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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]

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

Physical inactivity

Condition category

Condition code

Public Health

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]

Behaviour

Intervention code [2]

Lifestyle

Intervention code [3]

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]

Sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI)

Timepoint [1]

Assessed at baseline, 3 months and 6 months

Secondary outcome [1]

Weekly minutes of moderate to vigorous intensity physical activity measured using the Active Australia Questionnaire

Timepoint [1]

Assessed at baseline, 3 months and 6 months

Secondary outcome [2]

Symptoms severity of depression, anxiety and stress assessed using the Depression, Anxiety and Stress Scale - 21 (DASS-21)

Timepoint [2]

Assessed at baseline, 3 months and 6 months

Secondary outcome [3]

Health-related Quality of life measure using the SF-12

Timepoint [3]

Assessed at baseline, 3 months and 6 months

Secondary outcome [4]

Sleep Hygiene measured with the Sleep Hygiene Index

Timepoint [4]

Assessed at baseline, 3 months and 6 months

Secondary outcome [5]

Sitting behaviour measured using the Workforce Sitting Questionnaire.

Timepoint [5]

Assessed at baseline, 3 months and 6 months

Secondary outcome [6]

Usability of the app will be measured using the System Usability Scale.

Timepoint [6]

Assessed at the 3 month timepoint

Secondary outcome [7]

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]

Continuous measurement for the 6 month intervention period of each participant

Secondary outcome [8]

Sleep timing using the Sleep Timing Questionnaire

Timepoint [8]

Assessed at baseline, 3 months and 6 months

Secondary outcome [9]

Psychological distress measured using the Kessler 6

Timepoint [9]

Assessed at baseline, 3 months and 6 months

Secondary outcome [10]

Evaluation of the presence of symptoms of insomnia using the Sleep Condition Indicator

Timepoint [10]

Assessed at baseline, 3 months and 6 months

Secondary outcome [11]

Assessment of the severity of insomnia using the Insomnia Severity Index

Timepoint [11]

Assessed at baseline, 3 months and 6 months

Secondary outcome [12]

Assessment of a participants’ predilection for morningness or eveningness using the reduced scale Morning/Evening Questionnaire

Timepoint [12]

Assessed at baseline, 3 months and 6 months

Secondary outcome [13]

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]

Assessed at baseline, 3 months and 6 months.

Secondary outcome [14]

Energy and Fatigue will be measured using the vitality sub-scale of the RAND 36 survey.

Timepoint [14]

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]

Charities/Societies/Foundations

Name [1]

National Heart Foundation

Address [1]

Unit 1, Level 1, 17-23 Townshend Street
Phillip ACT 2606

Country [1]

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]

Individual

Name [1]

Prf Ron Plotnikoff

Address [1]

ATC Building, Level 3, The University of Newcastle, University Drive, Callaghan NSW 2308

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Ann Rayward

Address [2]

ATC Building, Level 3, The University of Newcastle, University Drive, Callaghan NSW 2308

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Newcastle Human Research Ethics Committee

Ethics committee address [1]

Research Services
Research Integrity Unit
NIER, Block C
The University of Newcastle
Callaghan NSW 2308

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/07/2016

Approval date [1]

19/09/2016

Ethics approval number [1]

H-2016-0267

Summary

Brief summary

This study will be a 3-arm randomised-control trial  to examine the efficacy of a combined physical activity and sleep health intervention to improve sleep quality in mid-aged adults, compared with a sleep health only intervention and a wait-list control group. The study will also compare the groups by physical activity, depressive symptoms and health-related quality of life. These outcomes will be assessed after 3 months (primary time point) and 6 months (follow-up). The interventions will be delivered using an internet-enabled app as well as email and text message support, using goal setting, action planning, self-monitoring, and feedback in relation to progress towards  goals, as behaviour change strategies. The combined physical activity and sleep health group will use these strategies to change both physical activity and sleep behaviours while the sleep health only group will only change their sleep behaviours. The wait-list control will be asked not to change their behaviours for the duration of the intervention but will be offered the combined physical activity and sleep intervention at the completion of the study.
Poor sleep health is associated with an increased risk of non-communicable diseases, decreased work productivity and high health care costs. Approximately 30-50% of adults worldwide report poor sleep quality. Only about half of these people have a diagnosable sleep disorder, yet most interventions to date are targeted at those with a sleep disorder.  Additionally, although physical activity has been shown to be effective at improving sleep quality, none of the studies included in a review of sleep health interventions provided participants with specific strategies and behaviour change techniques to foster changes in physical activity. Consequently, sleep health interventions that do not provide participants with targeted strategies to change physical activity may not maximise change in physical activity, nor the resulting flow on effects that physical activity may have on sleep health.  
The 3-arm design will allow us to determine whether the addition of physical activity enhances the effectiveness of a sleep intervention to improve sleep quality. The combination of a physical activity intervention with a sleep intervention is likely to further reduce the risk of chronic diseases associated with poor sleep such as cardiovascular disease and type 2 diabetes, by synergistically enhancing the effectiveness of the sleep intervention.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Mitch Duncan

Address

Priority Research Centre for Physical Activity and Nutrition
University of Newcastle
ATC Building, Level 2
University Drive
Callaghan, 2308 NSW

Country

Australia

Phone

+61 2 49217805

Fax

mitch.duncan@newcastle.edu.au

Contact person for public queries

Name

Mitch Duncan

Address

Priority Research Centre for Physical Activity and Nutrition
University of Newcastle
ATC Building, Level 2
University Drive
Callaghan, 2308 NSW

Country

Australia

Phone

+61 2 49217805

Fax

mitch.duncan@newcastle.edu.au

Contact person for scientific queries

Name

Mitch Duncan

Address

Priority Research Centre for Physical Activity and Nutrition
University of Newcastle
ATC Building, Level 2
University Drive
Callaghan, 2308 NSW

Country

Australia

Phone

+61 2 49217805

Fax

mitch.duncan@newcastle.edu.au

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

Source	Title	Year of Publication	DOI
Embase	A 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.	2018	https://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.

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