None listed
Conditions
Brief summary
A 2-arm randomised waitlist-controlled trial to test the efficacy of a m-health intervention to promote physical activity and sleep health in adults. The two main outcomes (MVPA and sleep quality) will be assessed after 3 months (primary endpoint) and followed up at the 6-month time point. The study will deliver a combined program including an app and message-based support to facilitate goal-setting, self-monitoring and feedback on progress towards goal for both behaviours. Physical inactivity is highly prevalent among adults and a large proportion of the population reports poor sleep health (characterised by inadequate sleep duration, low quality of sleep and inappropriate sleep timing, leaving people feeling insufficiently refreshed and unsatisfied with their sleep). Both behaviours independently influence risks for chronic disease and mortality and may have a bidirectional relationship, as such synergistic effects on health may be achieved. No studies to date have targeted the two behaviours simultaneously in a mobile device-delivered behaviour change intervention. In addition to testing the efficacy of such an intervention, we seek to identify potential moderators of intervention efficacy (e.g., age, gender, education) and test mediators of behaviour change (social cognitive factors, sleep hygiene).
Interventions
A 2-arm randomised waitlist-controlled trial with a primary endpoint at 3 months and a 6-month follow-up, testing the efficacy of a mobile device delivered (smartphone or tablet) program to improve physical activity and sleep. The 12-week intervention will be delivered using a combination of a mobile app and a message-based support service.
The mobile app will operationalise goal-setting, self-monitoring and feedback strategies in relation to physical activity and sleep health. The message-base
A 2-arm randomised waitlist-controlled trial with a primary endpoint at 3 months and a 6-month follow-up, testing the efficacy of a mobile device delivered (smartphone or tablet) program to improve physical activity and sleep. The 12-week intervention will be delivered using a combination of a mobile app and a message-based support service. The mobile app will operationalise goal-setting, self-monitoring and feedback strategies in relation to physical activity and sleep health. The message-based support service (Email and text messaging) will provide feedback on progress towards goals, prompts to practice the two behaviours and review/adjust goals, daily reminders (optional) and tool sheets on goal-setting, action planning and stress management. Participants will be asked to self-monitor their daily physical activity and sleep behaviours and set personal goals for both behaviours within the app. We will advise participants to log both behaviours on a daily basis, whereas goals can be reset at any time (if need be) or otherwise will remain unchanged. A summary report, which is sent to participants once weekly will assist with the process of goal review. Goal achievement is considered successful, if participants are within 20% of their goal. For example, if a participant aimed for 30 min of activity, their feedback dashboard (traffic light) will display a green light and their goal is reached , if the participant logged at least 24 min of activity or more for that day. Reference values for an orange light are 20-35% of goal and >35% of goal for a red light. Multiple entries per day are possible. In detail, the physical activity section of the app allows entries for moderate-to-vigorous intensity physical activity, a step count and resistance training sessions. The sleep section allows entries for bed and wake times, a sleep quality rating and a set of sleep hygiene behaviours (e.g. reducing the impact of noise and light in the bedroom, avoiding caffeine before bedtime, etc.). Based on the data entered by the participant, the app will generate instant feedback in the form of a traffic light, which changes colours by comparing individual goals against the data participants entered. In addition, progress charts will illustrate progress over time (daily, 1-week and 3-month charts) for both behaviours. A pedometer will be shipped to participants to facilitate the logging of a daily step count. Participants will be asked to set relevant and achievable goals (guidance provided); however, we will encourage individuals to gradually work towards the recommended minimum of physical activity (PA) and sleep as per national guidelines, which is 150 min/wk (plus 2 days of resistance training) for PA and 7-9 hours of sleep per night. The entirely remotely delivered trial will be advertised nationwide using social media and the baseline, 3-month and 6-month assessments will collect self-report measures of physical activity and sleep as well as secondary outcomes (mental health, health-related quality of life, sleep hygiene) and potential mediators (social cognitive correlates of physical activity and sleep) via online surveys. Fidelity and adherence will be assessed and reported as part of a process evaluation. The app and all other components are informed by social cognitive theories and follow behaviour change taxonomies to ensure consistency with implementation standards and reporting. Participants will be given continuous access to the app.
Sponsors
A/Prof Mitch J Duncan
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Participants will be eligible, if they self-report: 1. being aged 18 to 55 years; 2. living in Australia; 3. having a body weight and height consistent with a Body Mass Index (BMI) of 18.5 to 35; 4. accumulating less than 150 minutes of moderate to vigorous physical activity per week; 5. rating their sleep-quality (over the past month) as fairly bad or very bad; 6. being free of any condition that would make it unsafe to increase activity levels (frequency, intensity, duration) and being free of any condition that would make it unsafe to change sleep behaviours
Exclusion criteria
Individuals will be excluded from this study, if they 1. self-report having a diagnosed sleep disorder (chronic insomnia, sleep apnoea, sleepwalking, narcolepsy, restless legs syndrome, etc.); 2. are currently consuming hypnotics (sleep inducing medication); 3. are currently employed in night shift work; 4. are currently suffering from jet lag or planning to travel to a destination with a shift in time zone by more than three hours during the 3-month intervention period; 5. are currently pregnant or have given birth in the past 12 months; 6. are currently using a self-monitoring system or device to track or log physical activity and/or sleep (this includes non-device assisted applications); and 7. do not confirm that they have read and understood the information statement and consented to the terms & conditions that apply to the use of the intervention components (app).
Outcome results
None listed