ji-Sook; Cha, Yong-Jun; Lee, Kyung-Hea

    2016-01-01

    BACKGROUND/OBJECTIVES The anti-obesity effect of quercetin-rich onion peel extract (OPE) was suggested in rats, but information from human studies is limited. This study aimed to investigate the effects of OPE on the body composition of overweight and obese subjects. MATERIALS/METHODS In this 12-week, randomized, double-blind, placebo-controlled study, parallel clinical trials were performed in overweight and obese Korean subjects. Randomly assigned subjects were instructed to take daily either the placebo (male, 6 and female, 30) or OPE capsules containing 100 mg of quercetin (male, 5 and female, 31). Body composition was measured by using bioimpedance and dual-energy X-ray absorptiometry (DXA). Resting energy expenditure (REE) and respiratory quotient (RQ) were evaluated by using indirect calorie measurement methods. Fasting blood levels of glucose, insulin, lipids, and leptin were determined. RESULTS Quercetin-rich OPE supplementation significantly reduced the weight and percentage of body fat as measured by DXA (P = 0.02). These effects were not shown in the control group. Levels of blood glucose (P = 0.04) and leptin (P = 0.001 for placebo, P = 0.002 for OPE) decreased in both groups. Significant increases in REE and RQ were observed in both groups (P = 0.003 for placebo, P = 0.006 for OPE) and in the OPE group alone (P = 0.02), respectively. CONCLUSIONS Quercetin-rich OPE supplementation changed the body composition of the overweight and obese subjects. This result suggests a beneficial role of the anti-obesity effect of OPE human subjects. PMID:27087901

  5. A Pilot Study Exploring the Effects of a 12-Week T'ai Chi Intervention on Somatic Symptoms of Depression in Patients with Heart Failure

    PubMed Central

    Tsuang, Ming; Rusiewicz, Anna; Pandzic, Ines; Cammarata, Stephanie; Rutledge, Thomas; Hong, Suzi; Linke, Sarah; Mills, Paul J.

    2012-01-01

    Abstract Background Patients with chronic heart failure (HF) and with elevated depression symptoms are at greater risk of morbidity and mortality. Somatic symptoms of depression are particularly prevalent in HF and are related to worse disease prognosis. T'ai chi practice is related to increased emotional well-being in various clinical populations; however, relatively little is known about t'ai chi's effects on somatic versus cognitive symptom dimensions of depression in HF. Purpose The objective of the study was to measure whether a t'ai chi intervention effectively reduces somatic and/or cognitive symptoms of depression in patients with HF. Methods Patients with HF were assigned to either t'ai chi training (n=16) or a usual-care group (n=12). At baseline and after the 12-week intervention period, participants were evaluated for changes in depressive symptoms using Beck Depression Inventory (BDI) total scores (BDI-t) and subcategorized scores of BDI-somatic (BDI-s) and BDI-cognitive (BDI-c), and for symptoms of fatigue using the Multidimensional Fatigue Symptom Inventory–Short Form. Results Patients with HF in the t'ai chi group compared to the usual-care group had reduced BDI-s (p≤0.017), but not BDI-c (p=0.50) scores from pre- to postintervention. Although t'ai chi did not significantly reduce fatigue, changes in physical fatigue (p≤0.05) were independently associated with changes in BDI-t scores. Conclusions T'ai chi practice reduced somatic symptoms of depression, which have been linked to worse prognosis in HF. Reductions in fatigue appear to explain some but not all of the reductions in somatic symptoms of depression. PMID:22845485

  6. Efficacy and safety of tofacitinib as monotherapy in Japanese patients with active rheumatoid arthritis: a 12-week, randomized, phase 2 study

    PubMed Central

    Tanaka, Yoshiya; Takeuchi, Tsutomu; Yamanaka, Hisashi; Nakamura, Hiroyuki; Toyoizumi, Shigeyuki; Zwillich, Samuel

    2015-01-01

    Abstract Objectives. To evaluate oral tofacitinib versus placebo for treatment of active rheumatoid arthritis in Japanese patients with inadequate response to disease-modifying antirheumatic drugs. Methods. In this double-blind, placebo-controlled, randomized, parallel-group, 12-week, phase 2 study (clinicaltrials.gov NCT00687193), 317 patients received tofacitinib: 1, 3, 5, 10, or 15 mg as monotherapy or placebo twice daily (BID). Primary endpoint: response rate by American College of Rheumatology (ACR) ≥ 20% improvement criteria (ACR20) at week 12. Results. ACR20 response rates: 37.7% (20/53), 67.9% (36/53), 73.1% (38/52), 84.9% (45/53), and 90.7% (49/54) with tofacitinib: 1, 3, 5, 10, and 15 mg BID, respectively, versus 15.4% (8/52) with placebo (p < 0.01; all doses). Dose-dependent ACR20 responses with tofacitinib versus placebo occurred from week 2 onward (p < 0.05). Changes from baseline in 28-joint disease activity score using erythrocyte sedimentation rate improved with tofacitinib versus placebo from week 4 (p < 0.01; all doses). Six tofacitinib patients experienced treatment-related serious adverse events (AEs). Most common treatment-emergent AEs: nasopharyngitis (10% vs 12%) and hyperlipidemia (5% vs 0%). Serum creatinine, hemoglobin, and total-, low-, and high-density lipoprotein-cholesterol levels increased with tofacitinib. Conclusions. Tofacitinib produced dose-dependent ACR20 responses and reduced disease activity. The safety profile was consistent with that reported from global monotherapy trials. PMID:25496464

  7. Differences between men and women in dietary intakes and metabolic profile in response to a 12-week nutritional intervention promoting the Mediterranean diet.

    PubMed

    Leblanc, Vicky; Hudon, Anne-Marie; Royer, Marie-Michelle; Corneau, Louise; Dodin, Sylvie; Bégin, Catherine; Lemieux, Simone

    2015-01-01

    Few studies have compared men and women in response to nutritional interventions but none has assessed differences between men and women in the response to a nutritional intervention programme based on the self-determination theory (SDT) and using the Mediterranean diet (MedDiet) as a model of healthy eating, in a context of CVD prevention and within a non-Mediterranean population. The present study aimed to document differences between men and women in changes in dietary, anthropometric and metabolic variables, in response to a nutritional intervention programme promoting the adoption of the MedDiet and based on the SDT. A total of sixty-four men and fifty-nine premenopausal women presenting risk factors for CVD were recruited through different media advertisements in the Québec City Metropolitan area (Canada). The 12-week nutritional programme used a motivational interviewing approach and included individual and group sessions. A validated FFQ was administered to evaluate dietary intakes from which a Mediterranean score (Medscore) was derived. Both men and women significantly increased their Medscore in response to the intervention (P < 0·0001). Men showed a significantly greater decrease in red and processed meat (-0·4 (95 % CI -0·7, -0·1) portions per d) and a greater increase in fruit (0·9 (95 % CI 0·2, 1·6) portions per d) intakes than women. Significant decreases were observed for BMI and waist circumference in both men and women (P ≤ 0·04). Significant greater decreases were found for total cholesterol (total-C):HDL-cholesterol (HDL-C) (-0·2; 95 % CI -0·4, -0·03) and TAG:HDL-C (-0·2; 95 % CI -0·4, -0·04) ratios in men than in women. When adjusting for the baseline value of the response variable, differences between men and women became non-significant for red and processed meat and fruit intakes whereas significant differences between men and women (i.e. larger increases in men than women) were observed for legumes, nuts and seeds (0·6

  8. Differences between men and women in dietary intakes and metabolic profile in response to a 12-week nutritional intervention promoting the Mediterranean diet.

    PubMed

    Leblanc, Vicky; Hudon, Anne-Marie; Royer, Marie-Michelle; Corneau, Louise; Dodin, Sylvie; Bégin, Catherine; Lemieux, Simone

    2015-01-01

    Few studies have compared men and women in response to nutritional interventions but none has assessed differences between men and women in the response to a nutritional intervention programme based on the self-determination theory (SDT) and using the Mediterranean diet (MedDiet) as a model of healthy eating, in a context of CVD prevention and within a non-Mediterranean population. The present study aimed to document differences between men and women in changes in dietary, anthropometric and metabolic variables, in response to a nutritional intervention programme promoting the adoption of the MedDiet and based on the SDT. A total of sixty-four men and fifty-nine premenopausal women presenting risk factors for CVD were recruited through different media advertisements in the Québec City Metropolitan area (Canada). The 12-week nutritional programme used a motivational interviewing approach and included individual and group sessions. A validated FFQ was administered to evaluate dietary intakes from which a Mediterranean score (Medscore) was derived. Both men and women significantly increased their Medscore in response to the intervention (P < 0·0001). Men showed a significantly greater decrease in red and processed meat (-0·4 (95 % CI -0·7, -0·1) portions per d) and a greater increase in fruit (0·9 (95 % CI 0·2, 1·6) portions per d) intakes than women. Significant decreases were observed for BMI and waist circumference in both men and women (P ≤ 0·04). Significant greater decreases were found for total cholesterol (total-C):HDL-cholesterol (HDL-C) (-0·2; 95 % CI -0·4, -0·03) and TAG:HDL-C (-0·2; 95 % CI -0·4, -0·04) ratios in men than in women. When adjusting for the baseline value of the response variable, differences between men and women became non-significant for red and processed meat and fruit intakes whereas significant differences between men and women (i.e. larger increases in men than women) were observed for legumes, nuts and seeds (0·6

  9. Effect of ginger powder supplementation on nitric oxide and C-reactive protein in elderly knee osteoarthritis patients: A 12-week double-blind randomized placebo-controlled clinical trial.

    PubMed

    Naderi, Zahra; Mozaffari-Khosravi, Hassan; Dehghan, Ali; Nadjarzadeh, Azadeh; Huseini, Hassan Fallah

    2016-07-01

    There is limited evidence that ginger ( shēng jiāng) powder consumption can relieve pain and inflammation because of its special phytochemical properties. This study is aimed at investigating the effect of ginger powder supplementation on some inflammatory markers in patients suffering from knee osteoarthritis. This is a double-blind randomized placebo-controlled clinical trial with a follow-up period of 3 months that was conducted on 120 outpatients with moderately painful knee osteoarthritis. Patients were randomly divided up into two groups: ginger group (GG) or placebo group (PG). Both groups received two identical capsules on a daily basis for 3 months. Each ginger capsule contained 500 mg of ginger powder; the placebo capsules had 500 mg of starch in them. Serum samples were collected prior to and after the intervention and were stored at -70 °C until the end of the study. Serum concentration of nitric oxide (NO) and hs-C reactive protein (hs-CRP) were measured using enzyme-linked immunosorbent assay kits. There was no significant difference between the two groups in terms of inflammatory markers (i.e., NO and hs-CRP) prior to the intervention. However, after 3 months of supplementation, serum concentration of NO and hs-CRP decreased in the GG. After 12 weeks, the concentration of these markers declined more in the GG than in the PG. Ginger powder supplementation at a dose of 1 g/d can reduce inflammatory markers in patients with knee osteoarthritis, and it thus can be recommended as a suitable supplement for these patients. PMID:27419081

  10. Portuguese Special Course: 12 Weeks.

    ERIC Educational Resources Information Center

    Defense Language Inst., Washington, DC.

    This 12-week course in beginning Portuguese comprises four volumes of student text (Lessons 1-55) and a fifth volume of Portuguese-English/English-Portuguese vocabulary. Lesson materials consist of basic dialogs with English translation, recombination dialogs, readings and comprehension questions, oral exercises, and in later units, additional…

  11. Doenjang, a Korean fermented soy food, exerts antiobesity and antioxidative activities in overweight subjects with the PPAR-γ2 C1431T polymorphism: 12-week, double-blind randomized clinical trial.

    PubMed

    Cha, Youn-Soo; Park, Yongsoon; Lee, Myoungsook; Chae, Soo-Wan; Park, Kungmin; Kim, Yeonsoo; Lee, Haeng-Shin

    2014-01-01

    We examined the antiobesity and antioxidant effects of supplementation with doenjang, a fermented soybean paste, in overweight Koreans with the PPAR-γ2 C1431T polymorphism. Sixty overweight subjects were randomly assigned to consume either 9.8 g/day of doenjang or placebo for 12 weeks. Before and after the intervention, anthropometric and metabolic parameters, along with abdominal fat distribution and PPAR-γ2 polymorphisms, were measured. Fifty-one subjects completed the study, doenjang (n=26) and placebo (n=25) groups. Relative frequencies of the PPAR-γ2 genotypes CC, TC, and TT were 70% (n=41), 25.9% (15), and 3.4% (2), whereas those of the PPAR-γ2 alleles C and T were 81.6% and 18.4%. Visceral fat area (VFA) was significantly decreased by doenjang supplementation in subjects with a mutant T allele of PPAR-γ2 compared to those with a C allele after adjusting for age, sex, and body mass index. Plasma free fatty acid, insulin, and homeostatic model assessment insulin resistance (HOMA-IR) levels were also significantly increased in the doenjang group. Doenjang pills significantly activated radical clearance capacity (ORAC and DNA tail length) in subjects with the C allele. The catalase (CAT) activity was increased twofold in the doenjang-treated group with the C allele, but this phenomenon was reversed in those with the T allele. Doenjang-treated subjects tended to have low dietary carbohydrate and sodium intakes compared with those given placebo. We found that doenjang supplementation decreased visceral fat accumulation and aging most effectively in subjects with PPAR-γ polymorphisms. This study suggests that doenjang has antiobesity and antioxidative effects in overweight individuals with mutant alleles of PPAR-γ2. PMID:24456362

  12. Efficacy and safety of canagliflozin in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, 12-week study†

    PubMed Central

    Inagaki, N; Kondo, K; Yoshinari, T; Maruyama, N; Susuta, Y; Kuki, H

    2013-01-01

    Aims We examined the efficacy, safety and tolerability of canagliflozin, a sodium glucose co-transporter 2 inhibitor, in Japanese patients with type 2 diabetes (T2DM) undergoing diet and exercise therapy. Methods Patients aged 20–80 years with T2DM diagnosed ≥3 months previously, and HbA1c of 6.9–9.9% were randomized to 50, 100, 200 or 300 mg canagliflozin or placebo once daily for 12 weeks. The primary and secondary endpoints were changes in HbA1c, fasting plasma glucose (FPG), urinary glucose/creatinine and postprandial glycaemic parameters following a meal test. The safety assessments included adverse events (AEs) and clinical laboratory tests. Results Overall, 383 patients were randomized to receive either placebo (n = 75), or 50 mg (n = 82), 100 mg (n = 74), 200 mg (n = 77) or 300 mg canagliflozin (n = 75). At week 12, significant reductions in HbA1c were observed in all canagliflozin groups relative to placebo (−0.61, –0.80, –0.79 and −0.88% for 50, 100, 200 and 300 mg, respectively, versus +0.11% for placebo; all, p < 0.01). FPG and postprandial glycaemic parameters improved significantly in the canagliflozin groups. Body weight was significantly decreased by canagliflozin. No deaths or drug-related serious AEs were reported. There was no dose-dependent increase in the incidence of AEs in the canagliflozin groups. The incidence of hypoglycaemia was low; episodes were not severe or dose dependent. Canagliflozin did not affect serum creatinine levels or the urinary albumin/creatinine ratio. Conclusions Treatment with canagliflozin for 12 weeks significantly improved glycaemic control and reduced body weight in Japanese patients with T2DM. Canagliflozin was well tolerated. PMID:23782594

  13. Implementation of a 12-week disease management program improved clinical outcomes and quality of life in adults with asthma in a rural district hospital: pre- and post-intervention study.

    PubMed

    Chamnan, Parinya; Boonlert, Kittipa; Pasi, Wanit; Yodsiri, Songkran; Pong-on, Sirinya; Khansa, Bhoonsab; Yongkulwanitchanan, Pichapat

    2010-03-01

    Despite the availability of effective medical treatment and disease management guidelines, asthma remains a poorly controlled disease in developing countries. There is little evidence of the effectiveness of disease management guidelines in rural clinical practice. The effect of disease management guidelines on clinical outcomes and quality of life in asthmatic patients in a rural community hospital was examined. Fifty-seven patients aged > or = 16 years with physician-diagnosed asthma from a hospital outpatient clinic in Ubon-ratchathani, Thailand, were recruited. Asthma diagnosis was confirmed by reviewing clinical records. We implemented a 12-week disease management program, including the use of written asthma treatment plan and asthma action plan tailored to individual patients. Using one-group pre- and post-intervention design, we compared the average number of emergency visits and hospitalizations from acute asthmatic attacks before and after the implementation of interventions using the Wilcoxon matched-pairs signed-rank test. We also compared patient's asthma quality of life (AQL) scores, measured using the 7-point scaled Mini Asthma Quality of Life Questionnaire. It was found that among the 57 patients, 38 (67%) were women, and the mean age (SD) of the patients was 47.6 (17.0) years. Sixteen patients (28%) had a family history of asthma. Emergency visits decreased from 0.48 (SD = 0.83) per patient before implementation of interventions to 0.11 (0.37) per patient after implementation of interventions (p = 0.003). Hospitalizations with acute asthma attacks reduced from 0.14 (0.35) per patient to 0.04 (0.27) per patient (p = 0.034). Overall AQL scores increased significantly from 3.7 to 5.4 (p < 0.001), with most improvement observed in symptoms and emotions. It was concluded that implementation of a 12-week asthma disease management program could reduce emergency visits and hospitalizations, and improve patients' quality of life in a rural practice setting.

  14. Cardiovascular, renal and gastrointestinal effects of incretin-based therapies: an acute and 12-week randomised, double-blind, placebo-controlled, mechanistic intervention trial in type 2 diabetes

    PubMed Central

    Smits, Mark M; Tonneijck, Lennart; Muskiet, Marcel H A; Hoekstra, Trynke; Kramer, Mark H H; Pieters, Indra C; Cahen, Djuna L; Diamant, Michaela; van Raalte, Daniël H

    2015-01-01

    Introduction Incretin-based therapies, that is, glucagon-like peptide (GLP)-1 receptor agonists and dipeptidyl peptidase (DPP)-4 inhibitors, are relatively novel antihyperglycaemic drugs that are frequently used in type 2 diabetes management. Apart from glucose-lowering, these agents exhibit pleiotropic actions that may have favourable and unfavourable clinical consequences. Incretin-based therapies have been associated with heart rate acceleration, heart failure, acute renal failure and acute pancreatitis. Conversely, these agents may reduce blood pressure, glomerular hyperfiltration, albuminuria and hepatic steatosis. While large-sized cardiovascular safety trials can potentially identify the clinical significance of some of these pleiotropic actions, small-sized mechanistic studies are important to understand the (patho)physiological rationale of these findings. The current protocol describes a mechanistic study to assess cardiovascular, renal and gastrointestinal effects, and mechanisms of incretin-based therapies in type 2 diabetes. Methods and analyses 60 patients with type 2 diabetes will undergo acute and prolonged randomised, double-blind, intervention studies. The acute intervention will consist of intravenous administration of the GLP-1 receptor agonist exenatide or placebo. For the prolonged intervention, patients will be randomised to 12-week treatment with the GLP-1 receptor agonist liraglutide, the DPP-4 inhibitor sitagliptin or matching placebos. For each examined organ system, a primary end point is defined. Primary cardiovascular end point is change in resting heart rate variability assessed by beat-to-beat heart rate monitor and spectral analyses software. Primary renal end point is change in glomerular filtration rate assessed by the classic inulin clearance methodology. Primary gastrointestinal end points are change in pancreatic exocrine function assessed by MRI-techniques (acute intervention) and faecal elastase-1 levels (12-week intervention

  15. Protocol: the effect of 12 weeks of Tai Chi practice on anxiety in healthy but stressed people compared to exercise and wait-list comparison groups: a randomized controlled trial.

    PubMed

    Zheng, Shuai; Lal, Sara; Meier, Peter; Sibbritt, David; Zaslawski, Chris

    2014-06-01

    Stress is a major problem in today's fast-paced society and can lead to serious psychosomatic complications. The ancient Chinese mind-body exercise of Tai Chi may provide an alternative and self-sustaining option to pharmaceutical medication for stressed individuals to improve their coping mechanisms. The protocol of this study is designed to evaluate whether Tai Chi practice is equivalent to standard exercise and whether the Tai Chi group is superior to a wait-list control group in improving stress coping levels. This study is a 6-week, three-arm, parallel, randomized, clinical trial designed to evaluate Tai Chi practice against standard exercise and a Tai Chi group against a nonactive control group over a period of 6 weeks with a 6-week follow-up. A total of 72 healthy adult participants (aged 18-60 years) who are either Tai Chi naïve or have not practiced Tai Chi in the past 12 months will be randomized into a Tai Chi group (n = 24), an exercise group (n = 24) or a wait-list group (n = 24). The primary outcome measure will be the State Trait Anxiety Inventory with secondary outcome measures being the Perceived Stress Scale 14, heart rate variability, blood pressure, Short Form 36 and a visual analog scale. The protocol is reported using the appropriate Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) items.

  16. Augmenting Psychoeducation with a Mobile Intervention for Bipolar Disorder: A Randomized Controlled Trial

    PubMed Central

    Depp, Colin A; Ceglowski, Jenni; Wang, Vicki C; Yaghouti, Faraz; Mausbach, Brent T; Thompson, Wesley K; Granholm, Eric L

    2014-01-01

    Background Psychosocial interventions for bipolar disorder are frequently unavailable and resource intensive. Mobile technology may improve access to evidence-based interventions and may increase their efficacy. We evaluated the feasibility, acceptability and efficacy of an augmentative mobile ecological momentary intervention targeting self-management of mood symptoms. Methods This was a randomized single-blind controlled trial with 82 consumers diagnosed with bipolar disorder who completed a four-session psychoeducational intervention and were assigned to 10 weeks of either: 1) mobile device delivered interactive intervention linking patient-reported mood states with personalized self-management strategies, or 2) paper-and-pencil mood monitoring. Participants were assessed at baseline, 6 weeks (mid-point), 12 weeks (post-treatment), and 24 weeks (follow up) with clinician-rated depression and mania scales and self-reported functioning. Results Retention at 12 weeks was 93% and both conditions were associated with high satisfaction. Compared to the paper-and-pencil condition, participants in the augmented mobile intervention condition showed significantly greater reductions in depressive symptoms at 6 and 12 weeks (Cohen's d for both were d=0.48). However, these effects were not maintained at 24-week follow up. Conditions did not differ significantly in the impact on manic symptoms or functional impairment. Limitations This was not a definitive trial and was not powered to detect moderators and mediators. Conclusions Automated mobile-phone intervention is feasible, acceptable, and may enhance the impact of brief psychoeducation on depressive symptoms in bipolar disorder. However, sustainment of gains from symptom self-management mobile interventions, once stopped, may be limited. PMID:25479050

  17. Effects of a Brief Early Start Denver Model (ESDM)-Based Parent Intervention on Toddlers at Risk for Autism Spectrum Disorders: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Rogers, Sally J.; Estes, Annette; Lord, Catherine; Vismara, Laurie; Winter, Jamie; Fitzpatrick, Annette; Guo, Mengye; Dawson, Geraldine

    2012-01-01

    Objective: This study was carried out to examine the efficacy of a 12-week, low-intensity (1-hour/wk of therapist contact), parent-delivered intervention for toddlers at risk for autism spectrum disorders (ASD) aged 14 to 24 months and their families. Method: A randomized controlled trial involving 98 children and families was carried out in three…

  18. Web-based Intervention to Promote Physical Activity by Sedentary Older Adults: Randomized Controlled Trial

    PubMed Central

    Gelatt, Vicky A; Seeley, John R; Macfarlane, Pamela; Gau, Jeff M

    2013-01-01

    Background Physical activity (PA) for older adults has well-documented physical and cognitive benefits, but most seniors do not meet recommended guidelines for PA, and interventions are lacking. Objectives This study evaluated the efficacy of a 12-week Internet intervention to help sedentary older adults over 55 years of age adopt and maintain an exercise regimen. Methods A total of 368 sedentary men and women (M=60.3; SD 4.9) were recruited, screened, and assessed online. They were randomized into treatment and control groups and assessed at pretest, at 12 weeks, and at 6 months. After treatment group participants rated their fitness level, activity goals, and barriers to exercise, the Internet intervention program helped them select exercise activities in the areas of endurance, flexibility, strengthening, and balance enhancement. They returned to the program weekly for automated video and text support and education, with the option to change or increase their exercise plan. The program also included ongoing problem solving to overcome user-identified barriers to exercise. Results The multivariate model indicated significant treatment effects at posttest (P=.001; large effect size) and at 6 months (P=.001; medium effect size). At posttest, intervention participation showed significant improvement on 13 of 14 outcome measures compared to the control participants. At 6 months, treatment participants maintained large gains compared to the control participants on all 14 outcome measures. Conclusions These results suggest that an online PA program has the potential to positively impact the physical activity of sedentary older adult participants. More research is needed to replicate the study results, which were based on self-report measures. Research is also needed on intervention effects with older populations. PMID:23470322

  19. Happy Family Kitchen II: A Cluster Randomized Controlled Trial of a Community-Based Family Intervention for Enhancing Family Communication and Well-being in Hong Kong.

    PubMed

    Ho, Henry C Y; Mui, Moses; Wan, Alice; Ng, Yin-Lam; Stewart, Sunita M; Yew, Carol; Lam, Tai Hing; Chan, Sophia S

    2016-01-01

    Long working hours and stressful urban lifestyles pose major challenges to family communication and well-being in Hong Kong. A community-based family intervention derived from a positive psychology framework, by using cooking and dining as a platform, was developed for improving family communication and well-being. Social workers and teachers from 31 social service units and schools in collaboration with an academic partner organized and conducted the intervention programs for 2,070 individuals from 973 families in a deprived district in Hong Kong. The participants were randomly assigned into the intervention or control group in a cluster randomized controlled trial (cRCT). The core intervention covered one of five positive psychology themes: joy, gratitude, flow, savoring, and listening. Assessments at pre-intervention, immediate post-intervention, and 4 and 12 weeks post-intervention showed improved family communication and well-being with sustainable effects up to 12 weeks. Positive changes in family happiness and family health were greater in the intervention group than in the control group. The savoring intervention had the most improved outcomes among the five themes. We concluded that this large-scale brief cRCT developed and conducted in real-world settings provided evidence for the feasibility and effectiveness of a community-based family intervention. This study was registered under ClinicalTrials.gov (NCT01796275). PMID:27199864

  20. Happy Family Kitchen II: A Cluster Randomized Controlled Trial of a Community-Based Family Intervention for Enhancing Family Communication and Well-being in Hong Kong

    PubMed Central

    Ho, Henry C. Y.; Mui, Moses; Wan, Alice; Ng, Yin-Lam; Stewart, Sunita M.; Yew, Carol; Lam, Tai Hing; Chan, Sophia S.

    2016-01-01

    Long working hours and stressful urban lifestyles pose major challenges to family communication and well-being in Hong Kong. A community-based family intervention derived from a positive psychology framework, by using cooking and dining as a platform, was developed for improving family communication and well-being. Social workers and teachers from 31 social service units and schools in collaboration with an academic partner organized and conducted the intervention programs for 2,070 individuals from 973 families in a deprived district in Hong Kong. The participants were randomly assigned into the intervention or control group in a cluster randomized controlled trial (cRCT). The core intervention covered one of five positive psychology themes: joy, gratitude, flow, savoring, and listening. Assessments at pre-intervention, immediate post-intervention, and 4 and 12 weeks post-intervention showed improved family communication and well-being with sustainable effects up to 12 weeks. Positive changes in family happiness and family health were greater in the intervention group than in the control group. The savoring intervention had the most improved outcomes among the five themes. We concluded that this large-scale brief cRCT developed and conducted in real-world settings provided evidence for the feasibility and effectiveness of a community-based family intervention. This study was registered under ClinicalTrials.gov (NCT01796275). PMID:27199864

  1. Outcomes from a Randomized Controlled Trial of a Group Intervention for HIV Positive Men and Women Coping with AIDS-Related Loss and Bereavement

    ERIC Educational Resources Information Center

    Sikkema, Kathleen J.; Hansen, Nathan B.; Kochman, Arlene; Tate, David C.; DiFranceisco, Wayne

    2004-01-01

    The purpose of this study was to examine the impact of a group coping intervention for HIV-positive men and women who have lost a loved one(s) to AIDS in the past 2 years. Two hundred thirty-five participants, diverse with respect to race/ethnicity and sexual orientation, were randomly assigned to a 12-week cognitive-behavioral group intervention…

  2. A randomized, controlled study of computer-based intervention in middle school struggling readers.

    PubMed

    Given, Barbara K; Wasserman, John D; Chari, Sharmila A; Beattie, Karen; Eden, Guinevere F

    2008-08-01

    The current study was conducted to test the premise that computer-based intervention that targets auditory temporal processing combined with language exercises (Fast ForWord) is effective in remediating children with disorders of language and reading. Sixty-five middle school struggling readers were randomly assigned to one of five groups and over a 12-week-period received one of the following interventions: (1) two phases of intervention with Fast ForWord (FFW, experimental group), (2) two phases of intervention with SuccessMaker (SM, active control group), (3) FFW followed by SM, (4) SM followed by FFW, or (5) no intervention beyond the regular class curriculum (developmental control group). Changes in reading, phonemic awareness, spelling and language skills were assessed via a repeated measures MANOVA. Results indicated significant within-subjects effects (i.e., change for all participants over time), but no between-subject group differences, failing to show that Fast ForWord resulted in any gains over and above those seen in the other groups.

  3. Effect of 12 weeks of wrist and forearm training on high school baseball players.

    PubMed

    Szymanski, David J; Szymanski, Jessica M; Molloy, Joseph M; Pascoe, David D

    2004-08-01

    This study examined the effect of 12 weeks of wrist and forearm training on male high school baseball players (mean age = 15.3 +/- 1.1 years). Participants (N = 43) were tested for 10 repetition maximum (RM) wrist barbell flexion, wrist barbell extension, dominant (D) and nondominant (ND) hand-forearm supination, D and ND forearm pronation, D and ND wrist radial deviation, D and ND wrist ulnar deviation, D and ND grip strength, and a 3RM parallel squat (PS) and bench press (BP). Group 1 (n = 23) and group 2 (n = 20), randomly assigned by a stratified sampling technique, performed the same resistance exercises while training 3 days a week for 12 weeks according to a stepwise periodized model. Group 2 also performed wrist and forearm exercises 3 days a week for 12 weeks to determine if additional wrist and forearm training provided further wrist and forearm strength improvements. All wrist and forearm strength variables were measured before and after 12 weeks of training. The 3RM PS and BP were measured at 0 and after 4, 8, and 12 weeks of training. Both groups significantly increased wrist and forearm strength (kg +/- SD) except 10RM D and ND forearm supination for group 1 (p < 0.05). Group 2 showed statistically greater improvements (p < 0.05) in all wrist and forearm strength variables than did group 1 except for D and ND grip strength. Predicted 1RM (kg +/- SD) PS and BP increased significantly (p < 0.05) after weeks 4, 8, and 12 for both groups. These data indicate that a 12-week stepwise periodized training program can significantly increase wrist, forearm, PS, and BP strength for both groups. Additionally, group 2 had further wrist and forearm strength gains.

  4. Using Randomized Controlled Trials to Evaluate Interventions for Releasing Prisoners

    ERIC Educational Resources Information Center

    Pettus-Davis, Carrie; Howard, Matthew Owen; Dunnigan, Allison; Scheyett, Anna M.; Roberts-Lewis, Amelia

    2016-01-01

    Randomized controlled trials (RCTs) are rarely used to evaluate social and behavioral interventions designed for releasing prisoners. Objective: We use a pilot RCT of a social support intervention (Support Matters) as a case example to discuss obstacles and strategies for conducting RCT intervention evaluations that span prison and community…

  5. Computer-Assisted Dieting: Effects of a Randomized Nutrition Intervention

    ERIC Educational Resources Information Center

    Schroder, Kerstin E. E.

    2011-01-01

    Objectives: To compare the effects of a computer-assisted dieting intervention (CAD) with and without self-management training on dieting among 55 overweight and obese adults. Methods: Random assignment to a single-session nutrition intervention (CAD-only) or a combined CAD plus self-management group intervention (CADG). Dependent variables were…

  6. Family-School Intervention for Children with ADHD: Results of Randomized Clinical Trial

    PubMed Central

    Power, Thomas J.; Mautone, Jennifer A.; Soffer, Stephen L.; Clarke, Angela T.; Marshall, Stephen A.; Sharman, Jaclyn; Blum, Nathan J.; Glanzman, Marianne; Elia, Josephine; Jawad, Abbas F.

    2012-01-01

    Accumulating evidence highlights the importance of using psychosocial approaches to intervention for children with ADHD that target the family and school, as well as the intersection of family and school. Objective This study was designed to evaluate the effectiveness of a family-school intervention, referred to as Family-School Success (FSS), designed to improve the family and educational functioning of students in grades 2 through 6 who meet criteria for ADHD combined and inattentive types. Key components of FSS were conjoint behavioral consultation, daily report cards, and behavioral homework interventions. Methods FSS was provided over the course of 12 weekly sessions, which included 6 group sessions, 4 individualized family sessions, and 2 school-based consultations. Families participating in the study were given the choice of placing their children on medication; 43% of children were on medication at the time of random assignment. Children (n=199) were randomly assigned to FSS or a comparison group controlling for non-specific treatment effects. Outcomes were assessed at post intervention and 3-month follow-up. The analyses controlled for child medication status. Results Study findings indicated that FSS had a significant effect on the quality of the family-school relationship, homework performance, and parenting behavior. Conclusions The superiority of FSS was demonstrated even though about 40% of the participants in FSS and CARE were on an optimal dose of medication and there were significant Time effects on each measure. This relatively brief intervention was able to produce effect sizes that were comparable to those of the more intensive MTA behavioral intervention. PMID:22506793

  7. Randomized study designs for lifestyle interventions: a tutorial.

    PubMed

    Younge, John O; Kouwenhoven-Pasmooij, Tessa A; Freak-Poli, Rosanne; Roos-Hesselink, Jolien W; Hunink, Mg Myriam

    2015-12-01

    Unhealthy lifestyle behaviours are considered modifiable risk factors for many diseases. Lifestyle interventions that target these behaviours need rigorous evaluation to assess their effectiveness. The randomized controlled trial is the study design of choice when it comes to the evaluation of interventions. However, lifestyle interventions are often complex and subject to several important issues, such as patient preference and non-adherence, that may threaten the internal and external validity of studies. There is a strong demand for high-quality randomized controlled trials of interventions that promote healthy lifestyle behaviours. With this tutorial we aim to provide guidance in the choice of an optimal randomized controlled trial design in future trials of lifestyle interventions.

  8. Evaluation of effects of nutrition intervention on healing of pressure ulcers and nutritional states (randomized controlled trial).

    PubMed

    Ohura, Takehiko; Nakajo, Toshio; Okada, Shingo; Omura, Kenji; Adachi, Kayoko

    2011-01-01

    The objective of this study was to evaluate the effects of nutrition intervention on nutritional states and healing of pressure ulcers by standardizing or unified factors including nursing, care and treatment in a multicenter open randomized trial. Tube-fed patients with Stage III-IV pressure ulcers were selected. The control group (30 patients) received the same nutrition management as before participating in this trial, whereas the intervention group (30 patients) was given calories in the range of Basal Energy Expenditure (BEE) × 1.1 × 1.3 to 1.5. The intervention period was 12 weeks. The efficacy and safety were evaluated based on the nutritional states and the sizes of ulcers (length × width), and on the incidence of adverse events related to the study, respectively. The calories administered to the control and intervention groups were 29.1 ± 4.9 and 37.9 ± 6.5 kcal/kg/day, respectively. Significant interactions between the presence or absence of the intervention and the intervention period were noted for nutritional states (p<0.001 for body weight, p<0.05 for prealbumin). Similarly, the size of ulcers differed significantly between subjects in the intervention group and in the control group (p<0.001). The results suggest that nutrition intervention could directly enhance the healing process in pressure ulcer patients.

  9. Stimulant Reduction Intervention using Dosed Exercise (STRIDE) - CTN 0037: Study protocol for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background There is a need for novel approaches to the treatment of stimulant abuse and dependence. Clinical data examining the use of exercise as a treatment for the abuse of nicotine, alcohol, and other substances suggest that exercise may be a beneficial treatment for stimulant abuse, with direct effects on decreased use and craving. In addition, exercise has the potential to improve other health domains that may be adversely affected by stimulant use or its treatment, such as sleep disturbance, cognitive function, mood, weight gain, quality of life, and anhedonia, since it has been shown to improve many of these domains in a number of other clinical disorders. Furthermore, neurobiological evidence provides plausible mechanisms by which exercise could positively affect treatment outcomes. The current manuscript presents the rationale, design considerations, and study design of the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) CTN-0037 Stimulant Reduction Intervention using Dosed Exercise (STRIDE) study. Methods/Design STRIDE is a multisite randomized clinical trial that compares exercise to health education as potential treatments for stimulant abuse or dependence. This study will evaluate individuals diagnosed with stimulant abuse or dependence who are receiving treatment in a residential setting. Three hundred and thirty eligible and interested participants who provide informed consent will be randomized to one of two treatment arms: Vigorous Intensity High Dose Exercise Augmentation (DEI) or Health Education Intervention Augmentation (HEI). Both groups will receive TAU (i.e., usual care). The treatment arms are structured such that the quantity of visits is similar to allow for equivalent contact between groups. In both arms, participants will begin with supervised sessions 3 times per week during the 12-week acute phase of the study. Supervised sessions will be conducted as one-on-one (i.e., individual) sessions, although other

  10. Changes in Physical Activity and Sedentary Behavior in a Randomized Trial of an Internet-Based Versus Workbook-Based Family Intervention Study

    PubMed Central

    Catenacci, Victoria; Barrett, Christopher; Odgen, Lorraine; Browning, Ray; Schaefer, Christine Adele; Hill, James; Wyatt, Holly

    2015-01-01

    Background The America on the Move (AOM) Family Intervention Program has been shown to prevent excess weight gain in overweight children. Providing intervention materials via the internet would have the potential to reach more families but may increase sedentary behavior. The purpose was to evaluate whether delivering the AOM Family Intervention via the internet versus printed workbook would have a similar impact on sedentary behaviors in children. Methods 131 children (age 8–12) were randomized to receive the AOM Family Intervention via the internet or workbook for 12 weeks. Changes in objectively measured sedentary time and moderate-to vigorous physical activity (MVPA) as well as self-reported screen time were compared between groups. Results There were no significant differences between groups in screen time, sedentary time, or MVPA at the end of the 12 week intervention. Families receiving the intervention via the internet were more likely to remain in the study (98% vs. 82%, P = .016). Conclusions Using the internet to deliver the lifestyle intervention did not increase sedentary behavior in children. Attrition rates were lower when the program was delivered by internet versus via printed materials. These results provide support for using the internet to deliver healthy lifestyle programs for children. PMID:23364318

  11. Healthcare Resource Use among Heart Failure Patients in a Randomized Pilot Study of a Cognitive Training Intervention

    PubMed Central

    Pressler, Susan J.; Martineau, Alison; Grossi, Judith; Giordani, Bruno; Koelling, Todd M.; Ronis, David L.; Riley, Penny L.; Chou, Cheng-Chen; Sullivan, Barbara J; Smith, Dean G.

    2013-01-01

    Objectives To compare healthcare resource use of patients with heart failure (HF) randomized to the cognitive training intervention and to the health education active control intervention in a randomized controlled pilot study. Background Cognitive training interventions may be efficacious and improve patients’ memory and abilities to perform instrumental activities of daily living and self-care behaviors that may, in turn, lower healthcare resource use, but the influence of these interventions on healthcare resource use is unknown. Methods Thirty-four HF patients were randomized to the computerized plasticity-based cognitive training intervention called Brain Fitness and to the health education active control intervention and completed the study. The primary outcome variable for the study was memory (recall and delayed recall). The secondary purpose of the study that is the focus of this paper was to compare healthcare resource use between the two groups using the third-party payer perspective. Data were collected at baseline and at 8 and 12 weeks after baseline. Healthcare resources were priced at Medicare payment levels for services and average wholesale price for medications. Results Average costs of visits, procedures, and medications were similar between groups. Average costs of hospitalizations and tests, and therefore total costs, were half as much in the Brain Fitness group as compared to the active control group, but this difference was not significantly different from zero (p = .24). Conclusions Larger randomized controlled trials are needed that include analyses of program costs and costs associated with medical and non-medical services in order to fully evaluate efficacy of this intervention. PMID:23809197

  12. A Randomized Trial of an Avatar-Hosted Multiple Behavior Change Intervention for Young Adult Smokers

    PubMed Central

    2013-01-01

    Background Young adulthood is a critical transition period for the development of health behaviors. We present here the results of a randomized controlled trial of an online avatar-hosted personal health makeover program designed for young adult smokers. Methods We conducted a three-group randomized trial comparing delivery of general lifestyle content (Tx1), personally tailored health information (Tx2), and personally tailored health information plus online video–based peer coaching (Tx3) as part of a 6-week online health program. Participants were asked to set weekly goals around eating breakfast, exercise, alcohol use, and cigarette smoking. Eligibility criteria included age (18–30 years) and smoking status (any cigarette use in the previous 30 days). The primary outcome was self-reported 30-day abstinence measured 12 weeks postenrollment. Results Participant (n = 1698) characteristics were balanced across the groups (72% women, mean age 24, 26% nonwhite, 32% high school education or less, and 50% daily smokers). Considering intention to treat, 30-day smoking abstinence rates were statistically significantly higher in the intervention groups (Tx1 = 11%, Tx2 = 23%, Tx3 = 31%, P < .001). Participants in the intervention groups were also more likely to reduce their number of days spent on binge drinking and increase their number of days eating breakfast and exercising. Overall, intervention group participants were much more likely to make positive changes in at least three or four of the target behaviors (Tx1 = 19%, Tx2 = 39%, Tx3 = 41%, P < .001). Conclusions This online avatar-hosted personal health makeover “show” increased smoking abstinence and induced positive changes in multiple related health behaviors. Addition of the online video–based peer coaching further improved behavioral outcomes. PMID:24395994

  13. The efficacy of 12 weeks supervised exercise in obesity management.

    PubMed

    Herring, L Y; Wagstaff, C; Scott, A

    2014-08-01

    The objective of this randomized controlled trial was to investigate the effect of adding either aerobic training (AT) or resistance training (RT) to a multidisciplinary teamed (MDT) educational weight management programme on the health-related fitness of morbidly obese individuals. Males (n = 9) and females (n = 24) aged between 24 and 68 years with a body mass index (BMI) of ≥40 kg m(2) (≥35 kg m(2) with comorbidities) undertaking a weight management programme were recruited (Completion: M = 8, F = 19). Participants were randomly allocated to either AT (n = 12), RT (n = 11) or CON (n = 10). AT and RT undertook three structured ∼60 min moderate intensity sessions weekly, two supervised gym-based and one structured home-based session for 12 weeks; CON undertook usual care alone. Anthropometric, psychological and functional capacity measures were obtained pre- and post-intervention. Both exercise interventions elicited improvements compared with CON in the: shuttle walk test (AT [Δ 207.0 ± 123.0 metres, 68.0%, P = 0.04], RT [Δ 165.0 ± 183.3 m, 48.8%, P = 0.06], CON [Δ -14.3 ± 38.7 m, -6.2%]), triceps skin-fold (P ≤ 0.001), self-efficacy (P = 0.005) and interest/enjoyment (P = 0.006). RT displayed additional improvements compared with CON in BMI (RT [Δ -1.02 ± 0.91 kg·m(2) , -2.5%, P = 0.033], AT [Δ -1.84 ± 2.70 kg·m(2) , -4.3%, P = 0.142], CON [Δ -0.31 ± 1.47 kg·m(2) , -0.6%]), waist circumference (P = 0.022), competence (P = 0.019), biceps skin-fold (P = 0.012) and medial calf skin-fold (P = 0.013). No significant differences were observed between exercise modalities. Regardless of exercise mode, the addition of supervised and structured exercise to a MDT weight management programme significantly improved anthropometric, functional and psychological measures in obese participants with a BMI of ≥35 kg·m(2) . PMID

  14. The efficacy of 12 weeks supervised exercise in obesity management.

    PubMed

    Herring, L Y; Wagstaff, C; Scott, A

    2014-08-01

    The objective of this randomized controlled trial was to investigate the effect of adding either aerobic training (AT) or resistance training (RT) to a multidisciplinary teamed (MDT) educational weight management programme on the health-related fitness of morbidly obese individuals. Males (n = 9) and females (n = 24) aged between 24 and 68 years with a body mass index (BMI) of ≥40 kg m(2) (≥35 kg m(2) with comorbidities) undertaking a weight management programme were recruited (Completion: M = 8, F = 19). Participants were randomly allocated to either AT (n = 12), RT (n = 11) or CON (n = 10). AT and RT undertook three structured ∼60 min moderate intensity sessions weekly, two supervised gym-based and one structured home-based session for 12 weeks; CON undertook usual care alone. Anthropometric, psychological and functional capacity measures were obtained pre- and post-intervention. Both exercise interventions elicited improvements compared with CON in the: shuttle walk test (AT [Δ 207.0 ± 123.0 metres, 68.0%, P = 0.04], RT [Δ 165.0 ± 183.3 m, 48.8%, P = 0.06], CON [Δ -14.3 ± 38.7 m, -6.2%]), triceps skin-fold (P ≤ 0.001), self-efficacy (P = 0.005) and interest/enjoyment (P = 0.006). RT displayed additional improvements compared with CON in BMI (RT [Δ -1.02 ± 0.91 kg·m(2) , -2.5%, P = 0.033], AT [Δ -1.84 ± 2.70 kg·m(2) , -4.3%, P = 0.142], CON [Δ -0.31 ± 1.47 kg·m(2) , -0.6%]), waist circumference (P = 0.022), competence (P = 0.019), biceps skin-fold (P = 0.012) and medial calf skin-fold (P = 0.013). No significant differences were observed between exercise modalities. Regardless of exercise mode, the addition of supervised and structured exercise to a MDT weight management programme significantly improved anthropometric, functional and psychological measures in obese participants with a BMI of ≥35 kg·m(2) .

  15. Imagine HEALTH: results from a randomized pilot lifestyle intervention for obese Latino adolescents using Interactive Guided ImagerySM

    PubMed Central

    2014-01-01

    Background There is an urgent need for innovative and developmentally appropriate lifestyle interventions to promote healthy lifestyle behaviors and to prevent the early onset of type 2 diabetes and cardiovascular disease risk in obese Latino adolescents. Guided imagery offers promise to reduce stress and promote lifestyle behavior change to reduce disease risk in obese adolescents. Our objectives were: 1) To pilot test a new 12-wk lifestyle intervention using a randomized trial design in obese Latino adolescents, in order to determine the effects of the mind-body modality of Interactive Guided ImagerySM (IGI), over and above those of a didactic lifestyle education, on insulin resistance, eating and physical activity behaviors, stress and stress biomarkers; and 2) To explore the role of intervention-related changes in stress and stress biomarkers on changes in metabolic outcomes, particularly insulin resistance. Methods Obese (BMI > 95th percentile), Latino adolescents (n = 35, age 14-17) were randomized to receive either 12 weekly sessions of a lifestyle education plus guided imagery program (GI), or lifestyle education plus a digital storytelling computer program (DS). Between-group differences in behavioral, biological, and psychological outcomes were assessed using unpaired T-tests and ANCOVA in the 29 subjects who completed the intervention. Results The GI group demonstrated significant reductions in leisure sedentary behavior (p < .05) and increases in moderate physical activity (p < .05) compared to DS group, and a trend toward reduced caloric intake in GI vs DS (p = .09). Salivary cortisol was acutely reduced by stress-reduction guided imagery (p < .01). There were no group differences in adiposity, insulin resistance, perceived stress, or stress biomarkers across the 12-week intervention, though decrease in serum cortisol over the course of the intervention was associated with improved insulin sensitivity (p = .03) independent

  16. A 6-month randomized controlled trial to test the efficacy of a lifestyle intervention for weight gain management in schizophrenia

    PubMed Central

    2013-01-01

    Background Patients with schizophrenia have lower longevity than the general population as a consequence of a combination of risk factors connected to the disease, lifestyle and the use of medications, which are related to weight gain. Methods A multicentric, randomized, controlled-trial was conducted to test the efficacy of a 12-week group Lifestyle Wellness Program (LWP). The program consists of a one-hour weekly session to discuss topics like dietary choices, lifestyle, physical activity and self-esteem with patients and their relatives. Patients were randomized into two groups: standard care (SC) and standard care plus intervention (LWP). Primary outcome was defined as the weight and body mass index (BMI). Results 160 patients participated in the study (81 in the intervention group and 79 in the SC group). On an intent to treat analysis, after three months the patients in the intervention group presented a decrease of 0.48 kg (CI 95% -0.65 to 1.13) while the standard care group showed an increase of 0.48 kg (CI 95% 0.13 to 0.83; p=0.055). At six-month follow-up, there was a significant weight decrease of −1.15 kg, (CI 95% -2.11 to 0.19) in the intervention group compared to a weight increase in the standard care group (+0.5 kg, CI 95% -0.42–1.42, p=0.017). Conclusion In conclusion, this was a multicentric randomized clinical trial with a lifestyle intervention for individuals with schizophrenia, where the intervention group maintained weight and presented a tendency to decrease weight after 6 months. It is reasonable to suppose that lifestyle interventions may be important long-term strategies to avoid the tendency of these individuals to increase weight. Clinicaltrials.gov identifier NCT01368406 PMID:23418863

  17. Chronic flexibility improvement after 12 week of stretching program utilizing the ACSM recommendations: hamstring flexibility.

    PubMed

    Sainz de Baranda, P; Ayala, F

    2010-06-01

    The ACSM flexibility training recommendations emphasize proper stretching of muscles supporting the major joints, but there is a little evidence to support this recommendation in terms of effectiveness, and which stretching parameters (technique and single stretch duration) are more adequate. A randomized controlled clinical trial design was use to investigate whether the ACSM flexibility training recommendation parameters improve hip flexion range of motion. A total of 173 subjects, 122 men (21.3+/-2.5 years; 176.33+/-8.35 cm; 74.42+/-10.80 kg) and 51 women (20.7+/-1.6 years; 163.43+/-6.57 cm; 60.12+/-7.88 kg), classified as recreationally active young adult university students were randomly assigned to 1 of 7 groups: 1 control group (no stretching) or 1 of 6 stretching groups. All stretching groups performed 12 weeks of flexibility training with a consistent stretch daily dose (180 s) and frequency (3 days per week) parameters and different stretch technique (passive or active) and single stretch duration (15, 30, or 45 s). Hip flexion passive range of motion (PROM) was determined through the bilateral straight-leg raise test before, during (at 4 and 8 weeks), and after the program (12 weeks). All stretching groups performed hip flexion PROM after flexibility training. A significant improvement was identified in mean PROM for each stretching group, but no significant differences were found between stretch technique and single stretch duration (p>0.05). The control group's mean PROM decreased (Delta PROM: -0.08 degrees, 95% confidence interval [CI]=-2.3 to 5.3), whereas all stretching groups increased PROM (Delta PROM: 15.14 degrees, 95% CI=10.19 to 23.56) in hip flexion after 12 weeks of stretching (p<0.05). The present study suggests that the current ACSM flexibility training recommendations are effective for improving hip flexion ROM in recreationally active young adults.

  18. Parent-Targeted Mobile Phone Intervention to Increase Physical Activity in Sedentary Children: Randomized Pilot Trial

    PubMed Central

    Marker, Arwen M; Allen, H Raymond; Machtmes, Ryan; Han, Hongmei; Johnson, William D; Schuna Jr, John M; Broyles, Stephanie T; Tudor-Locke, Catrine; Church, Timothy S

    2014-01-01

    Background Low levels of moderate-to-vigorous physical activity are associated with adverse health consequences. Objective The intent of the study was to determine the feasibility and efficacy of a 12-week physical activity promotion program targeting children, which was delivered to parents through mobile phones. Methods Potential participants were recruited through advertisements placed in the newspaper, local hospitals and schools, and an email listserv. Sedentary children aged 6-10 years were randomly assigned to a minimal (MIG) or intensive (IIG) intervention group. Parents in the MIG were given a goal to increase (within 1 month) and maintain their child’s activity at 6000 pedometer steps/day above their baseline levels and to monitor their child’s steps daily. Parents in the IIG were given the same steps/day and monitoring goals, in addition to text messages and articles containing additional behavioral strategies (based on the Social Cognitive Theory) designed to promote their child’s physical activity. The intervention components were delivered via mobile phone. Anthropometrics, body composition, and questionnaires were administered in a clinic. Children wore a New Lifestyles pedometer (NL-1000) each day throughout the intervention and parents were to monitor their child’s step counts daily. Results Out of 59 children who screened for the study, a total of 27 children (mean age 8.7, SD 1.4 years; 56%, 15/27 female; 59%, 16/27 African American) were enrolled and completed the study. Overall, 97.90% (2220/2268; 98.20%, 1072/1092 for MIG; 97.60%, 1148/1176 for IIG) of expected step data were successfully entered by the parent or study coordinator. Parents in the MIG and IIG were sent approximately 7 and 13 text messages per week, respectively, averaged over the course of the study. IIG parents accessed an average of 6.1 (SD 4.4) articles over the course of the intervention and accessed a fewer number of articles in the last month compared to the first

  19. Intake of Novel Red Clover Supplementation for 12 Weeks Improves Bone Status in Healthy Menopausal Women

    PubMed Central

    Thorup, Anne Cathrine; Lambert, Max Norman; Kahr, Henriette Strøm; Bjerre, Mette; Jeppesen, Per Bendix

    2015-01-01

    Objective. To investigate the effect by which daily consumption of a novel red clover (RC) extract influences bone health, inflammatory status, and cardiovascular health in healthy menopausal women. Design. A 12-week randomized, double-blinded, placebo-controlled trial involving 60 menopausal women receiving a daily dose of 150 mL RC extract containing 37.1 mg isoflavones (33.8 mg as aglycones) or placebo. Methods. Bone parameters were changes in bone mineral density (BMD), bone mineral content (BMC), and T-score at the lumbar spine and femoral neck. Bone turnover (CTx) and inflammatory markers were measured in plasma and finally blood pressure (BP) was evaluated. Results. RC extract had positive effect on bone health, and only the women receiving the placebo experienced a decline in BMD (p < 0.01) at the lumbar spine. T-score at the lumbar spine only decreased in the placebo group (p < 0.01). CTx decreased in the RC group with −9.94 (±4.93)%, although not significant. Conclusion. Daily consumption of RC extract over a 12-week period was found to have a beneficial effect on bone health in menopausal women based on BMD and T-score at the lumbar spine and plasma CTx levels. No changes in BP or inflammation markers were found and no side effects were observed. PMID:26265926

  20. Pilot randomized controlled trial of an integrative intervention with methamphetamine-using men who have sex with men.

    PubMed

    Carrico, Adam W; Gómez, Walter; Siever, Michael D; Discepola, Michael V; Dilworth, Samantha E; Moskowitz, Judith T

    2015-10-01

    Contingency management (CM) is an evidence-based intervention that provides tangible rewards as positive reinforcement for biologically confirmed abstinence from substance use. Integrative approaches targeting positive affect regulation could boost the effectiveness of CM by sensitizing individuals to non-drug-related sources of reward and assisting them with effectively managing symptoms of withdrawal. This pilot randomized controlled trial with 21 methamphetamine-using men who have sex with men (MSM) examined the feasibility and acceptability of a 5-session, positive affect intervention delivered during CM-Affect Regulation Treatment to Enhance Methamphetamine Intervention Success (ARTEMIS). After completing 4 weeks of a 12-week CM program, participants were randomized to receive ARTEMIS+CM (n = 12) or CM-only (n = 9). Those randomized to receive the ARTEMIS positive affect intervention completed 98 % of sessions and reported marginally significant increases in positive affect over the five sessions. In exit interviews with ARTEMIS+CM participants, individuals noted that the positive affect regulation skills increased self-awareness and led to greater engagement in the recovery process. ARTEMIS+CM participants reported significant increases in positive affect and CM-only participants reported significant reductions in negative affect over a 2-month follow-up. These affective changes were not maintained, and no concurrent effects on stimulant use or sexual risk taking were observed over the 6-month follow-up. More definitive clinical research is necessary to examine the efficacy of ARTEMIS+CM with methamphetamine-using MSM. PMID:26123068

  1. Predictors of adherence to a 12-week exercise program among men treated for prostate cancer: ENGAGE study.

    PubMed

    Craike, Melinda; Gaskin, Cadeyrn J; Courneya, Kerry S; Fraser, Steve F; Salmon, Jo; Owen, Patrick J; Broadbent, Suzanne; Livingston, Patricia M

    2016-05-01

    Understanding the factors that influence adherence to exercise programs is necessary to develop effective interventions for people with cancer. We examined the predictors of adherence to a supervised exercise program for participants in the ENGAGE study - a cluster randomized controlled trial that assessed the efficacy of a clinician-referred 12-week exercise program among men treated for prostate cancer. Demographic, clinical, behavioral, and psychosocial data from 52 participants in the intervention group were collected at baseline through self-report and medical records. Adherence to the supervised exercise program was assessed through objective attendance records. Adherence to the supervised exercise program was 80.3%. In the univariate analyses, cancer-specific quality of life subscales (role functioning r = 0.37, P = 0.01; sexual activity r = 0.26, P = 0.06; fatigue r = -0.26, P = 0.06, and hormonal symptoms r = -0.31, P = 0.03) and education (d = -0.60, P = 0.011) were associated with adherence. In the subsequent multivariate analysis, role functioning (B = 0.309, P = 0.019) and hormonal symptoms (B = -0.483, P = 0.054) independently predicted adherence. Men who experienced more severe hormonal symptoms had lower levels of adherence to the exercise program. Those who experienced more positive perceptions of their ability to perform daily tasks and leisure activities had higher levels of adherence to the exercise program. Hormonal symptoms and role functioning need to be considered when conducting exercise programs for men who have been treated for prostate cancer. PMID:26872005

  2. An Interactive Text Message Intervention to Reduce Binge Drinking in Young Adults: A Randomized Controlled Trial with 9-Month Outcomes

    PubMed Central

    Suffoletto, Brian; Chung, Tammy; Jeong, Kwonho; Fabio, Anthony

    2015-01-01

    Background Binge drinking is associated with numerous negative consequences. The prevalence and intensity of binge drinking is highest among young adults. This randomized trial tested the efficacy of a 12-week interactive text message intervention to reduce binge drinking up to 6 months after intervention completion among young adults. Methods and Findings Young adult participants (18–25 y; n = 765) drinking above the low-risk limits (AUDIT-C score >3/4 women/men), but not seeking alcohol treatment, were enrolled from 4 Emergency Departments (EDs) in Pittsburgh, PA. Participants were randomized to one of three conditions in a 2:1:1 allocation ratio: SMS Assessments + Feedback (SA+F), SMS Assessments (SA), or control. For 12 weeks, SA+F participants received texts each Thursday querying weekend drinking plans and prompting drinking limit goal commitment and each Sunday querying weekend drinking quantity. SA+F participants received tailored feedback based on their text responses. To contrast the effects of SA+F with self-monitoring, SA participants received texts on Sundays querying drinking quantity, but did not receive alcohol-specific feedback. The control arm received standard care. Follow-up outcome data collected through web-based surveys were provided by 78% of participants at 3- months, 63% at 6-months and 55% at 9-months. Multiple imputation-derived, intent-to-treat models were used for primary analysis. At 9-months, participants in the SA+F group reported greater reductions in the number of binge drinking days than participants in the control group (incident rate ratio [IRR] 0.69; 95% CI .59 to.79), lower binge drinking prevalence (odds ratio [OR] 0.52; 95% CI 0.26 to 0.98]), less drinks per drinking day (beta -.62; 95% CI -1.10 to -0.15) and lower alcohol-related injury prevalence (OR 0.42; 95% CI 0.21 to 0.88). Participants in the SA group did not reduce drinking or alcohol-related injury relative to controls. Findings were similar using complete case

  3. Features Predicting Weight Loss in Overweight or Obese Participants in a Web-Based Intervention: Randomized Trial

    PubMed Central

    Freyne, Jill; Saunders, Ian; Berkovsky, Shlomo; Smith, Greg; Noakes, Manny

    2012-01-01

    Background Obesity remains a serious issue in many countries. Web-based programs offer good potential for delivery of weight loss programs. Yet, many Internet-delivered weight loss studies include support from medical or nutritional experts, and relatively little is known about purely web-based weight loss programs. Objective To determine whether supportive features and personalization in a 12-week web-based lifestyle intervention with no in-person professional contact affect retention and weight loss. Methods We assessed the effect of different features of a web-based weight loss intervention using a 12-week repeated-measures randomized parallel design. We developed 7 sites representing 3 functional groups. A national mass media promotion was used to attract overweight/obese Australian adults (based on body mass index [BMI] calculated from self-reported heights and weights). Eligible respondents (n = 8112) were randomly allocated to one of 3 functional groups: information-based (n = 183), supportive (n = 3994), or personalized-supportive (n = 3935). Both supportive sites included tools, such as a weight tracker, meal planner, and social networking platform. The personalized-supportive site included a meal planner that offered recommendations that were personalized using an algorithm based on a user’s preferences for certain foods. Dietary and activity information were constant across sites, based on an existing and tested 12-week weight loss program (the Total Wellbeing Diet). Before and/or after the intervention, participants completed demographic (including self-reported weight), behavioral, and evaluation questionnaires online. Usage of the website and features was objectively recorded. All screening and data collection procedures were performed online with no face-to-face contact. Results Across all 3 groups, attrition was high at around 40% in the first week and 20% of the remaining participants each week. Retention was higher for the supportive sites

  4. A Systematic Review and Meta-Analysis Estimating the Expected Dropout Rates in Randomized Controlled Trials on Yoga Interventions.

    PubMed

    Cramer, Holger; Haller, Heidemarie; Dobos, Gustav; Lauche, Romy

    2016-01-01

    A reasonable estimation of expected dropout rates is vital for adequate sample size calculations in randomized controlled trials (RCTs). Underestimating expected dropouts rates increases the risk of false negative results while overestimating rates results in overly large sample sizes, raising both ethical and economic issues. To estimate expected dropout rates in RCTs on yoga interventions, MEDLINE/PubMed, Scopus, IndMED, and the Cochrane Library were searched through February 2014; a total of 168 RCTs were meta-analyzed. Overall dropout rate was 11.42% (95% confidence interval [CI] = 10.11%, 12.73%) in the yoga groups; rates were comparable in usual care and psychological control groups and were slightly higher in exercise control groups (rate = 14.53%; 95% CI = 11.56%, 17.50%; odds ratio = 0.82; 95% CI = 0.68, 0.98; p = 0.03). For RCTs with durations above 12 weeks, dropout rates in yoga groups increased to 15.23% (95% CI = 11.79%, 18.68%). The upper border of 95% CIs for dropout rates commonly was below 20% regardless of study origin, health condition, gender, age groups, and intervention characteristics; however, it exceeded 40% for studies on HIV patients or heterogeneous age groups. In conclusion, dropout rates can be expected to be less than 15 to 20% for most RCTs on yoga interventions. Yet dropout rates beyond 40% are possible depending on the participants' sociodemographic and health condition. PMID:27413387

  5. Randomized interventions for needle procedures in children with cancer.

    PubMed

    Hedén, L; VON Essen, L; Ljungman, G

    2009-07-01

    The aim of this study was to examine whether children experience less fear, distress and pain connected to a routine needle insertion in an intravenous port when subjected to an intervention: blowing soap bubbles or having a heated pillow vs. standard care. Twenty-eight children, 2-7 years, cared for at a paediatric oncology unit, undergoing a routine needle insertion in an intravenous port were included consecutively. All children were subjected to two needle insertions; at the first they received standard care, and at the second standard care + a randomized intervention. Parents and nurses assessed children's fear, distress and pain on 0-100 mm visual analogue scales. According to parents' report, children experienced less fear when subjected to intervention vs. standard care reported by parents (P < 0.001). Children also experienced less fear (P < 0.05) and distress (P < 0.05) when subjected to standard care + blowing soap bubbles vs. standard care (n = 14), and less fear when subjected to standard care + heated pillow vs. standard care (P < 0.05). Nurses' reports did not show any differences for standard care + intervention vs. standard care. Blowing soap bubbles or having a heated pillow is more effective than standard care in reducing children's fear and distress in needle procedures, according to parents' report. PMID:19040458

  6. Randomized interventions for needle procedures in children with cancer.

    PubMed

    Hedén, L; VON Essen, L; Ljungman, G

    2009-07-01

    The aim of this study was to examine whether children experience less fear, distress and pain connected to a routine needle insertion in an intravenous port when subjected to an intervention: blowing soap bubbles or having a heated pillow vs. standard care. Twenty-eight children, 2-7 years, cared for at a paediatric oncology unit, undergoing a routine needle insertion in an intravenous port were included consecutively. All children were subjected to two needle insertions; at the first they received standard care, and at the second standard care + a randomized intervention. Parents and nurses assessed children's fear, distress and pain on 0-100 mm visual analogue scales. According to parents' report, children experienced less fear when subjected to intervention vs. standard care reported by parents (P < 0.001). Children also experienced less fear (P < 0.05) and distress (P < 0.05) when subjected to standard care + blowing soap bubbles vs. standard care (n = 14), and less fear when subjected to standard care + heated pillow vs. standard care (P < 0.05). Nurses' reports did not show any differences for standard care + intervention vs. standard care. Blowing soap bubbles or having a heated pillow is more effective than standard care in reducing children's fear and distress in needle procedures, according to parents' report.

  7. A Web-Based Intervention to Encourage Walking (StepWise): Pilot Randomized Controlled Trial

    PubMed Central

    Mutrie, Nanette; Fleming, Jade Dallas

    2016-01-01

    Background Despite Internet-based interventions that incorporate pedometers with appropriate goal-setting processes and other theoretically-based behavior change strategies being proposed as a means of increasing walking behavior, few have incorporated all of these key features or assessed maintenance of behavior change. Objective The objective of our study was to investigate the effect of a 12-week pedometer step goal walking program individually tailored to baseline step counts, combined with an interactive support website for step counts, health parameters and motivation over 12 and 24 weeks. Methods Low active participants (mean [SD] 46.2 [11.2] years) were randomly assigned to the Stepwise (SW) intervention group (n=49) or a comparison (CP) group (n=48). SW received a pedometer, step goal walking program and access to the SW website (containing interactive self-monitoring and goal feedback tools, motivational messages and action and coping planning strategies). CP received a pedometer and locally available physical activity information. Step counts, BMI, resting heart rate, blood pressure and glucose, cholesterol and triglyceride levels, psychological well-being, perceived health, self-efficacy and self-determined motivation were measured at baseline, 12 and 24 weeks. Results Linear mixed model analysis found that both groups’ step counts increased from baseline to week 12 (β = 11,002, CI 5739-16,266, P<.001) and 24 (β = 6810, CI 1190-12,431; P=.02). Group step counts were significantly different at week 24 with SW taking 8939 (CI 274-17604, P=.04) more steps compared to CP. Compared to baseline, both groups had improved triglyceride levels (0.14 mmol/L, CI -0.25 to -0.02, P=.02) at week 12, decreased diastolic blood pressure (4.22 mmHg, CI -6.73 to -1.72) at weeks 12 and 24 (3.17 mmHg, CI -5.55 to -0.78), improved positive (β = .21, CI 0.03-0.38, P=.02) and negative affect (β = -.15, CI -0.28 to -0.03, P=.02) at week 12, and perceived health at week 12

  8. Using Social Media While Waiting in Pain: A Clinical 12-Week Longitudinal Pilot Study

    PubMed Central

    Gray, Kathleen; Martin-Sanchez, Fernando; Mantopoulos, Steven; Hogg, Malcolm

    2015-01-01

    Background Chronic pain places an enormous burden on health care systems. Multidisciplinary pain management services are well documented as an effective means to improve patient outcomes. However, waiting lists to access these services are long and outcomes deteriorate. Innovative solutions such as social media are gaining attention as a way to decrease this burden and improve outcomes. It is a challenge to design research that demonstrates whether social media are acceptable to patients and clinically effective. Objective The aim was to conduct a longitudinal pilot study to understand what aspects of research design are key to the success of running a larger-scale study of social media use in the clinical management of chronic pain. Methods A 12-week study examined social media use by patients on the waiting list for the Royal Melbourne Hospital Pain Management Service. Selected social media resources were suggested for use by patients waiting for an appointment at the clinic. Patients filled out measures for pain interference and pain self-efficacy before and after the study. Follow-up was conducted at monthly intervals via telephone semistructured interviews to discuss engagement and garner individual perceptions towards social media use. A social media-use instrument was also administered as part of the after-study questionnaire. Results Targeted recruitment refined 235 patient referrals to 138 (58.7%) suitable potential participants. Contact was made with 84 out of 138 (60.9%) patients. After a further exclusion of 54 out of 84 (64%) patients for various reasons, this left 30 out of 84 (36%) patients fitting the inclusion criteria and interested in study participation. A final study cohort of 17 out of 30 (57%) was obtained. Demographics of the 17 patients were mixed. Low back pain was the primary condition reported as leading to chronic pain. Semistructured interviews collected data from 16 out of 17 (94%) patients who started the trial, and at final follow

  9. Low omega-6 vs. low omega-6 plus high omega-3 dietary intervention for Chronic Daily Headache: Protocol for a randomized clinical trial

    PubMed Central

    2011-01-01

    Background Targeted analgesic dietary interventions are a promising strategy for alleviating pain and improving quality of life in patients with persistent pain syndromes, such as chronic daily headache (CDH). High intakes of the omega-6 (n-6) polyunsaturated fatty acids (PUFAs), linoleic acid (LA) and arachidonic acid (AA) may promote physical pain by increasing the abundance, and subsequent metabolism, of LA and AA in immune and nervous system tissues. Here we describe methodology for an ongoing randomized clinical trial comparing the metabolic and clinical effects of a low n-6, average n-3 PUFA diet, to the effects of a low n-6 plus high n-3 PUFA diet, in patients with CDH. Our primary aim is to determine if: A) both diets reduce n-6 PUFAs in plasma and erythrocyte lipid pools, compared to baseline; and B) the low n-6 plus high n-3 diet produces a greater decline in n-6 PUFAs, compared to the low n-6 diet alone. Secondary clinical outcomes include headache-specific quality-of-life, and headache frequency and intensity. Methods Adults meeting the International Classification of Headache Disorders criteria for CDH are included. After a 6-week baseline phase, participants are randomized to a low n-6 diet, or a low n-6 plus high n-3 diet, for 12 weeks. Foods meeting nutrient intake targets are provided for 2 meals and 2 snacks per day. A research dietitian provides intensive dietary counseling at 2-week intervals. Web-based intervention materials complement dietitian advice. Blood and clinical outcome data are collected every 4 weeks. Results Subject recruitment and retention has been excellent; 35 of 40 randomized participants completed the 12-week intervention. Preliminary blinded analysis of composite data from the first 20 participants found significant reductions in erythrocyte n-6 LA, AA and %n-6 in HUFA, and increases in n-3 EPA, DHA and the omega-3 index, indicating adherence. Trial Registration ClinicalTrials.gov (NCT01157208) PMID:21496264

  10. Clinical pharmacology study of cariprazine (MP-214) in patients with schizophrenia (12-week treatment)

    PubMed Central

    Nakamura, Tadakatsu; Kubota, Tomoko; Iwakaji, Atsushi; Imada, Masayoshi; Kapás, Margit; Morio, Yasunori

    2016-01-01

    Purpose Cariprazine is a potent dopamine D3-preferring D3/D2 receptor partial agonist in development for the treatment of schizophrenia, bipolar mania, and depression. Pharmacokinetics of cariprazine and the two clinically relevant metabolites (desmethyl- and didesmethyl-cariprazine) was evaluated in a clinical pharmacology study. Methods This was a multicenter, randomized, open-label, parallel-group, fixed-dose (3, 6, or 9 mg/day) study of 28-week duration (≤4-week observation, 12-week open-label treatment, and 12-week follow-up). Once-daily cariprazine was administered to 38 adult patients with schizophrenia. The pharmacokinetics of cariprazine, metabolites, and total active moieties (sum of cariprazine and two metabolites) was evaluated; efficacy and safety were also assessed. Results Steady state was reached within 1–2 weeks for cariprazine and desmethyl-cariprazine, 4 weeks for didesmethyl-cariprazine, and 3 weeks for total active moieties. Cariprazine and desmethyl-cariprazine levels decreased >90% within 1 week after the last dose, didesmethyl-cariprazine decreased ~50% at 1 week, and total active moieties decreased ~90% within 4 weeks. Terminal half-lives of cariprazine, desmethyl-cariprazine, and didesmethyl-cariprazine ranged from 31.6 to 68.4, 29.7 to 37.5, and 314 to 446 hours, respectively. Effective half-life (calculated from time to steady state) of total active moieties was ~1 week. Incidence of treatment-emergent adverse events was 97.4%; 15.8% of patients discontinued due to adverse events. No abnormal laboratory values or major differences from baseline in extrapyramidal symptoms were observed. Conclusion Cariprazine and its active metabolites reached steady state within 4 weeks, and exposure was dose proportional over the range of 3–9 mg/day. Once-daily cariprazine was generally well tolerated in adult patients with schizophrenia. PMID:26834462

  11. The effect of a cognitive-motor intervention on voluntary step execution under single and dual task conditions in older adults: a randomized controlled pilot study

    PubMed Central

    Pichierri, Giuseppe; Coppe, Amos; Lorenzetti, Silvio; Murer, Kurt; de Bruin, Eling D

    2012-01-01

    Background This randomized controlled pilot study aimed to explore whether a cognitive-motor exercise program that combines traditional physical exercise with dance video gaming can improve the voluntary stepping responses of older adults under attention demanding dual task conditions. Methods Elderly subjects received twice weekly cognitive-motor exercise that included progressive strength and balance training supplemented by dance video gaming for 12 weeks (intervention group). The control group received no specific intervention. Voluntary step execution under single and dual task conditions was recorded at baseline and post intervention (Week 12). Results After intervention between-group comparison revealed significant differences for initiation time of forward steps under dual task conditions (U = 9, P = 0.034, r = 0.55) and backward steps under dual task conditions (U = 10, P = 0.045, r = 0.52) in favor of the intervention group, showing altered stepping levels in the intervention group compared to the control group. Conclusion A cognitive-motor intervention based on strength and balance exercises with additional dance video gaming is able to improve voluntary step execution under both single and dual task conditions in older adults. PMID:22865999

  12. Lifestyle Intervention Using an Internet-Based Curriculum with Cell Phone Reminders for Obese Chinese Teens: A Randomized Controlled Study

    PubMed Central

    Abraham, Anisha A.; Chow, Wing-Chi; So, Hung-Kwan; Yip, Benjamin Hon-Kei; Li, Albert M.; Kumta, Shekhar M.; Woo, Jean; Chan, Suk-Mei; Lau, Esther Yuet-Ying; Nelson, E. Anthony S.

