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Trial registered on ANZCTR


Registration number
ACTRN12624000811505
Ethics application status
Approved
Date submitted
14/06/2024
Date registered
2/07/2024
Date last updated
2/07/2024
Date data sharing statement initially provided
2/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving activity-sleep patterns to enhance glucose control in higher risk mid aged adults.
Scientific title
A randomised controlled trial to improve activity-sleep patterns and enhance glucose control in higher-risk mid-aged adults: The Move & Sleep Study.
Secondary ID [1] 312019 0
MRFF APP ID: 2023434
Universal Trial Number (UTN)
U1111-1306-1370
Trial acronym
Move and Sleep Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glucose control (Pre-diabetes) 333997 0
Condition category
Condition code
Metabolic and Endocrine 330667 330667 0 0
Diabetes
Public Health 330668 330668 0 0
Health promotion/education
Physical Medicine / Rehabilitation 330842 330842 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A parallel 3-arm randomised controlled trial will be conducted to examine the efficacy of a combined physical activity and sleep (PAS) intervention to improve glucose control over 24 weeks relative to a physical activity (PA) only intervention, and a control group (CON).
Arm 1: Participants in the PAS arm will receive access to a digital platform, including mobile app, and website via the Balanced digital platform. The intervention is designed to improve physical activity and sleep health using evidence-based behaviour change strategies. Intervention components and materials are described in more detail below.
Arm 2: Participants in the PA arm will only receive access to the physical activity content within the digital intervention which is accessible via the Balanced digital platform. The sleep content as described below will not be available for this group.
Intervention components and materials will contain:
a. information on the recommended amounts of physical activity and sleep duration for Australian adults as per national guidelines and the benefits of physical activity and improved sleep
b. action planning and goal setting tools
c. ideas on how to overcome barriers
d. Action planning strategies
e. Example activity plans
f. videos demonstrating muscle strengthening activities
g. a self-monitoring section where participants can manually log (i.e., self-monitor) daily physical activity {minutes of Moderate to vigorous intensity physical activity (MVPA), sessions of muscle strengthening activity (MSA)}, sitting time, sleep health {sleep duration and quality (1-5 Likert Scale), time to bed and wake}, and daily sleep hygiene behaviours (e.g., alcohol and caffeine intake) and set personalised goals for physical activity (daily MVPA, and MSA), sitting, and sleep health, and update these goals in line with their progress.
h. personalised feedback and detailed weekly summaries (e.g., most active days, number of days goals were achieved) of progress towards goals
i. audio and text-based resources to guide participants in practicing mindfulness, cognitive restructuring in relation to sleep, stress management, and relaxation techniques.
The Balanced intervention will be accessible by website, smartphone, and tablet. Access to the intervention materials will be restricted using a unique identifier (password + login) for each participant to ensure participants only receive intervention content related to their group allocation.
Intervention materials will promote participation in physical activity by increasing activity levels to level consistent with the 2014 National Physical Activity Guidelines for Australian Adults (i.e. 150 minutes of moderate-to-vigorous intensity physical activity, equal to or more than 2 sessions of muscle strengthening activity, minimise long periods of sitting and break up sitting regularly). Intervention materials promoting sleep will promote healthy sleep (i.e. a regular timing, quality, and duration of sleep that a person is satisfied with) and the Australian Sleep Health Foundation sleep duration guidelines for adults. Intervention materials will promote adherence to these guidelines dependent on group allocation throughout the intervention period.

The intervention platform will require participants set goals for target behaviours using a goal setting tool and goals can be updated at any time. Participants will manually enter information on activity and sleep into the platform to self-monitor the target behaviours. Resource materials/articles will provide participants with strategies to overcome common barriers to engaging in activity and health sleep. Resource materials/articles will also provide participants with example action planning resources and information to engage in action planning activities to help with overcoming barriers. Example weekly activity plans provide participants with suggested activity plans that vary in the volume of activity suggested based on different baseline activity levels (e.g., no prior activity, a little prior activity, some prior activity). This includes instructions on how to complete muscle strengthening activities using body weight and free weights (if participants have these).

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.

