- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05280925
Episodic Future Thinking to Improve Management of Type 2 Diabetes: Remote Delivery and Outcomes Assessment
Episodic Future Thinking to Improve Management of Type 2 Diabetes in Rural and Urban Patients: Remote Delivery and Outcomes Assessment to Increase Reach and Dissemination
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In a 24-week trial, 120 participants from both urban (n = 60) and rural (n = 60) areas will be assigned receive either remotely delivered episodic future thinking or a control condition. Participants will be prompted three times daily to engage in episodic future thinking or control thinking. All participants will also receive virtual diet and physical activity support; self-monitoring of diet, activity, and weight; and case management. Outcome measures will be assessed at baseline, 8 weeks, and 24 weeks.
In the week following informed consent, participants will complete remote assessments of dietary intake (ASA-24 food recalls) and self-reported physical activity (IPAQ-SF), as well as self-administered survey (requiring approximately 10 minutes) to obtain sociodemographic information and delay discounting measures.
The week following baseline, all participants will begin phone-based case management; online self-monitoring of diet, activity, and weight; and diet and activity support. Beginning in Week 3, participants will begin episodic future thinking or control thinking conditions. Here, participants assigned to the EFT group will complete an episodic event generation task to generate a number of positive, vivid events that may occur at several time frames in the future (1 month, 3 months, 6 months, 1 year, 3 years, 5 years, and 10 years; a total of 7 events). During this task, participants will also generate corresponding short text descriptions that will be used as cues to prompt episodic thinking in the natural environment. Participants will regenerate all cues during weeks 8, 16, and 24, with partial regenerations (regenerating only the 1 month and 3 month cues) scheduled during weeks 12 and 20. Participants will complete delay discounting tasks while viewing and imagining their EFT or HIT cues in weeks 3 and 16.
On the day following the event/cue generation, participants will begin thrice-daily smartphone app prompts to engage in EFT. In each prompt, participants will be presented with one of their EFT cues, chosen randomly, and asked to read and vividly imagine this event for a period of 30-60 seconds in a quiet location.
In contrast to the EFT condition, the control condition will be healthy information thinking (HIT). Specifically, participants assigned to the HIT group will be asked to read informational health vignettes on various topics related to T2D and health, adapted from publicly available information (e.g., information on the role of insulin and insulin resistance in T2D, nutrition labeling, understanding T2D risk factors). Participants will then be asked to describe, in 1-2 sentences, a specific piece of information they learned about each topic. This process is designed to mimic the event generation task used for the EFT group, with the number of topics matched to the number of future EFT events. Beginning in Week 3, participants will receive smartphone prompts to read and consider their self-generated topic descriptions with the same frequency and at approximately the same times of day as the EFT group. Moreover, HIT participants will regenerate these descriptions with the same frequency as the EFT group.
At Weeks 8 and 24, participants will complete the same primary and secondary outcome measures they completed during the baseline week, including delay discounting, BMI, and HbA1c.
In addition, during a debriefing stage after Week 24, participants will also rate the perceived helpfulness and convenience of each intervention component (EFT/control prompting, diet and activity support, self-monitoring, and case management) and remote outcomes assessment methods.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jeffrey Stein, PhD
- Phone Number: 540-526-2124
- Email: jstein1@vtc.vt.edu
Study Contact Backup
- Name: Megan Stuart
- Email: stuartma@vtc.vt.edu
Study Locations
-
-
Virginia
-
Roanoke, Virginia, United States, 24016
- Recruiting
- Fralin Biomedical Research Institute at VTC
-
Contact:
- Jeffrey Stein, PhD
- Email: jstein1@vtc.vt.edu
-
Contact:
- Kirstin Gatchalian, BS
- Email: kmgatch@vtc.vt.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- HbA1c greater than or equal to 7.7%
- from urban or rural area
- body mass index greater than or equal to 30
Exclusion Criteria:
- gestational diabetes
- pregnancy or lactating
- not ambulatory
- intellectual impairment
- unmanaged comorbid psychiatric diagnosis (including eating disorders)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Episodic Future Thinking
Participants will generate vivid, episodic events and be prompted via a guided smartphone app to engage in EFT in their daily lives.
