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

NCT ID: NCT03732209

Last Updated: 2024-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2021-08-31

Brief Summary

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.

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).

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Episodic future thinking

Intervention Type: BEHAVIORAL

Participants will engage in episodic future thinking, prompted via text-based cues, when making decisions about dietary, exercise, and medication adherence choices.

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..

Group Type: SHAM_COMPARATOR

Control Thinking

Intervention Type: BEHAVIORAL

Participants will engage in non-future-oriented control thinking, prompted via text-based cues, when making decisions about dietary, exercise, and medication adherence choices.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carilion Clinic

OTHER

Sponsor Role: collaborator

University at Buffalo

OTHER

Sponsor Role: collaborator

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Virginia Polytechnic Institute and State University

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey Stein

Research Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeff S Stein, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Tech Carilion School of Medicine and Research Institute

John W Epling, MD

Role: PRINCIPAL_INVESTIGATOR

Carilion Clinic

Locations

Fralin Biomedical Research Institute

Roanoke, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R21NR018349-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2696

Identifier Type: -

Identifier Source: org_study_id