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Trial registered on ANZCTR


Registration number
ACTRN12624001228572
Ethics application status
Approved
Date submitted
29/07/2024
Date registered
9/10/2024
Date last updated
9/10/2024
Date data sharing statement initially provided
9/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Imagine for better diabetes management: Modifying Delay Discounting and Physical Activity via Episodic Future Thinking: An Evaluation in adults with type 2 diabetes.
Scientific title
Imagine for better diabetes management: Modifying Delay Discounting and Physical Activity via Episodic Future Thinking: An Evaluation in adults with type 2 diabetes.
Secondary ID [1] 311167 0
Not applicable
Universal Trial Number (UTN)
U1111-1300-8986
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 332337 0
Obesity 334874 0
Condition category
Condition code
Metabolic and Endocrine 329047 329047 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Episodic Future Thinking (EFT) imagery plus standard care

This project presents a novel intervention combining mental imagery and episodic future thinking in diabetes management, targeting Type 2 diabetes. Modifying delay discounting to help people with Type 2 diabetes focus on the future rather than immediate rewards is an innovative and low-cost approach which can be adopted by individuals easily once they have learnt to generate the future-oriented mental pictures. Episodic future thinking (EFT) is a conceptual tool simulating the experience of the future. By cognitively simulating future outcomes and making them salient, it can motivate goal-directed health behaviours through enhanced consideration and valuation of the future. Through the process of EFT, individuals are more likely to make choices that focus on long-term outcomes.

The EFT condition focuses on thinking about future personalised events that participants look forward to and can imagine at different time frames. These events may be linked directly or indirectly to their participation in regular physical activity. Participants will be contacted by the research team to schedule an in-person (at La Trobe University or Western Sydney University) or virtual appointment (of their choice) which they will attend a psychologist-led session and learn a mental imagery technique and generate the corresponding imagery. Duration of the initial appointment would be around 30-45 minutes. The intervention group will be sent reminders to practice their future thinking imageries 3 times a day (15minutes per day) for 1 month. One week after the initial imagery session, each participant will be followed up via telephone call to check their imagery generation progress. At 1-, 3- and 6-months participants will be contacted again by telephone with instructions on how to complete a short follow-up questionnaire and be provided with and accelerometer via post. A link will be sent to participants for follow up questionnaires and they will be about 10 min to complete. They will wear the accelerometer for 1 week, they wear it when they wake up and take off before bed and shower and then return to the research team via pre-paid postage. The mobile application will record the cues that participants generated at the initial session and send reminders for imagery practice. The app will have data on engagement (log on frequency, how long they stay to read the cues before generating the imagery). The standard care for who are not randomised is whatever the doctor asks the patient to do, which may include medication or lifestyle behaviours.
Intervention code [1] 327610 0
Behaviour
Intervention code [2] 329344 0
Lifestyle
Comparator / control treatment
Non-EFT imagery control plus standard care

The control group will generate mental imagery of past events in the last 7 days timeframe. Participants will be contacted by the research team to schedule an in-person (at La Trobe University or Western Sydney University) or virtual appointment (of their choice) which they will attend a psychologist-led session and learn a mental imagery technique and generate the corresponding imagery. The control group will be prompted to practice their mental imagery of past events in the last 7 days timeframe for 3 times a day for 1 month. They will receive the details of the imagery instructions and reminders to practice after the intervention session. One week after the initial imagery session, each participant will be followed up via telephone call to check their imagery generation progress. At 1-, 3- and 6-months participants will be contacted again by telephone with instructions on how to complete a short follow-up questionnaire and be provided with and accelerometer via post. They will wear this for 1 week and then return to the research team via pre-paid postage.
Control group
Active

Outcomes
Primary outcome [1] 338701 0
Delay discounting

Delay discounting is the extent to which individuals value immediate rewards over future benefits.
Timepoint [1] 338701 0
Delay discounting is assessed at baseline and every follow-up (1-, 3- and 6-month post intervention commencement).
Primary outcome [2] 339181 0
Change in physical activity, i.e., energy expenditure
Timepoint [2] 339181 0
Baseline and 1-, 3-, 6- months post intervention commencement
Primary outcome [3] 339182 0
Physical activity intentions
Timepoint [3] 339182 0
baseline and 1-, 3-, 6- months post intervention commencement
Secondary outcome [1] 437069 0
Diabetes distress
Timepoint [1] 437069 0
baseline and 1-, 3-, 6- months post intervention commencement
Secondary outcome [2] 437070 0
Feasibility
Timepoint [2] 437070 0
baseline and 1-, 3-, 6- months post intervention commencement
Secondary outcome [3] 440483 0
Diabetes self-care
Timepoint [3] 440483 0
Baseline and follow-up (1-month, 3-month and 6-moth post intervention commencement)
Secondary outcome [4] 440487 0
Physical activity Action Planning
Timepoint [4] 440487 0
baseline and 1-, 3-, 6- months post intervention commencement
Secondary outcome [5] 440488 0
Engagement
Timepoint [5] 440488 0
The app collects daily data but averaged weekly data will be reported from intervention commencement.