    2015-01-01

    Objectives Obesity is an increasing public health problem affecting young people. The causes of obesity are multi-factorial among Chinese youth including lack of physical activity and poor eating habits. The use of an internet curriculum and cell phone reminders and texting may be an innovative means of increasing follow up and compliance with obese teens. The objectives of this study were to determine the feasibility of using an adapted internet curriculum and existing nutritional program along with cell phone follow up for obese Chinese teens. Design and Methods This was a randomized controlled study involving obese teens receiving care at a paediatric obesity clinic of a tertiary care hospital in Hong Kong. Forty-eight subjects aged 12 to 18 years were randomized into three groups. The control group received usual care visits with a physician in the obesity clinic every three months. The first intervention (IT) group received usual care visits every three months plus a 12-week internet-based curriculum with cell phone calls/texts reminders. The second intervention group received usual care visits every three months plus four nutritional counselling sessions. Results The use of the internet-based curriculum was shown to be feasible as evidenced by the high recruitment rate, internet log-in rate, compliance with completing the curriculum and responses to phone reminders. No significant differences in weight were found between IT, sLMP and control groups. Conclusion An internet-based curriculum with cell phone reminders as a supplement to usual care of obesity is feasible. Further study is required to determine whether an internet plus text intervention can be both an effective and a cost-effective adjunct to changing weight in obese youth. Trial Registration Chinese Clinical Trial Registry ChiCTR-TRC-12002624 PMID:25946465

  13. A Randomized Controlled Trial of a Standardized Behavior Management Intervention for Students with Externalizing Behavior

    ERIC Educational Resources Information Center

    Forster, Martin; Sundell, Knut; Morris, Richard J.; Karlberg, Martin; Melin, Lennart

    2012-01-01

    This study reports the results from a Swedish randomized controlled trial of a standardized behavior management intervention. The intervention targeted students with externalizing behavior in a regular education setting. First- and second-grade students (N = 100) from 38 schools were randomly assigned to either the intervention or an active…

  14. Caregiver-mediated intervention can improve physical functional recovery of patients with chronic stroke: a randomized controlled trial.

    PubMed

    Wang, Tzu-Chi; Tsai, Alan C; Wang, Jiun-Yi; Lin, Yu-Te; Lin, Ko-Long; Chen, Jiun Jiang; Lin, Bei Yi; Lin, Tai Ching

    2015-01-01

    Background and Purpose. Patients with chronic stroke may benefit from continuing rehabilitation training after hospital discharge. This study examined whether caregiver-mediated, home-based intervention (CHI) could improve physical functioning and social participation in these patients. Methods. A single-blind, randomized, controlled 12-week trial conducted with 51 patients from 3 hospitals in Taiwan who had chronic stroke (>6 months; Brunnstrom recovery stages III-V). Patients and their caregivers in the intervention arm (n = 25) were given weekly personalized CHI trainings designed by a physical therapist. Patients in the control arm (n = 26) received visits from the therapist without intervention. All were evaluated for physical recovery through the Stroke Impact Scale, Berg Balance Scale, 10-Meter Walk Test, 6-Minute Walk Test, and Barthel Index at baseline and endpoint. Caregivers were evaluated with the Caregiver Burden Scale. Results were analyzed through Mann-Whitney U test. Results. CHI significantly improved scores of the Stroke Impact Scale: strength (control vs intervention, respectively: 1.4 vs 15.5; P = .002), mobility (-0.5 vs 13.7; P < .001), composite physical (-0.7 vs 11.2; P < .001), and general recovery domain (0.2 vs 17.4; P < .001). CHI also significantly improved free-walking velocity (-1.4 vs 7.5 cm/s; P = .006), 6-minute walk distance (-10.5 vs 15.8 m; P = .003), Berg Balance Scale score (-0.8 vs 4.5; P = .006), and Barthel Index score (0.6 vs 7.2; P = .008). CHI did not significantly increase caregiver burden at endpoint. Conclusion. CHI can improve physical functional recovery and, possibly, social participation in patients with chronic stroke.

  15. A Randomized Trial of a Diet and Exercise Intervention for Overweight and Obese Women from Economically Disadvantaged Neighborhoods: Sisters Taking Action for Real Success (STARS)

    PubMed Central

    Wilcox, Sara; Sharpe, Patricia A.; Parra-Medina, Deborah; Granner, Michelle; Hutto, Brent

    2011-01-01

    Background Lower socioeconomic status at both the individual and neighborhood level is associated with increased health risks. Weight loss can reduce this risk, but few high quality weight loss studies target this population. Objectives STARS tests a culturally-appropriate, group-based behavioral and social support intervention on body weight and waist circumference in women from financially disadvantaged neighborhoods. Design A stratified (by BMI) randomized trial. Randomization to group was generated by a random numbers table with allocation concealment by opaque envelopes. Methods Participants 25–50 years who had a BMI ≥ 25 kg/m2 and a waist circumference ≥ 88 cm were recruited from 18 census tracts in Columbia, SC with high rates of poverty between November 2008 and November 2010. All participants received a dietary and exercise counseling session. Intervention participants then receive 16 theoretically-based and tailored weekly group sessions followed by 8 weeks of telephone maintenance counseling. Control participants receive 16 weekly health education mailings. Measurements correspond to baseline, post-group intervention, and post-telephone counseling, and for intervention participants, after a 12-week no-contact period. Measurement staff was blinded to group assignment. Results Participants (N=155; n=80 intervention, n=75 minimal intervention control) were primarily African American (86.5%) and averaged 38.9 years with a mean BMI of 40.1 kg/m2 and waist circumference of 115.4 cm. Food insecurity was reported by 43% of participants. Summary STARS targets an underserved population with an innovative, tailored, and theoretically-grounded, group-based intervention followed by telephone maintenance. If effective, the approach has the potential to be feasible and cost-effective for community delivery. PMID:21864718

  16. Improved cognitive function in postmenopausal women after 12 weeks of consumption of a soya extract containing isoflavones.

    PubMed

    Duffy, Rosanna; Wiseman, Helen; File, Sandra E

    2003-06-01

    We previously reported that a high soya diet improved memory and frontal lobe function in young volunteers, and since soya isoflavones are agonists at oestrogen receptors, they may improve these functions in postmenopausal women. Thirty-three postmenopausal women (50-65 years) not receiving conventional hormone replacement therapy (HRT) were randomly allocated in a double-blind parallel study to receive a soya supplement (60 mg total isoflavone equivalents/day) or placebo for 12 weeks. They received a battery of cognitive tests and completed analogue rating scales of mood and sleepiness, and a menopausal symptoms questionnaire before the start of treatment and then after 12 weeks of treatment. Those receiving the isoflavone supplement showed significantly greater improvements in recall of pictures and in a sustained attention task. The groups did not differ in their ability to learn rules, but the isoflavone supplement group showed significantly greater improvements in learning rule reversals. They also showed significantly greater improvement in a planning task. There was no effect of treatment on menopausal symptoms, self-ratings of mood, bodily symptoms or sleepiness. Thus, significant cognitive improvements in postmenopausal women can be gained from 12 weeks of consumption of a supplement containing soya isoflavones that are independent of any changes in menopausal symptoms, mood or sleepiness.

  17. Effects of 12 weeks combined aerobic and resistance exercise on heart rate variability in type 2 diabetes mellitus patients.

    PubMed

    Kang, Seol-Jung; Ko, Kwang-Jun; Baek, Un-Hyo

    2016-07-01

    [Purpose] This study evaluated the effects of 12 weeks combined aerobic and resistance exercise on heart rate variability in patients with Type 2 diabetes mellitus. [Subjects and Methods] The subjects were 16 female patients with Type 2 diabetes mellitus selected among the participants of a chronic disease management exercise class at C Region Public Health Center in South Korea. Subjects were randomly assigned to the exercise group (n=8; age, 55.97 ± 7.37) or the control group (n=8; age, 57.53 ± 4.63) The exercise group performed aerobic and resistance exercises for 60 minutes per day, 3 times per week for 12 weeks. Anthropometric measurements, biochemical markers, physical fitness, and heart rate variability were examined. [Results] After 12 weeks of exercise, weight, body fat percentage, waist circumference, blood glucose, insulin resistance, glycated hemoglobin level, systolic blood pressure, and diastolic blood pressure significantly decreased and cardiorespiratory fitness and muscular strength significantly increased in the exercise group. Although heart rate variability measures showed favorable changes with the exercise program, none were significant. [Conclusion] Although the exercise program did not show notable changes in heart rate variability in patients with Type 2 diabetes within the timeframe of the study, exercise may contribute to the prevention and control of cardiovascular autonomic neuropathy. PMID:27512271

  18. Effects of 12 weeks combined aerobic and resistance exercise on heart rate variability in type 2 diabetes mellitus patients

    PubMed Central

    Kang, Seol-Jung; Ko, Kwang-Jun; Baek, Un-Hyo

    2016-01-01

    [Purpose] This study evaluated the effects of 12 weeks combined aerobic and resistance exercise on heart rate variability in patients with Type 2 diabetes mellitus. [Subjects and Methods] The subjects were 16 female patients with Type 2 diabetes mellitus selected among the participants of a chronic disease management exercise class at C Region Public Health Center in South Korea. Subjects were randomly assigned to the exercise group (n=8; age, 55.97 ± 7.37) or the control group (n=8; age, 57.53 ± 4.63) The exercise group performed aerobic and resistance exercises for 60 minutes per day, 3 times per week for 12 weeks. Anthropometric measurements, biochemical markers, physical fitness, and heart rate variability were examined. [Results] After 12 weeks of exercise, weight, body fat percentage, waist circumference, blood glucose, insulin resistance, glycated hemoglobin level, systolic blood pressure, and diastolic blood pressure significantly decreased and cardiorespiratory fitness and muscular strength significantly increased in the exercise group. Although heart rate variability measures showed favorable changes with the exercise program, none were significant. [Conclusion] Although the exercise program did not show notable changes in heart rate variability in patients with Type 2 diabetes within the timeframe of the study, exercise may contribute to the prevention and control of cardiovascular autonomic neuropathy. PMID:27512271

  19. A Cluster Randomized Controlled Trial of Nonpharmacological Interventions for Old-Old Subjects with a Clinical Dementia Rating of 0.5: The Kurihara Project

    PubMed Central

    Nakatsuka, Masahiro; Nakamura, Kei; Hamanosono, Ryo; Takahashi, Yumi; Kasai, Mari; Sato, Yuko; Suto, Teiko; Nagatomi, Ryoichi; Meguro, Kenichi

    2015-01-01

    Background Evidence as to the benefits of nonpharmacological interventions for the boundary state between normal aging and dementia [mild cognitive impairment or a Clinical Dementia Rating (CDR) of 0.5] remains weak due to a lack of positive controls. Aims To directly compare the effects of cognitive interventions (CI), physical activities (PA) and a group reminiscence approach (GRA), we conducted a pilot study on the basis of a cluster randomized controlled trial design. Method A total of 127 participants aged >74 years with a CDR of 0.5 were cluster randomized into three groups for CI, PA and GRA. The intervention lasted 12 weeks and consisted of weekly group sessions and home assignments. Mini-Mental State Examination (MMSE), Trail Making Test part A (TMT-A), word fluency (WF), 6-meter walk time and Quality of Life (QOL) Face Scale scores were evaluated as primary outcomes. Results Methodology-related benefits of CI and PA were found for MMSE scores and walk time, respectively. TMT-A, WF and QOL Face Scale scores improved irrespective of the methodologies used. Conclusions Our findings suggest that CI and PA may be beneficial to cognitive and physical abilities, respectively. Executive functions and QOL may improve irrespective of the intervention methodologies used. PMID:26195978

  20. Nutrition intervention for migraine: a randomized crossover trial

    PubMed Central

    2014-01-01

    Background Limited evidence suggests that dietary interventions may offer a promising approach for migraine. The purpose of this study was to determine the effects of a low-fat plant-based diet intervention on migraine severity and frequency. Methods Forty-two adult migraine sufferers were recruited from the general community in Washington, DC, and divided randomly into two groups. This 36-week crossover study included two treatments: dietary instruction and placebo supplement. Each treatment period was 16 weeks, with a 4-week washout between. During the diet period, a low-fat vegan diet was prescribed for 4 weeks, after which an elimination diet was used. Participants were assessed at the beginning, midpoint, and end of each period. Significance was determined using student’s t-tests. Results Worst headache pain in last 2 weeks, as measured by visual analog scale, was initially 6.4/10 cm (SD 2.1 cm), and declined 2.1 cm during the diet period and 0.7 cm during the supplement period (p=0.03). Average headache intensity (0–10 scale) was initially 4.2 (SD 1.4) per week, and this declined by 1.0 during the diet period and by 0.5 during the supplement period (p=0.20). Average headache frequency was initially 2.3 (SD 1.8) per week, and this declined by 0.3 during the diet period and by 0.4 during the supplement period (p=0.61). The Patient’s Global Impression of Change showed greater improvement in pain during the diet period (p<0.001). Conclusions These results suggest that a nutritional approach may be a useful part of migraine treatment, but that methodologic issues necessitate further research. Trial registration Clinicaltrials.gov, NCT01699009 and NCT01547494. PMID:25339342

  1. A Cognitive Behavioral Therapy–Based Text Messaging Intervention Versus Medical Management for HIV-Infected Substance Users: Study Protocol for a Pilot Randomized Trial

    PubMed Central

    Patrick, Kevin; Ybarra, Michele L; Reback, Cathy J; Rawson, Richard A; Chokron Garneau, Helene; Chavez, Kathryn; Venegas, Alexandra

    2016-01-01

    Background Evidence-based psychosocial interventions for addictions and related conditions such as cognitive behavioral therapy (CBT) are underutilized. Obstacles to implementation of CBT in clinical settings include limited availability of quality training, supervision, and certification in CBT for clinicians; high rates of clinician turnover and high caseloads; and limited qualifications of the workforce to facilitate CBT expertise. Objective Mobile phone–based delivery of CBT, if demonstrated to be feasible and effective, could be transformative in broadening its application and improving the quality of addiction treatment. No experimental interventions that deliver CBT targeting both drug use and medication adherence using text messaging have been previously reported; as such, the objective of this study is to develop and test an SMS-based treatment program for HIV-positive adults with comorbid substance use disorders. Methods With user input, we developed a 12-week CBT-based text messaging intervention (TXT-CBT) targeting antiretroviral (ART) adherence, risk behaviors, and drug use in a population of HIV-infected substance users. Results The intervention has been developed and is presently being tested in a pilot randomized clinical trial. Results will be reported later this year. Conclusions This investigation will yield valuable knowledge about the utility of a cost-effective, readily deployable text messaging behavioral intervention for HIV-infected drug users. PMID:27341852

  2. Discourse-based intervention for modifying supervisory communication as leverage for safety climate and performance improvement: a randomized field study.

    PubMed

    Zohar, Dov; Polachek, Tal

    2014-01-01

    The article presents a randomized field study designed to improve safety climate and resultant safety performance by modifying daily messages in supervisor-member communications. Supervisors in the experimental group received 2 individualized feedback sessions regarding the extent to which they integrated safety and productivity-related issues in daily verbal exchanges with their members; those in the control group received no feedback. Feedback data originated from 7-9 workers for each supervisor, reporting about received supervisory messages during the most recent verbal exchange. Questionnaire data collected 8 weeks before and after the 12-week intervention phase revealed significant changes for safety climate, safety behavior, subjective workload, teamwork, and (independently measured) safety audit scores for the experimental group. Data for the control group (except for safety behavior) remained unchanged. These results are explained by corresponding changes (or lack thereof in the control group) in perceived discourse messages during the 6-week period between the 1st and 2nd feedback sessions. Theoretical and practical implications for climate improvement and organizational discourse research are discussed.

  3. Citalopram intervention for hostility: results of a randomized clinical trial.

    PubMed

    Kamarck, Thomas W; Haskett, Roger F; Muldoon, Matthew; Flory, Janine D; Anderson, Barbara; Bies, Robert; Pollock, Bruce; Manuck, Stephen B

    2009-02-01

    Hostility is associated with an increased risk for cardiovascular disease (CVD). Because central serotonin may modulate aggression, we might expect selective serotonin reuptake inhibitors (SSRIs) to be effective in reducing hostility. Such effects have never been examined in individuals scoring high on hostility who are otherwise free from major Axis I psychopathology according to criteria in the Diagnostic and Statistical Manual of Mental Disorders (4th ed., Text Revision; American Psychiatric Association, 2000). A total of 159 participants (ages 30?50 years, 50% female) scoring high on 2 measures of hostility and with no current major Axis I diagnosis were randomly assigned to 2 months of citalopram (40 mg, fixed-flexible dose) or placebo. Adherence was assessed by electronic measurement and by drug exposure assessment. Treated participants showed larger reductions in state anger (Condition x Time; p = .01), hostile affect (p = 02), and, among women only, physical and verbal aggression (p = .005) relative to placebo controls. Treatment was also associated with relative increases in perceived social support (p = .04). The findings have implications for understanding the central nervous system correlates of hostility, its associations with other psychosocial risk factors for CVD, and, potentially, the design of effective interventions. PMID:19170463

  4. A written language intervention for at-risk second grade students: a randomized controlled trial of the process assessment of the learner lesson plans in a tier 2 response-to-intervention (RtI) model.

    PubMed

    Hooper, Stephen R; Costa, Lara-Jeane C; McBee, Matthew; Anderson, Kathleen L; Yerby, Donna Carlson; Childress, Amy; Knuth, Sean B

    2013-04-01

    In a randomized controlled trial, 205 students were followed from grades 1 to 3 with a focus on changes in their writing trajectories following an evidence-based intervention during the spring of second grade. Students were identified as being at-risk (n=138), and then randomized into treatment (n=68) versus business-as-usual conditions (n=70). A typical group also was included (n=67). The writing intervention comprised Lesson Sets 4 and 7 from the Process Assessment of the Learner (PAL), and was conducted via small groups (three to six students) twice a week for 12 weeks in accordance with a response-to-intervention Tier 2 model. The primary outcome was the Wechsler Individual Achievement Test-II Written Expression Scale. Results indicated modest support for the PAL lesson plans, with an accelerated rate of growth in writing skills following treatment. There were no significant moderator effects, although there was evidence that the most globally impaired students demonstrated a more rapid rate of growth following treatment. These findings suggest the need for ongoing examination of evidence-based treatments in writing for young elementary students. PMID:21837551

  5. A written language intervention for at-risk second grade students: a randomized controlled trial of the process assessment of the learner lesson plans in a tier 2 response-to-intervention (RtI) model.

    PubMed

    Hooper, Stephen R; Costa, Lara-Jeane C; McBee, Matthew; Anderson, Kathleen L; Yerby, Donna Carlson; Childress, Amy; Knuth, Sean B

    2013-04-01

    In a randomized controlled trial, 205 students were followed from grades 1 to 3 with a focus on changes in their writing trajectories following an evidence-based intervention during the spring of second grade. Students were identified as being at-risk (n=138), and then randomized into treatment (n=68) versus business-as-usual conditions (n=70). A typical group also was included (n=67). The writing intervention comprised Lesson Sets 4 and 7 from the Process Assessment of the Learner (PAL), and was conducted via small groups (three to six students) twice a week for 12 weeks in accordance with a response-to-intervention Tier 2 model. The primary outcome was the Wechsler Individual Achievement Test-II Written Expression Scale. Results indicated modest support for the PAL lesson plans, with an accelerated rate of growth in writing skills following treatment. There were no significant moderator effects, although there was evidence that the most globally impaired students demonstrated a more rapid rate of growth following treatment. These findings suggest the need for ongoing examination of evidence-based treatments in writing for young elementary students.

  6. Self-presentation in exercise: changes over a 12-week cardiovascular programme for overweight and obese sedentary females.

    PubMed

    Pearson, Erin S; Hall, Craig R; Gammage, Kimberley L

    2013-01-01

    Self-presentational concerns, shown to influence exercise-related cognitions and behaviours, are evaluated frequently in the absence of exercise or following a single bout of physical activity. The purpose of the present study was to examine longitudinally, the extent to which participating in a structured 12-week cardiovascular exercise intervention elicited changes in self-presentational efficacy expectancy (SPEE) and social physique anxiety (SPA). Participants were 80 sedentary women with overweight or obesity (mean body mass index 29.02 kg/m(2), SD=4.71) between the ages of 19 and 45 wanting to begin an exercise programme (mean age 33.4 years, SD=7.6). The Self-Presentational Efficacy Scale (SPES) and the Social Physique Anxiety Scale (SPAS) were completed by each participant prior to commencing the study, and at the 6- and 12-week time points. For those who completed the programme, repeated measures ANOVAs indicated significant increases in SPEE between baseline and week 6 (P<0.001, η(2)=0.37), and week 6 to 12 (P<0.05, η(2)=0.10), while SPA decreased significantly between baseline and week 6 (P<0.01, η(2)=0.16). Bivariate correlation analyses revealed that length of participation in the study was positively related to SPEE and negatively related to SPA. Implications of focusing on these variables within a physical activity intervention are discussed with respect to exercise behaviour, programme development and adherence. PMID:23834547

  7. Exercise as an Intervention to Reduce Study-Related Fatigue among University Students: A Two-Arm Parallel Randomized Controlled Trial

    PubMed Central

    de Vries, Juriena D.; van Hooff, Madelon L. M.; Geurts, Sabine A. E.; Kompier, Michiel A. J.

    2016-01-01

    Background Many university students experience high levels of study-related fatigue. This high prevalence, and the negative impact of fatigue on health and academic performance, call for prevention and reduction of these symptoms. The primary aim of the current study was to investigate to what extent an exercise intervention is effective in reducing three indicators of study-related fatigue (emotional exhaustion, overall fatigue, and need for recovery). Effects of exercise on secondary outcomes (sleep quality, self-efficacy, physical fitness, and cognitive functioning) were also investigated. Methods Participants were students with high levels of study-related fatigue, currently not exercising or receiving other psychological or pharmacological treatments, and with no medical cause of fatigue. They were randomly assigned to either a six-week exercise intervention (low-intensity running three times a week, n = 49) or wait list (no intervention, n = 48). All participants were measured before the intervention (T0), and immediately after the intervention (T1). Exercisers were also investigated 4 weeks (T2) and 12 weeks (T3) after the intervention. Results Participants in the exercise condition showed a larger decrease in two of the three indicators of study-related fatigue (i.e., overall fatigue and need for recovery) as compared to controls. Additionally, sleep quality and some indicators of cognitive functioning improved more among exercisers than among controls. No effects were found for self-efficacy, and physical fitness. The initial effects of the exercise intervention lasted at follow-up (T2 and T3). At 12-week follow up (T3), 80% of participants in the exercise condition still engaged in regular exercise, and further enhancements were seen for emotional exhaustion, overall fatigue, and sleep quality. Conclusions These results underline the value of low-intensity exercise for university students with high levels of study-related fatigue. The follow-up effects

  8. Randomized Impact Evaluation of Education Interventions: Experiences and Lessons from a Reading to Learn Intervention in East Africa

    ERIC Educational Resources Information Center

    Ngware, Moses Waithanji; Abuya, Benta; Oketch, Moses; Admassu, Kassahun; Mutisya, Maurice; Musyoka, Peter

    2015-01-01

    This paper presents the experiences and lessons learnt during the design and implementation of the randomized impact evaluation (IE) of a reading to learn (RtL) intervention in early primary grades. The study was to assess the impact of RtL on literacy and numeracy among pupils in low-performing districts in East Africa. The intervention was…

  9. Can Group Interventions Facilitate Forgiveness of an Ex-Spouse?: A Randomized Clinical Trial

    ERIC Educational Resources Information Center

    Rye, Mark S.; Pargament, Kenneth I.; Pan, Wei; Yingling, David W.; Shogren, Karrie A.; Ito, Masako

    2005-01-01

    This study evaluated the effectiveness of 2 versions of an 8-session forgiveness group intervention for divorced individuals. Participants (randomized, n = 192; analyzed, n = 149) were randomly assigned to a secular forgiveness condition, a religious forgiveness condition, or a no-intervention comparison condition. Measures of forgiveness and…

  10. Changes in weight control behaviors and hedonic hunger during a 12-week commercial weight loss program.

    PubMed

    O'Neil, Patrick M; Theim, Kelly R; Boeka, Abbe; Johnson, Gail; Miller-Kovach, Karen

    2012-12-01

    Greater use of key self-regulatory behaviors (e.g., self-monitoring of food intake and weight) is associated with greater weight loss within behavioral weight loss treatments, although this association is less established within widely-available commercial weight loss programs. Further, high hedonic hunger (i.e., susceptibility to environmental food cues) may present a barrier to successful behavior change and weight loss, although this has not yet been examined. Adult men and women (N=111, body mass index M±SD=31.5±2.7kg/m(2)) were assessed before and after participating in a 12-week commercial weight loss program. From pre- to post-treatment, reported usage of weight control behaviors improved and hedonic hunger decreased, and these changes were inversely associated. A decrease in hedonic hunger was associated with better weight loss. An improvement in reported weight control behaviors (e.g., self-regulatory behaviors) was associated with better weight loss, and this association was even stronger among individuals with high baseline hedonic hunger. Findings highlight the importance of specific self-regulatory behaviors within weight loss treatment, including a commercial weight loss program developed for widespread community implementation. Assessment of weight control behavioral skills usage and hedonic hunger may be useful to further identify mediators of weight loss within commercial weight loss programs. Future interventions might specifically target high hedonic hunger and prospectively examine changes in hedonic hunger during other types of weight loss treatment to inform its potential impact on sustained behavior change and weight control.

  11. Efficacy of nonsurgical interventions for anterior knee pain: systematic review and meta-analysis of randomized trials.

    PubMed

    Collins, Natalie J; Bisset, Leanne M; Crossley, Kay M; Vicenzino, Bill

    2012-01-01

    Anterior knee pain is a chronic condition that presents frequently to sports medicine clinics, and can have a long-term impact on participation in physical activity. Conceivably, effective early management may prevent chronicity and facilitate physical activity. Although a variety of nonsurgical interventions have been advocated, previous systematic reviews have consistently been unable to reach conclusions to support their use. Considering a decade has lapsed since publication of the most recent data in these reviews, it is timely to provide an updated synthesis of the literature to assist sports medicine practitioners in making informed, evidence-based decisions. A systematic review and meta-analysis was conducted to evaluate the evidence for nonsurgical interventions for anterior knee pain. A comprehensive search strategy was used to search MEDLINE, EMBASE, CINAHL and Pre-CINAHL, PEDro, PubMed, SportDiscus, Web of Science, BIOSIS Previews, and the full Cochrane Library, while reference lists of included papers and previous systematic reviews were hand searched. Studies were eligible for inclusion if they were randomized clinical trials that used a measure of pain to evaluate at least one nonsurgical intervention over at least 2 weeks in participants with anterior knee pain. A modified version of the PEDro scale was used to rate methodological quality and risk of bias. Effect size calculation and meta-analyses were based on random effects models. Of 48 suitable studies, 27 studies with low-to-moderate risk of bias were included. There was minimal opportunity for meta-analysis because of heterogeneity of interventions, comparators and follow-up times. Meta-analysis of high-quality clinical trials supports the use of a 6-week multimodal physiotherapy programme (standardized mean difference [SMD] 1.08, 95% CI 0.73, 1.43), but does not support the addition of electromyography biofeedback to an exercise programme in the short-term (4 weeks: SMD -0.21, 95% CI -0.64, 0

  12. Promoting Early Intervention Referral through a Randomized Controlled Home-Visiting Program

    ERIC Educational Resources Information Center

    Schwarz, Donald F.; O'Sullivan, Ann L.; Guinn, Judith; Mautone, Jennifer A.; Carlson, Elyse C.; Zhao, Huaqing; Zhang, Xuemei; Esposito, Tara L.; Askew, Megan; Radcliffe, Jerilynn

    2012-01-01

    The MOM Program is a randomized, controlled trial of an intervention to promote mothers' care for the health and development of their children, including accessing early intervention (EI) services. Study aims were to determine whether, relative to controls, this intervention increased receipt of and referral to EI services. Mothers (N = 302)…

  13. A Body Image and Disordered Eating Intervention for Women in Midlife: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    McLean, Sian A.; Paxton, Susan J.; Wertheim, Eleanor H.

    2011-01-01

    Objective: This study examined the outcome of a body image and disordered eating intervention for midlife women. The intervention was specifically designed to address risk factors that are pertinent in midlife. Method: Participants were 61 women aged 30 to 60 years (M = 43.92, SD = 8.22) randomly assigned to intervention (n = 32) or (delayed…

  14. Randomized Trial of a Broad Preventive Intervention for Mexican American Adolescents

    ERIC Educational Resources Information Center

    Gonzales, Nancy A.; Dumka, Larry E.; Millsap, Roger E.; Gottschall, Amanda; McClain, Darya B.; Wong, Jessie J.; German, Miguelina; Mauricio, Anne M.; Wheeler, Lorey; Carpentier, Francesca D.; Kim, Su Yeong

    2012-01-01

    Objective: This randomized trial of a family-focused preventive intervention for Mexican American (MA) adolescents evaluated intervention effects on adolescent substance use, internalizing and externalizing symptoms, and school discipline and grade records in 8th grade, 1 year after completion of the intervention. The study also examined…

  15. Brief Motivational and Parent Interventions for College Students: A Randomized Factorial Study

    ERIC Educational Resources Information Center

    Wood, Mark D.; Fairlie, Anne M.; Fernandez, Anne C.; Borsari, Brian; Capone, Christy; Laforge, Robert; Carmona-Barros, Rosa

    2010-01-01

    Objective: Using a randomized factorial design, we examined the efficacy of a brief motivational intervention (BMI) and a parent-based intervention (PBI) as universal preventive interventions to reduce alcohol use among incoming college students. Method: Participants (N = 1,014) were assessed prior to matriculation and at 10 months and 22 months…

  16. Successfully Promoting 21st Century Online Research Skills: Interventions in 5th-Grade Classrooms

    ERIC Educational Resources Information Center

    Kingsley, Tara L.; Cassady, Jerrell C.; Tancock, Susan M.

    2015-01-01

    This quantitative study was developed to explore the ability to impact elementary student 21st Century online research skills with a planned classroom intervention curriculum. The repeated measures quasi-experimental study randomly assigned all 5th grade classes in a Midwestern, suburban school (n = 418) to a 12-week intervention or control…

  17. Effects of 12-Week Bacopa monnieri Consumption on Attention, Cognitive Processing, Working Memory, and Functions of Both Cholinergic and Monoaminergic Systems in Healthy Elderly Volunteers

    PubMed Central

    Peth-Nui, Tatimah; Wattanathorn, Jintanaporn; Muchimapura, Supaporn; Tong-Un, Terdthai; Piyavhatkul, Nawanant; Rangseekajee, Poonsri; Ingkaninan, Kornkanok; Vittaya-areekul, Sakchai

    2012-01-01

    At present, the scientific evidence concerning the effect of Bacopa monnieri on brain activity together with working memory is less available. Therefore, we aimed to determine the effect of B. monnieri on attention, cognitive processing, working memory, and cholinergic and monoaminergic functions in healthy elderly. A randomized double-blind placebo-controlled design was utilized. Sixty healthy elderly subjects (mean age 62.62 years; SD 6.46), consisting of 23 males and 37 females, received either a standardized extract of B. monnieri (300 and 600 mg) or placebo once daily for 12 weeks. The cholinergic and monoaminergic systems functions were determined using AChE and MAO activities. Working memory was assessed using percent accuracy and reaction time of various memory tests as indices, whereas attention and cognitive processing were assessed using latencies and amplitude of N100 and P300 components of event-related potential. All assessments were performed before treatment, every four weeks throughout study period, and at four weeks after the cessation of intervention. B. monnieri-treated group showed improved working memory together with a decrease in both N100 and P300 latencies. The suppression of plasma AChE activity was also observed. These results suggest that B. monnieri can improve attention, cognitive processing, and working memory partly via the suppression of AChE activity. PMID:23320031

  18. Improvement in Patient Performance of Skin Self-examinations After Intervention With Interactive Education and Telecommunication Reminders: A Randomized Controlled Study.

    PubMed

    Aneja, Savina; Brimhall, Angela K; Kast, Douglas R; Aneja, Sanjay; Carlson, Diana; Cooper, Kevin D; Bordeaux, Jeremy S

    2012-11-01

    OBJECTIVE To determine if interactive computerized patient education, skin self-examination (SSE) tutorials, and telecommunication reminders could be combined to increase patient performance of SSEs, increase confidence in ability to identify melanoma, and influence individual melanoma risk perception. DESIGN A total of 132 adult participants from our dermatology clinics were enrolled in an interventional study and randomized to a control group or an intervention group. Survey data were collected from all participants on the day of enrollment and 3 months after enrollment. SETTING University Hospitals Case Medical Center outpatient dermatology clinics. PARTICIPANTS English speakers older than 18 years. INTERVENTIONS The intervention group (1) participated in a computer-assisted learning tutorial, (2) took part in a hands-on SSE tutorial, (3) received monthly telecommunication reminders to perform SSEs for 12 weeks, and (4) received a brochure on melanoma detection. The control group received only the brochure on melanoma detection. MAIN OUTCOME MEASURES Self-report of performance of SSEs. Melanoma risk perception and confidence in ability to identify melanoma were secondary considerations. Logistic regressions, controlling for race, age, sex, education, and family history of melanoma, were used to assess the effectiveness of the intervention. RESULTS At the 3-month follow-up, those in the intervention group were more likely to perform SSEs (odds ratio [OR], 2.36; P ≤ .05). In addition, those who participated in the intervention were more likely to report being confident in their ability to identify melanoma during an SSE (OR, 2.72; P ≤ .05). CONCLUSION Computer-assisted patient education used in conjunction with a hands-on SSE tutorial and telecommunication reminders can increase patient performance of SSEs and confidence in the ability to identify melanoma.

  19. Paraneoplastic (non-metastatic) adrenal insufficiency preceded the onset of primary lung cancer by 12 weeks.

    PubMed

    Shantha, Ghanshyam Palamaner Subash; Kumar, Anita A; Jeyachandran, Vijay; Rajamanickam, Deepan; Bhaskar, Emmanuel; Paniker, Vinod K; Abraham, Georgi

    2009-01-01

    Clinically evident adrenal insufficiency associated with lung cancer is a rare entity. Among reported cases, adrenal insufficiency has occurred with or succeeded the primary lung cancer. Adrenal insufficiency has also been secondary to metastasis to the adrenal gland. The present report concerns a 61-year-old man, a chronic smoker, who presented to us with symptomatic adrenal insufficiency. He had no evidence of lung cancer during this visit. The primary lung cancer was only identified 12 weeks later. Additionally, his adrenals showed no evidence of metastasis. Hence his adrenal insufficiency had been a paraneoplastic manifestation of the lung cancer, and it had also preceded the primary by 12 weeks.

  20. Paraneoplastic (non-metastatic) adrenal insufficiency preceded the onset of primary lung cancer by 12 weeks

    PubMed Central

    Shantha, Ghanshyam Palamaner Subash; Kumar, Anita A; Jeyachandran, Vijay; Rajamanickam, Deepan; Bhaskar, Emmanuel; Paniker, Vinod K; Abraham, Georgi

    2009-01-01

    Clinically evident adrenal insufficiency associated with lung cancer is a rare entity. Among reported cases, adrenal insufficiency has occurred with or succeeded the primary lung cancer. Adrenal insufficiency has also been secondary to metastasis to the adrenal gland. The present report concerns a 61-year-old man, a chronic smoker, who presented to us with symptomatic adrenal insufficiency. He had no evidence of lung cancer during this visit. The primary lung cancer was only identified 12 weeks later. Additionally, his adrenals showed no evidence of metastasis. Hence his adrenal insufficiency had been a paraneoplastic manifestation of the lung cancer, and it had also preceded the primary by 12 weeks. PMID:21686682

  1. Effects of 12-week medicine ball training on muscle strength and power in young female handball players.

    PubMed

    Ignjatovic, Aleksandar M; Markovic, Zivorad M; Radovanovic, Dragan S

    2012-08-01

    The purpose of this study was to examine the effects of medicine ball training on the strength and power in young female handball athletes. Twenty-one young female handball players (age, 16.9 ± 1.2 years) were randomly assigned to experimental and control groups. Experimental group (n = 11) participated in a 12-week medicine ball training program incorporated into the regular training session, whereas controls (n = 10) participated only in the regular training. Performance in the medicine ball throws in standing and sitting positions, 1 repetition maximum (1RM) bench and shoulder press, and power test at 2 different loads (30 and 50% of 1RM) on bench and shoulder press were assessed at pre- and posttraining testing. The athletes participating in the medicine ball training program made significantly greater gains in all medicine ball throw tests compared with the controls (p < 0.01). Also, the experimental group made significantly greater gains in bench and shoulder press power than control group (p < 0.05). Both training groups (E) and (C) significantly (p < 0.05) increased 1RM bench and shoulder strength, with no differences observed between the groups. Additionally, medicine ball throw tests showed stronger correlation with power tests, than with 1RM tests. These data suggest that 12-week medicine ball training, when incorporated into a regular training session, can provide greater sport-specific training improvements in the upper body for young female handball players. PMID:22027860

  2. The Effects of a 12-Week Walking Program on Community-Dwelling Older Adults

    ERIC Educational Resources Information Center

    Cheng, Shun-Ping; Tsai, Tzu-I; Lii, Yun-Kung; Yu, Shu; Chou, Chen-Liang; Chen, I-Ju

    2009-01-01

    Walking is a popular and easily accessible form of physical activity. However, walking instruction for older adults is based on the evidence gathered from younger populations. This study evaluated walking conditions, strength, balance, and subjective health status after a 12-week walking-training program in community-dwelling adults greater than…

  3. The Treatment for Adolescents with Depression Study (TADS): Methods and Message at 12 Weeks

    ERIC Educational Resources Information Center

    March, John; Silva, Susan; Vitiello, Benedetto

    2006-01-01

    Funded by the National Institute of Mental Health, the Treatment for Adolescents With Depression Study (TADS) is intended to evaluate the short-term (12 weeks) and longer-term (36 weeks) effectiveness of four treatments for adolescents with DSM-IV major depressive disorder: clinical management with fluoxetine (FLX), cognitive-behavioral therapy…

  4. Achondrogenesis type 2 diagnosed by transvaginal ultrasound at 12 weeks' gestation.

    PubMed

    Soothill, P W; Vuthiwong, C; Rees, H

    1993-06-01

    Ultrasound examination at 12 weeks' gestation revealed severe generalised subcutaneous oedema in a pregnancy at risk for achondrogenesis type II. Transvaginal scanning confirmed the oedema and suggested abnormal limb development. The prenatal diagnosis was confirmed by X-ray examination after transvaginal termination. PMID:8372079

  5. Effects of a 12-week healthy-life exercise program on oxidized low-density lipoprotein cholesterol and carotid intima-media thickness in obese elderly women.

    PubMed

    Park, Jong-Hwan; Park, Hyuntae; Lim, Seung-Taek; Park, Jin-Kee

    2015-05-01

    [Purpose] This study examined the effects of a 12-week exercise program on plasma level of oxidized low-density lipoprotein cholesterol in obese elderly women, who are at increased risk of heart disease morbidity. [Subjects and Methods] Twenty participants were assigned into either a control (n = 10) or a supervised exercise program (n = 10) group. The 12-week exercise intervention was performed 3 days per week and involved combined aerobic exercise, resistance exercise, and traditional Korean dance. [Results] Two-factor analysis of variance revealed significant group × time interactions for body mass, diastolic blood pressure, appendicular muscle mass. For high-density lipoprotein cholesterol, oxidized low-density lipoprotein cholesterol, and the ratio of oxidized low-/high-density lipoprotein cholesterol, two-factor analysis of variance revealed significant interactions (group × time), indicating responses differed significantly between the control and exercise groups after 12 weeks. [Conclusion] A 12-week low- to moderate-intensity exercise program appears to be beneficial for obese elderly women by improving risk factors for cardiovascular disease.

  6. Randomized Controlled Trial of a Web-based Indoor Tanning Intervention: Acceptability and Preliminary Outcomes

    PubMed Central

    Stapleton, Jerod L.; Manne, Sharon L.; Darabos, Katie; Greene, Kathryn; Ray, Anne E.; Turner, Amber L.; Coups, Elliot J.

    2015-01-01

    Objective This manuscript describes the acceptability and preliminary behavioral outcomes from a pilot randomized control trial of a web-based indoor tanning intervention for young adult women. The intervention targets indoor tanning user’s perceptions of then benefits and value of tanning and addresses the role of body image-related constructs in indoor tanning. Methods Participants were 186 young adult women who reported indoor tanning at least once in the past 12 months. The study design was a 2-arm randomized controlled trial with pre and post assessments and random assignment to an intervention or control condition. Intervention acceptability was assessed by obtaining participants’ evaluation of the intervention. Regression analyses were used to test for intervention condition differences in preliminary behavioral outcomes measured at 6-weeks post-intervention. Results Participants provided favorable evaluations of the intervention on several dimensions and a highly positive overall rating. Intervention participants were more likely to report abstaining from indoor tanning and indicated a lower likelihood of using indoor tanning in the future compared to control participants on the post-intervention assessment. No differences were found for sunburns. Conclusions The results of this pilot randomized controlled trial provide evidence that the indoor tanning intervention is acceptable to participants and may encourage cessation of indoor tanning behavior. The findings provide preliminary support for an indoor tanning intervention that engages tanners to challenge their beliefs about the benefits of indoor tanning. The use of a web-based indoor tanning intervention is unique and provides strong potential for dissemination. PMID:26651469

  7. Use of a Structured Mirrors Intervention Does Not Reduce Delirium Incidence But May Improve Factual Memory Encoding in Cardiac Surgical ICU Patients Aged Over 70 Years: A Pilot Time-Cluster Randomized Controlled Trial

    PubMed Central

    Giraud, Kimberly; Pontin, Megan; Sharples, Linda D.; Fletcher, Paul; Dalgleish, Tim; Eden, Allaina; Jenkins, David P.; Vuylsteke, Alain

    2016-01-01

    Introduction: Post-operative delirium remains a significant problem, particularly in the older surgical patient. Previous evidence suggests that the provision of supplementary visual feedback about ones environment via the use of a mirror may positively impact on mental status and attention (core delirium diagnostic domains). We aimed to explore whether use of an evidence-based mirrors intervention could be effective in reducing delirium and improving post-operative outcomes such as factual memory encoding of the Intensive Care Unit (ICU) environment in older cardiac surgical patients. Methods: This was a pilot time-cluster randomized controlled trial at a 32-bed ICU, enrolling 223 patients aged 70 years and over, admitted to ICU after elective or urgent cardiac surgery from October 29, 2012 to June 23, 2013. The Mirrors Group received a structured mirrors intervention at set times (e.g., following change in mental status). The Usual Care Group received the standard care without mirrors. Primary outcome was ICU delirium incidence; secondary outcomes were ICU delirium days, ICU days with altered mental status or inattention, total length of ICU stay, physical mobilization (balance confidence) at ICU discharge, recall of factual and delusional ICU memories at 12 weeks, Health-Related Quality of Life at 12 weeks, and acceptability of the intervention. Results: The intervention was not associated with a significant reduction in ICU delirium incidence [Mirrors: 20/115 (17%); Usual Care: 17/108 (16%)] or duration [Mirrors: 1 (1–3); Usual Care: 2 (1–8)]. Use of the intervention on ICU was predictive of significantly higher recall of factual (but not delusional) items at 12 weeks after surgery (p = 0.003) and acceptability was high, with clinicians using mirrors at 86% of all recorded hourly observations. The intervention did not significantly impact on other secondary outcomes. Conclusion: Use of a structured mirrors intervention on the post-operative ICU does not

  8. A PARENT–ADOLESCENT INTERVENTION TO INCREASE SEXUAL RISK COMMUNICATION: RESULTS OF A RANDOMIZED CONTROLLED TRIAL

    PubMed Central

    Villarruel, Antonia M.; Cherry, Carol Loveland; Cabriales, Esther Gallegos; Ronis, David L.; Zhou, Yan

    2009-01-01

    This article reports results of a randomized controlled trial designed to test an intervention to increase parent–adolescent sexual risk communication among Mexican parents. Data were analyzed from parents (n = 791) randomly assigned to an HTV risk reduction or health promotion intervention. Measures were administered at pretest, posttest, and 6– and 12–month follow–ups. Generalized estimation equation (GEE) analysis indicates parents in the HIV risk reduction intervention reported significantly more general communication (p < .005), more sexual risk communication (p < .001) and more comfort with communication (p < .001) than parents in the control intervention. Behavioral, normative, and control beliefs significantly mediated the effect of the intervention on all communication outcomes. This study demonstrates the efficacy of an intervention to increase the quality and quantity of parent–adolescent communication related to general and sex–specific communication. PMID:18956979

  9. Using Multilevel Mixtures to Evaluate Intervention Effects in Group Randomized Trials

    ERIC Educational Resources Information Center

    Van Horn, M. Lee; Fagan, Abigail A.; Jaki, Thomas; Brown, Eric C.; Hawkins, J. David; Arthur, Michael W.; Abbott, Robert D.; Catalano, Richard F.

    2008-01-01

    There is evidence to suggest that the effects of behavioral interventions may be limited to specific types of individuals, but methods for evaluating such outcomes have not been fully developed. This study proposes the use of finite mixture models to evaluate whether interventions, and, specifically, group randomized trials, impact participants…

  10. An Intervention for Sensory Difficulties in Children with Autism: A Randomized Trial

    ERIC Educational Resources Information Center

    Schaaf, Roseann C.; Benevides, Teal; Mailloux, Zoe; Faller, Patricia; Hunt, Joanne; van Hooydonk, Elke; Freeman, Regina; Leiby, Benjamin; Sendecki, Jocelyn; Kelly, Donna

    2014-01-01

    This study evaluated a manualized intervention for sensory difficulties for children with autism, ages 4-8 years, using a randomized trial design. Diagnosis of autism was confirmed using gold standard measures. Results show that the children in the treatment group (n = 17) who received 30 sessions of the occupational therapy intervention scored…

  11. Randomized Controlled Caregiver Mediated Joint Engagement Intervention for Toddlers with Autism

    ERIC Educational Resources Information Center

    Kasari, Connie; Gulsrud, Amanda C.; Wong, Connie; Kwon, Susan; Locke, Jill

    2010-01-01

    This study aimed to determine if a joint attention intervention would result in greater joint engagement between caregivers and toddlers with autism. The intervention consisted of 24 caregiver-mediated sessions with follow-up 1 year later. Compared to caregivers and toddlers randomized to the waitlist control group the immediate treatment (IT)…

  12. A Randomized Test of a Small-Group Interactive Social Norms Intervention

    ERIC Educational Resources Information Center

    Reilly, Daniel William; Wood, Mark David

    2008-01-01

    Social norms interventions are a common approach to addressing the problem of college student drinking. An increasingly popular but not yet well-validated social-norms-based intervention consists of providing normative feedback to students in small groups. Objective, Participants, and Methods: In this study, the authors used a randomized design to…

  13. A Randomized Trial of a Multifaceted Intervention to Reduce Falls among Community-Dwelling Adults

    ERIC Educational Resources Information Center

    Fox, Patrick J.; Vazquez, Laurie; Tonner, Chris; Stevens, Judy A.; Fineman, Norman; Ross, Leslie K.

    2010-01-01

    Using a randomized controlled trial, we tested the efficacy of a fall prevention intervention to reduce falls among adults in a community-based health promotion program. Adults aged 65 and older within two counties were recruited (control n = 257; intervention n = 286). After 12 months, there was a significant decrease in the number of falls in…

  14. "Right from the Start": Randomized Trial Comparing an Attachment Group Intervention to Supportive Home Visiting

    ERIC Educational Resources Information Center

    Niccols, Alison

    2008-01-01

    Background: Infant attachment security is a protective factor for future mental health, and may be promoted by individual interventions. Given service demands, it is important to determine if a group-based intervention for parents could be used to enhance infant attachment security. Methods: In a randomized trial involving 76 mothers, an 8-session…

  15. Testing Mediators of Intervention Effects in Randomized Controlled Trials: An Evaluation of Three Depression Prevention Programs

    ERIC Educational Resources Information Center

    Stice, Eric; Rohde, Paul; Seeley, John R.; Gau, Jeff M.

    2010-01-01

    Objective: Evaluate a new 5-step method for testing mediators hypothesized to account for the effects of depression prevention programs. Method: In this indicated prevention trial, at-risk teens with elevated depressive symptoms were randomized to a group cognitive-behavioral (CB) intervention, group supportive expressive intervention, CB…

  16. Randomized Controlled Trial of a Preventive Intervention for Perinatal Depression in High-Risk Latinas

    ERIC Educational Resources Information Center

    Le, Huynh-Nhu; Perry, Deborah F.; Stuart, Elizabeth A.

    2011-01-01

    Objective: A randomized controlled trial was conducted to evaluate the efficacy of a cognitive-behavioral (CBT) intervention to prevent perinatal depression in high-risk Latinas. Method: A sample of 217 participants, predominantly low-income Central American immigrants who met demographic and depression risk criteria, were randomized into usual…

  17. Evaluating the Collaborative Strategic Reading Intervention: An Overview of Randomized Controlled Trial Options

    ERIC Educational Resources Information Center

    Hitchcock, John H.; Kurki, Anja; Wilkins, Chuck; Dimino, Joseph; Gersten, Russell

    2009-01-01

    When attempting to determine if an intervention has a causal impact, the "gold standard" of program evaluation is the randomized controlled trial (RCT). In education studies random assignment is rarely feasible at the student level, making RCTs harder to conduct. School-level assignment is more common but this often requires considerable resources…

  18. Lateralization of infant holding by mothers: A longitudinal evaluation of variations over the first 12 weeks.

    PubMed

    Todd, Brenda K; Banerjee, Robin

    2016-01-01

    The maternal preference to hold infants on the left rather than right side of the body was examined longitudinally, with attention to 4 explanations: maternal monitoring of infant state, maternal handedness, infant proximity to the mother's heartbeat, and preferred infant head position. The side and site of holding were measured over the first 12 weeks of the lives of 24 infants. Information about group and individual consistency in holding side allowed novel evaluation of the theories. A strong bias to hold on the left dropped below significance when the infants were aged 12 weeks and was limited to specific holding positions. Findings were generally consistent with the monitoring hypothesis, and little support was found for the 3 alternative explanations.

  19. The effect of 12-week Pilates exercises on wellness in the elderly.

    PubMed

    Roh, Su Yeon

    2016-04-01

    The purpose of this study is to examine the efficiency of 12-week Pilates exercises on wellness in the elderly. Before Pilates exercises training, the 88 elderly (63 females, 25 males) were given and completed a Wellness Scale. Then, the elderly participated in Pilates exercises and completed the same scale afterwards. Results of paired t-test showed that participants in 12-week Pilates exercises experienced significant improvement in physical (t=2.762, P<0.01), social (t=3.362, P<0.001), spiritual (t=2.307, P<0.05), and emotional wellness (t=2.489, P<0.05). Consequently, Pilates exercises helped improve wellness of the elderly. PMID:27162774

  20. The effect of 12-week Pilates exercises on wellness in the elderly

    PubMed Central

    Roh, Su Yeon

    2016-01-01

    The purpose of this study is to examine the efficiency of 12-week Pilates exercises on wellness in the elderly. Before Pilates exercises training, the 88 elderly (63 females, 25 males) were given and completed a Wellness Scale. Then, the elderly participated in Pilates exercises and completed the same scale afterwards. Results of paired t-test showed that participants in 12-week Pilates exercises experienced significant improvement in physical (t=2.762, P<0.01), social (t=3.362, P<0.001), spiritual (t=2.307, P<0.05), and emotional wellness (t=2.489, P<0.05). Consequently, Pilates exercises helped improve wellness of the elderly. PMID:27162774

  1. Intervention effects on negative affect of CPS-referred children: results of a randomized clinical trial.

    PubMed

    Lind, Teresa; Bernard, Kristin; Ross, Emily; Dozier, Mary

    2014-09-01

    Exposure to early adversity places young children at risk for behavioral, physiological, and emotional dysregulation, predisposing them to a range of long-term problematic outcomes. Attachment and Biobehavioral Catch-up (ABC) is a 10-session intervention designed to enhance children's self-regulatory capabilities by helping parents to behave in nurturing, synchronous, and non-frightening ways. The effectiveness of the intervention was assessed in a randomized clinical trial, with parents who had been referred to Child Protective Services (CPS) for allegations of maltreatment. Parent-child dyads received either the ABC intervention or a control intervention. Following the intervention, children from the ABC intervention (n=56) expressed lower levels of negative affect during a challenging task compared to children from the control intervention (n=61). PMID:24814751

  2. Lung function profiles and aerobic capacity of adult cigarette and hookah smokers after 12 weeks intermittent training

    PubMed Central

    Koubaa, Abdessalem; Triki, Moez; Trabelsi, Hajer; Masmoudi, Liwa; Zeghal, Khaled N.; Sahnoun, Zouhair; Hakim, Ahmed

    2015-01-01

    Introduction Pulmonary function is compromised in most smokers. Yet it is unknown whether exercise training improves pulmonary function and aerobic capacity in cigarette and hookah smokers and whether these smokers respond in a similar way as do non-smokers. Aim To evaluate the effects of an interval exercise training program on pulmonary function and aerobic capacity in cigarette and hookah smokers. Methods Twelve cigarette smokers, 10 hookah smokers, and 11 non-smokers participated in our exercise program. All subjects performed 30 min of interval exercise (2 min of work followed by 1 min of rest) three times a week for 12 weeks at an intensity estimated at 70% of the subject's maximum aerobic capacity (V.O2max). Pulmonary function was measured using spirometry, and maximum aerobic capacity was assessed by maximal exercise testing on a treadmill before the beginning and at the end of the exercise training program. Results As expected, prior to the exercise intervention, the cigarette and hookah smokers had significantly lower pulmonary function than the non-smokers. The 12-week exercise training program did not significantly affect lung function as assessed by spirometry in the non-smoker group. However, it significantly increased both forced expiratory volume in 1 second and peak expiratory flow (PEF) in the cigarette smoker group, and PEF in the hookah smoker group. Our training program had its most notable impact on the cardiopulmonary system of smokers. In the non-smoker and cigarette smoker groups, the training program significantly improved V.O2max (4.4 and 4.7%, respectively), v V.O2max (6.7 and 5.6%, respectively), and the recovery index (7.9 and 10.5%, respectively). Conclusions After 12 weeks of interval training program, the increase of V.O2max and the decrease of recovery index and resting heart rate in the smoking subjects indicated better exercise tolerance. Although the intermittent training program altered pulmonary function only partially, both

  3. 12 Weeks of Daclatasvir in Combination With Sofosbuvir for HIV-HCV Coinfection (ALLY-2 Study): Efficacy and Safety by HIV Combination Antiretroviral Regimens

    PubMed Central

    Luetkemeyer, Anne F.; McDonald, Cheryl; Ramgopal, Moti; Noviello, Stephanie; Bhore, Rafia; Ackerman, Peter

    2016-01-01

    Background. Highly effective hepatitis C virus (HCV) direct-acting antiviral therapies that do not require modification of human immunodeficiency virus (HIV) antiretroviral regimens are needed. We evaluated the efficacy and safety of daclatasvir + sofosbuvir (DCV + SOF) for 12 weeks by antiretroviral (ARV) regimen in HIV-HCV-coinfected patients. Methods. In the randomized, open-label ALLY-2 study, HIV-HCV-coinfected patients received 8 or 12 weeks of once-daily DCV 60 mg (dose-adjusted as-necessary for concomitant ARVs) + SOF 400 mg. Results were stratified by ARV class for the 151 patients who received 12 weeks of DCV + SOF. Results. Fifty-one patients were HCV treatment experienced, 100 were treatment naive, 89% male and 33% black. HCV genotypes were: genotype 1a (GT1a; 69%), GT1b (15%), GT2 (8%), GT3 (6%), and GT4 (2%). Sustained virologic response 12 weeks post-treatment (SVR12) was 97% and was similar across ARV regimens (P = .774): protease inhibitor-based, 97% (95% confidence interval [CI], 90%-99.7%); nonnucleoside reverse transcriptase inhibitor-based, 100% (95% CI, 91%-100%); and integrase inhibitor based, 95% (95% CI, 83%-99.4%). SVR12 among patients receiving either tenofovir disoproxil fumarate or abacavir as part of their antiretroviral therapy regimen was 98% (95% CI, 93%-99.5%) and 100% (95% CI, 85%-100%), respectively. Age, gender, race, cirrhosis, HCV treatment history, GT , and baseline HCV RNA did not affect SVR12. No discontinuations were attributed to treatment-related adverse events. Conclusions. DCV + SOF x12 weeks is a highly efficacious, all-oral, pan-GT HCV treatment for HIV-HCV coinfected patients across a broad range of ARV regimens. Clinical Trials Registration. NCT02032888. PMID:27025835

  4. Efficacy of a reading and language intervention for children with Down syndrome: a randomized controlled trial

    PubMed Central

    Burgoyne, Kelly; Duff, Fiona J; Clarke, Paula J; Buckley, Sue; Snowling, Margaret J; Hulme, Charles

    2012-01-01

    Background This study evaluates the effects of a language and literacy intervention for children with Down syndrome. Methods Teaching assistants (TAs) were trained to deliver a reading and language intervention to children in individual daily 40-min sessions. We used a waiting list control design, in which half the sample received the intervention immediately, whereas the remaining children received the treatment after a 20-week delay. Fifty-seven children with Down syndrome in mainstream primary schools in two UK locations (Yorkshire and Hampshire) were randomly allocated to intervention (40 weeks of intervention) and waiting control (20 weeks of intervention) groups. Assessments were conducted at three time points: pre-intervention, after 20 weeks of intervention, and after 40 weeks of intervention. Results After 20 weeks of intervention, the intervention group showed significantly greater progress than the waiting control group on measures of single word reading, letter-sound knowledge, phoneme blending and taught expressive vocabulary. Effects did not transfer to other skills (nonword reading, spelling, standardised expressive and receptive vocabulary, expressive information and grammar). After 40 weeks of intervention, the intervention group remained numerically ahead of the control group on most key outcome measures; but these differences were not significant. Children who were younger, attended more intervention sessions, and had better initial receptive language skills made greater progress during the course of the intervention. Conclusions A TA-delivered intervention produced improvements in the reading and language skills of children with Down syndrome. Gains were largest in skills directly taught with little evidence of generalization to skills not directly taught in the intervention. PMID:22533801

  5. A cluster randomized controlled trial to reduce childhood diarrhea using hollow fiber water filter and/or hygiene-sanitation educational interventions.

    PubMed

    Lindquist, Erik D; George, C M; Perin, Jamie; Neiswender de Calani, Karen J; Norman, W Ray; Davis, Thomas P; Perry, Henry

    2014-07-01

    Safe domestic potable water supplies are urgently needed to reduce childhood diarrheal disease. In periurban neighborhoods in Cochabamba, Bolivia, we conducted a cluster randomized controlled trial to evaluate the efficacy of a household-level hollow fiber filter and/or behavior change communication (BCC) on water, sanitation, and hygiene (WASH) to reduce the diarrheal disease in children less than 5 years of age. In total, 952 households were followed for a period of 12 weeks post-distribution of the study interventions. Households using Sawyer PointONE filters had significantly less diarrheal disease compared with the control arm during the intervention period, which was shown by diarrheal prevalence ratios of 0.21 (95% confidence interval [95% CI] = 0.15-0.30) for the filter arm and 0.27 (95% CI = 0.22-0.34) for the filter and WASH BCC arm. A non-significant reduction in diarrhea prevalence was reported in the WASH BCC study arm households (0.71, 95% CI = 0.59-0.86).

  6. A Cluster Randomized Controlled Trial to Reduce Childhood Diarrhea Using Hollow Fiber Water Filter and/or Hygiene–Sanitation Educational Interventions

    PubMed Central

    Lindquist, Erik D.; George, C. M.; Perin, Jamie; Neiswender de Calani, Karen J.; Norman, W. Ray; Davis, Thomas P.; Perry, Henry

    2014-01-01

    Safe domestic potable water supplies are urgently needed to reduce childhood diarrheal disease. In periurban neighborhoods in Cochabamba, Bolivia, we conducted a cluster randomized controlled trial to evaluate the efficacy of a household-level hollow fiber filter and/or behavior change communication (BCC) on water, sanitation, and hygiene (WASH) to reduce the diarrheal disease in children less than 5 years of age. In total, 952 households were followed for a period of 12 weeks post-distribution of the study interventions. Households using Sawyer PointONE filters had significantly less diarrheal disease compared with the control arm during the intervention period, which was shown by diarrheal prevalence ratios of 0.21 (95% confidence interval [95% CI] = 0.15–0.30) for the filter arm and 0.27 (95% CI = 0.22–0.34) for the filter and WASH BCC arm. A non-significant reduction in diarrhea prevalence was reported in the WASH BCC study arm households (0.71, 95% CI = 0.59–0.86). PMID:24865680

  7. Immune Function Alterations during 12 Weeks of Abstinence in Heroin Users.

    PubMed

    Wang, Z; Yang, X-R; Song, H; Cao, B-R; Yin, F; An, Z-M; Kang, L; Li, J

    2015-01-01

    The intent of the study was to evaluate immune system changes during 12 weeks of abstinence in heroin users. We recruited men (N = 65) aged 18-45 years and collected demographic and heroin use pattern data. Serum blood levels of total interleukin 2 (IL-2), interferon γ (IFN-γ), immunoglobulin (Ig) A, IgG, and IgM were assessed at five time points. The IL-2 level was increased on day 84 as compared to that in healthy controls. The IFN-γ level was higher in heroin users than in healthy controls between days 0 and 28, and was decreased on day 84. IgG and IgM levels in heroin users were higher than those in healthy controls in our 12-week study, and were in positive correlation with the way of using the drug, duration of heroin dependence, and daily heroin intake. Our data revealed that the immune system was not restored during the 12 weeks of heroin withdrawal. PMID:26789146

  8. Can the Onset of Type 2 Diabetes Be Delayed by a Group-Based Lifestyle Intervention in Women with Prediabetes following Gestational Diabetes Mellitus (GDM)? Findings from a Randomized Control Mixed Methods Trial

    PubMed Central

    O'Dea, Angela; Tierney, Marie; McGuire, Brian E.; Newell, John; Glynn, Liam G.; Gibson, Irene; Noctor, Eoin; Danyliv, Andrii; Connolly, Susan B.; Dunne, Fidelma P.

    2015-01-01

    Objective. To evaluate a 12-week group-based lifestyle intervention programme for women with prediabetes following gestational diabetes (GDM). Design. A two-group, mixed methods randomized controlled trial in which 50 women with a history of GDM and abnormal glucose tolerance postpartum were randomly assigned to intervention (n = 24) or wait control (n = 26) and postintervention qualitative interviews with participants. Main Outcome Measures. Modifiable biochemical, anthropometric, behavioural, and psychosocial risk factors associated with the development of type 2 diabetes. The primary outcome variable was the change in fasting plasma glucose (FPG) from study entry to one-year follow-up. Results. At one-year follow-up, the intervention group showed significant improvements over the wait control group on stress, diet self-efficacy, and quality of life. There was no evidence of an effect of the intervention on measures of biochemistry or anthropometry; the effect on one health behaviour, diet adherence, was close to significance. Conclusions. Prevention programmes must tackle the barriers to participation faced by this population; home-based interventions should be investigated. Strategies for promoting long-term health self-management need to be developed and tested. PMID:26347894

  9. Humour-related interventions for people with mental illness: a randomized controlled pilot study.

    PubMed

    Rudnick, Abraham; Kohn, Paul M; Edwards, Kim R; Podnar, David; Caird, Sara; Martin, Rod

    2014-08-01

    This study explored the feasibility and effects of humour-related interventions for mentally ill adults. Twelve, randomly assigned, participated in each of 3 arms--stand up comedy training (the experimental arm), discussing comedy videos (the active control arm), and no humour-related intervention (the passive control arm). Quantitative and qualitative data were collected at baseline, end of interventions (3 months) and follow up (after another 3 months). Scale comparisons were largely negative, although self-esteem marginally increased in the experimental arm. Interview responses indicated benefits for the interventions, including improved self-esteem in the experimental arm. These results, though mixed, justify further study.

  10. Randomized Trial of a Broad Preventive Intervention for Mexican American Adolescents

    PubMed Central

    Gonzales, N.A.; Dumka, L.E.; Millsap, R.E.; Gottschall, A.; McClain, D.B.; Wong, J.J.; Germán, M.; Mauricio, A.M.; Wheeler, L.; Carpentier, F.D.; Kim, S.Y.

    2012-01-01

    Objective This randomized trial of a family-focused preventive intervention for Mexican American (MA) adolescents evaluated intervention effects on adolescent substance use, internalizing and externalizing symptoms, and school discipline and grade records in 8th grade, one year after completion of the intervention. The study also examined hypothesized mediators and moderators of intervention effects. Method Stratified by language of program delivery (English vs. Spanish), the trial included a sample of 516 MA adolescents (50.8% female; M =12.3 years, SD=.54) and at least one caregiver that were randomized to receive a low dosage control group workshop or the 9-week group intervention that included parenting, adolescent coping, and conjoint family sessions. Results Positive program effects were found on all five outcomes at one-year posttest, but varied depending on whether adolescents, parents, or teachers reported on the outcome. Intervention effects were mediated by posttest changes in effective parenting, adolescent coping efficacy, adolescent school engagement, and family cohesion. The majority of direct and mediated effects were moderated by language, with a larger number of significant effects for families that participated in Spanish. Intervention effects also were moderated by baseline levels of mediators and outcomes, with the majority showing stronger effects for families with poorer functioning at baseline. Conclusion Findings support the efficacy of the intervention to decrease multiple problem outcomes for MA adolescents, but also demonstrate differential effects for parents and adolescents receiving the intervention in Spanish vs. English, and depending on their baseline levels of functioning. PMID:22103956

  11. Initial response as a predictor of 12-week buprenorphine-naloxone treatment response in a prescription opioid dependent population

    PubMed Central

    McDermott, Katherine A.; Griffin, Margaret L.; Connery, Hilary S.; Hilario, E. Yvette; Fiellin, David A.; Fitzmaurice, Garrett M.; Weiss, Roger D.

    2015-01-01

    Objective Initial medication response has been shown to predict treatment outcome across a variety of substance use disorders, but no studies have examined the predictive power of initial response to buprenorphine-naloxone in the treatment of prescription opioid dependence. We therefore conducted a secondary analysis of data from the Prescription Opioid Addiction Treatment Study to determine whether initial response to buprenorphine-naloxone predicted 12-week treatment outcome in a prescription opioid-dependent population. Method Using data from a multi-site, randomized controlled trial of buprenorphine-naloxone plus counseling for DSM-IV prescription opioid dependence (June 2006–July 2009), we conducted a secondary analysis to investigate the relationship between initial medication response and 12-week treatment outcome to establish how soon the efficacy of buprenorphine-naloxone could be predicted. Outcomes were determined from the Substance Use Report, a self-report measure of substance use, and confirmatory urinalysis. Predictive values were calculated to determine the importance of abstinence vs. use at various time points within the first month of treatment (week 1, weeks 1–2, 1–3, or 1–4) in predicting successful vs. unsuccessful treatment outcome (based on abstinence or near-abstinence from opioids) in the last 4 weeks of buprenorphine-naloxone treatment (weeks 9–12). Results Outcome was best predicted by medication response after two weeks of treatment. Two weeks of initial abstinence was moderately predictive of treatment success (positive predictive value = 71%), while opioid use in both of the first two weeks was strongly predictive of unsuccessful treatment outcome (negative predictive value (NPV) = 84%), especially when successful outcome was defined as total abstinence from opioids in weeks 9–12 (NPV = 94%). Conclusion Evaluating prescription opioid-dependent patients after two weeks of buprenorphine-naloxone treatment may help determine

  12. Gincosan (a combination of Ginkgo biloba and Panax ginseng): the effects on mood and cognition of 6 and 12 weeks' treatment in post-menopausal women.

