Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000680369
Ethics application status
Approved
Date submitted
5/05/2017
Date registered
12/05/2017
Date last updated
5/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
An e-health delivered trial to test the efficacy of a combined physical activity and sleep intervention to improve sleep quality in Australian adults with poor sleep quality: The Refresh Study
Scientific title
A randomised controlled trial to test the efficacy of an e-health delivered physical activity and sleep, multiple behaviour intervention to improve sleep quality in adults: The Refresh Study
Secondary ID [1] 291453 0
Nil known
Universal Trial Number (UTN)
U1111-1194-2680
Trial acronym
The Refresh Study: REsearch FoR Exercise, Sleep and Health
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poor sleep health 302489 0
Physical inactivity 302490 0
Condition category
Condition code
Public Health 302050 302050 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be a three-armed, randomised controlled trial with a 3-month primary time point and 6-month post-baseline follow-up, aimed at improving sleep quality including a combined Physical Activity and Sleep Health group, a Sleep Health Only group and a Waitlist Control group.
The multi-component intervention will be delivered over a 6 month period, using a mobile device (smart-phone or tablet) application “app” (called “Balanced”) and will provide additional support, for the first 3 months of the intervention, in the form of emails and text messages. Participants will have access to the app throughout the intervention period and are free to use the app as much or a little as they choose, although they will be encouraged to use it daily. Participants will be recruited from across all states of Australia using primarily nationwide advertising on social media (e.g., Facebook) in conjunction with local radio, posters in local businesses, on community noticeboards and around the University of Callaghan campus.
The core components of the intervention are education, self-monitoring, and feedback on performance.
Physical Activity and Sleep Health Group Intervention
The Physical Activity and Sleep Health intervention group will use the app to access educational material, set physical activity and sleep goals, self-monitor their physical activity and sleep behaviours and to receive graphical feedback in relation to their progress towards these goals. In addition to the app, participants in the physical activity and sleep intervention group will be mailed a pedometer, to assist with self-monitoring step count. Participants will also receive content and prompts via emails and text messages during the first 12 weeks of the intervention. These will include weekly communication in the form of a mid-week text message containing a brief educational fact about physical activity or sleep, and an end-of-week email containing a personalised summary of the participant’s weekly physical activity and sleep behaviours, based on the self-monitoring information they have provided. This summary will provide additional feedback and prompt the setting of new goals if required.
Education
Educational content will be found within the app and the participant handbook, which will include goal-setting, action planning and stress management “tools”, mailed and emailed to participants. The handbook and “tools” were developed specifically for the intervention and integrate information from current Australian Physical Activity Guidelines, National Sleep Foundation’s sleep duration recommendations, sleep hygiene practices, stress management techniques (sourced from the Black Dog Institute) and theoretical constructs and behaviour change techniques which have been found to facilitate behaviour change.
The goal setting tool will also provide specific guidance for which physical activity and sleep goals should be set, and how to set these goals. Participants will be encouraged to gradually change their physical activity levels and sleep times to meet national guideline recommendations (150- 300 minutes moderate to vigorous activity and at least two sessions of muscle strengthening exercise and 7-9 hours sleep/night). They will also be encouraged to choose a regular bed-time and wake time, and to practice some other sleep hygiene behaviours, building up their repertoire over time.
The action planning tool will include examples of action plans and exercise options, from which the participant can model their own. This will include: aerobic physical activities and resistance training physical activities as well as intensity, duration and frequency of activities. Participants will be encouraged to develop an action plan for both physical activity and sleep.
The stress management tool will provide step-by-step guides to progressive muscle relaxation, deep breathing exercises and mindfulness exercises. Information about how to use the app and interpret the feedback graphs and traffic light system of goal progress will be provided in the participant handbook.
Self-monitoring and goal setting
Participants will set goals for, and self-monitor their physical activity and sleep behaviours using the app. Goals to be set for physical activity will include; the daily number of minutes of moderate to vigorous intensity activity, daily step count and the weekly number of resistance training sessions, and for sleep: time to bed, time to wake, the daily number of sleep hygiene behaviours (out of 10) they wish to practice (e.g., avoiding caffeine late in the day, creating a comfortable bedroom environment). Participants will be required to self-monitor these behaviours by manually entering information about each of the behaviours for which they set goals as well as a sleep quality rating (using a star rating with five stars indicating excellent quality sleep). The goals will be entered into the app, reviewed weekly and updated if necessary.
Feedback
The participant’s goals will be compared with the activity and sleep information entered by the participant and used to provide graphical feedback using a traffic light system which indicates the participant’s progress in relation to their goal. A green light indicates a participant is meeting, exceeding or close to their goal; an orange light indicates they are progressing toward their goal although are not close; and a red light indicates they are markedly below their goal. The app will also show daily, weekly, and 3-month progress in the form of graphs for each behaviour. Additionally, participants will be emailed a personalised weekly summary of their behaviours and progress towards goals. The participant will be encouraged to use this feedback to evaluate their weekly performance and use this as a guide when reviewing their goals.

