The Move, Eat & Sleep study: an app-based physical activity, diet and sleep health weight loss program.

• Register: ANZCTR
• Last refreshed on: 27 August 2018
• Main ID: ACTRN12617000735358
• Date of registration: 19/05/2017
• Prospective Registration: Yes
• Primary sponsor: Associate Professor Mitch Duncan
• Public title: The Move, Eat & Sleep study: an app-based physical activity, diet and sleep health weight loss program.
• Scientific title: Examining the efficacy of an app-based physical activity, diet and sleep health intervention for weight loss in overweight or obese adults: the Move, Eat & Sleep randomized controlled trial
• Date of first enrolment: 8/06/2017
• Target sample size: 114
• Recruitment status: Active, not recruiting
• URL: http://www.anzctr.org.au/ACTRN12617000735358.aspx
• Study type: Interventional
• Study design: Randomised controlled trial Parallel
• Phase: Not Applicable

Health Condition(s) or Problem(s) studied

Overweight and obesity

Intervention(s)

The Move, Eat & Sleep study is a 3-arm randomised controlled trial (RCT) with three parallel groups involving an Enhanced intervention group, Traditional intervention group and a wait-list control group. The primary outcome is weight loss at the 6 month post baseline assessment. The study also includes a 12 month post baseline assessment.

The secondary aims of the study are to compare the relative efficacy of the enhanced intervention and traditional intervention on the following secondary outcomes: 1) waist circumference, 2) glycated haemoglobin (HbA1c), 3) physical activity, 4) sedentary behaviour, 5) dietary quality and intake, 6) eating behaviours, 7) sleep health, 8) severity of depression, anxiety and stress symptoms and 9) health related quality-of-life.

The Move, Eat & Sleep study is a technology-based, multi-behavioural intervention to promote weight loss in overweight and obese adults. This will be achieved by increasing physical activity levels, improving dietary quality and reducing energy intake to promote weight loss, and in the Enhanced group also improving sleep health.

Participants will receive access to a modified version of the Balanced app for a period of 12 months, a set of body weight scales to self-monitor weight, a Fitbit to self-monitor activity and sleep behaviours, a participant handbook and additional email and text message based support, and personalised dietary counselling. Participants in the Traditional Group will not self-monitor sleep health via the Balanced app or Fitbit, and will not receive any intervention content related to sleep health.
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 minutes of moderate-to-vigorous physical activity, daily steps taken and resistance training performed on a daily basis. Participants will also be encouraged to use the Balanced app to self-monitor dietary intake and quality on a daily basis using ten specific food goals. These food goals are designed in line with Australian Dietary Guidelines to promote a nutritionally balanced diet and a reduction in energy intake. Self-monitoring of sleep in the Balanced app consists of sleep time, wake time, sleep quality and sleep hygiene behaviours. Finally, using the scales provided participants will be encouraged to weigh themselves once per week and manually enter this into the Balanced app.

Participants will be provided with educational information via in-app content, email and text messages, a printed participant handbook and in person via the nutrition counselling session. This information will detail how target behaviours can influence weight loss and strategies to achieve weight loss. The single nutrition counselling session will be conducted by a qualified dietitian, in a one-on-one format at the University of Newcastle Callaghan campus at the completion of the baseline assessment. The session will last for 20-25 minutes, with the purpose of setting a weight loss goal for each participant, discussing the results of their previously completed Australian Eating Survey, and making recommendations on how they can improve their dietary intake and diet quality for weight loss. Topics covered in this session will include energy deficit for weight loss, Australian Dietary Guidelines, The Australian Guide to Healthy Eating, appropriate portion sizes, and how to interpret food labels. Weight loss recommendations are based on the Eat for Health Educator's Guide, by the National Health and Medical Research Council.

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 assist with weight loss. Weekly SMS will also be sent to prompt reengagement with self monitoring if self monitoring has stopped. Each week for the first 6 months of the intervention 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).

As indicated above in description of the exposure during the first 6 months of the study all participants receive a weekly educational ‘fact of the week’ SMS to provide insight on how behaviour can influence weight loss. If participants have stopped self monitoring during the week (no self monitoring on 4 days out of 7) they will also receive a weekly SMS to prompt them to reengage them with self-monitoring the