    PubMed

    Hartley, D E; Elsabagh, S; File, S E

    2004-01-01

    As memory and concentration impairments are a frequent complaint in post-menopausal women, this well-defined population was selected to investigate the effect on mood and cognition of chronic treatment with Gincosan. In a double-blind placebo controlled study, post-menopausal women aged 51-66 were randomly assigned to 12 weeks' treatment with Gincosan (320mg/day), containing 120mg Ginkgo biloba, and 200mg Panax ginseng (n = 30), or matched placebo (n = 27). They were given measurements of mood, somatic anxiety, sleepiness, and menopausal symptoms and a battery of cognitive tests before treatment and after 6 and 12 weeks of treatment. There were no significant effects of Gincosan treatment on ratings of mood, bodily symptoms of somatic anxiety, menopausal symptoms, or sleepiness or on any of the cognitive measures of attention, memory or frontal lobe function. Thus, after chronic administration, Gincosan appeared to have no beneficial effects in post-menopausal women.

  13. Psychological Intervention for Improving Cognitive Function in Cancer Survivors: A Literature Review and Randomized Controlled Trial

    PubMed Central

    King, Summer; Green, Heather Joy

    2015-01-01

    Although the impact of cancer and associated treatments on cognitive functioning is becoming an increasingly recognized problem, there are few published studies that have investigated psychological interventions to address this issue. A waitlist randomized controlled trial methodology was used to assess the efficacy of a group cognitive rehabilitation intervention (“ReCog”) that successfully targeted cancer-related cognitive decline in previously published pilot research. Participants were 29 cancer survivors who were randomly allocated to either the intervention group or a waitlist group who received the intervention at a later date, and 16 demographically matched community volunteers with no history of cancer (trial registration ACTRN12615000009516, available at http://www.ANZCTR.org.au/ACTRN12615000009516.aspx). The study was the first to include an adapted version of the Traumatic Brain Injury Self-Efficacy Scale to assess cognitive self-efficacy (CSE) in people who have experienced cancer. Results revealed participating in the intervention was associated with significantly faster performance on one objective cognitive task that measures processing speed and visual scanning. Significantly larger improvements for the intervention group were also found on measures of perceived cognitive impairments and CSE. There was some evidence to support the roles of CSE and illness perceptions as potential mechanisms of change for the intervention. Overall, the study provided additional evidence of feasibility and efficacy of group psychological intervention for targeting cancer-related cognitive decline. PMID:25859431

  14. Efficacy of Yoga for Vasomotor Symptoms: A Randomized Controlled Trial

    PubMed Central

    Newton, Katherine M.; Reed, Susan D.; Guthrie, Katherine A.; Sherman, Karen J.; Booth-LaForce, Cathryn; Caan, Bette; Sternfeld, Barbara; Carpenter, Janet S.; Learman, Lee A.; Freeman, Ellen W.; Cohen, Lee S.; Joffe, Hadine; Anderson, Garnet L.; Larson, Joseph C.; Hunt, Julie R.; Ensrud, Kristine E.; LaCroix, Andrea Z.

    2013-01-01

    Objective To determine the efficacy of yoga in alleviating VMS frequency and bother. Methods Three by two factorial design, randomized, controlled. Eligible women were randomized to yoga (n=107), exercise (n=106), or usual activity (n=142), and were simultaneously randomized to double-blind comparison of omega-3 fatty acid (n=177) or placebo (n=178) capsules. Yoga intervention was twelve, weekly, 90-minute yoga classes with daily home practice. Primary outcomes were VMS frequency and bother assessed by daily diaries at baseline, 6, and 12 weeks. Secondary outcomes included insomnia symptoms (Insomnia Severity Index) at baseline and 12 weeks. Results Among 249 randomized women, 237 (95%) completed 12-week assessments. Mean baseline VMS frequency was 7.4/day (95% CI 6.6, 8.1) in the yoga group and 8.0/day (95% CI 7.3, 8.7) in the usual activity group. Intent-to-treat analyses included all participants with response data (n=237). There was no difference between intervention groups in change in VMS frequency from baseline to 6 and 12 weeks (mean difference (yoga – usual activity) from baseline −0.3 (95% CI −1.1, 0.5) at 6 weeks and −0.3 (95% CI −1.2, 0.6) at 12 weeks (p=0.119 across both time points). Results were similar for VMS bother. At week 12, yoga was associated with an improvement in insomnia symptoms (mean difference [yoga-usual activity] in change –Insomnia Severity Index, 1.3 [95% CI −2.5, −0.1][p=0.007]). Conclusion Among healthy women, 12 weeks of yoga class plus home practice compared with usual activity did not improve VMS frequency or bother, but reduced insomnia symptoms. PMID:24045673

  15. Improving Parental Stress Levels Among Mothers Living with HIV: A Randomized Control Group Intervention Study

    PubMed Central

    Johnson, Erica R.; Davies, Susan L.; Aban, Inmaculada; Mugavero, Michael J.; Shrestha, Sadeep

    2015-01-01

    Abstract Limited knowledge exists regarding parenting efficacy interventions for mothers living with HIV (MLH). This study evaluated the impact of a supportive group intervention on lowering parenting stress among MLH. Eighty MLH were randomized to a parenting (N=34) or health focused (control) (N=46) group intervention. Pre- and post-intervention stress levels were assessed using the Parental Stress Index-Short Form (PSI/SF). Differences in PSI/SF scores were examined using ANOVA, and predictors of PSI/SF scores were evaluated using multivariable linear regression. Findings indicate that both groups experienced significant decreases in parenting stress from baseline to post-intervention (p=0.0001), with no significant differences between interventions. At baseline, 41% of participants were identified as highly stressed and 30% as clinically stressed, with PSI/SF scores above the 85th and 90th percentile, respectively. Amongst the highly stressed subpopulation, significant improvements in PSI/SF scores for Parental Distress PSI/SF (p=0.039), Difficult Child PSI/SF (p=0.048), and total PSI/SF (p=0.036) were seen, with greater improvements in the parenting intervention. Among the clinically stressed subpopulation, significant improvements in total post-intervention PSI/SF scores were seen (p=0.049), with greater improvements in the parenting intervention. Results indicate that screening for high levels of stress should be considered in clinical practice to effectively implement stress-reducing interventions among MLH. PMID:25734870

  16. A Randomized Clinical Trial of Self-Help Intervention for Smoking Cessation: Research Design, Interventions, and Baseline Data

    PubMed Central

    Unrod, Marina; Simmons, Vani N.; Sutton, Steven K.; Meltzer, Lauren R.; Harrell, Paul T.; Meade, Cathy D.; Craig, Benjamin M.; Lee, Ji-Hyun; Brandon, Thomas H.

    2014-01-01

    Tobacco smoking is the leading preventable cause of mortality and morbidity. Although behavioral counseling combined with pharmacotherapy is the most effective approach to aiding smoking cessation, intensive treatments are rarely chosen by smokers, citing inconvenience. In contrast, minimal self-help interventions have the potential for greater reach, with demonstrated efficacy for relapse prevention, but not for smoking cessation. This paper summarizes the design and methods used for a randomized controlled trial to assess the efficacy of a minimal self-help smoking cessation intervention that consists of a set of booklets delivered across time. Baseline participant recruitment data are also presented. Daily smokers were recruited nationally via multimedia advertisements and randomized to one of three conditions. The Usual Care (UC) group received a standard smoking-cessation booklet. The Standard Repeated Mailings (SRM) group received 8 booklets mailed over a 12-month period. The Intensive Repeated Mailings (IRM) group received 10 booklets and additional supplemental materials mailed monthly over 18 months. A total of 2641 smokers were screened, 2349 were randomized, and 1874 provided data for analyses. Primary outcomes will be self-reported abstinence at 6-month intervals up to 30 months. If the self-help booklets are efficacious, this minimal, low cost intervention can be widely disseminated and, hence, has the potential for significant public health impact with respect to reduction in smoking-related illness and mortality. PMID:24865525

  17. A randomized clinical trial of self-help intervention for smoking cessation: research design, interventions, and baseline data.

    PubMed

    Unrod, Marina; Simmons, Vani N; Sutton, Steven K; Meltzer, Lauren R; Harrell, Paul T; Meade, Cathy D; Craig, Benjamin M; Lee, Ji-Hyun; Brandon, Thomas H

    2014-07-01

    Tobacco smoking is the leading preventable cause of mortality and morbidity. Although behavioral counseling combined with pharmacotherapy is the most effective approach to aiding smoking cessation, intensive treatments are rarely chosen by smokers, citing inconvenience. In contrast, minimal self-help interventions have the potential for greater reach, with demonstrated efficacy for relapse prevention, but not for smoking cessation. This paper summarizes the design and methods used for a randomized controlled trial to assess the efficacy of a minimal self-help smoking cessation intervention that consists of a set of booklets delivered across time. Baseline participant recruitment data are also presented. Daily smokers were recruited nationally via multimedia advertisements and randomized to one of three conditions. The Usual Care (UC) group received a standard smoking-cessation booklet. The Standard Repeated Mailings (SRM) group received 8 booklets mailed over a 12-month period. The Intensive Repeated Mailings (IRM) group received 10 booklets and additional supplemental materials mailed monthly over 18months. A total of 2641 smokers were screened, 2349 were randomized, and 1874 provided data for analyses. Primary outcomes will be self-reported abstinence at 6-month intervals up to 30months. If the self-help booklets are efficacious, this minimal, low cost intervention can be widely disseminated and, hence, has the potential for significant public health impact with respect to reduction in smoking-related illness and mortality.

  18. A Randomized Control Trial of a Chronic Care Intervention for Homeless Women with Alcohol Use Problems

    PubMed Central

    Upshur, Carole; Weinreb, Linda; Bharel, Monica; Reed, George; Frisard, Christine

    2014-01-01

    A clinician-randomized trial was conducted using the chronic care model for disease management for alcohol use problems among n=82 women served in a health care for the homeless clinic. Women with problem alcohol use received either usual care or an intervention consisting of a Primary Care Provider (PCP) brief intervention, referral to addiction services, and on-going support from a Care Manager (CM) for 6 months. Both groups significantly reduced their alcohol consumption, with a small effect size favoring intervention at 3 months, but there were no significant differences between groups in reductions in drinking or in housing stability, or mental or physical health. However, intervention women had significantly more frequent participation in substance use treatment services. Baseline differences and small sample size limit generalizability, although substantial reductions in drinking for both groups suggest screening and PCP brief treatment are promising interventions for homeless women with alcohol use problems. PMID:25488504

  19. Coping Mediates Outcome Following a Randomized Group Intervention for HIV-Positive Bereaved Individuals

    PubMed Central

    Smith, Nathan Grant; Tarakeshwar, Nalini; Hansen, Nathan B.; Kochman, Arlene; Sikkema, Kathleen J.

    2013-01-01

    The purpose of this study was to examine the mechanisms responsible for the beneficial psychological effects of a coping-focused group intervention for HIV-positive individuals who had lost loved ones to AIDS. Data from 235 HIV-positive men and women enrolled in a randomized controlled clinical trial testing a coping-focused group intervention were analyzed using a multiple-indicator-multiple-cause (MIMIC) structural equation model. Results revealed that the effects of the intervention on decreases in depression and grief were mediated by decreases in avoidant coping. Specifically, participants in the intervention condition decreased their use of avoidant coping. Decreases in avoidant coping, in turn, were related to decreased depression and grief. The results of this study help to validate the use of coping-focused interventions for HIV-positive bereaved individuals. PMID:19152338

  20. An Integrated Intervention in Pregnant African Americans Reduces Postpartum Risk: A Randomized Trial

    PubMed Central

    El-Mohandes, Ayman A.E.; Kiely, Michele; Joseph, Jill G.; Subramanian, Siva; Johnson, Allan A.; Blake, Susn M.; Gantz, Marie G.; El-Khorazaty, M. Nabil

    2010-01-01

    Objective To evaluate the efficacy of an integrated multiple risk intervention delivered mainly during pregnancy, in reducing such risks (smoking, environmental tobacco smoke exposure, depression and intimate partner violence) postpartum. Design Data from this randomized controlled trial were collected prenatally and on average 10 weeks postpartum in six prenatal care sites in the District of Columbia. African Americans were screened, recruited and randomly assigned to the behavioral intervention or usual care. Clinic-based, individually tailored counseling was delivered to intervention women. The outcome measures were number of reisks reported postpartum and reduction of these risks between baseline and postpartum. Results The intervention was effective in significantly reducing the number of risks reported in the postpartum period. In Bivariate analyses, the intervention group was more successful in resolving all risks (47% compared with 35%, p=0.007), number needed to treat=9, 95% confidence interval [CI] 5-31) and in resolving some risks (63% compared with 54%, p=0.009), number needed to treat=11, 95% CI 7-43) as compared with the usual care group. In logistical regression analyses, women in the intervention group were more likely to resolve all risks (OR=1.86, 95% CI: 1.25-2.75) and in resolving at least one risk (OR=1.6, 95% CI: 1.15-2.22). Conclusions An integrated multiple risk factor intervention addressing psychosocial and behavioral risks delivered mainly during pregnancy can have beneficial effects in risk reduction postpartum. PMID:18757660

  1. Implementation of a Manualized Communication Intervention for School-Aged Children with Pragmatic and Social Communication Needs in a Randomized Controlled Trial: The Social Communication Intervention Project

    ERIC Educational Resources Information Center

    Adams, Catherine; Lockton, Elaine; Gaile, Jacqueline; Earl, Gillian; Freed, Jenny

    2012-01-01

    Background: Speech-language interventions are often complex in nature, involving multiple observations, variable outcomes and individualization in treatment delivery. The accepted procedure associated with randomized controlled trials (RCT) of such complex interventions is to develop and implement a manual of intervention in order that reliable…

  2. A randomized controlled trial of the efficacy of a stigma reduction intervention for HIV-infected women in the Deep South.

    PubMed

    Barroso, Julie; Relf, Michael V; Williams, Megan Scull; Arscott, Joyell; Moore, Elizabeth D; Caiola, Courtney; Silva, Susan G

    2014-09-01

    The aim of this study was to compare outcomes (self-esteem, coping self-efficacy, and internalized stigma) across time in HIV-infected women living in the Deep South who received a stigma reduction intervention (n=51) with those of a control group (n=49) who received the usual care at baseline, and at 30 and 90 days. We recruited 99 women from clinics and an AIDS service organization; they were randomized by recruitment site. A video developed from the results of a qualitative metasynthesis study of women with HIV infection was loaded onto iPod Touch devices. Participants were asked to watch the video weekly for 4 weeks, and to record the number of times they viewed it over a 12-week period. We examined the trajectory model results for efficacy outcomes for the intent-to-treat and the supplemental completers groups. There was a treatment-by-time effect for improved self-esteem (intent-to-treat: p=0.0308; completers: p=0.0284) and decreases in internalized stigma (intent-to-treat: p=0.0036; completers: p=0.0060), and a treatment-by-time-by-time effect for improved coping self-efficacy (intent-to-treat: p=0.0414; completers: p=0.0321). A medium effect of the intervention in terms of improving self-esteem was observed when compared with the control condition in those who completed the study. The magnitude of the intervention effect, however, was large with regard to reducing overall stigma, improving social relationships, and decreasing stereotypes in both groups. PMID:25084499

  3. A randomized controlled trial of the efficacy of a stigma reduction intervention for HIV-infected women in the Deep South.

    PubMed

    Barroso, Julie; Relf, Michael V; Williams, Megan Scull; Arscott, Joyell; Moore, Elizabeth D; Caiola, Courtney; Silva, Susan G

    2014-09-01

    The aim of this study was to compare outcomes (self-esteem, coping self-efficacy, and internalized stigma) across time in HIV-infected women living in the Deep South who received a stigma reduction intervention (n=51) with those of a control group (n=49) who received the usual care at baseline, and at 30 and 90 days. We recruited 99 women from clinics and an AIDS service organization; they were randomized by recruitment site. A video developed from the results of a qualitative metasynthesis study of women with HIV infection was loaded onto iPod Touch devices. Participants were asked to watch the video weekly for 4 weeks, and to record the number of times they viewed it over a 12-week period. We examined the trajectory model results for efficacy outcomes for the intent-to-treat and the supplemental completers groups. There was a treatment-by-time effect for improved self-esteem (intent-to-treat: p=0.0308; completers: p=0.0284) and decreases in internalized stigma (intent-to-treat: p=0.0036; completers: p=0.0060), and a treatment-by-time-by-time effect for improved coping self-efficacy (intent-to-treat: p=0.0414; completers: p=0.0321). A medium effect of the intervention in terms of improving self-esteem was observed when compared with the control condition in those who completed the study. The magnitude of the intervention effect, however, was large with regard to reducing overall stigma, improving social relationships, and decreasing stereotypes in both groups.

  4. Rationale and design of WEBCARE: A randomized, controlled, web-based behavioral intervention trial in cardioverter-defibrillator patients to reduce anxiety and device concerns and enhance quality of life

    PubMed Central

    2009-01-01

    Background The implantable cardioverter defibrillator (ICD) is generally well accepted, but 25-33% of patients experience clinical levels of anxiety, depression, and impaired quality of life (QoL) following implantation. Few trials in ICD patients have investigated whether behavioral intervention may mitigate the development of these adjustment problems. We present the rationale and study design of the WEB-based distress management program for implantable CARdioverter dEfibrillator patients (WEBCARE) trial. Methods WEBCARE is a multi-center, multi-disciplinary, randomized, controlled behavioral intervention trial designed to examine the effectiveness of a web-based approach in terms of reducing levels of anxiety and device concerns and enhancing QoL. Consecutive patients hospitalized for the implantation of an ICD will be approached for study participation while in hospital and randomized to the intervention arm (n = 175) versus usual care (n = 175) at baseline (5-10 days post implantation). Patients will complete assessments of patient-centered outcomes at baseline, 14, 26, and 52 weeks after implantation. Patients randomized to the intervention arm will receive a 12-week web-based behavioral intervention starting 2 weeks after implantation. Primary endpoints include (ii) patient-centered outcomes (i.e., anxiety, depression, ICD acceptance, QoL); (iii) health care utilization; and (iiii) cost-effectiveness. All primary endpoints will be assessed with standardized and validated disease-specific or generic questionnaires. Secondary endpoints include (iii) cortisol awakening response; and (iiii) ventricular arrhythmias. Discussion WEBCARE will show whether a behavioral intervention using a web-based approach is feasible and effective in reducing anxiety and ICD concerns and improving QoL in ICD patients. Trial Registration http://www.ClinicalTrials.gov. Identifier: NCT00895700. PMID:20030843

  5. Positive Family Intervention for Severe Challenging Behavior I: A Multisite Randomized Clinical Trial

    ERIC Educational Resources Information Center

    Durand, V. Mark; Hieneman, Meme; Clarke, Shelley; Wang, Mo; Rinaldi, Melissa L.

    2013-01-01

    The present study was a multisite randomized clinical trial assessing the effects of adding a cognitive-behavioral intervention to positive behavior support (PBS). Fifty-four families who met the criteria of (a) having a child with a developmental disability, (b) whose child displayed serious challenging behavior (e.g., aggression, self-injury,…

  6. Enhancing the Scientific Credibility of Single-Case Intervention Research: Randomization to the Rescue

    ERIC Educational Resources Information Center

    Kratochwill, Thomas R.; Levin, Joel R.

    2010-01-01

    In recent years, single-case designs have increasingly been used to establish an empirical basis for evidence-based interventions and techniques in a variety of disciplines, including psychology and education. Although traditional single-case designs have typically not met the criteria for a randomized controlled trial relative to conventional…

  7. Randomized Comparison of Augmented and Nonaugmented Language Interventions for Toddlers with Developmental Delays and Their Parents

    ERIC Educational Resources Information Center

    Romski, MaryAnn; Sevcik, Rose A.; Adamson, Lauren B.; Cheslock, Melissa; Smith, Ashlyn; Barker, R. Michael; Bakeman, Roger

    2010-01-01

    Purpose: This study compared the language performance of young children with developmental delays who were randomly assigned to 1 of 3 parent-coached language interventions. Differences in performance on augmented and spoken word size and use, vocabulary size, and communication interaction skills were examined. Method: Sixty-eight toddlers with…

  8. A Randomized Controlled Trial Study of the ABRACADABRA Reading Intervention Program in Grade 1

    ERIC Educational Resources Information Center

    Savage, Robert S.; Abrami, Philip; Hipps, Geoffrey; Deault, Louise

    2009-01-01

    This study reports a randomized controlled trial evaluation of a computer-based balanced literacy intervention, ABRACADABRA (http://grover.concordia.ca/abra/version1/abracadabra.html). Children (N = 144) in Grade 1 were exposed either to computer activities for word analysis, text comprehension, and fluency, alongside shared stories (experimental…

  9. A Randomized Clinical Trial of Alternative Stress Management Interventions in Persons with HIV Infection

    ERIC Educational Resources Information Center

    McCain, Nancy L.; Gray, D. Patricia; Elswick, R. K., Jr.; Robins, Jolynne W.; Tuck, Inez; Walter, Jeanne M.; Rausch, Sarah M.; Ketchum, Jessica McKinney

    2008-01-01

    Research in psychoneuroimmunology suggests that immunosuppression associated with perceived stress may contribute to disease progression in persons with HIV infection. While stress management interventions may enhance immune function, few alternative approaches have yet been tested. This randomized clinical trial was conducted to test effects of…

  10. Effects of a Voluntary Summer Reading Intervention on Reading Achievement: Results from a Randomized Field Trial

    ERIC Educational Resources Information Center

    Kim, James S.

    2006-01-01

    The effects of a voluntary summer reading intervention were assessed in a randomized field trial involving 552 students in 10 schools. In this study, fourth-grade children received eight books to read during their summer vacation and were encouraged by their teachers to practice oral reading at home with a family member and to use comprehension…

  11. A Randomized, Controlled Study of Computer-Based Intervention in Middle School Struggling Readers

    ERIC Educational Resources Information Center

    Given, Barbara K.; Wasserman, John D.; Chari, Sharmila A.; Beattie, Karen; Eden, Guinevere F.

    2008-01-01

    The current study was conducted to test the premise that computer-based intervention that targets auditory temporal processing combined with language exercises (Fast ForWord[R]) is effective in remediating children with disorders of language and reading. Sixty-five middle school struggling readers were randomly assigned to one of five groups and…

  12. Weight Control Intervention for Truck Drivers: The SHIFT Randomized Controlled Trial, United States

    PubMed Central

    Wipfli, Brad; Thompson, Sharon V.; Elliot, Diane L.; Anger, W. Kent; Bodner, Todd; Hammer, Leslie B.; Perrin, Nancy A.

    2016-01-01

    Objectives. To evaluate the effectiveness of the Safety and Health Involvement For Truckers (SHIFT) intervention with a randomized controlled design. Methods. The multicomponent intervention was a weight-loss competition supported with body weight and behavioral self-monitoring, computer-based training, and motivational interviewing. We evaluated intervention effectiveness with a cluster-randomized design involving 22 terminals from 5 companies in the United States in 2012 to 2014. Companies were required to provide interstate transportation services and operate at least 2 larger terminals. We randomly assigned terminals to intervention or usual practice control conditions. We assessed participating drivers (n = 452) at baseline and 6 months. Results. In an intent-to-treat analysis, the postintervention difference between groups in mean body mass index change was 1.00 kilograms per meters squared (P < .001; intervention = −0.73; control = +0.27). Behavioral changes included statistically significant improvements in fruit and vegetable consumption and physical activity. Conclusions. Results establish the effectiveness of a multicomponent and remotely administered intervention for producing significant weight loss among commercial truck drivers. PMID:27463067

  13. An effective group psychoeducational intervention for improving compliance with vaginal dilation: A randomized controlled trial

    SciTech Connect

    Jeffries, Sherryl A.; Robinson, John W. . E-mail: johnrobi@cancerboard.ab.ca; Craighead, Peter S.; Keats, Melanie R.

    2006-06-01

    Purpose: Although vaginal dilation is often recommended to minimize or prevent vaginal scarring after pelvic radiotherapy, compliance with this recommendation has historically been very low. Therefore, effective intervention strategies are needed to enhance compliance with vaginal dilation after radiotherapy for gynecologic cancer. Methods and Materials: This study was a randomized controlled clinical trial of a psychoeducational intervention specifically designed to increase compliance with vaginal dilation. The information-motivation-behavioral skills model of enhancing compliance with behavioral change was the basis for the intervention design. Forty-two sexually active women, 21 to 65 years of age, diagnosed with Stages Ic-III cervical or endometrial cancer, who received pelvic radiotherapy, were randomized to either the experimental psychoeducational group or the information-only control group. Assessment via questionnaire occurred before treatment and at 6-week, 6-month, 12-month, 18-month, and 24-month follow-up. Assessment via interview also occurred at 6-month, 12-month, 18-month, and 24-month follow-up. Results: The psychoeducational intervention was successful in increasing compliance with vaginal dilation. Conclusions: This study is the first randomized controlled study to demonstrate the effectiveness of an intervention in increasing compliance with the use of vaginal dilators.

  14. Behavioral approach with or without surgical intervention to the vulvar vestibulitis syndrome: a prospective randomized and non-randomized study.

    PubMed

    Weijmar Schultz, W C; Gianotten, W L; van der Meijden, W I; van de Wiel, H B; Blindeman, L; Chadha, S; Drogendijk, A C

    1996-09-01

    This article describes the outcome of a behavioral approach with or without preceding surgical intervention in 48 women with the vulvar vestibulitis syndrome. In the first part of the study, 14 women with the vulvar vestibulitis syndrome were randomly assigned to one of two treatment programs: either a behavioral approach or a behavioral approach preceded by surgery. In the second part of the study, 34 women and their partners were given a choice of treatment. Follow-up data were gathered a mean of 3 and 2 1/2 years after treatment, respectively. In the randomized patient population, the intervention had a positive effect on all of them: the complaints disappeared, diminished or did not change but formed less of a problem. The difference in outcome between the two different treatments, a behavioral approach with or without preceding surgery, was not statistically significant. In the second non-randomized part of the study, 28 out of the 34 women (82%) chose the behavioral approach without preceding surgery. The difference in outcome between the two treatments was not statistically significant. Two out of the 28 women who chose behavioral treatment without preceding surgery had to be referred for psychiatric consultation because of serious psycho-sexual problems. In one woman, psychiatric treatment was successful. Three other women, whose behavioral treatment failed, underwent additional surgery, which clearly helped them to overcome the deadlock in the behavioral approach. The behavioral approach should be the first choice of treatment for the vulvar vestibulitis syndrome. Surgical intervention should be considered as an additional form of treatment in some cases with the vulvar vestibulitis syndrome to facilitate breaking the vicious circle of irritation, pelvic floor muscle hypertonia and sexual maladaptive behavior.

  15. Randomized comparative efficacy study of parent-mediated interventions for toddlers with autism

    PubMed Central

    Kasari, Connie; Gulsrud, Amanda; Paparella, Tanya; Hellemann, Gerhard; Berry, Kathleen

    2016-01-01

    Objective This study compared effects of two parent-mediated interventions on joint engagement outcomes as augmentations of an early intervention program for toddlers with autism spectrum disorder (ASD). Method Participants included 86 toddlers (range 22 – 36 months) with ASD and their primary caregiver. Caregiver-child dyads were randomized to receive ten weeks of hands-on parent training in a naturalistic, developmental behavioral intervention (Joint Attention, Symbolic Play, Engagement and Regulation—JASPER) or a parent-only psychoeducational intervention (PEI). Dose was controlled in terms of researcher-parent contact and early intervention services received by the child. Results Results yielded significant effects of the JASPER intervention on the primary outcome of joint engagement. The treatment effect was large (Cohen’s f2=.69).and maintained over the six-month follow-up. JASPER effects were also found on secondary outcomes of play diversity, highest play level achieved, and generalization to the child’s classroom for child-initiated joint engagement. The PEI intervention was found to be effective in reducing parenting stress associated with child characteristics. All secondary effects were generally small to moderate. Conclusions These data highlight the benefit of a brief, targeted, parent-mediated intervention on child outcomes. Future studies may consider the combination of JASPER and PEI treatments for optimal parent and child outcomes. Trial registry # NCT00999778. PMID:25822242

  16. [Uterine rupture in a patient with bicornuate uterus at 12 weeks of amenorrhea: about a case].

    PubMed

    Itchimouh, Sanaa; Khabtou, Karima; Mahdaoui, Sakher; Boufettal, Houssine; Samouh, Naima

    2016-01-01

    The incidence of uterine malformations affecting reproduction is difficult to assess. Their identification requires a specific assessment (hysterosalpingography, hysteroscopy, laparoscopy). Spontaneous fertility can be affected depending on the type of uterine abnormality. All these abnormalities can affect the evolution of pregnancy causing early and late miscarriage, ectopic pregnancy, threat of premature labour, premature labour, vascular pathologies during pregnancy and inadequate intra-uterine growth. Bicornuate uterus is the most common uterine malformation and represents about half of all uterine anomalies The occurrence of this type of pregnancy is associated with an increased risk of maternal mortality, but early diagnosis and proper monitoring can lead pregnancies to term on malformed uterus. Ultrasound screening should allow for a systematic identification of such cases in order to take the necessary preventive measures. We report a case of uterine rupture in a patient with unicervical bicornuate uterus at 12 weeks of amenorrhea.

  17. [Uterine rupture in a patient with bicornuate uterus at 12 weeks of amenorrhea: about a case].

    PubMed

    Itchimouh, Sanaa; Khabtou, Karima; Mahdaoui, Sakher; Boufettal, Houssine; Samouh, Naima

    2016-01-01

    The incidence of uterine malformations affecting reproduction is difficult to assess. Their identification requires a specific assessment (hysterosalpingography, hysteroscopy, laparoscopy). Spontaneous fertility can be affected depending on the type of uterine abnormality. All these abnormalities can affect the evolution of pregnancy causing early and late miscarriage, ectopic pregnancy, threat of premature labour, premature labour, vascular pathologies during pregnancy and inadequate intra-uterine growth. Bicornuate uterus is the most common uterine malformation and represents about half of all uterine anomalies The occurrence of this type of pregnancy is associated with an increased risk of maternal mortality, but early diagnosis and proper monitoring can lead pregnancies to term on malformed uterus. Ultrasound screening should allow for a systematic identification of such cases in order to take the necessary preventive measures. We report a case of uterine rupture in a patient with unicervical bicornuate uterus at 12 weeks of amenorrhea. PMID:27642490

  18. Inflammatory suppression by endodontic sealers after aging 12 weeks In vitro.

    PubMed

    Brackett, Martha Goël; Marshall, Aksana; Lockwood, Petra E; Lewis, Jill B; Messer, Regina L W; Bouillaguet, Serge; Wataha, John C

    2009-11-01

    Dental endodontic sealers are in intimate contact with tissues around the root apex (periapical area) for extended periods. New endodontic sealers have been developed in the past decade, but the biological responses to many new products are not well documented. In this study, we assessed in vitro monocytic cytotoxic and inflammatory responses to several contemporary endodontic sealers. AH-Plus (AH), Pulp Canal Sealer (PC), Epiphany (EPH), Endo-Rez (ER), and an experimental Endo-Rez (ERx) were initially placed in buffered-saline for 12 weeks to simulate in vivo use. After "aging," specimens were placed in direct contact with THP1 monocytes for 72 h and their cytotoxicity (mitochondrial response; MTT) or ability to trigger or suppress cytokine secretion (ELISA; TNFalpha, IL1beta, IL=6; +/- lipopolysaccharide (LPS) exposure) were measured relative to Teflon (Tf) negative controls. Cellular responses among conditions were compared with ANOVA and Tukey post-hoc analysis (alpha = 0.05). Two of the five sealers, EPH and PC, still suppressed cell mitochondrial activity by 70% or more after 12 weeks of conditioning in saline. No sealer alone activated monocytic TNFalpha, IL1beta, or IL6 secretion (p > 0.05 vs. +LPS controls). When THP1 were activated by LPS after exposure to the sealers, differential suppression of TNFalpha, IL1beta, and IL6 secretion was observed for two of the five sealers tested. (EPH and PC) This data suggest that common endodontic sealers do not activate monocytic TNFalpha, IL1beta, and IL6 secretion in vitro by themselves, but degradation products of the sealers may suppress activation of monocytes.

  19. Do 12-week yoga program influence respiratory function of elderly women?

    PubMed

    Bezerra, Lídia Aguiar; de Melo, Helton Fabrício; Garay, Ana Paula; Reis, Victor Machado; Aidar, Felipe José; Bodas, Ana Rita; Garrido, Nuno Domingos; de Oliveira, Ricardo Jacó

    2014-09-29

    Aging produces several respiratory limitations and reduces tolerance to physical efforts, sometimes leading to pulmonary diseases in the elderly. The literature draws attention to the possible benefits of Yoga practice among the elderly, presenting evidence for significant improvements in quality of life. It was hypothesized that yoga practice can improve respiratory function in the elderly. The effects of a yoga program on pulmonary volumes and respiratory muscle strength were verified in 36 elderly women divided into a yoga group [YG] (63.1 ± 13.3 years of age) and a control group (61.0 ± 6.9 years of age). Maximal inspiratory and expiratory pressure (MIP and MEP) were assessed by a manovacuometer and tidal volume (VT), vital capacity (VC) and minute ventilation (VE) were measured by a ventilometer. The program comprised 65 min sessions, 3 times/week during 12 weeks. The heart rate and respiratory rate decreased significantly in the YG (76-39 ± 8-03 vs. 74-61±10.26 bpm and 18.61 ± 3.15 vs. 16.72 ± 3.12 resp/min, respectively). In the YG, VT and VE increased significantly (0.55 ± 0.22 vs. 0.64 ± 0.2 ml and 9.19 ± 2.39 vs. 10.05 ± 2.11 ml, respectively), as well as VC (1.48 ± 0.45 vs. 2.03 ± 0.72 ml). Improvements were also found in MIP and MEP in the YG (62.17 ± 14.77 vs. 73.06 ± 20.16 cmH2O and 80.56 ± 23.94 vs. 86.39 ± 20.16 cmH2O, respectively). It was concluded that a 12-week yoga program significantly improves pulmonary function of aged women. PMID:25713658

  20. Development of early mathematical skills with a tablet intervention: a randomized control trial in Malawi

    PubMed Central

    Pitchford, Nicola J.

    2015-01-01

    Evaluation of educational interventions is necessary prior to wide-scale rollout. Yet very few rigorous studies have been conducted on the effectiveness of tablet-based interventions, especially in the early years and in developing countries. This study reports a randomized control trial to evaluate the effectiveness of a tablet intervention for supporting the development of early mathematical skills in primary school children in Malawi. A total sample of 318 children, spanning Standards 1–3, attending a medium-sized urban primary school, were randomized to one of three groups: maths tablet intervention, non-maths tablet control, and standard face-to-face practice. Children were pre-tested using tablets at the start of the school year on two tests of mathematical knowledge and a range of basic skills related to scholastic progression. Class teachers then delivered the intervention over an 8-weeks period, for the equivalent of 30-min per day. Technical support was provided from the local Voluntary Service Overseas (VSO). Children were then post-tested on the same assessments as given at pre-test. A final sample of 283 children, from Standards 1–3, present at both pre- and post-test, was analyzed to investigate the effectiveness of the maths tablet intervention. Significant effects of the maths tablet intervention over and above standard face-to-face practice or using tablets without the maths software were found in Standards 2 and 3. In Standard 3 the greater learning gains shown by the maths tablet intervention group compared to both of the control groups on the tablet-based assessments transferred to paper and pencil format, illustrating generalization of knowledge gained. Thus, tablet technology can effectively support early years mathematical skills in developing countries if the software is carefully designed to engage the child in the learning process and the content is grounded in a solid well-constructed curriculum appropriate for the child

  1. An Intervention To Reduce Postpartum Depressive Symptoms: A Randomized Controlled Trial

    PubMed Central

    Howell, Elizabeth A; Bodnar-Deren, Susan; Balbierz, Amy; Loudon, Holly; Mora, Pablo A.; Zlotnick, Caron; Wang, Jason; Leventhal, Howard

    2013-01-01

    Depressive symptoms and depression are a common complication of childbirth and a growing body of literature suggests that there are modifiable factors associated with their occurrence. We developed a behavioral educational intervention targeting these factors and successfully reduced postpartum depressive symptoms in a randomized trial among low-income black and Latina women. We now report results of 540 predominantly white, high income mothers in a second randomized trial. Mothers in the intervention arm received a 2-step intervention that prepared and educated mothers about modifiable factors associated with postpartum depressive symptoms (e.g., physical symptoms, low self-efficacy), bolstered social support, and enhanced management skills. The control arm received enhanced usual care. Participants were surveyed prior to randomization, 3-weeks, 3-months, and 6-months postpartum. Depressive symptoms were assessed using the Edinburgh Postnatal Depression Scale (EPDS of 10 or greater). Prevalence of depressive symptoms postpartum were unexpectedly low precluding detection of difference in rates of depressive symptoms among intervention vs. enhanced usual care post hospitalization: 3-weeks (6.0 % vs. 5.6%, p=.83), 3-months (5.1% vs. 6.5%, p=.53) and 6-months (3.6% vs. 4.6%, p=.53). PMID:24019052

  2. Do Hospitalized Premature Infants Benefit from Music Interventions? A Systematic Review of Randomized Controlled Trials

    PubMed Central

    Oliai Araghi, Sadaf; Jeekel, Johannes; Reiss, Irwin K. M; Hunink, M. G. Myriam; van Dijk, Monique

    2016-01-01

    Objective Neonatal intensive care units (NICU) around the world increasingly use music interventions. The most recent systematic review of randomized controlled trials (RCT) dates from 2009. Since then, 15 new RCTs have been published. We provide an updated systematic review on the possible benefits of music interventions on premature infants’ well-being. Methods We searched 13 electronic databases and 12 journals from their first available date until August 2016. Included were all RCTs published in English with at least 10 participants per group, including infants born prematurely and admitted to the NICU. Interventions were either recorded music interventions or live music therapy interventions. All control conditions were accepted as long as the effects of the music intervention could be analysed separately. A meta-analysis was not possible due to incompleteness and heterogeneity of the data. Results After removal of duplicates the searches retrieved 4893 citations, 20 of which fulfilled the inclusion/exclusion criteria. The 20 included studies encompassed 1128 participants receiving recorded or live music interventions in the NICU between 24 and 40 weeks gestational age. Twenty-six different outcomes were reported which we classified into three categories: physiological parameters; growth and feeding; behavioural state, relaxation outcomes and pain. Live music interventions were shown to improve sleep in three out of the four studies and heart rate in two out of the four studies. Recorded music improved heart rate in two out of six studies. Better feeding and sucking outcomes were reported in one study using live music and in two studies using recorded music. Conclusions Although music interventions show promising results in some studies, the variation in quality of the studies, age groups, outcome measures and timing of the interventions across the studies makes it difficult to draw strong conclusions on the effects of music in premature infants. PMID

  3. Effectiveness of a Multidimensional Randomized Control Intervention to Reduce Quartz Exposure Among Construction Workers.

    PubMed

    van Deurssen, Erik; Meijster, Tim; Oude Hengel, Karen M; Boessen, Ruud; Spaan, Suzanne; Tielemans, Erik; Heederik, Dick; Pronk, Anjoeka

    2015-10-01

    There is little evidence with respect to the effectiveness of intervention programs that focus on the reduction of occupational quartz exposure in the construction industry. This article evaluates the effectiveness of a multidimensional intervention which was aimed at reducing occupational quartz exposure among construction workers by increasing the use of technical control measures. Eight companies participating in the cluster randomized controlled trial were randomly allocated to the intervention (four companies) or control condition (four companies). The multidimensional intervention included engineering, organizational, and behavioural elements at both organizational and individual level. Full-shift personal quartz exposure measurements and detailed observations were conducted before and after the intervention among bricklayers, carpenters, concrete drillers, demolishers, and tuck pointers (n = 282). About 59% of these workers measured at baseline were reassessed during follow-up. Bayesian hierarchical models were used to evaluate the intervention effect on exposure levels. Concrete drillers in the intervention group used technical control measures, particularly water suppression, for a significantly greater proportion of the time spent on abrasive tasks during follow-up compared to baseline (93 versus 62%; P < 0.05). A similar effect, although not statistically significant, was observed among demolishers. A substantial overall reduction in quartz exposure (73 versus 40% in the intervention and control group respectively; P < 0.001) was observed for concrete drillers, demolishers, and tuck pointers. The decrease in exposure in the intervention group compared to controls was significantly larger for demolishers and tuck pointers, but not for concrete drillers. The observed effect could at least partly be explained by the introduced interventions; the statistically significant increased use of control measures among concrete drillers explains the observed effect

  4. Effectiveness of a Multidimensional Randomized Control Intervention to Reduce Quartz Exposure Among Construction Workers.

    PubMed

    van Deurssen, Erik; Meijster, Tim; Oude Hengel, Karen M; Boessen, Ruud; Spaan, Suzanne; Tielemans, Erik; Heederik, Dick; Pronk, Anjoeka

    2015-10-01

    There is little evidence with respect to the effectiveness of intervention programs that focus on the reduction of occupational quartz exposure in the construction industry. This article evaluates the effectiveness of a multidimensional intervention which was aimed at reducing occupational quartz exposure among construction workers by increasing the use of technical control measures. Eight companies participating in the cluster randomized controlled trial were randomly allocated to the intervention (four companies) or control condition (four companies). The multidimensional intervention included engineering, organizational, and behavioural elements at both organizational and individual level. Full-shift personal quartz exposure measurements and detailed observations were conducted before and after the intervention among bricklayers, carpenters, concrete drillers, demolishers, and tuck pointers (n = 282). About 59% of these workers measured at baseline were reassessed during follow-up. Bayesian hierarchical models were used to evaluate the intervention effect on exposure levels. Concrete drillers in the intervention group used technical control measures, particularly water suppression, for a significantly greater proportion of the time spent on abrasive tasks during follow-up compared to baseline (93 versus 62%; P < 0.05). A similar effect, although not statistically significant, was observed among demolishers. A substantial overall reduction in quartz exposure (73 versus 40% in the intervention and control group respectively; P < 0.001) was observed for concrete drillers, demolishers, and tuck pointers. The decrease in exposure in the intervention group compared to controls was significantly larger for demolishers and tuck pointers, but not for concrete drillers. The observed effect could at least partly be explained by the introduced interventions; the statistically significant increased use of control measures among concrete drillers explains the observed effect

  5. A Randomized Controlled Trial of an Appearance-focused Intervention to Prevent Skin Cancer

    PubMed Central

    Hillhouse, Joel; Turrisi, Rob; Stapleton, Jerod; Robinson, June

    2014-01-01

    BACKGROUND Skin cancer represents a significant health threat with over 1.3 million diagnoses, 8000 melanoma deaths, and more than $1 billion spent annually for skin cancer healthcare in the US. Despite findings from laboratory, case-control, and prospective studies that indicate a link between youthful indoor tanning (IT) and skin cancer, IT is increasing among US youth. Appearance-focused interventions represent a promising method to counteract these trends. METHODS A total of 430 female indoor tanners were randomized into intervention or no intervention control conditions. Intervention participants received an appearance-focused booklet based on decision-theoretical models of health behavior. Outcome variables included self-reports of IT behavior and intentions, as well as measures of cognitive mediating variables. RESULTS Normative increases in springtime IT rates were significantly lower (ie, over 35%) at 6-month follow-up in intervention versus control participants with similar reductions in future intentions. Mediation analyses revealed 6 cognitive variables (IT attitudes, fashion attitudes, perceived susceptibility to skin cancer and skin damage, subjective norms, and image norms) that significantly mediated change in IT behavior. CONCLUSIONS The appearance-focused intervention demonstrated strong effects on IT behavior and intentions in young indoor tanners. Appearance-focused approaches to skin cancer prevention need to present alternative behaviors as well as alter IT attitudes. Mediational results provide guides for strengthening future appearance-focused interventions directed at behaviors that increase risk of skin cancer. PMID:18937268

  6. Efficacy of musical interventions in dementia: evidence from a randomized controlled trial.

    PubMed

    Narme, Pauline; Clément, Sylvain; Ehrlé, Nathalie; Schiaratura, Loris; Vachez, Sylvie; Courtaigne, Bruno; Munsch, Frédéric; Samson, Séverine

    2014-01-01

    Although musical interventions have recently gained popularity as a non-pharmacological treatment in dementia, there is still insufficient evidence of their effectiveness. To investigate this issue, a single-center randomized controlled trial was conducted with forty-eight patients with Alzheimer's disease or mixed dementia to compare the effects of music versus cooking interventions in the emotional, cognitive, and behavioral domain, as well as on professional caregiver distress. Each intervention lasted four weeks (two one-hour sessions a week). Multi-component evaluations (with blind assessors) were conducted before, during, and after the interventions to assess their short and long-term effects (up to four weeks post interventions). Analyses revealed that both music and cooking interventions led to positive changes in the patients' emotional state and decreased the severity of their behavioral disorders, as well as reduced caregiver distress. However, no benefit on the cognitive status of the patients was seen. While results did not demonstrate a specific benefit of music on any of the considered measures, the present study suggests the efficacy of two pleasant non-pharmacological treatments in patients with moderate to severe dementia. Our findings highlight the potential of such interventions in improving the well-being of patients living in residential care, as well as reducing caregiver distress. PMID:23969994

  7. Interventions with family caregivers of cancer patients: meta-analysis of randomized trials.

    PubMed

    Northouse, Laurel L; Katapodi, Maria C; Song, Lixin; Zhang, Lingling; Mood, Darlene W

    2010-01-01

    Family caregivers of cancer patients receive little preparation, information, or support to perform their caregiving role. However, their psychosocial needs must be addressed so they can maintain their own health and provide the best possible care to the patient. The purpose of this article is to analyze the types of interventions offered to family caregivers of cancer patients, and to determine the effect of these interventions on various caregiver outcomes. Meta-analysis was used to analyze data obtained from 29 randomized clinical trials published from 1983 through March 2009. Three types of interventions were offered to caregivers: psychoeducational, skills training, and therapeutic counseling. Most interventions were delivered jointly to patients and caregivers, but they varied considerably with regard to dose and duration. The majority of caregivers were female (64%) and Caucasian (84%), and ranged in age from 18 to 92 years (mean age, 55 years). Meta-analysis indicated that although these interventions had small to medium effects, they significantly reduced caregiver burden, improved caregivers' ability to cope, increased their self-efficacy, and improved aspects of their quality of life. Various intervention characteristics were also examined as potential moderators. Clinicians need to deliver research-tested interventions to help caregivers and patients cope effectively and maintain their quality of life.

  8. Randomized Controlled Trial Lifestyle Interventions for Asian Americans: A Systematic Review

    PubMed Central

    Bender, Melinda S.; Choi, JiWon; Won, Gloria Y.; Fukuoka, Yoshimi

    2014-01-01

    Objective Asian Americans are the fastest-growing race in the United States. However, they are largely underrepresented in health research, particularly lifestyle interventions. A systematic review was conducted to analyze the characteristics and quality of lifestyle intervention literature promoting changes in physical activity (PA), diet, and/or weight management targeting Asian Americans. Method A systematic electronic database search identified randomized controlled clinical trials (RCT), involving lifestyle interventions for Asian Americans, published from 1995 to 2013 conducted in the U.S. Data extraction was conducted from August through December 2013. Results Seven RCTs met the review criteria. Cross-study comparisons were difficult due to diversity in: RCT intervention designs, cultural appropriateness, outcome measures, sample size, and race/ethnic groups. Overall, risk of bias and cultural appropriateness scores were moderate to low. Five out of seven RCTs showed significant between group differences for PA, diet, and weight. In general, sample sizes were small or lacked sufficient power to fully analyze intervention efficacy. Conclusion Evidence of the efficacy for lifestyle interventions among Asian Americans was mixed. Recommendations include: more rigorous RCT designs, more objective measures, larger Asian American sample sizes, culturally appropriate interventions, individual tailoring, maintenance phase with support, and providing education and modeling of lifestyle behaviors. PMID:25086326

  9. Efficacy of musical interventions in dementia: evidence from a randomized controlled trial.

    PubMed

    Narme, Pauline; Clément, Sylvain; Ehrlé, Nathalie; Schiaratura, Loris; Vachez, Sylvie; Courtaigne, Bruno; Munsch, Frédéric; Samson, Séverine

    2014-01-01

    Although musical interventions have recently gained popularity as a non-pharmacological treatment in dementia, there is still insufficient evidence of their effectiveness. To investigate this issue, a single-center randomized controlled trial was conducted with forty-eight patients with Alzheimer's disease or mixed dementia to compare the effects of music versus cooking interventions in the emotional, cognitive, and behavioral domain, as well as on professional caregiver distress. Each intervention lasted four weeks (two one-hour sessions a week). Multi-component evaluations (with blind assessors) were conducted before, during, and after the interventions to assess their short and long-term effects (up to four weeks post interventions). Analyses revealed that both music and cooking interventions led to positive changes in the patients' emotional state and decreased the severity of their behavioral disorders, as well as reduced caregiver distress. However, no benefit on the cognitive status of the patients was seen. While results did not demonstrate a specific benefit of music on any of the considered measures, the present study suggests the efficacy of two pleasant non-pharmacological treatments in patients with moderate to severe dementia. Our findings highlight the potential of such interventions in improving the well-being of patients living in residential care, as well as reducing caregiver distress.

  10. Context by treatment interactions as the primary object of study in cluster randomized controlled trials of population health interventions.

    PubMed

    Fuller, Daniel; Potvin, Louise

    2012-06-01

    Cluster randomized controlled trials are increasingly used in population health intervention research. Through randomization, researchers attempt to isolate the treatment effect and remove all other effects, including any effects of social context. In many cases, the constant effect assumption cannot be satisfied in cluster randomized controlled trials. We argue that when studying population health interventions, the effective mechanism of intervention lies in the interaction between the treatment and social context. Researchers should be cognizant that attempts to remove the effect of social context using CRTC may fail. The interaction between the treatment and social context should be the primary object of study in population health intervention research.

  11. Promoting First Relationships: Randomized Trial of a Relationship-Based Intervention for Toddlers in Child Welfare

    PubMed Central

    Spieker, Susan J.; Oxford, Monica L.; Kelly, Jean F.; Nelson, Elizabeth M.; Fleming, Charles B.

    2013-01-01

    We conducted a community based, randomized control trial of Promoting First Relationships (PFR; Kelly, Sandoval, Zuckerman, & Buehlman, 2008) to improve parenting and toddler outcomes for toddlers in state dependency. Toddlers (10 – 24 months; N = 210) with a recent placement disruption were randomized to 10-week PFR or a comparison condition. Community agency providers were trained to use PFR in the intervention for caregivers. From baseline to post-intervention follow-up, observational ratings of caregiver sensitivity improved more in the PFR condition than in the comparison condition, with an effect size for the difference in adjusted means post-intervention of d = .41. Caregiver understanding of toddlers’ social emotional needs and caregiver reports of child competence also differed by intervention condition post-intervention (d = .36 and d = .42) with caregivers in the PFR condition reporting more understanding of toddlers and child competence. Models of PFR effects on within-individual change were significant for caregiver sensitivity and understanding of toddlers. At the 6-month follow-up 61% of original sample dyads were still intact and there were no significant differences on caregiver or child outcomes, although caregivers in the PFR group did report marginally (p<.10) fewer child sleep problems (d = −.34). PMID:22949743

  12. Effectiveness and moderators of the preventive intervention kids in divorce situations: A randomized controlled trial.

    PubMed

    Pelleboer-Gunnink, Hannah A; Van der Valk, Inge E; Branje, Susan J T; Van Doorn, Muriel D; Deković, Maja

    2015-10-01

    Children of divorced parents have an increased risk of a variety of problems in comparison to children from intact families. Therefore, several intervention programs have been developed directed at children of divorced parents. Yet, empirical data on the effectiveness of these interventions are limited. This study evaluated the school-based, child-directed prevention program Kids In Divorce Situations (KIDS) using a randomized controlled trial. The sample consisted of 156 children randomly assigned at the school level into an experimental (80 children) and control condition (76 children). In addition, 131 mothers and 76 fathers participated in the study. Four assessments took place: a pretest, a posttest, and two follow-up assessments conducted 6 months and 1 year after finishing KIDS. Latent growth analyses demonstrated that the intervention significantly reduced child-reported emotional problems and enhanced child-reported communication with the father and mother-reported communication with the child. The effect sizes ranged from .30-.63. Few moderation effects of gender, time since divorce, or perceived parental conflict on the intervention effects were found. After parental divorce, a limited school-based intervention for children can be efficacious in promoting children's emotional well-being and parent-child communication.

  13. Effectiveness and moderators of the preventive intervention kids in divorce situations: A randomized controlled trial.

    PubMed

    Pelleboer-Gunnink, Hannah A; Van der Valk, Inge E; Branje, Susan J T; Van Doorn, Muriel D; Deković, Maja

    2015-10-01

    Children of divorced parents have an increased risk of a variety of problems in comparison to children from intact families. Therefore, several intervention programs have been developed directed at children of divorced parents. Yet, empirical data on the effectiveness of these interventions are limited. This study evaluated the school-based, child-directed prevention program Kids In Divorce Situations (KIDS) using a randomized controlled trial. The sample consisted of 156 children randomly assigned at the school level into an experimental (80 children) and control condition (76 children). In addition, 131 mothers and 76 fathers participated in the study. Four assessments took place: a pretest, a posttest, and two follow-up assessments conducted 6 months and 1 year after finishing KIDS. Latent growth analyses demonstrated that the intervention significantly reduced child-reported emotional problems and enhanced child-reported communication with the father and mother-reported communication with the child. The effect sizes ranged from .30-.63. Few moderation effects of gender, time since divorce, or perceived parental conflict on the intervention effects were found. After parental divorce, a limited school-based intervention for children can be efficacious in promoting children's emotional well-being and parent-child communication. PMID:26121535

  14. Clown intervention to reduce preoperative anxiety in children and parents: a randomized controlled trial.

    PubMed

    Dionigi, Alberto; Sangiorgi, Diego; Flangini, Roberto

    2014-03-01

    This study investigated whether a clown doctor intervention could reduce preoperative anxiety in children hospitalized for minor surgery and in their parents. A randomized controlled trial was conducted with 77 children and 119 parents: the clown group consisted of 52 children accompanied in the preoperating room by their parents (n = 89) and two clowns while the comparison group consisted of children accompanied by the parents only. The clown intervention significantly reduced the children's preoperative anxiety: children benefited from the clown's presence and showed better adjustment than children in the comparison group. Mothers in Comparison Group showed higher anxiety. PMID:23362335

  15. Clown intervention to reduce preoperative anxiety in children and parents: a randomized controlled trial.

    PubMed

    Dionigi, Alberto; Sangiorgi, Diego; Flangini, Roberto

    2014-03-01

    This study investigated whether a clown doctor intervention could reduce preoperative anxiety in children hospitalized for minor surgery and in their parents. A randomized controlled trial was conducted with 77 children and 119 parents: the clown group consisted of 52 children accompanied in the preoperating room by their parents (n = 89) and two clowns while the comparison group consisted of children accompanied by the parents only. The clown intervention significantly reduced the children's preoperative anxiety: children benefited from the clown's presence and showed better adjustment than children in the comparison group. Mothers in Comparison Group showed higher anxiety.

  16. A Randomized Controlled Trial of a Cognitive Behavioural Intervention for Anger Management in Children Diagnosed with Asperger Syndrome

    ERIC Educational Resources Information Center

    Sofronoff, Kate; Attwood, Tony; Hinton, Sharon; Levin, Irina

    2007-01-01

    The purpose of the study described was to evaluate the effectiveness of a cognitive behavioural intervention for anger management with children diagnosed with Asperger syndrome. Forty-five children and their parents were randomly assigned to either intervention or wait-list control conditions. Children in the intervention participated in six 2-h…

  17. Video-Feedback Intervention to Promote Positive Parenting Adapted to Autism (VIPP-AUTI): A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Poslawsky, Irina E; Naber, Fabiënne BA; Bakermans-Kranenburg, Marian J; van Daalen, Emma; van Engeland, Herman; van IJzendoorn, Marinus H

    2015-01-01

    In a randomized controlled trial, we evaluated the early intervention program Video-feedback Intervention to promote Positive Parenting adapted to Autism (VIPP-AUTI) with 78 primary caregivers and their child (16-61 months) with Autism Spectrum Disorder. VIPP-AUTI is a brief attachment-based intervention program, focusing on improving parent-child…

  18. Early Intervention for Toddlers With Language Delays: A Randomized Controlled Trial

    PubMed Central

    Kaiser, Ann P.

    2015-01-01

    OBJECTIVE: Early interventions for toddlers with expressive and receptive language delays have not resulted in positive expressive language outcomes. This randomized controlled trial tested the effects on language outcomes of a caregiver-implemented communication intervention targeting toddlers at risk for persistent language delays. METHODS: Participants included 97 toddlers, who were between 24 and 42 months with language scores at least 1.33 SDs below the normative mean and no other developmental delays, and their caregivers. Toddlers were randomly assigned to the caregiver-implemented intervention or a usual-care control group. Caregivers and children participated in 28 sessions in which caregivers were taught to implement the intervention. The primary outcome was the Preschool Language Scale, Fourth Edition, a broad-based measure of language. Outcome measurement was not blinded. RESULTS: Caregivers in the intervention improved their use of all language facilitation strategies, such as matched turns (adjusted mean difference, intervention-control, 40; 95% confidence interval 34 to 46; P < .01). Children in the intervention group had significantly better receptive language skills (5.3; 95% confidence interval 0.15 to 10.4), but not broad-based expressive language skills (0.37, 95% confidence interval −4.5 to 5.3; P = .88). CONCLUSIONS: This trial provides preliminary evidence of the short-term effects of systematic caregiver instruction on caregiver use of language facilitation strategies and subsequent changes in children’s language skills. Future research should investigate the ideal dosage levels for optimizing child outcomes and determine which language facilitation strategies are associated with specific child outcomes. Research on adaptations for families from culturally and linguistically diverse backgrounds is needed. PMID:25733749

  19. Early psychological intervention in accidentally injured children ages 2–16: a randomized controlled trial

    PubMed Central

    Kramer, Didier N.; Landolt, Markus A.

    2014-01-01

    Background Road traffic accidents (RTA) and burns are frequent events in children. Although many children recover spontaneously, a considerable number develop long-term psychological sequelae. Evidence on early psychological interventions to prevent such long-term problems is still scarce for school-age children and completely lacking for pre-school children. Objectives To evaluate the efficacy of an early two-session cognitive-behavioral intervention in 108 children ages 2–16 after RTAs and burns. Methods Children assessed at risk for the development of posttraumatic stress disorder (PTSD) were randomly assigned to either a control group offered treatment as usual or an intervention group. Primary outcomes were PTSD, behavioral problems, and depression symptoms. Baseline and blinded 3- and 6-month follow-up assessments were conducted. Results In pre-school children, no intervention effects were found. School-age children in the intervention group exhibited significantly fewer internalizing problems at 3-month follow-up relative to controls and a borderline significant time-by-group effect for PTSD intrusion symptoms was found (p=0.06). Conclusions This is the first study examining the efficacy of an indicated, early psychological intervention among both school-age and pre-school-age children. Because the intervention was ineffective for young children, no evidence-based practice can currently be suggested. Given that parents of pre-school children perceived the intervention as helpful, brief counseling of parents in terms of psychoeducation and training in coping skills still should be provided by clinicians, despite the current lack of evidence. To prevent trauma-related disorders in school-age children, the intervention might be used in a step-wise manner, where only children at risk for long-term psychological maladjustment are provided with psychological support. PMID:24987498

  20. Quality and Reporting of Cluster Randomized Controlled Trials Evaluating Occupational Therapy Interventions

    PubMed Central

    Tokolahi, Ema; Hocking, Clare; Kersten, Paula; Vandal, Alain C.

    2015-01-01

    Growing use of cluster randomized control trials (RCTs) in health care research requires careful attention to study designs, with implications for the development of an evidence base for practice. The objective of this study is to investigate the characteristics, quality, and reporting of cluster RCTs evaluating occupational therapy interventions to inform future research design. An extensive search of cluster RCTs evaluating occupational therapy was conducted in several databases. Fourteen studies met our inclusion criteria; four were protocols. Eleven (79%) justified the use of a cluster RCT and accounted for clustering in the sample size and analysis. All full studies reported the number of clusters randomized, and five reported intercluster correlation coefficients (50%): Protocols had higher compliance. Risk of bias was most evident in unblinding of participants. Statistician involvement was associated with improved trial quality and reporting. Quality of cluster RCTs of occupational therapy interventions is comparable with those from other areas of health research and needs improvement. PMID:27504689

  1. Attachment-Focused Integrative Reminiscence with Older African-Americans: A Randomized Controlled Intervention Study

    PubMed Central

    Henderson, Charles R.; Kang, Suk-Young; Pillemer, Karl

    2015-01-01

    Objectives Prior integrative reminiscence interventions have had a limited focus on attachment themes. The Attachment-Focused Integrative Reminiscence (AFIR) intervention differs from these in its central emphasis on attachment themes. The wide range of health benefits resulting from integrative reminiscence may be due in part to reminiscing about, mourning, and integrating unresolved attachment experiences. Method Participants were randomized into treatment and wait-list control conditions; completed a pre-test; met for 8 consecutive weekly 2-hour sessions of largely attachment-focused reminiscence; then completed post-tests immediately following the intervention and again 6 months later. Results Results show treatment effects for depression (p = .01 and .05 at 8 weeks and 6 months), perceived stress (p = .01 and .04), and emergency room (ER) visits at 6 months (p = .04), with the intervention group showing lower depression and stress and fewer ER visits. Conclusion Integrative reminiscence interventions are cost-effective, have rapid impact, and carry a certain appeal to older adults. Augmenting such interventions with a focus on attachment experiences may reduce perceived stress, an important health risk factor. Wider application of AFIRs may further reduce health disparities among U.S. older adults. PMID:25812080

  2. An Adaptive Physical Activity Intervention for Overweight Adults: A Randomized Controlled Trial

    PubMed Central

    Adams, Marc A.; Sallis, James F.; Norman, Gregory J.; Hovell, Melbourne F.; Hekler, Eric B.; Perata, Elyse

    2013-01-01

    Background Physical activity (PA) interventions typically include components or doses that are static across participants. Adaptive interventions are dynamic; components or doses change in response to short-term variations in participant's performance. Emerging theory and technologies make adaptive goal setting and feedback interventions feasible. Objective To test an adaptive intervention for PA based on Operant and Behavior Economic principles and a percentile-based algorithm. The adaptive intervention was hypothesized to result in greater increases in steps per day than the static intervention. Methods Participants (N = 20) were randomized to one of two 6-month treatments: 1) static intervention (SI) or 2) adaptive intervention (AI). Inactive overweight adults (85% women, M = 36.9±9.2 years, 35% non-white) in both groups received a pedometer, email and text message communication, brief health information, and biweekly motivational prompts. The AI group received daily step goals that adjusted up and down based on the percentile-rank algorithm and micro-incentives for goal attainment. This algorithm adjusted goals based on a moving window; an approach that responded to each individual's performance and ensured goals were always challenging but within participants' abilities. The SI group received a static 10,000 steps/day goal with incentives linked to uploading the pedometer's data. Results A random-effects repeated-measures model accounted for 180 repeated measures and autocorrelation. After adjusting for covariates, the treatment phase showed greater steps/day relative to the baseline phase (p<.001) and a group by study phase interaction was observed (p = .017). The SI group increased by 1,598 steps/day on average between baseline and treatment while the AI group increased by 2,728 steps/day on average between baseline and treatment; a significant between-group difference of 1,130 steps/day (Cohen's d = .74). Conclusions The adaptive

  3. Educational interventions to improve screening mammography interpretation: a randomized, controlled trial

    PubMed Central

    BM, Geller; A, Bogart; PA, Carney; EA, Sickles; RA, Smith; B, Monsees; LW, Bassett; DM, Buist; K, Kerlikowske; T, Onega; B, Yankaskas; S, Haneuse; DA, Hill; M, Wallis; DL, Miglioretti

    2014-01-01

    Purpose Conduct a randomized controlled trial of educational interventions to improve performance of screening mammography interpretation. Materials and Methods We randomly assigned physicians who interpret mammography to one of three groups: (1) self-paced DVD; (2) live, expert-led educational session; or (3) control. The DVD and live interventions used mammography cases of varying difficulty and associated teaching points. Interpretive performance was compared using a pre-/post-test design. Sensitivity, specificity, and positive predictive value (PPV) were calculated relative to two outcomes: cancer status and consensus of three experts about recall, and each were compared using logistic regression adjusting for pre-test performance. Results 102 radiologists completed all aspects of the trial. After adjustment for pre-intervention performance, the odds of improved sensitivity for correctly identifying a lesion relative to expert recall were 1.34 times higher for DVD participants than controls (95% confidence interval [CI]: 1.00, 1.81; P=0.050). The odds of improved PPV for correctly identifying a lesion relative to both expert recall (odds ratio [OR]=1.94, 95% CI: 1.24, 3.05; P=0.004) and cancer status (OR=1.81, 95% CI: 1.01, 3.23; P=0.045) were significantly improved for DVD participants compared to controls with no significant change in specificity. For the live-intervention group, specificity was significantly lower than the control group (OR relative to expert recall=0.80; 95% CI: 0.64, 1.00; P=0.048; OR relative to cancer=0.79; 95% CI: 0.65, 0.95; P=0.015). Conclusion In this randomized controlled trial, the DVD educational intervention resulted in a significant improvement in mammography interpretive screening performance on a test-set, which could translate into improved clinical interpretative performance. PMID:24848854

  4. A Multidisciplinary Intervention Utilizing Virtual Communication Tools to Reduce Health Disparities: A Pilot Randomized Controlled Trial.

    PubMed

    Emerson, John F; Welch, Madelyn; Rossman, Whitney E; Carek, Stephen; Ludden, Thomas; Templin, Megan; Moore, Charity G; Tapp, Hazel; Dulin, Michael; McWilliams, Andrew

    2016-01-01

    Advances in technology are likely to provide new approaches to address healthcare disparities for high-risk populations. This study explores the feasibility of a new approach to health disparities research using a multidisciplinary intervention and advanced communication technology to improve patient access to care and chronic disease management. A high-risk cohort of uninsured, poorly-controlled diabetic patients was identified then randomized pre-consent with stratification by geographic region to receive either the intervention or usual care. Prior to enrollment, participants were screened for readiness to make a behavioral change. The primary outcome was the feasibility of protocol implementation, and secondary outcomes included the use of patient-centered medical home (PCMH) services and markers of chronic disease control. The intervention included a standardized needs assessment, individualized care plan, intensive management by a multidisciplinary team, including health coach-facilitated virtual visits, and the use of a cloud-based glucose monitoring system. One-hundred twenty-seven high-risk, potentially eligible participants were randomized. Sixty-one met eligibility criteria after an in-depth review. Due to limited resources and time for the pilot, we only attempted to contact 36 participants. Of these, we successfully reached 20 (32%) by phone and conducted a readiness to change screen. Ten participants screened in as ready to change and were enrolled, while the remaining 10 were not ready to change. Eight enrolled participants completed the final three-month follow-up. Intervention feasibility was demonstrated through successful implementation of 13 out of 14 health coach-facilitated virtual visits, and 100% of participants indicated that they would recommend the intervention to a friend. Protocol feasibility was demonstrated as eight of 10 participants completed the entire study protocol. At the end of the three-month intervention, participants had a

  5. A Multidisciplinary Intervention Utilizing Virtual Communication Tools to Reduce Health Disparities: A Pilot Randomized Controlled Trial.

    PubMed

    Emerson, John F; Welch, Madelyn; Rossman, Whitney E; Carek, Stephen; Ludden, Thomas; Templin, Megan; Moore, Charity G; Tapp, Hazel; Dulin, Michael; McWilliams, Andrew

    2015-12-22

    Advances in technology are likely to provide new approaches to address healthcare disparities for high-risk populations. This study explores the feasibility of a new approach to health disparities research using a multidisciplinary intervention and advanced communication technology to improve patient access to care and chronic disease management. A high-risk cohort of uninsured, poorly-controlled diabetic patients was identified then randomized pre-consent with stratification by geographic region to receive either the intervention or usual care. Prior to enrollment, participants were screened for readiness to make a behavioral change. The primary outcome was the feasibility of protocol implementation, and secondary outcomes included the use of patient-centered medical home (PCMH) services and markers of chronic disease control. The intervention included a standardized needs assessment, individualized care plan, intensive management by a multidisciplinary team, including health coach-facilitated virtual visits, and the use of a cloud-based glucose monitoring system. One-hundred twenty-seven high-risk, potentially eligible participants were randomized. Sixty-one met eligibility criteria after an in-depth review. Due to limited resources and time for the pilot, we only attempted to contact 36 participants. Of these, we successfully reached 20 (32%) by phone and conducted a readiness to change screen. Ten participants screened in as ready to change and were enrolled, while the remaining 10 were not ready to change. Eight enrolled participants completed the final three-month follow-up. Intervention feasibility was demonstrated through successful implementation of 13 out of 14 health coach-facilitated virtual visits, and 100% of participants indicated that they would recommend the intervention to a friend. Protocol feasibility was demonstrated as eight of 10 participants completed the entire study protocol. At the end of the three-month intervention, participants had a

  6. A Multidisciplinary Intervention Utilizing Virtual Communication Tools to Reduce Health Disparities: A Pilot Randomized Controlled Trial

    PubMed Central

    Emerson, John F.; Welch, Madelyn; Rossman, Whitney E.; Carek, Stephen; Ludden, Thomas; Templin, Megan; Moore, Charity G.; Tapp, Hazel; Dulin, Michael; McWilliams, Andrew

    2015-01-01

    Advances in technology are likely to provide new approaches to address healthcare disparities for high-risk populations. This study explores the feasibility of a new approach to health disparities research using a multidisciplinary intervention and advanced communication technology to improve patient access to care and chronic disease management. A high-risk cohort of uninsured, poorly-controlled diabetic patients was identified then randomized pre-consent with stratification by geographic region to receive either the intervention or usual care. Prior to enrollment, participants were screened for readiness to make a behavioral change. The primary outcome was the feasibility of protocol implementation, and secondary outcomes included the use of patient-centered medical home (PCMH) services and markers of chronic disease control. The intervention included a standardized needs assessment, individualized care plan, intensive management by a multidisciplinary team, including health coach-facilitated virtual visits, and the use of a cloud-based glucose monitoring system. One-hundred twenty-seven high-risk, potentially eligible participants were randomized. Sixty-one met eligibility criteria after an in-depth review. Due to limited resources and time for the pilot, we only attempted to contact 36 participants. Of these, we successfully reached 20 (32%) by phone and conducted a readiness to change screen. Ten participants screened in as ready to change and were enrolled, while the remaining 10 were not ready to change. Eight enrolled participants completed the final three-month follow-up. Intervention feasibility was demonstrated through successful implementation of 13 out of 14 health coach-facilitated virtual visits, and 100% of participants indicated that they would recommend the intervention to a friend. Protocol feasibility was demonstrated as eight of 10 participants completed the entire study protocol. At the end of the three-month intervention, participants had a

  7. An intervention for sensory difficulties in children with autism: a randomized trial.

    PubMed

    Schaaf, Roseann C; Benevides, Teal; Mailloux, Zoe; Faller, Patricia; Hunt, Joanne; van Hooydonk, Elke; Freeman, Regina; Leiby, Benjamin; Sendecki, Jocelyn; Kelly, Donna

    2014-07-01

    This study evaluated a manualized intervention for sensory difficulties for children with autism, ages 4-8 years, using a randomized trial design. Diagnosis of autism was confirmed using gold standard measures. Results show that the children in the treatment group (n = 17) who received 30 sessions of the occupational therapy intervention scored significantly higher (p = 0.003, d = 1.2) on Goal Attainment Scales (primary outcome), and also scored significantly better on measures of caregiver assistance in self-care (p = 0.008 d = 0.9) and socialization (p = 0.04, d = 0.7) than the Usual Care control group (n = 15). The study shows high rigor in its measurement of treatment fidelity and use of a manualized protocol, and provides support for the use of this intervention for children with autism. Findings are discussed in terms of their implications for practice and future research.

