Murawski Beatrice, Plotnikoff Ronald C, Rayward Anna T, Vandelanotte Corneel, Brown Wendy J, Duncan Mitch J
Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Newcastle, Australia.
School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, Callaghan, Australia.
BMJ Open. 2018 Feb 8;8(2):e018997. doi: 10.1136/bmjopen-2017-018997.
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.
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.
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.
ACTRN12617000376347; Pre-results.
有必要减少成年人群中的身体活动不足和睡眠健康不佳的情况，以降低慢性病发病率及相关负担。鉴于这些风险行为的高患病率，有必要开展具有广泛影响力的有效干预措施。
这项双臂随机对照试验的目的是测试为期三个月的个性化移动应用程序干预对两个主要结果的影响：中等至剧烈强度身体活动的分钟数和整体睡眠质量。此外，将评估健康相关生活质量和心理健康状况的组间变化作为次要结果。预先设定的中介因素和调节因素包括社会认知因素、邻里环境、健康状况（体重指数、抑郁、焦虑、压力）、社会人口统计学因素（年龄、性别、教育程度）和应用程序使用情况。将在三个月（主要终点）和六个月（随访）后进行评估。干预措施将提供一个专门开发的移动应用程序，参与者可以通过该应用程序设定活跃分钟数、每日步数、阻力训练、睡眠时间和睡眠卫生习惯的目标。该应用程序还允许参与者每天记录自己的行为，并查看进度条以及与目标相关的即时反馈。个性化支持系统将包括每周总结报告、教育和指导材料、关于脱离接触的提示以及每周事实。
澳大利亚纽卡斯尔大学人类研究伦理委员会给予了全面批准：H-2016-0181。本研究将评估联合行为干预的效果、行为改变的机制并收集高质量的过程数据，所有这些都将有助于完善未来的试验。研究结果的传播将包括在同行评审期刊上发表以及在国家或国际会议上展示。参与者将收到一份通俗易懂的结果总结报告。
ACTRN12617000376347；预结果。
