A pilot-RCT of an app-based intervention to reduce the cardiovascular disease risk in shift-workers through targeting multiple lifestyle behaviours.

The Move, Eat & Sleep Shift-worker study is a pilot study that uses a randomised controlled trial (RCT) with two parallel groups involving an Intervention group, and a wait-list control group. The primary aim of the proposed pilot- randomised controlled trial is to evaluate the feasibility of the study protocol and the acceptability and appropriateness of the shift-worker tailored intervention in a 4-week trial in adult shift-workers. The secondary aim is to assess the preliminary efficacy of the intervention by comparing changes in physical activity levels, diet quality and sleep quality in the Intervention (n=20) and education only control (n=20) groups. Participants will receive access to the specifically designed app (Balanced). Educational materials as part of the app will include educational materials on physical activity, dietary and sleep duration guidelines, information on the physical, mental and social benefits of increasing physical activity, and improving diet and sleep quality. SMART goal setting techniques, overcoming barriers, how to create action plans, an action planning tool, relaxation and stress management techniques provided via the app. Participants are also emailed an electronic version (pdf document) of these Educational Resources information in the form of a participant ‘handbook’. These resources have been developed based on existing resources (i.e. doi:10.1136/bmjopen-2017-018997; https://doi.org/10.1016/j.cct.2018.08.007 ; ACTRN12617000735358) and adapted to the shiftworker population. These modifications included suggestions on the timing of sleep (including naps) to adapt to changing shift schedules and promote recovery between shifts, timing of physical activity and meals to align with shift schedules. The participant handbook includes an overview of the key app features and functionality and a brief “how to guide” for participants which includes both graphical (from the app) and text based examples. No in person introduction is provided to the app. Participants will be asked to use the Balanced app daily for self-monitoring of behaviours but are instructed they can use the app as much or as little as they like and they will have access to the app continuously throughout the entire study period. Participants will be able to self-monitor daily physical activity (minutes of MVPA, sessions of resistance training, daily steps (if they have a step counting device), improved diet quality (number of serves of core foods, soft-drink/fast food free days) and improved sleep (duration, quality, hygiene and variability [time to bed and awake]) and update these goals in line with their progress. Personalised feedback on progress towards goals will be provided using graphs on a daily, weekly and monthly basis. Additional weekly summaries with more detailed feedback (e.g. most active days, # of days where goals were achieved) will be emailed to participants. Participants will receive automated self-monitoring SMS/e-mail reminders. Secondary outcomes will be assessed using an online survey. Participants will be sent weekly SMS to provide educational and motivating ‘facts’ about how target behaviours (physical activity, diet and sleep (if in enhanced group) can influence health. Weekly SMS will also be sent to prompt reengagement with self monitoring if self monitoring has stopped (defined as no self monitoring on 4 days out of 7). Intervention group participants will receive an email that provides a weekly summary of their self-monitored behaviours and progress against goals. This is intended to build self-efficacy for changing behaviours. Feedback will be provided to participants on behaviour and weight via in-app feedback, emailed personalised weekly summaries, and for dietary behaviours only, additional in person, and online feedback via completion of the Healthy Eating Quiz (www.healthyeatingquiz.com.au). Adherence to the intervention will be assessed by monitoring the usage of the intervention app provided to self monitor behaviours. This provides information on date and time a self monitoring entry is made and also the details of the actual entry (eg. 30 minutes of activity).