  8. Programming generality into a performance feedback writing intervention: A randomized controlled trial.

    PubMed

    Hier, Bridget O; Eckert, Tanya L

    2016-06-01

    Substantial numbers of students in the United States are performing below grade-level expectations in core academic areas, and these deficits are most pronounced in the area of writing. Although performance feedback procedures have been shown to produce promising short-term improvements in elementary-aged students' writing skills, evidence of maintenance and generalization of these intervention effects is limited. The purpose of this study was to examine the immediate, generalized, and sustained effects of incorporating multiple exemplar training into the performance feedback procedures of a writing intervention using a randomized controlled trial (RCT). Results indicated that although the addition of multiple exemplar training did not improve students' writing performance on measures of stimulus and response generalization, it did result in greater maintenance of intervention effects in comparison to students who received performance feedback without generality programming and students who engaged in weekly writing practice alone.

  9. Randomized Controlled Trial of the Combined Effects of Web and Quitline Interventions for Smokeless Tobacco Cessation

    PubMed Central

    Danaher, Brian G.; Severson, Herbert H.; Zhu, Shu-Hong; Andrews, Judy A.; Cummins, Sharon E.; Lichtenstein, Edward; Tedeschi, Gary J.; Hudkins, Coleen; Widdop, Chris; Crowley, Ryann; Seeley, John R.

    2015-01-01

    Background Use of smokeless tobacco (moist snuff and chewing tobacco) is a significant public health problem but smokeless tobacco users have few resources to help them quit. Web programs and telephone-based programs (Quitlines) have been shown to be effective for smoking cessation. We evaluate the effectiveness of a Web program, a Quitline, and the combination of the two for smokeless users recruited via the Web. Objectives To test whether offering both a Web and Quitline intervention for smokeless tobacco users results in significantly better long-term tobacco abstinence outcomes than offering either intervention alone; to test whether the offer of Web or Quitline results in better outcome than a self-help manual only Control condition; and to report the usage and satisfaction of the interventions when offered alone or combined. Methods Smokeless tobacco users (N= 1,683) wanting to quit were recruited online and randomly offered one of four treatment conditions in a 2×2 design: Web Only, Quitline Only, Web + Quitline, and Control (printed self-help guide). Point-prevalence all tobacco abstinence was assessed at 3- and 6-months post enrollment. Results 69% of participants completed both the 3- and 6-month assessments. There was no significant additive or synergistic effect of combining the two interventions for Complete Case or the more rigorous Intent To Treat (ITT) analyses. Significant simple effects were detected, individually the interventions were more efficacious than the control in achieving repeated 7-day point prevalence all tobacco abstinence: Web (ITT, OR = 1.41, 95% CI = 1.03, 1.94, p = .033) and Quitline (ITT: OR = 1.54, 95% CI = 1.13, 2.11, p = .007). Participants were more likely to complete a Quitline call when offered only the Quitline intervention (OR = 0.71, 95% CI = .054, .093, p = .013), the number of website visits and duration did not differ when offered alone or in combination with Quitline. Rates of program helpfulness (p <.05) and

  10. Effects of a 12-week resistance exercise program on physical self-perceptions in college students.

    PubMed

    Moore, Justin B; Mitchell, Nathanael G; Bibeau, Wendy S; Bartholomew, John B

    2011-06-01

    There is an increase in literature suggesting exercise can promote positive changes in physical self-perceptions that can manifest as an increase in global self-esteem. In the present study, we assessed self-esteem using the hierarchical framework of the Exercise and Self-Esteem Model (EXSEM) along with cognitive facets at the subdomain level (e.g., competence, certainty, importance, and ideal self-discrepancy). This allowed for an analysis of cognitive facets as possible contributors to changes in physical self-perceptions. We addressed these aims with a sample of 120 college-age adults who completed a 12-week resistance exercise program. Results indicated significant improvements in self-perception constructs at all levels of the EXSEM. The hierarchical structure of the EXSEM was partially supported, as we observed successively smaller improvements at each level of the model (e.g., self-esteem showed lesser improvements than physical self-worth). In addition, a path model developed to explain the impact of strength changes on self-esteem proved a good fit for the data. Results are discussed in terms of contemporary models of self-perception, potential mediators of exercise on self-esteem, and the need to consider cognitive facets of self-perception. PMID:21699109

  11. Can Targeted Intervention Mitigate Early Emotional and Behavioral Problems?: Generating Robust Evidence within Randomized Controlled Trials

    PubMed Central

    Doyle, Orla; McGlanaghy, Edel; O’Farrelly, Christine; Tremblay, Richard E.

    2016-01-01

    This study examined the impact of a targeted Irish early intervention program on children’s emotional and behavioral development using multiple methods to test the robustness of the results. Data on 164 Preparing for Life participants who were randomly assigned into an intervention group, involving home visits from pregnancy onwards, or a control group, was used to test the impact of the intervention on Child Behavior Checklist scores at 24-months. Using inverse probability weighting to account for differential attrition, permutation testing to address small sample size, and quantile regression to characterize the distributional impact of the intervention, we found that the few treatment effects were largely concentrated among boys most at risk of developing emotional and behavioral problems. The average treatment effect identified a 13% reduction in the likelihood of falling into the borderline clinical threshold for Total Problems. The interaction and subgroup analysis found that this main effect was driven by boys. The distributional analysis identified a 10-point reduction in the Externalizing Problems score for boys at the 90th percentile. No effects were observed for girls or for the continuous measures of Total, Internalizing, and Externalizing problems. These findings suggest that the impact of this prenatally commencing home visiting program may be limited to boys experiencing the most difficulties. Further adoption of the statistical methods applied here may help to improve the internal validity of randomized controlled trials and contribute to the field of evaluation science more generally. Trial Registration: ISRCTN Registry ISRCTN04631728 PMID:27253184

  12. Targeting and Managing Behavioral Symptoms in Individuals with Dementia: A Randomized Trial of a Nonpharmacologic Intervention

    PubMed Central

    Gitlin, Laura N.; Winter, Laraine; Dennis, Marie P.; Hodgson, Nancy; Hauck, Walter W.

    2010-01-01

    Objectives Test effects of an intervention that helps families manage distressful behaviors. Design Two-group randomized trial Setting In-home Participants 272 caregivers and dementia patients Intervention Up to 11 home/telephone contacts over 16-weeks by health professionals who identified potential triggers of patient behaviors including communication, environment, patient undiagnosed medical conditions (by obtaining blood/urine samples), and trained caregivers in strategies to modify triggers and reduce caregiver upset. Between 16–24 weeks, 3 telephone contacts reinforced strategy use. Measurements Primary outcomes included frequency of targeted problem behavior, and caregiver upset with and confidence managing it at 16-weeks. Secondary outcomes included caregiver well-being and management skills at 16 and 24 weeks, and caregiver perceived benefits. Prevalence of medical conditions for intervention patients were also examined. Results At 16 weeks, 67.5% of intervention caregivers reported patient improvement in targeted problem behavior compared to 45.8% of caregivers in a no-treatment control group (p=.002), reduced upset with (p=.028) and enhanced confidence managing (p=.011) the behavior. Additionally, compared to controls, intervention caregivers reported less upset with all problem behaviors (p=.001), negative communication (p=.017), burden (p=.051), and improved well-being (p=.001). Fewer intervention caregivers had depressive symptoms (53.0%) than control group caregivers (67.8%, p=.020). Similar caregiver outcomes occurred at 24-weeks. Compared to controls, intervention caregivers perceived more study benefits (p values <.05) including ability to keep patients home. Blood/urine samples of intervention patients showed 40 (34.1%) had undiagnosed illnesses requiring physician follow-up. Conclusion Targeting behaviors upsetting to caregivers and modifying potential triggers improves patient symptomatology and caregiver well-being and skills. PMID:20662955

  13. ¡Cocinar Para Su Salud!: Randomized controlled trial of a culturally-based dietary intervention among Hispanic breast cancer survivors

    PubMed Central

    Greenlee, Heather; Gaffney, Ann Ogden; Aycinena, A. Corina; Koch, Pam; Contento, Isobel; Karmally, Wahida; Richardson, John M.; Lim, Emerson; Tsai, Wei-Yann; Crew, Katherine; Maurer, Matthew; Kalinsky, Kevin; Hershman, Dawn L.

    2015-01-01

    BACKGROUND There is a need for culturally-relevant nutrition programs targeted to underserved cancer survivors. OBJECTIVE To examine the effect of a culturally-based approach to dietary change on increasing fruit/vegetable intake and decreasing fat intake among Hispanic breast cancer (BC) survivors. DESIGN Participants were randomized to intervention (IG) and control (CG) groups. Diet recalls, detailed interviews, fasting blood, and anthropometric measures were collected at baseline, 3-, 6- and 12-months. PARTICIPANTS/SETTING Hispanic women (n=70) with stage 0-III BC who completed adjuvant treatment and lived in New York City were randomized between April 2011 and March 2012. INTERVENTION The IG (n=34) participated in ¡Cocinar Para Su Salud! (¡CPSS!), a culturally-based 9-session (24-hours over 12 weeks) intervention including nutrition education, cooking classes and food shopping field trips. The CG (n=36) received written dietary recommendations for BC survivors. MAIN OUTCOME MEASURES Change at 6 months in daily fruit/vegetable servings and % calories from total fat. STATISTICAL ANALYSES Linear regression models adjusted for stratification factors and estimated marginal means were used to compare changes in diet from baseline to 3- and 6-months. RESULTS Baseline characteristics: mean age 56.6 years (SD 9.7), mean time since diagnosis 3.4 years (SD 2.7), mean BMI 30.9 kg/m2 (SD 6.0), 62.9% with annual household income ≤$15,000, average daily servings of all fruits/vegetables 5.3 (targeted fruits/vegetables 3.7 servings excluding legumes/juices/starchy vegetables/fried foods) and 27.7% of daily calories from fat. Over 60% in the IG attended ≥7/9 classes with overall study retention of 87% retention at 6 months. At month 6, the IG compared to CG reported an increase in mean servings of fruits/vegetables from baseline (all fruits/vegetables: +2.0 vs. −0.1, P=0.005; targeted fruits/vegetables: +2.7 vs. +0.5, P=0.002) and a non-significant decrease in

  14. Lay Health Worker Intervention Improved Compliance with Hepatitis B Vaccination in Asian Americans: Randomized Controlled Trial

    PubMed Central

    Park, Eunmi; Lee, Sunmin

    2016-01-01

    Background This study aimed to evaluate the effect of a lay health worker (LHW) telephone intervention on completing a series of hepatitis B virus (HBV) vaccinations among foreign-born Asian Americans in the Baltimore-Washington Metropolitan area. Methods During the period of April 2013 and March 2014, we recruited Asian Americans who were 18 years of age and older in the community-based organizations. Of the 645 eligible participants, 600 (201 Chinese, 198 Korean, 201 Vietnamese) completed a pretest survey and received hepatitis B screening. Based on the screening results, we conducted a randomized controlled trial among those unprotected (HBsAg-/HBsAB-) by assigning them either to an intervention group (n = 124) or control group (n = 108). The intervention group received a list of resources by mails for where to get free vaccinations as well as reminder calls for vaccinations from trained LHWs, while the control group received only list of resources by mail. Seven months after mailing the HBV screening results, trained LHWs followed up with all participants by phone to ask how many of the recommended series of 3 vaccinations they had received: none, 1 or 2, or all 3 (complete). Their self-reported vaccinations were verified with the medical records. Multinomial logistic regressions were used to examine the effect of the LHW intervention. Process evaluation was conducted by asking study participants in the intervention group to evaluate the performance of the LHWs. Results After seven months, those in the intervention group were more likely to have 1 or more vaccines than the control group, compared to the no vaccination group (OR = 3.04, 95% CI, 1.16, 8.00). Also, those in the intervention group were more likely to complete a series of vaccinations than the control group, compared to the no vaccination group (OR = 7.29, 95% CI 3.39, 15.67). The most important barrier preventing them from seeking hepatitis B vaccinations was lack of time to get the vaccination

  15. Effects of a Brief Intervention for Reducing Violence and Alcohol Misuse Among Adolescents: A Randomized Trial

    PubMed Central

    Cunningham, Rebecca M.; Chermack, Stephen T.; Shope, Jean T.; Bingham, C. Raymond; Zimmerman, Marc A.; Blow, Frederic C.; Walton, Maureen A.

    2013-01-01

    Context The Emergency Department (ED) visit presents an opportunity to deliver brief interventions (BIs) to reduce violence and alcohol misuse among urban adolescents at risk for future injury. Objectives To determine the efficacy of BIs addressing violence and alcohol among adolescents presenting to an urban ED. Design, Setting, and Participants Patients (ages 14–18; 12 pm–11 pm; 7 days/week) at a Level 1 ED in Flint, MI, completed a computerized survey. Adolescents reporting past year alcohol use and aggression were enrolled in a randomized trial (SafERteens) which included: a computerized baseline assessment, randomization to a control group, or a 35-minute brief intervention delivered by a computer or therapist in the ED, and follow-up assessments at 3 and 6 months. Intervention Combining motivational interviewing with skills training, the BI for violence and alcohol included: review of goals, tailored feedback, decisional balance exercise, role plays, and referrals. Main Outcome Measures Self-report measures included peer aggression and violence, violence consequences, alcohol use, binge drinking, alcohol consequences. Results 3338 adolescents were screened (n=446, 12% refused): 1452 (43.5%) male; 1866 (55.9%) African-American. Of those, 829 (24.8%) screened positive for both alcohol and violence; 726 were randomized. As compared to the control, participants in the therapist intervention showed self-reported reductions in the occurrence of peer aggression (−34.3% therapist, −16.4% control; RR=0.74, CI=0.61–0.90), experience of peer violence (10.4% therapist, +4.7% control; RR=0.70, CI=0.52–0.95), and violence consequences (30.4% therapist, −13.0% control; RR=0.76, CI=0.64–0.90) at three months. At 6 months, participants in the therapist intervention showed self-reported reductions in peer aggression (−37.7% therapist, −28.4% control; RR=0.85, CI=0.68–1.06) and alcohol consequences (−32.2% therapist, −17.5% control; RR=0.56, CI=0.34

  16. Selection of intervention components in an internet stop smoking participant preference trial: beyond randomized controlled trials.

    PubMed

    Schueller, Stephen M; Leykin, Yan; Pérez-Stable, Eliseo J; Muñoz, Ricardo F

    2013-01-30

    To address health problems that have a major impact on global health requires research designs that go beyond randomized controlled trials. One such design, the participant preference trial, provides additional information in an ecologically valid manner, once intervention efficacy has been demonstrated. The current study presents illustrative data from a participant preference trial of an internet-based smoking cessation intervention. Participants (N=7763) from 124 countries accessed the intervention and were allowed to choose from nine different site components to aid their quit attempt. Of consenting participants, 36.7% completed at least one follow-up assessment. Individuals with depression were more likely to choose a mood management module and participants who smoked a higher number of cigarettes were more likely to choose a cigarette counter and a nicotine replacement therapy guide. Furthermore, depressed participants selecting the mood management component were more likely to report at least one successful 7 day quit (37.2% vs. 22.2%) in the 12 months following the intervention. Thus, participants with depressive symptoms appear to make choices on the basis of their needs and to benefit from these decisions. This suggests that providing the ability to customize previously validated resources may be a successful way to widely disseminate interventions.

  17. Estimating the health benefit of reducing indoor air pollution in a randomized environmental intervention

    PubMed Central

    Peng, Roger D.; Butz, Arlene M.; Hackstadt, Amber J.; Williams, D'Ann L.; Diette, Gregory B.; Breysse, Patrick N.; Matsui, Elizabeth C.

    2016-01-01

    Recent intervention studies targeted at reducing indoor air pollution have demonstrated both the ability to improve respiratory health outcomes and to reduce particulate matter (PM) levels in the home. However, these studies generally do not address whether it is the reduction of PM levels specifically that improves respiratory health. In this paper we apply the method of principal stratification to data from a randomized air cleaner intervention designed to reduce indoor PM in homes of children with asthma. We estimate the health benefit of the intervention amongst study subjects who would experience a substantial reduction in PM in response to the intervention. For those subjects we find an increase in symptom-free days that is almost three times as large as the overall intention-to-treat effect. We also explore the presence of treatment effects amongst those subjects whose PM levels would not respond to the air cleaner. This analysis demonstrates the usefulness of principal stratification for environmental intervention trials and its potential for much broader application in this area. PMID:27695203

  18. What qualitative research can contribute to a randomized controlled trial of a complex community intervention.

    PubMed

    Nelson, Geoffrey; Macnaughton, Eric; Goering, Paula

    2015-11-01

    Using the case of a large-scale, multi-site Canadian Housing First research demonstration project for homeless people with mental illness, At Home/Chez Soi, we illustrate the value of qualitative methods in a randomized controlled trial (RCT) of a complex community intervention. We argue that quantitative RCT research can neither capture the complexity nor tell the full story of a complex community intervention. We conceptualize complex community interventions as having multiple phases and dimensions that require both RCT and qualitative research components. Rather than assume that qualitative research and RCTs are incommensurate, a more pragmatic mixed methods approach was used, which included using both qualitative and quantitative methods to understand program implementation and outcomes. At the same time, qualitative research was used to examine aspects of the intervention that could not be understood through the RCT, such as its conception, planning, sustainability, and policy impacts. Through this example, we show how qualitative research can tell a more complete story about complex community interventions.

  19. Impact of a Social Work Care Coordination Intervention on Hospital Readmission: A Randomized Controlled Trial.

    PubMed

    Bronstein, Laura R; Gould, Paul; Berkowitz, Shawn A; James, Gary D; Marks, Kris

    2015-07-01

    This study assessed how a social work-led care coordination intervention would reduce the within-30-day hospital readmission rate among moderate- and high-risk patients age 50 years or older. Authors ran a randomized controlled trial to determine whether there was a significant difference in within-30-day readmission rates between patients receiving usual care post-discharge and those receiving intervention from an MSW intern (one home visit and one to two phone calls). Results were obtained using a sample of hospitalized patients with a LACE index score of 7 or higher (N = 89). Analysis suggests that the intervention improved the likelihood of not being readmitted by some 22 percent (RR = 1.222; 95% CI = 1.063-1.405). The risk improvement with the intervention was highly statistically significant (p = .003). This study shows that a time-efficient care coordination intervention by MSW interns may decrease hospital readmission rates. Replications of this study in other communities, with more diverse populations, and with larger numbers of patients will indicate whether results are generalizable.

  20. Brief Motivational Feedback and Cognitive Behavioral Interventions for Prevention of Disordered Gambling: A Randomized Clinical Trial

    PubMed Central

    Larimer, Mary E.; Neighbors, Clayton; Lostutter, Ty W.; Whiteside, Ursula; Cronce, Jessica M.; Kaysen, Debra; Walker, Denise D.

    2012-01-01

    Aims The purpose of the current study was to evaluate feasibility and efficacy of two promising approaches to indicated prevention of disordered gambling in a college population. Design Randomized controlled trial with assignment to a Personalized Feedback Intervention (PFI), Cognitive-Behavioral Intervention (CBI), or Assessment-Only Control (AOC). PFI was individually delivered in a single session and included feedback regarding gambling behavior, norms, consequences, and risk-reduction tips, delivered in a motivational interviewing style. CBI was delivered in small groups over 4-6 sessions and included functional analysis, brief cognitive correction, as well as identification of and alternatives for responding to gambling triggers. Setting College campus. Participants At-risk or probable pathological gamblers (N = 147; 65.3% male; group assignment: PFI, n = 52; CBI, n = 44; AOC, n = 51). Measurements Self-reported gambling quantity, frequency, consequences, psychopathology, normative perceptions, and beliefs. Findings Relative to control, results at 6-month follow-up indicated reductions in both interventions for gambling consequences (PFI d = .48; CBI d = .39) and DSM-IV criteria (PFI d=.60; CBI d=.48), reductions in frequency for PFI (d = .48). CBI was associated with reduced illusions of control, whereas PFI was associated with reduced perceptions of gambling frequency norms. Reductions in perceived gambling frequency norms mediated effects of PFI on gambling frequency. Conclusions A single-session Personalized Feedback Intervention and a multi-session Cognitive-Behavioral Intervention may be helpful in reducing disordered gambling in US college students. PMID:22188239

  1. A randomized intervention trial to reduce mechanical exposures in the Colombian flower industry.

    PubMed

    Barrero, L H; Ceballos, C; Ellegast, R; Pulido, J A; Monroy, M; Berrio, S; Quintana, L A

    2012-01-01

    Evidence on the effectiveness of ergonomic interventions to reduce mechanical demands and upper-extremity MSDs is scarce in agriculture. We conducted an intervention to reduce mechanical exposures during manual flower cutting through job rotation, education and reduction of force requirements. One-hundred and twenty workers (20 to 60 years old; 89% women) from six companies that cultivate roses participated in this study. Three companies were randomly assigned to control and intervention groups. We studied changes between baseline and follow-up in self-reported effort and upper-extremity postures, kinematics and muscular activity. Most of the observed changes were moderate for both groups. The intervention group showed differential improvements compared to the control group for the maximum wrist radial deviation and forearm pronation, and acceleration of the forearm supination-pronation and elbow flexion-extension; and the muscular activity of the flexor and extensor carpi radialis and the flexor carpi ulnaris. However, we also observed that the maximum ulnar deviation, velocity of the wrist flexion-extension and muscular activity of the extensor carpi ulnaris improved more in the control group. These mixed results may be related to limited time for intervention adjustment, and uncontrolled task changes in the control group. Future research should address these issues and test other solutions.

  2. Estimating the health benefit of reducing indoor air pollution in a randomized environmental intervention

    PubMed Central

    Peng, Roger D.; Butz, Arlene M.; Hackstadt, Amber J.; Williams, D'Ann L.; Diette, Gregory B.; Breysse, Patrick N.; Matsui, Elizabeth C.

    2016-01-01

    Recent intervention studies targeted at reducing indoor air pollution have demonstrated both the ability to improve respiratory health outcomes and to reduce particulate matter (PM) levels in the home. However, these studies generally do not address whether it is the reduction of PM levels specifically that improves respiratory health. In this paper we apply the method of principal stratification to data from a randomized air cleaner intervention designed to reduce indoor PM in homes of children with asthma. We estimate the health benefit of the intervention amongst study subjects who would experience a substantial reduction in PM in response to the intervention. For those subjects we find an increase in symptom-free days that is almost three times as large as the overall intention-to-treat effect. We also explore the presence of treatment effects amongst those subjects whose PM levels would not respond to the air cleaner. This analysis demonstrates the usefulness of principal stratification for environmental intervention trials and its potential for much broader application in this area.

  3. A randomized intervention trial to reduce mechanical exposures in the Colombian flower industry.

    PubMed

    Barrero, L H; Ceballos, C; Ellegast, R; Pulido, J A; Monroy, M; Berrio, S; Quintana, L A

    2012-01-01

    Evidence on the effectiveness of ergonomic interventions to reduce mechanical demands and upper-extremity MSDs is scarce in agriculture. We conducted an intervention to reduce mechanical exposures during manual flower cutting through job rotation, education and reduction of force requirements. One-hundred and twenty workers (20 to 60 years old; 89% women) from six companies that cultivate roses participated in this study. Three companies were randomly assigned to control and intervention groups. We studied changes between baseline and follow-up in self-reported effort and upper-extremity postures, kinematics and muscular activity. Most of the observed changes were moderate for both groups. The intervention group showed differential improvements compared to the control group for the maximum wrist radial deviation and forearm pronation, and acceleration of the forearm supination-pronation and elbow flexion-extension; and the muscular activity of the flexor and extensor carpi radialis and the flexor carpi ulnaris. However, we also observed that the maximum ulnar deviation, velocity of the wrist flexion-extension and muscular activity of the extensor carpi ulnaris improved more in the control group. These mixed results may be related to limited time for intervention adjustment, and uncontrolled task changes in the control group. Future research should address these issues and test other solutions. PMID:22317489

  4. Improving Maternal Mental Health Following Preterm Birth Using an Expressive Writing Intervention: A Randomized Controlled Trial.

    PubMed

    Horsch, Antje; Tolsa, Jean-François; Gilbert, Leah; du Chêne, Lauranne Jan; Müller-Nix, Carole; Bickle Graz, Myriam

    2016-10-01

    Evaluations of evidence-based, easily accessible, psychological interventions to improve maternal mental health following very preterm birth are scarce. This study investigated the efficacy and acceptability of the expressive writing paradigm for mothers of very preterm infants. The level of maternal posttraumatic stress and depressive symptoms was the primary outcome. Participants were 67 mothers of very preterm babies who were randomly allocated into the intervention (expressive writing; n = 33) or control group (treatment-as-usual; n = 32) when their infant was aged 3 months (corrected age, CA). Measurements were taken at 3 months (pre-intervention), 4 months (post-intervention), and 6 months CA (follow-up). Results showed reduced maternal posttraumatic stress (d = 0.42), depressive symptoms (d = 0.67), and an improved mental health status (d = 1.20) in the intervention group, which were maintained at follow-up. Expressive writing is a brief, cost-effective, and acceptable therapeutic approach that could be offered as part of the NICU care.

  5. A Behavioral Intervention for War-Affected Youth in Sierra Leone: A Randomized Controlled Trial

    PubMed Central

    Betancourt, Theresa S.; McBain, Ryan; Newnham, Elizabeth A.; Akinsulure-Smith, Adeyinka M.; Brennan, Robert T.; Weisz, John R.; Hansen, Nathan B.

    2016-01-01

    Objective Youth in war-affected regions are at risk for poor psychological, social, and educational outcomes. Effective interventions are needed to improve mental health, social behavior, and school functioning. This randomized controlled trial tested the effectiveness of a 10-session cognitive-behavioral therapy (CBT)–based group mental health intervention for multisymptomatic war-affected youth (aged 15–24 years) in Sierra Leone. Method War-affected youth identified by elevated distress and impairment via community screening were randomized (stratified by sex and age) to the Youth Readiness Intervention (YRI) (n = 222) or to a control condition (n = 214). After treatment, youth were again randomized and offered an education subsidy immediately (n = 220) or waitlisted (n = 216). Emotion regulation, psychological distress, prosocial attitudes/behaviors, social support, functional impairment, and posttraumatic stress disorder (PTSD) symptoms were assessed at pre- and postintervention and at 6-month follow-up. For youth in school, enrollment, attendance, and classroom performance were assessed after 8 months. Linear mixed-effects regressions evaluated outcomes. Results The YRI showed significant postintervention effects on emotion regulation, prosocial attitudes/behaviors, social support, and reduced functional impairment, and significant follow-up effects on school enrollment, school attendance, and classroom behavior. In contrast, education subsidy was associated with better attendance but had no effect on mental health or functioning, school retention, or classroom behavior. Interactions between education subsidy and YRI were not significant. Conclusion YRI produced acute improvements in mental health and functioning as well as longer-term effects on school engagement and behavior, suggesting potential to prepare war-affected youth for educational and other opportunities. Clinical trial registration information-Trial of the Youth Readiness Intervention (YRI

  6. Randomized Multilevel Intervention to Improve Outcomes of Residents in Nursing Homes in Need of Improvement

    PubMed Central

    Rantz, Marilyn J.; Nahm, Helen E.; Zwygart-Stauffacher, Mary; Hicks, Lanis; Mehr, David; Flesner, Marcia; Petroski, Gregory F.; Madsen, Richard W.; Scott-Cawiezell, Jill

    2012-01-01

    Purpose A comprehensive multilevel intervention was tested to build organizational capacity to create and sustain improvement in quality of care and subsequently improve resident outcomes in nursing homes in need of improvement. Intervention facilities (n=29) received a two-year multilevel intervention with monthly on-site consultation from expert nurses with graduate education in gerontological nursing. Attention control facilities (n=29) that also needed to improve resident outcomes received monthly information about aging and physical assessment of elders. Design and Methods Randomized clinical trial of nursing homes in need of improving resident outcomes of bladder and bowel incontinence, weight loss, pressure ulcers, and decline in activities of daily living (ADL). It was hypothesized that following the intervention, experimental facilities would have better resident outcomes, higher quality of care, higher staff retention, more organizational attributes of improved working conditions than control facilities, similar staffing and staff mix, and lower total and direct care costs. Results The intervention did improve quality of care (p=0.02); there were improvements in pressure ulcers (p=0.05), weight loss (p=0.05). Staff retention, organizational working conditions, staffing, and staff mix and most costs were not affected by the intervention. Leadership turnover was surprisingly excessive in both intervention and control groups. Implications Some facilities that are in need of improving quality of care and resident outcomes are able to build the organizational capacity to improve while not increasing staffing or costs of care. Improvement requires continuous supportive consultation and leadership willing to involve staff and work together to build the systematic improvements in care delivery needed. PMID:21816681

  7. A Randomized Stepped Care Intervention Trial Targeting Posttraumatic Stress Disorder for Surgically Hospitalized Injury Survivors

    PubMed Central

    Zatzick, Douglas; Jurkovich, Gregory; Rivara, Frederick P.; Russo, Joan; Wagner, Amy; Wang, Jin; Dunn, Chris; Lord, Sarah Peregrine; Petrie, Megan; O’Connor, Stephen S.; Katon, Wayne

    2013-01-01

    Objective To test the effectiveness of a stepped care intervention model targeting posttraumatic stress disorder (PTSD) symptoms after injury. Background Few investigations have evaluated interventions for injured patients with PTSD and related impairments that can be feasibly implemented in trauma surgical settings. Methods The investigation was a pragmatic effectiveness trial in which 207 acutely injured hospitalized trauma survivors were screened for high PTSD symptom levels and then randomized to a stepped combined, care management, psychopharmacology, and cognitive behavioral psychotherapy intervention (n = 104) or usual care control (n = 103) conditions. The symptoms of PTSD and functional limitations were reassessed at one-, three-, six-, nine-, and twelve-months after the index injury admission. Results Regression analyses demonstrated that over the course of the year after injury, intervention patients had significantly reduced PTSD symptoms when compared to controls (group by time effect, CAPS, F(2, 185) = 5.50, P < 0.01; PCL-C, F(4, 185) = 5.45, P < 0.001). Clinically and statistically significant PTSD treatment effects were observed at the six-, nine-, and twelve-month post-injury assessments. Over the course of the year after injury, intervention patients also demonstrated significant improvements in physical function (MOS SF-36 PCS main effect, F(1, 172) = 9.87, P < 0.01). Conclusion Stepped care interventions can reduce PTSD symptoms and improve functioning over the course of the year after surgical injury hospitalization. Orchestrated investigative and policy efforts could systematically introduce and evaluate screening and intervention procedures for PTSD at United States trauma centers. (Trial Registration: clinicaltrials.gov identifier: NCT00270959) PMID:23222034

  8. Randomized Trial of Psychological Interventions to Preventing Postpartum Depression among Iranian First-time Mothers

    PubMed Central

    Fathi-Ashtiani, Ali; Ahmadi, Ahmad; Ghobari-Bonab, Bagher; Azizi, Mohammed Parsa; Saheb-Alzamani, Sayeh Moosavi

    2015-01-01

    Background: The current study was conducted to examine the effect of cognitive behavior therapy on the reduction postpartum mood disorder and increasing the self-esteem of at-risk Iranian mothers. Methods: In this quasi-experimental study, 135 at-risk mothers were selected from the population by means of cluster sampling and randomly assigned into one of two groups: Intervention (n = 64), or control (n = 71). The control group received usual medical care, and the intervention group received an eight sessions’ cognitive behavior program during pregnancy. Assessments were administered at two time points (pretest at the beginning of the third trimester and posttest at 2 weeks postpartum). Beck anxiety, beck depression, Edinburgh postpartum depression, (PPD) Coopersmith self-esteem, and religious attitude questionnaire were used to collect data. Results: The mean age of participants was 25.8 ± 3.7 years. One-third of them had either bachelor or higher degrees in education (33%). About two-third of participants were unemployment with similar distribution in both the groups (intervention = 80%, control = 83%). The majority (70%) of the participants had cesarean section deliveries. There were no statistically significant differences respects to sociodemographic characteristics between the control and intervention groups (P > 0.05). The multivariate analysis of covariance results showed that the average scores of PPD were reduced significantly in the intervention group (P < 0.001). Also while the mean score of anxiety in the intervention group decreased from 23.31 (standard error [SE] =12.11) to 16.64 (SE = 8.33) and self-esteem increased from 29.09 (SE = 3.51) to 31.81 (SE = 2.76), no change was statistically significant in comparison to the control group. Conclusions: According to the findings of the present study, cognitive behavior intervention is effective in reducing PPD in at-risk mothers. PMID:26682030

  9. Brief Cognitive-Behavioral and Relaxation Training Interventions for Breast Cancer: A Randomized Controlled Trial

    PubMed Central

    Gudenkauf, Lisa M.; Antoni, Michael H.; Stagl, Jamie M.; Lechner, Suzanne C.; Jutagir, Devika R.; Bouchard, Laura C.; Blomberg, Bonnie B.; Glück, Stefan; Derhagopian, Robert P.; Giron, Gladys L.; Avisar, Eli; Torres-Salichs, Manuel A.; Carver, Charles S.

    2015-01-01

    Objective Women with breast cancer (BCa) report elevated distress post-surgery. Group-based cognitive-behavioral stress management (CBSM) following surgery improves psychological adaptation, though its key mechanisms remain speculative. This randomized controlled dismantling trial compared two interventions featuring elements thought to drive CBSM effects: a 5-week Cognitive-Behavioral Training (CBT) and 5-week Relaxation Training (RT) vs. a 5-week Health Education (HE) control group. Method Women with stage 0-III BCa (N = 183) were randomized to CBT, RT, or HE condition 2–10 weeks post-surgery. Psychosocial measures were collected at baseline (T1) and post-intervention (T2). Repeated-measures ANOVAs tested whether CBT and RT treatments improved primary measures of psychological adaptation and secondary measures of stress management resource perceptions from pre- to post-intervention relative to HE. Results Both CBT and RT groups reported reduced depressive affect. The CBT group reported improved emotional well-being/quality of life and less cancer-specific thought intrusions. The RT group reported improvements on illness-related social disruption. Regarding stress management resources, the CBT group reported increased reliability of social support networks, while the RT group reported increased confidence in relaxation skills. Psychological adaptation and stress management resource constructs were unchanged in the HE control group. Conclusions Non-metastatic breast cancer patients participating in two forms of brief, 5-week group-based stress management intervention after surgery showed improvements in psychological adaptation and stress management resources compared to an attention-matched control group. Findings provide preliminary support suggesting that using brief group-based stress management interventions may promote adaptation among non-metastatic breast cancer patients. PMID:25939017

  10. Self-Management Intervention for Long-Term Indwelling Urinary Catheter Users: Randomized Clinical Trial

    PubMed Central

    Wilde, Mary H.; McMahon, James M.; McDonald, Margaret V.; Tang, Wan; Wang, Wenjuan; Brasch, Judith; Fairbanks, Eileen; Shah, Shivani; Zhang, Feng; Chen, Ding-Geng (Din)

    2014-01-01

    Background People using long-term indwelling urinary catheters experience multiple recurrent catheter problems. Self-management approaches are needed to avoid catheter-related problems. Objectives The aim was to determine effectiveness of a self-management intervention in prevention of adverse outcomes (catheter-related urinary tract infection, blockage, and accidental dislodgement). Healthcare treatment associated with the adverse outcomes and catheter-related quality of life was also studied. Method A randomized clinical trial was conducted. The intervention involved learning catheter-related self-monitoring and self-management skills during home visits by a study nurse (twice during the first month and at four months—with a phone call at two months). The control group received usual care. Data were collected during an initial face-to-face home interview followed by bimonthly phone interviews. A total of 202 adult long-term urinary catheter users participated. Participants were randomized to treatment or control groups following collection of baseline data. Generalized estimating equations (GEE) were used for the analysis of treatment effect. Results In the intervention group, there was a significant decrease in reported blockage in the first six months (p = .02), but the effect did not persist. There were no significant effects for catheter-related urinary tract infection or dislodgment. Comparison of baseline rates of adverse outcomes with subsequent periods suggested that both groups improved over 12 months. Discussion A simple–to–use catheter problems calendar and the bimonthly interviews might have functioned as a modest self-monitoring intervention for persons in the control group. A simplified intervention using a self-monitoring calendar is suggested—with optimal and consistent fluid intake likely to add value. PMID:25502058

  11. A 12-Week Exercise Program for Pregnant Women with Obesity to Improve Physical Activity Levels: An Open Randomised Preliminary Study

    PubMed Central

    Alméras, Natalie; Dufresne, Sébastien S.; Robitaille, Julie; Rhéaume, Caroline; Bujold, Emmanuel; Frenette, Jérôme; Tremblay, Angelo

    2015-01-01

    Objective To evaluate whether a 12-week supervised exercise program promotes an active lifestyle throughout pregnancy in pregnant women with obesity. Methods In this preliminary randomised trial, pregnant women (body mass index ≥ 30 kg/m2) were allocated to either standard care or supervised training, from 15 to 27 weeks of gestation. Physical activity was measured by accelerometry at 14, 28 and 36 weeks, while fitness (oxygen consumption (VO2) at the anaerobic threshold), nutrition (caloric intake and macronutrients percentage) and anthropometry were assessed at 14 and 28 weeks of gestation. Analyses were performed using repeated measures ANOVA. Results A total of fifty (50) women were randomised, 25 in each group. There was no time-group interaction for time spent at moderate and vigorous activity (pinteraction = 0.064), but the exercise group’s levels were higher than controls’ at all times (pgroup effect = 0.014). A significant time-group interaction was found for daily physical activity (p = 0.023); similar at baseline ((22.0 ± 6.7 vs 21.8 ± 7.3) x 104 counts/day) the exercise group had higher levels than the control group following the intervention ((22.8 ± 8.3 vs 19.2 ± 4.5) x 104 counts/day, p = 0.020) and at 36 weeks of gestation ((19.2 ± 1.5 vs 14.9 ± 1.5) x 104 counts/day, p = 0.034). Exercisers also gained less weight than controls during the intervention period despite similar nutritional intakes (difference in weight change = -0.1 kg/week, 95% CI -0.2; -0.02, p = 0.016) and improved cardiorespiratory fitness (difference in fitness change = 8.1%, 95% CI 0.7; 9.5, p = 0.041). Conclusions Compared with standard care, a supervised exercise program allows pregnant women with obesity to maintain fitness, limit weight gain and attenuate the decrease in physical activity levels observed in late pregnancy. Trial Registration ClinicalTrials.gov NCT01610323 PMID:26375471

  12. Randomized Controlled Trial of Personalized Motivational Interventions in Substance Using Patients With Facial Injuries

    PubMed Central

    Shetty, Vivek; Murphy, Debra A.; Zigler, Corwin; Yamashita, Dennis-Duke R.; Belin, Thomas R.

    2011-01-01

    Purpose The proximate use of illicit drugs or alcohol (substance use) is the most common precipitator of facial injuries among socioeconomically disadvantaged populations. Reducing these risky behaviors could minimize adverse health sequelae and potential reinjury. The objective of our study was to test whether a culturally competent, personalized motivational intervention incorporated into surgical care could significantly reduce existing substance use behaviors in facial injury patients. Patients and Methods Substance-using subjects (n = 218) presenting with facial injuries to a level 1 trauma center were randomly assigned to either a personalized motivational intervention (PMI) condition or a health-information (HI) control condition. After a brief assessment of the individual’s substance use severity and willingness to change these behaviors, both groups attended 2 counseling sessions with a trained interventionist. The PMI subjects (n = 118) received individualized, motivational interventions, whereas the HI subjects (n = 100) received only general health information. Both groups were reassessed at 6 and 12 months postinjury, and changes in substance-use patterns were measured to assess the effects of intervention. Results The PMI and HI groups were closely matched on their sociodemographic and substance use characteristics. Subjects in the PMI group showed statistically significant declines in drug use at both the 6- and 12-month assessments. The intervention’s effect on lowering illicit drug use was greatest at the 6-month assessment but had weakened by the 1-year follow-up. The efficacy of the PMI was moderated by an individual’s initial drug use severity; individuals with greater drug use dependency at baseline were seen to have larger intervention effects, as did individuals who were most aware of their drug problem and willing to change their substance use behaviors. Unlike illicit drug use, changes in alcohol use did not differ significantly

  13. The effect of 12 weeks Prop Pilates Exercise Program (PPEP) on body stability and pain for fruit farmers with MSDs.

    PubMed

    Kim, Hye-Jin; Nam, Sang-Nam; Bae, Ung Ryel; Hwang, Ryong; Lee, Jong-Bok; Kim, Jong-Hyuck

    2014-01-01

    The purpose of this study was to determine possible effects of 12-week Prop Pilates Exercise Program (PPEP) for the fruit farmers (grape, tomato, apple) with musculoskeletal disorders (MSD) on body stability and pain. 131 fruit farmers with MSD were selected and asked to join a 12-week Prop Pilates Exercise Program (PPEP) from 2009 to 2012. The subjects (female=74, male=57) aged 50 to 65 years old voluntarily participated. As a result, it was found that lateral-medial and anterior-posterior of body stability significantly improved in male and female fruit farmers. It was found that pain index (VAS) after 12-week Prop Pilates Exercise Program (PPEP) showed a significant decrease. PMID:24704650

  14. Effects of Interventions on Use of Hearing Protectors among Farm Operators: A Randomized Controlled Trial

    PubMed Central

    McCullagh, Marjorie C.; Banerjee, Tanima; Cohen, Michael A.; Yang, James J.

    2016-01-01

    Objective The purpose of this study was to compare the effectiveness of three interventions designed to promote hearing protector device (HPD) use. Design Randomized controlled trial. Study Sample Farm operators (n=491) were randomly assigned to one of 5 intervention groups: 1) interactive Web-based information with mailed assortment of HPDs; 2) Interactive Web-based information only; 3) static Web-based information with mailed assortment of HPDs; 4) Static Web-based information only; or 5) mailed assortment of HPDs only. Data were analyzed using a mixed model approach. Results HPD use increased among all participants, and increased more among participants receiving the mailed HPDs (with or without information) compared to participants receiving other interventions. Participants receiving the interactive Web-based information had comparable increased use of HPDs to those receiving the static Web-based information. Participants receiving the mailed HPDs had more positive situational influences scale scores than other participants. Program satisfaction was highest among mailed and Web-based information groups. Conclusions A mailed assortment of hearing protectors was more effective than information. Interactive and static information delivered via Web were similarly effective. Programs interested in increasing HPD use among farmers should consider making hearing protectors more available to farmers. PMID:26766172

  15. The effects of 12-week psyllium fibre supplementation or healthy diet on blood pressure and arterial stiffness in overweight and obese individuals.

    PubMed

    Pal, Sebely; Khossousi, Alireza; Binns, Colin; Dhaliwal, Satvinder; Radavelli-Bagatini, Simone

    2012-03-01

    Endothelial dysfunction and increased arterial stiffness occur early in the pathogenesis of the metabolic syndrome and they are both powerful independent predictors of cardiovascular risk. A high-fibre diet has been correlated with lower BMI and a lower incidence of hyperlipidaemia, CVD, hypertension and diabetes. The present randomised, parallel-design study compared the effects of fibre intake from a healthy diet v. fibre supplement diets on blood pressure (BP) and vascular function over 12 weeks. Overweight and obese adults were randomised to one of three groups: control (with placebo), fibre supplement (FIB) or healthy eating group with placebo (HLT). Systolic blood pressure (SBP) was lower in the FIB group compared with the control group at week 6, but not at week 12. However, SBP was lower in the HLT group compared with control group at week 12. At week 6, the FIB group presented lower diastolic blood pressure and augmentation index compared with the control group, but this result did not persist to the end of the study. The present study did not show any improvements in BP or vascular function in overweight and obese individuals with psyllium fibre supplementation over 12 weeks of intervention. However, a healthy diet provided the greatest improvements in BP in overweight and obese subjects. Further research with hypertensive individuals is necessary to elucidate whether increased fibre consumption in the form of psyllium supplementation may provide a safe and acceptable means to reduce BP, vascular function and the risk of developing CVD.

  16. [Education programs on atopic eczema. Design and first results of the German Randomized Intervention Multicenter Study].

    PubMed

    Diepgen, T L; Fartasch, M; Ring, J; Scheewe, S; Staab, D; Szcepanski, R; Werfel, T; Wahn, U; Gieler, U

    2003-10-01

    Atopic eczema (AE) is a common, chronically relapsing, inflammatory skin disease with an early onset during infancy associated with a high loss of quality of life and socioeconomic burden. In the past few years, an Atopic Eczema Prevention Program was established to improve disease management and the quality of life of patients with atopic eczema. In Germany, the Task Force on Education Programs for Atopic Eczema (AGNES = Arbeitsgemeinschaft Neurodermitis Schulung) for children, youths, and parents was founded as well as the Task Force on Dermatological Prevention (ADP) for adults. These groups ensure structure and process quality of the prevention programs and organize train-the-trainer workshops. In a randomized prospective controlled trial (the German Randomized Intervention Multicenter Study = GRIMS), we are currently comparing the effectiveness of an atopic eczema group intervention program in (1) parents of atopic eczema children aged 0-7 years, (2) parents and children 7-12 years old, and (3) youths with AE aged between 13 and 18 years. The groups were randomized and compared with a waiting control group. The design and first results will be reported. PMID:14513241

  17. Protocol for the Cognitive Interventions and Nutritional Supplements (CINS) trial: A randomized controlled multicenter trial of a brief intervention (BI) versus a BI plus cognitive behavioral treatment (CBT) versus nutritional supplements for patients with long-lasting muscle and back pain

    PubMed Central

    2011-01-01

    Abstract Background Brief intervention programs are clinically beneficial, and cost efficient treatments for low back pain, when offered at 8-12 weeks, compared with treatment as usual. However, about 30% of the patients do not return to work. The European Guidelines for treatment of chronic low back pain recommends Cognitive Behavioral Therapy (CBT), but conclude that further research is needed to evaluate the effectiveness of CBT for chronic low back pain. Methods/Design The aim of the multicenter CINS trial (Cognitive Interventions and Nutritional Supplements) is to compare the effectiveness of 4 different interventions; Brief Intervention, Brief Intervention and CBT, Brief Intervention and nutritional supplements of seal oil, and Brief Intervention and nutritional supplements of soy oil. All participants will be randomly assigned to the interventions. The nutritional supplements will be tested in a double blind design. 400 patients will be recruited from a population of chronic low back pain patients that have been sick listed for 2-10 months. Four outpatient clinics, located in different parts of Norway, will participate in recruitment and treatment of the patients. The Brief Intervention is a one session cognitive, clinical examination program based on a non-injury model, where return to normal activity and work is the main goal, and is followed by two booster sessions. The CBT is a tailored treatment involving 7 sessions, following a detailed manual. The nutritional supplements consist of a dosage of 10 grams of either soy or seal oil (capsules) per day for 3 months, administered in a double blind design. All patients will be followed up with questionnaires after 3, 6 and 12 months, while sick leave data will be collected up to at least 24 months after randomization. The primary outcome of the study is sick leave and will be based on register data from the National Insurance Administration. Secondary outcomes include self-reported data on disability, pain

  18. Effects of a multifactorial injury prevention intervention in physical education teachers: A randomized controlled trial.

    PubMed

    Vercruysse, Sien; Haerens, Leen; Verhagen, Evert; Goossens, Lennert; De Clercq, Dirk

    2016-10-01

    Physical education (PE) teachers are at a high risk of musculoskeletal sports or work-related injuries because of the physical activity as inherent part of their profession. Such injuries have a negative impact on work and leisure time activities, and effective injury prevention interventions are needed. The present study aimed at testing the effectiveness of an injury prevention intervention that was developed and optimized according to PE teachers' wishes and values. Fifty-five PE teachers were randomly assigned to intervention or control group. Intervention group teachers engaged in two days of training during which they familiarized with eight injury prevention strategies (seven intrinsic and one extrinsic). A special feature of the intervention was that the way of delivery was based on the self-determination theory in order to stimulate participants' motivation to adhere to the proposed strategies. Prospective registrations during one school year were conducted concerning injuries and preventive behaviours. Results showed that the intervention group teachers had a lower number of injuries per 1000 h time of exposure (TOE) than the controls (INT: 0.49, CON: 1.14 injuries/1000 h TOE, OR: 2.32, 95% CI: 1.06-5.07), and applied a broader variety of strategies including dynamic and static stretching, core stability, balance and strength training, when compared to the controls who mainly engaged in warming-up. In conclusion, with the same amount of time, an injury reduction was found in PE teachers through a more balanced use of provided preventive strategies. PMID:26848872

  19. A randomized controlled trial of a videoconferencing smoking cessation intervention for Korean American women: preliminary findings

    PubMed Central

    Kim, Sun S; Sitthisongkram, Somporn; Bernstein, Kunsook; Fang, Hua; Choi, Won S; Ziedonis, Douglas

    2016-01-01

    Introduction Korean women are reluctant to pursue in-person smoking cessation treatment due to stigma attached to women smokers and prefer treatment such as telephone and online smoking cessation programs that they can access secretively at home. However, there is some evidence that face-to-face interaction is the most helpful intervention component for them to quit smoking. Methods This study is a pilot clinical trial that examined the acceptability and feasibility of a videoconferencing smoking cessation intervention for Korean American women and compared its preliminary efficacy with a telephone-based intervention. Women of Korean ethnicity were recruited nationwide in the United States and randomly assigned at a ratio of 1:1 to either a video arm or a telephone arm. Both arms received eight 30-minute weekly individualized counseling sessions of a deep cultural smoking cessation intervention and nicotine patches for 8 weeks. Participants were followed over 3 months from the quit day. Results The videoconferencing intervention was acceptable and feasible for Korean women aged <50 years, whereas it was not for older women. Self-reported abstinence was high at 67% and 48% for the video and telephone arm at 1 month post-quit, respectively. The rates declined to 33% for the video arm and 28% for the telephone arm at 3 months post-quit when salivary cotinine test was performed. Conclusion Findings support that both videoconferencing and telephone counseling can be effective, and personal preference is likely an important factor in treatment matching. The deep cultural smoking cessation intervention may account for the outcomes of telephone counseling being better than prior studies in the literature for Korean women. PMID:27660494

  20. Weight change among people randomized to minimal intervention control groups in weight loss trials

    PubMed Central

    Johns, David J.; Hartmann‐Boyce, Jamie; Jebb, Susan A.; Aveyard, Paul

    2016-01-01

    Objective Evidence on the effectiveness of behavioral weight management programs often comes from uncontrolled program evaluations. These frequently make the assumption that, without intervention, people will gain weight. The aim of this study was to use data from minimal intervention control groups in randomized controlled trials to examine the evidence for this assumption and the effect of frequency of weighing on weight change. Methods Data were extracted from minimal intervention control arms in a systematic review of multicomponent behavioral weight management programs. Two reviewers classified control arms into three categories based on intensity of minimal intervention and calculated 12‐month mean weight change using baseline observation carried forward. Meta‐regression was conducted in STATA v12. Results Thirty studies met the inclusion criteria, twenty‐nine of which had usable data, representing 5,963 participants allocated to control arms. Control arms were categorized according to intensity, as offering leaflets only, a single session of advice, or more than one session of advice from someone without specialist skills in supporting weight loss. Mean weight change at 12 months across all categories was −0.8 kg (95% CI −1.1 to −0.4). In an unadjusted model, increasing intensity by moving up a category was associated with an additional weight loss of −0.53 kg (95% CI −0.96 to −0.09). Also in an unadjusted model, each additional weigh‐in was associated with a weight change of −0.42 kg (95% CI −0.81 to −0.03). However, when both variables were placed in the same model, neither intervention category nor number of weigh‐ins was associated with weight change. Conclusions Uncontrolled evaluations of weight loss programs should assume that, in the absence of intervention, their population would weigh up to a kilogram on average less than baseline at the end of the first year of follow‐up. PMID:27028279

  1. A randomized controlled trial of a videoconferencing smoking cessation intervention for Korean American women: preliminary findings

    PubMed Central

    Kim, Sun S; Sitthisongkram, Somporn; Bernstein, Kunsook; Fang, Hua; Choi, Won S; Ziedonis, Douglas

    2016-01-01

    Introduction Korean women are reluctant to pursue in-person smoking cessation treatment due to stigma attached to women smokers and prefer treatment such as telephone and online smoking cessation programs that they can access secretively at home. However, there is some evidence that face-to-face interaction is the most helpful intervention component for them to quit smoking. Methods This study is a pilot clinical trial that examined the acceptability and feasibility of a videoconferencing smoking cessation intervention for Korean American women and compared its preliminary efficacy with a telephone-based intervention. Women of Korean ethnicity were recruited nationwide in the United States and randomly assigned at a ratio of 1:1 to either a video arm or a telephone arm. Both arms received eight 30-minute weekly individualized counseling sessions of a deep cultural smoking cessation intervention and nicotine patches for 8 weeks. Participants were followed over 3 months from the quit day. Results The videoconferencing intervention was acceptable and feasible for Korean women aged <50 years, whereas it was not for older women. Self-reported abstinence was high at 67% and 48% for the video and telephone arm at 1 month post-quit, respectively. The rates declined to 33% for the video arm and 28% for the telephone arm at 3 months post-quit when salivary cotinine test was performed. Conclusion Findings support that both videoconferencing and telephone counseling can be effective, and personal preference is likely an important factor in treatment matching. The deep cultural smoking cessation intervention may account for the outcomes of telephone counseling being better than prior studies in the literature for Korean women.

  2. Computer-Delivered Screening and Brief Intervention for Alcohol Use in Pregnancy: A Pilot Randomized Trial

    PubMed Central

    Ondersma, Steven J.; Beatty, Jessica R.; Svikis, Dace S.; Strickler, Ronald C.; Tzilos, Golfo K.; Chang, Grace; Divine, W.; Taylor, Andrew R.; Sokol, Robert J.

    2015-01-01

    Background Although screening and brief intervention (SBI) for unhealthy alcohol use has demonstrated efficacy in some trials, its implementation has been limited. Technology-delivered approaches are a promising alternative, particularly during pregnancy when the importance of alcohol use is amplified. The present trial evaluated the feasibility and acceptability of an interactive, empathic, video-enhanced, and computer-delivered SBI (e-SBI) plus three separate tailored mailings, and estimated intervention effects. Methods We recruited 48 pregnant women who screened positive for alcohol risk at an urban prenatal care clinic. Participants were randomly assigned to the e-SBI plus mailings or to a control session on infant nutrition, and were reevaluated during their postpartum hospitalization. The primary outcome was 90-day period-prevalence abstinence as measured by timeline follow-back interview. Results Participants rated the intervention as easy to use and helpful (4.7-5.0 on a 5-point scale). Blinded follow-up evaluation at childbirth revealed medium-size intervention effects on 90-day period prevalence abstinence (OR = 3.4); similarly, intervention effects on a combined healthy pregnancy outcome variable (live birth, normal birthweight, and no NICU stay) were also of moderate magnitude in favor of e-SBI participants (OR=3.3). As expected in this intentionally under-powered pilot trial, these effects were non-significant (p = .19 and .09, respectively). Conclusions This pilot trial demonstrated the acceptability and preliminary efficacy of a computer-delivered screening and brief intervention (e-SBI) plus tailored mailings for alcohol use in pregnancy. These findings mirror the promising results of other trials using a similar approach, and should be confirmed in a fully-powered trial. PMID:26010235

  3. Intervention to promote physician well-being, job satisfaction, and professionalism: a randomized clinical trial.

    PubMed

    West, Colin P; Dyrbye, Liselotte N; Rabatin, Jeff T; Call, Tim G; Davidson, John H; Multari, Adamarie; Romanski, Susan A; Hellyer, Joan M Henriksen; Sloan, Jeff A; Shanafelt, Tait D

    2014-04-01

    IMPORTANCE Despite the documented prevalence and clinical ramifications of physician distress, few rigorous studies have tested interventions to address the problem. OBJECTIVE To test the hypothesis that an intervention involving a facilitated physician small-group curriculum would result in improvement in well-being. DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial of 74 practicing physicians in the Department of Medicine at the Mayo Clinic in Rochester, Minnesota, conducted between September 2010 and June 2012. Additional data were collected on 350 nontrial participants responding to annual surveys timed to coincide with the trial surveys. INTERVENTIONS The intervention involved 19 biweekly facilitated physician discussion groups incorporating elements of mindfulness, reflection, shared experience, and small-group learning for 9 months. Protected time (1 hour of paid time every other week) for participants was provided by the institution. MAIN OUTCOMES AND MEASURES Meaning in work, empowerment and engagement in work, burnout, symptoms of depression, quality of life, and job satisfaction assessed using validated metrics. RESULTS Empowerment and engagement at work increased by 5.3 points in the intervention arm vs a 0.5-point decline in the control arm by 3 months after the study (P = .04), an improvement sustained at 12 months (+5.5 vs +1.3 points; P = .03). Rates of high depersonalization at 3 months had decreased by 15.5% in the intervention arm vs a 0.8% increase in the control arm (P = .004). This difference was also sustained at 12 months (9.6% vs 1.5% decrease; P = .02). No statistically significant differences in stress, symptoms of depression, overall quality of life, or job satisfaction were seen. In additional comparisons including the nontrial physician cohort, the proportion of participants strongly agreeing that their work was meaningful increased 6.3% in the study intervention arm but decreased 6.3% in the study control arm

  4. Intervention Effects on Adolescent Physical Activity in the Multicomponent SPACE Study: A Cluster Randomized Controlled Trial

    PubMed Central

    Toftager, Mette; Christiansen, Lars B.; Ersbøll, Annette K.; Kristensen, Peter L.; Due, Pernille; Troelsen, Jens

    2014-01-01

    Background Multicomponent school-based interventions have the potential to reduce the age-related decline in adolescents' physical activity (PA), yet there is not consistent evidence to guide non-curricular and school environment interventions. The aim of this study was to assess the effectiveness of a multicomponent environmental school-based intervention, designed to reduce the age-related decline in PA among adolescents. Methods A cluster randomized controlled trial was conducted with 7 intervention and 7 control schools. Baseline measurements were carried out in spring 2010 with 2 years of follow-up. A total of 1,348 students (11–13 years, in grade 5 and 6) enrolled in the study at baseline. The 14 schools included in the study were located in the Region of Southern Denmark. The intervention consisted of organizational and physical changes in the school environment with a total of 11 intervention components. The primary outcome measure was overall PA (cpm, counts per minute) and was supported by analyses of time spent in MVPA, and time spent sedentary. Furthermore, a secondary outcome measure was PA in school time and during recess. PA was measured using accelerometer (Actigraph GT3X). Results A total of 797 students completed the trial and had valid accelerometer data. No significant difference was found for overall PA with an adjusted difference of −19.1 cpm (95% CI: −93, 53) or for school time activity with an adjusted difference of 6 cpm (95% CI: −73, 85). A sensitivity analysis revealed a positive significant intervention effect of PA in recess with an adjusted difference of 95 cpm. Conclusions No evidence was found of the overall effect of a non-curricular multicomponent school-based intervention on PA among Danish adolescents. The intervention was positively associated with PA during school time and recess, however, with small estimates. Lack of effect on overall PA could be due to both program theory and different degrees of implementation

  5. Intervention to promote physician well-being, job satisfaction, and professionalism: a randomized clinical trial.

    PubMed

    West, Colin P; Dyrbye, Liselotte N; Rabatin, Jeff T; Call, Tim G; Davidson, John H; Multari, Adamarie; Romanski, Susan A; Hellyer, Joan M Henriksen; Sloan, Jeff A; Shanafelt, Tait D

    2014-04-01

    IMPORTANCE Despite the documented prevalence and clinical ramifications of physician distress, few rigorous studies have tested interventions to address the problem. OBJECTIVE To test the hypothesis that an intervention involving a facilitated physician small-group curriculum would result in improvement in well-being. DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial of 74 practicing physicians in the Department of Medicine at the Mayo Clinic in Rochester, Minnesota, conducted between September 2010 and June 2012. Additional data were collected on 350 nontrial participants responding to annual surveys timed to coincide with the trial surveys. INTERVENTIONS The intervention involved 19 biweekly facilitated physician discussion groups incorporating elements of mindfulness, reflection, shared experience, and small-group learning for 9 months. Protected time (1 hour of paid time every other week) for participants was provided by the institution. MAIN OUTCOMES AND MEASURES Meaning in work, empowerment and engagement in work, burnout, symptoms of depression, quality of life, and job satisfaction assessed using validated metrics. RESULTS Empowerment and engagement at work increased by 5.3 points in the intervention arm vs a 0.5-point decline in the control arm by 3 months after the study (P = .04), an improvement sustained at 12 months (+5.5 vs +1.3 points; P = .03). Rates of high depersonalization at 3 months had decreased by 15.5% in the intervention arm vs a 0.8% increase in the control arm (P = .004). This difference was also sustained at 12 months (9.6% vs 1.5% decrease; P = .02). No statistically significant differences in stress, symptoms of depression, overall quality of life, or job satisfaction were seen. In additional comparisons including the nontrial physician cohort, the proportion of participants strongly agreeing that their work was meaningful increased 6.3% in the study intervention arm but decreased 6.3% in the study control arm

  6. Improving well-being at work: A randomized controlled intervention based on selection, optimization, and compensation.

    PubMed

    Müller, Andreas; Heiden, Barbara; Herbig, Britta; Poppe, Franziska; Angerer, Peter

    2016-04-01

    This study aimed to develop, implement, and evaluate an occupational health intervention that is based on the theoretical model of selection, optimization, and compensation (SOC). We conducted a stratified randomized controlled intervention with 70 nurses of a community hospital in Germany (94% women; mean age 43.7 years). Altogether, the training consisted of 6 sessions (16.5 hours) over a period of 9 months. The training took place in groups of 6-8 employees. Participants were familiarized with the SOC model and developed and implemented a personal project based on SOC to cope effectively with 1 important job demand or to activate a job resource. Consistent with our hypotheses, we observed a meaningful trend that the proposed SOC training enhanced mental well-being, particularly in employees with a strong commitment to the intervention. While highly committed training participants reported higher levels of job control at follow-up, the effects were not statistical significant. Additional analyses of moderation effects showed that the training is particularly effective to enhance mental well-being when job control is low. Contrary to our assumptions, perceived work ability was not improved by the training. Our study provides first indications that SOC training might be a promising approach to occupational health and stress prevention. Moreover, it identifies critical success factors of occupational interventions based on SOC. However, additional studies are needed to corroborate the effectiveness of SOC trainings in the occupational contexts. PMID:26322438

  7. Early intervention and child physical health: Evidence from a Dublin-based randomized controlled trial.

    PubMed

    Doyle, Orla; Fitzpatrick, Nick; Lovett, Judy; Rawdon, Caroline

    2015-12-01

    This article investigates the impact of an early intervention program, which experimentally modifies the parenting and home environment of disadvantaged families, on child physical health in the first 3 years of life. We recruited and randomized 233 (115 intervention, 118 control) pregnant women from a socioeconomically disadvantaged community in Dublin, Ireland into an intervention or control group. The treatment includes regular home visits commencing antenatally and an additional parenting course commencing at 2 years. Maternal reports of child health are assessed at 6, 12, 18, 24, and 36 months. Treatment effects are estimated using permutation testing to account for small sample size, inverse probability weighting to account for differential attrition, and both the stepdown procedure and an indices approach to account for multiple hypothesis testing. Following adjustment for multiple testing and attrition, we observe a positive and statistically significant main treatment effect for wheezing/asthma. The intervention group are 15.5 percentage points (pp) less likely to require medical attention for wheezing/asthma compared to the control group. Subgroup analysis reveals more statistically significant adjusted treatment effects for boys than girls regarding fewer health problems (d=0.63), accidents (23.9pp), and chest infections (22.8-37.9pp). Our results suggest that a community-based home visiting program may have favorable impacts on early health conditions.

  8. Psychological Outcomes After a Sexual Assault Video Intervention: A Randomized Trial.

    PubMed

    Miller, Katherine E; Cranston, Christopher C; Davis, Joanne L; Newman, Elana; Resnick, Heidi

    2015-01-01

    Sexual assault survivors are at risk for a number of mental and physical health problems, including posttraumatic stress disorder and anxiety. Unfortunately, few seek physical or mental health services after a sexual assault (Price, Davidson, Ruggiero, Acierno, & Resnick, 2014). Mitigating the impact of sexual assault via early interventions is a growing and important area of research. This study adds to this literature by replicating and expanding previous studies (e.g., Resnick, Acierno, Amstadter, Self-Brown, & Kilpatrick, 2007) examining the efficacy of a brief video-based intervention that provides psychoeducation and modeling of coping strategies to survivors at the time of a sexual assault nurse examination. Female sexual assault survivors receiving forensic examinations were randomized to standard care or to the video intervention condition (N = 164). The participants completed mental health assessments 2 weeks (n = 69) and 2 months (n = 74) after the examination. Analyses of covariance revealed that women in the video condition had significantly fewer anxiety symptoms at the follow-up assessments. In addition, of those participants in the video condition, survivors reporting no previous sexual assault history reported significantly fewer posttraumatic stress symptoms 2 weeks after the examination than those with a prior assault history. Forensic nurses have the unique opportunity to intervene immediately after a sexual assault. This brief video intervention is a cost-effective tool to aid with that process. PMID:26291847

  9. Brief intervention in substance-use among adolescent psychiatric patients: a randomized controlled trial.

    PubMed

    Goti, Javier; Diaz, Rosa; Serrano, Lourdes; Gonzalez, Laura; Calvo, Rosa; Gual, Antoni; Castro, Josefina

    2010-06-01

    Objective of the study is to assess the efficacy of a brief motivational enhancement intervention in adolescents referred to psychiatric treatment who reported substance-use. In a sample of adolescents (n = 237) consecutively admitted to a psychiatry department, 143 were identified as users. Subjects were randomly allocated to one of two groups: an experimental group that received a brief intervention aimed at increasing their awareness of the risks of substance-use, or a control group. All subjects received standard treatment according to the primary diagnosis. Structured questionnaires assessing knowledge, problems, perception of risks and intention of use of psychoactive substances were administered upon admission and 1 month later. Fifty-nine subjects entered the experimental group and 44 the control group. No significant differences between the two groups were identified in socio-demographic features or substance-use. Non-parametric analyses showed a significant increase across time in overall knowledge about drugs and perception of risk in the experimental group (P < 0.05). A significant increase in overall knowledge in the experimental group compared to controls was found (P < 0.05). No differences were observed for other variables such as intention of use or perception of risk. Brief intervention in adolescents entering psychiatric treatment led to a significant change in overall knowledge about psychoactive substances but not in other variables related to use. Our results point to the need of more intensive interventions.

  10. Effects of a Telephone-Based Exercise Intervention for Dementia Caregiving Wives: A Randomized Controlled Trial

    PubMed Central

    Connell, Cathleen M; Janevic, Mary R.

    2011-01-01

    Despite the importance of self-care for dementia caregivers, few interventions have included a focus on health behaviors. The current study reports outcomes of a telephone-based exercise intervention designed for women caring for a spouse with dementia. Caregivers (N = 137) were randomized to intervention or control conditions. Participants with at or below-median exercise scores at baseline had a significantly greater increase in exercise at six-month follow-up compared to their control counterparts. At 6 months, participants had greater reductions in perceived stress relative to controls. Participants also reported significantly greater increases in exercise self-efficacy than caregivers in the control group at both follow-up points. . Results indicate that spouse caregivers are able to increase their physical activity and that a focus on exercise in multi-component interventions may be beneficial. Debate and discussion is needed to inform expectations for program impacts and their maintenance and to explore the interface between enhanced self-care and caregiving perceptions. PMID:21709757

  11. Reaching an underserved population with a randomly assigned home safety intervention

    PubMed Central

    Hendrickson, S

    2005-01-01

    Objective: To access an underserved, mobile segment of a monolingual Spanish speaking population and to improve maternal self efficacy for home safety behaviors using a culturally appropriate intervention. Design: A pre- and post-test experimental design tested differences in maternal childhood injury health beliefs (MCIHB) and controllable safety hazards (CHS). Participants were randomly assigned to experimental and control groups. Baseline data assessed demographic and study variables comparability. The intervention included counseling, assessment of maternal safety practices, and provision of safety items. Setting: A non-urban area in Texas where low income, largely migrant Hispanics represent the majority of residents. Participants: Eighty two mothers of 1–4 year old children. Results: The 95% retention rate of an itinerant, hard to reach population suggests that minority participants may be receptive to culturally appropriate home visits. The intervention group demonstrated improved self efficacy for home safety behaviors (F (2, 77) = 7.50, p = 0.01). Mothers with stronger self efficacy and fewer perceived barriers had fewer accessible in-home hazards. Observed home hazard predictors were: (a) never being married; (b) poor home repair, (c) lower self efficacy for safety behaviors; and (d) control group status. Conclusions: Safety items coupled with a home visit tailored to child age and maternal culture was an effective intervention in a hard to reach population. This study contributes to designing research for a monolingual population with limited local language proficiency and community residency. Injuries represent a major source of health disparities in these neglected populations. PMID:16203842

  12. In randomization we trust? There are overlooked problems in experimenting with people in behavioral intervention trials☆

    PubMed Central

    McCambridge, Jim; Kypri, Kypros; Elbourne, Diana

    2014-01-01

    Objectives Behavioral intervention trials may be susceptible to poorly understood forms of bias stemming from research participation. This article considers how assessment and other prerandomization research activities may introduce bias that is not fully prevented by randomization. Study Design and Setting This is a hypothesis-generating discussion article. Results An additivity assumption underlying conventional thinking in trial design and analysis is problematic in behavioral intervention trials. Postrandomization sources of bias are somewhat better known within the clinical epidemiological and trials literatures. Neglect of attention to possible research participation effects means that unintended participant behavior change stemming from artifacts of the research process has unknown potential to bias estimates of behavioral intervention effects. Conclusion Studies are needed to evaluate how research participation effects are introduced, and we make suggestions for how research in this area may be taken forward, including how these issues may be addressed in the design and conduct of trials. It is proposed that attention to possible research participation effects can improve the design of trials evaluating behavioral and other interventions and inform the interpretation of existing evidence. PMID:24314401

  13. Psychological Outcomes After a Sexual Assault Video Intervention: A Randomized Trial.

    PubMed

    Miller, Katherine E; Cranston, Christopher C; Davis, Joanne L; Newman, Elana; Resnick, Heidi

    2015-01-01

    Sexual assault survivors are at risk for a number of mental and physical health problems, including posttraumatic stress disorder and anxiety. Unfortunately, few seek physical or mental health services after a sexual assault (Price, Davidson, Ruggiero, Acierno, & Resnick, 2014). Mitigating the impact of sexual assault via early interventions is a growing and important area of research. This study adds to this literature by replicating and expanding previous studies (e.g., Resnick, Acierno, Amstadter, Self-Brown, & Kilpatrick, 2007) examining the efficacy of a brief video-based intervention that provides psychoeducation and modeling of coping strategies to survivors at the time of a sexual assault nurse examination. Female sexual assault survivors receiving forensic examinations were randomized to standard care or to the video intervention condition (N = 164). The participants completed mental health assessments 2 weeks (n = 69) and 2 months (n = 74) after the examination. Analyses of covariance revealed that women in the video condition had significantly fewer anxiety symptoms at the follow-up assessments. In addition, of those participants in the video condition, survivors reporting no previous sexual assault history reported significantly fewer posttraumatic stress symptoms 2 weeks after the examination than those with a prior assault history. Forensic nurses have the unique opportunity to intervene immediately after a sexual assault. This brief video intervention is a cost-effective tool to aid with that process.

