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Trial registered on ANZCTR


Registration number
ACTRN12622000426785
Ethics application status
Approved
Date submitted
7/03/2022
Date registered
16/03/2022
Date last updated
16/03/2022
Date data sharing statement initially provided
16/03/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
A smartphone-based real time and adaptive intervention to encourage people with type 2 diabetes sit less and move more
Scientific title
Efficacy of a smartphone-based sedentary behaviour and physical activity just-in-time adaptive intervention (JITAI): A micro-randomized trial (MRT) among people with type 2 diabetes
Secondary ID [1] 306633 0
Nil Known
Universal Trial Number (UTN)
U1111-1275-0893
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
type 2 diabetes 325451 0
sedentary behaviour 325452 0
physical activity 325453 0
Condition category
Condition code
Metabolic and Endocrine 322833 322833 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A micro-randomised trial (MRT) will be conducted. Intervention duration will be 42 days continuously.

Objectives:
To evaluate a smartphone-based just-in-time adaptive intervention (JITAI) to interrupt sedentary behaviour (SB) and promote physical activity (PA).
Aims:
1- To assess the proximal and distal effects of each intervention component.
2- To identify how the effect of the intervention changes over time.
3- To identify factors (e.g., contextual) that moderate the effect of intervention components.

Randomization:
The following probabilities is used for randomization: 70% in the intervention (35% Sit Less, 35% Move More) and 30% as active control at that particular decision point (please see below).

Procedure:
A user-friendly Android smartphone app (called iMove) and a prototype activity tracker developed by our team will be used. Motivational messages, in the form of notifications, will be used as “intervention components”. The length of intervention messages will be varied taking between 8 to 15 seconds read. There will be 2 “intervention options”; a sedentary interruption (Sit Less) and a walking PA intervention (Move More), as well as 1 control (no messages). Participants can select “Switch Off” messages for a certain amount of time in a particular day.
Notification messages will be contextually adapted (based on location, weather and time of day), and delivered at 5 times throughout a day (see “decision points or times” section). Messages to interrupt SB will encourage participants to stand up and move. PA messages will aim to increase walking by 2 to 6 minutes.
At each decision point, participants will be randomized only if they are available, meaning that they are not driving, not sleeping, not already active, and they are connected to the Internet. GPS will assist with recognition of driving if the user is on the move. A pre-set time (8:30 p.m. to 8:00 a.m.) will be considered for rest and sleeping. In addition, sleeping can be manually modified by user.

Decision points (times):
Five decision points, from 8:00 a.m. to 8:30 p.m., will be selected as follows:
morning, lunchtime, afternoon, late afternoon, evening

Participants, who are available, will be randomized to receive (Sit Less/ Move More) intervention or not to receive it (control) at each decision points.

Sample Size:
A total of 22 adults with type 2 diabetes (T2D) will be invited.

A total of 22 participants was estimated to detect a small proximal treatment effect size (ES) of 0.13, with 80% power, at the level of 5% statistical significance. This is based on the assumptions of 5 decision points per day, constant randomization probability of 0.7, and expected participant availability of 70%.

Intervention code [1] 323006 0
Behaviour
Intervention code [2] 323007 0
Lifestyle
Comparator / control treatment
30% of available sedentary users will be randomised to active control (at each decision point).

Control group will have access to the iMove app and will be able to monitor their sitting, standing and walking behaviour.
Control group
Active

Outcomes
Primary outcome [1] 330642 0
Proximal outcome 1:
Time spent standing (Ts) within 1 hour after sending the push notification.
Ts will be recorded using a prototype sensor.
Timepoint [1] 330642 0
Multiple time points:
Five times (morning, lunchtime, afternoon, late afternoon, evening) per day during 42 days.
Primary outcome [2] 330643 0
Proximal outcome 2:
Time spent walking (Tw) within 1 hour after sending the push notification.
Tw will be recorded using a prototype sensor.
Timepoint [2] 330643 0
Multiple time points
Five times (morning, lunchtime, afternoon, late afternoon, evening) per day during 42 days.
Primary outcome [3] 330697 0
Proximal outcome 3:
Time spent sitting (Tsit) within 1 hour after sending the push notification.
Tsit will be recorded using a prototype sensor.
Timepoint [3] 330697 0
Multiple time points
Five times (morning, lunchtime, afternoon, late afternoon, evening) per day during 42 days.
Secondary outcome [1] 407062 0
Average sitting time

A prototype activity tracker (called SORD) will be used to measure sitting time. SORD communicates with the iMove app to collect sitting data and send them to the main server via the internet.
Timepoint [1] 407062 0
Daily for 6 weeks after starting the intervention
Secondary outcome [2] 407063 0
Total sitting time

A prototype activity tracker (called SORD) will be used to measure sitting time. SORD communicates with the iMove app to collect sitting data and send them to the main server via the internet.
Timepoint [2] 407063 0
Total time spent sitting over 6 weeks after starting the intervention
Secondary outcome [3] 407064 0
Average standing time

A prototype activity tracker (called SORD) will be used to measure standing time. SORD communicates with the iMove app to collect sitting data and send them to the main server via the internet.
Timepoint [3] 407064 0
Daily for 6 weeks after starting the intervention
Secondary outcome [4] 407065 0
Total standing time