Intervention platform generated feedback via the intervention portal, SMS/Email is provided to participants based on their self-monitored behaviours in relation to their goals and guidelines for target behaviours. Intervention platform generated reminders are also used to prompt login and use of the intervention platform based on user usage patterns.
Intervention code [1] 328735 0
Prevention
Intervention code [2] 328736 0
Lifestyle
Intervention code [3] 328737 0
Behaviour
Comparator / control treatment
Control group (CON) will be an education-only group. Participants in the control (CON) arm will only receive basic educational information about the national physical activity and sleep guidelines for Australian adults. This content will be available within the digital intervention, which is accessible via the Balanced digital platform,
Control group
Active

Outcomes
Primary outcome [1] 338415 0
Glucose Control: Percentage time in the normal range for blood glucose range 3.9-6.0 mmol/L
Timepoint [1] 338415 0
Baseline (i.e., 0 weeks), 12 weeks (primary endpoint) and 24 weeks after study group allocation
Secondary outcome [1] 435818 0
Glucose control measures
Average 24-hr glucose (mmol/L)
Timepoint [1] 435818 0
Baseline (i.e., 0 weeks), 12 weeks and 24 weeks after study group allocation
Secondary outcome [2] 435819 0
Glycaemic variability
Timepoint [2] 435819 0
Baseline (i.e., 0 weeks), 12 weeks and 24 weeks after study group allocation
Secondary outcome [3] 435820 0
Glucose management indicator
Timepoint [3] 435820 0
Baseline (i.e., 0 weeks), 12 weeks and 24 weeks after study group allocation
Secondary outcome [4] 435821 0
Time above/below the normal range for blood glucose equal or greater than 3.9 mmol/L to 6.0 mmol/L
Timepoint [4] 435821 0
Baseline (i.e., 0 weeks), 12 weeks and 24 weeks after study group allocation.
Secondary outcome [5] 435822 0
Cardiometabolic risk factors
HbA1c levels (glycated haemoglobin)
Timepoint [5] 435822 0
Baseline (i.e., 0 weeks), 12 weeks and 24 weeks after study group allocation.
Secondary outcome [6] 435823 0
Cardiometabolic risk factors
Total cholesterol
Timepoint [6] 435823 0
Baseline (i.e., 0 weeks), 12 weeks and 24 weeks after study group allocation.
Secondary outcome [7] 435824 0
Accelerometer-measured outcomes
Daily minutes of MVPA
Timepoint [7] 435824 0
Baseline (i.e., 0 weeks), 6, 12 weeks and 24 weeks after study group allocation.
Secondary outcome [8] 435825 0
Daily minutes of sedentary time
Timepoint [8] 435825 0
Baseline (0 weeks), 6, 12 weeks and 24 weeks after study group allocation.
Secondary outcome [9] 435826 0
Sleep Duration
Total sleep duration (hours per night)
Timepoint [9] 435826 0
Baseline (i.e., 0 weeks), 6, 12 weeks and 24 weeks after study group allocation.
Validated via participant-reported logs detailing bed and wake times and times of device removal.
Secondary outcome [10] 435827 0
Sleep efficiency
Timepoint [10] 435827 0
Baseline (i.e., 0 weeks), 6, 12 weeks and 24 weeks after study group allocation. Validated via participant-reported logs detailing bed and wake times and times of device removal.
Secondary outcome [11] 435828 0
Timing of sleep (i.e., consistent bed and wake times)
Timepoint [11] 435828 0
Baseline (i.e., 0 weeks), 6, 12 weeks and 24 weeks after study group allocation. Validated via participant-reported logs detailing bed and wake times and times of device removal.
Secondary outcome [12] 435829 0
Self-report measures
Minutes of moderate- to vigorous-intensity physical activity per week
Timepoint [12] 435829 0
Baseline (i.e., 0 weeks), 6, 12 weeks and 24 weeks after study group allocation.
Secondary outcome [13] 435830 0
Frequency of doing muscle strengthening exercises
Timepoint [13] 435830 0
Baseline (i.e., 0 weeks), 6, 12 weeks and 24 weeks after study group allocation.
Secondary outcome [14] 435831 0
Daily minutes of Sitting time
Timepoint [14] 435831 0
Baseline (i.e., 0 weeks), 6, 12 weeks and 24 weeks after study group allocation.
Secondary outcome [15] 435832 0
Perceived sleep health, consisting of regularity, satisfaction, alertness, timing, efficiency and duration of sleep
Timepoint [15] 435832 0
Baseline (i.e., 0 weeks), 6, 12 weeks and 24 weeks after study group allocation.
Secondary outcome [16] 435837 0
Activity-Sleep Patterns
Timepoint [16] 435837 0
Baseline (i.e., 0 weeks), 6, 12 weeks and 24 weeks after study group allocation.
Secondary outcome [17] 435838 0
Insomnia Symptom Severity
Timepoint [17] 435838 0
Baseline (i.e., 0 weeks), 12 weeks and 24 weeks after study group allocation.
Secondary outcome [18] 435839 0
Diet quality
Timepoint [18] 435839 0
Baseline (i.e., 0 weeks), 6, 12 weeks and 24 weeks after study group allocation.
Secondary outcome [19] 435841 0
Health-related quality of life
Timepoint [19] 435841 0
Baseline (i.e., 0 weeks), 12 weeks and 24 weeks after study group allocation.
Secondary outcome [20] 435842 0
Workplace productivity
Timepoint [20] 435842 0
Baseline (i.e., 0 weeks), 12 weeks and 24 weeks after study group allocation.
Secondary outcome [21] 435843 0
Sleep apnoea
Timepoint [21] 435843 0
Baseline (i.e., 0 weeks), 12 weeks and 24 weeks after study group allocation.
Secondary outcome [22] 435845 0
Depression symptoms
Timepoint [22] 435845 0
Baseline (i.e., 0 weeks), 12 weeks and 24 weeks after study group allocation.
Secondary outcome [23] 435846 0
Anxiety symptoms
Timepoint [23] 435846 0
Baseline (i.e., 0 weeks), 12 weeks and 24 weeks after study group allocation.
Secondary outcome [24] 435847 0
Perceived Sleep Need
Timepoint [24] 435847 0
Baseline (0 weeks)
Secondary outcome [25] 435848 0
System usability of the intervention
Timepoint [25] 435848 0
12 weeks after study group allocation.
Secondary outcome [26] 436704 0
Cardiometabolic risk factors
HDL levels
Timepoint [26] 436704 0
Baseline (i.e., 0 weeks), 12 weeks and 24 weeks after study group allocation.
Secondary outcome [27] 436706 0
Cardiometabolic risk factors
LDL levels
Timepoint [27] 436706 0
Baseline (i.e., 0 weeks), 12 weeks and 24 weeks after study group allocation.
Secondary outcome [28] 436707 0
Cardiometabolic risk factors
Triglycerides
Timepoint [28] 436707 0
Baseline (i.e., 0 weeks), 12 weeks and 24 weeks after study group allocation.
Secondary outcome [29] 436712 0
User satisfaction with the intervention
Timepoint [29] 436712 0
12 weeks after study group allocation.

