Randomised controlled trial using a theory-based m-health intervention to improve physical activity and sleep health in adults: the Synergy Study protocol

Vandelanotte, CL ORCiD: 0000-0002-4445-8094INTRODUCTION: There is a need to reduce physical inactivity and poor sleep health in the adult population to decrease chronic disease rates and the associated burden. Given the high prevalence of these risk behaviours, effective interventions with potential for wide reach are warranted. METHODS AND ANALYSIS: The aim of this two-arm RCT will be to test the effect of a three month personalised mobile app intervention on two main outcomes: minutes of moderate-to-vigorous-intensity physical activity and overall sleep quality. In addition, between-group changes in health-related quality of life and mental health status will be assessed as secondary outcomes. The pre-specified mediators and moderators include social cognitive factors, the neighbourhood environment, health (BMI, depression, anxiety, stress), sociodemographic factors (age, gender, education) and app usage. Assessments will be conducted after three months (primary endpoint) and six months (follow-up). The intervention will provide access to a specifically developed mobile app, through which participants can set goals for active minutes, daily step counts, resistance training, sleep times and sleep hygiene practice. The app also allows participants to log their behaviours daily and view progress bars as well as instant feedback in relation to goals. The personalised support system will consist of weekly summary reports, educational and instructional materials, prompts on disengagement and weekly facts. ETHICS AND DISSEMINATION: The Human Research Ethics Committee of The University of Newcastle, Australia granted full approval: H-2016-0181. This study will assess the efficacy of a combined behaviour intervention, mechanisms of behaviour change and gather high-quality process data, all of which will help refine future trials. Dissemination of findings will include publication in a peer-reviewed journal and presentation at national or international conferences. Participants will receive a plain English summary report of results. TRIAL REGISTRATION NUMBER: ACTRN12617000376347; Pre-results