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Trial registered on ANZCTR


Trial ID
ACTRN12617000735358
Ethics application status
Approved
Date submitted
12/05/2017
Date registered
19/05/2017
Date last updated
26/03/2018
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] 291354 0
Nil known
Universal Trial Number (UTN)
Trial acronym
The Move, Eat & Sleep Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight and obesity 302339 0
Condition category
Condition code
Public Health 302631 302631 0 0
Health promotion/education
Diet and Nutrition 302715 302715 0 0
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] 297383 0
Behaviour
Intervention code [2] 298016 0
Lifestyle
Intervention code [3] 298069 0
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] 301354 0
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] 301354 0
Assessed at baseline, 6 months and 12 months
Secondary outcome [1] 332395 0
Waist circumference
Timepoint [1] 332395 0
Assessed at baseline, 6 months and 12 months
Secondary outcome [2] 332396 0
Glycated haemoglobin, measured using A1C NOW+
Timepoint [2] 332396 0
Assessed at baseline, 6 months and 12 months
Secondary outcome [3] 332398 0
Dietary intake and diet quality, measured using the Australian Eating Survey
Timepoint [3] 332398 0
Assessed at baseline, 6 months and 12 months
Secondary outcome [4] 332399 0
Eating behaviours, measured using the Three-Factor Eating Questionnaire R-18 and the Modified Yale Food Addiction Scale
Timepoint [4] 332399 0
Assessed at baseline, 6 months and 12 months
Secondary outcome [5] 332400 0
Symptoms severity of depression, anxiety and stress, assessed using the Depression, Anxiety and Stress Scale - 21 (DASS-21)
Timepoint [5] 332400 0
Assessed at baseline, 6 months and 12 months
Secondary outcome [6] 332401 0
Health related quality of life, measured using the Health Survey SF-36
Timepoint [6] 332401 0
Assessed at baseline, 6 months and 12 months
Secondary outcome [7] 334691 0
Sleep quality, measured via accelerometer and the Pittsburgh Sleep Quality Index
Timepoint [7] 334691 0
Assessed at baseline, 6 months and 12 months
Secondary outcome [8] 334692 0
Sleep hygiene, measured using the Sleep Hygiene Index
Timepoint [8] 334692 0
Assessed at baseline, 6 months and 12 months
Secondary outcome [9] 334693 0
Insomnia severity, measured using the Insomnia Severity Index
Timepoint [9] 334693 0
Assessed at baseline, 6 months and 12 months
Secondary outcome [10] 334694 0
Sleep timing, measured using the Sleep Timing Questionnaire
Timepoint [10] 334694 0
Assessed at baseline, 6 months and 12 months
Secondary outcome [11] 334695 0
Physical activity behaviours, measured via accerometer and the Active Australia Questionnaire
Timepoint [11] 334695 0
Assessed at baseline, 6 months and 12 months
Secondary outcome [12] 334696 0
Sedentary behaviour, measured via accelerometer and the Workforce Sitting Questionnaire
Timepoint [12] 334696 0
Assessed at baseline, 6 months and 12 months.

Eligibility
Key inclusion criteria
(i) Aged between 18-65 years
(ii) Weight and height consistent with a Body Mass Index (BMI) between 25.0-40.0kg/m2
(iii) Access to either an iOS or Android smartphone or tablet that can access the internet
(iv) Being willing and able to attend the University of Newcastle Callaghan campus on four occasions to complete assessments
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) Currently using a tracking device for physical activity and/or sleep eg. Fitbit, Jawbone
(ii) Pregnant
(iii) Diagnosis of a sleep disorder eg. insomnia, restless legs, narcolepsy, obstructive sleep apnoea
(iv) Currently taking medication that may affect sleep or weight management
(v) Have a condition which would contraindicate participation in physical activity
(vi) Have a condition which would contraindicate modifying diet and sleep
(vii) Weight loss of 4.5kg or more in the past 3 months
(viii) Are intending on participating in another weight loss program during the study period
(ix) Have had weight loss surgery
(x) Currently employed as a shift worker (rotating roster)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A statistician independent of the current trial will develop the randomisation sequence using varying block sizes and stratification by BMI (25.0-29.9, 30.0-34.9, 35.0-40.0 kg/m2). The randomisation sequence will be stored on an online randomisation portal hosted by Clinical Research Design, IT and Statistical Support (CReDITSS) unit at the Hunter Medical Research Institute.
Following completion of the baseline assessment the project manager will access the password protected online randomisation portal to reveal the participant allocation. Group allocation is not accessible prior to accessing the portal.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A statistician independent of the current trial will develop the randomisation sequence using varying block sizes and stratification by BMI (25.0-29.9, 30.0-40.0 kg/m2). The randomisation sequence will be stored on an online randomisation portal hosted by Clinical Research Design, IT and Statistical Support (CReDITSS) unit at the Hunter Medical Research Institute.

Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The primary analysis will compare the control group to the two combined intervention groups (difference 3.6 kg; alpha = 0.05; power = 0.80). A secondary analysis will conducted to compare the two intervention groups. To provide 80% power to detect a difference of 3.6 kg difference between control and the combined intervention groups, total of 31 participants per group is required. This calculation assumes an alpha level of 0.05, a pre post correlation of 0.9, and a standard deviation of 13.4kg. A meta-analysis of eHealth weight loss interventions reported an average dropout rate of 22%, which varied greatly between studies, and we have achieved <20% drop out in previous weight loss studies over 6 months. We conservatively assumed a dropout rate of 17% in the current study, which would lead to 38 participants required in each group after accounting for drop out (total n=114).
All analyses will follow an intention-to-treat principle.
The primary comparison will be between the combined intervention groups (group 1: traditional and group 2: enhanced) and control. A secondary (exploratory) analysis will also explore if there are differences between treatment groups (group 1: traditional and group 2: enhanced). Secondary analyses will also examine between group differences in primary and secondary outcomes at 12 months.

