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Randomised controlled trial using a theory-based m-health intervention to improve physical activity and sleep health in adults: the Synergy Study protocol
  1. Beatrice Murawski1,2,
  2. Ronald C Plotnikoff1,3,
  3. Anna T Rayward1,2,
  4. Corneel Vandelanotte4,
  5. Wendy J Brown5,
  6. Mitch J Duncan1,2
  1. 1 Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Newcastle, Australia
  2. 2 School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, Callaghan, Australia
  3. 3 School of Education, Faculty of Education and Arts, University of Newcastle, Callaghan, Australia
  4. 4 School of Health, Medical and Applied Science, Physical Activity Research Group, Central Queensland University, Rockhampton, Australia
  5. 5 Centre for Research on Exercise, Physical Activity and Health, School of Human Movement and Nutrition Studies, The University of Queensland, Brisbane, Australia
  1. Correspondence to Dr Mitch J Duncan; mitch.duncan{at}


Introduction 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.

  • physical activity
  • sleep health
  • behaviour change
  • m-health
  • adults
  • study protocol

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  • Contributors All authors meet ICMJE criteria for authorship in that they have contributed substantially to the conceptual design; or the processes of data collection, analysis or interpretation; the drafts and revisions of the study protocol and manuscript; granted approval of the final version of the study protocol and acknowledged their accountability with regard to the integrity and accuracy of this study protocol. In detail, the first author of this protocol (BM) will be responsible for administrative and managerial procedures related to all phases of the trial, which will be supervised by MJD and RCP. ATR will fulfil this role, in the case of BM’s temporary illness or absence. BM, MJD, ATR and RCP contributed to the development of study materials, MJD, CV and WJB have contributed to the conceptual design of the trial and all authors (BM, RCP, ATR, CV, WJB and MJD) contributed to the writing of the protocol and will be involved in the interpretation of results, the evaluation of the trial and dissemination of study findings.

  • Funding ATR is supported by a Wests Scholarship (ID G1201152). MJD (ID 100029) and CV (ID 100427) are supported by a Future Leader Fellowship from the National Heart Foundation of Australia.

  • Competing interests None declared.

  • Patient consent Detail has been removed from this case description/these case descriptions to ensure anonymity. The editors and reviewers have seen the detailed information available and are satisfied that the information backs up the case the authors are making.

  • Ethics approval Full ethical approval was obtained from the Human Research Ethics Committee of The University of Newcastle, Australia (Approval Number: H-2016–0181).

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Author note Any amendments to the study protocol will be submitted to the Human Research Ethics Committee (HREC)and updated on the trial register (ANZCTR) once full ethical approval has been obtained.