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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.
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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.
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Secondary ID [1]
311167
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Not applicable
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Universal Trial Number (UTN)
U1111-1300-8986
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes
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Obesity
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Condition category
Condition code
Metabolic and Endocrine
329047
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0
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Diabetes
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
327610
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Behaviour
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Intervention code [2]
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Lifestyle
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Delay discounting
Delay discounting is the extent to which individuals value immediate rewards over future benefits.
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Assessment method [1]
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Delay discount is via self-reported questionnaire at baseline and every follow-up (1-, 3- and 6-month post intervention commencement).
Delay Discounting is measured by the Quick Delay Discounting Questionnaire (Clare et al., 2010), with 10 self-reported items assessing delay aversion e.g., “I hate waiting for things” and delay discounting e.g., “Even if I have to wait a long time for something I won’t give up if it is important to me”. Each subscale has 5 items. An additional subscale with 5 items is used to assess health-specific delay discounting e.g., “I take action now to preserve my health for the future” (O’Donnell & Chan 2021). Subscale scores were summed, and the total was used to determine DD, with higher scoring indicating higher DD. This measure has very good internal consistency within its three subgroups Health-Specific DD (a = .88), Delay Aversion (a = .83), General DD (a = .80).
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Timepoint [1]
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Delay discounting is assessed at baseline and every follow-up (1-, 3- and 6-month post intervention commencement).
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Primary outcome [2]
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Change in physical activity, i.e., energy expenditure
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Assessment method [2]
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Physical Activity levels - Objective Accelerometers over a 1-week period
Follow-up:
Physical Activity levels - Objective Accelerometers over a 1-week period.
Physical activity is assessed via self-reported physical activity questionnaire and objectively via accelerometers. . International Physical Activity Questionnaire (IPAQ)-short form (Craig et al., 2003). The IPAQ is a self-report measure of an individual’s frequency, intensity and duration of physical activity over the past week. The IPAQ assesses any activities, which may include occupational activities and are not limited to exercise. The IPAQ is validated and well used in physical activity research.
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Timepoint [2]
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Baseline and 1-, 3-, 6- months post intervention commencement
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Primary outcome [3]
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Physical activity intentions
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Assessment method [3]
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Physical activity intentions: Intentions to be physically active in the next week were assessed with a 3-item measure, (Ajzen, 2002), e.g., ‘‘I intend to be physically active on most days in the next week’’, (a = .93). Ratings ranged from 0 (very unlikely) to 5 (very likely) and were summed to produce the total score.
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Timepoint [3]
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baseline and 1-, 3-, 6- months post intervention commencement
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Secondary outcome [1]
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Diabetes distress
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Assessment method [1]
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Baseline:
Diabetes distress - the 20-item Problem Areas In Diabetes (PAID) scale (Polonsky et al., 1995).
Follow-up:
Diabetes distress - the 20-item Problem Areas In Diabetes (PAID) scale (Polonsky et al., 1995).
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Timepoint [1]
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baseline and 1-, 3-, 6- months post intervention commencement
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Secondary outcome [2]
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Feasibility
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Assessment method [2]
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Intervention:
Intervention Feasibility - (provided via 0-10 Likert scales with 10 being very easy/helpful) of the initial EFT session and ongoing EFT practice through the mobile application.
Follow-up:
Intervention Feasibility - (provided via 0-10 Likert scales with 10 being very easy/helpful) of the initial EFT session and ongoing EFT practice.
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Timepoint [2]
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baseline and 1-, 3-, 6- months post intervention commencement
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Secondary outcome [3]
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Diabetes self-care
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Assessment method [3]
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Summary of Diabetes Self-Care Activities (health diet and physical activity subscales)
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Timepoint [3]
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Baseline and follow-up (1-month, 3-month and 6-moth post intervention commencement)
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Secondary outcome [4]
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Physical activity Action Planning
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Assessment method [4]
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Action planning: Planning regarding physical activity was assessed using a self-reported measure adapted by (Norman & Conner, 2005). The items were: ‘‘I have made a detailed plan regarding (1) when, (2) where, (3) how, and (4) how often to be physically active over the next week’’, (a = .93).
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Timepoint [4]
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baseline and 1-, 3-, 6- months post intervention commencement
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Secondary outcome [5]
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Engagement
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Assessment method [5]
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Engagement of the app will be assessed using data from the mobile app. These include, log in frequency and duration.
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Timepoint [5]
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The app collects daily data but averaged weekly data will be reported from intervention commencement.
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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
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• Pregnancy
• cognitive impairment precluding consent;
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
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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.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/11/2024
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Actual
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Date of last participant enrolment
Anticipated
1/05/2025
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Actual
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Date of last data collection
Anticipated
1/11/2025
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Campbelltown Hospital - Campbelltown
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Recruitment hospital [2]
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Camden Hospital - Camden
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Recruitment hospital [3]
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Bendigo Health Care Group - Bendigo Hospital - Bendigo
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Recruitment hospital [4]
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Goulburn Valley Health - Shepparton campus - Shepparton
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Recruitment postcode(s) [1]
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2560 - Campbelltown
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Recruitment postcode(s) [2]
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2570 - Camden
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Recruitment postcode(s) [3]
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3550 - Bendigo
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Recruitment postcode(s) [4]
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3630 - Shepparton
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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La Trobe University
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Address [1]
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to do
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Western Sydney University
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Address
Locked Bag 1797 Penrith 2751
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
318293
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Country [1]
318293
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Bendigo Health Human Research Ethics Committee
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Ethics committee address [1]
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https://www.bendigohealth.org.au/Ethicsandresearchgovernance/
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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01/11/2021
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Approval date [1]
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02/03/2022
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Ethics approval number [1]
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Ethics committee name [2]
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South Western Sydney Local Health District Human Research Ethics Committee
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Ethics committee address [2]
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https://www.swslhd.health.nsw.gov.au/ethics/
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Ethics committee country [2]
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Australia
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Date submitted for ethics approval [2]
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20/11/2023
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Approval date [2]
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09/04/2024
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Ethics approval number [2]
314948
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Summary
Brief summary
This project presents a novel intervention combining mental imagery and episodic future thinking (EFT) 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. The present study will apply EFT and mental imagery to people with diabetes and assess the feasibility, acceptability, and potential behavioural impact of offering an intervention that guides people with diabetes to 'imagine the future' using mental imagery.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Carina Chan
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Address
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La Trobe University, Edwards Rd, Flora Hill, Bendigo, Victoria 3552
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Country
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Australia
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Phone
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+61354447157
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Carina Chan
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Address
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La Trobe University, Edwards Rd, Flora Hill, Bendigo, Victoria 3552
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Country
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Australia
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Phone
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+61354447157
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Carina Chan
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Address
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La Trobe University, Edwards Rd, Flora Hill, Bendigo, Victoria, 3552
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Country
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Australia
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Phone
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+61354447157
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
21929
Study protocol
387042-(Uploaded-23-04-2024-15-31-49)-Study-related document.docx
21930
Ethical approval
387042-(Uploaded-26-03-2024-12-53-34)-Study-related document.pdf
21976
Informed 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.
Download to PDF