An e-health delivered trial to test the efficacy of a combined physical activity and sleep intervention to improve sleep quality in Australian adults with poor sleep quality: The Refresh Study

The intervention will be a three-armed, randomised controlled trial with a 3-month primary time point and 6-month post-baseline follow-up, aimed at improving sleep quality including a combined Physical Activity and Sleep Health group, a Sleep Health Only group and a Waitlist Control group. The multi-component intervention will be delivered over a 6 month period, using a mobile device (smart-phone or tablet) application “app” (called “Balanced”) and will provide additional support, for the first 3 months of the intervention, in the form of emails and text messages. Participants will have access to the app throughout the intervention period and are free to use the app as much or a little as they choose, although they will be encouraged to use it daily. Participants will be recruited from across all states of Australia using primarily nationwide advertising on social media (e.g., Facebook) in conjunction with local radio, posters in local businesses, on community noticeboards and around the University of Callaghan campus. The core components of the intervention are education, self-monitoring, and feedback on performance. Physical Activity and Sleep Health Group Intervention The Physical Activity and Sleep Health intervention group will use the app to access educational material, set physical activity and sleep goals, self-monitor their physical activity and sleep behaviours and to receive graphical feedback in relation to their progress towards these goals. In addition to the app, participants in the physical activity and sleep intervention group will be mailed a pedometer, to assist with self-monitoring step count. Participants will also receive content and prompts via emails and text messages during the first 12 weeks of the intervention. These will include weekly communication in the form of a mid-week text message containing a brief educational fact about physical activity or sleep, and an end-of-week email containing a personalised summary of the participant’s weekly physical activity and sleep behaviours, based on the self-monitoring information they have provided. This summary will provide additional feedback and prompt the setting of new goals if required. Education Educational content will be found within the app and the participant handbook, which will include goal-setting, action planning and stress management “tools”, mailed and emailed to participants. The handbook and “tools” were developed specifically for the intervention and integrate information from current Australian Physical Activity Guidelines, National Sleep Foundation’s sleep duration recommendations, sleep hygiene practices, stress management techniques (sourced from the Black Dog Institute) and theoretical constructs and behaviour change techniques which have been found to facilitate behaviour change. The goal setting tool will also provide specific guidance for which physical activity and sleep goals should be set, and how to set these goals. Participants will be encouraged to gradually change their physical activity levels and sleep times to meet national guideline recommendations (150- 300 minutes moderate to vigorous activity and at least two sessions of muscle strengthening exercise and 7-9 hours sleep/night). They will also be encouraged to choose a regular bed-time and wake time, and to practice some other sleep hygiene behaviours, building up their repertoire over time. The action planning tool will include examples of action plans and exercise options, from which the participant can model their own. This will include: aerobic physical activities and resistance training physical activities as well as intensity, duration and frequency of activities. Participants will be encouraged to develop an action plan for both physical activity and sleep. The stress management tool will provide step-by-step guides to progressive muscle relaxation, deep breathing exercises and mindfulness exercises. Information about how to use the app and interpret the feedback graphs and traffic light system of goal progress will be provided in the participant handbook. Self-monitoring and goal setting Participants will set goals for, and self-monitor their physical activity and sleep behaviours using the app. Goals to be set for physical activity will include; the daily number of minutes of moderate to vigorous intensity activity, daily step count and the weekly number of resistance training sessions, and for sleep: time to bed, time to wake, the daily number of sleep hygiene behaviours (out of 10) they wish to practice (e.g., avoiding caffeine late in the day, creating a comfortable bedroom environment). Participants will be required to self-monitor these behaviours by manually entering information about each of the behaviours for which they set goals as well as a sleep quality rating (using a star rating with five stars indicating excellent quality sleep). The goals will be entered into the app, reviewed weekly and updated if necessary. Feedback The participant’s goals will be compared with the activity and sleep information entered by the participant and used to provide graphical feedback using a traffic light system which indicates the participant’s progress in relation to their goal. A green light indicates a participant is meeting, exceeding or close to their goal; an orange light indicates they are progressing toward their goal although are not close; and a red light indicates they are markedly below their goal. The app will also show daily, weekly, and 3-month progress in the form of graphs for each behaviour. Additionally, participants will be emailed a personalised weekly summary of their behaviours and progress towards goals. The participant will be encouraged to use this feedback to evaluate their weekly performance and use this as a guide when reviewing their goals. Sleep Health Only Group The Sleep Health Only group will receive the same sleep education, goal setting, action planning and monitoring as the combined Physical Activity and Sleep Health group. They will not receive a pedometer or any of the physical activity components of that intervention group beyond the general advice to “exercise regularly” as part of the overall sleep hygiene recommendations. Wait-list Control Group The Wait-list Control group will be asked not to change their physical activity and sleep behaviours until they have completed the 6-month follow-up survey, after which time they will be offered the combined physical activity and sleep intervention. Assessments Participants will complete online assessments as baseline, 3-month primary time point and at the 6-month post-baseline follow-up. These will measure self-reported sleep behaviours as well as secondary outcomes including physical activity, mental health and health-related quality of life as well as assessment of app usability and usage as part of a process evaluation.