A Remotely Delivered Episodic Future Thinking Intervention to Improve Management of Type 2 Diabetes
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Type 2 Diabetes
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Participants will engage in episodic future or control thinking in the natural environment. All participants will also receive case management regarding the Traffic Light Diet, modified for type 2 diabetes to include glycemic index of foods, as well as the Traffic Light Activity Plan and other techniques to aid in weight loss (e.g., self-monitoring).Masking: Double (Participant, Outcomes Assessor)Masking Description: Participants assigned to both groups will be masked to experimental hypotheses. Research personnel who will be conducting assessment sessions, including weight measurements, will not be informed of participants' group assignments.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 ep...
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).
Tracking Information
- NCT #
- NCT03732209
- Collaborators
- Carilion Clinic
- University at Buffalo
- National Institute of Nursing Research (NINR)
- Investigators
- Principal Investigator: Jeff S Stein, PhD Virginia Tech Carilion School of Medicine and Research Institute Principal Investigator: John W Epling, MD Carilion Clinic