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

NCT05280925 | Completed

• 1 other identifier: 21-440
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Type 2 Diabetes; Overweight and Obesity

Outcome Measures

Primary Outcomes (4)

• Change in glycemic control from baseline (Week 0) to 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

  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

  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

  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 Outcomes (7)

• Change in dietary intake from baseline (Week 0) to Week 8

  Baseline, Week 8

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

  Baseline, Week 24

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

  Baseline, Week 8

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

  Baseline, Week 24

• Change in self-reported adherence to glucose-lowering medication from baseline (Week 0) to Week 8

  Baseline, Week 8

Other Outcomes (2)

• Change in delay discounting from baseline (Week 0) to Week 8

  Baseline, Week 8

• Change in delay discounting from baseline (Week 0) to Week 24

  Baseline, Week 24

Study Arms (2)

Episodic Future Thinking

EXPERIMENTAL

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.

Behavioral: Episodic Future Thinking

Healthy Information Thinking

ACTIVE COMPARATOR

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.

Behavioral: Healthy Information Thinking

Interventions

Episodic Future Thinking BEHAVIORAL

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

Episodic Future Thinking

Healthy Information Thinking BEHAVIORAL

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

Healthy Information Thinking

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead
• Carilion Clinic: collaborator
• University at Buffalo: collaborator

Study Sites (1)

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, 24016, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Overweight; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeffrey Stein, PhD

  Fralin Biomedical Research Institute at Virginia Tech Carilion

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants assigned to both groups will be masked to experimental hypotheses. Research personnel who will be conducting assessment sessions, including weight and HbA1c measurements, will not be informed of participants' group assignments
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Model Details: 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

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: March 15, 2022
• Study Start: July 20, 2022
• Primary Completion: January 15, 2025
• Study Completion: April 15, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)