A prototype activity tracker (called SORD) will be used to measure standing time. SORD communicates with the iMove app to collect sitting data and send them to the main server via the internet.
Timepoint [4] 407065 0
Total time spent standing over 6 weeks after starting the intervention
Secondary outcome [5] 407066 0
Average walking time

A prototype activity tracker (called SORD) will be used to measure walking time. SORD communicates with the iMove app to collect sitting data and send them to the main server via the internet.
Timepoint [5] 407066 0
Daily for 6 weeks after starting the intervention
Secondary outcome [6] 407067 0
Total walking time

A prototype activity tracker (called SORD) will be used to measure walking time. SORD communicates with the iMove app to collect sitting data and send them to the main server via the internet.
Timepoint [6] 407067 0
Total time spent walking over 6 weeks after starting the intervention
Secondary outcome [7] 407068 0
Average time spent not sitting (standing + walking)

A prototype activity tracker (called SORD) will be used to measure standing and walking time. SORD communicates with the iMove app to collect sitting data and send them to the main server via the internet.
Timepoint [7] 407068 0
Daily for 6 weeks after starting the intervention
Secondary outcome [8] 407069 0
Total time spent not sitting (standing + walking)

A prototype activity tracker (called SORD) will be used to measure standing and walking time. SORD communicates with the iMove app to collect sitting data and send them to the main server via the internet.
Timepoint [8] 407069 0
Total time spent being active (standing+walking) over 6 weeks after starting the intervention

Eligibility
Key inclusion criteria
Eligible participants will be adults with type 2 diabetes, aged 35 to 65 years, own an Android smartphone (version 5.0 or higher) and currently interact or engage with apps, have no limitation (including physical problems and medical complications) to engage in low-intensity and moderate intensity PA, are able to communicate in English, and can provide informed consent.
Minimum age
35 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals who use other activity trackers and mobile apps that target PA, highly active people, and those diagnosed with T2D less than 3 months ago will be excluded.

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Micro-randomised (multiple randomisation during the day)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
MRT data are analysed using the weighted and cantered least-squares (WCLS) estimator (Boruvka, 2018). Using this analysis method, time-varying covariates can be handled, and the causal effect can be consistently estimated.

Statistical analyses will be performed using R software by employing the geepack R package (Højsgaard et al. 2019).


Boruvka, A., Almirall, D., Witkiewitz, K., and Murphy, S. A. 2018. “Assessing Time-Varying Causal Effect Moderation in Mobile Health,” Journal of the American Statistical Association (113:523), pp. 1112–1121.

Højsgaard, S., Halekoh, U., Yan, J., and Ekstrøm, C. 2019. “Generalized Estimating Equation Package.” (https://cran.r-project.org/web/packages/geepack/geepack.pdf).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
20/01/2022
Date of last participant enrolment
Anticipated
2/05/2022
Actual
Date of last data collection
Anticipated
20/06/2022
Actual
Sample size
Target
22
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 310890 0
University
Name [1] 310890 0
Deakin University
Country [1] 310890 0
Australia
Primary sponsor type
University
Name
Deakin University (Institute for Physical Activity and Nutrition)
Address
221 Burwood Hw Burwood Victoria 3125
Country
Australia
Secondary sponsor category [1] 312167 0
Other Collaborative groups
Name [1] 312167 0
NHMRC Centre of Research Excellence (CRE) in Digital Technology to Transform Chronic Disease Outcomes
Address [1] 312167 0
75 Commercial Road,
Melbourne, VIC 3004
Australia
Country [1] 312167 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310450 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 310450 0
Ethics committee country [1] 310450 0
Australia
Date submitted for ethics approval [1] 310450 0
29/06/2021
Approval date [1] 310450 0
01/11/2021
Ethics approval number [1] 310450 0
2021-258

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

Contacts
Principal investigator
Name 117714 0
Prof Ralph Maddison
Address 117714 0
221 Burwood Highway Burwood
Victoria 3125

Institute for Physical Activity and Nutrition
Deakin University
Country 117714 0
Australia
Phone 117714 0
+613 924 46218
Fax 117714 0
Email 117714 0
ralph.maddison@deakin.edu.au
Contact person for public queries
Name 117715 0
Reza Daryabeygi
Address 117715 0
221 Burwood Highway Burwood
Victoria 3125

Institute for Physical Activity and Nutrition
Deakin University
Country 117715 0
Australia
Phone 117715 0
+61 3 924 45936
Fax 117715 0
Email 117715 0
reza.d@deakin.edu.au
Contact person for scientific queries
Name 117716 0
Reza Daryabeygi
Address 117716 0
221 Burwood Highway Burwood
Victoria 3125

Institute for Physical Activity and Nutrition
Deakin University
Country 117716 0
Australia
Phone 117716 0
+61 3 924 45936
Fax 117716 0
Email 117716 0
reza.d@deakin.edu.au

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 data will be published in journals and shared with researchers at Deakin University (upon reasonable request from Principal Investigator).
When will data be available (start and end dates)?
Available from when the primary micro-randomised trial results are published until 3 years.
Available to whom?
Upon request from the principal investigator:
- Researchers at Deakin University
Available for what types of analyses?
Secondary analysis for modelling of human activity (control system model)
How or where can data be obtained?
Researchers can access the study data on a secured server and upon reasonable request from the principal investigator.

Prof. Ralph Maddison
Email: ralph.maddison@deakin.edu.au


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.