A randomised controlled trial to examine the effectiveness of a novel technology based intervention to improve physical activity, sitting and sleep behaviours: the Balance study

This study compares the effectiveness of a novel device-based self-monitoring intervention to improve adults’ physical activity, sedentary, and sleep-wake behaviours, compared with a user-entered self-monitoring intervention. The intervention used in this study, “Balance”, will be a freely available “app” that can be used on a mobile device (smartphone or tablet) with a self-monitoring device (device-measured (Fitbit); Group 1) or without one (user-entered; Group 2). The proposed project will involve the development of a 2 arm intervention (Group 1: device (device-measured (Fitbit); Group 2: no device, user-entered) to engage participants in daily self-monitoring of physical activity, sitting and sleep-wake behaviours and to improve these behaviours. The intervention duration is 9 weeks and participants can access the intervention throughout the entire study period, both groups will be encouraged to engage in daily self-monitoring of behaviours. The proposed intervention may contribute to reducing levels of physical inactivity and insufficient sleep. We aim to recruit a minimum of 64 adults aged 18-55 years from the Hunter Region, NSW, Australia. Participants will be low active, report frequent insufficient sleep and have a BMI between 18.5-35. It has been determined that a minimum of 32 participants per group would be required to detect statistically significant effects assuming a drop out of 35%. Eligible participants will be asked to complete both physiological and survey based assessments at baseline, and 3 weeks, 6 weeks and 9 weeks post baseline. Participants will have access to the intervention throughout the entire study period and following the completion of the study. Participants in both intervention groups will be able to self-monitor physical activity, sitting and sleep-wake behaviours, set goals for these behaviours, be provided with graphical feedback on their behaviour. Only the method of self-monitoring will differ, device measured or user-entered. In the device measured group, Fitbit data is automatically synchronized with the Balance platform via bluetooth and the internet (either wifi or phone network). Both groups will receive educational materials outlining the health effects of physical inactivity and insufficient sleep and strategies to assist in improving these behaviours.