  14. A Yoga Intervention for Posttraumatic Stress: A Preliminary Randomized Control Trial.

    PubMed

    Jindani, Farah; Turner, Nigel; Khalsa, Sat Bir S

    2015-01-01

    Yoga may be effective in the reduction of PTSD symptomology. The purpose of this study was to evaluate the impact of a Kundalini Yoga (KY) treatment on PTSD symptoms and overall wellbeing. To supplement the current field of inquiry, a pilot randomized control trial (RCT) was conducted comparing an 8-session KY intervention with a waitlist control group. 80 individuals with current PTSD symptoms participated. Both groups demonstrated changes in PTSD symptomology but yoga participants showed greater changes in measures of sleep, positive affect, perceived stress, anxiety, stress, and resilience. Between-groups effect sizes were small to moderate (0.09-0.25). KY may be an adjunctive or alternative intervention for PTSD. Findings indicate the need for further yoga research to better understand the mechanism of yoga in relation to mental and physical health, gender and ethnic comparisons, and short- and long-term yoga practice for psychiatric conditions. PMID:26366179

  15. Randomized Controlled Trial of a Family Cognitive-Behavioral Preventive Intervention for Children of Depressed Parents

    PubMed Central

    Compas, Bruce E.; Forehand, Rex; Keller, Gary; Champion, Jennifer E.; Rakow, Aaron; Reeslund, Kristen L.; McKee, Laura; Fear, Jessica M.; Colletti, Christina J. M.; Hardcastle, Emily; Merchant, Mary Jane; Roberts, Lori; Potts, Jennifer; Garai, Emily; Coffelt, Nicole; Roland, Erin; Sterba, Sonya K.; Cole, David A.

    2010-01-01

    A family cognitive-behavioral preventive intervention for parents with a history of depression and their 9–15-year-old children was compared with a self-study written information condition in a randomized clinical trial (n = 111 families). Outcomes were assessed at postintervention (2 months), after completion of 4 monthly booster sessions (6 months), and at 12-month follow-up. Children were assessed by child reports on depressive symptoms, internalizing problems, and externalizing problems; by parent reports on internalizing and externalizing problems; and by child and parent reports on a standardized diagnostic interview. Parent depressive symptoms and parent episodes of major depression also were assessed. Evidence emerged for significant differences favoring the family group intervention on both child and parent outcomes; strongest effects for child outcomes were found at the 12-month assessment with medium effect sizes on most measures. Implications for the prevention of adverse outcomes in children of depressed parents are highlighted. PMID:19968378

  16. Brief interventions to reduce Ecstasy use: a multi-site randomized controlled trial.

    PubMed

    Norberg, Melissa M; Hides, Leanne; Olivier, Jake; Khawar, Laila; McKetin, Rebecca; Copeland, Jan

    2014-11-01

    Studies examining the ability of motivational enhancement therapy (MET) to augment education provision among ecstasy users have produced mixed results and none have examined whether treatment fidelity was related to ecstasy use outcomes. The primary objectives of this multi-site, parallel, two-group randomized controlled trial were to determine if a single-session of MET could instill greater commitment to change and reduce ecstasy use and related problems more so than an education-only intervention and whether MET sessions delivered with higher treatment fidelity are associated with better outcomes. The secondary objective was to assess participants' satisfaction with their assigned interventions. Participants (N=174; Mage=23.62) at two Australian universities were allocated randomly to receive a 15-minute educational session on ecstasy use (n=85) or a 50-minute session of MET that included an educational component (n=89). Primary outcomes were assessed at baseline, and then at 4-, 16-, and 24-weeks postbaseline, while the secondary outcome measure was assessed 4-weeks postbaseline by researchers blind to treatment allocation. Overall, the treatment fidelity was acceptable to good in the MET condition. There were no statistical differences at follow-up between the groups on the primary outcomes of ecstasy use, ecstasy-related problems, and commitment to change. Both intervention groups reported a 50% reduction in their ecstasy use and a 20% reduction in the severity of their ecstasy-related problems at the 24-week follow up. Commitment to change slightly improved for both groups (9%-17%). Despite the lack of between-group statistical differences on primary outcomes, participants who received a single session of MET were slightly more satisfied with their intervention than those who received education only. MI fidelity was not associated with ecstasy use outcomes. Given these findings, future research should focus on examining mechanisms of change. Such work may

  17. Effectiveness of an intervention designed to optimize statins use: a primary prevention randomized clinical trial

    PubMed Central

    2014-01-01

    Background Although hypercholesterolemia is considered a cardiovascular risk factor, in isolation it is not necessarily sufficient cause for a cardiovascular event. To improve event prediction, cardiovascular risk calculators have been developed; the REGICOR calculator has been validated for use in our population. The objective of this project is to develop an intervention with general practitioners (GPs) and evaluate its impact on prescription adequacy of cholesterol-lowering drugs in primary prevention of cardiovascular disease and in controlling the costs associated with this disease. Methods This nonblinded, cluster-randomized clinical trial analyzes data from primary care electronic medical records (ECAP) and other databases. Inclusion criteria are patients aged 35 to 74 years with no known cardiovascular disease and a new prescription for cholesterol-lowering drugs during the 2-year study period. Dependent variables include the following: RETIRA, defined as new cholesterol-lowering drugs initiated during the year preceding the intervention, considered inadequate, and withdrawn during the study period; EVITA, defined as new cholesterol-lowering drugs initiated during the study period and considered inadequate; COST, defined as the total cost of inadequate new treatments prescribed; and REGISTER, defined as the recording of cardiovascular risk factors. Independent variables include the GP’s quality-of-care indicators and randomly assigned study group (intervention vs control), patient demographics, and clinical variables. Aggregated descriptive analysis will be done at the GP level and multilevel analysis will be performed to estimate the intervention effect, adjusted for individual and GP variables. Discussion The study objective is to generate evidence about the effectiveness of implementing feedback information programs directed to GPs in the context of Primary Care. The goal is to improve the prescription adequacy of lipid-lowering therapies for primary

  18. TAILORING A FRUIT AND VEGETABLE INTERVENTION ON ETHNIC IDENTITY: RESULTS OF A RANDOMIZED STUDY

    PubMed Central

    Resnicow, Ken; Davis, Rachel; Zhang, Nanhua; Saunders, Ed; Strecher, Victor; Tolsma, Dennis; Calvi, Josephine; Alexander, Gwen; Anderson, Julia; Wiese, Cheryl; Cross, William

    2009-01-01

    Objective Many targeted health interventions have been developed and tested with African American (AA) populations; however, AAs are a highly heterogeneous group. One characteristic that varies across AAs is Ethnic Identity (EI). Despite the recognition that AAs are heterogeneous with regard to EI, little research has been conducted on how to incorporate EI into the design of health messages and programs. Design This randomized trial tested whether tailoring a print-based fruit and vegetable (F & V) intervention based on individual EI would enhance program impact beyond that of social cognitive tailoring alone. AA adults were recruited from two integrated healthcare delivery systems, one based in the Detroit Metro area and the other in the Atlanta Metro area, and then randomized to receive three newsletters focused on F & V behavior change over three months. One set of newsletters was tailored only on demographic, behavioral, and social cognitive variables (control condition) whereas the other (experimental condition) was additionally tailored on EI. Main Outcome Measures The primary outcome for the study was F & V intake, which was assessed at baseline and three months later using the composite of two brief self-report frequency measures. Results A total of 560 eligible participants were enrolled, of which 468 provided complete 3-month follow-up data. The experimental group increased their daily mean F & V intake by 1.1 servings compared to .8 servings in the control group (p = .13). Several variables were found to interact with intervention group. For instance, Afrocentric experimental group participants showed a 1.4 increase in F & V servings per day compared to a .43 servings per day increase among Afrocentric controls (p < .05). Conclusions Although the overall between-group effects were not significant, this study confirms that AAs are a highly diverse population and that tailoring dietary messages on ethnic identity may improve intervention impact for some

  19. Randomized controlled trial of a family intervention for children bullied by peers.

    PubMed

    Healy, Karyn L; Sanders, Matthew R

    2014-11-01

    This study examined the effects of a family intervention on victimization and emotional distress of children bullied by peers. The intervention, Resilience Triple P, combined facilitative parenting and teaching children social and emotional skills relevant to developing strong peer relationships and addressing problems with peers. Facilitative parenting is parenting that supports the development of children's peer relationship skills. A randomized controlled trial was conducted with 111 families who reported chronic bullying of children aged 6 to 12 years. Families were randomly allocated to either an immediate start to Resilience Triple P (RTP) or an assessment control (AC) condition. Assessments involving children, parents, teachers, and observational measures were conducted at 0 (pre), 3 (post) and 9 months follow-up. RTP families had significantly greater improvements than AC families on measures of victimization, child distress, child peer and family relationships, including teacher reports of overt victimization (d=0.56), child internalizing feelings (d=0.59), depressive symptoms (d=0.56), child overt aggression towards peers (d=0.51), acceptance by same sex and opposite sex peers (d=0.46/ 0.60), and child liking school (d=0.65). Families in both conditions showed significant improvements on most variables over time including child reports of bullying in the last week reducing to a near zero and indistinguishable from the normative sample. The intervention combining facilitative parenting and social and emotional skills training for children produced better results than the comparison assessment control condition. This study demonstrated that family interventions can reduce victimization and distress and strengthen school efforts to address bullying. PMID:25311286

  20. What's in a name? The challenge of describing interventions in systematic reviews: analysis of a random sample of reviews of non-pharmacological stroke interventions

    PubMed Central

    Hoffmann, Tammy C; Walker, Marion F; Langhorne, Peter; Eames, Sally; Thomas, Emma; Glasziou, Paul

    2015-01-01

    Objective To assess, in a sample of systematic reviews of non-pharmacological interventions, the completeness of intervention reporting, identify the most frequently missing elements, and assess review authors’ use of and beliefs about providing intervention information. Design Analysis of a random sample of systematic reviews of non-pharmacological stroke interventions; online survey of review authors. Data sources and study selection The Cochrane Library and PubMed were searched for potentially eligible systematic reviews and a random sample of these assessed for eligibility until 60 (30 Cochrane, 30 non-Cochrane) eligible reviews were identified. Data collection In each review, the completeness of the intervention description in each eligible trial (n=568) was assessed by 2 independent raters using the Template for Intervention Description and Replication (TIDieR) checklist. All review authors (n=46) were invited to complete a survey. Results Most reviews were missing intervention information for the majority of items. The most incompletely described items were: modifications, fidelity, materials, procedure and tailoring (missing from all interventions in 97%, 90%, 88%, 83% and 83% of reviews, respectively). Items that scored better, but were still incomplete for the majority of reviews, were: ‘when and how much’ (in 31% of reviews, adequate for all trials; in 57% of reviews, adequate for some trials); intervention mode (in 22% of reviews, adequate for all trials; in 38%, adequate for some trials); and location (in 19% of reviews, adequate for all trials). Of the 33 (71%) authors who responded, 58% reported having further intervention information but not including it, and 70% tried to obtain information. Conclusions Most focus on intervention reporting has been directed at trials. Poor intervention reporting in stroke systematic reviews is prevalent, compounded by poor trial reporting. Without adequate intervention descriptions, the conduct, usability and

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

    PubMed Central

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

    2015-01-01

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

  2. Analyzing Direct Effects in Randomized Trials with Secondary Interventions: An Application to HIV Prevention Trials.

    PubMed

    Rosenblum, Michael; Jewell, Nicholas P; van der Laan, Mark; Shiboski, Steve; van der Straten, Ariane; Padian, Nancy

    2009-04-01

    The Methods for Improving Reproductive Health in Africa (MIRA) trial is a recently completed randomized trial that investigated the effect of diaphragm and lubricant gel use in reducing HIV infection among susceptible women. 5,045 women were randomly assigned to either the active treatment arm or not. Additionally, all subjects in both arms received intensive condom counselling and provision, the "gold standard" HIV prevention barrier method. There was much lower reported condom use in the intervention arm than in the control arm, making it difficult to answer important public health questions based solely on the intention-to-treat analysis. We adapt an analysis technique from causal inference to estimate the "direct effects" of assignment to the diaphragm arm, adjusting for condom use in an appropriate sense. Issues raised in the MIRA trial apply to other trials of HIV prevention methods, some of which are currently being conducted or designed. PMID:20827388

  3. Analyzing Direct Effects in Randomized Trials with Secondary Interventions: An Application to HIV Prevention Trials

    PubMed Central

    Rosenblum, Michael; Jewell, Nicholas P.; van der Laan, Mark; Shiboski, Steve; van der Straten, Ariane; Padian, Nancy

    2010-01-01

    Summary The Methods for Improving Reproductive Health in Africa (MIRA) trial is a recently completed randomized trial that investigated the effect of diaphragm and lubricant gel use in reducing HIV infection among susceptible women. 5,045 women were randomly assigned to either the active treatment arm or not. Additionally, all subjects in both arms received intensive condom counselling and provision, the “gold standard” HIV prevention barrier method. There was much lower reported condom use in the intervention arm than in the control arm, making it difficult to answer important public health questions based solely on the intention-to-treat analysis. We adapt an analysis technique from causal inference to estimate the “direct effects” of assignment to the diaphragm arm, adjusting for condom use in an appropriate sense. Issues raised in the MIRA trial apply to other trials of HIV prevention methods, some of which are currently being conducted or designed. PMID:20827388

  4. To Wait in Tier 1 or Intervene Immediately: A Randomized Experiment Examining First Grade Response to Intervention (RTI) in Reading

    ERIC Educational Resources Information Center

    Al Otaiba, Stephanie; Connor, Carol M.; Folsom, Jessica S.; Wanzek, Jeanne; Greulich, Luana; Schatschneider, Christopher; Wagner, Richard K.

    2015-01-01

    This randomized control study compares the efficacy of two response-to-intervention (RTI) models: (1) Dynamic RTI, which immediately refers grade 1 students with the weakest skills to the most intensive intervention supports (Tier 2 or Tier 3); and (2) Typical RTI, which starts all students in Tier 1 and after 8 weeks, decides whether students who…

  5. A Parent-Directed Language Intervention for Children of Low Socioeconomic Status: A Randomized Controlled Pilot Study

    ERIC Educational Resources Information Center

    Suskind, Dana L.; Leffel, Kristin R.; Graf, Eileen; Hernandez, Marc W.; Gunderson, Elizabeth A.; Sapolich, Shannon G.; Suskind, Elizabeth; Leininger, Lindsey; Goldin-Meadow, Susan; Levine, Susan C.

    2016-01-01

    We designed a parent-directed home-visiting intervention targeting socioeconomic status (SES) disparities in children's early language environments. A randomized controlled trial was used to evaluate whether the intervention improved parents' knowledge of child language development and increased the amount and diversity of parent talk.…

  6. Randomized Controlled Trial for Early Intervention for Autism: A Pilot Study of the Autism 1-2-3 Project

    ERIC Educational Resources Information Center

    Wong, Virginia C. N.; Kwan, Queenie K.

    2010-01-01

    We piloted a 2-week "Autism-1-2-3" early intervention for children with autism and their parents immediately after diagnosis that targeted at (1) eye contact, (2) gesture and (3) vocalization/words. Seventeen children were randomized into the Intervention (n = 9) and Control (n = 8) groups. Outcome measures included the Autism Diagnostic…

  7. Mathematics Learned by Young Children in An Intervention Based on Learning Trajectories: A Large-Scale Cluster Randomized Trial

    ERIC Educational Resources Information Center

    Clements, Douglas H.; Sarama, Julie; Spitler, Mary Elaine; Lange, Alissa A.; Wolfe, Christopher B.

    2011-01-01

    This study employed a cluster randomized trial design to evaluate the effectiveness of a research-based intervention for improving the mathematics education of very young children. This intervention includes the "Building Blocks" mathematics curriculum, which is structured in research-based learning trajectories, and congruous professional…

  8. Effects of a Randomized Couple-Based Intervention on Quality of Life of Breast Cancer Patients and Their Partners

    ERIC Educational Resources Information Center

    Kayser, Karen; Feldman, Barry N.; Borstelmann, Nancy A.; Daniels, Ann A.

    2010-01-01

    The purpose of this study was to determine the effectiveness of a couple-based intervention on the quality of life (QOL) of early-stage breast cancer patients and their partners. A randomized controlled design was used to assign couples to either the hospital standard social work services (SSWS) or a couple-based intervention, the Partners in…

  9. A Randomized Intervention Study to Evaluate Whether Electronic Messaging Can Increase Human Papillomavirus Vaccine Completion and Knowledge among College Students

    ERIC Educational Resources Information Center

    Richman, Alice R.; Maddy, LaDonna; Torres, Essie; Goldberg, Ellen J.

    2016-01-01

    Objective: To evaluate an intervention aimed at increasing human papillomavirus (HPV) vaccine completion of the 3-dose series and knowledge. Participants: Two hundred sixty-four male and female US college students 18-26 years old who were receiving HPV vaccine dose 1. Methods: Students were randomly assigned to the intervention or control group.…

  10. Randomized Trial of a Brief Dietary Intervention To Decrease Consumption of Fat and Increase Consumption of Fruits and Vegetables.

    ERIC Educational Resources Information Center

    Stevens, Victor J.; Glasgow, Russell E.; Toobert, Deborah J.; Karanja, Njeri; Smith, K. Sabina

    2002-01-01

    Tested the efficacy of a computer-assisted counseling intervention to reduce diet-related cancer risk. Healthy female HMO members were randomly assigned to nutrition counseling or attention-control interventions. Women completed dietary recalls and eating behavior questionnaires. Four-month follow-up results indicated that this moderate-intensity…

  11. Promoting Healthy Beginnings: A Randomized Controlled Trial of a Preventive Intervention to Preserve Marital Quality During the Transition to Parenthood

    ERIC Educational Resources Information Center

    Schulz, Marc S.; Cowan, Carolyn Pape; Cowan, Philip A.

    2006-01-01

    Couples expecting their first child were randomly assigned to intervention (n = 28) and comparison groups (n = 38) to assess the efficacy of a couples intervention and examine marital satisfaction trajectories across the transition to parenthood. The primarily European American sample (M age = 30 years) completed assessments of marital…

  12. Evaluation of a Brief Parent Intervention Teaching Coping-Promoting Behavior for the Infant Immunization Context: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Bustos, Theona; Jaaniste, Tiina; Salmon, Karen; Champion, G. David

    2008-01-01

    This study was designed to investigate whether a brief intervention encouraging parental coping-promoting talk within the treatment room would have beneficial effects on infant pain responses to an immunization injection. Infant-parent dyads were recruited from a 6-month immunization clinic and randomized to an intervention group (n = 25) or…

  13. Non-Speech Oro-Motor Exercises in Post-Stroke Dysarthria Intervention: A Randomized Feasibility Trial

    ERIC Educational Resources Information Center

    Mackenzie, C.; Muir, M.; Allen, C.; Jensen, A.

    2014-01-01

    Background: There has been little robust evaluation of the outcome of speech and language therapy (SLT) intervention for post-stroke dysarthria. Non-speech oro-motor exercises (NSOMExs) are a common component of dysarthria intervention. A feasibility study was designed and executed, with participants randomized into two groups, in one of which…

  14. A preliminary, randomized trial of aerobic exercise for alcohol dependence.

    PubMed

    Brown, Richard A; Abrantes, Ana M; Minami, Haruka; Read, Jennifer P; Marcus, Bess H; Jakicic, John M; Strong, David R; Dubreuil, Mary Ella; Gordon, Alan A; Ramsey, Susan E; Kahler, Christopher W; Stuart, Gregory L

    2014-07-01

    Interventions targeting physical activity may be valuable as an adjunct to alcohol treatment, but have been relatively untested. In the current study, alcohol dependent, physically sedentary patients were randomized to: a 12-week moderate-intensity, group aerobic exercise intervention (AE; n=25) or a brief advice to exercise intervention (BA-E; n=23). Results showed that individuals in AE reported significantly fewer drinking and heavy drinking days, relative to BA-E during treatment. Furthermore adherence to AE strengthened the beneficial effect of intervention on alcohol use outcomes. While high levels of moderate-intensity exercise appeared to facilitate alcohol recovery regardless of intervention arm, attending the group-based AE intervention seemed to further enhance the positive effects of exercise on alcohol use. Study findings indicate that a moderate intensity, group aerobic exercise intervention is an efficacious adjunct to alcohol treatment. Improving adherence to the intervention may enhance its beneficial effects on alcohol use.

  15. Nutrition education intervention for dependent patients: protocol of a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Malnutrition in dependent patients has a high prevalence and can influence the prognosis associated with diverse pathologic processes, decrease quality of life, and increase morbidity-mortality and hospital admissions. The aim of the study is to assess the effect of an educational intervention for caregivers on the nutritional status of dependent patients at risk of malnutrition. Methods/Design Intervention study with control group, randomly allocated, of 200 patients of the Home Care Program carried out in 8 Primary Care Centers (Spain). These patients are dependent and at risk of malnutrition, older than 65, and have caregivers. The socioeconomic and educational characteristics of the patient and the caregiver are recorded. On a schedule of 0–6–12 months, patients are evaluated as follows: Mini Nutritional Assessment (MNA), food intake, dentures, degree of dependency (Barthel test), cognitive state (Pfeiffer test), mood status (Yesavage test), and anthropometric and serum parameters of nutritional status: albumin, prealbumin, transferrin, haemoglobin, lymphocyte count, iron, and ferritin. Prior to the intervention, the educational procedure and the design of educational material are standardized among nurses. The nurses conduct an initial session for caregivers and then monitor the education impact at home every month (4 visits) up to 6 months. The North American Nursing Diagnosis Association (NANDA) methodology will be used. The investigators will study the effect of the intervention with caregivers on the patient’s nutritional status using the MNA test, diet, anthropometry, and biochemical parameters. Bivariate normal test statistics and multivariate models will be created to adjust the effect of the intervention. The SPSS/PC program will be used for statistical analysis. Discussion The nutritional status of dependent patients has been little studied. This study allows us to know nutritional risk from different points of view: diet

  16. An Internet-Based Intervention for Depression in Primary Care in Spain: A Randomized Controlled Trial

    PubMed Central

    Montero-Marín, Jesús; Araya, Ricardo; Mayoral, Fermín; Gili, Margalida; Botella, Cristina; Baños, Rosa; Castro, Adoración; Romero-Sanchiz, Pablo; López-Del-Hoyo, Yolanda; Nogueira-Arjona, Raquel; Vives, Margarita; Riera, Antoni; García-Campayo, Javier

    2016-01-01

    Background Depression is the most prevalent cause of illness-induced disability worldwide. Face-to-face psychotherapeutic interventions for depression can be challenging, so there is a need for other alternatives that allow these interventions to be offered. One feasible alternative is Internet-based psychological interventions. This is the first randomized controlled trial (RCT) on the effectiveness of an Internet-based intervention on depression in primary health care in Spain. Objective Our aim was to compare the effectiveness of a low-intensity therapist-guided (LITG) Internet-based program and a completely self-guided (CSG) Internet-based program with improved treatment as usual (iTAU) care for depression. Methods Multicenter, three-arm, parallel, RCT design, carried out between November 2012 and January 2014, with a follow-up of 15 months. In total, 296 adults from primary care settings in four Spanish regions, with mild or moderate major depression, were randomized to LITG (n=96), CSG (n=98), or iTAU (n=102). Research completers at follow-up were 63.5%. The intervention was Smiling is Fun, an Internet program based on cognitive behavioral therapy. All patients received iTAU by their general practitioners. Moreover, LITG received Smiling is Fun and the possibility of psychotherapeutic support on request by email, whereas CSG received only Smiling is Fun. The main outcome was the Beck Depression Inventory-II at 3 months from baseline. Mixed-effects multilevel analysis for repeated measures were undertaken. Results There was no benefit for either CSG [(B coefficient=-1.15; P=.444)] or LITG [(B=-0.71; P=.634)] compared to iTAU, at 3 months. There were differences at 6 months [iTAU vs CSG (B=-4.22; P=.007); iTAU vs LITG (B=-4.34; P=.005)] and 15 months [iTAU vs CSG (B=-5.10; P=.001); iTAU vs LITG (B=-4.62; P=.002)]. There were no differences between CSG and LITG at any time. Adjusted and intention-to-treat models confirmed these findings. Conclusions An Internet

  17. A brief intervention for weight management in primary care: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Obesity affects 25% of the UK adult population but modest weight loss can reduce the incidence of obesity-related chronic disease. Some effective weight loss treatments exist but there is no nationally available National Health Service (NHS) treatment service, and general practitioners (GPs) rarely discuss weight management with patients or support behavior change. Evidence shows that commercial weight management services, that most primary care trusts have 'on prescription', are more effective than primary care treatment. Methods/design We propose a controlled trial where patients will be randomized to receive either the offer of help by referral to a weight management service and follow-up to assess progress, or advice to lose weight on medical grounds. The primary outcome will be weight change at 12-months. Other questions are: what actions do people take to manage their weight in response to the two GP intervention types? How do obese patients feel about GPs opportunistically discussing weight management and how does this vary by intervention type? How do GPs feel about raising the issue opportunistically and giving the two types of brief intervention? What is the cost per kg/m2 lost for each intervention? Research assistants visiting GP practices in England (n = 60) would objectively measure weight and height prior to GP consultations and randomize willing patients (body mass index 30+, excess body fat, 18+ years) using sealed envelopes. Full recruitment (n = 1824) is feasible in 46 weeks, requiring six sessions of advice-giving per GP. Participants will be contacted at 3 months (postintervention) via telephone to identify actions they have taken to manage their weight. We will book appointments for participants to be seen at their GP practice for a 12-month follow-up. Discussion Trial results could make the case for brief interventions for obese people consulting their GP and introduce widespread simple treatments akin to the NHS Stop

  18. Web-Based and Mobile Stress Management Intervention for Employees: A Randomized Controlled Trial

    PubMed Central

    Lehr, Dirk; Ebert, David Daniel; Berking, Matthias; Riper, Heleen

    2016-01-01

    Background Work-related stress is highly prevalent among employees and is associated with adverse mental health consequences. Web-based interventions offer the opportunity to deliver effective solutions on a large scale; however, the evidence is limited and the results conflicting. Objective This randomized controlled trial evaluated the efficacy of guided Web- and mobile-based stress management training for employees. Methods A total of 264 employees with elevated symptoms of stress (Perceived Stress Scale-10, PSS-10≥22) were recruited from the general working population and randomly assigned to an Internet-based stress management intervention (iSMI) or waitlist control group. The intervention (GET.ON Stress) was based on Lazarus’s transactional model of stress, consisted of seven sessions, and applied both well-established problem solving and more recently developed emotion regulation strategies. Participants also had the opportunity to request automatic text messages on their mobile phone along with the iSMI. Participants received written feedback on every completed session from an e-coach. The primary outcome was perceived stress (PSS-10). Web-based self-report assessments for both groups were scheduled at baseline, 7 weeks, and 6 months. At 12 months, an extended follow-up was carried out for the iSMI group only. Results An intention-to-treat analysis of covariance revealed significantly large effect differences between iSMI and waitlist control groups for perceived stress at posttest (F 1,261=58.08, P<.001; Cohen’s d=0.83) and at the 6-month follow-up (F 1,261=80.17, P<.001; Cohen’s d=1.02). The effects in the iSMI group were maintained at 12-month follow-up. Conclusions This Web- and mobile-based intervention has proven effective in reducing stress in employees in the long term. Internet-based stress management interventions should be further pursued as a valuable alternative to face-to-face interventions. Trial Registration German Clinical Trials

  19. A Mixed Methods Evaluation of a 12-Week Insurance-Sponsored Weight Management Program Incorporating Cognitive-Behavioral Counseling

    ERIC Educational Resources Information Center

    Abildso, Christiaan; Zizzi, Sam; Gilleland, Diana; Thomas, James; Bonner, Daniel

    2010-01-01

    Physical activity is critical in healthy weight loss, yet there is still much to be learned about psychosocial mechanisms of physical activity behavior change in weight loss. A sequential mixed methods approach was used to assess the physical and psychosocial impact of a 12-week cognitive-behavioral weight management program and explore factors…

  20. Evaluating the impact of a school-based health intervention using a randomized field experiment.

    PubMed

    Greve, Jane; Heinesen, Eskil

    2015-07-01

    We conduct an econometric evaluation of a health-promoting programme in primary and lower secondary schools in Denmark. The programme includes health-related measurements of the students, communication of knowledge about health, and support of health-promoting projects for students. Half of the schools in the fourth largest municipality in Denmark were randomly selected into a treatment group implementing the programme, while the remainder served as a control group. We estimate both OLS models using only post-intervention observations and difference in differences (DID) models using also pre-intervention observations. We estimate effects of the initiative on BMI, waist/height ratio, overweight and obesity for the entire sample and by gender and grade. We find no consistent effect of the programme. When we use the entire sample, no estimates are statistically significant at conventional levels, although the point estimates for the effect on BMI, indicating an average reduction in the range of 0.10-0.15 kg/m(2), are consistent with the results in a recent Cochrane review evaluating 55 studies of diet and exercise interventions targeting children; and DID estimates which are marginally significant (at the 10% level) indicate that the intervention reduces the risk of obesity by 1% point. Running separate estimations by gender and grade we find a few statistically significant estimates: OLS estimates indicate that the intervention reduces BMI in females in grade 5 by 0.39 kg/m(2) and reduces the risk of obesity in females in grade 9 by 2.6% points; DID estimates indicate an increase in waist for females in preschool class by 1.2 cm and an increase in the risk of obesity in grade 9 males by 4% points. However, if we corrected for multiple hypotheses testing these estimates would be insignificant. There is no statistically significant correlation between participation in the programme and the number of other health-promoting projects at the schools. PMID:25898077

  1. Effects of a physical education intervention on cognitive function in young children: randomized controlled pilot study

    PubMed Central

    2011-01-01

    Background Randomized controlled trials (RCT) are required to test relationships between physical activity and cognition in children, but these must be informed by exploratory studies. This study aimed to inform future RCT by: conducting practical utility and reliability studies to identify appropriate cognitive outcome measures; piloting an RCT of a 10 week physical education (PE) intervention which involved 2 hours per week of aerobically intense PE compared to 2 hours of standard PE (control). Methods 64 healthy children (mean age 6.2 yrs SD 0.3; 33 boys) recruited from 6 primary schools. Outcome measures were the Cambridge Neuropsychological Test Battery (CANTAB), the Attention Network Test (ANT), the Cognitive Assessment System (CAS) and the short form of the Connor's Parent Rating Scale (CPRS:S). Physical activity was measured habitually and during PE sessions using the Actigraph accelerometer. Results Test- retest intraclass correlations from CANTAB Spatial Span (r 0.51) and Spatial Working Memory Errors (0.59) and ANT Reaction Time (0.37) and ANT Accuracy (0.60) were significant, but low. Physical activity was significantly higher during intervention vs. control PE sessions (p < 0.0001). There were no significant differences between intervention and control group changes in CAS scores. Differences between intervention and control groups favoring the intervention were observed for CANTAB Spatial Span, CANTAB Spatial Working Memory Errors, and ANT Accuracy. Conclusions The present study has identified practical and age-appropriate cognitive and behavioral outcome measures for future RCT, and identified that schools are willing to increase PE time. Trial registration number ISRCTN70853932 (http://www.controlled-trials.com) PMID:22034850

  2. Social learning theory parenting intervention promotes attachment-based caregiving in young children: randomized clinical trial.

    PubMed

    O'Connor, Thomas G; Matias, Carla; Futh, Annabel; Tantam, Grace; Scott, Stephen

    2013-01-01

    Parenting programs for school-aged children are typically based on behavioral principles as applied in social learning theory. It is not yet clear if the benefits of these interventions extend beyond aspects of the parent-child relationship quality conceptualized by social learning theory. The current study examined the extent to which a social learning theory-based treatment promoted change in qualities of parent-child relationship derived from attachment theory. A randomized clinical trial of 174 four- to six-year-olds selected from a high-need urban area and stratified by conduct problems were assigned to a parenting program plus a reading intervention (n = 88) or nonintervention condition (n = 86). In-home observations of parent-child interactions were assessed in three tasks: (a) free play, (b) challenge task, and (c) tidy up. Parenting behavior was coded according to behavior theory using standard count measures of positive and negative parenting, and for attachment theory using measures of sensitive responding and mutuality; children's attachment narratives were also assessed. Compared to the parents in the nonintervention group, parents allocated to the intervention showed increases in the positive behavioral counts and sensitive responding; change in behavioral count measures overlapped modestly with change in attachment-based changes. There was no reliable change in children's attachment narratives associated with the intervention. The findings demonstrate that standard social learning theory-based parenting interventions can change broader aspects of parent-child relationship quality and raise clinical and conceptual questions about the distinctiveness of existing treatment models in parenting research.

  3. Interventions to Improve Medication Adherence among Older Adults: Meta-Analysis of Adherence Outcomes among Randomized Controlled Trials

    ERIC Educational Resources Information Center

    Conn, Vicki S.; Hafdahl, Adam R.; Cooper, Pamela S.; Ruppar, Todd M.; Mehr, David R.; Russell, Cynthia L.

    2009-01-01

    Purpose: This study investigated the effectiveness of interventions to improve medication adherence (MA) in older adults. Design and Methods: Meta-analysis was used to synthesize results of 33 published and unpublished randomized controlled trials. Random-effects models were used to estimate overall mean effect sizes (ESs) for MA, knowledge,…

  4. Randomized, Controlled Trial of the LEAP Model of Early Intervention for Young Children with Autism Spectrum Disorders

    ERIC Educational Resources Information Center

    Strain, Phillip S.; Bovey, Edward H.

    2011-01-01

    A clustered randomized design was used in which 28 inclusive preschool classrooms were randomly assigned to receive 2 years of training and coaching to fidelity in the LEAP (Learning Experiences and Alternative Program for Preschoolers and Their Parents) preschool model, and 28 inclusive classes were assigned to receive intervention manuals only.…

  5. A Web- and Mobile-Based Intervention for Women Treated for Breast Cancer to Manage Chronic Pain and Symptoms Related to Lymphedema: Randomized Clinical Trial Rationale and Protocol

    PubMed Central

    Scagliola, Joan

    2016-01-01

    encouraged to enhance their learning by accessing the program and following the daily exercises during the study period. Participants will have monthly online self-report of pain and symptoms at 4 and 8 weeks post-intervention. During the two in-person research visits prior to and 12 weeks post-intervention, participants will be measured for limb volume difference, BMI, and complete self-report of pain, symptoms, self-care behaviors, and QOL. Results This trial is currently open for recruitment. The anticipated completion date for the study is July 2017. The primary endpoint for the study is absence or reduction of pain reported by the participants at week 12 post-intervention. Conclusions The-Optimal-Lymph-Flow is a unique Web- and mobile-based self-care and patient-reported outcome system designed to effectively help women treated for breast cancer manage daily pain and symptoms related to lymphedema. Patients learn self-care strategies from a Web- and mobile-based program and track their symptoms. The RCT will directly benefit all women treated for breast cancer who suffer from or at risk for pain and symptoms related to lymph fluid accumulation. Trial Registration Clinicaltrials.gov NCT02462226; https://clinicaltrials.gov/ct2/show/NCT02462226 (Archived by WebCite at http://www.webcitation.org/6du4IupG5) PMID:26795447

  6. Supporting Self-Care for Families of Children With Eczema With a Web-Based Intervention Plus Health Care Professional Support: Pilot Randomized Controlled Trial

    PubMed Central

    Muller, Ingrid; Yardley, Lucy; Burgess, Hana; Selinger, Hannah; Stuart, Beth L; Little, Paul

    2014-01-01

    Background Childhood eczema, or childhood atopic dermatitis, causes significant distress to children and their families through sleep disturbance and itch. The main cause of treatment failure is nonuse of prescribed treatments. Objective The objective of this study was to develop and test a Web-based intervention to support families of children with eczema, and to explore whether support from a health care professional (HCP) is necessary to engage participants with the intervention. Methods We followed the PRECEDE-PROCEED model: regular emollient use was the target behavior we were seeking to promote and we identified potential techniques to influence this. LifeGuide software was used to write the intervention website. Carers of children with eczema were invited through primary care mail-out and randomized to 3 groups: (1) website only, (2) website plus HCP support, or (3) usual care. Patient-Oriented Eczema Measure (POEM) scores were measured online by carer report at baseline and at 12 weeks. Qualitative interviews were carried out with 13 HCPs (primarily practice nurses) and 26 participants to explore their experiences of taking part in the study. Results A total of 143 carers were recruited through 31 practices. We found a decrease of ≥2 in follow-up compared with baseline POEM score in 23 of 42 (55%) participants in the website only group, 16 of 49 (33%) in the usual care group, and 18 of 47 (38%) in the website plus HCP group. Website use data showed that 75 of 93 (81%) participants allocated to the website groups completed the core modules, but less than half used other key components (videos: 35%; regular text reminders: 39%). There were no consistent differences in website use between the website only or the website plus HCP groups. Qualitative feedback showed that most HCPs had initial concerns about providing support for eczema self-care because this was not a condition that they felt expert in. However, HCPs reported productive consultations and that

  7. Diffusion of an Evidence-Based Smoking Cessation Intervention Through Facebook: A Randomized Controlled Trial

    PubMed Central

    Cobb, Nathan K.; Jacobs, Megan A.; Wileyto, Paul; Valente, Thomas

    2016-01-01

    Objectives. To examine the diffusion of an evidence-based smoking cessation application (“app”) through Facebook social networks and identify specific intervention components that accelerate diffusion. Methods. Between December 2012 and October 2013, we recruited adult US smokers (“seeds”) via Facebook advertising and randomized them to 1 of 12 app variants using a factorial design. App variants targeted components of diffusion: duration of use (t), “contagiousness” (β), and number of contacts (Z). The primary outcome was the reproductive ratio (R), defined as the number of individuals installing the app (“descendants”) divided by the number of a seed participant’s Facebook friends. Results. We randomized 9042 smokers. App utilization metrics demonstrated between-variant differences in expected directions. The highest level of diffusion (R = 0.087) occurred when we combined active contagion strategies with strategies to increase duration of use (incidence rate ratio = 9.99; 95% confidence interval = 5.58, 17.91; P < .001). Involving nonsmokers did not affect diffusion. Conclusions. The maximal R value (0.087) is sufficient to increase the numbers of individuals receiving treatment if applied on a large scale. Online interventions can be designed a priori to spread through social networks. PMID:27077358

  8. Effect of a physical conditioning versus health promotion intervention in dancers: a randomized controlled trial.

    PubMed

    Roussel, Nathalie A; Vissers, Dirk; Kuppens, Kevin; Fransen, Erik; Truijen, Steven; Nijs, Jo; De Backer, Wilfried

    2014-12-01

    Although dancing requires extensive physical exertion, dancers do not often train their physical fitness outside dance classes. Reduced aerobic capacity, lower muscle strength and altered motor control have been suggested as contributing factors for musculoskeletal injuries in dancers. This randomized controlled trial examined whether an intervention program improves aerobic capacity and explosive strength and reduces musculoskeletal injuries in dancers. Forty-four dancers were randomly allocated to a 4-month conditioning (i.e. endurance, strength and motor control training) or health promotion program (educational sessions). Outcome assessment was conducted by blinded assessors. When accounting for differences at baseline, no significant differences were observed between the groups following the intervention, except for the subscale "Pain" of the Short Form 36 Questionnaire (p = 0.03). Injury incidence rate and the proportion of injured dancers were identical in both groups, but dancers following the conditioning program had significant less low back injuries (p = 0.02). Supplementing regular dance training with a 4-month conditioning program does not lead to a significant increase in aerobic capacity or explosive strength in pre-professional dancers compared to a health promotion program without conditioning training, but leads to less reported pain. Further research should explore how additional training may be organized, taking into account the demanding dance schedule of pre-professional dancers. The trial is registered at ClinicalTrials.gov, number NCT01440153. PMID:24951437

  9. Effect of a physical conditioning versus health promotion intervention in dancers: a randomized controlled trial.

    PubMed

    Roussel, Nathalie A; Vissers, Dirk; Kuppens, Kevin; Fransen, Erik; Truijen, Steven; Nijs, Jo; De Backer, Wilfried

    2014-12-01

    Although dancing requires extensive physical exertion, dancers do not often train their physical fitness outside dance classes. Reduced aerobic capacity, lower muscle strength and altered motor control have been suggested as contributing factors for musculoskeletal injuries in dancers. This randomized controlled trial examined whether an intervention program improves aerobic capacity and explosive strength and reduces musculoskeletal injuries in dancers. Forty-four dancers were randomly allocated to a 4-month conditioning (i.e. endurance, strength and motor control training) or health promotion program (educational sessions). Outcome assessment was conducted by blinded assessors. When accounting for differences at baseline, no significant differences were observed between the groups following the intervention, except for the subscale "Pain" of the Short Form 36 Questionnaire (p = 0.03). Injury incidence rate and the proportion of injured dancers were identical in both groups, but dancers following the conditioning program had significant less low back injuries (p = 0.02). Supplementing regular dance training with a 4-month conditioning program does not lead to a significant increase in aerobic capacity or explosive strength in pre-professional dancers compared to a health promotion program without conditioning training, but leads to less reported pain. Further research should explore how additional training may be organized, taking into account the demanding dance schedule of pre-professional dancers. The trial is registered at ClinicalTrials.gov, number NCT01440153.

  10. Family nurture intervention (FNI): methods and treatment protocol of a randomized controlled trial in the NICU

    PubMed Central

    2012-01-01

    Background The stress that results from preterm birth, requisite acute care and prolonged physical separation in the Neonatal Intensive Care Unit (NICU) can have adverse physiological/psychological effects on both the infant and the mother. In particular, the experience compromises the establishment and maintenance of optimal mother-infant relationship, the subsequent development of the infant, and the mother's emotional well-being. These findings highlight the importance of investigating early interventions that are designed to overcome or reduce the effects of these environmental insults and challenges. Methods This study is a randomized controlled trial (RCT) with blinded assessment comparing Standard Care (SC) with a novel Family Nurture Intervention (FNI). FNI targets preterm infants born 26-34 weeks postmenstrual age (PMA) and their mothers in the NICU. The intervention incorporates elements of mother-infant interventions with known efficacy and organizes them under a new theoretical context referred to collectively as calming activities. This intervention is facilitated by specially trained Nurture Specialists in three ways: 1) In the isolette through calming interactions between mother and infant via odor exchange, firm sustained touch and vocal soothing, and eye contact; 2) Outside the isolette during holding and feeding via the Calming Cycle; and 3) through family sessions designed to engage help and support the mother. In concert with infant neurobehavioral and physiological assessments from birth through 24 months corrected age (CA), maternal assessments are made using standard tools including anxiety, depression, attachment, support systems, temperament as well as physiological stress parameters. Quality of mother-infant interaction is also assessed. Our projected enrolment is 260 families (130 per group). Discussion The FNI is designed to increase biologically important activities and behaviors that enhance maternally-mediated sensory experiences of

  11. Multi-component access to a community-based weight loss program: 12 week results

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The current study examined weight loss between a comprehensive lifestyle modification program (Weight Watchers PointsPlus program) that included three ways to access and a self-help (SH) condition. A total of 293 participants were randomized to either a Weight Watchers condition (WW) (n=148) or a SH...

  12. Randomized controlled trial of parental responsiveness intervention for toddlers at high risk for autism.

    PubMed

    Kasari, Connie; Siller, Michael; Huynh, Linh N; Shih, Wendy; Swanson, Meghan; Hellemann, Gerhard S; Sugar, Catherine A

    2014-11-01

    This study tested the effects of a parent-mediated intervention on parental responsiveness with their toddlers at high risk for an autism spectrum disorder (ASD). Participants included caregivers and their 66 toddlers at high risk for ASD. Caregivers were randomized to 12 sessions of an individualized parent education intervention aimed at improving parental responsiveness or to a monitoring control group involving 4 sessions of behavioral support. Parental responsiveness and child outcomes were measured at three time points: at beginning and end of the 3-month treatment and at 12-months post-study entry. Parental responsiveness improved significantly in the treatment group but not the control group. However, parental responsiveness was not fully maintained at follow up. There were no treatment effects on child outcomes of joint attention or language. Children in both groups made significant developmental gains in cognition and language skills over one year. These results support parental responsiveness as an important intervention target given its general association with child outcomes in the extant literature; however, additional supports are likely needed to fully maintain the treatment effect and to affect child outcomes.

  13. A Randomized Trial of Two Behavioral Interventions to Improve Outcomes Following Inpatient Detoxification for Alcohol Dependence

    PubMed Central

    Blondell, Richard D.; Frydrych, Lynne M.; Jaanimägi, Urmo; Ashrafioun, Lisham; Homish, Gregory G.; Foschio, Elisa M.; Bashaw, Heather L.

    2011-01-01

    To determine if the addition of a behavioral intervention during alcohol detoxification would facilitate initiation of subsequent care, we randomized 150 detoxification patients to receive: treatment as usual (TAU), a Motivation Enhancement Therapy (MET) intervention, or a Peer-delivered Twelve Step Facilitation (P-TSF) intervention. The main outcome was the initiation of any type of subsequent care (i.e., professional treatment or self-help) within 30 and 90 days of discharge. Other outcomes included: alcohol and drug use, completion of subsequent professional treatment, and readmission for detoxification. The mean age of the participants was 45 years; 65% were men, and 84% were white. At the 30-day follow-up, there was no significant difference among the groups in the rate of initiation of any type of subsequent care (82%, 74%, and 82% respectively, p = 0.617); however, the MET group had significantly more patients initiate subsequent inpatient treatment by the 90-day follow-up compared to the P-TSF group (31% and 61%, p = 0.007) and a greater proportion of MET participants completed subsequent inpatient treatment compared to both TAU and P-TSF. There were no differences in drinking-related outcomes (e.g., number of days before first drink, percent days abstinent) between the groups. We conclude that MET during detoxification may provide additional benefits in terms of initiating and maintaining patients in aftercare inpatient treatment programs. PMID:21491295

  14. Intervention for homeless, substance abusing mothers: findings from a non-randomized pilot.

    PubMed

    Slesnick, Natasha; Erdem, Gizem

    2012-01-01

    Little empirically-based information is available regarding how best to intervene with substance-abusing homeless mothers. This study pilot-tested a comprehensive intervention with 15 homeless women and their 2- to 6-year-old children, recruited from a local family shelter. All participants were offered integrated intervention with three major components. The first component was housing which included 3 months of rental and utility assistance, and these services were not contingent upon women's abstinence from drugs or alcohol. The second and third components included 6 months of case management services and an evidence-based substance abuse treatment (Community Reinforcement Approach; CRA). Analysis revealed that women showed reductions in substance use (F(2,22) = 3.63; p < .05), homelessness (F(2,24) = 25.31; p < .001), and mental health problems (F(2,20) = 8.5; p < .01). Further, women reported reduced internalizing (F(2,22) = 4.08; p < .05) and externalizing problems (F(2,24) = 7.7; p = .01) among their children. The findings suggest that the intervention is a promising approach to meet the multiple needs of this vulnerable population. These positive outcomes support the need for future research to replicate the findings with a larger sample using a randomized design.

  15. Preoperative Cognitive Intervention Reduces Cognitive Dysfunction in Elderly Patients after Gastrointestinal Surgery: A Randomized Controlled Trial

    PubMed Central

    Saleh, Amin J.; Tang, Guan-Xiu; Hadi, Sally M.; Yan, Liao; Chen, Ming-Hua; Duan, Kai-Ming; Tong, Jianbin; Ouyang, Wen

    2015-01-01

    Background Preoperative conditions may play a significant role in postoperative cognitive dysfunction (POCD) development in elderly patients. We aimed to investigate whether preoperative cognitive training could lower the incidence of POCD one week after surgery. Material/Methods A total of 141 ASA I–III elderly patients who underwent gastrointestinal surgery were enrolled into the study. Patients were randomized into either the Intervention group (69 analyzed) or the Control group (72 analyzed). Patients in the intervention group were instructed and trained in a cognition mnemonic skill for a total of three 1-hour sessions with the method of loci (MoL). Controls did not receive any cognitive training during hospitalization. All patients were tested using neuropsychological battery tests (NPTs) on admission and one week after surgery. Result The incidence of POCD in the intervention group (15.9%) was significantly lower than in the controls (36.1%) (P<0.05). Patients’ performance in Brief Visuospatial Memory Test-Revised and Symbol-Digit Modalities Test were improved by the cognitive training. Increasing age, longer length of anesthesia and surgery, and lack of cognitive training were associated with a significantly higher risk of POCD (P<0.05). Conclusions Cognitive training with MoL can reduce the decline of early postoperative cognitive function in elderly patients undergoing major gastrointestinal surgery. PMID:25782136

  16. Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia.

    PubMed

    Osrin, David; Azad, Kishwar; Fernandez, Armida; Manandhar, Dharma S; Mwansambo, Charles W; Tripathy, Prasanta; Costello, Anthony M

    2009-10-01

    Public health interventions usually operate at the level of groups rather than individuals, and cluster randomized controlled trials (RCTs) are one means of evaluating their effectiveness. Using examples from six such trials in Bangladesh, India, Malawi and Nepal, we discuss our experience of the ethical issues that arise in their conduct. We set cluster RCTs in the broader context of public health research, highlighting debates about the need to reconcile individual autonomy with the common good and about the ethics of public health research in low-income settings in general. After a brief introduction to cluster RCTs, we discuss particular challenges we have faced. These include the nature of - and responsibility for - group consent, and the need for consent by individuals within groups to intervention and data collection. We discuss the timing of consent in relation to the implementation of public health strategies, and the problem of securing ethical review and approval in a complex domain. Finally, we consider the debate about benefits to control groups and the standard of care that they should receive, and the issue of post-trial adoption of the intervention under test.

  17. Interventions employing mobile technology for overweight and obesity: an early systematic review of randomized controlled trials

    PubMed Central

    Bacigalupo, R; Cudd, P; Littlewood, C; Bissell, P; Hawley, M S; Buckley Woods, H

    2013-01-01

    Summary Obesity is a global epidemic with major healthcare implications and costs. Mobile technologies are potential interventions to promote weight loss. An early systematic review of this rapidly growing area of research was conducted. Electronic databases were searched for articles published between January 1998 and October 2011. Data sources included Medline, Embase and the Cochrane Central Register of Controlled Trials. Ongoing research was searched for using clinical trials databases and registers. Out of 174 articles retrieved, 21 met the inclusion criteria of randomized controlled trials (RCTs) on mobile technology interventions facilitating weight loss in overweight and obese adults with any other comparator. A narrative synthesis was undertaken. Seven articles were included and appraised using the Cochrane risk of bias tool: four presented a low risk of bias and three presented a high risk of bias. There is consistent strong evidence across the included multiple high-quality RCTs that weight loss occurs in the short-term because of mobile technology interventions, with moderate evidence for the medium-term. Recommendations for improving the reporting and quality of future trials are made including reporting weight loss in percent to meet clinical standards, and including features such as long-term follow-up, cost-effectiveness and patient acceptability. PMID:23167478

  18. A randomized clinical trial of the effectiveness of premarital intervention: moderators of divorce outcomes.

    PubMed

    Markman, Howard J; Rhoades, Galena K; Stanley, Scott M; Peterson, Kristina M

    2013-02-01

    This study examined the effects of premarital relationship intervention on divorce during the first 8 years of first marriage. Religious organizations were randomly assigned to have couples marrying through them complete the Prevention and Relationship Education Program (PREP) or their naturally occurring premarital services. Results indicated no differences in overall divorce rates between naturally occurring services (n = 44), PREP delivered by clergy at religious organizations (n = 66), or PREP delivered by professionals at a university (n = 83). Three moderators were also tested. Measured premaritally and before intervention, the level of negativity of couples' interactions moderated effects. Specifically, couples observed to have higher levels of negative communication in a video task were more likely to divorce if they received PREP than if they received naturally occurring services; couples with lower levels of premarital negative communication were more likely to remain married if they received PREP. A history of physical aggression in the current relationship before marriage and before intervention showed a similar pattern as a moderator, but the effect was only marginally significant. Family-of-origin background (parental divorce and/or aggression) was not a significant moderator of prevention effects across the two kinds of services. Implications for defining risk, considering divorce as a positive versus negative outcome, the practice of premarital relationship education, and social policy are discussed.

  19. A Randomized Controlled Trial of a Brief Intervention for Delayed Psychological Effects in Snakebite Victims

    PubMed Central

    Wijesinghe, Chamara A.; Williams, Shehan S.; Kasturiratne, Anuradhani; Dolawaththa, Nishantha; Wimalaratne, Piyal; Wijewickrema, Buddhika; Jayamanne, Shaluka F.; Isbister, Geoffrey K.; Dawson, Andrew H.; Lalloo, David G.; de Silva, H. Janaka

    2015-01-01

    Background Snakebite results in delayed psychological morbidity and negative psycho-social impact. However, psychological support is rarely provided to victims. Aim To assess the effectiveness of a brief intervention which can be provided by non-specialist doctors aimed at reducing psychological morbidity following snakebite envenoming. Method In a single blind, randomized controlled trial, snakebite victims with systemic envenoming [n = 225, 168 males, mean age 42.1 (SD 12.4) years] were randomized into three arms. One arm received no intervention (n = 68, Group A), the second received psychological first aid and psychoeducation (dispelling prevalent cultural beliefs related to snakebite which promote development of a sick role) at discharge from hospital (n = 65, Group B), while the third received psychological first aid and psychoeducation at discharge and a second intervention one month later based on cognitive behavioural principles (n = 69, Group C). All patients were assessed six months after hospital discharge for the presence of psychological symptoms and level of functioning using standardized tools. Results At six months, there was a decreasing trend in the proportion of patients who were positive for psychiatric symptoms of depression and anxiety from Group A through Group B to Group C (Chi square test for trend = 7.901, p = 0.005). This was mainly due to a decreasing trend for symptoms of anxiety (chi-square for trend = 11.256, p = 0.001). There was also decreasing trend in the overall prevalence of disability from Group A through Group B to Group C (chi square for trend = 7.551, p = 0.006), predominantly in relation to disability in family life (p = 0.006) and social life (p = 0.005). However, there was no difference in the proportion of patients diagnosed with depression between the three groups (chi square for trend = 0.391, p = 0.532), and the intervention also had no effect on post-traumatic stress disorder. Conclusions A brief psychological

  20. Safety and effectiveness using dexmedetomidine versus propofol TCI sedation during oesophagus interventions: a randomized trial

    PubMed Central

    2013-01-01

    Background Endoscopic treatment of early neoplastic lesions in oesophagus has evolved as a valid and less invasive alternative to surgical resection. These endoscopic interventions are minimal invasive treatment options usually done with sedation on an outpatient basis. The aim of this trial is to determine the safety and effectiveness of dexmedetomidine sedation compared to the standard used propofol TCI sedation during endoscopic oesophageal interventions. Methods The study will be performed as a randomized controlled trial. The first 64 consenting patients will be randomized to either the propofol or the dexmedetomidine group. Following endoscopy patients and gastroenterologists have to fill in questionnaires (PSSI, CSSI) (see abbreviations) about their sedation experiences. Additionally, patients have to accomplish the Trieger test before and after the procedure. Patient monitoring includes time adapted HR, SO2, ECG, NIBP, exCO2, NICO, sweat conductance measurement, OAA/S, and the Aldrete score. Effectiveness of sedation, classified by satisfaction levels and pain and sedation score measured by questionnaires is the primary outcome parameter. Respiratory and hemodynamic complications are surrogate parameters for the secondary outcome parameter “safety”. Discussion The acceptance level among patients after propofol sedation is high. Dexmedetomidine is a relatively new representative for procedural sedation. Has this new form of conscious sedation the potential to be safer and more effective for patients and endoscopists than propofol during endoscopic oesophageal interventions? Trial registration This trial is registered in the ISRCTN Register (ISRCTN 68599804). It will be conducted in accordance with the protocol and in compliance with the moral, ethical, and scientific principles governing clinical research as set out in the Declaration of Helsinki (1989) and Good Clinical Practice (GCP). The Departments of Anesthesiology and Gastroenterology & Hepatology

  1. A Group-Based Yoga Therapy Intervention for Urinary Incontinence in Women: A Pilot Randomized Trial

    PubMed Central

    Huang, Alison J.; Jenny, Hillary E.; Chesney, Margaret A.; Schembri, Michael; Subak, Leslee L.

    2015-01-01

    Objective To examine the feasibility, efficacy, and safety of a group-based yoga therapy intervention for middle-aged and older women with urinary incontinence. Methods We conducted a pilot randomized trial of ambulatory women aged 40 years and older with stress, urgency, or mixed-type incontinence. Women were randomized to a 6-week yoga therapy program (N=10) consisting of twice weekly group classes and once weekly home practice or a waitlist control group (N=9). All participants also received written pamphlets about standard behavioral self-management strategies for incontinence. Changes in incontinence were assessed by 7-day voiding diaries. Results Mean (±SD) age was 61.4 (±8.2) years, and mean baseline frequency of incontinence was 2.5 (±1.3) episodes/day. After 6 weeks, total incontinence frequency decreased by 66% (1.8 [±0.9] fewer episodes/day) in the yoga therapy versus 13% (0.3 [±1.7] fewer episodes/day) in the control group (P=0.049). Participants in the yoga therapy group also reported an average 85% decrease in stress incontinence frequency (0.7 [±0.8] fewer episodes/day) compared to a 25% increase in controls (0.2 [± 1.1] more episodes/day) (P=0.039). No significant differences in reduction in urgency incontinence were detected between the yoga therapy versus control groups (1.0 [±1.0] versus 0.5 [±0.5] fewer episodes/day, P=0.20). All women starting the yoga therapy program completed at least 90% of group classes and practice sessions. Two participants in each group reported adverse events unrelated to the intervention. Conclusions Findings provide preliminary evidence to support the feasibility, efficacy, and safety of a group-based yoga therapy intervention to improve urinary incontinence in women. PMID:24763156

  2. Alcohol Interventions Among Underage Drinkers in the ED: A Randomized Controlled Trial

    PubMed Central

    Chermack, Stephen T.; Ehrlich, Peter F.; Carter, Patrick M.; Booth, Brenda M.; Blow, Frederic C.; Barry, Kristen L.; Walton, Maureen A.

    2015-01-01

    OBJECTIVES: This study examined the efficacy of emergency department (ED)-based brief interventions (BIs), delivered by a computer or therapist, with and without a post-ED session, on alcohol consumption and consequences over 12 months. METHODS: Patients (ages 14–20 years) screening positive for risky drinking were randomized to: BI (n = 277), therapist BI (n = 278), or control (n = 281). After the 3-month follow-up, participants were randomized to receive a post-ED BI session or control. Incorporating motivational interviewing, the BIs addressed alcohol consumption and consequences, including driving under the influence (DUI), and alcohol-related injury, as well as other concomitant drug use. The computer BI was an offline, Facebook-styled program. RESULTS: Among 4389 patients screened, 1054 patients reported risky drinking and 836 were enrolled in the randomized controlled trial. Regression models examined the main effects of the intervention conditions (versus control) and the interaction effects (ED condition × post-ED condition) on primary outcomes. The therapist and computer BIs significantly reduced consumption at 3 months, consequences at 3 and 12 months, and prescription drug use at 12 months; the computer BI reduced the frequency of DUI at 12 months; and the therapist BI reduced the frequency of alcohol-related injury at 12 months. The post-ED session reduced alcohol consequences at 6 months, benefiting those who had not received a BI in the ED. CONCLUSIONS: A single-session BI, delivered by a computer or therapist in the ED, shows promise for underage drinkers. Findings for the fully automated stand-alone computer BI are particularly appealing given the ease of future implementation. PMID:26347440

  3. The role of gender in a smoking cessation intervention: a cluster randomized clinical trial

    PubMed Central

    2011-01-01

    Background The prevalence of smoking in Spain is high in both men and women. The aim of our study was to evaluate the role of gender in the effectiveness of a specific smoking cessation intervention conducted in Spain. Methods This study was a secondary analysis of a cluster randomized clinical trial in which the randomization unit was the Basic Care Unit (family physician and nurse who care for the same group of patients). The intervention consisted of a six-month period of implementing the recommendations of a Clinical Practice Guideline. A total of 2,937 current smokers at 82 Primary Care Centers in 13 different regions of Spain were included (2003-2005). The success rate was measured by a six-month continued abstinence rate at the one-year follow-up. A logistic mixed-effects regression model, taking Basic Care Units as random-effect parameter, was performed in order to analyze gender as a predictor of smoking cessation. Results At the one-year follow-up, the six-month continuous abstinence quit rate was 9.4% in men and 8.5% in women (p = 0.400). The logistic mixed-effects regression model showed that women did not have a higher odds of being an ex-smoker than men after the analysis was adjusted for confounders (OR adjusted = 0.9, 95% CI = 0.7-1.2). Conclusions Gender does not appear to be a predictor of smoking cessation at the one-year follow-up in individuals presenting at Primary Care Centers. ClinicalTrials.gov Identifier NCT00125905. PMID:21605389

  4. Skin and needle hygiene intervention for injection drug users: Results from a randomized, controlled Stage I pilot trial

    PubMed Central

    Phillips, Kristina T.; Stein, Michael D.; Anderson, Bradley J.; Corsi, Karen F.

    2012-01-01

    A new skin and needle hygiene intervention, designed to reduce high-risk injection practices associated with bacterial and viral infections, was tested in a pilot, randomized controlled trial. Participants included 48 active heroin injectors recruited through street outreach and randomized to either the two-session intervention or an assessment-only condition (AO) and followed for six months. The primary outcome was skin and needle cleaning behavioral skills measured by videotaped demonstration. Secondary outcomes were high-risk injection practices, intramuscular injection, and bacterial infections. Intervention participants had greater improvements on the skin (d = 1.00) and needle cleaning demonstrations (d = .52) and larger reductions in high-risk injection practices (d = .32) and intramuscular injection (d = .29), with a lower incidence rate of bacterial infections (HR = .80), at 6-months compared to AO. The new intervention appears feasible and promising as a brief intervention to reduce bacterial and viral risks associated with drug injection. PMID:22341554

  5. Improving blood pressure control in end stage renal disease through a supportive educative nursing intervention.

    PubMed

    Kauric-Klein, Zorica

    2012-01-01

    Hypertension in patients on hemodialysis (HD) contributes significantly to their morbidity and mortality. This study examined whether a supportive nursing intervention incorporating monitoring, goal setting, and reinforcement can improve blood pressure (BP) control in a chronic HD population. A randomized controlled design was used and 118 participants were recruited from six HD units in the Detroit metro area. The intervention consisted of (1) BP education sessions; (2) a 12-week intervention, including monitoring, goal setting, and reinforcement; and (3) a 30-day post-intervention follow-up period. Participants in the treatment were asked to monitor their BP, sodium, and fluid intake weekly for 12 weeks in weekly logs. BP, fluid and sodium logs were reviewed weekly with the researcher to determine if goals were met or not met. Reinforcement was given for goals met and problem solving offered when goals were not met. The control group received standard care. Both systolic and diastolic BPs were significantly decreased in the treatment group.

  6. Randomized Trial of a Cellular Phone-Enhanced Home Visitation Parenting Intervention

    PubMed Central

    Lefever, Jennifer Burke; Bigelow, Kathryn; Borkowski, John; Warren, Steven F.

    2013-01-01

    BACKGROUND AND OBJECTIVES: Although home visiting programs have been documented to improve parenting in high-risk families, their effectiveness is diminished when parents disengage from programs. Cellular phones offer an approach to promoting parent engagement and enhancing parenting outcomes. Our objective was to examine whether mothers in a parenting intervention, Planned Activities Training (PAT), or cellular phone-enhanced version (CPAT) of the intervention would demonstrate greater use of parenting strategies after treatment and at 6 months post-treatment compared with a wait-list control (WLC). METHODS: A sample of 371 low-income mothers and their 3.5- to 5.5-year-old children were randomly assigned to condition and assessed at pre-test, post-intervention, and 6 months post-intervention. Treatment efficacy was evaluated through observations of mother-child interactions as well as maternal interviews about depression, parenting stress, and child behaviors. RESULTS: Mothers receiving PAT and CPAT demonstrated more frequent use of parenting strategies and engaged in more responsive parenting than mothers in the WLC. Mothers receiving CPAT used more PAT parenting strategies than mothers in the other 2 groups and experienced greater reductions in depression and stress. Children of mothers receiving PAT and CPAT demonstrated higher rates of positive engagement, and children of CPAT mothers demonstrated higher levels of adaptive behaviors than children in the WLC. Importantly, changes in parenting, depression, and stress predicted positive child behaviors. CONCLUSIONS: PAT and CPAT conditions improved parenting strategies and child engagement and reduced children’s challenging behaviors. The addition of cellular phones to a home visiting program enhanced maternal responsivity and reduced depression and stress. PMID:24187120

  7. Interventions for atopic dermatitis in dogs: a systematic review of randomized controlled trials.

    PubMed

    Olivry, Thierry; Foster, Aiden P; Mueller, Ralf S; McEwan, Neil A; Chesney, Christopher; Williams, Hywel C

    2010-02-01

    The objective of this systematic review, which was performed following the guidelines of the Cochrane collaboration, was to assess the effects of interventions for treatment of atopic dermatitis (AD) in dogs. Citations identified from three databases (MEDLINE, Thomson's Science Citation Index Expanded and CAB Abstracts) and trials published by December 2007 were selected. Proceedings books from the major veterinary dermatology international congresses were hand searched for relevant citations. The authors selected randomized controlled trials (RCTs), published from January 1980 to December 2007, which reported the efficacy of topical or systemic interventions for treatment or prevention of canine AD. Studies had to report assessments of either pruritus or skin lesions, or both. Studies were selected and data extracted by two reviewers, with discrepancies resolved by a third arbitrator. Missing data were requested from study authors of recently published trials. Pooling of results and meta-analyses were performed for studies reporting similar interventions and outcome measures. A total of 49 RCTs were selected, which had enrolled 2126 dogs. This review found some evidence of efficacy of topical tacrolimus (3 RCTs), topical triamcinolone (1), oral glucocorticoids (5), oral ciclosporin (6), subcutaneous recombinant gamma-interferon (1) and subcutaneous allergen-specific immunotherapy (3) to decrease pruritus and/or skin lesions of AD in dogs. One high-quality RCT showed that an oral essential fatty acid supplement could reduce prednisolone consumption by approximately half. Additional RCTs of high design quality must be performed to remedy previous flaws and to test interventions for prevention of flares of this disease.

  8. Patients' communication with doctors: a randomized control study of a brief patient communication intervention.

    PubMed

    Talen, Mary R; Muller-Held, Christine F; Eshleman, Kate Grampp; Stephens, Lorraine

    2011-09-01

    In research on doctor-patient communication, the patient role in the communication process has received little attention. The dynamic interactions of shared decision making and partnership styles which involve active patient communication are becoming a growing area of focus in doctor-patient communication. However, patients rarely know what makes "good communication" with medical providers and even fewer have received coaching in this type of communication. In this study, 180 patients were randomly assigned to either an intervention group using a written communication tool to facilitate doctor-patient communication or to standard care. The goal of this intervention was to assist patients in becoming more effective communicators with their physicians. The physicians and patients both rated the quality of the communication after the office visit based on the patients' knowledge of their health concerns, organizational skills and questions, and attitudes of ownership and partnership. The results supported that patients in the intervention group had significantly better communication with their doctors than patients in the standard care condition. Physicians also rated patients who were in the intervention group as having better overall communication and organizational skills, and a more positive attitude during the office visit. This study supports that helping patients structure their communication using a written format can facilitate doctor-patient communication. Patients can become more adept at describing their health concerns, organizing their needs and questions, and being proactive, which can have a positive effect on the quality of the doctor-patient communication during outpatient office visits. (PsycINFO Database Record (c) 2011 APA, all rights reserved). PMID:21787080

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

    PubMed Central

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

    2014-01-01

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

  10. Effects of a three-month therapeutic lifestyle modification program to improve bone health in postmenopausal Korean women in a rural community: a randomized controlled trial.

    PubMed

    Oh, Eui Geum; Yoo, Jae Yong; Lee, Jung Eun; Hyun, Sa Saeng; Ko, Il Sun; Chu, Sang Hui

    2014-08-01

    In this randomized controlled trial, we examined the effects of a 3-month therapeutic lifestyle modification (TLM) intervention on knowledge, self-efficacy, and health behaviors related to bone health in postmenopausal women in rural Korea. Forty-one women ages 45 or older were randomly assigned to either the intervention (n = 21) or control (n = 20) group. The intervention group completed a 12-week, 24-session TLM program of individualized health monitoring, group health education, exercise, and calcium-vitamin D supplementation. Compared with the control group, the intervention group showed significant increases in knowledge and self-efficacy and improvement in diet and exercise after 12 weeks, providing evidence that a comprehensive TLM program can be effective in improving health behaviors to maintain bone health in women at high risk of osteoporosis.