Eligibility
Key inclusion criteria
• Type 2 diabetes diagnosis (with HbA1c >= 7.0%)
• 18 Years and over
• English-speaking
• No Conditions that preclude physical activity
• Access and ability to use smartphone;
• No psychiatric conditions


Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Pregnancy
• cognitive impairment precluding consent;

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The envelope will contain equal amounts of paper A and B’s. Researchers will randomly choose from the envelope when conducting intervention with participants.
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
Descriptive statistics will be used to summarise baseline characteristics and rates of drop-outs and completion. An intention-to-treat method will be adopted. Longitudinal physical activity data for each group will be analysed using Linear Mixed Modelling. This technique intrinsically accounts for missing data and attrition in longitudinal studies by modelling trajectories for each participant from available data. To take a conservative approach, it will be assumed that non-completers do not show further gains subsequent to the last data point available. The longitudinal association between DD and physical activity will be analysed with a cross-lagged longitudinal structural equation model which will account for autoregression between variables at a particular time-point and the same variable at a subsequent timepoint. Significance level of hypothesis testing will be set at 0.05.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
1/05/2025
Actual
Date of last data collection
Anticipated
1/11/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 26291 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [2] 26292 0
Camden Hospital - Camden
Recruitment hospital [3] 26293 0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Recruitment hospital [4] 26453 0
Goulburn Valley Health - Shepparton campus - Shepparton
Recruitment postcode(s) [1] 42263 0
2560 - Campbelltown
Recruitment postcode(s) [2] 42264 0
2570 - Camden
Recruitment postcode(s) [3] 42265 0
3550 - Bendigo
Recruitment postcode(s) [4] 42432 0
3630 - Shepparton

Funding & Sponsors
Funding source category [1] 315421 0
University
Name [1] 315421 0
La Trobe University
Country [1] 315421 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Locked Bag 1797 Penrith 2751
Country
Australia
Secondary sponsor category [1] 318293 0
None
Name [1] 318293 0
Address [1] 318293 0
Country [1] 318293 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314336 0
Bendigo Health Human Research Ethics Committee
Ethics committee address [1] 314336 0
Ethics committee country [1] 314336 0
Australia
Date submitted for ethics approval [1] 314336 0
01/11/2021
Approval date [1] 314336 0
02/03/2022
Ethics approval number [1] 314336 0
Ethics committee name [2] 314948 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [2] 314948 0
Ethics committee country [2] 314948 0
Australia
Date submitted for ethics approval [2] 314948 0
20/11/2023
Approval date [2] 314948 0
09/04/2024
Ethics approval number [2] 314948 0

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

Contacts
Principal investigator
Name 131226 0
A/Prof Carina Chan
Address 131226 0
La Trobe University, Edwards Rd, Flora Hill, Bendigo, Victoria 3552
Country 131226 0
Australia
Phone 131226 0
+61354447157
Fax 131226 0
Email 131226 0
carina.chan@latrobe.edu.au
Contact person for public queries
Name 131227 0
Carina Chan
Address 131227 0
La Trobe University, Edwards Rd, Flora Hill, Bendigo, Victoria 3552
Country 131227 0
Australia
Phone 131227 0
+61354447157
Fax 131227 0
Email 131227 0
carina.chan@latrobe.edu.au
Contact person for scientific queries
Name 131228 0
Carina Chan
Address 131228 0
La Trobe University, Edwards Rd, Flora Hill, Bendigo, Victoria, 3552
Country 131228 0
Australia
Phone 131228 0
+61354447157
Fax 131228 0
Email 131228 0
carina.chan@latrobe.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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21929Study protocol    387042-(Uploaded-23-04-2024-15-31-49)-Study-related document.docx
21930Ethical approval    387042-(Uploaded-26-03-2024-12-53-34)-Study-related document.pdf
21976Informed consent form    387042-(Uploaded-26-03-2024-12-53-44)-Study-related document.pdf



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.