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

Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. 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. © Author(s) (or their employer(s)) 2018