EFT will be paired with diet and physical activity support.
|
Participants will be prompted three times daily to think vividly about personally meaningful future events.
|
Active Comparator: Healthy Information Thinking
Participants will be prompted via a guided smartphone app to thinking about their written responses to informational health vignettes during their daily lives.
The HIT condition will be paired with diet and physical activity support.
|
Participants will be prompted three times daily to think about their responses to informational health vignettes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in glycemic control from baseline (Week 0) to Week 8
Time Frame: Baseline, Week 8
|
Hemoglobin A1c (HbA1C) will be assessed by the A1CNOW system
|
Baseline, Week 8
|
Change in glycemic control from baseline (Week 0) to Week 24
Time Frame: Baseline, Week 24
|
Hemoglobin A1c (HbA1C) will be assessed by the A1CNOW system
|
Baseline, Week 24
|
Change in body mass index from baseline (Week 0) to Week 8
Time Frame: Baseline, Week 8
|
Weight will be assessed with a wireless-enabled scale.
Height will be assessed through self-report.
Height and weight will be used to calculate BMI (kg/m2).
|
Baseline, Week 8
|
Change in body mass index from baseline (Week 0) to Week 24
Time Frame: Baseline, Week 24
|
Weight will be assessed with a wireless-enabled scale.
Height will be assessed through self-report.
Height and weight will be used to calculate BMI (kg/m2).
|
Baseline, Week 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in dietary intake from baseline (Week 0) to Week 8
Time Frame: Baseline, Week 8
|
Dietary intake will be assessed by ASA-24 online food recalls
|
Baseline, Week 8
|
Change in dietary intake from baseline (Week 0) to Week 24
Time Frame: Baseline, Week 24
|
Dietary intake will be assessed by ASA-24 online food recalls
|
Baseline, Week 24
|
Change in physical activity from baseline (Week 0) to Week 8
Time Frame: Baseline, Week 8
|
Physical activity will be assessed using the International Physical Activity Questionnaire Short Form (IPAQ-SF)
|
Baseline, Week 8
|
Change in physical activity from baseline (Week 0) to Week 24
Time Frame: Baseline, Week 24
|
Physical activity will be assessed using the International Physical Activity Questionnaire Short Form (IPAQ-SF)
|
Baseline, Week 24
|
Change in self-reported adherence to glucose-lowering medication from baseline (Week 0) to Week 8
Time Frame: Baseline, Week 8
|
Medication adherence will self reported by an 11-point assessment.
Participants will self-report the frequency they have taken all of their glucose-lowering medications
|
Baseline, Week 8
|
Change in self-reported adherence to glucose-lowering medication from baseline (Week 0) to Week 24
Time Frame: Baseline, Week 24
|
Medication adherence will self reported by an 11-point assessment.
Participants will self-report the frequency they have taken all of their glucose-lowering medications
|
Baseline, Week 24
|
Ease of Use and Treatment Effectiveness Questionnaire, Likert scale
Time Frame: Week 24
|
Perceived ease of use and effectiveness of assessment methods and intervention components will be collected by self-reported ratings on 5-point Likert-style scales.
|
Week 24
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in delay discounting from baseline (Week 0) to Week 8
Time Frame: Baseline, Week 8
|
Monetary delay discounting will be assessed by an adjusting-amount task
|
Baseline, Week 8
|
Change in delay discounting from baseline (Week 0) to Week 24
Time Frame: Baseline, Week 24
|
Monetary delay discounting will be assessed by an adjusting-amount task
|
Baseline, Week 24
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jeffrey Stein, PhD, Fralin Biomedical Research Institute at Virginia Tech Carilion
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-440
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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