Sleep Health Only Group
The Sleep Health Only group will receive the same sleep education, goal setting, action planning and monitoring as the combined Physical Activity and Sleep Health group. They will not receive a pedometer or any of the physical activity components of that intervention group beyond the general advice to “exercise regularly” as part of the overall sleep hygiene recommendations.

Wait-list Control Group
The Wait-list Control group will be asked not to change their physical activity and sleep behaviours until they have completed the 6-month follow-up survey, after which time they will be offered the combined physical activity and sleep intervention.

Assessments
Participants will complete online assessments as baseline, 3-month primary time point and at the 6-month post-baseline follow-up. These will measure self-reported sleep behaviours as well as secondary outcomes including physical activity, mental health and health-related quality of life as well as assessment of app usability and usage as part of a process evaluation.
Intervention code [1] 297516 0
Behaviour
Intervention code [2] 297517 0
Lifestyle
Intervention code [3] 297518 0
Treatment: Devices
Comparator / control treatment
The Wait-list Control group will be asked not to change their physical activity and sleep behaviours until they have completed the 6-month follow-up survey, after which time they will be offered the combined physical activity and sleep intervention.
Control group
Active

Outcomes
Primary outcome [1] 301484 0
Sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI)
Timepoint [1] 301484 0
Assessed at baseline, 3 months and 6 months
Secondary outcome [1] 332799 0
Weekly minutes of moderate to vigorous intensity physical activity measured using the Active Australia Questionnaire
Timepoint [1] 332799 0
Assessed at baseline, 3 months and 6 months
Secondary outcome [2] 333388 0
Symptoms severity of depression, anxiety and stress assessed using the Depression, Anxiety and Stress Scale - 21 (DASS-21)
Timepoint [2] 333388 0
Assessed at baseline, 3 months and 6 months
Secondary outcome [3] 333389 0
Health-related Quality of life measure using the SF-12
Timepoint [3] 333389 0
Assessed at baseline, 3 months and 6 months
Secondary outcome [4] 333390 0
Sleep Hygiene measured with the Sleep Hygiene Index
Timepoint [4] 333390 0
Assessed at baseline, 3 months and 6 months
Secondary outcome [5] 333391 0
Sitting behaviour measured using the Workforce Sitting Questionnaire.
Timepoint [5] 333391 0
Assessed at baseline, 3 months and 6 months
Secondary outcome [6] 333394 0
Usability of the app will be measured using the System Usability Scale.
Timepoint [6] 333394 0
Assessed at the 3 month timepoint
Secondary outcome [7] 333396 0
App usage during the intervention period will be measured via the app database. For example this will include how many self-monitoring entries are made and the length of time the app is regularly interacted with during the intervention.
Timepoint [7] 333396 0
Continuous measurement for the 6 month intervention period of each participant
Secondary outcome [8] 334557 0
Sleep timing using the Sleep Timing Questionnaire
Timepoint [8] 334557 0
Assessed at baseline, 3 months and 6 months
Secondary outcome [9] 334558 0
Psychological distress measured using the Kessler 6
Timepoint [9] 334558 0
Assessed at baseline, 3 months and 6 months
Secondary outcome [10] 334560 0
Evaluation of the presence of symptoms of insomnia using the Sleep Condition Indicator
Timepoint [10] 334560 0
Assessed at baseline, 3 months and 6 months
Secondary outcome [11] 334561 0
Assessment of the severity of insomnia using the Insomnia Severity Index
Timepoint [11] 334561 0
Assessed at baseline, 3 months and 6 months
Secondary outcome [12] 334562 0
Assessment of a participants’ predilection for morningness or eveningness using the reduced scale Morning/Evening Questionnaire
Timepoint [12] 334562 0
Assessed at baseline, 3 months and 6 months
Secondary outcome [13] 335610 0
Self-reported resistance training will be assessed using two items which assess the number of days in a typical week over the past month that resistance training was performed and the amount of time engaged in resistance training each day.
Timepoint [13] 335610 0
Assessed at baseline, 3 months and 6 months.
Secondary outcome [14] 335611 0
Energy and Fatigue will be measured using the vitality sub-scale of the RAND 36 survey.
Timepoint [14] 335611 0
Assessed at baseline, 3 months and 6 months.

Eligibility
Key inclusion criteria
To be eligible for inclusion in this study, individuals must satisfy the following criteria:
1. be aged between 40 and 65 years,
2. report a BMI between 18.5 and 35,
3. participate in less than 30 minutes of moderate or vigorous exercise (such as walking or a sport) on three or more days of the week .
4. report fairly bad or very bad sleep quality,
5. have access to either an iOS or Android smartphone or tablet that can access the internet.
Minimum age
40 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals will be excluded from the study if they:
1. have a diagnosis of a sleep disorder such as insomnia, restless legs, narcolepsy, obstructive sleep apnoea,
2. take medication for inducing sleep,
3. are pregnant or have given birth in the past 12 months,
4. have any condition which would contraindicate participation in physical activity or changing sleep,
5. are currently employed as a shift-worker,
6. are planning to travel to a destination with a shift in time zone of more than three hours during the intervention period
7. live outside Australia
8. are currently using a device or self-monitoring system (including apps) for tracking physical activity and/or sleep,
9. have not confirmed that they have read and understood the participant information statement and provided informed consent.

