A Remotely Delivered Episodic Future Thinking Intervention to Improve Management of Type 2 Diabetes

The goals of this project are to assess the efficacy of remotely delivered episodic future thinking for reducing delay discounting and improving management of type 2 diabetes, including glycemic control, weight loss, medication adherence, dietary intake, physical activity, and blood pressure. This will be accomplished by randomly assigning participants (N = 64) to episodic future thinking or control thinking groups, while tracking outcome measures before, during, and after the 4-month intervention, as well at a 6-month follow-up visit. Participants in both groups will also receive access to an information-based weight loss intervention.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: Episodic future thinking; Behavioral: Control Thinking

Detailed Description

Participants (N = 64) will be randomly assigned to either an episodic future thinking group or control thinking groups. Participants will generate episodic future events or control information, as well as related text-based cues, and will be prompted via smartphone or web application to engage in episodic future or control thinking frequently in their natural environment (e.g., at home or work, before meal times, and in high-risk situations) for a 4-month period. Participants in both groups will be provided with one-on-one, phone-based case management and provided with instructional materials and behavioral tools for weight loss and diabetes management. Instructional materials will include: 1) a modified version of the Traffic Light Diet, which utilizes red, yellow, and green labels for food to guide participants toward the goal of consuming low energy dense, low glycemic, high nutrient dense foods; 2) the Traffic Light Activity Program, which also utilizes red, yellow, and green labels for different levels of caloric expenditure, and 3) tools for self-monitoring of weight, diet, and/or physical activity.

Participants will complete four laboratory-based assessment sessions in which the investigators assess body weight, height, waist and hip circumference, glycemic control (HbA1C), adherence to oral glucose-lowering medication, delay discounting, reinforcing efficacy of food, and blood pressure. These assessments will be completed before the intervention (Week 0), during the intervention (8 weeks), and immediately after the intervention (Week 16), as well after a 2-month post-intervention follow-up (Week 24). The latter three assessments sessions will also include questions to measure participants' perceived effectiveness and ease of use of the intervention. Participants will also complete several remote assessments, including dietary intake and physical activity (during Weeks 0, 8, and 16; via accelerometer), as well as delay discounting and reinforcing efficacy of food (during Weeks 3, 8, and 16).

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Roanoke, Virginia, United States, 24016
      • Fralin Biomedical Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Overweight or obese (BMI of 25 or greater)
• Poorly controlled type 2 diabetes (HbA1C of 8% or greater)
• Prescribed or recommended oral glucose-lowering medication

Exclusion Criteria:

• Current insulin therapy for type 2 diabetes
• History of gestational diabetes
• Pregnant or lactating
• Not ambulatory
• Intellectual impairment
• Unmanaged medical or psychiatric disorder
• Abnormal glucose related to medications (e.g, glucocorticoids)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Episodic future thinking; Participants will generate positive future events and related text cues that will be accessed via an electronic app to engage in episodic future thinking.	Behavioral: Episodic future thinking; Participants will engage in episodic future thinking, prompted via text-based cues, when making decisions about dietary, exercise, and medication adherence choices.
Sham Comparator: Control thinking; Participants will generate non-future-oriented information and related text cues that will be accessed via an electronic app to engage in control thinking..	Behavioral: Control Thinking; Participants will engage in non-future-oriented control thinking, prompted via text-based cues, when making decisions about dietary, exercise, and medication adherence choices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Glycosylated Hemoglobin	Glycemic control will be assessed by change in glycosylated hemoglobin (hemoglobin A1C, or HbA1c), a standardized diagnostic measure for type 2 diabetes. Negative change scores indicate a reduction in percentage of glycosylated hemoglobin (improved glycemic control); positive scores indicate an increase in percentage of glycosylated hemoglobin (worsened glycemic control)	Baseline, 8 weeks, 16 weeks, and 24 weeks
Change in kg/m^2 (Body Mass Index)	Change in kg/m^2 (body mass index) will be measures using a digital scale Negative scores indicate reductions in kg/m^2; positive scores indicate increases in BMI.	Baseline, 8 weeks, 16 weeks, and 24 weeks
Change in Delay Discounting Area Under the Curve (Normalized)	Delay discounting will be assessed using a computerized task that assess participants' indifference points, or the objective amount of a smaller, immediate reward that is subjectively equivalent to a delayed, larger reward ($100), across a range of delays (1 month, 3 months, 6 months, 1 year, 3 years, 5 years, and 12 years). Indifference points will be expressed as a proportion of the larger reward (0 to 1). This delay discounting curve (indifference points as a function of delay) will be summarized using area under the curve (AUC), calculated using subjective value of the delayed reward (0 to 1) as the y-axis unit and delay as the x-axis unit. Individual delays are converted to ordinal units (1-7) prior to analysis. AUC is expressed as a proportion of the maximum possible AUC. This normalized measure of AUC varies from 0 (maximum discounting) to 1 (minimum discounting). Positive scores indicate reductions in delay discounting (i.e., increases in AUC across time); negative sco	Baseline, 8 weeks, 16 weeks, and 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Treatment Effectiveness	Perceived treatment effectiveness for the EFT and control conditions will be measured using a 5-point scale, ranging from 1 (not at all) to 5 (extremely). Higher scores reflect greater perceived effectiveness.	8 weeks, 16 weeks, and 24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived treatment effectiveness and ease of use	Ease of use and perceived treatment effectiveness for each intervention component will be measured using the Ease of Use and Treatment Effectiveness Questionnaire (EUTEQ), a custom-designed questionnaire modified from a previous scale used in treatment for alcohol use disorder. Scores will be calculated for each intervention component (e.g., episodic thinking, Traffic Light Diet) separately for ease of use and treatment effectiveness. Scale ranges from 1 (not at all easy to use/effective) to 5 (very easy to use/effective). Higher scores represent greater ease of use, perceived effectiveness.	8 weeks, 16 weeks, and 24 weeks

Collaborators and Investigators

• Sponsor: Virginia Polytechnic Institute and State University
• Collaborators: National Institute of Nursing Research (NINR); Carilion Clinic; University at Buffalo
• Investigators: Principal Investigator: Jeff S Stein, PhD, Virginia Tech Carilion School of Medicine and Research Institute; Principal Investigator: John W Epling, MD, Carilion Clinic

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: November 4, 2018
• First Submitted That Met QC Criteria: November 4, 2018
• First Posted (Actual): November 6, 2018

Study Record Updates

• Last Update Posted (Estimated): November 1, 2024
• Last Update Submitted That Met QC Criteria: October 31, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: 2696; 1R21NR018349-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No