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Examining the efficacy of a multicomponent m-Health physical activity, diet and sleep intervention for weight loss in overweight and obese adults: randomised controlled trial protocol.

ABSTRACT: INTRODUCTION:Traditional behavioural weight loss trials targeting improvements in physical activity and diet are modestly effective. It has been suggested that sleep may have a role in weight loss and maintenance. Improving sleep health in combination with physical activity and dietary behaviours may be one strategy to enhance traditional behavioural weight loss trials. Yet the efficacy of a weight loss intervention concurrently targeting improvements in physical activity, dietary and sleep behaviours remains to be tested. METHODS AND ANALYSIS:The primary aim of this three-arm randomised controlled trial is to examine the efficacy of a multicomponent m-Health behaviour change weight loss intervention relative to a waitlist control group. The secondary aims are to compare the relative efficacy of a physical activity, dietary behaviour and sleep intervention (enhanced intervention), compared with a physical activity and dietary behaviour only intervention (traditional intervention), on the primary outcome of weight loss and secondary outcomes of waist circumference, glycated haemoglobin, physical activity, diet quality and intake, sleep health, eating behaviours, depression, anxiety and stress and quality of life. Assessments will be conducted at baseline, 6 months (primary endpoint) and 12 months (follow-up). The multicomponent m-Health intervention will be delivered using a smartphone/tablet 'app', supplemented with email and SMS and individualised in-person dietary counselling. Participants will receive a Fitbit, body weight scales to facilitate self-monitoring, and use the app to access educational material, set goals, self-monitor and receive feedback about behaviours. Generalised linear models using an analysis of covariance (baseline adjusted) approach will be used to identify between-group differences in primary and secondary outcomes, following an intention-to-treat principle. ETHICS AND DISSEMINATION:The Human Research Ethics Committee of The University of Newcastle Australia provided approval: H-2017-0039. Findings will be disseminated via publication in peer-reviewed journals, conference presentations, community presentations and student theses. TRIAL REGISTRATION NUMBER:ACTRN12617000735358; UTN1111-1219-2050.

SUBMITTER: Duncan MJ

PROVIDER: S-EPMC6224765 | biostudies-other | 2018 Oct

REPOSITORIES: biostudies-other

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Examining the efficacy of a multicomponent m-Health physical activity, diet and sleep intervention for weight loss in overweight and obese adults: randomised controlled trial protocol.

Duncan Mitch J MJ Brown Wendy J WJ Burrows Tracy L TL Collins Clare E CE Fenton Sasha S Glozier Nicholas N Kolt Gregory S GS Morgan Philip J PJ Hensley Michael M Holliday Elizabeth G EG Murawski Beatrice B Plotnikoff Ronald C RC Rayward Anna T AT Stamatakis Emmanuel E Vandelanotte Corneel C

BMJ open 20181030 10

<h4>Introduction</h4>Traditional behavioural weight loss trials targeting improvements in physical activity and diet are modestly effective. It has been suggested that sleep may have a role in weight loss and maintenance. Improving sleep health in combination with physical activity and dietary behaviours may be one strategy to enhance traditional behavioural weight loss trials. Yet the efficacy of a weight loss intervention concurrently targeting improvements in physical activity, dietary and sl ...[more]

PMID: 30381313

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Project description:Aims and objectivesTo determine whether a weight management intervention (WMI) plus cardiac rehabilitation (CR) compared to CR alone improves outcomes for overweight and obese cardiac revascularisation patients.BackgroundDespite participating in cardiac rehabilitation (CR), few cardiac patients lose enough weight to achieve clinically significant cardiovascular disease risk reduction.DesignA randomised controlled design was used with measurements at baseline, 4 and 6 months, guided by the CONSORT checklist, see Supporting Information File S1. Adults who had undergone either coronary artery bypass surgery (CABS) or percutaneous coronary intervention (PCI) and participated in a rural CR programmes were recruited. Subjects were randomised to a 12-week telehealth WMI or control group. The primary outcome was weight loss. Secondary outcomes included physical activity, patient activation, perceived self-efficacy and use of weight management behaviours.ResultsA total of 43 subjects participated, with a mean age of 63 (±9.3) years. The WMI group had significantly more weight loss averaged across the 4 and 6 months of 13.8 (±2.8) pounds compared to the control group [mean = 7.8 (±2.2) pounds]. There were no significant differences in physical activity (activity counts or daily minutes in moderate or more intense activity). The WMI group had significantly higher levels of patient activation. They also had significantly higher total scores on the Diet and Exercise Self-Management survey, and subscales that included self-efficacy for specific eating habits and managing diet behaviour.ConclusionsFindings demonstrated the usefulness and feasibility of using telehealth delivery of the WMI for cardiac rehabilitation participants in rural communities to improve weight management outcomes.Relevance to practiceStudy findings underscore the opportunity to further improve weight loss of overweight and obese cardiac participants using a weight management intervention to augment CR participation.