  11. WalkMore: a randomized controlled trial of pedometer-based interventions differing on intensity messages

    PubMed Central

    2014-01-01

    Background Pedometer-based programs have elicited increased walking behaviors associated with improvements in blood pressure in sedentary/low active postmenopausal women, a population at increased risk of cardiovascular disease. Such programs typically encourage increasing the volume of physical activity with little regard for its intensity. Recent advances in commercially available pedometer technology now permit tracking of both steps/day and time in moderate (or greater) intensity physical activity on a daily basis. It is not known whether the dual message to increase steps/day while also increasing time spent at higher intensity walking will elicit additional improvements in blood pressure relative to a message to only focus on increasing steps/day. The purpose of this paper is to present the rationale, study design, and protocols employed in WalkMore, a 3-arm 3-month blinded and randomized controlled trial (RCT) designed to compare the effects of two community pedometer-based walking interventions (reflecting these separate and combined messages) relative to a control group on blood pressure in sedentary/low active post-menopausal women, a population at increased risk of cardiovascular disease. Methods/Design 120 sedentary/low active post-menopausal women (45-74 years of age) will be randomly assigned (computer-generated) to 1 of 3 groups: A) 10,000 steps/day (with no guidance on walking intensity/speed/cadence; BASIC intervention, n = 50); B) 10,000 steps/day and at least 30 minutes in moderate intensity (i.e., a cadence of at least 100 steps/min; ENHANCED intervention, n = 50); or a Control group (n = 20). An important strength of the study is the strict control and quantification of the pedometer-based physical activity interventions. The primary outcome is systolic blood pressure. Secondary outcomes include diastolic blood pressure, anthropometric measurements, fasting blood glucose and insulin, flow mediated dilation, gait speed, and

  12. Effectiveness of a cognitive behavioral intervention in patients with medically unexplained symptoms: cluster randomized trial

    PubMed Central

    2012-01-01

    Background Medically unexplained symptoms are an important mental health problem in primary care and generate a high cost in health services. Cognitive behavioral therapy and psychodynamic therapy have proven effective in these patients. However, there are few studies on the effectiveness of psychosocial interventions by primary health care. The project aims to determine whether a cognitive-behavioral group intervention in patients with medically unexplained symptoms, is more effective than routine clinical practice to improve the quality of life measured by the SF-12 questionary at 12 month. Methods/design This study involves a community based cluster randomized trial in primary healthcare centres in Madrid (Spain). The number of patients required is 242 (121 in each arm), all between 18 and 65 of age with medically unexplained symptoms that had seeked medical attention in primary care at least 10 times during the previous year. The main outcome variable is the quality of life measured by the SF-12 questionnaire on Mental Healthcare. Secondary outcome variables include number of consultations, number of drug (prescriptions) and number of days of sick leave together with other prognosis and descriptive variables. Main effectiveness will be analyzed by comparing the percentage of patients that improve at least 4 points on the SF-12 questionnaire between intervention and control groups at 12 months. All statistical tests will be performed with intention to treat. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in this analysis. Discussion This study aims to provide more insight to address medically unexplained symptoms, highly prevalent in primary care, from a quantitative methodology. It involves intervention group conducted by previously trained nursing staff to diminish the progression to the chronicity of the symptoms, improve

  13. Lifestyle intervention can reduce the risk of gestational diabetes: a meta-analysis of randomized controlled trials.

    PubMed

    Song, C; Li, J; Leng, J; Ma, R C; Yang, X

    2016-10-01

    This study aimed to examine the effect of lifestyle intervention on the risk of gestational diabetes mellitus (GDM). We searched PubMed, Springer and other databases to retrieve articles published in English and Chinese up to 30 September 2015. The inclusion criteria were randomized controlled trials evaluating the effects of lifestyle intervention on risk of GDM. Exclusion criteria were studies with prepregnancy diabetes mellitus or interventions with nutrient supplements. Random-effect and fixed-effect model analyses were used to obtain pooled relative risks and 95% confidence intervals (CIs) of diet and physical activity on the risk of GDM. Subgroup analyses were performed to check the consistency of effect sizes across groups where appropriate. We identified 29 randomized controlled trials with 11,487 pregnant women, addressing the effect of lifestyle intervention on the risk of GDM. In the pooled analysis, either diet or physical activity resulted in an 18% (95%CI 5-30%) reduction in the risk of GDM (P = 0.0091). Subgroup analysis showed that such intervention was effective among women with intervention before the 15th gestational week (relative risk: 0.80, 95%CI 0.66-0.97), but not among women receiving the intervention afterwards. We conclude that lifestyle modification during pregnancy, especially before the 15th gestational week, can reduce the risk of GDM. © 2016 World Obesity.

  14. A Randomized Trial of Brief Interventions for Problem and Pathological Gamblers

    PubMed Central

    Petry, Nancy M.; Weinstock, Jeremiah; Ledgerwood, David; Morasco, Benjamin

    2009-01-01

    Limited research exists regarding methods for reducing problem gambling. Problem gamblers (N=180) were randomly assigned to: assessment only control, 10 minutes of Brief Advice, 1 session of motivational enhancement therapy (MET), or 1 session of MET plus 3 sessions of cognitive-behavioral therapy (CBT). Gambling was assessed at baseline, 6 weeks later, and a 9-month follow-up. Relative to assessment only, Brief Advice was the only condition that significantly decreased gambling between baseline and week 6, and it was associated with clinically significant reductions in gambling at month 9. Between week 6 and month 9, MET+CBT evidenced significantly reduced gambling on one index compared to the control condition. These results suggest the efficacy of a very brief intervention for reducing gambling among problem and pathological gamblers not actively seeking gambling treatment. PMID:18377127

  15. A postdeployment expressive writing intervention for military couples: a randomized controlled trial.

    PubMed

    Baddeley, Jenna L; Pennebaker, James W

    2011-10-01

    The current study tested the effectiveness of a brief expressive writing intervention on the marital adjustment of 102 military couples recently reunited following a deployment to Iraq or Afghanistan. Active duty soldiers and their spouses were randomly assigned to write about either their relationship or a nonemotional topic on 3 occasions on a single day. The resulting design included 4 couple-level writing topic conditions: soldier-expressive/spouse-expressive, soldier-expressive/spouse-control, soldier-control/spouse-expressive, and soldier-control/spouse-control. Participants completed marital adjustment measures before writing, 1 month, and 6 months after writing. When soldiers, but not spouses, did expressive writing, couples increased in marital satisfaction over the next month, particularly if the soldier had had high combat exposure.

  16. Sex effects in cocaine using methadone patients randomized to contingency management interventions

    PubMed Central

    Burch, Ashley E.; Rash, Carla J.; Petry, Nancy M.

    2015-01-01

    Contingency management (CM) is an effective treatment for promoting cocaine abstinence in patients receiving methadone maintenance. However, few studies have examined the effect of sex on treatment outcomes in this population. This study evaluated the impact of sex on longest duration of abstinence (LDA) and percent negative urine samples in 323 cocaine-using methadone patients from four randomized clinical trials comparing CM to standard methadone care. Overall, women had better treatment outcomes compared to men, demonstrated by an increase in both LDA and percentages of negative samples. Patients receiving CM also had significantly higher LDA and percentages of negative samples compared to patients receiving standard care, but sex by treatment condition effects were not significant. These data suggest that cocaine using methadone patients who are women have better substance use outcomes than men in interventions that regularly monitor cocaine use, and CM is equally efficacious regardless of sex. PMID:26237326

  17. An Eight Month Randomized Controlled Exercise Intervention Alters Resting State Synchrony in Overweight Children

    PubMed Central

    Krafft, Cynthia E.; Pierce, Jordan E.; Schwarz, Nicolette F.; Chi, Lingxi; Weinberger, Abby L.; Schaeffer, David J.; Rodrigue, Amanda L.; Camchong, Jazmin; Allison, Jerry D.; Yanasak, Nathan E.; Liu, Tianming; Davis, Catherine L.; McDowell, Jennifer E.

    2014-01-01

    Children with low aerobic fitness have altered brain function compared to higher-fit children. This study examined the effect of an 8-month exercise intervention on resting state synchrony. Twenty-two sedentary, overweight (body mass index ≥ 85th percentile) children 8–11 years old were randomly assigned to one of two after-school programs: aerobic exercise (n=13) or sedentary attention control (n=9). Before and after the 8-month programs, all subjects participated in resting state functional magnetic resonance imaging scans. Independent components analysis identified several networks, with four chosen for between-group analysis: salience, default mode, cognitive control, and motor networks. The default mode, cognitive control, and motor networks showed more spatial refinement over time in the exercise group compared to controls. The motor network showed increased synchrony in the exercise group with the right medial frontal gyrus compared to controls. Exercise behavior may enhance brain development in children. PMID:24096138

  18. Effect of a 12-week complex training on the body composition and cardiorespiratory system of female college students

    PubMed Central

    Kim, Seungsuk; Han, Gunsoo

    2016-01-01

    [Purpose] The aim of this study was to examine the effects of a complex exercise program on the body composition and cardiorespiratory system of female college students. [Subjects and Methods] This study included 20 female college students who had not participated in any particular sports in the last 3 months. The complex exercise program consisted of two parts, aerobic exercise and weight training. First, aerobic exercise was implemented (30 min 5 times a week for 12 weeks) according to the participants’ exercise tolerance. Second, weight training was implemented (40 min 5 times a week for 12 weeks) with 60% of 1 repetition maximum (RM). [Results] The t-test results showed significant differences in body composition between the before and after the complex exercise program. The subjects’ body weights and body fat percentages were decreased, and their skeletal muscle masses were increased. Increased levels of maximal oxygen uptake (VO2max), maximal expiratory volume (VEmax), and maximal heart rate (HRmax) were also observed. [Conclusion] In conclusion, the 12-week complex exercise program, including aerobic and weight training, had positive effects on the body composition and cardiorespiratory system of the female college students. PMID:27630436

  19. Effect of a 12-week complex training on the body composition and cardiorespiratory system of female college students.

    PubMed

    Kim, Seungsuk; Han, Gunsoo

    2016-08-01

    [Purpose] The aim of this study was to examine the effects of a complex exercise program on the body composition and cardiorespiratory system of female college students. [Subjects and Methods] This study included 20 female college students who had not participated in any particular sports in the last 3 months. The complex exercise program consisted of two parts, aerobic exercise and weight training. First, aerobic exercise was implemented (30 min 5 times a week for 12 weeks) according to the participants' exercise tolerance. Second, weight training was implemented (40 min 5 times a week for 12 weeks) with 60% of 1 repetition maximum (RM). [Results] The t-test results showed significant differences in body composition between the before and after the complex exercise program. The subjects' body weights and body fat percentages were decreased, and their skeletal muscle masses were increased. Increased levels of maximal oxygen uptake (VO2max), maximal expiratory volume (VEmax), and maximal heart rate (HRmax) were also observed. [Conclusion] In conclusion, the 12-week complex exercise program, including aerobic and weight training, had positive effects on the body composition and cardiorespiratory system of the female college students. PMID:27630436

  20. Effect of a 12-week complex training on the body composition and cardiorespiratory system of female college students

    PubMed Central

    Kim, Seungsuk; Han, Gunsoo

    2016-01-01

    [Purpose] The aim of this study was to examine the effects of a complex exercise program on the body composition and cardiorespiratory system of female college students. [Subjects and Methods] This study included 20 female college students who had not participated in any particular sports in the last 3 months. The complex exercise program consisted of two parts, aerobic exercise and weight training. First, aerobic exercise was implemented (30 min 5 times a week for 12 weeks) according to the participants’ exercise tolerance. Second, weight training was implemented (40 min 5 times a week for 12 weeks) with 60% of 1 repetition maximum (RM). [Results] The t-test results showed significant differences in body composition between the before and after the complex exercise program. The subjects’ body weights and body fat percentages were decreased, and their skeletal muscle masses were increased. Increased levels of maximal oxygen uptake (VO2max), maximal expiratory volume (VEmax), and maximal heart rate (HRmax) were also observed. [Conclusion] In conclusion, the 12-week complex exercise program, including aerobic and weight training, had positive effects on the body composition and cardiorespiratory system of the female college students.

  1. A dietary intervention for chronic diabetic neuropathy pain: a randomized controlled pilot study

    PubMed Central

    Bunner, A E; Wells, C L; Gonzales, J; Agarwal, U; Bayat, E; Barnard, N D

    2015-01-01

    Background: Diabetic neuropathy is a common and often debilitating condition for which available treatments are limited. Because a low-fat plant-based diet has been shown to improve glycemic control in individuals with type 2 diabetes, we hypothesized that such a diet would reduce painful symptoms of diabetic neuropathy. Methods: In this 20-week pilot study, individuals with type 2 diabetes and painful diabetic neuropathy were randomly assigned to two groups. The intervention group was asked to follow a low-fat, plant-based diet, with weekly classes for support in following the prescribed diet, and to take a vitamin B12 supplement. The control group was asked to take the same vitamin B12 supplement, but received no other intervention. At baseline, midpoint and 20 weeks, clinical, laboratory and questionnaire data were collected. Questionnaires included an analog ‘worst pain' scale, Michigan Neuropathy Screening Instrument, global impression scale, Short Form McGill Pain Questionnaire, Neuropathy Total Symptom Score, a weekly pain diary and Norfolk Quality of Life Questionnaire. Results: After 20 weeks, body weight change with the intervention was −6.4 kg (95% confidence interval (CI) −9.4 to −3.4, P<0.001) in an effect size analysis. Electrochemical skin conductance in the foot improved by an average of 12.4 microseimens (95% CI 1.2–23.6, P=0.03) with the intervention in an effect size analysis. The between-group difference in change in pain, as measured by the McGill pain questionnaire, was −8.2 points (95% CI −16.1 to −0.3, P=0.04). Michigan Neuropathy Screening Instrument questionnaire score change was −1.6 points (95% CI −3.0 to −0.2, P=0.03). Conclusions: Improvements were seen in some clinical and pain measures. This pilot study suggests the potential value of a plant-based diet intervention, including weekly support classes, for treating painful diabetic neuropathy. PMID:26011582

  2. Time-Based Physical Activity Interventions for Weight Loss: A Randomized Trial

    PubMed Central

    Jakicic, John M.; Rickman, Amy D.; Lang, Wei; Davis, Kelliann K.; Gibbs, Bethany Barone; Neiberg, Rebecca; Marcus, Marsha D.

    2014-01-01

    Purpose To examine whether enhancing standard behavior weight loss interventions (SBWP) with additional strategies at the initiation of the intervention (ADOPT) or providing the additional strategies at predetermined times over the intervention period (MAINTAIN) enhances 18 month weight loss. Methods This was a clinical trial with participants (n=195; age= 43.2±8.6 yrs; BMI= 33.0±3.4 kg/m2) randomized to SBWP, ADOPT, or MAINTAIN. All were prescribed an energy restricted diet and physical activity, with group intervention sessions delivered over 18 months. ADOPT received additional phone contact (months 1–3), supervised exercise (months 1–6), and behavior campaigns (months 4–9). MAINTAIN received additional phone contact (months 4–6), supervised exercise (months 7–12), and behavior campaigns (months 13–18). Results There was a significant Group X Time interaction for weight loss (p=0.0032). SBWP lost 9.3±0.9, 7.8±1.1, and 5.9±1.2 kg at 6, 12, and 18 months, respectively. ADOPT lost 8.9±0.9, 7.6±1.2, and 5.8±1.2 kg, and MAINTAIN lost 9.7±0.9, 11.0±1.2, and 9.0±1.2 kg at 6, 12, and 18 months, respectively. The Group X Time interaction for SBWP vs. MAINTAIN (p=0.0033) and ADOPT vs. MAINTAIN (p=0.0075) was significant. There was a significant Group X Time interaction for change in fitness (p=0.0060). The Group X Time interaction for MAINTAIN vs. ADOPT (p=0.0018) was significant with a trend for MAINTAIN vs. SBWP (p=0.0525). Conclusions MAINTAIN improved 18-month weight loss compared to SBWP and ADOPT, with statistical trends that MAINTAIN resulted in greater improvements in fitness. These results suggest that time-based strategies emphasizing physical activity conferred greater benefits when delivered later and over the full course of intervention. This provides valuable information for the implementation of time-based strategies to improve long-term weight loss and fitness in overweight and obese adults. PMID:25160843

  3. Impact of pedometer-based walking on menopausal women's sleep quality: a randomized controlled trial.

    PubMed

    Tadayon, M; Abedi, P; Farshadbakht, F

    2016-08-01

    Objective Sleep disturbances are one of the most common psycho-physiological issues among postmenopausal women. This study was designed to evaluate the impact of walking with a pedometer on the sleep quality of postmenopausal Iranian women. Methods This randomized, controlled trial was conducted on 112 women who were randomly assigned to two groups. The women in the intervention group (n = 56) were asked to walk with a pedometer each day for 12 weeks and to increase their walking distance by 500 steps per week. A sociodemographic instrument and the Pittsburgh Sleep Quality Index were used to collect data. Sleep quality was measured at baseline, 4, 8, and 12 weeks after intervention. The control group (n = 56) did not receive any intervention. Results After 12 weeks, subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction improved to a significantly greater extent in the intervention group than in the control group (p < 0.05). The total sleep quality score was significantly higher in the intervention group than in the control group (0.64 vs. 0.98, p = 0.001). Conclusion This study showed that walking with a pedometer is an easy and cost-effective way to improve the quality of sleep among postmenopausal women. Use of this method in public health centers is recommended.

  4. Impact of pedometer-based walking on menopausal women's sleep quality: a randomized controlled trial.

    PubMed

    Tadayon, M; Abedi, P; Farshadbakht, F

    2016-08-01

    Objective Sleep disturbances are one of the most common psycho-physiological issues among postmenopausal women. This study was designed to evaluate the impact of walking with a pedometer on the sleep quality of postmenopausal Iranian women. Methods This randomized, controlled trial was conducted on 112 women who were randomly assigned to two groups. The women in the intervention group (n = 56) were asked to walk with a pedometer each day for 12 weeks and to increase their walking distance by 500 steps per week. A sociodemographic instrument and the Pittsburgh Sleep Quality Index were used to collect data. Sleep quality was measured at baseline, 4, 8, and 12 weeks after intervention. The control group (n = 56) did not receive any intervention. Results After 12 weeks, subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction improved to a significantly greater extent in the intervention group than in the control group (p < 0.05). The total sleep quality score was significantly higher in the intervention group than in the control group (0.64 vs. 0.98, p = 0.001). Conclusion This study showed that walking with a pedometer is an easy and cost-effective way to improve the quality of sleep among postmenopausal women. Use of this method in public health centers is recommended. PMID:26757356

  5. Web Intervention for Adolescents Affected by Disaster: Population-Based Randomized Controlled Trial

    PubMed Central

    Ruggiero, Kenneth J.; Price, Matthew; Adams, Zachary; Stauffacher, Kirstin; McCauley, Jenna; Danielson, Carla Kmett; Knapp, Rebecca; Hanson, Rochelle F.; Davidson, Tatiana M.; Amstadter, Ananda B.; Carpenter, Matthew J.; Saunders, Benjamin E.; Kilpatrick, Dean G.; Resnick, Heidi S.

    2015-01-01

    Objective To assess the efficacy of Bounce Back Now (BBN), a modular, web-based intervention for disaster-affected adolescents and their parents. Method A population-based randomized controlled trial used address-based sampling to enroll 2,000 adolescents and parents from communities affected by tornadoes in Joplin, MO, and Alabama. Data collection via baseline and follow-up semi-structured telephone interviews was completed between September 2011 and August 2013. All families were invited to access the BBN study web portal irrespective of mental health status at baseline. Families who accessed the web portal were assigned randomly to 3 groups: (1) BBN, which featured modules for adolescents and parents targeting adolescents’ mental health symptoms; (2) BBN plus additional modules targeting parents’ mental health symptoms; or (3) assessment only. The primary outcomes were adolescent symptoms of posttraumatic stress disorder (PTSD) and depression. Results Nearly 50% of families accessed the web portal. Intent-to-treat analyses revealed time × condition interactions for PTSD symptoms (B=−0.24, SE=0.08, p<.01) and depressive symptoms (B=−0.23, SE=0.09, p<.01). Post-hoc comparisons revealed fewer PTSD and depressive symptoms for adolescents in the experimental vs. control conditions at 12-month follow-up (PTSD: B=−0.36, SE=0.19, p=.06; depressive symptoms: B=−0.42, SE=0.19, p=0.03). A time × condition interaction also was found favoring the BBN vs. BBN + parent self-help condition for PTSD symptoms (B=0.30, SE=0.12, p=.02), but not depressive symptoms (B=0.12, SE=0.12, p=.33). Conclusion Results supported the feasibility and initial efficacy of BBN as a scalable disaster mental health intervention for adolescents. Technology-based solutions have tremendous potential value if found to reduce the mental health burden of disasters. PMID:26299292

  6. Multifaceted Intervention to Prevent Venous Thromboembolism in Patients Hospitalized for Acute Medical Illness: A Multicenter Cluster-Randomized Trial

    PubMed Central

    Roy, Pierre-Marie; Rachas, Antoine; Meyer, Guy; Le Gal, Grégoire; Durieux, Pierre; El Kouri, Dominique; Honnart, Didier; Schmidt, Jeannot; Legall, Catherine; Hausfater, Pierre; Chrétien, Jean-Marie; Mottier, Dominique

    2016-01-01

    Background Misuse of thromboprophylaxis may increase preventable complications for hospitalized medical patients. Objectives To assess the net clinical benefit of a multifaceted intervention in emergency wards (educational lectures, posters, pocket cards, computerized clinical decision support systems and, where feasible, electronic reminders) for the prevention of venous thromboembolism. Patients/Methods Prospective cluster-randomized trial in 27 hospitals. After a pre-intervention period, centers were randomized as either intervention (n = 13) or control (n = 14). All patients over 40 years old, admitted to the emergency room, and hospitalized in a medical ward were included, totaling 1,402 (712 intervention and 690 control) and 15,351 (8,359 intervention and 6,992 control) in the pre-intervention and intervention periods, respectively. Results Symptomatic venous thromboembolism or major bleeding (primary outcome) occurred at 3 months in 3.1% and 3.2% of patients in the intervention and control groups, respectively (adjusted odds ratio: 1.02 [95% confidence interval: 0.78–1.34]). The rates of thromboembolism (1.9% vs. 1.9%), major bleedings (1.2% vs. 1.3%), and mortality (11.3% vs. 11.1%) did not differ between the groups. Between the pre-intervention and intervention periods, the proportion of patients who received prophylactic anticoagulant treatment more steeply increased in the intervention group (from 35.0% to 48.2%: +13.2%) than the control (40.7% to 44.1%: +3.4%), while the rate of adequate thromboprophylaxis remained stable in both groups (52.4% to 50.9%: -1.5%; 49.1% to 48.8%: -0.3%). Conclusions Our intervention neither improved adequate prophylaxis nor reduced the rates of clinical events. New strategies are required to improve thromboembolism prevention for hospitalized medical patients. Trial Registration ClinicalTrials.gov NCT01212393 PMID:27227406

  7. Effect of an herbal/botanical supplement on strength, balance, and muscle function following 12-weeks of resistance training: a placebo controlled study

    PubMed Central

    2014-01-01

    Background StemSport (SS; StemTech International, Inc. San Clemente, CA) contains a proprietary blend of the botanical Aphanizomenon flos-aquae and several herbal antioxidant and anti-inflammatory substances. SS has been purported to accelerate tissue repair and restore muscle function following resistance exercise. Here, we examine the effects of SS supplementation on strength adaptations resulting from a 12-week resistance training program in healthy young adults. Methods Twenty-four young adults (16 males, 8 females, mean age = 20.5 ± 1.9 years, mass = 70.9 ± 11.9 kg, stature = 176.6 ± 9.9 cm) completed the twelve week training program. The study design was a double-blind, placebo controlled parallel group trial. Subjects either received placebo or StemSport supplement (SS; mg/day) during the training. 1-RM bench press, 1-RM leg press, vertical jump height, balance (star excursion and center of mass excursion), isokinetic strength (elbow and knee flexion/extension) and perception of recovery were measured at baseline and following the 12-week training intervention. Results Resistance training increased 1-RM strength (p < 0.008), vertical jump height (p < 0.03), and isokinetic strength (p < 0.05) in both SS and placebo groups. No significant group-by-time interactions were observed (all p-values >0.10). Conclusions These data suggest that compared to placebo, the SS herbal/botanical supplement did not enhance training induced adaptations to strength, balance, and muscle function above strength training alone. PMID:24910543

  8. Patient-centered community health worker intervention to improve posthospital outcomes: a randomized clinical trial.

    PubMed

    Kangovi, Shreya; Mitra, Nandita; Grande, David; White, Mary L; McCollum, Sharon; Sellman, Jeffrey; Shannon, Richard P; Long, Judith A

    2014-04-01

    IMPORTANCE Socioeconomic and behavioral factors can negatively influence posthospital outcomes among patients of low socioeconomic status (SES). Traditional hospital personnel often lack the time, skills, and community linkages required to address these factors. OBJECTIVE To determine whether a tailored community health worker (CHW) intervention would improve posthospital outcomes among low-SES patients. DESIGN, SETTING, AND PARTICIPANTS A 2-armed, single-blind, randomized clinical trial was conducted between April 10, 2011, and October 30, 2012, at 2 urban, academically affiliated hospitals. Of 683 eligible general medical inpatients (ie, low-income, uninsured, or Medicaid) that we screened, 237 individuals (34.7%) declined to participate. The remaining 446 patients (65.3%) were enrolled and randomly assigned to study arms. Nearly equal percentages of control and intervention group patients completed the follow-up interview (86.6% vs 86.9%). INTERVENTIONS During hospital admission, CHWs worked with patients to create individualized action plans for achieving patients' stated goals for recovery. The CHWs provided support tailored to patient goals for a minimum of 2 weeks. MAIN OUTCOMES AND MEASURES The prespecified primary outcome was completion of primary care follow-up within 14 days of discharge. Prespecified secondary outcomes were quality of discharge communication, self-rated health, satisfaction, patient activation, medication adherence, and 30-day readmission rates. RESULTS Using intention-to-treat analysis, we found that intervention patients were more likely to obtain timely posthospital primary care (60.0% vs 47.9%; P = .02; adjusted odds ratio [OR], 1.52; 95% CI, 1.03-2.23), to report high-quality discharge communication (91.3% vs 78.7%; P = .002; adjusted OR, 2.94; 95% CI, 1.5-5.8), and to show greater improvements in mental health (6.7 vs 4.5; P = .02) and patient activation (3.4 vs 1.6; P = .05). There were no significant differences

  9. Results of a large-scale randomized behavior change intervention on road safety in Kenya

    PubMed Central

    Habyarimana, James; Jack, William

    2015-01-01

    Road accidents kill 1.3 million people each year, most in the developing world. We test the efficacy of evocative messages, delivered on stickers placed inside Kenyan matatus, or minibuses, in reducing road accidents. We randomize the intervention, which nudges passengers to complain to their drivers directly, across 12,000 vehicles and find that on average it reduces insurance claims rates of matatus by between one-quarter and one-third and is associated with 140 fewer road accidents per year than predicted. Messages promoting collective action are especially effective, and evocative images are an important motivator. Average maximum speeds and average moving speeds are 1–2 km/h lower in vehicles assigned to treatment. We cannot reject the null hypothesis of no placebo effect. We were unable to discern any impact of a complementary radio campaign on insurance claims. Finally, the sticker intervention is inexpensive: we estimate the cost-effectiveness of the most impactful stickers to be between $10 and $45 per disability-adjusted life-year saved. PMID:26261326

  10. Randomized controlled evaluation of an early intervention to prevent post-rape psychopathology.

    PubMed

    Resnick, Heidi; Acierno, Ron; Waldrop, Angela E; King, Lynda; King, Daniel; Danielson, Carla; Ruggiero, Kenneth J; Kilpatrick, Dean

    2007-10-01

    A randomized between-group design was used to evaluate the efficacy of a video intervention to reduce post-traumatic stress disorder (PTSD) and other mental health problems, implemented prior to the forensic medical examination conducted within 72 h post-sexual assault. Participants were 140 female victims of sexual assault (68 video/72 nonvideo) aged 15 years or older. Assessments were targeted for 6 weeks (Time 1) and 6 months (Time 2) post-assault. At Time 1, the intervention was associated with lower scores on measures of PTSD and depression among women with a prior rape history relative to scores among women with a prior rape history in the standard care condition. At Time 2, depression scores were also lower among those with a prior rape history who were in the video relative to the standard care condition. Small effects indicating higher PTSD and Beck Anxiety Inventory (BAI) scores among women without a prior rape history in the video condition were observed at Time 1. Accelerated longitudinal growth curve analysis indicated a videoxprior rape history interaction for PTSD, yielding four patterns of symptom trajectory over time. Women with a prior rape history in the video condition generally maintained the lowest level of symptoms.

  11. The selection and design of control conditions for randomized controlled trials of psychological interventions.

    PubMed

    Mohr, David C; Spring, Bonnie; Freedland, Kenneth E; Beckner, Victoria; Arean, Patricia; Hollon, Steven D; Ockene, Judith; Kaplan, Robert

    2009-01-01

    The randomized controlled trial (RCT) provides critical support for evidence-based practice using psychological interventions. The control condition is the principal method of removing the influence of unwanted variables in RCTs. There is little agreement or consistency in the design and construction of control conditions. Because control conditions have variable effects, the results of RCTs can depend as much on control condition selection as on the experimental intervention. The aim of this paper is to present a framework for the selection and design of control conditions for these trials. Threats to internal validity arising from modern RCT methodology are reviewed and reconsidered. The strengths and weaknesses of several categories of control conditions are examined, including the ones that are under experimental control, the ones that are under the control of clinical service providers, and no-treatment controls. Considerations in the selection of control conditions are discussed and several recommendations are proposed. The aim of this paper is to begin to define principles by which control conditions can be selected or developed in a manner that can assist both investigators and grant reviewers.

  12. Replicating the Safer Sex Intervention: 9-Month Impact Findings of a Randomized Controlled Trial

    PubMed Central

    Walker, Jessica T.; Layzer, Jean; Price, Cristofer; Juras, Randall

    2016-01-01

    Objectives. To test the effects of the Safer Sex Intervention (SSI) on female adolescents’ sexual behavior and possible antecedents of behavior such as sexual health attitudes, knowledge, motivation, intentions, and skills. Methods. A randomized controlled trial compared SSI (n = 1196) with no intervention (n = 613) among female adolescents aged 13 to 20 years at 3 sites across the United States from 2012 to 2015. Intent-to-treat impacts were estimated at 9 months after baseline, overall, and for key subgroups. Results. Compared with control participants, SSI participants were less likely to have sexual intercourse without birth control, more likely to report positive attitudes toward protection and intention to use condoms, and more confident of their ability to refuse sex. SSI did not affect sexual risk knowledge or motivation to delay childbearing. Positive impacts on sexual behavior and sexual risk were observed among key subgroups of youths who were aged 18 years or older, Hispanic, not sexually experienced at baseline, and enrolled at the Minnesota site. Conclusions. SSI produced meaningful changes in sexual behavior and sexual risk and successfully addressed some potential antecedents of sexual risk behavior. PMID:27689494

  13. A regular curd consumption improves gastrointestinal status assessed by a randomized controlled nutritional intervention.

    PubMed

    Navas-Carretero, Santiago; Abete, Itziar; Cuervo, Marta; Zulet, M Ángeles; Martínez, J Alfredo

    2013-09-01

    This study evaluated the influence of curd consumption (a dairy product in which most whey proteins are discarded) on nutritional status markers and on gastrointestinal symptoms through an open-label randomized nutritional intervention. A total of 20 males and 20 females were involved in the study. Body weight and plasma levels of different health markers were measured at baseline and at the end of the study. Gastrointestinal symptoms and satiety were assessed by self-reported subjective questionnaires. There were neither relevant changes in body weight and composition, nor in all screened plasma determinations after the intervention. Satiety score analyses revealed no differences between the two experimental groups. The regular consumption of curd-improved abdominal pain (19%) and deposition scores (16%) when compared with those participants non-consuming curd, which may indicate a better tolerability of this product. Curd intake within a balanced diet improved some subjective markers of gastrointestinal status, which may be explained by the nutritional composition of curds.

  14. Results of a large-scale randomized behavior change intervention on road safety in Kenya.

    PubMed

    Habyarimana, James; Jack, William

    2015-08-25

    Road accidents kill 1.3 million people each year, most in the developing world. We test the efficacy of evocative messages, delivered on stickers placed inside Kenyan matatus, or minibuses, in reducing road accidents. We randomize the intervention, which nudges passengers to complain to their drivers directly, across 12,000 vehicles and find that on average it reduces insurance claims rates of matatus by between one-quarter and one-third and is associated with 140 fewer road accidents per year than predicted. Messages promoting collective action are especially effective, and evocative images are an important motivator. Average maximum speeds and average moving speeds are 1-2 km/h lower in vehicles assigned to treatment. We cannot reject the null hypothesis of no placebo effect. We were unable to discern any impact of a complementary radio campaign on insurance claims. Finally, the sticker intervention is inexpensive: we estimate the cost-effectiveness of the most impactful stickers to be between $10 and $45 per disability-adjusted life-year saved.

  15. A Randomized Controlled Trial of Positive-Affect Intervention and Medication Adherence in Hypertensive African Americans

    PubMed Central

    Ogedegbe, Gbenga O.; Boutin-Foster, Carla; Wells, Martin T.; Allegrante, John P.; Isen, Alice M.; Jobe, Jared B.; Charlson, Mary E.

    2015-01-01

    Background Poor adherence explains poor blood pressure (BP) control; however African Americans suffer worse hypertension-related outcomes. Methods This randomized controlled trial evaluated whether a patient education intervention enhanced with positive-affect induction and self-affirmation (PA) was more effective than patient education (PE) alone in improving medication adherence and BP reduction among 256 hypertensive African Americans followed up in 2 primary care practices. Patients in both groups received a culturally tailored hypertension self-management workbook, a behavioral contract, and bimonthly telephone calls designed to help them overcome barriers to medication adherence. Also, patients in the PA group received small gifts and bimonthly telephone calls to help them incorporate positive thoughts into their daily routine and foster self-affirmation. The main outcome measures were medication adherence (assessed with electronic pill monitors) and within-patient change in BP from baseline to 12 months. Results The baseline characteristics were similar in both groups: the mean BP was 137/82 mm Hg; 36% of the patients had diabetes; 11% had stroke; and 3% had chronic kidney disease. Based on the intention-to-treat principle, medication adherence at 12 months was higher in the PA group than in the PE group (42% vs 36%, respectively; P =.049). The within-group reduction in systolic BP (2.14 mm Hg vs 2.18 mm Hg; P =.98) and diastolic BP (−1.59 mm Hg vs −0.78 mm Hg; P=.45) for the PA group and PE group, respectively, was not significant. Conclusions A PE intervention enhanced with PA led to significantly higher medication adherence compared with PE alone in hypertensive African Americans. Future studies should assess the cost-effectiveness of integrating such interventions into primary care. Trial Registration clinicaltrials.gov Identifier: NCT00227175 PMID:22269592

  16. Clinical Application of Revised Laboratory Classification Criteria for Antiphospholipid Antibody Syndrome: Is the Follow-Up Interval of 12 Weeks Instead of 6 Weeks Significantly Useful?

    PubMed Central

    Park, Sang Hyuk; Park, Chan-Jeoung; Chi, Hyun-Sook

    2016-01-01

    Background. According to revised classification criteria of true antiphospholipid antibody syndrome, at least one of three antiphospholipid antibodies should be present on two or more occasions at least 12 weeks apart. However, it can be inconvenient to perform follow-up tests with interval of 12 weeks. We investigated clinical application of follow-up tests with interval of 12 weeks. Method. Totals of 67, 199, and 332 patients tested positive initially for the lupus anticoagulants confirm, the anti-β2 glycoprotein-I antibody, and the anti-cardiolipin antibody test, respectively, from Jan 2007 to Jul 2009. We investigated clinical symptoms of patients, follow-up interval, and results of each test. Results. Among patients with initial test positive, 1.5%–8.5% were subjected to follow-up tests at interval of more than 12 weeks. Among 25 patients with negative conversion in tests, patients with interval of more than 12 weeks showed clinical symptom positivity of 33.3%, which was higher than that of 12.5% with 6–12 weeks. Among 34 patients with persistent test positive, clinical symptoms positivity trended to be more evident in patients at interval of 6–12 weeks (47.4% versus 26.7%, P = 0.191) than more than 12 weeks. Conclusion. Less than 10% of patients with initial test positive had follow-up tests at interval of more than 12 weeks and the patients with persistent test positive at interval of more than 12 weeks showed trends toward having lower clinical symptoms than 6–12 weeks. More research is needed focused on the evidence that follow-up test at interval of more than 12 weeks should be performed instead of 6 weeks. PMID:27610369

  17. Clinical Application of Revised Laboratory Classification Criteria for Antiphospholipid Antibody Syndrome: Is the Follow-Up Interval of 12 Weeks Instead of 6 Weeks Significantly Useful?

    PubMed

    Park, Sang Hyuk; Jang, Seongsoo; Park, Chan-Jeoung; Chi, Hyun-Sook

    2016-01-01

    Background. According to revised classification criteria of true antiphospholipid antibody syndrome, at least one of three antiphospholipid antibodies should be present on two or more occasions at least 12 weeks apart. However, it can be inconvenient to perform follow-up tests with interval of 12 weeks. We investigated clinical application of follow-up tests with interval of 12 weeks. Method. Totals of 67, 199, and 332 patients tested positive initially for the lupus anticoagulants confirm, the anti-β 2 glycoprotein-I antibody, and the anti-cardiolipin antibody test, respectively, from Jan 2007 to Jul 2009. We investigated clinical symptoms of patients, follow-up interval, and results of each test. Results. Among patients with initial test positive, 1.5%-8.5% were subjected to follow-up tests at interval of more than 12 weeks. Among 25 patients with negative conversion in tests, patients with interval of more than 12 weeks showed clinical symptom positivity of 33.3%, which was higher than that of 12.5% with 6-12 weeks. Among 34 patients with persistent test positive, clinical symptoms positivity trended to be more evident in patients at interval of 6-12 weeks (47.4% versus 26.7%, P = 0.191) than more than 12 weeks. Conclusion. Less than 10% of patients with initial test positive had follow-up tests at interval of more than 12 weeks and the patients with persistent test positive at interval of more than 12 weeks showed trends toward having lower clinical symptoms than 6-12 weeks. More research is needed focused on the evidence that follow-up test at interval of more than 12 weeks should be performed instead of 6 weeks. PMID:27610369

  18. Asenapine as adjunctive treatment for acute mania associated with bipolar disorder: results of a 12-week core study and 40-week extension.

    PubMed

    Szegedi, Armin; Calabrese, Joseph R; Stet, Let; Mackle, Mary; Zhao, Jun; Panagides, John

    2012-02-01

    In a 12-week randomized, placebo-controlled study evaluating the efficacy and safety of adjunctive asenapine, bipolar I disorder patients experiencing manic or mixed episodes despite pretreatment with lithium or valproate monotherapy were treated with flexible-dose, twice-daily asenapine 5 or 10 mg (n = 158) or placebo (n = 166). The primary efficacy end point was change from baseline Young Mania Rating Scale (YMRS) total score at week 3. Secondary outcomes included YMRS response and remission and Clinical Global Impression for Bipolar Disorder and Montgomery-Asberg Depression Rating Scale score changes. Patients completing the core study were eligible for a 40-week double-blind extension assessing safety and tolerability. Adjunctive asenapine significantly improved mania versus placebo at week 3 (primary end point) and weeks 2 to 12. The YMRS response rates were similar at week 3 but significantly better with asenapine at week 12. The YMRS remission rates and changes from baseline on Clinical Global Impression for Bipolar Disorder for mania and overall illness were significantly better with asenapine at weeks 3 and 12. No other statistically significant differences on secondary outcomes were observed. Only a small number of patients entered the extension, making firm statistical conclusions on efficacy difficult. Treatment-emergent adverse events reported by 5% or more of asenapine patients and at twice the incidence of placebo were sedation, somnolence, depression/depressive symptoms, oral hypoesthesia, and increased weight in the 12-week core study. Adjunctive asenapine to lithium or valproate was more effective than mood stabilizer monotherapy in the core study and was well tolerated for up to 52 weeks.

  19. Adding Memantine to Rivastigmine Therapy in Patients With Mild-to-Moderate Alzheimer's Disease: Results of a 12-Week, Open-Label Pilot Study

    PubMed Central

    Riepe, Matthias W.; Adler, Georg; Ibach, Bernd; Weinkauf, Birgit; Gunay, Ibrahim; Tracik, Ferenc

    2006-01-01

    Objective: At present, inhibition of cholines-terase is the treatment of choice for subjects with mild-to-moderate Alzheimer's disease (AD). Memantine, a noncompetitive antagonist at N-methyl-d-aspartate receptors, is currently used to treat subjects with moderate-to-severe AD. The goal of this multicenter, open-label pilot study was to investigate whether combination therapy with memantine added to rivastigmine is safe and beneficial in subjects with mild-to-moderate AD. Method: Patients with a DSM-IV diagnosis of dementia of the Alzheimer's type (N = 95), who were treated with rivastigmine (6–12 mg/day) for a maximum duration of 24 weeks prior to baseline, received memantine (5–20 mg/day) in combination with rivastigmine for 12 weeks. The primary efficacy variable was the change in the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) total score at the end of 12 weeks compared with baseline. The study was conducted between September 15, 2003, and May 27, 2004. Results: There was a statistically significant difference between baseline and week 12 for the ADAS-cog total score, showing a positive effect of combination therapy. Combination therapy did not evidence any unexpected safety concerns and was well-tolerated by most patients. Conclusion: Memantine in combination with rivastigmine appears to be safe and beneficial in patients with mild-to-moderate AD. Our results need to be confirmed in a large, long-term, randomized, double-blind, placebo-controlled clinical trial. PMID:17235381

  20. An Intervention Targeting Service Providers and Clients for Methadone Maintenance Treatment in China: A Cluster-randomized Trial

    PubMed Central

    Li, Li; Wu, Zunyou; Liang, Li-Jung; Lin, Chunqing; Zhang, Linglin; Guo, Sam; Rou, Keming; Li, Jianhua

    2012-01-01

    Aims This study examines the preliminary outcomes of an intervention targeting service providers in methadone maintenance therapy clinics in China. The intervention effects on both service providers and clients are reported. Design The MMT CARE intervention pilot was developed and implemented collaboratively with local health educators. After three group intervention sessions, trained providers in intervention clinics delivered two individual motivational interviewing sessions with their clients. Settings Six clinics in Sichuan, China, were randomized to either the MMT CARE intervention condition or a standard care condition. Participants A total of 41 providers and 179 clients were sampled from the six clinics. Measurements At baseline and 3-, 6-, and 9-month assessments, providers completed self-administrated paper/pencil questionnaires regarding provider-client interaction, methadone maintenance therapy knowledge, perceived job-related stigma, and clinic support. Clients completed a face-to-face survey about their concurrent drug use and drug avoidance self-efficacy. Mixed-effects regression models with clinic-level random effect were used to assess the intervention effects. Findings Significant intervention effects for providers were found in improved methadone maintenance therapy knowledge, provider-client interaction, and perceived clinic support. For clients, better improvements in drug avoidance self-efficacy and reduced concurrent drug use were observed for the intervention compared to the standard care group. Conclusions The methadone maintenance therapy CARE intervention targeting providers in methadone maintenance clinics can improve providers’ treatment knowledge and their interaction with clients. The intervention can also reduce clients’ drug using behavior through motivational interviewing sessions conducted by trained providers. PMID:22788780

  1. The Empowering Role of Mobile Apps in Behavior Change Interventions: The Gray Matters Randomized Controlled Trial

    PubMed Central

    Nugent, Chris D; McClean, Sally I; Cleland, Ian; Tschanz, JoAnn T; Clark, Christine J; Norton, Maria C

    2016-01-01

    Background Health education and behavior change programs targeting specific risk factors have demonstrated their effectiveness in reducing the development of future diseases. Alzheimer disease (AD) shares many of the same risk factors, most of which can be addressed via behavior change. It is therefore theorized that a behavior change intervention targeting these risk factors would likely result in favorable rates of AD prevention. Objective The objective of this study was to reduce the future risk of developing AD, while in the short term promoting vascular health, through behavior change. Methods The study was an interventional randomized controlled trial consisting of subjects who were randomly assigned into either treatment (n=102) or control group (n=42). Outcome measures included various blood-based biomarkers, anthropometric measures, and behaviors related to AD risk. The treatment group was provided with a bespoke “Gray Matters” mobile phone app designed to encourage and facilitate behavior change. The app presented evidence-based educational material relating to AD risk and prevention strategies, facilitated self-reporting of behaviors across 6 behavioral domains, and presented feedback on the user’s performance, calculated from reported behaviors against recommended guidelines. Results This paper explores the rationale for a mobile phone–led intervention and details the app’s effect on behavior change and subsequent clinical outcomes. Via the app, the average participant submitted 7.3 (SD 3.2) behavioral logs/day (n=122,719). Analysis of these logs against primary outcome measures revealed that participants who improved their high-density lipoprotein cholesterol levels during the study duration answered a statistically significant higher number of questions per day (mean 8.30, SD 2.29) than those with no improvement (mean 6.52, SD 3.612), t97.74=−3.051, P=.003. Participants who decreased their body mass index (BMI) performed significantly

  2. An integrated randomized intervention to reduce behavioral and psychosocial risks: pregnancy and neonatal outcomes.

    PubMed

    Subramanian, Siva; Katz, Kathy S; Rodan, Margaret; Gantz, Marie G; El-Khorazaty, Nabil M; Johnson, Allan; Joseph, Jill

    2012-04-01

    While biomedical risks contribute to poor pregnancy and neonatal outcomes in African American (AA) populations, behavioral and psychosocial risks (BPSR) may also play a part. Among low income AA women with psychosocial risks, this report addresses the impacts on pregnancy and neonatal outcomes of an integrated education and counseling intervention to reduce BPSR, as well as the contributions of other psychosocial and biomedical risks. Subjects were low income AA women ≥18 years living in the Washington, DC, metropolitan area and seeking prenatal care. Subjects (n = 1,044) were screened for active smoking, environmental tobacco smoke exposure (ETSE), depression, or intimate partner violence (IPV) and then randomized to intervention (IG) or usual care (UCG) groups. Data were collected prenatally, at delivery, and postpartum by maternal report and medical record abstraction. Multiple imputation methodology was used to estimate missing variables. Rates of pregnancy outcomes (miscarriage, live birth, perinatal death), preterm labor, Caesarean section, sexually transmitted infection (STI) during pregnancy, preterm birth (<37 weeks), low birth weight (<2,500 g), very low birth weight (<1,500 g), small for gestational age, neonatal intensive care unit (NICU) admission, and >2 days of hospitalization were compared between IG and UCG. Logistic regression models were created to predict outcomes based on biomedical risk factors and the four psychosocial risks (smoking, ETSE, depression, and IPV) targeted by the intervention. Rates of adverse pregnancy and neonatal outcomes were high and did not differ significantly between IG and UCG. In adjusted analysis, STI during the current pregnancy was associated with IPV (OR = 1.41, 95% CI 1.04-1.91). Outcomes such as preterm labor, caesarian section in pregnancy and preterm birth, low birth weight, small for gestational age, NICU admissions and >2 day hospitalization of the infants were associated with biomedical risk

  3. Efficacy of a group-based dietary intervention for limiting gestational weight gain among obese women: a randomized trial

    PubMed Central

    Vesco, Kimberly K.; Karanja, Njeri; King, Janet C.; Gillman, Matthew W.; Leo, Michael C.; Perrin, Nancy; McEvoy, Cindy T.; Eckhardt, Cara L.; Smith, K. Sabina; Stevens, Victor J.

    2014-01-01

    Objective Observational studies suggest that minimal gestational weight gain (GWG) may optimize pregnancy outcomes for obese women. This trial tested the efficacy of a group-based weight management intervention for limiting GWG among obese women. Methods We randomized 114 obese women (BMI [mean±SD] 36.7±4.9 kg/m2) between 7–21 weeks’ (14.9±2.6) gestation to intervention (n=56) or usual care control conditions (n=58). The intervention included individualized calorie goals, advice to maintain weight within 3% of randomization and follow the Dietary Approaches to Stop Hypertension dietary pattern without sodium restriction, and attendance at weekly group meetings until delivery. Control participants received one-time dietary advice. Our three main outcomes were maternal weight change from randomization to 2 weeks postpartum and from randomization to 34 weeks gestation, and newborn large-for-gestational age (birth weight >90th percentile, LGA). Results Intervention participants gained less weight from randomization to 34 weeks gestation (5.0 vs 8.4 kg, mean difference=−3.4 kg, 95% CI [−5.1, −1.8]), and from randomization to 2 weeks postpartum (−2.6 vs +1.2 kg, mean difference=−3.8 kg, 95% CI [−5.9, −1.7]). They also had a lower proportion of LGA babies (9% vs. 26%, odds ratio=0.28, 95% CI [0.09, 0.84]). Conclusions The intervention resulted in lower GWG and lower prevalence of LGA newborns. PMID:25164259

  4. The relation between anthropometric and physiological variables and bat velocity of high-school baseball players before and after 12 weeks of training.

    PubMed

    Szymanski, David J; Szymanski, Jessica M; Schade, Ryan L; Bradford, T Jason; McIntyre, Joseph S; DeRenne, Coop; Madsen, Nels H

    2010-11-01

    The purpose of this article was to investigate the relation between anthropometric and physiological variables to linear bat swing velocity (BV) of 2 groups of high-school baseball players before and after completing a 12-week periodized resistance exercise program. Participants were randomly assigned to 1 of 2 training groups using a stratified sampling technique. Group 1 (n = 24) and group 2 (n = 25) both performed a stepwise periodized resistance exercise program and took 100 swings a day, 3 d·wk-1, for 12 weeks with their normal game bat. Group 2 performed additional rotational and full-body medicine ball exercises 3 d·wk-1 for 12 weeks. Fourteen variables were measured or calculated before and after 12 weeks of training. Anthropometric and physiological variables tested were height, body mass, percent body fat, lean body mass (LBM), dominant torso rotational strength (DTRS) and nondominant torso rotational strength (NDTRS), sequential hip-torso-arm rotational strength measured by a medicine ball hitter's throw (MBHT), estimated 1 repetition maximum parallel squat (PS) and bench press (BP), vertical jump (VJ), estimated peak power, angular hip velocity (AHV), and angular shoulder velocity (ASV). The baseball-specific skill of linear BV was also measured. Statistical analysis indicated a significant moderately high positive relationship (p ≤ 0.05) between prelinear BV and pre-NDTRS for group 1, pre-LBM, DTRS, NDTRS, peak power, and ASV for group 2; moderate positive relationship between prelinear BV and preheight, LBM, DTRS, peak power, BP, PS, and ASV for group 1, preheight, body mass, MBHT, BP, and PS for group 2. Significantly high positive relationships were indicated between postlinear BV and post-NDTRS for group 1, post-DTRS and NDTRS for group 2; moderately high positive relationships between postlinear BV and post-LBM, DTRS, peak power, BP, and PS for group 1, postheight, LBM, VJ, peak power for group 2; moderate positive relationships between

  5. The relation between anthropometric and physiological variables and bat velocity of high-school baseball players before and after 12 weeks of training.

    PubMed

    Szymanski, David J; Szymanski, Jessica M; Schade, Ryan L; Bradford, T Jason; McIntyre, Joseph S; DeRenne, Coop; Madsen, Nels H

    2010-11-01

    The purpose of this article was to investigate the relation between anthropometric and physiological variables to linear bat swing velocity (BV) of 2 groups of high-school baseball players before and after completing a 12-week periodized resistance exercise program. Participants were randomly assigned to 1 of 2 training groups using a stratified sampling technique. Group 1 (n = 24) and group 2 (n = 25) both performed a stepwise periodized resistance exercise program and took 100 swings a day, 3 d·wk-1, for 12 weeks with their normal game bat. Group 2 performed additional rotational and full-body medicine ball exercises 3 d·wk-1 for 12 weeks. Fourteen variables were measured or calculated before and after 12 weeks of training. Anthropometric and physiological variables tested were height, body mass, percent body fat, lean body mass (LBM), dominant torso rotational strength (DTRS) and nondominant torso rotational strength (NDTRS), sequential hip-torso-arm rotational strength measured by a medicine ball hitter's throw (MBHT), estimated 1 repetition maximum parallel squat (PS) and bench press (BP), vertical jump (VJ), estimated peak power, angular hip velocity (AHV), and angular shoulder velocity (ASV). The baseball-specific skill of linear BV was also measured. Statistical analysis indicated a significant moderately high positive relationship (p ≤ 0.05) between prelinear BV and pre-NDTRS for group 1, pre-LBM, DTRS, NDTRS, peak power, and ASV for group 2; moderate positive relationship between prelinear BV and preheight, LBM, DTRS, peak power, BP, PS, and ASV for group 1, preheight, body mass, MBHT, BP, and PS for group 2. Significantly high positive relationships were indicated between postlinear BV and post-NDTRS for group 1, post-DTRS and NDTRS for group 2; moderately high positive relationships between postlinear BV and post-LBM, DTRS, peak power, BP, and PS for group 1, postheight, LBM, VJ, peak power for group 2; moderate positive relationships between

  6. Internet Mindfulness Meditation Intervention for the General Public: Pilot Randomized Controlled Trial

    PubMed Central

    2016-01-01

    Background Mindfulness meditation interventions improve a variety of health conditions and quality of life, are inexpensive, easy to implement, have minimal if any side effects, and engage patients to take an active role in their treatment. However, the group format can be an obstacle for many to take structured meditation programs. Internet Mindfulness Meditation Intervention (IMMI) is a program that could make mindfulness meditation accessible to all people who want and need to receive it. However, the feasibility, acceptability, and ability of IMMI to increase meditation practice have yet to be evaluated. Objectives The primary objectives of this pilot randomized controlled study were to (1) evaluate the feasibility and acceptability of IMMIs in the general population and (2) to evaluate IMMI’s ability to change meditation practice behavior. The secondary objective was to collect preliminary data on health outcomes. Methods Potential participants were recruited from online and offline sources. In a randomized controlled trial, participants were allocated to IMMI or Access to Guided Meditation arm. IMMI included a 1-hour Web-based training session weekly for 6 weeks along with daily home practice guided meditations between sessions. The Access to Guided Meditation arm included a handout on mindfulness meditation and access to the same guided meditation practices that the IMMI participants received, but not the 1-hour Web-based training sessions. The study activities occurred through the participants’ own computer and Internet connection and with research-assistant telephone and email contact. Feasibility and acceptability were measured with enrollment and completion rates and participant satisfaction. The ability of IMMI to modify behavior and increase meditation practice was measured by objective adherence of daily meditation practice via Web-based forms. Self-report questionnaires of quality of life, self-efficacy, depression symptoms, sleep disturbance

  7. Effects of 12-week proprioception training program on postural stability, gait, and balance in older adults: a controlled clinical trial.

    PubMed

    Martínez-Amat, Antonio; Hita-Contreras, Fidel; Lomas-Vega, Rafael; Caballero-Martínez, Isabel; Alvarez, Pablo J; Martínez-López, Emilio

    2013-08-01

    The purpose of this study was to evaluate the effect of a 12-week-specific proprioceptive training program on postural stability, gait, balance, and fall prevention in adults older than 65 years. The present study was a controlled clinical trial. Forty-four community dwelling elderly subjects (61-90 years; mean age, 78.07 ± 5.7 years) divided into experimental (n = 20) and control (n = 24) groups. The participants performed the Berg balance test before and after the training program, and we assessed participants' gait, balance, and the risk of falling, using the Tinetti scale. Medial-lateral plane and anterior-posterior plane displacements of the center of pressure, Sway area, length and speed, and the Romberg quotient about surface, speed, and distance were calculated in static posturography analysis (EPS pressure platform) under 2 conditions: eyes open and eyes closed. After a first clinical evaluation, patients were submitted to 12 weeks proprioception training program, 2 sessions of 50 minutes every week. This program includes 6 exercises with the BOSU and Swiss ball as unstable training tools that were designed to program proprioceptive training. The training program improved postural balance of older adults in mediolateral plane with eyes open (p < 0.05) and anterior-posterior plane with eyes closed (p < 0.01). Significant improvements were observed in Romberg quotient about surface (p < 0.05) and speed (p < 0.01) but not about distance (p > 0.05). After proprioception training, gait (Tinetti), and balance (Berg) test scores improved 14.66% and 11.47% respectively. These results show that 12 weeks proprioception training program in older adults is effective in postural stability, static, and dynamic balance and could lead to an improvement in gait and balance capacity, and to a decrease in the risk of falling in adults aged 65 years and older.

  8. Intervention to Improve Follow-up for Abnormal Papanicolaou Tests: A Randomized Clinical Trial

    PubMed Central

    Breitkopf, Carmen Radecki; Dawson, Lauren; Grady, James J.; Breitkopf, Daniel M.; Nelson-Becker, Carolyn; Snyder, Russell R.

    2014-01-01

    Objective To evaluate the effect of a theory-based, culturally-targeted intervention on adherence to follow-up among low-income and minority women who experience an abnormal Pap test. Methods 5,049 women were enrolled and underwent Pap testing. Of these, 378 had an abnormal result and 341 (90%) were randomized to 1 of 3 groups to receive their results: Intervention (I): culturally-targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling; Active Control (AC): non-targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling; or Standard Care Only (SCO). The primary outcome was attendance at the initial follow-up appointment. Secondary outcomes included delay in care, completion of care at 18 months, state anxiety (STAI Y-6), depressive symptoms (CES-D), and distress (CDDQ). Anxiety was assessed at enrollment, notification of results, and 7–14 days later with the CDDQ and CES-D. Results 299 women were included in intent-to-treat analyses. Adherence rates were 60% (I), 54% (AC), and 58% (SCO), p=0.73. Completion rates were 39% (I) and 35% in the AC and SCO groups, p=0.77. Delay in care (in days) was (M ±SD): 58 ±75 (I), 69 ±72 (AC), and 54 ±75 (SCO), p=0.75. Adherence was associated with higher anxiety at notification, p<0.01 while delay <90 days (vs. 90+) was associated with greater perceived personal responsibility, p<0.05. Women not completing their care (vs. those who did) had higher CES-D scores at enrollment, p<0.05. Conclusions A theory-based, culturally-targeted message was not more effective than a non-targeted message or standard care in improving behavior. PMID:23730719

  9. A Randomized Clinical Trial of a Telephone Depression Intervention to Reduce Employee Presenteeism and Absenteeism

    PubMed Central

    Lerner, Debra; Adler, David A.; Rogers, William H.; Chang, Hong; Greenhill, Annabel; Cymerman, Elina; Azocar, Francisca

    2015-01-01

    Objectives The study tested an intervention aimed at improving work functioning among middle-aged and older adults with depression and work limitations. Methods A randomized clinical trial allocated an initial sample of 431 eligible employed adults (age ≥45) to a work-focused intervention (WFI) or usual care. Inclusion criteria were depression as measured by the Patient Health Questionnaire–9 (PHQ-9) and at-work limitations indicated by a productivity loss score ≥5% on the Work Limitations Questionnaire (WLQ). Study sites included 19 employers and five related organizations. Telephone-based counseling provided three integrated modalities: care coordination, cognitive-behavioral therapy strategy development, and work coaching and modification. Effectiveness (change in productivity loss scores from preintervention to four months postintervention) was tested with mixed models adjusted for confounders. Secondary outcomes included change in WLQ work performance scales, self-reported absences, and depression. Results Of 1,227 eligible employees (7% of screened), 431 (35%) enrolled and 380 completed the study (12% attrition). At-work productivity loss improved 44% in the WFI group versus 13% in usual care (difference in change, p<.001). WFI group scores on the four WLQ scales improved 44% to 47%, significantly better than in usual care (p<.001 for each scale). Absence days declined by 53% in the WFI group versus 13% in usual care (difference in change, p<.001). Mean PHQ-9 depression symptom severity scores declined 51% for WFI versus 26% for usual care (difference in change, p<.001). Conclusions The WFI was more effective than usual care at four-month follow-up. Given increasing efforts to provide more patient-centered, value-based care, the WFI could be an important resource. PMID:25726984

  10. Project QUIT (Quit Using Drugs Intervention Trial): A randomized controlled trial of a primary care-based multi-component brief intervention to reduce risky drug use

    PubMed Central

    Gelberg, Lillian; Andersen, Ronald M.; Afifi, Abdelmonem A.; Leake, Barbara D.; Arangua, Lisa; Vahidi, Mani; Singleton, Kyle; Yacenda-Murphy, Julia; Shoptaw, Steve; Fleming, Michael F.; Baumeister, Sebastian E.

    2015-01-01

    Aims To assess the effect of a multi-component primary care (PC)-delivered BI for reducing risky drug use (RDU) among patients identified by screening. Design Multicenter single-blind two-arm randomized controlled trial of patients enrolled from February 2011 to November 2012 with 3-month follow-up. Randomization and allocation to trial group were computer-generated. Setting Primary care waiting rooms of 5 federally qualified health centers (FQHCs) in Los Angeles County (LAC), USA. Participants 334 adult primary care patients (171 intervention; 163 control) with RDU scores (4–26) on the WHO Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) self-administered on tablet PCs; 261 (78%) completed follow-up. Mean age was 41.7 years; 63% were male; 38% were Caucasian. Intervention(s) and Measurement Intervention patients received brief (typically 3–4 minutes) clinician advice to quit/reduce their drug use reinforced by a video doctor message, health education booklet, and up to two 20–30 minute follow-up telephone drug use coaching sessions. Controls received usual care and cancer screening information. Primary outcome was patient self-reported use of highest scoring drug (HSD) at follow-up. Findings Intervention and control patients reported equivalent baseline HSD use; at follow-up, after adjustment for covariates in a linear regression model, intervention patients reported using their HSD an average of 2.21 fewer days in the previous month than controls (p<0.005). No compensatory increases in use of other measured substances were found (p>0.10). Conclusions A clinician-delivered brief intervention with follow-up counseling calls may decrease drug use among risky users compared with usual care in low-income community health centers of Los Angeles County, USA. PMID:26471159

  11. A Web-Based Sexual Violence Bystander Intervention for Male College Students: Randomized Controlled Trial

    PubMed Central

    Vivolo-Kantor, Alana; Hardin, James; Berkowitz, Alan

    2014-01-01

    Background Bystander intervention approaches offer promise for reducing rates of sexual violence on college campuses. Most interventions are in-person small-group formats, which limit their reach and reduce their overall public health impact. Objective This study evaluated the efficacy of RealConsent, a Web-based bystander approach to sexual violence prevention, in enhancing prosocial intervening behaviors and preventing sexual violence perpetration. Methods A random probability sample of 743 male undergraduate students (aged 18 to 24 years) attending a large, urban university located in the southeastern United States was recruited online and randomized to either RealConsent (n=376) or a Web-based general health promotion program (n=367). Participants were surveyed online at baseline, postintervention, and 6-months postintervention. RealConsent was delivered via a password-protected Web portal that contained six 30-minute media-based and interactive modules covering knowledge of informed consent, communication skills regarding sex, the role of alcohol and male socialization in sexual violence, empathy for rape victims, and bystander education. Primary outcomes were self-reported prosocial intervening behaviors and sexual violence perpetration. Secondary outcomes were theoretical mediators (eg, knowledge, attitudes). Results At 6-month follow-up RealConsent participants intervened more often (P=.04) and engaged in less sexual violence perpetration (P=.04) compared to controls. In addition, RealConsent participants reported greater legal knowledge of sexual assault (P<.001), greater knowledge of effective consent (P<.001), less rape myths (P<.001), greater empathy for rape victims (P<.001), less negative date rape attitudes (P<.001), less hostility toward women (P=.01), greater intentions to intervene (P=.04), less hyper-gender ideology (P<.001), less positive outcome expectancies for nonconsensual sex (P=.03), more positive outcome expectancies for intervening (P

  12. Reducing the Risk of Internalizing Symptoms among High-risk Hispanic Youth through a Family Intervention: A Randomized Controlled Trial.

    PubMed

    Perrino, Tatiana; Pantin, Hilda; Huang, Shi; Brincks, Ahnalee; Brown, C Hendricks; Prado, Guillermo

    2016-03-01

    Familias Unidas is an intervention that has been found to be efficacious in preventing and reducing substance use, sexual risk, and problem behaviors among Hispanic youth. While it does not specifically target youth internalizing symptoms, the intervention works to strengthen parenting and family factors associated with reduced risk of internalizing symptoms (i.e., depression, anxiety symptoms). This study examines the effects of Familias Unidas on internalizing symptoms among high-risk youth, as well as the role of family level factors in the intervention's effects. A total of 242 12-17-year-old Hispanic youth with a history of delinquency and their primary caregivers were recruited from the school and juvenile justice systems, and randomly assigned to the Familias Unidas intervention or community practice control. A linear latent growth model was used to examine intervention effects on the trajectory of adolescent internalizing symptoms from baseline to 6 and 12 months post-baseline. Results show that the Familias Unidas intervention was more efficacious than control in reducing youth internalizing symptoms. Baseline youth externalizing and internalizing symptoms did not moderate the intervention's effects on the trajectory of youth internalizing symptoms. While parent-adolescent communication did not significantly moderate the intervention's effects, changes in parent-adolescent communication mediated the intervention's effects on internalizing symptoms, showing stronger intervention effects for youth starting with poorer communication. Findings indicate that the Familias Unidas intervention can reduce internalizing symptoms among high-risk Hispanic youth, and that improving parent-youth communication, a protective family factor, may be one of the mechanisms by which the intervention influences youth internalizing symptoms. PMID:25683164

  13. Reducing the Risk of Internalizing Symptoms among High-risk Hispanic Youth through a Family Intervention: A Randomized Controlled Trial.

    PubMed

    Perrino, Tatiana; Pantin, Hilda; Huang, Shi; Brincks, Ahnalee; Brown, C Hendricks; Prado, Guillermo

    2016-03-01

    Familias Unidas is an intervention that has been found to be efficacious in preventing and reducing substance use, sexual risk, and problem behaviors among Hispanic youth. While it does not specifically target youth internalizing symptoms, the intervention works to strengthen parenting and family factors associated with reduced risk of internalizing symptoms (i.e., depression, anxiety symptoms). This study examines the effects of Familias Unidas on internalizing symptoms among high-risk youth, as well as the role of family level factors in the intervention's effects. A total of 242 12-17-year-old Hispanic youth with a history of delinquency and their primary caregivers were recruited from the school and juvenile justice systems, and randomly assigned to the Familias Unidas intervention or community practice control. A linear latent growth model was used to examine intervention effects on the trajectory of adolescent internalizing symptoms from baseline to 6 and 12 months post-baseline. Results show that the Familias Unidas intervention was more efficacious than control in reducing youth internalizing symptoms. Baseline youth externalizing and internalizing symptoms did not moderate the intervention's effects on the trajectory of youth internalizing symptoms. While parent-adolescent communication did not significantly moderate the intervention's effects, changes in parent-adolescent communication mediated the intervention's effects on internalizing symptoms, showing stronger intervention effects for youth starting with poorer communication. Findings indicate that the Familias Unidas intervention can reduce internalizing symptoms among high-risk Hispanic youth, and that improving parent-youth communication, a protective family factor, may be one of the mechanisms by which the intervention influences youth internalizing symptoms.

  14. Bereaved Adults with Intellectual Disabilities: A Combined Randomized Controlled Trial and Qualitative Study of Two Community-Based Interventions

    ERIC Educational Resources Information Center

    Dowling, S.; Hubert, J.; White, S.; Hollins, S.

    2006-01-01

    Background: Bereaved adults with intellectual disabilities are known to experience prolonged and atypical grief which is often unrecognized. The aim of this project was to find an effective way to improve mental health and behavioural outcomes. Methods: Subjects were randomized to two different therapeutic interventions: traditional counselling by…

  15. High School Students with Reading Comprehension Difficulties: Results of a Randomized Control Trial of a Two-Year Reading Intervention

    ERIC Educational Resources Information Center

    Vaughn, Sharon; Roberts, Greg; Wexler, Jade; Vaughn, Michael G.; Fall, Anna-Mária; Schnakenberg, Jennifer B.

    2015-01-01

    A 2-year, randomized control trial with 9th to 10th grade students with significant reading problems was provided for 50 minutes a day in small groups. Comparison students were provided an elective class and treatment students the reading intervention. Students were identified as demonstrating reading difficulties through failure on their state…

  16. Intervention for First Graders with Limited Number Knowledge: Large-Scale Replication of a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Gersten, Russell; Rolfhus, Eric; Clarke, Ben; Decker, Lauren E.; Wilkins, Chuck; Dimino, Joseph

    2015-01-01

    Replication studies are extremely rare in education. This randomized controlled trial (RCT) is a scale-up replication of Fuchs et al., which in a sample of 139 found a statistically significant positive impact for Number Rockets, a small-group intervention for at-risk first graders that focused on building understanding of number operations. The…

  17. Outcomes of a Telehealth Intervention for Homebound Older Adults with Heart or Chronic Respiratory Failure: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Gellis, Zvi D.; Kenaley, Bonnie; McGinty, Jean; Bardelli, Ellen; Davitt, Joan; Ten Have, Thomas

    2012-01-01

    Purpose: Telehealth care is emerging as a viable intervention model to treat complex chronic conditions, such as heart failure (HF) and chronic obstructive pulmonary disease (COPD), and to engage older adults in self-care disease management. Design and Methods: We report on a randomized controlled trial examining the impact of a multifaceted…

  18. Extended Follow-Up of a Randomized Controlled Trial of the Lidcombe Program of Early Stuttering Intervention

    ERIC Educational Resources Information Center

    Jones, Mark; Onslow, Mark; Packman, Ann; O'Brian, Sue; Hearne, Anna; Williams, Shelley; Ormond, Tika; Schwarz, Ilsa

    2008-01-01

    Background: In the Lidcombe Program of Early Stuttering Intervention, parents present verbal contingencies for stutter-free and stuttered speech in everyday situations. A previous randomized controlled trial of the programme with preschool-age children from 2005, conducted in two public speech clinics in New Zealand, showed that the odds of…

  19. Randomized Trial Outcomes of a TTM-Tailored Condom Use and Smoking Intervention in Urban Adolescent Females

    ERIC Educational Resources Information Center

    Redding, Colleen A.; Prochaska, James O.; Armstrong, Kay; Rossi, Joseph S.; Hoeppner, Bettina B.; Sun, Xiaowu; Kobayashi, Hisanori; Yin, Hui-Qing; Coviello, Donna; Evers, Kerry; Velicer, Wayne F.

    2015-01-01

    Smoking and sexual risk behaviors in urban adolescent females are prevalent and problematic. Family planning clinics reach those who are at most risk. This randomized effectiveness trial evaluated a transtheoretical model (TTM)-tailored intervention to increase condom use and decrease smoking. At baseline, a total of 828 14- to 17-year-old females…

  20. Randomized Controlled Trial of the Prevent-Teach-Reinforce (PTR) Tertiary Intervention for Students with Problem Behaviors: Preliminary Outcomes

    ERIC Educational Resources Information Center

    Iovannone, Rose; Greenbaum, Paul E.; Wang, Wei; Kincaid, Don; Dunlap, Glen; Strain, Phil

    2009-01-01

    Although there is literature supporting the effectiveness of tertiary behavioral supports, the majority of the studies have been conducted with single-subject designs. The Prevent-Teach-Reinforce (PTR) model is a standardized model of a school-based tertiary intervention. This study reports initial results from a randomized controlled trial to…

  1. Unanticipated Effect of a Randomized Peer Network Intervention on Depressive Symptoms among Young Methamphetamine Users in Thailand

    ERIC Educational Resources Information Center

    German, D.; Sutcliffe, C. G.; Sirirojn, B.; Sherman, S. G.; Latkin, C. A.; Aramrattana, A.; Celentano, D. D.

