Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000376347
Ethics application status
Approved
Date submitted
9/03/2017
Date registered
13/03/2017
Date last updated
13/05/2019
Date data sharing statement initially provided
13/05/2019
Date results provided
13/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing the effectiveness of a mobile device delivered program to improve physical activity and sleep among inactive Australian adults with poor sleep.
Scientific title
Efficacy of a m-health intervention to improve physical activity and sleep health in adults: A randomised waitlist-controlled trial
Secondary ID [1] 289971 0
None
Universal Trial Number (UTN)
U1111-1186-6588
Trial acronym
The Synergy Study
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 299969 0
Poor sleep health 299970 0
Condition category
Condition code
Public Health 299860 299860 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 2-arm randomised waitlist-controlled trial with a primary endpoint at 3 months and a 6-month follow-up, testing the efficacy of a mobile device delivered (smartphone or tablet) program to improve physical activity and sleep. The 12-week intervention will be delivered using a combination of a mobile app and a message-based support service.

The mobile app will operationalise goal-setting, self-monitoring and feedback strategies in relation to physical activity and sleep health. The message-based support service (Email and text messaging) will provide feedback on progress towards goals, prompts to practice the two behaviours and review/adjust goals, daily reminders (optional) and tool sheets on goal-setting, action planning and stress management.

Participants will be asked to self-monitor their daily physical activity and sleep behaviours and set personal goals for both behaviours within the app. We will advise participants to log both behaviours on a daily basis, whereas goals can be reset at any time (if need be) or otherwise will remain unchanged. A summary report, which is sent to participants once weekly will assist with the process of goal review. Goal achievement is considered successful, if participants are within 20% of their goal. For example, if a participant aimed for 30 min of activity, their feedback dashboard (traffic light) will display a green light and their goal is reached , if the participant logged at least 24 min of activity or more for that day. Reference values for an orange light are 20-35% of goal and >35% of goal for a red light. Multiple entries per day are possible.

In detail, the physical activity section of the app allows entries for moderate-to-vigorous intensity physical activity, a step count and resistance training sessions. The sleep section allows entries for bed and wake times, a sleep quality rating and a set of sleep hygiene behaviours (e.g. reducing the impact of noise and light in the bedroom, avoiding caffeine before bedtime, etc.). Based on the data entered by the participant, the app will generate instant feedback in the form of a traffic light, which changes colours by comparing individual goals against the data participants entered. In addition, progress charts will illustrate progress over time (daily, 1-week and 3-month charts) for both behaviours.

A pedometer will be shipped to participants to facilitate the logging of a daily step count. Participants will be asked to set relevant and achievable goals (guidance provided); however, we will encourage individuals to gradually work towards the recommended minimum of physical activity (PA) and sleep as per national guidelines, which is 150 min/wk (plus 2 days of resistance training) for PA and 7-9 hours of sleep per night.

The entirely remotely delivered trial will be advertised nationwide using social media and the baseline, 3-month and 6-month assessments will collect self-report measures of physical activity and sleep as well as secondary outcomes (mental health, health-related quality of life, sleep hygiene) and potential mediators (social cognitive correlates of physical activity and sleep) via online surveys. Fidelity and adherence will be assessed and reported as part of a process evaluation.

The app and all other components are informed by social cognitive theories and follow behaviour change taxonomies to ensure consistency with implementation standards and reporting. Participants will be given continuous access to the app.
Intervention code [1] 295660 0
Behaviour
Intervention code [2] 295661 0
Lifestyle
Intervention code [3] 295662 0
Treatment: Devices
Comparator / control treatment
Participants in the waitlist-control arm will not receive an intervention and be asked to not change their usual physical activity and sleep behaviours between baseline and the 6-month time point. They will however, receive full access to an identical program following completion of their 6-month assessment.
Control group
Active

