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

INTERVENTION: 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. Self‐monitoring and goal setting CONDITION: Physical inactivity Poor sleep health PRIMARY OUTCOME: Sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI) INCLUSION CRITERIA: To be eligible for inclusion in this study, individuals must satisfy the following criteria: 1. be aged between 40 and 65 years, 2. report a BMI between 18.5 and 35, 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. 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 neces SECONDARY OUTCOME: App usage during the intervention period will be measured via the app database. For example this will include how many self‐monitoring entries are made and the length of time the app is regularly interacted with during the intervention. Assessment of a participants’ predilection for morningness or eveningness using the reduced scale Morning/Evening Questionnaire Assessment of the severity of insomnia using the Insomnia Severity Index Energy and Fatigue will be measured using the vitality sub‐scale of the RAND 36 survey. Evaluation of the presence of symptoms of insomnia using the Sleep Condition Indicator Health‐related Quality of life measure using the SF‐12 Psychological distress measured using the Kessler 6 Self‐reported resistance training will be assessed using two items which assess the number of days in a typical week over the past month that resistance training was performed and the amount of time engaged in resistance training each day. Sitting behaviour measured using the Workforce Sitting Questionnaire. Sleep Hygiene measured with the Sleep Hygiene Index Sleep timing using the Sleep Timing Questionnaire Symptoms severity of depression, anxiety and stress assessed using the Depression, Anxiety and Stress Scale ‐ 21 (DASS‐21) Usability of the app will be measured using the System Usability Scale. Weekly minutes of moderate to vigorous intensity physical activity measured using the Active Australia Questionnaire 3. participate in less than 30 minutes of moderate or vigorous exercise (such as walking or a sport) on three or more days of the week . 4. report fairly bad or very bad sleep quality, 5. have access to either an iOS or Android smartphone or tablet that can access the internet.