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)
Allocation sequence will be concealed by the use of sequentially numbered, opaque sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
After completion of the baseline survey, participants will be randomised into one of three groups (physical activity and sleep health, sleep-health only, or wait-list control) in a ratio of 1:2:2 generated using a program written SAS V9.4, utilising 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
The study is powered on change in the primary outcome of sleep quality measured by the Pittsburgh Sleep Quality Index, at the 3 month primary time point. Based on meta-analyses and pilot data, and accounting for a sub-clinical population, it is hypothesised that both the Sleep Health-Only (d=0.30) and combined Physical Activity and Sleep Health interventions (d = 0.65) will significantly improve sleep quality relative to the control group. A step-wise gateway approach will be applied to control family-wise error rate. First the control group will be compared to both intervention groups pooled (d = 0.48; a = 0.05; power = 0.80) and if this test is significant the two intervention groups will then be compared with each other (d = 0.35; a = 0.05; power = 0.80). Due to the larger anticipated effect at Step 1, the sample size of the control group can be smaller (n = 41) than the two intervention groups (n = 82 per group). Internet-based interventions are known for high drop-out rates so to allow for 25% loss to follow-up, a total sample of 275 (control = 55, Sleep Health Only = 110, combined Physical Activity and Sleep Health= 110) participants is needed.

Analysis
To examine differences between intervention groups at 3 months, a generalised linear mixed models (GLMM) using an ANCOVA approach, will be used. A random intercept will be used to account for repeated measures on individuals and treatment effects will be estimated by including fixed effects for group, time and the group x time interaction. Secondary outcomes will be assessed using a similar GLMM approach. The proposed mediators will be examined using established approaches to conducting mediation analysis. Generalized linear mixed models and survival analysis will be used to examine differences in usage patterns. All analyses will be conducted according the intention-to-treat principle including all available data. Sensitivity analyses such as multiple imputation will be undertaken to investigate the robustness of conclusions to different assumed missing data mechanisms.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/05/2017
Actual
31/05/2017
Date of last participant enrolment
Anticipated
Actual
19/09/2017
Date of last data collection
Anticipated
17/02/2018
Actual
4/04/2018
Sample size
Target
275
Accrual to date
Final
275
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 295923 0
Charities/Societies/Foundations
Name [1] 295923 0
National Heart Foundation
Country [1] 295923 0
Australia
Primary sponsor type
Individual
Name
A/Prof Mitch Duncan
Address
ATC Building, Level 3, The University of Newcastle, University Drive, Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 294794 0
Individual
Name [1] 294794 0
Prf Ron Plotnikoff
Address [1] 294794 0
ATC Building, Level 3, The University of Newcastle, University Drive, Callaghan NSW 2308
Country [1] 294794 0
Australia
Secondary sponsor category [2] 294980 0
Individual
Name [2] 294980 0
Ann Rayward
Address [2] 294980 0
ATC Building, Level 3, The University of Newcastle, University Drive, Callaghan NSW 2308
Country [2] 294980 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297200 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 297200 0
Ethics committee country [1] 297200 0
Australia
Date submitted for ethics approval [1] 297200 0
28/07/2016
Approval date [1] 297200 0
19/09/2016
Ethics approval number [1] 297200 0
H-2016-0267

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

Contacts
Principal investigator
Name 73322 0
A/Prof Mitch Duncan
Address 73322 0
Priority Research Centre for Physical Activity and Nutrition
University of Newcastle
ATC Building, Level 2
University Drive
Callaghan, 2308 NSW
Country 73322 0
Australia
Phone 73322 0
+61 2 49217805
Fax 73322 0
Email 73322 0
[email protected]
Contact person for public queries
Name 73323 0
Mitch Duncan
Address 73323 0
Priority Research Centre for Physical Activity and Nutrition
University of Newcastle
ATC Building, Level 2
University Drive
Callaghan, 2308 NSW
Country 73323 0
Australia
Phone 73323 0
+61 2 49217805
Fax 73323 0
Email 73323 0
[email protected]
Contact person for scientific queries
Name 73324 0
Mitch Duncan
Address 73324 0
Priority Research Centre for Physical Activity and Nutrition
University of Newcastle
ATC Building, Level 2
University Drive
Callaghan, 2308 NSW
Country 73324 0
Australia
Phone 73324 0
+61 2 49217805
Fax 73324 0
Email 73324 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA randomised controlled trial to test the efficacy of an m-health delivered physical activity and sleep intervention to improve sleep quality in middle-aged adults: The Refresh Study Protocol.2018https://dx.doi.org/10.1016/j.cct.2018.08.007
N.B. These documents automatically identified may not have been verified by the study sponsor.