Project description:The proportion of women entering pregnancy overweight or obese has been rising and, in turn, is associated with adverse maternal and fetal outcomes. Gestational weight gain (GWG) exceeding Institute of Medicine (IOM) guidelines further increases health risks and has been independently associated with postpartum weight retention. Hispanic women are disproportionately affected by overweight and obesity, but have had limited access to interventions that promote healthy lifestyles due to cultural, socioeconomic, and language barriers. Therefore, the overall goal of this randomized controlled trial is to test the efficacy of a culturally and linguistically modified, individually-tailored lifestyle intervention to reduce excess GWG, increase postpartum weight loss, and improve maternal metabolic status among overweight/obese Hispanic women.Overweight/obese Hispanic women are recruited in early pregnancy and randomly assigned to a Lifestyle Intervention (n = 150) or a Comparison Health and Wellness (control) intervention (n = 150). Multimodal contacts (i.e., in-person, telephone counseling, and mailed print-based materials) are used to deliver the intervention from early pregnancy (12 weeks gestation) to 6 months postpartum, with follow-up to 1 year postpartum. Targets of the intervention are to achieve IOM Guidelines for GWG and postpartum weight loss; American Congress of Obstetrician and Gynecologist guidelines for physical activity; and American Diabetes Association guidelines for diet. The intervention draws from Social Cognitive Theory and the Transtheoretical Model and includes strategies to address the specific social, cultural, and economic challenges faced by low-income Hispanic women. Assessments are conducted at baseline (~10 weeks gestation), mid pregnancy (24-28 weeks gestation), late pregnancy (32-34 weeks gestation) and postpartum at 6-weeks, 6-months, and 12-months by bicultural and bilingual personnel blinded to the intervention arm. Efficacy is assessed via GWG, postpartum weight loss, and biomarkers of glycemic control, insulin resistance, and cardiovascular disease risk factors. Changes in physical activity and diet are measured via 7-day accelerometer data and 24-h dietary recalls at each assessment time period.Hispanic women are the fastest growing minority group in the U.S. and are disproportionately affected by overweight and obesity. This randomised trial uses a high-reach, low-cost strategy that can readily be translated into clinical practice in underserved and minority populations.NCT01868230 May 29, 2013.

Project description:This study compared the efficacy of two multi-component m-health interventions with a wait-list control group on body weight (primary outcome), and secondary outcomes of cardiovascular risk factors, lifestyle behaviours, and mental health. Three-arm randomised controlled trial (Enhanced: physical activity, diet, sleep, Traditional: physical activity, diet, Control) with assessments conducted at baseline, 6 and 12 months. Participants (n = 116) were overweight or obese adults aged 19-65 (M = 44.5 [SD = 10.5]). The 6-month intervention was delivered via a smartphone app providing educational materials, goal-setting, self-monitoring and feedback, and also included one face-to-face dietary consultation, a Fitbit and scales. The trial was prospectively registered and conducted between May 2017 and September 2018. Group differences on primary and secondary outcomes were examined between the Pooled Intervention groups (Pooled Intervention = Enhanced and Traditional) and Control groups, and then between Enhanced and Traditional groups. Nineteen participants (16.4%) formally withdrew from the trial. Compared with the Control group, average body weight of the Pooled Intervention group did not differ at 6 (between-group difference = -0.92, (95% CI -3.33, 1.48)) or 12 months (0.00, (95% CI -2.62, 2.62)). Compared with the Control group, the Pooled Intervention group significantly increased resistance training (OR = 7.83, (95% CI 1.08, 56.63)) and reduced energy intake at 6 months (-1037.03, (-2028.84, -45.22)), and improved insomnia symptoms at 12 months (-2.59, (-4.79, -0.39)). Compared with the Traditional group, the Enhanced group had increased waist circumferences (2.69, (0.20, 5.18)) and sedentary time at 6 months (105.66, (30.83, 180.48)), and improved bed time variability at 12 months (-1.08, (-1.86, -0.29)). No other significant differences were observed between groups. Relative to Controls, the Pooled Intervention groups did not differ on body weight but improved resistance training, and reduced energy intake and insomnia symptom severity. No additional weight loss was apparent when targeting improvements in physical activity, diet and sleep in combination compared with physical activity and diet.

Project description:IntroductionThere has been a steep increase in the prevalence of adolescent overweight and obesity globally and in India, demonstrating that present prevention strategies are insufficient. Available evidence suggests that multifactorial interventions may improve short-term physical activity (PA), nutrition and psychological behaviour of overweight and obese adolescents but long-term follow-ups and strategies are needed. This study will investigate the effects of a structured multifactorial (school-based and family-based) intervention on adolescent obesity, compared with a single or no intervention.Methods and analysisA pragmatic, clustered randomised controlled trial with 12 weeks of interventions and 3-month, 6-month and 12-month follow-ups will be conducted at multiple participating schools in Karnataka, India. The participants will be overweight and obese male and female adolescents aged 11-16 years and will be randomly assigned by school into three groups: group A (multifactorial intervention, exercise and dietary advice); group B (exercise only); and group C (controls, no interventions). Primary outcome measures are the level of PA and body composition. Secondary outcomes are dietary change, behaviour change, food behaviours, cardiovascular and muscular fitness, quality of life, parental behaviours (physical and mental) and family functioning. Positive intervention results may reduce obesity in adolescents and promote a healthier lifestyle for students and families. A larger, culturally diverse population can benefit from a similar methodology.Ethics and disseminationThe study has been approved by the Institutional Research and Ethics Committee (IEC 536-2018), Kasturba Hospital, Manipal, Udupi District, Karnataka, India. A written and verbal informed consent (supplemental material) will be provided to the participants prior to participation. On completion of the trial, the results can be communicated to adolescents and their parents on request, and will be published at national and international conferences and in peer-reviewed journals.Trial registration numberCTRI/2019/04/018834.

Dataset Information

Examining the efficacy of a multicomponent m-Health physical activity, diet and sleep intervention for weight loss in overweight and obese adults: randomised controlled trial protocol.

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Examining the efficacy of a multicomponent m-Health physical activity, diet and sleep intervention for weight loss in overweight and obese adults: randomised controlled trial protocol.

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