ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617000735358

Ethics application status

Approved

Date submitted

12/05/2017

Date registered

19/05/2017

Date last updated

21/08/2018

Type of registration

Prospectively registered

Titles & IDs

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

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1219-2050

Trial acronym

The Move, Eat & Sleep Study

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Overweight and obesity

Condition category

Condition code

Public Health

Health promotion/education

Diet and Nutrition

Obesity

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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 their behaviours. This will occur in the first 6 months of the intervention.

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).

Intervention code [1]

Behaviour

Intervention code [2]

Lifestyle

Intervention code [3]

Treatment: Other

Comparator / control treatment

The wait-list control group will attend assessments but will receive no intervention materials during the 6 month study period and will be asked to maintain current sleep, activity and dietary behaviours.

Control group

Active

Outcomes

Primary outcome [1]

Weight change (kilograms)

Measured on calibrated digital scales to 0.01kg (Biospace BSM370 Portable Automatic BMI Stadiometer, Biospace CO, Ltd., Seoul, Korea). Weight will be measured twice, with acceptable values within 0.1kg. If the measurements vary by more than 0.1kg a third measurement will be taken. The average of the two acceptable measures that are within 0.1kg will be reported.

Timepoint [1]