Eligibility
Key inclusion criteria
All of the following criteria will have to be met:
1) Compliance with the run-in protocol for more than 5 out of 7 days
2) Aged 45 – 64 years
3) Not meeting physical activity guidelines (i.e., less than 150 minutes of MVPA and less than 2 muscle strengthening sessions per week)
4) Self-report poor sleep health (i.e., reporting more or equal to 3 of the 6 RU-SATED sleep health dimensions as poor)
5) report elevated waist circumference (i.e., using sex/ethnicity-specific cut points as per clothing size in line with the AUSDRisk online tool from Diabetes Australia)
6) Impaired fasting glucose in prediabetes range (i.e., 6.1-6.9 mmol/L)
7) Access to a smartphone and/or computer to access the internet

Run-in period
Those who meet eligibility criteria will be asked to complete a 1-week run-in period, which is intended to identify non-compliant participants and thus, limit attrition/non-compliance in the actual study. To minimise the risk of potential confounding, participants will be asked to use an online form in REDCap to self-monitor their daily fluid intake including the amount and type/s of fluids consumed (i.e., water, soft drink, coffee, tea, alcohol). Participants who complete this form on less than 5 out of 7 days will be omitted from participating the trial. Those who are deemed compliant will be invited to have their FBG assessed using a point-of-care device (CardioChek PA) at one of the University of Newcastle locations. Participants whose FBG falls within the prediabetes range (6.1-6.9mmol/L) will proceed to complete baseline assessments.
Minimum age
45 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Doctor-diagnosed type-1 or type-2 diabetes
2) Diagnosed sleep apnoea or at high risk of sleep apnoea (i.e., (STOP Score equal or more than 2 + Male + BMI score more than 35)
3) Diagnosed insomnia or severe insomnia symptoms (i.e., Insomnia Severity Index Score equal or more than 22)
4) Reporting a condition that would make it unsafe to change physical activity and/or sleep
5) Employed in night shift-work (i.e., outside of 9 am-5 pm work hours)
6) No internet access
7) Currently taking prescribed medications to promote sleep

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation schedule will be automated using an online portal which will be accessed by the project manager once eligible participants have agreed to participate.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will use permuted block randomisation using blocks of six and nine. The randomisation sequence will be developed off-site by an independent statistician and stratified by sex (Males/Females), and participants’ Diabetes risk category based on sex- and ethnicity-specific waist circumference (moderate/high risk).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size
A sample including 324 participants (CON: 108; PA: 108; PAS: 108) would provide more than80% power (standard deviation (sd) =15, alpha=0.017, pre-post correlation of 0.7) to detect a 5% difference in glucose time in range measured using the CGM (d=0.33) between groups at 12 weeks after intervention commencement, allowing for 10% attrition.