Generalized Linear Models will be used to examine baseline-adjusted weight at 6 months. Treatment group differences in weight will be estimated in an ANCOVA framework (i.e adjusting for baseline values of the outcome). The model will include fixed effects group, and the BMI stratification variable. Generalized Linear Mixed Models (GLMM) will be used to examine baseline-adjusted weight at 12 months. Treatment group differences in weight will be estimated in an ANCOVA framework (i.e adjusting for baseline values of the outcome). The model will include fixed effects for time, group, the time x group interaction and the BMI stratification variable, and a random intercept will be used to account for the repeated measures on individuals.

Differences between groups in primary and secondary outcomes will be examined using a similar GLM and GLMM approach using a response distribution and link function appropriate to the outcome, and an alpha level of 0.05. The GLMMs provide unbiased estimates of the treatment effect under the assumption that data are missing at random. Sensitivity analyses using methods such as multiple imputation and pattern mixture modelling will be undertaken to investigate the robustness of conclusions to different assumed missing data mechanisms. Analysis of mediators will be examined using established frameworks and analysis of moderators will be assessed by including an interaction term in the model of interest. All analyses will be conducted using Stata.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 15499 0
2308 - Newcastle University
Recruitment postcode(s) [2] 15946 0
2308 - Callaghan
Recruitment postcode(s) [3] 15976 0
2300 - Newcastle
Recruitment postcode(s) [4] 15977 0
2320 - Maitland

Funding & Sponsors
Funding source category [1] 295827 0
Charities/Societies/Foundations
Name [1] 295827 0
National Heart Foundation of Australia
Address [1] 295827 0
PO Box 373
Mawson ACT 2607
Country [1] 295827 0
Australia
Funding source category [2] 296140 0
Charities/Societies/Foundations
Name [2] 296140 0
Diabetes Australia
Address [2] 296140 0
PO Box 3156
Canberra ACT 2601
Country [2] 296140 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Mitch Duncan
Address
Level 3
Advanced Technology Centre
University of Newcastle
University Dr
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 295038 0
None
Name [1] 295038 0
Address [1] 295038 0
Country [1] 295038 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297110 0
Human Research Ethics Committee University of Newcastle
Ethics committee address [1] 297110 0
Research & Innovation Services Research Integrity Unit
NIER, Block C
The University of Newcastle
Callaghan NSW 2308
Ethics committee country [1] 297110 0
Australia
Date submitted for ethics approval [1] 297110 0
09/02/2017
Approval date [1] 297110 0
01/05/2017
Ethics approval number [1] 297110 0
H-2017-0039

Summary
Brief summary
Overweight and obesity is highly prevalent among Australian adults and being overweight or obese increases the risk of developing stroke, coronary heart disease and type 2 diabetes mellitus. For optimum health and to prevent the development of chronic diseases individuals should aim to maintain Body Mass Index in the range 18.5 to 24.9 kg/m2. For individuals who are overweight or obese, weight loss of >5% is a key prevention and treatment recommendation to reduce the risk of type 2 diabetes. Traditional weight loss interventions combining physical activity and dietary behaviour change are only modestly effective, as interventions often fail to achieve the weight loss target of 5%, on average achieving only 3.3% weight loss. Consequently, the efficacy of behavioural weight loss interventions need to be improved. One potential way to enhance the efficacy of traditional weight loss interventions is to concurrently target improvements in sleep health.

The Move, Eat & Sleep Study is a 3-arm randomised controlled trial to assess the relative efficacy of a physical activity, dietary behaviour, and sleep health intervention (enhanced), compared with a physical activity and dietary behaviour only intervention (traditional), and wait-list control for weight loss, in overweight/obese adults. The primary outcome of weight change will be assessed after 6 months and followed up at the 12 month time point.

It is hypothesised that both the enhanced and the traditional interventions will achieve a statistically significant reduction in weight relative to the wait list control at 6 months primary time point, and that the enhanced intervention will achieve a statistically significant greater reduction in weight relative to the traditional intervention at 6 months.

The Move, Eat & Sleep study is a technology-based, multi-behavioural intervention to promote weight loss. 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, 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73010 0
A/Prof Mitch Duncan
Address 73010 0
Level 3
Advanced Technology Centre
University of Newcastle
University Dr
Callaghan NSW 2308
Country 73010 0
Australia
Phone 73010 0
+ 61 2 49217805
Fax 73010 0
+61 2 49212084
Email 73010 0
mitch.duncan@newcastle.edu.au
Contact person for public queries
Name 73011 0
A/Prof Mitch Duncan
Address 73011 0
Level 3
Advanced Technology Centre
University of Newcastle
University Dr
Callaghan NSW 2308
Country 73011 0
Australia
Phone 73011 0
+ 61 2 49217805
Fax 73011 0
+61 2 49212084
Email 73011 0
mitch.duncan@newcastle.edu.au
Contact person for scientific queries
Name 73012 0
A/Prof Mitch Duncan
Address 73012 0
Level 3
Advanced Technology Centre
University of Newcastle
University Dr
Callaghan NSW 2308
Country 73012 0
Australia
Phone 73012 0
+ 61 2 49217805
Fax 73012 0
+61 2 49212084
Email 73012 0
mitch.duncan@newcastle.edu.au