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A randomized trial testing the efficacy of a novel approach to weight loss among men with overweight and obesity.

ABSTRACT: OBJECTIVE:To test the efficacy of a weight loss intervention designed to appeal to men. METHODS:A randomized trial tested the efficacy of the Rethinking Eating and FITness (REFIT) weight loss program compared to a wait-list control. The 6-month intervention was delivered via two face-to-face sessions followed by Internet contacts. REFIT encouraged participants to create calorie deficits by making six 100-calorie changes to their eating daily while increasing physical activity, and the program encouraged customization through selection of specific diet strategies evaluated each week. RESULTS:Participants (N?=?107, 44.2 years, 31.4 kg/m(2) , 76.6% white) were randomized into the study, and 90.6% provided data at 6 months. REFIT participants lost -5.0 kg (95% CI: -6.1, -3.9) at 3 months, which was maintained through 6 months (-5.3 kg, 95% CI: -6.5, -4.2); this was greater than the control group (p?

SUBMITTER: Crane MM

PROVIDER: S-EPMC4700541 | biostudies-literature | 2015 Dec

REPOSITORIES: biostudies-literature

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A randomized trial testing the efficacy of a novel approach to weight loss among men with overweight and obesity.

Crane Melissa M MM Lutes Lesley D LD Ward Dianne S DS Bowling J Michael JM Tate Deborah F DF

Obesity (Silver Spring, Md.) 20151201 12

<h4>Objective</h4>To test the efficacy of a weight loss intervention designed to appeal to men.<h4>Methods</h4>A randomized trial tested the efficacy of the Rethinking Eating and FITness (REFIT) weight loss program compared to a wait-list control. The 6-month intervention was delivered via two face-to-face sessions followed by Internet contacts. REFIT encouraged participants to create calorie deficits by making six 100-calorie changes to their eating daily while increasing physical activity, and ...[more]

PMID: 26727117

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Project description:ImportanceThe efficacy and safety of time-restricted eating have not been explored in large randomized clinical trials.ObjectiveTo determine the effect of 16:8-hour time-restricted eating on weight loss and metabolic risk markers.InterventionsParticipants were randomized such that the consistent meal timing (CMT) group was instructed to eat 3 structured meals per day, and the time-restricted eating (TRE) group was instructed to eat ad libitum from 12:00 pm until 8:00 pm and completely abstain from caloric intake from 8:00 pm until 12:00 pm the following day.Design, setting, and participantsThis 12-week randomized clinical trial including men and women aged 18 to 64 years with a body mass index (BMI, calculated as weight in kilograms divided by height in meters squared) of 27 to 43 was conducted on a custom mobile study application. Participants received a Bluetooth scale. Participants lived anywhere in the United States, with a subset of 50 participants living near San Francisco, California, who underwent in-person testing.Main outcomes and measuresThe primary outcome was weight loss. Secondary outcomes from the in-person cohort included changes in weight, fat mass, lean mass, fasting insulin, fasting glucose, hemoglobin A1c levels, estimated energy intake, total energy expenditure, and resting energy expenditure.ResultsOverall, 116 participants (mean [SD] age, 46.5 [10.5] years; 70 [60.3%] men) were included in the study. There was a significant decrease in weight in the TRE (-0.94 kg; 95% CI, -1.68 to -0.20; P = .01), but no significant change in the CMT group (-0.68 kg; 95% CI, -1.41 to 0.05, P = .07) or between groups (-0.26 kg; 95% CI, -1.30 to 0.78; P = .63). In the in-person cohort (n = 25 TRE, n = 25 CMT), there was a significant within-group decrease in weight in the TRE group (-1.70 kg; 95% CI, -2.56 to -0.83; P < .001). There was also a significant difference in appendicular lean mass index between groups (-0.16 kg/m2; 95% CI, -0.27 to -0.05; P = .005). There were no significant changes in any of the other secondary outcomes within or between groups. There were no differences in estimated energy intake between groups.Conclusions and relevanceTime-restricted eating, in the absence of other interventions, is not more effective in weight loss than eating throughout the day.Trial registrationClinicalTrials.gov Identifiers: NCT03393195 and NCT03637855.