Analysis plan
Analyses will include all available observations . Between-group differences in the primary and secondary outcomes will be estimated using Generalised Linear Mixed Models (GLMM), adjusted for baseline values of the outcome (i.e., ANCOVA). Models will include an appropriate link function and fixed effects for group, time, the group × time interaction, baseline values of the outcome, and both stratification variables (i.e., sex (M/F); waist circumference (moderate/elevated)), as well as a random intercept to account for repeated measures over time. The primary outcome will be examined using an alpha level of 0.017 to account for multiple comparisons between groups, and secondary outcomes will be analysed using an alpha of 0.05. Missing baseline data will be imputed where necessary for the purpose of conducting sensitivity analyses using multiple imputation and pattern mixture modelling to investigate the robustness of the results. Between-group differences in the secondary outcomes will be assessed using a similar modelling approach (i.e., ANCOVA).

Mediation analyses based on a causal mediation framework will examine the mediating effect of activity-sleep patterns at 6 weeks on outcomes at 12 and 24 weeks. Intervention usage and engagement will also be examined as effect mediators.

Economic analysis will be two-fold and include (i) a prospective trial-based cost-consequence analysis (CCA) and (ii) a cost-effectiveness analysis (CEA) of the PAS intervention, relative to the CON and PA groups. Results from the CCA will reflect the range of measured trial outcomes, presented in scorecard format. The CEA will be based on secondary outcomes (i.e., MVPA and health-related quality of life). Quality adjusted life year (QALYS) will be calculated using utility data from baseline, 12 and 24 weeks after intervention commencement, Incremental cost-effectiveness ratio (ICER), in Dollars per QALY gained will be calculated using costs and health outcomes. We will use non-parametric bootstrapping to calculate 95% uncertainty intervals and to determine the probability of intervention cost-effectiveness against a threshold of $30,000/QALY. ICER results will be displayed by way of a cost-effectiveness plane. Affordability issues will be addressed in an acceptability curve. CEA results will be considered in the context of other decision-making criteria such as strength of evidence, capacity and sustainability.

A range of process data will be examined to generate insights into user perspectives, app usage and engagement during the intervention period. Process measures include the number and frequency of manual entries of behavioural data that are recorded in the app, time spent using the app and features used. Additionally, there will be data from semi-structured interviews with a sub-sample of participants (n= approximately 25) that will provide insights into user perceptions and how the intervention may be improved to suit participant needs and preferences. This knowledge, coupled with our findings on efficacy, mechanisms of impact (i.e., mediating covariates) will inform the optimisation of the intervention for potential scale-up.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/07/2024
Actual
Date of last participant enrolment
Anticipated
28/02/2025
Actual
Date of last data collection
Anticipated
14/08/2025
Actual
Sample size
Target
324
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 316369 0
Government body
Name [1] 316369 0
National Health and Medical Research Council (NHMRC)/Medical Research Future Fund (MRFF)
Country [1] 316369 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
Country
Australia
Secondary sponsor category [1] 318552 0
None
Name [1] 318552 0
Address [1] 318552 0
Country [1] 318552 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315177 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 315177 0
Ethics committee country [1] 315177 0
Australia
Date submitted for ethics approval [1] 315177 0
Approval date [1] 315177 0
14/02/2024
Ethics approval number [1] 315177 0
H-2023-0277

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

Contacts
Principal investigator
Name 133902 0
Prof Mitch J Duncan
Address 133902 0
The University of Newcastle, ATC-315, University drive, Callaghan, 2308, NSW, Australia
Country 133902 0
Australia
Phone 133902 0
+61 49217085
Fax 133902 0
Email 133902 0
Mitch.Duncan@newcastle.edu.au
Contact person for public queries
Name 133903 0
Mitch J Duncan
Address 133903 0
The University of Newcastle, ATC-315, University drive, Callaghan, 2308, NSW, Australia
Country 133903 0
Australia
Phone 133903 0
+61 49217085
Fax 133903 0
Email 133903 0
Mitch.Duncan@newcastle.edu.au
Contact person for scientific queries
Name 133904 0
Mitch J Duncan
Address 133904 0
The University of Newcastle, ATC-315, University drive, Callaghan, 2308, NSW, Australia
Country 133904 0
Australia
Phone 133904 0
+61 49217085
Fax 133904 0
Email 133904 0
Mitch.Duncan@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Non-identifiable data may be shared with other parties as part of a peer-review process to verify the robustness and integrity of the study, or to contribute to further research and public knowledge.


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
No additional documents have been identified.