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Community-based weight loss programme targeting overweight Chinese adults with pre-diabetes: study protocol of a randomised controlled trial.

ABSTRACT: INTRODUCTION:Type 2 diabetes mellitus (T2DM) is one of the world's fastest growing health problems. Asians have a strong ethnic predisposition for T2DM, developing T2DM at a lower degree of obesity and at younger ages than other ethnic groups. T2DM has a gradual onset, with most individuals progressing through a pre-diabetic state, providing an opportunity to prevent T2DM and its complications. This study aims to evaluate the effectiveness of a community-based lifestyle intervention programme on weight loss and improvements in insulin sensitivity and cardiometabolic profiles in Chinese adults with pre-diabetes. METHODS AND ANALYSIS:This study is a 12-month, assessor-blinded randomised controlled trial. Adults with pre-diabetes (aged 40-64 years, n=180) with pre-diabetes are randomised into either an intervention group (receiving group-based lifestyle interventions) or a control group (receiving text messages containing health information). The intervention programme targets a weight loss of 5% during the first 6 months by restricting caloric intake and increasing physical activity. Participants in the intervention group will attend six group sessions and two individual face-to-face diet counselling sessions during the first 6 months, followed by monthly telephone support during the 6-month maintenance phase. Participants in the control group will receive monthly text messages containing general health information only. The primary outcome is weight loss (%). Secondary outcomes include insulin sensitivity (assessed using fasting insulin level and homeostatic model assessment of insulin resistance), glycaemic control (assessed using glycated haemoglobin level), lipid profile, blood pressure, carotid artery thickness, dietary intake and level of physical activity. Intention-to-treat analysis will be conducted using a generalised linear mixed effects model with a logit link and linear mixed models. ETHICS AND DISSEMINATION:This study has been approved by the relevant research ethics committee. The results will be disseminated through peer-reviewed journals and scientific presentations. TRIAL REGISTRATION NUMBER:NCT03609697.

SUBMITTER: Ho M

PROVIDER: S-EPMC7245377 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Community-based weight loss programme targeting overweight Chinese adults with pre-diabetes: study protocol of a randomised controlled trial.

Ho Mandy M Chau Pui Hing PH Yu Esther Yee Tak EYT Ying Michael Tin-Cheung MT Lam Cindy Lo Kuen CLK

BMJ open 20200408 4

<h4>Introduction</h4>Type 2 diabetes mellitus (T2DM) is one of the world's fastest growing health problems. Asians have a strong ethnic predisposition for T2DM, developing T2DM at a lower degree of obesity and at younger ages than other ethnic groups. T2DM has a gradual onset, with most individuals progressing through a pre-diabetic state, providing an opportunity to prevent T2DM and its complications. This study aims to evaluate the effectiveness of a community-based lifestyle intervention prog ...[more]

PMID: 32273317

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Project description:IntroductionOverweight and obesity are highly prevalent among Australian men. Professional sports settings can act as a powerful 'hook' to engage men in weight loss programmes; the Football Fans in Training programme delivered in professional UK soccer clubs was successful and cost-effective in helping men lose weight. The Australian Football League (AFL) is a potentially attractive setting to engage men in a weight loss programme. We aim to develop, pilot and evaluate the feasibility of a weight loss intervention for overweight/obese middle-aged men, delivered in AFL settings, to promote weight loss and healthier lifestyles and determine its suitability for a future randomised control trial.Methods and analysis120 overweight/obese male fans will complete baseline physical and psychological health measures and objective measures of physical activity (PA), weight, waist size and blood pressure prior to randomisation into the intervention or waitlist comparison group. The intervention group will receive 12 weekly 90 min workshops incorporating PA, nutrition education, behaviour change techniques and principles of effective motivation. Four community coaches will be trained to deliver Aussie-FIT at two AFL clubs in Western Australia. Measurements will be repeated in both groups at 3 months (post-intervention) and 6 months (follow-up). Outcomes will include programme uptake, attendance, changes in lifestyle and weight variables to inform power calculations for a future definitive trial, fidelity of programme delivery, acceptability, satisfaction with the programme and perceptions of effectiveness. We will also determine trial feasibility and potential to gather cost-effectiveness data.Ethics and disseminationEthics approval was granted by Curtin University's Human Research Ethics Committee (HREC2017-0458). Results will be disseminated via peer-reviewed publications, conference presentations and reports. A multicomponent dissemination strategy will include targeted translation and stakeholder engagement events to establish strategies for sustainability and policy change.Trial registration numberACTRN12617000515392; Pre-results.