    2012-01-01

    We examined the effect on depressive symptoms of a peer network-oriented intervention effective in reducing sexual risk behavior and methamphetamine (MA) use. Current Thai MA users aged 18-25 years and their drug and/or sex network members enrolled in a randomized controlled trial with 4 follow-ups over 12 months. A total of 415 index participants…

  2. Improvement in Personal Meaning Mediates the Effects of a Life Review Intervention on Depressive Symptoms in a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Westerhof, Gerben J.; Bohlmeijer, Ernst T.; van Beljouw, Ilse M. J.; Pot, Anne Margriet

    2010-01-01

    Purpose: The purpose of the study was to assess the impact of a life review intervention on personal meaning in life and the mediating effect of personal meaning on depressive symptoms as the primary outcome of this form of indicated prevention. Design and Methods: A multicenter randomized controlled trial was conducted with one group of older…

  3. Randomized Trial of Group Interventions to Reduce HIV/STD Risk and Change Theoretical Mediators among Detained Adolescents

    ERIC Educational Resources Information Center

    Schmiege, Sarah J.; Broaddus, Michelle R.; Levin, Michael; Bryan, Angela D.

    2009-01-01

    Criminally involved adolescents engage in high levels of risky sexual behavior and alcohol use, and alcohol use may contribute to lack of condom use. Detained adolescents (n = 484) were randomized to (1) a theory-based sexual risk reduction intervention (GPI), (2) the GPI condition with a group-based alcohol risk reduction motivational enhancement…

  4. Effects of a Psychological Intervention in a Primary Health Care Center for Caregivers of Dependent Relatives: A Randomized Trial

    ERIC Educational Resources Information Center

    Rodriguez-Sanchez, Emiliano; Patino-Alonso, Maria C.; Mora-Simon, Sara; Gomez-Marcos, Manuel A.; Perez-Penaranda, Anibal; Losada-Baltar, Andres; Garcia-Ortiz, Luis

    2013-01-01

    Purpose: To assess, in the context of Primary Health Care (PHC), the effect of a psychological intervention in mental health among caregivers (CGs) of dependent relatives. Design and Methods: Randomized multicenter, controlled clinical trial. The 125 CGs included in the trial were receiving health care in PHC. Inclusion criteria: Identifying…

  5. To Wait in Tier 1 or Intervene Immediately: A Randomized Experiment Examining First-Grade Response to Intervention in Reading

    ERIC Educational Resources Information Center

    Al Otaiba, Stephanie; Connor, Carol M.; Folsom, Jessica S.; Wanzek, Jeanne; Greulich, Luana; Schatschneider, Christopher; Wagner, Richard K.

    2014-01-01

    This randomized controlled experiment compared the efficacy of two response-to-intervention (RTI) models--typical RTI and dynamic RTI--and included 34 first-grade classrooms (n = 522 students) across 10 socioeconomically and culturally diverse schools. Typical RTI was designed to follow the two-stage RTI decision rules that wait to assess response…

  6. Improving the Design of Science Intervention Studies: An Empirical Investigation of Design Parameters for Planning Group Randomized Trials

    ERIC Educational Resources Information Center

    Westine, Carl; Spybrook, Jessaca

    2013-01-01

    The capacity of the field to conduct power analyses for group randomized trials (GRTs) of educational interventions has improved over the past decade (Authors, 2009). However, a power analysis depends on estimates of design parameters. Hence it is critical to build the empirical base of design parameters for GRTs across a variety of outcomes and…

  7. A Randomized Controlled Trial of a Behavioral Economic Supplement to Brief Motivational Interventions for College Drinking

    PubMed Central

    Murphy, James G.; Dennhardt, Ashley A.; Skidmore, Jessica R.; Borsari, Brian; Barnett, Nancy P.; Colby, Suzanne M.; Martens, Matthew P.

    2012-01-01

    Objective Behavioral economic theory suggests that a reduction in substance use is most likely when there is an increase in rewarding substance-free activities. The goal of this randomized controlled clinical trial was to evaluate the incremental efficacy of a novel behavioral economic supplement (Substance-Free Activity Session, SFAS) to a standard alcohol brief motivational interviewing (BMI) session for heavy drinking college students. Method Participants were 82 first-year college students (50% female, 81.7% White/European American, Mean age = 18.5 years, SD = .71) who reported two or more past-month heavy drinking episodes. After completing a baseline assessment and an individual alcohol-focused BMI, participants were randomized to either the SFAS or to a Relaxation Training (RT) control session. The SFAS was delivered in an MI style and attempted to increase the salience of delayed academic and career rewards and the patterns of behavior leading to those rewards. Results The combination of an alcohol BMI plus the SFAS was associated with significantly greater reductions in alcohol problems compared to an alcohol BMI plus RT at the 1-month and 6-month follow-up assessments (p = .015, ηp2 = .07), an effect that was partially mediated by increases in protective behavioral strategies. BMI + SFAS was also associated with greater reductions in heavy drinking among participants who at baseline reported low levels of substance-free reinforcement or symptoms of depression. Conclusion These results are consistent with behavioral economic theory and suggest that a single session focused on increasing engagement in alternatives to drinking can enhance the effects of brief alcohol interventions. PMID:22663899

  8. A Randomized Controlled Trial of a Behavioral Economic Intervention for Alcohol and Marijuana Use

    PubMed Central

    Yurasek, Ali M.; Dennhardt, Ashley A.; Murphy, James G.

    2015-01-01

    Objective A recent study demonstrated that a single 50-minute supplemental session that targeted the behavioral economic mechanisms of substance-free reinforcement and delayed reward discounting (Substance Free Activity Session: SFAS) enhanced the efficacy of a standard alcohol brief motivational intervention (BMI) for college drinkers. The purpose of the current study was to conduct a randomized controlled trial intended to replicate and extend the aforementioned study by focusing on both drug and alcohol misuse and reducing session length in order to enhance dissemination potential. Method Participants were 97 college students (58.8% women; 59.8% white/Caucasian & 30.9% African American; M age = 20.01, SD = 2.23) who reported at least one heavy drinking episode in the past month (M = 4.01 episodes). Most participants (62%) reported recent marijuana use (M = 12.22 days of past-month use). After completing a baseline assessment and an individual 30-minute alcohol-focused BMI, participants were randomized to either the 30-minute SFAS session or an education control session. Results A series of mixed model intent-to-treat analyses revealed that both groups reported drinking reductions and that participants in the BMI+SFAS group reported fewer days using marijuana at the 6-month follow-up. Conclusions These results do not support the incremental efficacy of the briefer SFAS for reducing drinking but suggest that it may improve marijuana outcomes. Future research is needed to identify the ideal length and timing of the SFAS supplement to BMIs. PMID:26191947

  9. The Ontogeny of Face Recognition: Eye Contact and Sweet Taste Induce Face Preference in 9- and 12-Week-Old Human Infants.

    ERIC Educational Resources Information Center

    Blass, Elliott M.; Camp, Carole A.

    2001-01-01

    Calm or crying 9- and 12-week-olds sat facing a researcher who gazed into their eyes or at their forehead and delivered either a sucrose solution or pacifier or delivered nothing. Found that combining sweet taste and eye contact was necessary and sufficient for calm 9- and 12-week-olds to form a preference for the researcher, but not for crying…

  10. An Internet-Based Intervention to Promote Mental Fitness for Mildly Depressed Adults: Randomized Controlled Trial

    PubMed Central

    Haverman, Merel; Kramer, Jeannet; Westerhof, Gerben J; Riper, Heleen; Walburg, Jan A; Boon, Brigitte; Bohlmeijer, Ernst

    2013-01-01

    Background Depression is a worldwide problem warranting global solutions to tackle it. Enhancing well-being has benefits in its own right and could be a good strategy for preventing depression. Providing well-being interventions via the Internet may have synergetic effects. Objective Psyfit (“mental fitness online”) is a fully automated self-help intervention to improve well-being based on positive psychology. This study examines the clinical effects of this intervention. Methods We conducted a 2-armed randomized controlled trial that compared the effects of access to Psyfit for 2 months (n=143) to a waiting-list control condition (n=141). Mild to moderately depressed adults in the general population seeking self-help were recruited. Primary outcome was well-being measured by Mental Health Continuum-Short Form (MHC-SF) and WHO Well-being Index (WHO-5); secondary outcomes were depressive symptoms, anxiety, vitality, and general health measured by Center for Epidemiological Studies Depression Scale (CES-D), Hospital Anxiety and Depression Scale Anxiety subscale (HADS-A), and Medical Outcomes Study-Short Form (MOS-SF) vitality and general health subscales, respectively. Online measurements were taken at baseline, 2 months, and 6 months after baseline. Results The dropout rate was 37.8% in the Psyfit group and 22.7% in the control group. At 2-month follow-up, Psyfit tended to be more effective in enhancing well-being (nonsignificantly for MHC-SF: Cohen’s d=0.27, P=.06; significantly for WHO-5: Cohen’s d=0.31, P=.01), compared to the waiting-list control group. For the secondary outcomes, small but significant effects were found for general health (Cohen’s d=0.14, P=.01), vitality (d=0.22, P=.02), anxiety symptoms (Cohen’s d=0.32, P=.001), and depressive symptoms (Cohen’s d=0.36, P=.02). At 6-month follow-up, there were no significant effects on well-being (MHC-SF: Cohen’s d=0.01, P=.90; WHO-5: Cohen’s d=0.26, P=.11), whereas depressive symptoms

  11. High School Students With Reading Comprehension Difficulties: Results of a Randomized Control Trial of a Two-Year Reading Intervention.

    PubMed

    Vaughn, Sharon; Roberts, Greg; Wexler, Jade; Vaughn, Michael G; Fall, Anna-Mária; Schnakenberg, Jennifer B

    2015-01-01

    A 2-year, randomized control trial with 9th to 10th grade students with significant reading problems was provided for 50 minutes a day in small groups. Comparison students were provided an elective class and treatment students the reading intervention. Students were identified as demonstrating reading difficulties through failure on their state accountability test and were randomly assigned to one of three treatment conditions and a business as usual (BAU) condition: reading without dropout prevention, reading with dropout prevention, dropout prevention without reading, or a BAU condition. Findings from the 2-year reading intervention (reading with and without dropout prevention combined and BAU) are reported in this article. Students in reading treatment compared to students in BAU demonstrated significant gains on reading comprehension (effect size = .43), and improved reading was associated with better grades in social studies. Findings from this study provide a rationale for further implementation and investigation of intensive intervention for high school students with reading difficulties.

  12. A water-based training program that includes perturbation exercises improves speed of voluntary stepping in older adults: a randomized controlled cross-over trial.

    PubMed

    Elbar, Ori; Tzedek, Irit; Vered, Elisha; Shvarth, Gali; Friger, Michael; Melzer, Itshak

    2013-01-01

    This study evaluated the effects of a water exercise training program that includes perturbation exercises (WEP) to improve the speed of voluntary stepping reaction in older adults. Speed of voluntary stepping considered as an important skill to prevent a fall when balance is lost. In a single-blinded randomized controlled trial with a crossover design thirty-six independent old adults (64-88 years old) were divided into two groups. Group A received WEP for the first 12 weeks, followed by no intervention for the second 12 weeks. Group B did not receive intervention for the first 12 weeks and received WEP for the second 12 weeks. Voluntary Step Execution Test and postural stability in upright standing (eyes open and closed conditions) were measured at baseline, 12 weeks, and 24 weeks. A significant interaction effect between group and time was found for the step execution, due to improvement in initiation phase and swing phase durations in the WEP group. Also significant improvement in postural stability parameters in eyes open and closed conditions is noted. The present results indicate that the primary benefit of WEP that include perturbations to induce stepping, was a reduction in voluntary stepping times. The WEP generalized to a better control of balance in up-right standing. PMID:22951028

  13. A water-based training program that includes perturbation exercises improves speed of voluntary stepping in older adults: a randomized controlled cross-over trial.

    PubMed

    Elbar, Ori; Tzedek, Irit; Vered, Elisha; Shvarth, Gali; Friger, Michael; Melzer, Itshak

    2013-01-01

    This study evaluated the effects of a water exercise training program that includes perturbation exercises (WEP) to improve the speed of voluntary stepping reaction in older adults. Speed of voluntary stepping considered as an important skill to prevent a fall when balance is lost. In a single-blinded randomized controlled trial with a crossover design thirty-six independent old adults (64-88 years old) were divided into two groups. Group A received WEP for the first 12 weeks, followed by no intervention for the second 12 weeks. Group B did not receive intervention for the first 12 weeks and received WEP for the second 12 weeks. Voluntary Step Execution Test and postural stability in upright standing (eyes open and closed conditions) were measured at baseline, 12 weeks, and 24 weeks. A significant interaction effect between group and time was found for the step execution, due to improvement in initiation phase and swing phase durations in the WEP group. Also significant improvement in postural stability parameters in eyes open and closed conditions is noted. The present results indicate that the primary benefit of WEP that include perturbations to induce stepping, was a reduction in voluntary stepping times. The WEP generalized to a better control of balance in up-right standing.

  14. Home-based community health worker intervention to reduce pesticide exposures to farmworkers' children: A randomized-controlled trial.

    PubMed

    Salvatore, Alicia L; Castorina, Rosemary; Camacho, José; Morga, Norma; López, Jesús; Nishioka, Marcia; Barr, Dana B; Eskenazi, Brenda; Bradman, Asa

    2015-01-01

    We conducted a randomized-controlled trial of a home-based intervention to reduce pesticide exposures to farmworkers' children in Monterey County, California (n=116 families). The intervention consisted of three home-based educational sessions delivered by community health workers in Spanish. Measurements of organophosphate (OP) insecticide metabolites in child urine (n=106) and pesticides in home floor wipes (n=103) were collected before and after the intervention. Median child urinary dialkyl phosphate (DAP) metabolite levels were slightly lower among the intervention group children at follow-up compared with baseline, albeit nonsignificantly. DAP metabolite levels in the control group children were markedly higher at follow-up compared with baseline. In adjusted models, intervention participation was associated with a 51% decrease in total DAP metabolite levels. Carbaryl, chlorpyrifos, cypermethrin, dacthal, diazinon, malathion, and trans-permethrin were commonly detected in the floor wipes. In adjusted models, intervention participation was significantly associated with a 37% decrease in trans-permethrin floor wipe levels in homes, but not OP or other agricultural pesticides. In summary, intervention group children had slightly reduced pesticide exposures, whereas child exposures were higher among the control group. Additional intervention studies evaluating methods to reduce pesticide exposures to farmworker families and children are needed.

  15. A Mood Management Intervention in an Internet Stop Smoking Randomized Controlled Trial Does Not Prevent Depression: A Cautionary Tale

    PubMed Central

    Schueller, Stephen M.; Pérez-Stable, Eliseo J.; Muñoz, Ricardo F.

    2014-01-01

    Smoking and depression are related, and mood management interventions included in smoking cessation interventions can increase smoking abstinence rates. Could a mood management intervention embedded in an Internet-based smoking cessation intervention prevent major depressive episodes? Spanish- and English-speaking smokers (N = 17,430) from 191 countries were randomized to one of four online self-help intervention conditions (two with mood management). We analyzed preventive effects among those participants without a major depressive episode at baseline. The mood management intervention did not reduce the incidence of major depressive episodes in the following 12 months. However, we found a mood management by depression risk interaction (OR = 1.77, p = .004), such that high-risk participants who received the mood management intervention had an increased occurrence of major depressive episodes (32.8% vs. 26.6%), but not low-risk participants (11.6% vs. 10.8%). Further research on whether mood management interventions may have deleterious effects on subsets of smokers appears warranted. PMID:25525565

  16. Two Fully Automated Web-Based Interventions for Risky Alcohol Use: Randomized Controlled Trial

    PubMed Central

    Strüber, Evelin

    2013-01-01

    Background Excessive alcohol use is a widespread problem in many countries, especially among young people. To reach more people engaging in high-risk drinking behaviors, a number of online programs have been developed in recent years. Change Your Drinking is a German, diary-based, fully automated alcohol intervention. In 2010, a revised version of the program was developed. It is more strongly oriented to concepts of relapse prevention than the previous version, includes more feedback, and offers more possibilities to interact with the program. Moreover, the program duration was extended from 10 to 14 days. Objective This paper examines whether the revised version of Change Your Drinking is more effective in reducing alcohol consumption than the original version. Methods The effectiveness of both program versions was compared in a Web-based, open, randomized controlled trial with follow-up surveys 6 weeks and 3 months after registration. Participants were recruited online and were randomly assigned to either the original or the revised version of Change Your Drinking. The following self-assessed outcomes were used: alcohol use days, alcohol intake in grams, the occurrence of binge drinking and risky drinking (all referring to the past 7 days prior to each survey), and the number of alcohol-related problems. Results A total of 595 participants were included in the trial. Follow-up rates were 58.0% after 6 weeks and 49.6% after 3 months. No significant group differences were found in any of the outcomes. However, the revised version was used by more participants (80.7%) than the original version (55.7%). A significant time effect was detected in all outcomes (alcohol use days: P=.002; alcohol intake in grams: P<.001; binge drinking: P<.001; alcohol-related problems: P=.004; risky drinking: P<.001). Conclusions The duration and complexity of the program played a minor role in reducing alcohol consumption. However, differences in program usage between the versions

  17. The Effects of Music Intervention on Background Pain and Anxiety in Burn Patients: Randomized Controlled Clinical Trial.

    PubMed

    Najafi Ghezeljeh, Tahereh; Mohades Ardebili, Fatimah; Rafii, Forough; Haghani, Hamid

    2016-01-01

    This study aimed to investigate the effect of music on the background pain, anxiety, and relaxation levels in burn patients. In this pretest-posttest randomized controlled clinical trial, 100 hospitalized burn patients were selected through convenience sampling. Subjects randomly assigned to music and control groups. Data related to demographic and clinical characteristics, analgesics, and physiologic measures were collected by researcher-made tools. Visual analog scale was used to determine pain, anxiety, and relaxation levels before and after the intervention in 3 consecutive days. Patients' preferred music was offered once a day for 3 days. The control group only received routine care. Data were analyzed using SPSS-PC (V. 20.0). According to paired t-test, there were significant differences between mean scores of pain (P < .001), anxiety (P < .001), and relaxation (P < .001) levels before and after intervention in music group. Independent t-test indicated a significant difference between the mean scores of changes in pain, anxiety, and relaxation levels before and after intervention in music and control groups (P < .001). No differences were detected in the mean scores of physiologic measures between groups before and after music intervention. Music is an inexpensive, appropriate, and safe intervention for applying to burn patients with background pain and anxiety at rest. To produce more effective comfort for patients, it is necessary to compare different types and time lengths of music intervention to find the best approach.

  18. A play and joint attention intervention for teachers of young children with autism: a randomized controlled pilot study.

    PubMed

    Wong, Connie S

    2013-05-01

    The aim of this study was to pilot test a classroom-based intervention focused on facilitating play and joint attention for young children with autism in self-contained special education classrooms. Thirty-three children with autism between the ages of 3 and 6 years participated in the study with their classroom teachers (n = 14). The 14 preschool special education teachers were randomly assigned to one of three groups: (1) symbolic play then joint attention intervention, (2) joint attention then symbolic intervention, and (3) wait-list control period then further randomized to either group 1 or group 2. In the intervention, teachers participated in eight weekly individualized 1-h sessions with a researcher that emphasized embedding strategies targeting symbolic play and joint attention into their everyday classroom routines and activities. The main child outcome variables of interest were collected through direct classroom observations. Findings indicate that teachers can implement an intervention to significantly improve joint engagement of young children with autism in their classrooms. Furthermore, multilevel analyses showed significant increases in joint attention and symbolic play skills. Thus, these pilot data emphasize the need for further research and implementation of classroom-based interventions targeting play and joint attention skills for young children with autism.

  19. A randomized control study of psychological intervention to reduce anxiety, amotivation and psychological distress among medical students

    PubMed Central

    Saravanan, Coumaravelou; Kingston, Rajiah

    2014-01-01

    Background: Test anxiety aggravates psychological distress and reduces the motivation among graduate students. This study aimed to identify psychological intervention for test anxiety, which reduces the level of psychological distress, amotivation and increases the intrinsic and extrinsic motivation among medical students. Materials and Methods: Westside test anxiety scale, Kessler Perceived Stress Scale and Academic Motivation Scale were used to measure test anxiety, psychological distress and motivation on 436 1st year medical students. Out of 436 students, 74 students who exhibited moderate to high test anxiety were randomly divided into either experimental or waiting list group. In this true randomized experimental study, 32 participants from the intervention group received five sessions of psychological intervention consist of psychoeducation, relaxation therapy and systematic desensitization. Thirty-three students from waiting list received one session of advice and suggestions. Results: After received psychological intervention participants from the intervention group experienced less anxiety, psychological distress, and amotivation (P < 0.01) and high intrinsic and extrinsic motivation (P < 0.01) in the postassessment compared with their preassessment scores. Conclusion: Overall psychological intervention is effective to reduce anxiety scores and its related variables. PMID:25097619

  20. Telephone-delivered behavioral intervention among blacks with sleep apnea and metabolic syndrome: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Lack of adherence to recommended treatment for obstructive sleep apnea remains an ongoing public health challenge. Despite evidence that continuous positive airway pressure (CPAP) is effective and improves overall quality of life, adherence with the use of CPAP in certain racial/ethnic groups, especially blacks, is suboptimal. Evidence indicates that the incidence and prevalence of obstructive sleep apnea are higher among blacks, relative to whites, and blacks are less likely to adhere to recommended treatment compared with other racial/ethnic groups. Methods Using a two-arm randomized controlled design, this study will evaluate the effectiveness of a culturally and linguistically tailored telephone-delivered intervention to promote adherence to physician-recommended sleep apnea assessment and treatment among blacks with metabolic syndrome, versus an attention-control arm. The intervention is designed to foster adherence to recommended sleep apnea care using the stages-of-change model. The intervention will be delivered entirely over the telephone. Participants in the intervention arm will receive 10 phone calls to address challenges and barriers to recommended care. Outcomes will be assessed at baseline, and at 6- and 12-months post-randomization. Discussion This tailored behavioral intervention will improve adherence to sleep apnea assessment and treatment among blacks with metabolic syndrome. We expect to demonstrate that this intervention modality is feasible in terms of time and cost and can be replicated in populations with similar racial/ethnic backgrounds. Trial registration The study is registered at clinicaltrials.gov NCT01946659 (February 2013) PMID:24925227

  1. Lifestyle intervention in general practice for physical activity, smoking, alcohol consumption and diet in elderly: a randomized controlled trial.

    PubMed

    Vrdoljak, Davorka; Marković, Biserka Bergman; Puljak, Livia; Lalić, Dragica Ivezić; Kranjčević, Ksenija; Vučak, Jasna

    2014-01-01

    The purpose of the study was to compare the effectiveness of programmed and intensified intervention on lifestyle changes, including physical activity, cigarette smoking, alcohol consumption and diet, in patients aged ≥ 65 with the usual care of general practitioners (GP). In this multicenter randomized controlled trial, 738 patients aged ≥ 65 were randomly assigned to receive intensified intervention (N = 371) or usual care (N = 367) of a GP for lifestyle changes, with 18-month follow-up. The main outcome measures were physical activity, smoking, alcohol consumption and diet. The study was conducted in 59 general practices in Croatia between May 2008 and May 2010. The patients' mean age was 72.3 ± 5.2 years. Significant diet correction was achieved after 18-month follow-up in the intervention group, comparing to controls. More patients followed strictly Mediterranean diet and consumed healthy foods more frequently. There was no significant difference between the groups in physical activity, tobacco smoking and alcohol consumption or diet after the intervention. In conclusion, an 18-month intensified GP's intervention had limited effect on lifestyle habits. GP intervention managed to change dietary habits in elderly population, which is encouraging since elderly population is very resistant regarding lifestyle habit changes. Clinical trial registration number. ISRCTN31857696.

  2. The Effects of Music Intervention on Background Pain and Anxiety in Burn Patients: Randomized Controlled Clinical Trial.

    PubMed

    Najafi Ghezeljeh, Tahereh; Mohades Ardebili, Fatimah; Rafii, Forough; Haghani, Hamid

    2016-01-01

    This study aimed to investigate the effect of music on the background pain, anxiety, and relaxation levels in burn patients. In this pretest-posttest randomized controlled clinical trial, 100 hospitalized burn patients were selected through convenience sampling. Subjects randomly assigned to music and control groups. Data related to demographic and clinical characteristics, analgesics, and physiologic measures were collected by researcher-made tools. Visual analog scale was used to determine pain, anxiety, and relaxation levels before and after the intervention in 3 consecutive days. Patients' preferred music was offered once a day for 3 days. The control group only received routine care. Data were analyzed using SPSS-PC (V. 20.0). According to paired t-test, there were significant differences between mean scores of pain (P < .001), anxiety (P < .001), and relaxation (P < .001) levels before and after intervention in music group. Independent t-test indicated a significant difference between the mean scores of changes in pain, anxiety, and relaxation levels before and after intervention in music and control groups (P < .001). No differences were detected in the mean scores of physiologic measures between groups before and after music intervention. Music is an inexpensive, appropriate, and safe intervention for applying to burn patients with background pain and anxiety at rest. To produce more effective comfort for patients, it is necessary to compare different types and time lengths of music intervention to find the best approach. PMID:26132048

  3. A Double-Blind, 12-Week Study to Evaluate the Antiaging Efficacy of a Cream Containing the NFκB Inhibitor 4-Hexyl-1, 3-Phenylenediol and Ascorbic Acid-2 Glucoside in Adult Females.

    PubMed

    Roure, Romain; Nollent, Virginie; Dayan, Liliane; Camel, Etienne; Bertin, Christiane

    2016-06-01

    The 5 main physical manifestations of aged skin are wrinkles, uneven tone, brown spots, loss of elasticity, and dryness. One mechanism resulting in these physical manifestations is increased activity of the nuclear factor kappa B (NFκB) protein. This 12-week, double-blind, placebo-controlled, randomized split-face study compared the antiaging effect and safety of a face cream containing 4-Hexyl-1, 3-phenylenediol, an NFκB inhibitor, and ascorbic acid-2 glucoside versus placebo in adult females aged 45-70 years old. Subjects (n=42) applied active treatment or placebo to the same half face twice daily at home for 12 weeks. Clinical evaluation was carried out by a dermatologist. Subjects carried out similar self-grading assessments. Colorimetric measurements analyzed skin color, and biomechanical skin properties were evaluated. Clinical grading showed that most wrinkle parameters were significantly improved after 8 weeks of active treatment compared with baseline and placebo (P≤.05), with improvements maintained after 12 weeks. Only Marionette wrinkles did not show a significant improvement. Brown spots (color intensity/number), overall photodamage, and most complexion parameters improved significantly after 8 and 12 weeks compared with baseline and placebo (P≤.05). Self-grading yielded similar results compared with baseline. Self-grading did not demonstrate improvements with active treatment versus placebo, except for skin firmness at 8 and 12 weeks (P≤.05). A significant difference was seen with active treatment compared with placebo in all colorimetric parameters (L*, b*, and ITA°) after 8 weeks, and in spot coloration (b*) after 12 weeks (P<.05). Improvements in skin elasticity were not significantly different between treatments. Overall tolerability of active treatment was judged as good. In conclusion, a cream containing 4-Hexyl-1, 3-phenylenediol and ascorbic acid-2 glucoside improves the clinical appearance of aged

  4. Cytology in nipple aspirate fluid during a randomized soy food intervention among premenopausal women.

    PubMed

    Maskarinec, Gertraud; Suzuki, Shana; Pagano, Ian S; Morimoto, Yukiko; Franke, Adrian A; Ehya, Hormoz

    2013-01-01

    Because soy food consumption may influence breast tissue activity, we examined its effect on the presence of epithelial cells in nipple aspirate fluid (NAF). In a randomized, crossover design, 82 premenopausal women completed a high-soy and a low-soy diet for 6 mo each, separated by a 1-mo washout period. They provided NAF samples at baseline, 6 mo, and 13 mo during the midluteal phase of the menstrual cycle. Papanicolaou-stained cytology slides (for 33 women at baseline, 24 at low-soy, and 36 at high-soy) were evaluated in women with sufficient NAF. Mixed models evaluated the effect of the high-soy diet on epithelial cytology as compared to baseline and the low-soy diet. At the end of the high-soy diet, cytological subclass had decreased in 8 (24%) and increased in 3 (9%) women as compared to baseline, whereas the respective values were 3 (14%) and 6 (29%) for the low-soy diet samples (P = 0.32). Only the change in subclass indicated a trend in lower cytological class (P = 0.06). Contrary to an earlier report, the number of NAF samples with hyperplastic epithelial cells did not increase after a soy intervention in amounts consumed by Asians.

  5. My Disaster Recovery: a pilot randomized controlled trial of an Internet intervention.

    PubMed

    Steinmetz, Sarah E; Benight, Charles C; Bishop, Sheryl L; James, Lori E

    2012-01-01

    This pilot study tested the efficacy of the My Disaster Recovery (MDR) website to decrease negative affect and increase coping self-efficacy. Fifty-six survivors of Hurricane Ike were recruited from a larger study being conducted at the University of Texas Medical Branch at the first anniversary of the storm. Restricted randomization was used to assign participants to the MDR website, an information-only website, or a usual care condition. Group×time interactions indicated that MDR reduced participant worry more than the other conditions. A similar trend was also identified for depression. Both websites were accessed a small to moderate amount and participants reported mixed satisfaction for both websites. Although the effect sizes for worry and depression were in the moderate to large range, small sample size and timing of the intervention qualify the findings. These preliminary findings encourage further evaluation of MDR with a larger, demographically diverse sample and indicate that the MDR website might be helpful in reducing worry and depression.

  6. Video-feedback intervention increases sensitive parenting in ethnic minority mothers: a randomized control trial.

    PubMed

    Yagmur, Sengul; Mesman, Judi; Malda, Maike; Bakermans-Kranenburg, Marian J; Ekmekci, Hatice

    2014-01-01

    Using a randomized control trial design we tested the effectiveness of a culturally sensitive adaptation of the Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline (VIPP-SD) in a sample of 76 Turkish minority families in the Netherlands. The VIPP-SD was adapted based on a pilot with feedback of the target mothers, resulting in the VIPP-TM (VIPP-Turkish Minorities). The sample included families with 20-47-month-old children with high levels of externalizing problems. Maternal sensitivity, nonintrusiveness, and discipline strategies were observed during pretest and posttest home visits. The VIPP-TM was effective in increasing maternal sensitivity and nonintrusiveness, but not in enhancing discipline strategies. Applying newly learned sensitivity skills in discipline situations may take more time, especially in a cultural context that favors more authoritarian strategies. We conclude that the VIPP-SD program and its video-feedback approach can be successfully applied in immigrant families with a non-Western cultural background, with demonstrated effects on parenting sensitivity and nonintrusiveness. PMID:24972105

  7. Incorporating family therapy into asthma group intervention: a randomized waitlist-controlled trial.

    PubMed

    Ng, S M; Li, Albert M; Lou, Vivian W Q; Tso, Ivy F; Wan, Pauline Y P; Chan, Dorothy F Y

    2008-03-01

    Asthma psychoeducational programs have been found to be effective in terms of symptom-related outcome. They are mostly illness-focused, and pay minimal attention to systemic/familial factors. This study evaluated a novel asthma psychoeducation program that adopted a parallel group design and incorporated family therapy. A randomized waitlist-controlled crossover clinical trial design was adopted. Children with stable asthma and their parents were recruited from a pediatric chest clinic. Outcome measures included, for the patients: exhaled nitric oxide (eNO), spirometry, and adjustment to asthma; and for the parents: perceived efficacy in asthma management, Hospital Anxiety and Depression Scale anxiety subscale, Body Mind Spirit Well-being Inventory emotion subscale, and Short Form 12 health-related quality of life scale. Forty-six patients participated in the study. Attrition rates were 13.0% and 26.0% for the active and control groups, respectively. Repeated-measures ANOVA revealed a significant decrease in airway inflammation, as indicated by eNO levels, and an increase in patient's adjustment to asthma and parents' perceived efficacy in asthma management. Serial trend analysis revealed that most psychosocial measures continued to progress steadily after intervention. Significant improvements in both symptom-related measures and mental health and relationship measures were observed. The findings supported the value of incorporating family therapy into asthma psychoeducation programs.

  8. Biofeedback Intervention for Stress and Anxiety among Nursing Students: A Randomized Controlled Trial.

    PubMed

    Ratanasiripong, Paul; Ratanasiripong, Nop; Kathalae, Duangrat

    2012-01-01

    Purpose. It has been well documented that nursing students across the world experience stress and anxiety throughout their education and training. The purpose of this randomized controlled study is to investigate the impact of biofeedback intervention program on nursing students' levels of stress and anxiety during their first clinical training. Methods. Participants consisted of 60 second-year baccalaureate nursing students. The 30 participants in the biofeedback group received training on how to use the biofeedback device to assist in stress and anxiety management for 5 weeks while the 30 in the control group did not receive any training. Findings. Results indicated that the biofeedback group was able to maintain the stress level while the control group had a significant increase in the stress level over the 5-week period of clinical training. Additionally, the biofeedback group had a significant reduction in anxiety, while the control group had a moderate increase in anxiety. Conclusions. The better the nursing students can manage their stress and anxiety, the more successful they can be in their clinical training. Ultimately, the more psychologically healthy the nursing students are, the more likely they will flourish and graduate to become productive and contributing members of the nursing profession. PMID:22811932

  9. Effects of free leucine supplementation and resistance training on muscle strength and functional status in older adults: a randomized controlled trial

    PubMed Central

    Trabal, Joan; Forga, Maria; Leyes, Pere; Torres, Ferran; Rubio, Jordi; Prieto, Esther; Farran-Codina, Andreu

    2015-01-01

    Objective To assess the effect of free leucine supplementation combined with resistance training versus resistance training only on muscle strength and functional status in older adults. Methods This was a randomized, double-blind, placebo-controlled, parallel study with two intervention groups. Thirty older adults were randomly assigned to receive either 10 g leucine/day (leucine group [LG], n=15) or a placebo (control group [CG], n=15), plus resistance training over a 12-week period. Maximal overcoming isometric leg strength, functional status, nutritional status, body composition, health-related quality of life, depression, and dietary intake were assessed at 4 and 12 weeks. Missing data at 12 weeks were handled using mixed models for repeated measurements for data imputation. Results Twenty-four subjects completed the 4-week assessment and eleven completed the 12-week intervention. Clinically significant gains were found in isometric leg strength at both assessment time points. Analysis of the effect size also showed how participants in LG outperformed those in CG for chair stands and the timed up and go test. No significant changes were observed for the rest of the outcomes. Conclusion Our combined analysis showed moderate changes in isometric leg muscle strength and certain components of functional status. The magnitude of changes found on these outcomes should be qualified as a positive effect of the concomitant intervention. PMID:25926725

  10. Effect of 12 Weeks of Accelerated Rehabilitation Exercise on Muscle Function of Patients with ACL Reconstruction of the Knee Joint.

    PubMed

    Lee, Joong-Chul; Kim, Ji Youn; Park, Gi Duck

    2013-12-01

    [Purpose] To examine changes in the knee joint's isokinetic muscle functions following systematic and gradual rehabilitation exercises lasting for 12 weeks for male and female patients who underwent anterior cruciate ligament (ACL) reconstruction. Differences in muscle functions between the uninvolved side (US) and the involved side (IS) before surgery, differences in muscle functions between US and IS after rehabilitation exercises lasting for 12 weeks, and changes in muscle functions on US and IS between before and after surgery were analyzed to examine the effects of accelerated rehabilitation exercises after ACL reconstruction. [Subjects] The study subjects were 10 patients, five females and five males, who underwent ACL reconstruction performed by the same surgeon. [Methods] As a measuring tool, a Biodex Multi-joint system 3pro (USA), which is an isokinetic measuring device, was used to examine the flexion and extension forces of the knee joint. During isokinetic muscle strength evaluation, the ROM of US was set to be the same as that of IS for consistency of measurement. [Results] At 60°/s, the isokinetic muscle functions of the females did not show any significant change between before and after surgery in any of the variables on both US and IS. At 60°/s, the isokinetic muscle functions of the males did not show any significant change between before and after surgery in the peak torque, average power, and entire work done on US. In extension, peak torque on IS did not show any significant change.

  11. Randomized controlled pilot study of a SystemCHANGE™ weight management intervention in stroke survivors: rationale and protocol

    PubMed Central

    2013-01-01

    Background Over 65% of stroke survivors are either overweight or obese and have multiple cardiovascular risk factors. However, few studies have examined the effects of comprehensive lifestyle behavior interventions to promote weight loss and control cardiovascular risk factors in stroke survivors. Thus, the purpose of this study is to examine a novel behavior change approach - SystemCHANGE™ - to promote weight loss and improve health and function in stroke survivors. SystemCHANGE™ focuses on redesigning the social environment to achieve a specific goal. Methods We will conduct a randomized controlled pilot study to examine the efficacy, feasibility, and safety of the SystemCHANGE™ weight management program in overweight and obese stroke survivors. The central hypothesis of the study is that the SystemCHANGE™ intervention will help overweight and obese stroke survivors lose 5% of their body weight, thereby improving health and function. Thirty-five stroke survivors will be randomized into either the 6-month SystemCHANGE™ intervention or a contact-control intervention. Outcome measures will be assessed at baseline and again at 3 and 6 months after the interventions. Body composition will be assessed using a Bod Pod. Patient-reported outcomes will be the Stroke Impact Scale and Reintegration to Normal Living Index. Objective outcomes will include the 6-Minute Walking Test and Rivermead Motor Assessment. Discussion This study will be the first randomized controlled trial to evaluate the efficacy and safety of a weight management intervention in stroke survivors using the SystemCHANGE™ approach. Furthermore, it will be the first empirically-examined comprehensive lifestyle intervention designed to target physical activity, nutrition, and sleep to promote weight loss in stroke survivors. Trial registration ClinicalTrials.gov Identifier: NCT01776034 PMID:23782741

  12. Strengths-based positive psychology interventions: a randomized placebo-controlled online trial on long-term effects for a signature strengths- vs. a lesser strengths-intervention.

    PubMed

    Proyer, René T; Gander, Fabian; Wellenzohn, Sara; Ruch, Willibald

    2015-01-01

    Recent years have seen an increasing interest in research in positive psychology interventions. There is broad evidence for their effectiveness in increasing well-being and ameliorating depression. Intentional activities that focus on those character strengths, which are most typical for a person (i.e., signature strengths, SS) and encourage their usage in a new way have been identified as highly effective. The current study aims at comparing an intervention aimed at using SS with one on using individual low scoring (or lesser) strengths in a randomized placebo-controlled trial. A total of 375 adults were randomly assigned to one of the two intervention conditions [i.e., using five signature vs. five lesser strengths (LS) in a new way] or a placebo control condition (i.e., early memories). We measured happiness and depressive symptoms at five time points (i.e., pre- and post-test, 1-, 3-, and 6-months follow-ups) and character strengths at pre-test. The main findings are that (1) there were increases in happiness for up to 3 months and decreases in depressive symptoms in the short term in both intervention conditions; (2) participants found working with strengths equally rewarding (enjoyment and benefit) in both conditions; (3) those participants that reported generally higher levels of strengths benefitted more from working on LS rather than SS and those with comparatively lower levels of strengths tended to benefit more from working on SS; and (4) deviations from an average profile derived from a large sample of German-speakers completing the Values-in-Action Inventory of Strengths were associated with greater benefit from the interventions in the SS-condition. We conclude that working on character strengths is effective for increasing happiness and discuss how these interventions could be tailored to the individual for promoting their effectiveness.

  13. Results of the Chronic Heart Failure Intervention to Improve MEdication Adherence (CHIME) Study: A Randomized Intervention in High-Risk Patients

    PubMed Central

    Granger, Bradi B.; Ekman, Inger; Hernandez, Adrian F.; Sawyer, Tenita; Bowers, Margaret; DeWald, Tracy; Zhao, Yanfang; Levy, Janet; Bosworth, Hayden B.

    2015-01-01

    Background Poor adherence to evidence-based medications in heart failure (HF) is a major cause of avoidable hospitalizations, disability, and death. To test the feasibility of improving medication adherence, we performed a randomized proof-of-concept study of a self-management intervention in high-risk patients with HF. Methods Patients with HF who screened positively for poor adherence (<6 Morisky Medication Adherence Scale 8-item) were randomized to either the intervention or attention control group. In the intervention group (n=44), a nurse conducted self-management training prior to discharge that focused on identification of medication goals, facilitation of medication-symptom associations, and use of a symptom-response plan. The attention control group (n=42) received usual care; both groups received follow-up calls at 1 week. However, the content of follow-up calls for the attention control group was unrelated to HF medications or symptoms. General linear mixed models were used to evaluate the magnitude of change in adherence and symptom-related events at 3-, 6-, and 12-month follow-up clinic visits. Efficacy was measured as improved medication adherence using nurse-assessed pill counts at each time point. Results Pooled over all time points, patients in the intervention group were more likely to be adherent to medications compared with patients in the attention control group (odds ratio [OR] 3.92, t=3.51, p=0.0007). Conclusions A nurse-delivered, self-care intervention improved medication adherence in patients with advanced HF. Further work is needed to examine whether this intervention can be sustained to improve clinical outcomes. PMID:25819861

  14. Strengths-based positive psychology interventions: a randomized placebo-controlled online trial on long-term effects for a signature strengths- vs. a lesser strengths-intervention

    PubMed Central

    Proyer, René T.; Gander, Fabian; Wellenzohn, Sara; Ruch, Willibald

    2015-01-01

    Recent years have seen an increasing interest in research in positive psychology interventions. There is broad evidence for their effectiveness in increasing well-being and ameliorating depression. Intentional activities that focus on those character strengths, which are most typical for a person (i.e., signature strengths, SS) and encourage their usage in a new way have been identified as highly effective. The current study aims at comparing an intervention aimed at using SS with one on using individual low scoring (or lesser) strengths in a randomized placebo-controlled trial. A total of 375 adults were randomly assigned to one of the two intervention conditions [i.e., using five signature vs. five lesser strengths (LS) in a new way] or a placebo control condition (i.e., early memories). We measured happiness and depressive symptoms at five time points (i.e., pre- and post-test, 1-, 3-, and 6-months follow-ups) and character strengths at pre-test. The main findings are that (1) there were increases in happiness for up to 3 months and decreases in depressive symptoms in the short term in both intervention conditions; (2) participants found working with strengths equally rewarding (enjoyment and benefit) in both conditions; (3) those participants that reported generally higher levels of strengths benefitted more from working on LS rather than SS and those with comparatively lower levels of strengths tended to benefit more from working on SS; and (4) deviations from an average profile derived from a large sample of German-speakers completing the Values-in-Action Inventory of Strengths were associated with greater benefit from the interventions in the SS-condition. We conclude that working on character strengths is effective for increasing happiness and discuss how these interventions could be tailored to the individual for promoting their effectiveness. PMID:25954221

  15. A Randomized Controlled Trial of an Individualized Preoperative Education Intervention for Symptom Management After Total Knee Arthroplasty.

    PubMed

    Wilson, Rosemary A; Watt-Watson, Judith; Hodnett, Ellen; Tranmer, Joan

    2016-01-01

    Pain and nausea limit recovery after total knee arthroplasty (TKA) patients. The aim of this study was to determine the effect of a preoperative educational intervention on postsurgical pain-related interference in activities, pain, and nausea. Participants (n = 143) were randomized to intervention or standard care. The standard care group received the usual teaching. The intervention group received the usual teaching, a booklet containing symptom management after TKA, an individual teaching session, and a follow-up support call. Outcome measures assessed pain, pain interference, and nausea. There were no differences between groups in patient outcomes. There were no group differences for pain at any time point. Respondents had severe postoperative pain and nausea and received inadequate doses of analgesia and antiemetics. Individualizing education content was insufficient to produce a change in symptoms for patients. Further research involving the modification of system factors affecting the provision of symptom management interventions is warranted. PMID:26814004

  16. HIV Sexual Risk-Reduction Interventions for Youth: A Review and Methodological Critique of Randomized Controlled Trials

    PubMed Central

    Pedlow, C. Teal; Carey, Michael P.

    2008-01-01

    We review and provide a methodological critique of randomized controlled studies of HIV risk reduction interventions that measured sexual risk behavior outcomes with adolescents. Studies conducted in school, community, and health care settings were reviewed. Overall, 13 of 23 interventions (57%) were effective in reducing sexual risk behavior. Methodological strengths of extant studies included an emphasis on a theoretical framework, evaluation of both group- and individualized intervention formats, use of multiple assessments of risk behavior including biological outcomes, and inclusion of efficacy and effectiveness trials. Methodological limitations included limited evaluation of theoretical mediators of risk reduction, failure to report effect sizes, and lack of sustained findings. Inconsistencies were found in data analytic procedures and reporting, including how nested designs, skewed data, and attrition were addressed. Recommendations for designing methodologically-rigorous interventions are provided. PMID:12705104

  17. Single-session interventions for problem gambling may be as effective as longer treatments: Results of a randomized control trial.

    PubMed

    Toneatto, Tony

    2016-01-01

    Empirically supported treatments for problem gambling tend to be multimodal combining cognitive, behavior and motivational interventions. Since problem gamblers often prefer briefer treatments it is important that interventions adopt strategies that are optimally effective. In this study, 99 community-recruited problem gamblers (74% male, mean age: 47.5 years) were randomized to one of four treatments: six sessions of cognitive therapy, behavior therapy, and motivational therapy or a single-session intervention. The sample was followed up for 12 months post-treatment. In both the Intent-to-Treat and Completer statistical analyses, no significant group differences on key gambling variables (i.e., frequency, expenditures, severity) were found. All four treatments showed significant improvement as a result of treatment that endured throughout the follow-up period. These results, although preliminary, suggest that very brief, single-session interventions may be as effective as longer treatments.

  18. Impact of financial and educational interventions on maternity care: results of cluster randomized trials in rural China, CHIMACA.

    PubMed

    Hemminki, Elina; Long, Qian; Zhang, Wei-Hong; Wu, Zhuochun; Raven, Joanna; Tao, Fangbiao; Yan, Hong; Wang, Yang; Klemetti, Reija; Zhang, Tuohong; Regushevskaya, Elena; Tang, Shenglan

    2013-02-01

    To report on the design and basic outcomes of three interventions aimed at improving the use and quality of maternity care in rural China: financial interventions, training in clinical skills, and training in health education. Community-based cluster randomized trials were carried out in one central and two western provinces between 2007 and 2009: (1) financial interventions covered part of women's costs for prenatal and postnatal care, (2) training of midwives in clinical skills was given by local maternity care experts in two- or three-group training courses, (3) health education training for midwives and village doctors were given by local experts in health education in two- or three-group training courses. A survey was conducted in a stratified random sample of women who had been pregnant in the study period. 73% of women (n = 3,673) were interviewed within 1-10 months of giving birth. Outcomes were compared by the different intervention and control groups. Adjusted odds ratios were calculated by logistic regression to adjust for varying maternal characteristics. Most of the differences found between the groups were small and some varied between provinces. The financial intervention did not influence the number of visits, but was associated with increased caesarean sections and a decrease in many ultrasound tests. The clinical intervention influenced some indicators of care content. There was no consistent finding for the health education intervention. Financial and training interventions have the potential to improve maternity care, but better implementation is required. Unintended consequences, including overuse of technology, are possible.

  19. A pilot randomized controlled trial of a brief parenting intervention in low-resource settings in Panama.

    PubMed

    Mejia, Anilena; Calam, Rachel; Sanders, Matthew R

    2015-07-01

    The aim of this study was to determine whether an intervention from the Triple P Positive Parenting Program system was effective in reducing parental reports of child behavioral difficulties in urban low-income settings in Panama City. A pilot parallel-group randomized controlled trial was carried out. A total of 108 parents of children 3 to 12 years old with some level of parent-rated behavioral difficulties were randomly assigned to a discussion group on "dealing with disobedience" or to a no intervention control. Blinded assessments were carried out prior to the intervention, 2 weeks, 3 months, and 6 months later. Results indicated that parental reports of child behavioral difficulties changed over time and decreased more steeply in the intervention than in the control group. The effects of the intervention on parental reports of behavioral difficulties were moderate at post-intervention and 3-month follow-up, and large at 6-month follow-up. Parents who participated in the discussion group reported fewer behavioral difficulties in their children after the intervention than those in the control condition. They also reported reduced parental stress and less use of dysfunctional parenting practices. There is a limited amount of evidence on the efficacy of parenting interventions in low-resource settings. This pilot trial was carried out using a small convenience sample living in low-income urban communities in Panama City, and therefore, the findings are of reduced generalizability to other settings. However, the methodology employed in this trial represents an example for future work in other low-resource settings. PMID:25703382

  20. A psychological intervention reduces inflammatory markers by alleviating depressive symptoms: Secondary analysis of a randomized controlled trial

    PubMed Central

    Thornton, Lisa M.; Andersen, Barbara L.; Schuler, Tammy A.; Carson, William E.

    2013-01-01

    Objective Depression and inflammation are common among cancer patients. Data suggest that inflammation can contribute to depressive symptoms, while the converse remains untested. We experimentally test whether a psychological intervention reduces depression-related symptoms and markers of inflammation among cancer patients, and further, we test one mechanism for the intervention effects. Methods As part of a randomized clinical trial, newly diagnosed breast cancer patients (N=45) with clinically significant depressive symptoms were evaluated and randomized to Psychological Intervention with assessment or Assessment only study arms. The intervention spanned 12 months, with assessments at baseline, 4, 8, and 12, months. Mixed effects modeling tested the hypothesis that the intervention reduced self reported depressive symptoms (Center for Epidemiological Studies Depression scale, Profile of Mood States Depression and Fatigue subscales, and SF-36 Bodily Pain subscale) and immune cell numbers that are elevated in the presence of inflammation (white blood cell [WBC] count, neutrophil count, and helper:suppressor ratio). Mediation analyses tested whether change in depressive symptoms, pain, or fatigue predicted change in WBC count, neutrophil count, or the helper:suppressor ratio. Results The intervention significantly reduced depressive symptoms, pain, fatigue, and inflammation markers. Moreover, the intervention effect on inflammation was mediated by its effect on depressive symptoms. Conclusions This is the first experiment to test whether psychological treatment effective in reducing depressive symptoms would also reduce indicators of inflammation. Data show that the intervention directly reduced depressive symptoms and indirectly reduced inflammation. Psychological treatment may effectively treat depressive symptoms, pain, and fatigue among cancer patients. PMID:19622708

  1. Shamba Maisha: Randomized controlled trial of an agricultural and finance intervention to improve HIV health outcomes in Kenya

    PubMed Central

    WEISER, Sheri D.; BUKUSI, Elizabeth A.; STEINFELD, Rachel L.; FRONGILLO, Edward A.; WEKE, Elly; DWORKIN, Shari L.; PUSATERI, Kyle; SHIBOSKI, Stephen; SCOW, Kate; BUTLER, Lisa M.; COHEN, Craig R.

    2015-01-01

    Objectives Food insecurity and HIV/AIDS outcomes are inextricably linked in sub-Saharan Africa. We report on health and nutritional outcomes of a multisectoral agricultural intervention trial among HIV-infected adults in rural Kenya. Design Pilot cluster randomized controlled trial Methods The intervention included a human-powered water pump, a microfinance loan to purchase farm commodities, and education in sustainable farming practices and financial management. Two health facilities in Nyanza Region, Kenya were randomly assigned as intervention or control. HIV-infected adults 18 to 49 years old who were on antiretroviral therapy and had access to surface water and land were enrolled beginning in April 2012 and followed quarterly for one year. Data were collected on nutritional parameters, CD4 T lymphocyte counts, and HIV RNA. Difference in difference fixed-effects regression models were used to test whether patterns in health outcomes differed over time from baseline between the intervention and control arms. Results We enrolled 72 and 68 participants in the intervention and control groups, respectively. At 12 months follow-up, we found a statistically significant increase in CD4 cell counts (165 cells/mm3, p<0.001) and proportion virologically suppressed in the intervention arm compared to the control arm (comparative improvement in proportion of 0.33 suppressed, OR 7.6, 95% CI: 2.2–26.8). Intervention participants experienced significant improvements in food security (3.6 scale points higher, p<0.001) and frequency of food consumption (9.4 times per week greater frequency, p=0.013) compared to controls. Conclusion Livelihood interventions may be a promising approach to tackle the intersecting problems of food insecurity, poverty and HIV/AIDS morbidity. PMID:26214684

  2. Brief Intervention Decreases Drinking Frequency in HIV-Infected, Heavy Drinking Women: Results of a Randomized Controlled Trial

    PubMed Central

    Chander, Geetanjali; Hutton, Heidi E.; Lau, Bryan; Xu, Xiaoqiang; McCaul, Mary E.

    2015-01-01

    Objective Hazardous alcohol use by HIV-infected women is associated with poor HIV outcomes and HIV transmission risk behaviors. We examined the effectiveness of brief alcohol intervention (BI) among hazardous drinking women receiving care in an urban, HIV clinic. Methods Women were randomized to a 2-session BI or usual care. Outcomes assessed at baseline, 3, 6 and 12 months included 90-day frequency of any alcohol use and heavy/binge drinking (≥4 drinks per occasion), and average drinks per drinking episode. Secondary outcomes included HIV medication and appointment adherence, HIV1-RNA suppression, and days of unprotected vaginal sex. We examined intervention effectiveness using generalized mixed effect models and quantile regression. Results Of 148 eligible women, 74 were randomized to each arm. In mixed effects models, 90-day drinking frequency decreased among intervention group compared to control, with women in the intervention condition less likely to have a drinking day (OR: 0.42 (95% CI: 0.23–0.75). Heavy/binge drinking days and drinks per drinking day did not differ significantly between groups. Quantile regression demonstrated a decrease in drinking frequency in the middle to upper ranges of the distribution of drinking days and heavy/binge drinking days that differed significantly between intervention and control conditions. At follow-up, the intervention group had significantly fewer episodes of unprotected vaginal sex. No intervention effects were observed for other outcomes. Conclusions Brief alcohol intervention reduces frequency of alcohol use and unprotected vaginal sex among HIV-infected women. More intensive services may be needed to lower drinks per drinking day and enhance care for more severely affected drinkers. PMID:25967270

  3. A Randomized Controlled Trial of a Response-to-Intervention (RTI) Tier 2 Literacy Program: Leveled Literacy Intervention (LLI)

    ERIC Educational Resources Information Center

    Ransford-Kaldon, Carolyn; Flynt, E. Sutton; Ross, Cristin

    2011-01-01

    The purpose of this study was twofold: (1) to determine the efficacy of the Leveled Literacy Intervention program (LLI) in increasing reading achievement for K-2 students and (2) to examine LLI program implementation fidelity. This study evaluated LLI in two U.S. school districts and used a mixed-method design to address the following key research…

  4. Turkish 12 Week Course.

    ERIC Educational Resources Information Center

    Defense Language Inst., Washington, DC.

    This audiolingual beginner's course has been prepared for the Defense Language Institute intensive program in modern spoken Turkish. The course, consisting of six volumes of basic text in 55 units begins with an introductory section which presents the linguistic background, phonology, and distinguishing features of Turkish. The lesson format…

  5. Issues Relating to Confounding and Meta-analysis When Including Non-Randomized Studies in Systematic Reviews on the Effects of Interventions

    ERIC Educational Resources Information Center

    Valentine, Jeffrey C.; Thompson, Simon G.

    2013-01-01

    Background: Confounding caused by selection bias is often a key difference between non-randomized studies (NRS) and randomized controlled trials (RCTs) of interventions. Key methodological issues: In this third paper of the series, we consider issues relating to the inclusion of NRS in systematic reviews on the effects of interventions. We discuss…

  6. Impact of a primary care based intervention on breast cancer knowledge, risk perception and concern: A randomized, controlled trial

    PubMed Central

    Livaudais-Toman, Jennifer; Karliner, Leah S.; Tice, Jeffrey A.; Kerlikowske, Karla; Gregorich, Steven; Pérez-Stable, Eliseo J.; Pasick, Rena J.; Chen, Alice; Quinn, Jessica; Kaplan, Celia P.

    2015-01-01

    Purpose To estimate the effects of a tablet-based, breast cancer risk education intervention for use in primary care settings (BreastCARE) on patients' breast cancer knowledge, risk perception and concern. Methods From June 2011–August 2012, we enrolled women from two clinics, aged 40–74 years with no personal breast cancer history, and randomized them to the BreastCARE intervention group or to the control group. All patients completed a baseline telephone survey and risk assessment (via telephone for controls, via tablet computer in clinic waiting room prior to visit for intervention). All women were categorized as high or average risk based on the Referral Screening Tool, the Gail model or the Breast Cancer Surveillance Consortium model. Intervention patients and their physicians received an individualized risk report to discuss during the visit. All women completed a follow-up telephone survey 1–2 weeks after risk assessment. Post-test comparisons estimated differences at follow-up in breast cancer knowledge, risk perception and concern. Results 580 intervention and 655 control women completed follow-up interviews. Mean age was 56 years (SD = 9). At follow-up, 73% of controls and 71% of intervention women correctly perceived their breast cancer risk and 22% of controls and 24% of intervention women were very concerned about breast cancer. Intervention patients had greater knowledge (≥75% correct answers) of breast cancer risk factors at follow-up (24% vs. 16%; p = 0.002). In multivariable analysis, there were no differences in correct risk perception or concern, but intervention patients had greater knowledge ([OR] = 1.62; 95% [CI] = 1.19–2.23). Conclusions A simple, practical intervention involving physicians at the point of care can improve knowledge of breast cancer without increasing concern. Trial Registration ClinicalTrials.gov identifier NCT01830933. PMID:26476466

  7. Changes in Body Composition over Eight Years in a Randomized Trial of a Lifestyle Intervention: The Look AHEAD Study

    PubMed Central

    Pownall, Henry J.; Bray, George A.; Wagenknecht, Lynne E.; Walkup, Michael P.; Heshka, Stanley; Hubbard, Van S.; Hill, James; Kahn, Steven E.; Nathan, David M.; Schwartz, Anne V.; Johnson, Karen C.

    2014-01-01

    Objective To determine the effects of an intensive lifestyle intervention vs. a comparison group on body composition in obese or overweight persons with type 2 diabetes at baseline and at 1, 4, and 8 years. Design and Methods Body composition was measured by dual energy X-ray absorptiometry in a subset of 1019 Look Ahead study volunteers randomized to intervention or comparison groups. The intervention was designed to achieve and maintain ≥7% weight loss through increased physical activity and reduced caloric intake. The comparison group received social support and diabetes education. Results At 1 year, the intervention group lost fat (5.6 ± 0.2 kg) and lean mass (2.3 ± 0.1 kg) but regained fat (~100%), and lost lean mass between years 1 and 8. Between baseline and year-8, weight-loss was greater in intervention vs. comparison groups (4.0 ± 0.4 vs. 2.3 ± 0.4 kg); comparison group weight-loss was mostly lean mass (2.1 ± 0.17 kg). Fat mass in the intervention group was lower than that of the comparison group at all post-baseline time points. Conclusions Reduced FM may place the intervention group at a lower risk of obesity-linked sequelae, a hypothesis that can be tested by future studies of this cohort. Trial Registration ClinicalTrials.gov Identifier: NCT00017953 PMID:25707379

  8. Comparison of Explicit Forgiveness Interventions with an Alternative Treatment: A Randomized Clinical Trial

    ERIC Educational Resources Information Center

    Wade, Nathaniel G.; Worthington, Everett L.; Haake, Shawn

    2009-01-01

    Forgiveness interventions can help people forgive past offenses. However, few studies have compared forgiveness interventions with genuine alternative treatments. The authors compared forgiveness interventions with a therapeutic alternative treatment. Participants reduced unforgiveness and increased forgiveness regardless of treatment condition.…

  9. Effects of a 12-week Pilates course on lower limb muscle strength and trunk flexibility in women living in the community.

    PubMed

    Kao, Yu-Hsiu; Liou, Tsan-Hon; Huang, Yi-Ching; Tsai, Ya-Wen; Wang, Kuo-Ming

    2015-01-01

    Researchers in Taiwan studying regular adult physical activity found that among married women aged 26 to 55 years, 56% participated in physical activity, and that the convenience and safety of the activity were major factors contributing to their willingness to exercise. Muscle weakness and poor trunk flexibility are closely related to some chronic diseases in women. In this cross-sectional survey, we used the Polestar Pilates™ method to explore the effects of a 12-week Pilates course on the physical fitness of women living in the community. Fifty-three members of the experimental group (mean age: 42.30 ± 9.97) and 43 of the control group (mean age: 41.23 ± 9.83) were included. We confirm that a convenient Pilates exercise intervention can significantly improve muscle strength and trunk flexibility in women. Our findings serve as an important reference for health authorities in Taiwan and provide higher awareness of women's health and physical fitness, which can help prevent chronic and cardiovascular diseases. PMID:24611630

  10. Effects of a 12-week Pilates course on lower limb muscle strength and trunk flexibility in women living in the community.

    PubMed

    Kao, Yu-Hsiu; Liou, Tsan-Hon; Huang, Yi-Ching; Tsai, Ya-Wen; Wang, Kuo-Ming

    2015-01-01

    Researchers in Taiwan studying regular adult physical activity found that among married women aged 26 to 55 years, 56% participated in physical activity, and that the convenience and safety of the activity were major factors contributing to their willingness to exercise. Muscle weakness and poor trunk flexibility are closely related to some chronic diseases in women. In this cross-sectional survey, we used the Polestar Pilates™ method to explore the effects of a 12-week Pilates course on the physical fitness of women living in the community. Fifty-three members of the experimental group (mean age: 42.30 ± 9.97) and 43 of the control group (mean age: 41.23 ± 9.83) were included. We confirm that a convenient Pilates exercise intervention can significantly improve muscle strength and trunk flexibility in women. Our findings serve as an important reference for health authorities in Taiwan and provide higher awareness of women's health and physical fitness, which can help prevent chronic and cardiovascular diseases.

  11. Behavioral Intervention Improves Treatment Outcomes Among HIV-Infected Individuals Who Have Delayed, Declined, or Discontinued Antiretroviral Therapy: A Randomized Controlled Trial of a Novel Intervention

    PubMed Central

    Cleland, Charles M.; Applegate, Elizabeth; Belkin, Mindy; Gandhi, Monica; Salomon, Nadim; Banfield, Angela; Leonard, Noelle; Riedel, Marion; Wolfe, Hannah; Pickens, Isaiah; Bolger, Kelly; Bowens, DeShannon; Perlman, David; Mildvan, Donna

    2015-01-01

    Nationally up to 60 % of persons living with HIV are neither taking antiretroviral therapy (ART) nor well engaged in HIV care, mainly racial/ethnic minorities. This study examined a new culturally targeted multi-component intervention to address emotional, attitudinal, and social/structural barriers to ART initiation and HIV care. Participants (N = 95) were African American/Black and Latino adults with CD4<500 cells/mm3 not taking ART, randomized 1:1 to intervention or control arms, the latter receiving treatment as usual. Primary endpoints were adherence, evaluated via ART concentrations in hair samples, and HIV viral load suppression. The intervention was feasible and acceptable. Eight months post-baseline, intervention participants tended to be more likely to evidence “good” (that is, 7 days/week) adherence (60 vs. 26.7 %; p = 0.087; OR = 3.95), and had lower viral load levels than controls (t(22) = 2.29, p = 0.032; OR = 5.20), both large effect sizes. This highly promising intervention merits further study. PMID:25835462

  12. Methadone induction in primary care (ANRS-Methaville): a phase III randomized intervention trial

    PubMed Central

    2012-01-01

    Background In France, the rapid scale-up of buprenorphine, an opioid maintenance treatment (OMT), in primary care for drug users has led to an impressive reduction in HIV prevalence among injecting drug users (IDU) but has had no major effect on Hepatitis C incidence. To date, patients willing to start methadone can only do so in a methadone clinic (a medical centre for drug and alcohol dependence (CSAPA) or a hospital setting) and are referred to primary care physicians after dose stabilization. This study aims to assess the effectiveness of methadone in patients who initiated treatment in primary care compared with those who initiated it in a CSAPA, by measuring abstinence from street opioid use after one year of treatment. Methods/Design The ANRS-Methaville study is a randomized multicenter non-inferiority control trial comparing methadone induction (lasting approximately 2 weeks) in primary care and in CSAPA. The model of care chosen for methadone induction in primary care was based on study-specific pre-training of all physicians, exclusion criteria and daily supervision of methadone during the initiation phase. Between January 2009 and January 2011, 10 sites each having one CSAPA and several primary care physicians, were identified to recruit patients to be randomized into two groups, one starting methadone in primary care (n = 147), the other in CSAPA (n = 48). The primary outcome of the study is the proportion of participants abstinent from street opioids after 1 year of treatment i.e. non-inferiority of primary care model in terms of the proportion of patients not using street opioids compared with the proportion observed in those starting methadone in a CSAPA. Discussion The ANRS-Methaville study is the first in France to use an interventional trial to improve access to OMT for drug users. Once the non-inferiority results become available, the Ministry of Health and agency for the safety of health products may change the the New Drug Application

  13. Mobile phone intervention and weight loss among overweight and obese adults: a meta-analysis of randomized controlled trials.

    PubMed

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

    2015-03-01

    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.

  14. Mobile phone intervention and weight loss among overweight and obese adults: a meta-analysis of randomized controlled trials.

    PubMed

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

    2015-03-01

    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

  15. Continuous quality improvement (CQI) in addiction treatment settings: design and intervention protocol of a group randomized pilot study

    PubMed Central

    2014-01-01

    Background Few studies have designed and tested the use of continuous quality improvement approaches in community based substance use treatment settings. Little is known about the feasibility, costs, efficacy, and sustainment of such approaches in these settings. Methods/Design A group-randomized trial using a modified stepped wedge design is being used. In the first phase of the study, eight programs, stratified by modality (residential, outpatient) are being randomly assigned to the intervention or control condition. In the second phase, the initially assigned control programs are receiving the intervention to gain additional information about feasibility while sustainment is being studied among the programs initially assigned to the intervention. Discussion By using this design in a pilot study, we help inform the field about the feasibility, costs, efficacy and sustainment of the intervention. Determining information at the pilot stage about costs and sustainment provides value for designing future studies and implementation strategies with the goal to reduce the time between intervention development and translation to real world practice settings. PMID:24467770

  16. Multifactorial assessment and targeted intervention to reduce falls among the oldest-old: a randomized controlled trial

    PubMed Central

    Ferrer, Assumpta; Formiga, Francesc; Sanz, Héctor; de Vries, Oscar J; Badia, Teresa; Pujol, Ramón

    2014-01-01

    Background The purpose of this study was to assess the effectiveness of a multifactorial intervention to reduce falls among the oldest-old people, including individuals with cognitive impairment or comorbidities. Methods A randomized, single-blind, parallel-group clinical trial was conducted from January 2009 to December 2010 in seven primary health care centers in Baix Llobregat (Barcelona). Of 696 referred people who were born in 1924, 328 were randomized to an intervention group or a control group. The intervention model used an algorithm and was multifaceted for both patients and their primary care providers. Primary outcomes were risk of falling and time until falls. Data analyses were by intention-to-treat. Results Sixty-five (39.6%) subjects in the intervention group and 48 (29.3%) in the control group fell during follow-up. The difference in the risk of falls was not significant (relative risk 1.28, 95% confidence interval [CI] 0.94–1.75). Cox regression models with time from randomization to the first fall were not significant. Cox models for recurrent falls showed that intervention had a negative effect (hazard ratio [HR] 1.46, 95% CI 1.03–2.09) and that functional impairment (HR 1.42, 95% CI 0.97–2.12), previous falls (HR 1.09, 95% CI 0.74–1.60), and cognitive impairment (HR 1.08, 95% CI 0.72–1.60) had no effect on the assessment. Conclusion This multifactorial intervention among octogenarians, including individuals with cognitive impairment or comorbidities, did not result in a reduction in falls. A history of previous falls, disability, and cognitive impairment had no effect on the program among the community-dwelling subjects in this study. PMID:24596458

  17. Intrauterine synechiae after myomectomy; laparotomy versus laparoscopy: Non-randomized interventional trial

    PubMed Central

    Asgari, Zahra; Hafizi, Leili; Hosseini, Rayhaneh; Javaheri, Atiyeh; Rastad, Hathis

    2015-01-01

    Background: Leiomyomata is the most frequent gynecological neoplasm. One of the major complications of myomectomy is intrauterine adhesion (synechiae). Objective: To evaluate and compare the rate and severity of synechiae formation after myomectomy by laparotomy and laparoscopy. Materials and Methods: In this non-randomized interventional trial, hysteroscopy was performed in all married fertile women who had undergone myomectomy (type 3-6 interamural and subserosal fibroids) via laparotomy and laparoscopy in Tehran’s Arash Hospital from 2010 to 2013. Three months after the operation, the occurrence rate and severity of intrauterine synechiae, and its relationship with type, number and location of myomas were investigated and compared in both groups. Results: Forty patients (19 laparoscopy and 21 laparotomy cases) were studied. Both groups were similar regarding the size, type (subserosal or intramural), number and location of myoma. The occurrence rate of synechiae in the laparoscopy and laparotomy group was 21% and 19%, respectively; showing no significant difference (p=0.99). Among all patients, no significant relationship was found between the endometrial opening (p=0.92), location (p=0.14) and type of myoma (p=0.08) with the occurrence rate of synechiae. However, a significant relationship was observed between myoma’s size (p=0.01) and the location of the largest myoma with the occurrence of synechiae (p=0.02). Conclusion: With favorable suturing methods, the outcome of intrauterine synechiae formation after myomectomy, either performed by laparotomy or laparoscopy, is similar. In all cases of myomectomy in reproductive-aged women, postoperative hysteroscopy is highly recommended to better screen intrauterine synechiae. PMID:26000007

  18. Intervention with Substance Abusing Runaway Adolescents and their Families: Results of a Randomized Clinical Trial

    PubMed Central

    Slesnick, Natasha; Erdem, Gizem; Bartle-Haring, Suzanne; Brigham, Gregory S.

    2013-01-01

    Objectives To examine the efficacy of three theoretically distinct interventions among substance-abusing runaway adolescents and to explore individual differences in trajectories of change. Methods Adolescents (N=179) between the ages of 12–17 were recruited from a runaway shelter in a Midwestern city. The sample included 94 females (52.5%) and 85 males (47.5%), the majority of the adolescents were African American (n= 118, 65.9%). Adolescents were randomly assigned to the Community Reinforcement Approach (CRA, n = 57), Motivational Interviewing (MI, n = 61), or Ecologically-Based Family Therapy (EBFT, n = 61). Substance use was assessed at baseline, 3, 6, 9, 12, 18, and 24 months via Form 90 and urine screens. Results Hierarchical linear modeling revealed statistically significant improvement in frequency of substance use among runaways in all three treatment groups with a slight increase at post-treatment. Latent trajectory profile analysis explored individual differences in change trajectories and yielded a 3 class model. The majority of adolescents (n = 136, 76%) showed reductions in substance use over time with a slight increase at follow-up (Class 1: Decreasing). Twenty-four (13.4%) adolescents had shown high levels of substance use over time with patterns of increase and decrease (Class 2: Fluctuating high users), and 19 (10.6%) decreased but returned to baseline levels by two years post-baseline (Class 3: U shaped). Few differences among treatment conditions were noted; within the “decreasing” group, adolescents in MI treatment showed a quicker decline in their substance use but a faster relapse compared to those receiving EBFT. Conclusions These findings suggest that CRA, EBFT and MI are viable treatments for runaway substance-abusing adolescents. PMID:23895088

  19. Issues Relating to Study Design and Risk of Bias When Including Non-Randomized Studies in Systematic Reviews on the Effects of Interventions

    ERIC Educational Resources Information Center

    Higgins, Julian P. T.; Ramsay, Craig; Reeves, Barnaby C.; Deeks, Jonathan J.; Shea, Beverley; Valentine, Jeffrey C.; Tugwell, Peter; Wells, George

    2013-01-01

    Non-randomized studies may provide valuable evidence on the effects of interventions. They are the main source of evidence on the intended effects of some types of interventions and often provide the only evidence about the effects of interventions on long-term outcomes, rare events or adverse effects. Therefore, systematic reviews on the effects…

  20. A 12-week placebo-controlled double-blind study of prazosin in the treatment of prostatic obstruction due to benign prostatic hyperplasia.