Outcomes
Primary outcome [1] 299337 0
Minutes of moderate-to-vigorous intensity physical activity (weekly) measured using the Active Australia Questionnaire
Timepoint [1] 299337 0
Assessed at baseline, 3 months and 6 months
Primary outcome [2] 299338 0
Sleep quality (past 30 days) as per Pittsburgh Sleep Quality Index (PSQI)
NB. All PSQI component scores will be assessed and reported.
Timepoint [2] 299338 0
Assessed at baseline, 3 months and 6 months
Secondary outcome [1] 326885 0
Health-related quality of life measured with the SF-12 as well as 3 additional items from the RAND-36 forming the energy/fatigue sub-scale.
Timepoint [1] 326885 0
Assessed at baseline, 3 months and 6 months
Secondary outcome [2] 332441 0
Mental Health measured with the DASS-21
Timepoint [2] 332441 0
Assessed at baseline, 3 months and 6 months
Secondary outcome [3] 332442 0
Sitting Behaviour measured with the Workforce Sitting Questionnaire
Timepoint [3] 332442 0
Assessed at baseline, 3 months and 6 months
Secondary outcome [4] 332443 0
Daytime sleepiness measured with the Epworth Sleepiness Scale
Timepoint [4] 332443 0
Assessed at baseline, 3 months and 6 months
Secondary outcome [5] 332444 0
Sleep hygiene measured with the Sleep Hygiene Index
Timepoint [5] 332444 0
Assessed at baseline, 3 months and 6 months
Secondary outcome [6] 332633 0
Social cognitive factors relating to physical activity (based on Social Cognitive Theory)
Constructs assessed include self-efficacy, outcome expectations/expectancies, sociostructural factors, goals, action planning and habit strength. Items for each construct are based on previously validated items
Timepoint [6] 332633 0
Assessed at baseline, 3 months and 6 months
Secondary outcome [7] 332634 0
Social cognitive factors relating to sleep hygiene (based on Social Cognitive Theory)
Constructs assessed include self-efficacy, outcome expectations/expectancies, sociostructural factors, goals, action planning and habit strength. Items for each construct are based on previously validated items
Timepoint [7] 332634 0
Assessed at baseline, 3 months and 6 months
Secondary outcome [8] 332635 0
Participants' confidence in using the mobile app measured with the Internet Self-Efficacy Scale
Timepoint [8] 332635 0
Assessed at the 3-month time point
Secondary outcome [9] 332636 0
Perceived user satisfaction measured with the CAMPUS Scale
Timepoint [9] 332636 0
Assessed at the 3-month time point
Secondary outcome [10] 332637 0
Usability of the app measured with the System Usability Scale
Timepoint [10] 332637 0
Assessed at the 3-month time point
Secondary outcome [11] 332638 0
Overall interaction with the app throughout the intervention period measured through the app database (administrative management system), e.g., number of self-monitoring entries made and the duration of self-monitoring throughout the intervention
Timepoint [11] 332638 0
continuous
Secondary outcome [12] 335670 0
The number of days on which resistance training sessions occurred and the duration of resistance training per session will be assessed using 2 items.

The outcome for resistance training (RT) will be the frequency (number of days per week) of participation in resistance training. The duration per session (in hours and minutes) will be reported as descriptive information for those participants engaging in resistance training.

The two items are adapted from previously used items to assess resistance training. They were adapted specifically for the current study to assess RT participation over the last week.
Timepoint [12] 335670 0
Assessed at baseline, 3 months and 6 months

Eligibility
Key inclusion criteria
Participants will be eligible, if they self-report:
1. being aged 18 to 55 years;
2. living in Australia;
3. having a body weight and height consistent with a Body Mass Index (BMI) of 18.5 to 35;
4. accumulating less than 150 minutes of moderate to vigorous physical activity per week;
5. rating their sleep-quality (over the past month) as fairly bad or very bad;
6. being free of any condition that would make it unsafe to increase activity levels (frequency, intensity, duration) and being free of any condition that would make it unsafe to change sleep behaviours
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals will be excluded from this study, if they
1. self-report having a diagnosed sleep disorder (chronic insomnia, sleep apnoea, sleepwalking, narcolepsy, restless legs syndrome, etc.);
2. are currently consuming hypnotics (sleep inducing medication);
3. are currently employed in night shift work;
4. are currently suffering from jet lag or planning to travel to a destination with a shift in time zone by more than three hours during the 3-month intervention period;
5. are currently pregnant or have given birth in the past 12 months;
6. are currently using a self-monitoring system or device to track or log physical activity and/or sleep (this includes non-device assisted applications); and
7. do not confirm that they have read and understood the information statement and consented to the terms & conditions that apply to the use of the intervention components (app).