Project description:BACKGROUND:Obesity is a major health problem in Brazil affecting 19% of Brazilian adults with a rising incidence over the last 10 years. Moreover, low fruit/vegetables consumption and high sweetened beverage intake are major issues. Facing the challenge of universal healthcare access, internet-based programs have the potential to reach a large number of inhabitants, be widely accessible and cost effective. Our aim is to to assess the efficacy of a web-based platform to promote weight loss and diet and physical activity habits change in a Brazilian adult population. METHODS:We designed a three-arm parallel randomized controlled trial including 18-60 years university students or employees with 25 kg/m2 minimum body mass index (BMI). Pregnancy, conditions with specific dietary requirements and participation in other weight loss programs are exclusion criteria. Participants are allocated to one of three groups: (1) waitlist with minimal intervention, (2) web-based platform, (3) web-based platform plus online dietician assistance. Assessors are blinded. Weight and BMI loss are the primary outcomes. Diet and physical activity behaviours, health perception and online activity features are secondary outcomes. The intervention comprises recommendations of diet and physical activity habits tailored to the Brazilian population and principles of behaviour change. The web-based platform has online social network and gamification features. Analysis will be on an intention-to-treat basis at 12 and 24 weeks after baseline. Differences in weight loss between groups will be performed by analysis of covariate. Linear regression will be used to assess whether treatment group allocation is an independent predictor of weight loss. The study was approved by the Federal University of Minas Gerais (UFMG) Ethics Research Committee. All participants signed an informed consent form prior to recruitment. DISCUSSION:We present the study protocol of a three arm parallel randomized controlled trial which aims to test the efficacy of an online platform to promote weight loss for adults with overweight and obesity. We anticipate that the adoption of healthy lifestyle habits and weight loss will be more important in participants randomized to the online platform group. TRIAL REGISTRATION:NCT03435445 on February 16th, 2018.

Project description:BackgroundEfforts to manage obesity through weight loss are often unsuccessful as most adults are not able to sustain the major changes in behaviour that are required to maintain weight loss long term. We sought to determine whether small changes in physical activity and diet prevent weight gain in adults with overweight and obesity.MethodsWe randomized 320 sedentary adults with overweight or obesity to monitoring alone (MA, n = 160) or a small change approach (SCA, n = 160). In Phase I (2 yr), MA participants were asked to maintain their normal lifestyle and SCA participants were counselled to make small changes in diet and physical activity, namely a suggested increase in daily step count of 2000 steps with a decrease in energy intake of 100 kcal per day, with group and individual support. Phase II (1 yr) was a passive follow-up period. The difference in change in body weight between groups at 24 and 36 months from baseline was the primary outcome. Additional outcomes included waist circumference and cardiorespiratory fitness.ResultsOverall, 268 participants (83.8%) completed the 2-year intervention, and 239 (74.7%) returned at the end of the follow-up period at 3 years. The difference in body weight change between the SCA and MA groups was significant at 3, 6, 12 and 15 months from baseline, but was no longer significant at 24 months (mean change 0.9 [standard error (SE) 0.5] kg v. -0.4 [SE 0.5] kg; difference -0.6, 95% confidence interval [CI] -1.9 to 0.8) or at 36 months (-1.2 [SE 0.8] v. -0.7 [SE 0.8] kg; difference -0.5, 95% CI -2.2 to 1.2). Changes in waist circumference and cardiorespiratory fitness were not significantly different between groups at 24 or 36 months (both p > 0.1).InterpretationThe SCA did not prevent weight gain compared with monitoring alone at 2 or 3 years in adults with overweight or obesity. On average, we observed prevention of weight gain in both arms of the trial.Trial registrationClinicalTrials.gov, no. NCT02027077.

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A randomized trial testing the efficacy of a novel approach to weight loss among men with overweight and obesity.

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A randomized trial testing the efficacy of a novel approach to weight loss among men with overweight and obesity.

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