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Type 2 DiabetesNCT05280925

Episodic Future Thinking to Improve Management of Type 2 Diabetes: Remote Delivery and Outcomes Assessment

A study testing Episodic Future Thinking and Healthy Information Thinking in people with Type 2 Diabetes and Overweight and Obesity, run by Virginia Polytechnic Institute and State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Successful management of type 2 diabetes (T2D) requires adherence to a dietary, physical activity, and medication plan agreed upon between a patient and their healthcare providers. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes, Overweight and Obesity
What is being tested?
Episodic Future Thinking and Healthy Information Thinking
Could I receive a placebo?
No, everyone receives an active treatment
How many people
137 participants
Where
1 siteUnited States
Study dates
20 Jul 2022to 15 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • HbA1c greater than or equal to 7.7%
  • from urban or rural area
  • body mass index greater than or equal to 30

Who cannot join

  • gestational diabetes
  • pregnancy or lactating
  • not ambulatory
  • intellectual impairment
  • unmanaged comorbid psychiatric diagnosis (including eating disorders)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Fralin Biomedical Research Institute at VTC

    Roanoke, Virginia, 24016

Other trials in United States

About this study

Official title: 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

Successful management of type 2 diabetes (T2D) requires adherence to a dietary, physical activity, and medication plan agreed upon between a patient and their healthcare providers. The lifestyle changes involved in these collaborative care plans (CCPs) often provide little to no short-term benefit and may instead be aversive (e.g., caloric restriction and physical activity). However, these changes provide critical health benefits in the future, allowing patients with T2D to halt or reverse disease progression and avoid T2D-related complications (e.g., renal disease or diabetic retinopathy). Thus, successful management of T2D requires one's present behavior to be guided by future outcomes. Unfortunately, accumulating evidence indicates that individuals with T2D and prediabetes show elevated rates of delay discounting (i.e., devaluation of delayed consequences). Moreover, high rates of delay discounting are cross-sectionally and longitudinally associated with poor treatment adherence and clinical outcomes in T2D and prediabetes. These data suggest that high rates of delay discounting prevent successful management of T2D through a mechanism in which the health benefits of lifestyle changes are too delayed to motivate behavioral change. Thus, we believe delay discounting serves as a therapeutic target in T2D, where improving participants' valuation of the future will facilitate healthy lifestyle changes and, in turn, improve T2D management. This study will conduct a randomized 24-week remote clinical trial comparing repeated measures ANOVA, with group (episodic future thinking [EFT]/control) and area (urban vs. rural) as between-subjects factors, and time (baseline, week 8, and week 24 assessments) as within-subjects factors in adults with type 2 diabetes.

Read the 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.

Being tested
Episodic Future Thinking, Healthy Information Thinking
Medical subject headings
Diabetes Mellitus, Type 2, Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Episodic Future ThinkingBehavioural

    Participants will be prompted three times daily to think vividly about personally meaningful future events.

  • Healthy Information ThinkingBehavioural

    Participants will be prompted three times daily to think about their responses to informational health vignettes.

Study groups in NCT05280925
Study groupRoleWhat they receive
Episodic Future ThinkingExperimentalParticipants 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.
Receives: Behavioral: Episodic Future Thinking
Healthy Information ThinkingActive comparatorParticipants 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.
Receives: Behavioral: Healthy Information Thinking

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in glycemic control from baseline (Week 0) to Week 8

    Hemoglobin A1c (HbA1C) will be assessed by the A1CNOW system

    Measured: Baseline, Week 8

  2. Change in glycemic control from baseline (Week 0) to Week 24

    Hemoglobin A1c (HbA1C) will be assessed by the A1CNOW system

    Measured: Baseline, Week 24

  3. Change in body mass index from baseline (Week 0) to 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).

    Measured: Baseline, Week 8

  4. Change in body mass index from baseline (Week 0) to 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).

    Measured: Baseline, Week 24

Secondary outcomes (7)
  1. Change in dietary intake from baseline (Week 0) to Week 8

    Dietary intake will be assessed by ASA-24 online food recalls

    Measured: Baseline, Week 8

  2. Change in dietary intake from baseline (Week 0) to Week 24

    Dietary intake will be assessed by ASA-24 online food recalls

    Measured: Baseline, Week 24

  3. Change in physical activity from baseline (Week 0) to Week 8

    Physical activity will be assessed using the International Physical Activity Questionnaire Short Form (IPAQ-SF)

    Measured: Baseline, Week 8

  4. Change in physical activity from baseline (Week 0) to Week 24

    Physical activity will be assessed using the International Physical Activity Questionnaire Short Form (IPAQ-SF)

    Measured: Baseline, Week 24

  5. Change in self-reported adherence to glucose-lowering medication from baseline (Week 0) to 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

    Measured: Baseline, Week 8

  6. Change in self-reported adherence to glucose-lowering medication from baseline (Week 0) to 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

    Measured: Baseline, Week 24

  7. Ease of Use and Treatment Effectiveness Questionnaire, Likert scale

    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.

    Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2022
  2. Study start20 Jul 2022
  3. Primary completion15 Jan 2025
  4. Study completion15 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
24-week remote randomized controlled trial. Analysis plan: repeated measures ANOVA, with group (EFT/control) and area (urban vs. rural) as between-subjects factors, and time (baseline, week 8, and week 24 assessments) as within-subjects factors
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
137 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05280925
Sponsor's protocol ID
21-440
Status last verified
Jun 2025
First submitted
15 Feb 2022
Last updated
26 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Episodic Future Thinking and Healthy Information Thinking in people with Type 2 Diabetes and Overweight and Obesity, run by Virginia Polytechnic Institute and State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in glycemic control from baseline (Week 0) to Week 8 (time frame: Baseline, Week 8). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.

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