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)
The allocation sequence will be held by an independent allocation officer with no direct involvement in the study. Following completion of baseline assessment, a member of the research team will contact the allocation officer to reveal the participant allocation to one of the 2 study arms.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised into two groups (intervention or control) by a researcher not associated with the study using permuted block randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power: Based on estimated changes in physical activity and sleep using data from meta-analyses and a pilot study that targeted similar outcomes in a sample with similar characteristics, using similar intervention approaches and assuming an alpha of 0.025 (due to measuring two main outcomes), power of 0.80, a moderate effect size (d = 0.45 for physical activity; d = 0.65 for sleep) and a correlation between measures of 0.6, a total of 60 participants per group is required for physical activity and 35 per group for sleep quality. Therefore, the larger sample size is used. A drop-out rate of 25% is assumed and the sample is inflated to account for this. In summary, the total sample size is 80 participants per group or 160 in total.

Analyses: All analyses will follow an intention-to-treat principle. Any analyses to be conducted will be blinded to group allocation and overseen by an independent statistician. The primary aim is to examine differences in sleep quality and physical activity between the control group and intervention group at the 3-month time point. Between-group differences in physical activity and sleep quality (PSQI) will be estimated using Generalized Linear Mixed Models (GLMM) adjusting for baseline sleep quality (ANCOVA), including all available data in the analysis. Two separate GLMM will be used to examine changes in physical activity and sleep. Group differences in secondary outcome measures will be estimated using the same linear mixed modelling approach, setting an alpha of 0.05 for each outcome. Potential moderators of intervention group effects (secondary aims) will be explored by behaviour using linear mixed models with interaction terms, or stratification

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2017
Actual
3/06/2017
Date of last participant enrolment
Anticipated
Actual
10/08/2017
Date of last data collection
Anticipated
10/05/2018
Actual
30/03/2018
Sample size
Target
160
Accrual to date
Final
160
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 294342 0
Charities/Societies/Foundations
Name [1] 294342 0
National Heart Foundation of Australia
Country [1] 294342 0
Australia
Primary sponsor type
Individual
Name
A/Prof Mitch J Duncan
Address
ATC Building Level 3, The University of Newcastle, University Drive, Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 293181 0
Individual
Name [1] 293181 0
Prof Ron C Plotnikoff
Address [1] 293181 0
ATC Building Level 3, The University of Newcastle, University Drive, Callaghan NSW 2308
Country [1] 293181 0
Australia
Secondary sponsor category [2] 294748 0
Individual
Name [2] 294748 0
Beatrice Murawski
Address [2] 294748 0
ATC Building Level 3, The University of Newcastle, University Drive, Callaghan NSW 2308
Country [2] 294748 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295760 0
Human Research Ethics Committee
Ethics committee address [1] 295760 0
Ethics committee country [1] 295760 0
Australia
Date submitted for ethics approval [1] 295760 0
30/05/2016
Approval date [1] 295760 0
26/09/2016
Ethics approval number [1] 295760 0
H-2016-0181

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68382 0
A/Prof Mitch Duncan
Address 68382 0
Priority Research Centre for Physical Activity and Nutrition University of Newcastle ATC Building, Level 3 University Drive Callaghan, 2308 NSW
Country 68382 0
Australia
Phone 68382 0
+61 2 4921 2084
Fax 68382 0
Email 68382 0
[email protected]
Contact person for public queries
Name 68383 0
Mitch Duncan
Address 68383 0
Priority Research Centre for Physical Activity and Nutrition University of Newcastle ATC Building, Level 3 University Drive Callaghan, 2308 NSW
Country 68383 0
Australia
Phone 68383 0
+61 2 4921 2084
Fax 68383 0
Email 68383 0
[email protected]
Contact person for scientific queries
Name 68384 0
Mitch Duncan
Address 68384 0
Priority Research Centre for Physical Activity and Nutrition University of Newcastle ATC Building, Level 3 University Drive Callaghan, 2308 NSW
Country 68384 0
Australia
Phone 68384 0
+61 2 4921 2084
Fax 68384 0
Email 68384 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data collected during the trial
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
Researchers who provide a methodologically sound proposal
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator and Ethics Committee, requiring a signed data access agreement


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseRandomised controlled trial using a theory-based m-health intervention to improve physical activity and sleep health in adults: The Synergy Study protocol.2018https://dx.doi.org/10.1136/bmjopen-2017-018997
EmbaseEfficacy of an m-Health Physical Activity and Sleep Health Intervention for Adults: A Randomized Waitlist-Controlled Trial.2019https://dx.doi.org/10.1016/j.amepre.2019.05.009
EmbaseEffect of a physical activity and sleep m-health intervention on a composite activity-sleep behaviour score and mental health: a mediation analysis of two randomised controlled trials.2021https://dx.doi.org/10.1186/s12966-021-01112-z
N.B. These documents automatically identified may not have been verified by the study sponsor.