Project description:OBJECTIVES:We examined the effect of a telemedical coaching (TMC) programme accompanied with or without telemonitoring on weight loss in an occupational healthcare setting with a three-armed randomised controlled trial (NCT01837134 'Pre-results'). METHODS:Overweight employees (n=104, body mass index [BMI] ?25?kg/m2) were invited by their medical corporate department and randomised into either a TMC group (n=34) or in one of the two control groups (C1, n=34; C2, n=36). TMC and C1 were equipped with telemonitoring devices (scales and pedometers) at baseline, and C2 after 6 months. Telemonitoring devices automatically transferred data into a personalised online portal. TMC was coached with weekly care calls in months 3-6 and monthly calls from months 7 to 12. C2 had a short coaching phase in months 6-9. C1 received no further support. After the 12-month intervention phase, participants could take advantage of further company health promotion offers. Follow-up data were determined after 12 months of intervention and per-protocol (PP) and intention-to-treat (ITT) analyses were performed. Weight change was followed up after 36 months. Estimated treatment difference (ETD) was calculated for weight reduction. RESULTS:ETD from TMC to C1 (-3.6?kg 95% CI -7.40 to -0.1, p=0.047) and to C2 (-4.2?kg [-7.90 to -0.5], p=0.026) was significantly different at the 12?months follow-up in the PP-analysis, but lost significance in the ITT analysis. All groups reduced weight after 12 months (-3.3 to -8.4?kg [5.5-10.3?kg], all p<0.01) and sustained it during the 36?months follow-up (-4.8 to -7.8?kg [5.6-12.8?kg], all p<0.01). ETD analyses revealed no difference between all groups neither in the PP nor in the ITT analysis at the 3?years follow-up. All groups reduced BMI, systolic and diastolic blood pressure and improved eating behaviour in the PP or ITT analyses. CONCLUSIONS:TMC and/or telemonitoring support long-term weight reduction in overweight employees. The combination of both interventions points towards an additional effect. TRIAL REGISTRATION NUMBER:NCT01837134.

Project description:BackgroundExercise and diet are the cornerstones for the treatment of obesity in obese children and adolescents. However, compensatory changes in appetite and energy expenditure elicited by exercise and dieting make it hard to maintain a reduced weight over the longterm. The anorexic effect of hypoxia can be potentially utilized to counteract this compensatory increase, thereby enhancing the success of weight loss. The purpose of the study is to assess the effectiveness of four week intermittent hypoxia exposure added to a traditional exercise and diet intervention on inducing short- and longterm weight loss in obese adolescents.Methods/designIn this randomized parallel group controlled clinical trial, 40 obese adolescents (20 boys and 20 girls, 11 to 15-years-old), will be recruited from a summer weight loss camp at the Shanghai University of Sport, China. Participants will be stratified by gender and randomly assigned to either the control group or the hypoxia group. During the four-week intervention period, both groups will exercise and eat a balanced diet. Additionally, the control group will sleep in normal conditions, while the hypoxia group will sleep in a normobaric hypoxia chamber (sleep high and train low). The primary outcome will be body composition and the main secondary outcomes will be the circulating levels of appetite regulatory gastrointestinal hormones. All the outcome measures will be assessed at baseline, after the four-week intervention, and at two months follow-up.DiscussionOur study will be the first to evaluate the effectiveness of 'sleep high and train low' on short- and longterm weight loss among obese adolescents. A potential mechanism for the appetite regulatory effect of hypoxia will also be explored. The results of the study will provide an evidence-based recommendation for the use of hypoxia in a weight loss intervention among obese children and adolescents. Furthermore, the clarification of mechanisms leading to weight loss in 'sleep high and train low' might provide information for the development of new strategies in combating obesity.Trial registrationThis trial was registered on 10 January 2014 at the Chinese Clinical Trial Registry with the registration number: ChiCTR-TRC-14004106.

Project description:BackgroundThe prevalence of male obesity is increasing but few men take part in weight loss programmes. We assessed the effect of a weight loss and healthy living programme on weight loss in football (soccer) fans.MethodsWe did a two-group, pragmatic, randomised controlled trial of 747 male football fans aged 35-65 years with a body-mass index (BMI) of 28 kg/m(2) or higher from 13 Scottish professional football clubs. Participants were randomly assigned with SAS (version 9·2, block size 2-9) in a 1:1 ratio, stratified by club, to a weight loss programme delivered by community coaching staff in 12 sessions held every week. The intervention group started a weight loss programme within 3 weeks, and the comparison group were put on a 12 month waiting list. All participants received a weight management booklet. Primary outcome was mean difference in weight loss between groups at 12 months, expressed as absolute weight and a percentage of their baseline weight. Primary outcome assessment was masked. Analyses were based on intention to treat. The trial is registered with Current Controlled Trials, number ISRCTN32677491.Findings374 men were allocated to the intervention group and 374 to the comparison group. 333 (89%) of the intervention group and 355 (95%) of the comparison group completed 12 month assessments. At 12 months the mean difference in weight loss between groups, adjusted for baseline weight and club, was 4·94 kg (95% CI 3·95-5·94) and percentage weight loss, similarly adjusted, was 4·36% (3·64-5·08), both in favour of the intervention (p<0·0001). Eight serious adverse events were reported, five in the intervention group (lost consciousness due to drugs for pre-existing angina, gallbladder removal, hospital admission with suspected heart attack, ruptured gut, and ruptured Achilles tendon) and three in the comparison group (transient ischaemic attack, and two deaths). Of these, two adverse events were reported as related to participation in the programme (gallbladder removal and ruptured Achilles tendon).InterpretationThe FFIT programme can help a large proportion of men to lose a clinically important amount of weight; it offers one effective strategy to challenge male obesity.FundingScottish Government and The UK Football Pools funded delivery of the programme through a grant to the Scottish Premier League Trust. The National Institute for Health Research Public Health Research Programme funded the assessment (09/3010/06).

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Community-based weight loss programme targeting overweight Chinese adults with pre-diabetes: study protocol of a randomised controlled trial.

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Community-based weight loss programme targeting overweight Chinese adults with pre-diabetes: study protocol of a randomised controlled trial.

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