    PubMed

    Chapple, C R; Stott, M; Abrams, P H; Christmas, T J; Milroy, E J

    1992-09-01

    A series of 93 normotensive patients with benign prostatic hyperplasia and maximum urinary flow rates < 15 ml/s, treated at 2 hospital centres using an identical protocol, was randomly assigned to receive a 12-week course of treatment with prazosin or placebo in a double-blind parallel group trial. A total of 75 patients completed the study and were suitable for the final analysis. Prazosin was administered orally in doses of 0.5 mg and then 1 mg twice daily for 4 days and 2 mg twice daily for the remainder of the trial. Patients on treatment with prazosin exhibited a significantly increased maximum urinary flow rate as compared with placebo, with a significant reduction in maximum voiding detrusor pressure. Prazosin therapy did not produce a significant effect on either frequency or standard parameters of detrusor instability. A double-blind overall assessment of drug efficacy and tolerance significantly favoured prazosin therapy. A total of 30 patients receiving prazosin and 28 receiving placebo reported varied adverse effects. Eighteen patients were excluded from the final analysis, 10 being withdrawn because of adverse effects, 7 on treatment with prazosin and 3 in the placebo group. In long-term usage oral prazosin was well tolerated and appeared to improve obstructed voiding in patients with benign prostatic hyperplasia.

  1. A 12-week comparison regarding symptom improvement in an urban university-based outpatient child psychiatry clinic.

    PubMed

    Adams, Adrienne L; Meaden, Patricia

    2014-01-01

    To compare the efficacy of pharmacotherapy versus combination pharmacotherapy and psychotherapy for externalizing, conduct, and aggressive behaviors in children aged 6 through 18 years in an urban academic outpatient facility. Data from a child psychiatry outpatient population whose scores were identified as "at risk" or "clinically significant" based on a validated and standardized assessment tool were assessed at baseline and 12 weeks or more after treatment. Conduct symptoms worsened with medication management alone but improved with combination treatment (P < 0.05). Females and older youth were more likely to have therapy included in their treatment. Conduct problems that can be seen in a variety of youth disorders, such as disruptive behaviors, mood, and anxiety disorders, have a better probability of improving with treatment that includes psychotherapy versus medication management alone.

  2. The influence of maternal age on the outcomes of pregnancies complicated by bleeding at less than 12 weeks.

    PubMed

    Mbugua Gitau, Godfrey; Liversedge, Helen; Goffey, Dawn; Hawton, Annemarie; Liversedge, Neil; Taylor, Myles

    2009-01-01

    The effect of maternal age on the outcome of threatened miscarriage after ultrasound has confirmed fetal heart (FH) pulsation was assessed. At a university teaching hospital, 138 women presenting with bleeding before 12 weeks' gestation were followed up until delivery or pregnancy loss. Those with multiple or ectopic pregnancy, social termination of pregnancy, assisted conception and temporary residence were excluded. Outcome measures were pregnancy loss, fetal abnormalities, preterm delivery, low birthweight and cesarean delivery. Age over 35 years was significantly associated with reduced live-birth and increased miscarriage rates. Women over 35 years of age had higher cesarean section and pregnancy loss rates than the younger women. The combination of bleeding in early pregnancy and advanced age increases risk of pregnancy loss even after ultrasound has confirmed FH pulsation. PMID:19140048

  3. A multicomponent behavioral intervention to reduce stroke risk factor behaviors: The SHARE Cluster-Randomized Controlled Trial

    PubMed Central

    Brown, Devin L.; Conley, Kathleen M.; Sánchez, Brisa N.; Resnicow, Kenneth; Cowdery, Joan E.; Sais, Emma; Murphy, Jillian; Skolarus, Lesli E.; Lisabeth, Lynda D.; Morgenstern, Lewis B.

    2015-01-01

    Background and Purpose The Stroke Health and Risk Education (SHARE) Project was a cluster-randomized, faith-based, culturally-sensitive, theory-based multicomponent behavioral intervention trial to reduce key stroke risk factor behaviors in Hispanics/Latinos and European Americans. Methods Ten Catholic churches were randomized to intervention or control group. The intervention group received a 1-year multicomponent intervention (with poor adherence) that included self-help materials, tailored newsletters, and motivational interviewing counseling calls. Multilevel modeling, accounting for clustering within subject pairs and parishes, was used to test treatment differences in the average change since baseline (ascertained at 6 and 12 months) in dietary sodium, fruit and vegetable intake, and physical activity, measured using standardized questionnaires. A priori, the trial was considered successful if any one of the three outcomes was significant at the 0.05/3 level. Results Of 801 subjects who consented, 760 completed baseline data assessments, and of these, 86% completed at least one outcome assessment. The median age was 53; 84% were Hispanic/Latino; 64% were women. The intervention group had a greater increase in fruit and vegetable intake than the control group (0.25 cups per day (95% CI: 0.08, 0.42), p = 0.002), a greater decrease in sodium intake (−123.17 mg/day (−194.76, −51.59), p=0.04), but no difference in change in moderate or greater intensity physical activity (−27 MET-minutes per week (−526, 471), p=0.56). Conclusions This multicomponent behavioral intervention targeting stroke risk factors in predominantly Hispanics/Latinos was effective in increasing fruit and vegetable intake, reaching its primary endpoint. The intervention also seemed to lower sodium intake. Church-based health promotions can be successful in primary stroke prevention efforts. PMID:26374480

  4. Efficacy of Personalized Normative Feedback as a Brief Intervention for College Student Gambling: A Randomized Controlled Trial

    PubMed Central

    Neighbors, Clayton; Rodriguez, Lindsey M.; Rinker, Dipali V.; Agana, Maigen; Gonzales, Rubi G.; Tackett, Jennifer L.; Foster, Dawn W.

    2016-01-01

    Objective Social influences on gambling among adolescents and adults have been well documented and may be particularly evident among college students, who have higher rates of problem and pathological gambling relative to the general population. Personalized normative feedback (PNF) is a brief intervention designed to correct misperceptions regarding the prevalence of problematic behavior by showing individuals engaging in such behaviors that their own behavior is atypical with respect to actual norms. The current randomized controlled trial evaluated a computer-delivered PNF intervention for problem gambling college students. Method Following a baseline assessment, 252 college student gamblers scoring 2+ on the South Oaks Gambling Screen (SOGS) were randomly assigned to receive PNF or attention-control feedback. Follow-up assessments were completed 3 and 6 months postintervention. Results Results indicated significant intervention effects in reducing perceived norms for quantities lost and won, and in reducing actual quantity lost and gambling problems at the 3-month follow-up. All intervention effects except reduced gambling problems remained at the 6-month follow-up. Mediation results indicated that changes in perceived norms at 3 months mediated the intervention effects. Further, the intervention effects were moderated by self-identification with other student gamblers, suggesting that PNF worked better at reducing gambling for those who more strongly identified with other student gamblers. Conclusions Results support the use of PNF as a stand-alone brief intervention for at-risk gambling students. Extending this approach more broadly may provide an accessible, empirically supported gambling prevention option for universities and related institutions. PMID:26009785

  5. Child Support Grant access and receipt among 12-week-old infants in an urban township setting in South Africa

    PubMed Central

    Zembe-Mkabile, Wanga; Doherty, Tanya; Sanders, David; Jackson, Debra

    2014-01-01

    Background Cash transfers (CTs) are increasingly used as a strategy to alleviate poverty and improve child health outcomes in low- and middle-income countries. The Child Support Grant (CSG) is the largest CT programme in South Africa, and on the continent, targeting poor children from birth until the age of 18 with a monthly sum of R300 (USD30). Evidence on the CSG shows that early receipt of the grant is associated with improved child health outcomes. Since its implementation, one of the major concerns about the grant has been take-up rates, particularly for younger children. This paper reports results on take-up rates for 12-week-old infants residing in an urban township in South Africa. Methods This is a descriptive study utilising data from a community-based, cluster-randomised trial which evaluated a programme providing pregnancy and post-natal home visits by community health workers to 3,494 mothers in Umlazi township, South Africa. Results At the 12-week visit, half (52%) of the mothers who had enrolled in the study had applied for the CSG on behalf of their children, while 85% of the mothers who had not applied were still planning to apply. Only 38% (1,327) of all children had received the CSG. Conclusions In this study, many mothers had not applied for the CSG in the first few months after delivery, and only a third of children had accessed the grant. Further research is needed to understand what the current barriers are that prevent mothers from applying for this important form of social protection in the early months after delivery. PMID:25160516

  6. Psychological correlates of performance in female athletes during a 12-week off-season strength and conditioning program.

    PubMed

    Jones, Margaret T; Matthews, Tracey D; Murray, Mimi; Van Raalte, Judy; Jensen, Barbara E

    2010-03-01

    Examination of the relationship between performance testing and psychological measures before and after a 12-week strength and conditioning program was the study's purpose. Female NCAA Division-III soccer (n = 28), field hockey (n = 28), and softball (n = 19) athletes completed pre- and post-testing held 12 weeks apart. On day 1, athletes completed informed consent, 3 psychological measures (Profile of Mood States [POMS], Physical Self Perception Profile [PSPP], and Athlete's Self Perception of Physical Abilities [ASPPA]), and 2 strength tests (1 repetition maximum [1RM] bench, 1RM back squat). Day 2 consisted of the 30-yd sprint, pro agility run (PRO), vertical jump (VJ), and standing long jump (SLJ). All sports improved (p < 0.01) in 1RM bench and squat and reported increases in perceived Physical Strength on the PSPP (p < 0.01). Soccer athletes improved (p < 0.01) in VJ, SLJ, and PRO (p < 0.05). No differences were found in POMS scores. The POMS scores indicated that the athletes were not overtrained or experiencing staleness. A series of correlations showed relationships between physical and psychological measures. Specifically, Physical Strength was correlated with 1RM upper-body (r = 0.49, p < 0.01) and lower-body (r = 0.42, p < 0.01) strength. The PSPP Physical Strength was correlated with ASPPA ratings of upper-body (r = 0.68, p < 0.01) and lower-body (r = 0.57, p < 0.01) strength. The PSPP Sport Competence correlated with ASPPA ratings of power (r = 0.45, p < 0.01) and PRO (r = 0.38, p < 0.05). The study's results highlight the benefits of strength and conditioning. Furthermore, these results demonstrate how physical changes are related to athletes' physical self-perceptions and self-assessment of ability within their teams.

  7. The effect of a structured intervention on caregivers of patients with dementia and problem behaviors: a randomized controlled pilot study.

    PubMed

    Nobili, Alessandro; Riva, Emma; Tettamanti, Mauro; Lucca, Ugo; Liscio, Mariarosaria; Petrucci, Bianca; Porro, Gabriella Salvini

    2004-01-01

    The objective was to assess the effect of a structured intervention on caregiver stress and the institutionalization rate of patients with dementia and problem behaviors. Caregivers contacting the Federazione Alzheimer Italia (AI) to receive help, advice, or information in relation to problem behaviors of outpatients were enrolled. Eligible caregiver-patient dyads were randomized to receive either a structured intervention or the counseling AI usually provides (control group). After basal assessment, families were reassessed at 6 and 12 months. Problem behavior (particularly agitation) was the only variable significantly correlated (P = 0.006) with the baseline caregivers' stress score. Thirty-nine families completed the 12-month follow-up; the mean problem behavior score was significantly lower in the intervention than the control group (p < 0.03); the time needed for care of the patient increased by 0.5 +/- 9.7 hours/day in the control group and decreased by 0.3 +/- 4.1 in the intervention group (p = 0.4, Wilcoxon test). The main determinant of institutionalization seemed to be the level of caregiver stress (p = 0.03). In patients of the intervention group, there was a significant reduction in the frequency of delusions. This pilot study suggests that caregiver stress is relieved by a structured intervention. The number of families lost to follow-up, the relatively short duration of the study, and the ceiling effect due to the severity of the clinical characteristics of patients probably all partly dilute the observed findings.

  8. Can Genetics Predict Response to Complex Behavioral Interventions? Evidence from a Genetic Analysis of the Fast Track Randomized Control Trial

    PubMed Central

    Albert, Dustin; Belsky, Daniel W.; Crowley, D. Max; Latendresse, Shawn J.; Aliev, Fazil; Riley, Brien; Sun, Cuie; Dick, Danielle M.; Dodge, Kenneth R.

    2014-01-01

    Early interventions are a preferred method for addressing behavioral problems in high-risk children, but often have only modest effects. Identifying sources of variation in intervention effects can suggest means to improve efficiency. One potential source of such variation is the genome. We conducted a genetic analysis of the Fast Track Randomized Control Trial, a 10-year-long intervention to prevent high-risk kindergarteners from developing adult externalizing problems including substance abuse and antisocial behavior. We tested whether variants of the glucocorticoid receptor gene NR3C1 were associated with differences in response to the Fast Track intervention. We found that in European-American children, a variant of NR3C1 identified by the single-nucleotide polymorphism rs10482672 was associated with increased risk for externalizing psychopathology in control group children and decreased risk for externalizing psychopathology in intervention group children. Variation in NR3C1 measured in this study was not associated with differential intervention response in African-American children. We discuss implications for efforts to prevent externalizing problems in high-risk children and for public policy in the genomic era. PMID:26106668

  9. Using online computer tailoring to promote physical activity: a randomized trial of text, video, and combined intervention delivery modes.

    PubMed

    Soetens, Katja C M; Vandelanotte, Corneel; de Vries, Hein; Mummery, Kerry W

    2014-12-01

    Website-delivered interventions are increasingly used to deliver physical activity interventions, yet problems with engagement and retention result in reduced effectiveness. Hence, alternative modes of online intervention delivery need to be explored. Therefore, this study aimed to evaluate the acceptability and effectiveness of a computer-tailored physical activity intervention delivered on the Internet in 3 delivery modes: video, text, or both. Australian adults (N = 803), recruited through e-mail, were randomized into the three delivery modes and received personal physical activity advice. Intervention content was identical across groups. Repeated measures analyses of variance were used to compare the three groups regarding acceptability, website usability, and physical activity. Participants in the video group accepted the content of the physical activity advice significantly better (F = 5.59; p < .01), and spent significantly more time on the website (F = 21.19; p < .001) compared with the text and combination groups. Total physical activity improved significantly over time in all groups (F = 3.95; p < .01). Although the combination group increased physical activity the most, few significant differences between groups were observed. Providing video-tailored feedback has advantages over the conventional text-tailored interventions; however, this study revealed few behavioral differences. More studies, examining alternative delivery modes, that can overcome the limitations of the present study, are needed.

  10. A Randomized Phase I Trial of a Brief Computer-Delivered Intervention for Alcohol Use During Pregnancy

    PubMed Central

    Sokol, Robert J.; Ondersma, Steven J.

    2011-01-01

    Abstract Background Drinking alcohol during pregnancy has a range of negative consequences for the developing fetus. Screening and brief intervention approaches have significant promise, but their population impact may be limited by a range of challenges to implementation. We, therefore, conducted preliminary acceptability and feasibility evaluation of a computer-delivered brief intervention for alcohol use during pregnancy. Methods Participants were 50 pregnant women who screened positive for risky drinking during a routine prenatal clinic visit and were randomly assigned to computer-delivered brief intervention or assessment-only conditions. Results Ratings of intervention ease of use, helpfulness, and other factors were high (4.7–5.0 on a 1–5 scale). Participants in both conditions significantly decreased alcohol use at follow-up, with no group differences; however, birth weights for infants born to women in the intervention group were significantly higher (p<0.05, d = 0.62). Conclusions Further development and study of computer-delivered screening and intervention for alcohol use during pregnancy are warranted. PMID:21823917

  11. Effects of a Randomized Reading Intervention Study Aimed at 9-Year-Olds: A 5-Year Follow-up.

    PubMed

    Wolff, Ulrika

    2016-05-01

    The present paper reports on a 5-year follow-up of a randomized reading intervention in grade 3 in Sweden. An intervention group (n = 57) received daily training for 12 weeks in phoneme/grapheme mapping, reading comprehension and reading speed, whereas a control group (n = 55) participated in ordinary classroom activities. The main aim was to investigate if there were remaining effects of the intervention on reading-related skills. Previous analyses showed that the intervention group performed significantly better than the control group on spelling, reading speed, reading comprehension and phoneme awareness at the immediate post-test with sustained effects 1 year later. Results from the 5-year follow-up show that the only significant difference between the intervention (n = 47) and the control group (n = 37) was on word decoding. There was also a significant interaction effect of group assignment and initial word decoding, in the way that the lowest-performing students benefitted the most from the intervention. Another aim was to examine if the children identified in a screening (n = 2212) as poor readers in grade 2 still performed worse than typical readers. The analyses showed that the typically developing students (n = 66) outperformed the students identified as poor readers in grade 2 on working memory, spelling, reading comprehension and word decoding. Copyright © 2016 John Wiley & Sons, Ltd. PMID:27146373

  12. Can Genetics Predict Response to Complex Behavioral Interventions? Evidence from a Genetic Analysis of the Fast Track Randomized Control Trial.

    PubMed

    Albert, Dustin; Belsky, Daniel W; Crowley, D Max; Latendresse, Shawn J; Aliev, Fazil; Riley, Brien; Sun, Cuie; Dick, Danielle M; Dodge, Kenneth A

    2015-01-01

    Early interventions are a preferred method for addressing behavioral problems in high-risk children, but often have only modest effects. Identifying sources of variation in intervention effects can suggest means to improve efficiency. One potential source of such variation is the genome. We conducted a genetic analysis of the Fast Track randomized control trial, a 10-year-long intervention to prevent high-risk kindergarteners from developing adult externalizing problems including substance abuse and antisocial behavior. We tested whether variants of the glucocorticoid receptor gene NR3C1 were associated with differences in response to the Fast Track intervention. We found that in European-American children, a variant of NR3C1 identified by the single-nucleotide polymorphism rs10482672 was associated with increased risk for externalizing psychopathology in control group children and decreased risk for externalizing psychopathology in intervention group children. Variation in NR3C1 measured in this study was not associated with differential intervention response in African-American children. We discuss implications for efforts to prevent externalizing problems in high-risk children and for public policy in the genomic era.

  13. Parent-Directed Intervention for Children With Cancer-Related Neurobehavioral Late Effects: A Randomized Pilot Study

    PubMed Central

    Ross, Paula; Cuevas, Michelle; Turk, Anne; Kim, Heeyoung; Lo, Tracy T. Y.; Wong, Lennie F.; Bhatia, Smita

    2014-01-01

    Objective To evaluate feasibility and preliminary efficacy of an intervention directed at parents of childhood cancer survivors (CCSs) with neurobehavioral late effects to improve targeted parenting skills, and thus to indirectly benefit the child’s educational functioning. Methods 44 CCSs and their parents were randomized. Intervention-arm parents participated in eight individual training sessions augmented by a 3-month telephone support period. Pre- and postparent measures and child performance on Wechsler Individual Achievement Test-II and School Motivation and Learning Strategies Inventory assessed intervention effects. Results 90% of intervention parents completed the program with high adherence/perceived benefit. Between-group effect sizes ranged from d = 0.77 to d = 1.45 for parent knowledge, efficacy, frequency of pro-learning behaviors, and d = 0.21 to d = 0.76 for child academic scores. Parental time spent in intervention activities was associated with academic change. Conclusions A parent-directed intervention to indirectly promote academic functioning in CCSs appears feasible and effective in improving targeted parenting outcomes and for selected child academic outcomes. PMID:24966398

  14. Parent-directed intervention for children with cancer-related neurobehavioral late effects: a randomized pilot study.

    PubMed

    Patel, Sunita K; Ross, Paula; Cuevas, Michelle; Turk, Anne; Kim, Heeyoung; Lo, Tracy T Y; Wong, Lennie F; Bhatia, Smita

    2014-10-01

    OBJECTIVE : To evaluate feasibility and preliminary efficacy of an intervention directed at parents of childhood cancer survivors (CCSs) with neurobehavioral late effects to improve targeted parenting skills, and thus to indirectly benefit the child's educational functioning.  METHODS : 44 CCSs and their parents were randomized. Intervention-arm parents participated in eight individual training sessions augmented by a 3-month telephone support period. Pre- and postparent measures and child performance on Wechsler Individual Achievement Test-II and School Motivation and Learning Strategies Inventory assessed intervention effects.  RESULTS : 90% of intervention parents completed the program with high adherence/perceived benefit. Between-group effect sizes ranged from d = 0.77 to d = 1.45 for parent knowledge, efficacy, frequency of pro-learning behaviors, and d = 0.21 to d = 0.76 for child academic scores. Parental time spent in intervention activities was associated with academic change.  CONCLUSIONS : A parent-directed intervention to indirectly promote academic functioning in CCSs appears feasible and effective in improving targeted parenting outcomes and for selected child academic outcomes. PMID:24966398

  15. A Web-Based and Mobile Health Social Support Intervention to Promote Adherence to Inhaled Asthma Medications: Randomized Controlled Trial

    PubMed Central

    Koufopoulos, Justin T; Conner, Mark T; Gardner, Peter H

    2016-01-01

    Background Online communities hold great potential as interventions for health, particularly for the management of chronic illness. The social support that online communities can provide has been associated with positive treatment outcomes, including medication adherence. There are few studies that have attempted to assess whether membership of an online community improves health outcomes using rigorous designs. Objective Our objective was to conduct a rigorous proof-of-concept randomized controlled trial of an online community intervention for improving adherence to asthma medicine. Methods This 9-week intervention included a sample of asthmatic adults from the United Kingdom who were prescribed an inhaled corticosteroid preventer. Participants were recruited via email and randomized to either an “online community” or “no online community” (diary) condition. After each instance of preventer use, participants (N=216) were required to report the number of doses of medication taken in a short post. Those randomized to the online community condition (n=99) could read the posts of other community members, reply, and create their own posts. Participants randomized to the no online community condition (n=117) also posted their medication use, but could not read others’ posts. The main outcome measures were self-reported medication adherence at baseline and follow-up (9 weeks postbaseline) and an objective measure of adherence to the intervention (visits to site). Results In all, 103 participants completed the study (intervention: 37.8%, 39/99; control: 62.2%, 64/117). MANCOVA of self-reported adherence to asthma preventer medicine at follow-up was not significantly different between conditions in either intention-to-treat (P=.92) or per-protocol (P=.68) analysis. Site use was generally higher in the control compared to intervention conditions. Conclusions Joining an online community did not improve adherence to preventer medication for asthma patients. Without

  16. Effectiveness of a Randomized Controlled Lifestyle Intervention to Prevent Obesity among Chinese Primary School Students: CLICK-Obesity Study

    PubMed Central

    Xu, Fei; Ware, Robert S.; Leslie, Eva; Tse, Lap Ah; Wang, Zhiyong; Li, Jiequan; Wang, Youfa

    2015-01-01

    Background Childhood obesity has been increasing rapidly worldwide. There is limited evidence for effective lifestyle interventions to prevent childhood obesity worldwide, especially in developing countries like China. The objective of this study was to assess the effectiveness of a school-based multi-component lifestyle childhood obesity prevention program (the CLICK-Obesity study) in Mainland China. Methods A cluster randomized controlled trial was developed among grade 4 students from 8 urban primary schools (638 students in intervention, 544 as control) in Nanjing City, China. Students were randomly allocated to the control or intervention group at school-level. A one-year multi-component intervention program (classroom curriculum, school environment support, family involvement and fun programs/events) together with routine health education was provided to the intervention group, while the control group received routine health education only. The main outcome variables assessed were changes in body mass index, obesity occurrence, obesity-related lifestyle behaviors and knowledge. Results Overall, 1108 (93.7%) of the 1182 enrolled students completed the intervention study. The intervention group had a larger marginal reduction than did the control group in overall mean BMI value (-0.32±1.36 vs. -0.29±1.40, p = 0.09), although this was not significant. Compared with the control group, the intervention group was more likely to decrease their BMI (OR = 1.44, 95%CI = 1.10, 1.87) by 0.5 kg/m2 or above, increase the frequency of jogging/running (OR = 1.55, 95%CI = 1.18, 2.02), decrease the frequency of TV/computer use (OR = 1.41, 95%CI = 1.09, 1.84) and of red meat consumption (OR = 1.50, 95%CI = 1.15, 1.95), change commuting mode to/from school from sedentary to active mode (OR = 2.24, 95%CI = 1.47, 3.40), and be aware of the harm of selected obesity risk factors. Conclusions The school-based lifestyle intervention program was practical and effective in improving

  17. Improvement in Social Competence Using a Randomized Trial of a Theatre Intervention for Children with Autism Spectrum Disorder

    ERIC Educational Resources Information Center

    Corbett, Blythe A.; Key, Alexandra P.; Qualls, Lydia; Fecteau, Stephanie; Newsom, Cassandra; Coke, Catherine; Yoder, Paul

    2016-01-01

    The efficacy of a peer-mediated, theatre-based intervention on social competence in participants with autism spectrum disorder (ASD) was tested. Thirty 8-to-14 year-olds with ASD were randomly assigned to the treatment (n = 17) or a wait-list control (n = 13) group. Immediately after treatment, group effects were seen on social ability,…

  18. Using community readiness key informant assessments in a randomized group prevention trial: impact of a participatory community-media intervention.

    PubMed

    Slater, Michael D; Edwards, Ruth W; Plested, Barbara A; Thurman, Pamela J; Kelly, Kathleen J; Comello, Maria Leonora G; Keefe, Thomas J

    2005-02-01

    This study examines the role of key informant community readiness assessments in a randomized group trial testing the impact of a participatory community-media intervention (which was also complemented by in-school efforts). These assessments were used to help match communities in random assignment, as a source of formative data about the community, as the basis for a coalition-building workshop, and as an evaluation tool, with a follow-up set of surveys approximately 2 years after the baseline survey. Results of the nested, random effects analysis indicated that the intervention influenced community knowledge of efforts and (at marginally significant levels) improved prevention leadership quality and community climate supportive of prevention efforts. There was evidence that the professional affiliation of informants in some cases had an effect on their assessments, which could be controlled in the analysis. The authors conclude that key informant community readiness assessments can usefully serve to supplement aggregated measures of individual attitudes and behavior (reported elsewhere for this study) in evaluating community-based interventions. PMID:15751598

  19. Neonatal Bathing and Massage Intervention with Fathers, Behavioural Effects 12 Weeks after Birth of the First Baby: The Sunraysia Australia Intervention Project.

    ERIC Educational Resources Information Center

    Scholz, Kim; Samuels, Curtis A.

    1992-01-01

    Examined the effect on father-infant relationships of a parent training program on infant massage and bathing. Infants in the treatment group greeted fathers with more eye contact, smiles, vocalizing, reaching, and orienting responses and showed less avoidance behavior than did control group infants. Fathers in the treatment group showed greater…

  20. 12-week, placebo-controlled trial of add-on riluzole in the treatment of childhood-onset obsessive-compulsive disorder.

    PubMed

    Grant, Paul J; Joseph, Lisa A; Farmer, Cristan A; Luckenbaugh, David A; Lougee, Lorraine C; Zarate, Carlos A; Swedo, Susan E

    2014-05-01

    Many children with childhood-onset obsessive-compulsive disorder (OCD) fail to respond adequately to standard therapies. Evidence from preclinical and clinical studies suggests that the glutamatergic neurotransmitter system might be an alternative treatment target. This study examined the efficacy of riluzole, a glutamatergic modulator, as an adjunctive therapy for children with treatment-resistant OCD. In a 12-week, double-blind, placebo-controlled study, 60 treatment-resistant children and adolescents (mean age=14.5 ± 2.4 years), with moderate to severe OCD (mean Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)=28.2 ± 3.7), 17 of whom also had concomitant autism spectrum disorder, were randomized to receive riluzole (final dose of 100 mg/day) or placebo in addition to the existing treatment regimen. Fifty-nine subjects completed the randomized trial. Primary outcome measures were changes on the CY-BOCS, the Clinical Global Impressions Scale, and the Children's Global Assessment Scale. Riluzole was fairly well tolerated, although it was associated with one case of pancreatitis and five instances of slight increases in transaminases. All subjects showed significant reductions in CY-BOCS scores during treatment; however, there was no significant difference between placebo and riluzole on any of the primary or secondary outcome measures. The study failed to demonstrate superiority of riluzole over placebo as an adjunctive treatment for children with childhood-onset OCD. However, future studies may show benefits for less treatment-refractory children with fewer concomitant medications.

  1. A randomized control trial of a psychosocial intervention for caregivers of allogeneic hematopoietic stem cell transplant patients: Effects on distress

    PubMed Central

    Laudenslager, Mark L.; Simoneau, Teri L.; Kilbourn, Kristin; Natvig, Crystal; Philips, Sam; Spradley, Janet; Benitez, Patrick; McSweeney, Peter; Mikulich-Gilbertson, Susan K.

    2015-01-01

    Caregivers of patients receiving allogeneic hematopoietic stem cell transplants (Allo-HSCT) serve a pivotal role in patient care but experience high stress, anxiety, and depression as a result. We theorized that a stress management adapted for Allo-HSCT caregivers would reduce distress compared to treatment as usual (TAU). From 267 consecutive caregivers of Allo-HSCT patients approached, 148 (mean=53.5 years, 75.7% female) were randomized to either psychosocial intervention (n=74) or TAU (n=74). Eight 1-on-1 stress management sessions delivered across the 100 day post-transplant period focused on understanding stress, changing role(s) as caregiver, cognitive behavioral stress management, pacing respiration, and identifying social support. Primary outcomes included perceived stress (psychological) and salivary cortisol awakening response (CAR) (physiological). Randomized groups were not statistically different at baseline. Mixed models analysis of covariance (intent-to-treat) showed that intervention was associated with significantly lower caregiver stress 3 months post-transplant (Mean=20.0, CI95=17.9-22.0) compared to TAU (Mean=23.0, CI95=21.0-25.0) with an effect size (ES) of 0.39 (p=0.039). Secondary psychological outcomes, including depression and anxiety, were significantly reduced with ESs of 0.46 and 0.66 respectively. Caregiver CAR did not differ from non-caregiving controls at baseline and was unchanged by intervention. Despite significant caregiving burden, this psychosocial intervention significantly mitigated distress in Allo-HSCT caregivers. PMID:25961767

  2. A Multilingual Mass Communication Intervention for Seniors and People with Disabilities on Medicaid: A Randomized Controlled Trial

    PubMed Central

    Kurtovich, Elaine; Ivey, Susan L; Neuhauser, Linda; Graham, Carrie; Constantine, Wendy; Barkan, Howard

    2010-01-01

    Objectives To evaluate the following: (1) baseline knowledge, attitudes, and behavioral intentions about Medicaid managed care (MMC) among seniors and people with disabilities (SPD) receiving Medicaid benefits; (2) SPD Medicaid beneficiaries' use of and satisfaction with a user-designed MMC guidebook; and (3) guidebook effects on changes in MMC knowledge, attitudes, and intended behaviors of SPD beneficiaries. Data Sources/Study Setting Survey data collected between February and May 2008 from a random sample of SPD receiving Medicaid benefits in three California counties. Study Design This randomized controlled trial of 319 intervention and 373 control SPD Medicaid beneficiaries used pre- and postintervention telephone surveys to compare changes in MMC knowledge, attitudes, and intended behaviors. Data Collection Methods Baseline and follow-up telephone interviews were conducted in English, Spanish, Cantonese, and Mandarin. Principal Findings Seventy-seven percent of intervention participants reported using the guidebook. Nearly all (97.9 percent) found it somewhat or very useful. Intervention participants showed gains in knowledge, positive attitudes, and intentions to enroll in MMC that are statistically significant compared with control participants. However, knowledge levels remained low even among intervention participants. Conclusions Findings suggest that the guidebook is an effective way to improve recipients' MMC knowledge, confidence, and behavioral intentions. PMID:20070389

  3. A case management intervention targeted to reduce healthcare consumption for frequent Emergency Department visitors: results from an adaptive randomized trial

    PubMed Central

    Anderson, Jacqueline; Dolk, Anders; Torgerson, Jarl; Nyberg, Svante; Skau, Tommy; Forsberg, Birger C.; Werr, Joachim; Öhlen, Gunnar

    2016-01-01

    Background A small group of frequent visitors to Emergency Departments accounts for a disproportionally large fraction of healthcare consumption including unplanned hospitalizations and overall healthcare costs. In response, several case and disease management programs aimed at reducing healthcare consumption in this group have been tested; however, results vary widely. Objectives To investigate whether a telephone-based, nurse-led case management intervention can reduce healthcare consumption for frequent Emergency Department visitors in a large-scale setup. Methods A total of 12 181 frequent Emergency Department users in three counties in Sweden were randomized using Zelen’s design or a traditional randomized design to receive either a nurse-led case management intervention or no intervention, and were followed for healthcare consumption for up to 2 years. Results The traditional design showed an overall 12% (95% confidence interval 4–19%) decreased rate of hospitalization, which was mostly driven by effects in the last year. Similar results were achieved in the Zelen studies, with a significant reduction in hospitalization in the last year, but mixed results in the early development of the project. Conclusion Our study provides evidence that a carefully designed telephone-based intervention with accurate and systematic patient selection and appropriate staff training in a centralized setup can lead to significant decreases in healthcare consumption and costs. Further, our results also show that the effects are sensitive to the delivery model chosen. PMID:25969342

  4. 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

  5. Effectiveness of specific factors in community-based intervention for child-witnesses of interparental violence: a randomized trial.

    PubMed

    Overbeek, Mathilde M; de Schipper, J Clasien; Lamers-Winkelman, Francien; Schuengel, Carlo

    2013-12-01

    A community-based intervention with specific factors for children and parents exposed to interparental violence (IPV) was compared with a control intervention based on non-specific factors. We hypothesized that participation in an intervention with specific factors, focused on IPV, parenting and coping, would be associated with better recovery. IPV exposed children and parents were group randomized over a specific factors- and control intervention. Baseline, posttest and follow-up measurements of 155 parents and children (aged 6-12 years, 55.5% boys) were fitted in a multilevel model. Outcomes were parent and teacher reported children's internalizing and externalizing problems (CBCL, TRF), child self-reported depressive symptoms (CDI) and parent and child reported children's post-traumatic stress symptoms (TSCYC, TSCC). Based on intention-to-treat and completer analyses, children in the specific factors intervention did not show better recovery than children in the control intervention. Children in both interventions decreased significantly in parent-reported children's internalizing and externalizing problems and post-traumatic stress symptoms. Children reported a decrease in their mean level of depressive and post-traumatic stress symptoms. Teachers reported a decrease in internalizing problems, but not in externalizing problems. No association between time since exposure and level and course of symptoms was found. Treatment differentiation was assessed and both programs were significantly different on hypothesized effective factors. Higher treatment adherence in both programs did not result in a larger difference in recovery. IPV exposed children improve over the course and after participating in a community-based child- and parent program, but specific factors in intervention may not carry additional benefits when implemented in community settings.

  6. Reduction in sick leave by a workplace educational low back pain intervention: A cluster randomized controlled trial

    PubMed Central

    Ree, Eline; Lie, Stein Atle; Eriksen, Hege R.; Malterud, Kirsti; Indahl, Aage; Samdal, Oddrun; Harris, Anette

    2016-01-01

    Aims: The aim of this study was to investigate whether a workplace educational low back pain intervention had an effect on sick leave at the individual level and to identify possible predictors of the effect of intervention. Methods: Work units in two municipalities were cluster randomized to (a) educational meetings and peer support (45 units), (b) educational meetings, peer support and access to an outpatient clinic if needed (48 units) or (c) a control group (42 units). Both intervention groups attended educational meetings with information about back pain based on a non-injury model. A peer adviser was selected from among their colleagues. The outcome was days of sick leave at the individual level at 3, 6, 9 and 12 months, adjusting for previous sick leave at the unit level. As a result of similar effects on sick leave, the two intervention groups were merged (n=646) and compared with the control group (n=211). The predictors were different levels of belief in back pain myths, pain-related fear, helplessness/hopelessness and low back pain. Results: The intervention group had significantly less days of sick leave at the three month (4.9 days, p=0.001) and six month (4.4 days, p=0.016) follow ups compared with the control group. At three months, a low level of pain-related fear was the only predictor for the intervention effect (8.0 less days of sick leave, p<0.001). Conclusions: A workplace educational back pain intervention had an effect on sick leave for up to six months. A low score on pain-related fear was a predictor of the intervention effect. PMID:27307465

  7. A randomized pilot trial of a telephone-based couples intervention for physical intimacy and sexual concerns in colorectal cancer

    PubMed Central

    Reese, Jennifer Barsky; Porter, Laura S.; Regan, Katelyn R.; Keefe, Francis J.; Azad, Nilofer S.; Diaz, Luis A.; Herman, Joseph M.; Haythomthwaite, Jennifer A.

    2015-01-01

    Background We previously developed and piloted a telephone-based intimacy enhancement (IE) intervention addressing sexual concerns of colorectal cancer patients and their partners in an uncontrolled study. The current study tested the feasibility, acceptability, and preliminary efficacy of the IE intervention in a randomized, controlled trial. Methods Twenty-three couples were randomized to either the four-session IE condition or to a wait list control condition and completed sexual and relationship outcomes measures. The IE intervention teaches skills for coping with sexual concerns and improving intimacy. Feasibility and acceptability were assessed through enrollment and post-treatment program evaluations, respectively. Effect sizes were calculated by comparing differences in average pre/post change scores across completers in the two groups (n = 18 couples). Results Recruitment and attrition data supported feasibility. Program evaluations for process (e.g., ease of participation) and content (e.g., relevance) demonstrated acceptability. Engaging in intimacy-building activities and communication were the skills rated as most commonly practiced and most helpful. For patients, positive effects of the IE intervention were found for female and male sexual function, medical impact on sexual function, and self-efficacy for enjoying intimacy (≥.58); no effects were found on sexual distress or intimacy and small negative effects for sexual communication, and two self-efficacy items. For partners, positive IE effects were found for all outcomes; the largest were for sexual distress (.69), male sexual function (1.76), communication (.97), and two self-efficacy items (≥.87). Conclusions The telephone-based IE intervention shows promise for couples facing colorectal cancer. Larger multi-site intervention studies are necessary to replicate findings. PMID:24615831

  8. Efficacy of a brief multifactorial adherence-based intervention in reducing blood pressure: a randomized clinical trial

    PubMed Central

    Leiva, Alfonso; Aguiló, Antonio; Fajó-Pascual, Marta; Moreno, Lucia; Martín, Mª Carmen; Garcia, Elena Marina; Duro, Rosa Elena; Serra, Francisca; Dagosto, Pilar; Iglesias-Iglesias, Ana Aurelia; Company, Rosa Maria; Yañez, Aina; Llobera, Joan

    2014-01-01

    Background Lowering blood pressure (BP) by antihypertensive (AHT) drugs reduces the risks of cardiovascular events, stroke, and total mortality. However, poor adherence to AHT medications reduces their effectiveness and increases the risk of adverse events. Objective To evaluate the effectiveness of a multifactorial adherence-based intervention in a primary care setting in lowering BP. Methods/design Multicenter parallel randomized controlled trial. Thirty two nurses in 28 primary care centers of three Spanish regions. Patients aged 18–80 years, taking AHT drugs with uncontrolled BP (n=221) were randomized to a control group (usual care) or a multifactorial adherence-based intervention including nurse-led motivational interviews, pill reminders, family support, BP self-recording, and simplification of the dosing regimen by a pharmacist. Main outcome measures The primary outcome was 12-month blinded measure of systolic BP (mean of three measurements). The secondary outcomes were 12-month diastolic BP and proportion of patients with adequately controlled BP. Results One hundred and fourteen patients were allocated to the intervention group and 109 to the control group. At 12 months, 212 (89%) participants completed the study. The systolic BP in the intervention group was 151.3 versus 153.7 in the control group (P=0.294). The diastolic BP did not differ between groups (83.4 versus 83.6). Of the patients in the control group, 9.2% achieved BP control versus a 15.8% in the intervention group. The relative risk for achieving BP control was 1.72 (95% confidence interval: 0.83–3.56). Conclusion A multifactorial intervention based on improving adherence in patients with uncontrolled hypertension failed to find evidence of effectiveness in lowering systolic BP. Trial registration ISRCTN21229328. PMID:25525344

  9. Family Ties to Health Program: A Randomized Intervention to Improve Vegetable Intake in Children

    ERIC Educational Resources Information Center

    Tabak, Rachel G.; Tate, Deborah F.; Stevens, June; Siega-Riz, Anna Maria; Ward, Dianne S.

    2012-01-01

    Objective: Evaluate a home-based intervention targeted toward parents to improve vegetable intake in preschool-aged children. Methods: Four-month feasibility study of home-based intervention consisting of 4 tailored newsletters and 2 motivational phone calls compared to control; 4 children's books for the control group; and measured pre and post…

  10. Efficacy of a Reading and Language Intervention for Children with Down Syndrome: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Burgoyne, Kelly; Duff, Fiona J.; Clarke, Paula J.; Buckley, Sue; Snowling, Margaret J.; Hulme, Charles

    2012-01-01

    Background: This study evaluates the effects of a language and literacy intervention for children with Down syndrome. Methods: Teaching assistants (TAs) were trained to deliver a reading and language intervention to children in individual daily 40-min sessions. We used a waiting list control design, in which half the sample received the…

  11. A Family-School Intervention for Children with ADHD: Results of a Randomized Clinical Trial

    ERIC Educational Resources Information Center

    Power, Thomas J.; Mautone, Jennifer A.; Soffer, Stephen L.; Clarke, Angela T.; Marshall, Stephen A.; Sharman, Jaclyn; Blum, Nathan J.; Glanzman, Marianne; Elia, Josephine; Jawad, Abbas F.

    2012-01-01

    Objective: Accumulating evidence highlights the importance of using psychosocial approaches to intervention for children with attention-deficit/hyperactivity disorder (ADHD) that target the family and school, as well as the intersection of family and school. This study evaluated the effectiveness of a family-school intervention, Family-School…

  12. A randomized clinical trial of a coping improvement group intervention for HIV-infected older adults

    PubMed Central

    Sikkema, Kathleen J.; Hansen, Nathan; Kochman, Arlene; Heh, Victor; Neufeld, Sharon

    2011-01-01

    This research tested if a 12-session coping improvement group intervention (n = 104) reduced depressive symptoms in HIV-infected older adults compared to an interpersonal support group intervention (n = 105) and an individual therapy upon request (ITUR) control condition (n = 86). Participants were 295 HIV-infected men and women 50-plus years of age living in New York City, Cincinnati, OH, and Columbus, OH. Using A-CASI assessment methodology, participants provided data on their depressive symptoms using the Geriatric Depression Screening Scale (GDS) at pre-intervention, post-intervention, and 4- and 8-month follow-up. Whether conducted with all participants (N = 295) or only a subset of participants diagnosed with mild, moderate, or severe depressive symptoms (N = 171), mixed models analyses of repeated measures found that both coping improvement and interpersonal support group intervention participants reported fewer depressive symptoms than ITUR controls at post-intervention, 4-month follow-up, and 8-month follow-up. The effect sizes of the differences between the two active interventions and the control group were greater when outcome analyses were limited to those participants with mild, moderate, or severe depressive symptoms. At no assessment period did coping improvement and interpersonal support group intervention participants differ in depressive symptoms. PMID:20857188

  13. A randomized clinical trial of a coping improvement group intervention for HIV-infected older adults.

    PubMed

    Heckman, Timothy G; Sikkema, Kathleen J; Hansen, Nathan; Kochman, Arlene; Heh, Victor; Neufeld, Sharon

    2011-04-01

    This research tested if a 12-session coping improvement group intervention (n = 104) reduced depressive symptoms in HIV-infected older adults compared to an interpersonal support group intervention (n = 105) and an individual therapy upon request (ITUR) control condition (n = 86). Participants were 295 HIV-infected men and women 50-plus years of age living in New York City, Cincinnati, OH, and Columbus, OH. Using A-CASI assessment methodology, participants provided data on their depressive symptoms using the Geriatric Depression Screening Scale (GDS) at pre-intervention, post-intervention, and 4- and 8-month follow-up. Whether conducted with all participants (N = 295) or only a subset of participants diagnosed with mild, moderate, or severe depressive symptoms (N = 171), mixed models analyses of repeated measures found that both coping improvement and interpersonal support group intervention participants reported fewer depressive symptoms than ITUR controls at post-intervention, 4-month follow-up, and 8-month follow-up. The effect sizes of the differences between the two active interventions and the control group were greater when outcome analyses were limited to those participants with mild, moderate, or severe depressive symptoms. At no assessment period did coping improvement and interpersonal support group intervention participants differ in depressive symptoms.

  14. A Novel Early Intervention for Preschool Depression: Findings from a Pilot Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Luby, Joan; Lenze, Shannon; Tillman, Rebecca

    2012-01-01

    Background: Validation for depression in preschool children has been established; however, to date no empirical investigations of interventions for the early onset disorder have been conducted. Based on this and the modest efficacy of available treatments for childhood depression, the need for novel early interventions has been emphasized. Large…

  15. A Randomized Controlled Trial of Preschool-Based Joint Attention Intervention for Children with Autism

    ERIC Educational Resources Information Center

    Kaale, Anett; Smith, Lars; Sponheim, Eili

    2012-01-01

    Background: Deficits in joint attention (JA) and joint engagement (JE) represent a core problem in young children with autism as these affect language and social development. Studies of parent-mediated and specialist-mediated JA-intervention suggest that such intervention may be effective. However, there is little knowledge about the success of…

  16. Evaluation of the Effectiveness of a Psychoeducational Intervention in Treatment-Naïve Patients with Antidepressant Medication in Primary Care: A Randomized Controlled Trial

    PubMed Central

    Casañas, R.; Catalán, R.; Penadés, R.; Real, J.; Valero, S.; Muñoz, MA.; Lalucat-Jo, LL.; Casas, M.

    2015-01-01

    Background. There is evidence supporting the effectiveness of psychoeducation (PE) in patients with symptoms of depression in primary care (PC), but very few studies have assessed this intervention in antidepressant-naïve patients. The aim of this study is to assess the effectiveness of a PE program in these patients, since the use of antidepressant (AD) medication may interfere with the effects of the intervention. Methods. 106 participants were included, 50 from the PE program (12 weekly 1.5-hour sessions) and 56 from the control group (CG) that received the usual care. Patients were assessed at baseline and at 3, 6, and 9 months. The main outcome measures were the Beck Depression Inventory (BDI) and remission based on the BDI. The analysis was carried out on an intention-to-treat basis. Results. The PE program group showed remission of symptoms of 40% (P = 0.001) posttreatment and 42% (P = 0.012) at 6 months. The analysis only showed significant differences in the BDI score posttreatment (P = 0.008; effect size Cohen's d′ = 0.55). Conclusions. The PE intervention is an effective treatment in the depressive population not treated with AD medication. Before taking an AD, psychoeducational intervention should be considered. PMID:26380366

  17. A participatory parent-focused intervention promoting physical activity in preschools: design of a cluster-randomized trial

    PubMed Central

    2010-01-01

    Background With rates of childhood obesity increasing, physical activity (PA) promotion especially in young children has assumed greater importance. Given the limited effectiveness of most interventions to date, new approaches are needed. The General Systems theory suggests that involving parents as intervention targets may be effective in fostering healthier life styles in children. We describe the development of a parent-focused participatory intervention and the procedures used to evaluate its effectiveness in increasing daily PA in preschoolers. Methods/Design Thirty-seven South German preschools were identified for this study and agreed to participate. Using a two-armed, controlled cluster-randomized trial design we test a participatory intervention with parents as the primary target group and potential agents of behavioural change. Specifically, the intervention is designed to engage parents in the development, refinement and selection of project ideas to promote PA and in incorporating these ideas into daily routines within the preschool community, consisting of children, teachers and parents. Our study is embedded within an existing state-sponsored programme providing structured gym lessons to preschool children. Thus, child-based PA outcomes from the study arm with the parent-focused intervention and the state-sponsored programme are compared with those from the study arm with the state-sponsored programme alone. The evaluation entails baseline measurements of study outcomes as well as follow-up measurements at 6 and 12 months. Accelerometry measures PA intensity over a period of six days, with the mean over six days used as the primary outcome measure. Secondary outcomes include childrens' BMI, a sum of averaged skin fold thickness measurements across multiple sites, and PA behaviour. Longitudinal multilevel models are used to assess within-subject change and between-group differences in study outcomes, adjusted for covariates at the preschool and

  18. Action 3:30: protocol for a randomized feasibility trial of a teaching assistant led extracurricular physical activity intervention

    PubMed Central

    2013-01-01

    Background Many children do not meet physical activity (PA) guidelines. Extracurricular programmes could provide a mechanism to increase the PA levels of primary-school-aged children. Teaching assistants (TAs) are a valuable resource in all UK primary schools and could be trained to delivery after-school PA programmes. The aim of this feasibility study is to examine whether the Action 3:30 PA intervention, which is delivered by TAs, could be effective in increasing the PA of Year 5 and 6 children. Methods/Design A feasibility trial will be conducted in 20 primary schools. Schools will be randomly assigned to intervention or control arms. Intervention schools will receive a 25-hour TA training programme for two TAs, a first-aid certificate course for two TAs; ongoing TA support; 40 one-hour session plans that can be delivered by TAs; Action 3:30 clubs that run twice a week for 20 weeks; and ten sets of parent information sheets that are distributed biweekly. All measures will be assessed at baseline (Time 0), at the end of the intervention period (Time 1) and four months after the intervention has ended (Time 2). As this is a feasibility study, our primary interest is in estimating the recruitment of schools and children, adherence to the intervention, and completeness of data collection for outcomes and costs. As the most likely primary outcome measure in a future definitive trial will be accelerometer-determined minutes of moderate-to-vigorous PA (MVPA) per day, participants will wear accelerometers for five days (including two weekend days). Several psychosocial variables that could act as mediators in a future trial will be assessed via a questionnaire. Process evaluations of the session attendance, perceived enjoyment and perceived exertion will be assessed during the intervention. At the end of the intervention period, qualitative assessments will be conducted to identify how the programme could be improved before proceeding to a larger trial. Discussion The

  19. Adolescent depressive disorders and family based interventions in the family options multicenter evaluation: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background There is increasing community and government recognition of the magnitude and impact of adolescent depression. Family based interventions have significant potential to address known risk factors for adolescent depression and could be an effective way of engaging adolescents in treatment. The evidence for family based treatments of adolescent depression is not well developed. The objective of this clinical trial is to determine whether a family based intervention can reduce rates of unipolar depressive disorders in adolescents, improve family functioning and engage adolescents who are reluctant to access mental health services. Methods/Design The Family Options study will determine whether a manualized family based intervention designed to target both individual and family based factors in adolescent depression (BEST MOOD) will be more effective in reducing unipolar depressive disorders than an active (standard practice) control condition consisting of a parenting group using supportive techniques (PAST). The study is a multicenter effectiveness randomized controlled trial. Both interventions are delivered in group format over eight weekly sessions, of two hours per session. We will recruit 160 adolescents (12 to 18 years old) and their families, randomized equally to each treatment condition. Participants will be assessed at baseline, eight weeks and 20 weeks. Assessment of eligibility and primary outcome will be conducted using the KID-SCID structured clinical interview via adolescent and parent self-report. Assessments of family mental health, functioning and therapeutic processes will also be conducted. Data will be analyzed using Multilevel Mixed Modeling accounting for time x treatment effects and random effects for group and family characteristics. This trial is currently recruiting. Challenges in design and implementation to-date are discussed. These include diagnosis and differential diagnosis of mental disorders in the context of adolescent

  20. Effects of Telephone Counseling Intervention by Pharmacists (TelCIP) on Medication Adherence; Results of a Cluster Randomized Trial

    PubMed Central

    Kooij, Marcel J.; Heerdink, Eibert R.; van Dijk, Liset; van Geffen, Erica C. G.; Belitser, Svetlana V.; Bouvy, Marcel L.

    2016-01-01

    Objectives: To assess the effect of a pharmacist telephone counseling intervention on patients' medication adherence. Design: Pragmatic cluster randomized controlled trial. Setting: 53 Community pharmacies in The Netherlands. Participants: Patients ≥18 years initiating treatment with antidepressants, bisphosphonates, Renin-Angiotensin System (RAS)-inhibitors, or statins (lipid lowering drugs). Pharmacies in arm A provided the intervention for antidepressants and bisphosphonates and usual care for RAS-inhibitors and statins. Pharmacies in arm B provided the intervention for RAS-inhibitors and statins and usual care for antidepressants and bisphosphonates. Intervention: Intervention consisted of a telephone counseling intervention 7–21 days after the start of therapy. Counseling included assessment of practical and perceptual barriers and provision of information and motivation. Main outcome measure: Primary outcome was refill adherence measured over 1 year expressed as continuous outcome and dichotomous (refill rate≥80%). Secondary outcome was discontinuation within 1 year. Results: In the control arms 3627 patients were eligible and in the intervention arms 3094 patients. Of the latter, 1054 patients (34%) received the intervention. Intention to treat analysis showed no difference in adherence rates between the intervention and the usual care arm (74.7%, SD 37.5 respectively 74.5%, 37.9). More patients starting with RAS-inhibitors had a refill ratio ≥80% in the intervention arm compared to usual care (81.4 vs. 74.9% with odds ratio (OR) 1.43, 95%CI 1.11–1.99). Comparing patients with counseling to patients with usual care (per protocol analysis), adherence was statistically significant higher for patients starting with RAS-inhibitors, statins and bisphosphonates. Patients initiating antidepressants did not benefit from the intervention. Conclusions: Telephone counseling at start of therapy improved adherence in patients initiating RAS-inhibitors. The per

  1. Effects of Telephone Counseling Intervention by Pharmacists (TelCIP) on Medication Adherence; Results of a Cluster Randomized Trial

    PubMed Central

    Kooij, Marcel J.; Heerdink, Eibert R.; van Dijk, Liset; van Geffen, Erica C. G.; Belitser, Svetlana V.; Bouvy, Marcel L.

    2016-01-01

    Objectives: To assess the effect of a pharmacist telephone counseling intervention on patients' medication adherence. Design: Pragmatic cluster randomized controlled trial. Setting: 53 Community pharmacies in The Netherlands. Participants: Patients ≥18 years initiating treatment with antidepressants, bisphosphonates, Renin-Angiotensin System (RAS)-inhibitors, or statins (lipid lowering drugs). Pharmacies in arm A provided the intervention for antidepressants and bisphosphonates and usual care for RAS-inhibitors and statins. Pharmacies in arm B provided the intervention for RAS-inhibitors and statins and usual care for antidepressants and bisphosphonates. Intervention: Intervention consisted of a telephone counseling intervention 7–21 days after the start of therapy. Counseling included assessment of practical and perceptual barriers and provision of information and motivation. Main outcome measure: Primary outcome was refill adherence measured over 1 year expressed as continuous outcome and dichotomous (refill rate≥80%). Secondary outcome was discontinuation within 1 year. Results: In the control arms 3627 patients were eligible and in the intervention arms 3094 patients. Of the latter, 1054 patients (34%) received the intervention. Intention to treat analysis showed no difference in adherence rates between the intervention and the usual care arm (74.7%, SD 37.5 respectively 74.5%, 37.9). More patients starting with RAS-inhibitors had a refill ratio ≥80% in the intervention arm compared to usual care (81.4 vs. 74.9% with odds ratio (OR) 1.43, 95%CI 1.11–1.99). Comparing patients with counseling to patients with usual care (per protocol analysis), adherence was statistically significant higher for patients starting with RAS-inhibitors, statins and bisphosphonates. Patients initiating antidepressants did not benefit from the intervention. Conclusions: Telephone counseling at start of therapy improved adherence in patients initiating RAS-inhibitors. The per

  2. The effect of complex rehabilitation training for 12 weeks on trunk muscle function and spine deformation of patients with SCI

    PubMed Central

    Sung, Dong-Hun; Yoon, Seong-Deok; Park, Gi Duck

    2015-01-01

    [Purpose] It is important for patients with incomplete spinal cord injury (SCI) to strengthen their muscle strength and return to the work force one of the ultimate objectives of rehabilitation. This study reports how a single patient with SCI became stabilized in terms of abdominal muscles and back extension muscles, as well as returning the back to the neutral position from spinal deformation, as result of complex exercises performed for 12 weeks. [Subjects] The degree of damage of the subject was rated as C grade. The subject of this study had unstable posture due to paralysis in the lower extremities of the left side after removal of a malignant tumor by surgical operation, and tilting and torsion in the pelvis increased followed by increase of kyphosis in the thoracolumbar spine. The subject was more than two years since diagnosis of incomplete SCI after surgery. [Methods] Using isokinetic lumbar muscle strength measurement equipment, peak torque/weight, total work and average power in flexion and extension of the lumbar region were measured. A trunk measurement system (Formetric 4D, DIERS, Germany), which is a 3D image processing apparatus with high resolution for vertebrae, was used in order to measure 3D vertebrae and pelvis deformation as well as static balance abilities. As an exercise method, a foam roller was used to conduct fascia relaxation massage for warming-up, and postural kyphosis was changed into postural lordosis by lat pull-down using equipment, performed in 5 sets of 15 times preset at 60% intensity of 1RM 4 set of 10 crunch exercises per set using Togu’s were done while sitting at the end of Balance pad, and 4 sets of 15 bridge exercises. [Results] All angular speed tests showed a gradual increase in muscle strength. Flexion and extension showed 10% and 3% improvements, respectively. The spine deformation test showed that isokinetic exercise and lat pull-down exercise for 12 weeks resulted in improved spinal shape. [Conclusion] In this

  3. Effects of 12 weeks of aerobic training on autonomic modulation, mucociliary clearance, and aerobic parameters in patients with COPD

    PubMed Central

    Leite, Marceli Rocha; Ramos, Ercy Mara Cipulo; Kalva-Filho, Carlos Augusto; Freire, Ana Paula Coelho Figueira; de Alencar Silva, Bruna Spolador; Nicolino, Juliana; de Toledo-Arruda, Alessandra Choqueta; Papoti, Marcelo; Vanderlei, Luiz Carlos Marques; Ramos, Dionei

    2015-01-01

    Introduction Patients with chronic obstructive pulmonary disease (COPD) exhibit aerobic function, autonomic nervous system, and mucociliary clearance alterations. These parameters can be attenuated by aerobic training, which can be applied with continuous or interval efforts. However, the possible effects of aerobic training, using progressively both continuous and interval sessions (ie, linear periodization), require further investigation. Aim To analyze the effects of 12-week aerobic training using continuous and interval sessions on autonomic modulation, mucociliary clearance, and aerobic function in patients with COPD. Methods Sixteen patients with COPD were divided into an aerobic (continuous and interval) training group (AT) (n=10) and a control group (CG) (n=6). An incremental test (initial speed of 2.0 km·h−1, constant slope of 3%, and increments of 0.5 km·h−1 every 2 minutes) was performed. The training group underwent training for 4 weeks at 60% of the peak velocity reached in the incremental test (vVO2peak) (50 minutes of continuous effort), followed by 4 weeks of sessions at 75% of vVO2peak (30 minutes of continuous effort), and 4 weeks of interval training (5×3-minute effort at vVO2peak, separated by 1 minute of passive recovery). Intensities were adjusted through an incremental test performed at the end of each period. Results The AT presented an increase in the high frequency index (ms2) (P=0.04), peak oxygen uptake (VO2peak) (P=0.01), vVO2peak (P=0.04), and anaerobic threshold (P=0.02). No significant changes were observed in the CG (P>0.21) group. Neither of the groups presented changes in mucociliary clearance after 12 weeks (AT: P=0.94 and CG: P=0.69). Conclusion Twelve weeks of aerobic training (continuous and interval sessions) positively influenced the autonomic modulation and aerobic parameters in patients with COPD. However, mucociliary clearance was not affected by aerobic training. PMID:26648712

  4. The effect of complex rehabilitation training for 12 weeks on trunk muscle function and spine deformation of patients with SCI.

    PubMed

    Sung, Dong-Hun; Yoon, Seong-Deok; Park, Gi Duck

    2015-03-01

    [Purpose] It is important for patients with incomplete spinal cord injury (SCI) to strengthen their muscle strength and return to the work force one of the ultimate objectives of rehabilitation. This study reports how a single patient with SCI became stabilized in terms of abdominal muscles and back extension muscles, as well as returning the back to the neutral position from spinal deformation, as result of complex exercises performed for 12 weeks. [Subjects] The degree of damage of the subject was rated as C grade. The subject of this study had unstable posture due to paralysis in the lower extremities of the left side after removal of a malignant tumor by surgical operation, and tilting and torsion in the pelvis increased followed by increase of kyphosis in the thoracolumbar spine. The subject was more than two years since diagnosis of incomplete SCI after surgery. [Methods] Using isokinetic lumbar muscle strength measurement equipment, peak torque/weight, total work and average power in flexion and extension of the lumbar region were measured. A trunk measurement system (Formetric 4D, DIERS, Germany), which is a 3D image processing apparatus with high resolution for vertebrae, was used in order to measure 3D vertebrae and pelvis deformation as well as static balance abilities. As an exercise method, a foam roller was used to conduct fascia relaxation massage for warming-up, and postural kyphosis was changed into postural lordosis by lat pull-down using equipment, performed in 5 sets of 15 times preset at 60% intensity of 1RM 4 set of 10 crunch exercises per set using Togu's were done while sitting at the end of Balance pad, and 4 sets of 15 bridge exercises. [Results] All angular speed tests showed a gradual increase in muscle strength. Flexion and extension showed 10% and 3% improvements, respectively. The spine deformation test showed that isokinetic exercise and lat pull-down exercise for 12 weeks resulted in improved spinal shape. [Conclusion] In this study

  5. Video-feedback Intervention to promote Positive Parenting adapted to Autism (VIPP-AUTI): A randomized controlled trial.

    PubMed

    Poslawsky, Irina E; Naber, Fabiënne Ba; Bakermans-Kranenburg, Marian J; van Daalen, Emma; van Engeland, Herman; van IJzendoorn, Marinus H

    2015-07-01

    In a randomized controlled trial, we evaluated the early intervention program Video-feedback Intervention to promote Positive Parenting adapted to Autism (VIPP-AUTI) with 78 primary caregivers and their child (16-61 months) with Autism Spectrum Disorder. VIPP-AUTI is a brief attachment-based intervention program, focusing on improving parent-child interaction and reducing the child's individual Autism Spectrum Disorder-related symptomatology in five home visits. VIPP-AUTI, as compared with usual care, demonstrated efficacy in reducing parental intrusiveness. Moreover, parents who received VIPP-AUTI showed increased feelings of self-efficacy in child rearing. No significant group differences were found on other aspects of parent-child interaction or on child play behavior. At 3-months follow-up, intervention effects were found on child-initiated joint attention skills, not mediated by intervention effects on parenting. Implementation of VIPP-AUTI in clinical practice is facilitated by the use of a detailed manual and a relatively brief training of interveners.

  6. Interventions for the prevention of overweight and obesity in preschool children: a systematic review of randomized controlled trials.

    PubMed

    Monasta, L; Batty, G D; Macaluso, A; Ronfani, L; Lutje, V; Bavcar, A; van Lenthe, F J; Brug, J; Cattaneo, A

    2011-05-01

    The objective of this study was to analyse interventions for the prevention of overweight and obesity in children under 5 years of age. We carried out a systematic review focusing exclusively on randomized controlled trials (RCTs). Data sources include Medline, Cochrane Library, EMBASE, CINHAL, PsychInfo and Web of Science. Data were extracted from seventeen articles describing seven RCTs identified through electronic search, screening of references in systematic reviews, own files and contact with authors. RCTs were assessed with the Jadad scale. Four trials were carried out in preschool settings, one with an exclusive educational component, two with an exclusive physical activity component and one with both. Two trials were family-based, with education and counselling for parents and children. The remaining trial was carried out in maternity hospitals, with a training intervention on breastfeeding. None of the interventions had an effect in preventing overweight and obesity. The failure to show an effect may be due to the choice of outcomes, the quality of the RCTs, the suboptimal implementation of the interventions, the lack of focus on social and environmental determinants. More rigorous research is needed on interventions and on social and environmental factors that could impact on lifestyle.

  7. A comparison of three interventions for homeless youth evidencing substance use disorders: results of a randomized clinical trial.

    PubMed

    Slesnick, Natasha; Guo, Xiamei; Brakenhoff, Brittany; Bantchevska, Denitza

    2015-07-01

    While research on homeless adolescents and young adults evidencing substance use disorder is increasing, there is a dearth of information regarding effective interventions, and more research is needed to guide those who serve this population. The current study builds upon prior research showing promising findings of the community reinforcement approach (CRA) (Slesnick, Prestopnik, Meyers, & Glassman, 2007). Homeless adolescents and young adults between the ages of 14 to 20 years were randomized to one of three theoretically distinct interventions: (1) CRA (n = 93), (2) motivational enhancement therapy (MET, n = 86), or (3) case management (CM, n = 91). The relative effectiveness of these interventions was evaluated at 3, 6, and 12 months post-baseline. Findings indicated that substance use and associated problems were significantly reduced in all three interventions across time. Several moderating effects were found, especially for sex and history of childhood abuse. Findings show little evidence of superiority or inferiority of the three interventions and suggest that drop-in centers have choices for addressing the range of problems that these adolescents and young adults face. PMID:25736623

  8. Health Literacy and Weight Change in a Digital Health Intervention for Women: A Randomized Controlled Trial in Primary Care Practice.

    PubMed

    Lanpher, Michele G; Askew, Sandy; Bennett, Gary G

    2016-01-01

    In the United States, 90 million adults have low health literacy. An important public health challenge is developing obesity treatment interventions suitable for those with low health literacy. The objective of this study was to examine differences in sociodemographic and clinical characteristics as well as weight and intervention engagement outcomes by health literacy. We randomized 194 participants to usual care or to the Shape Program intervention, a 12-month digital health treatment aimed at preventing weight gain among overweight and Class I obese Black women in primary care practice. We administered the Newest Vital Sign instrument to assess health literacy. More than half (55%) of participants had low health literacy, which was more common among those with fewer years of education and lower income. There was no effect of health literacy on 12-month weight change or on intervention engagement outcomes (completion of coaching calls and interactive voice response self-monitoring calls). Low health literacy did not preclude successful weight gain prevention in the Shape Program intervention. Goal-focused behavior change approaches like that used in Shape may be particularly helpful for treating and engaging populations with low health literacy.

  9. A Comparison of Three Interventions for Homeless Youth Evidencing Substance Use Disorders: Results of a Randomized Clinical Trial

    PubMed Central

    Slesnick, Natasha; Guo, Xiamei; Brakenhoff, Brittany; Bantchevska, Denitza

    2015-01-01

    While research on homeless adolescents and young adults evidencing substance use disorder is increasing, there is a dearth of information regarding effective interventions, and more research is needed to guide those who serve this population. The current study builds upon prior research showing promising findings of the Community Reinforcement Approach (CRA) (Slesnick, Prestopnik, Meyers, & Glassman, 2007). Homeless adolescents and young adults between the ages of 14 to 20 years were randomized to one of three theoretically distinct interventions: (1) CRA (n = 93), (2) Motivational Enhancement Therapy (MET, n = 86), or (3) Case Management (CM, n = 91). The relative effectiveness of these interventions was evaluated at 3, 6, and 12 months post-baseline. Findings indicated that substance use and associated problems were significantly reduced in all three interventions across time. Several moderating effects were found, especially for sex and history of childhood abuse. Findings show little evidence of superiority or inferiority of the three interventions and suggest that drop-in centers have choices for addressing the range of problems that these adolescents and young adults face. PMID:25736623

  10. Breast Health Intervention Effects on Knowledge and Beliefs Over Time Among Chinese American Immigrants--a Randomized Controlled Study.

    PubMed

    Lee-Lin, Frances; Pedhiwala, Nisreen; Nguyen, Thuan; Menon, Usha

    2015-09-01

    Chinese American immigrant women, nonadherent with mammography in the past 12 months, (N = 300) were enrolled in a randomized controlled trial designed to change knowledge and beliefs and increase mammogram use. This report describes intervention effects on changes in knowledge and beliefs between the control and educational groups over four time points (baseline and 3, 6, and 12 months). Variables measured included knowledge, perceived susceptibility, perceived general barriers to mammography, perceived benefits to mammography, and four cultural barriers to mammography (crisis orientation, modesty, use of Eastern medicine, reliance on others). At all three post-intervention time points, women in the education group had significantly higher knowledge scores than those in the control group, regardless of whether they had completed a mammogram during the study. Women in the education group reported higher perceived susceptibility to breast cancer at 3-month post-intervention. At 3- and 6-month post-intervention, regardless of mammogram screening completion, women reported lower concerns about modesty related to mammography when compared to the control group. By the 12-month post-intervention, women in the education group reported significantly fewer perceived barriers than the control group. A targeted breast health program successfully changed breast health knowledge and beliefs that were sustained for up to 6-12 months. Education targeted to women's knowledge and beliefs has significant potential for decreasing disparity in mammogram use among Chinese American immigrant women.

  11. Effectiveness of a low-threshold physical activity intervention in residential aged care – results of a randomized controlled trial

    PubMed Central

    Cichocki, Martin; Quehenberger, Viktoria; Zeiler, Michael; Adamcik, Tanja; Manousek, Matthias; Stamm, Tanja; Krajic, Karl

    2015-01-01

    Purpose Research on effectiveness of low-threshold mobility interventions that are viable for users of residential aged care is scarce. Low-threshold is defined as keeping demands on organizations (staff skills, costs) and participants (health status, discipline) rather low. The study explored the effectiveness of a multi-faceted, low-threshold physical activity program in three residential aged-care facilities in Austria. Main goals were enhancement of mobility by conducting a multi-faceted training program to foster occupational performance and thus improve different aspects of health-related quality of life (QoL). Participants and methods The program consisted of a weekly session of 60 minutes over a period of 20 weeks. A standardized assessment of mobility status and health-related QoL was applied before and after the intervention. A total of 222 of 276 participants completed the randomized controlled trial study (intervention group n=104, control group n=118; average age 84 years, 88% female). Results Subjective health status (EuroQoL-5 dimensions: P=0.001, d=0.36) improved significantly in the intervention group, and there were also positive trends in occupational performance (Canadian Occupational Performance Measure). No clear effects were found concerning the functional and cognitive measures applied. Conclusion Thus, the low-threshold approach turned out to be effective primarily on subjective health-related QoL. This outcome could be a useful asset for organizations offering low-threshold physical activity interventions. PMID:26056438

  12. Health Literacy and Weight Change in a Digital Health Intervention for Women: A Randomized Controlled Trial in Primary Care Practice.

    PubMed

    Lanpher, Michele G; Askew, Sandy; Bennett, Gary G

    2016-01-01

    In the United States, 90 million adults have low health literacy. An important public health challenge is developing obesity treatment interventions suitable for those with low health literacy. The objective of this study was to examine differences in sociodemographic and clinical characteristics as well as weight and intervention engagement outcomes by health literacy. We randomized 194 participants to usual car