Clinical trial NCT03732209: A Remotely Delivered Episodic Future Thinking Intervention to Improve Management of Type 2 Diabetes
Official title: A Remotely Delivered Episodic Future Thinking Intervention to Improve Management of Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Type 2 Diabetes
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
Collaborators: name: Carilion Clinic
name: University at Buffalo
name: National Institute of Nursing Research (NINR)
First posted: 2018-11-06
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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).

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)

Primary outcomes:
measure: Change in Glycosylated Hemoglobin
timeFrame: Baseline, 8 weeks, 16 weeks, and 24 weeks
measure: Change in kg/m^2 (Body Mass Index)
timeFrame: Baseline, 8 weeks, 16 weeks, and 24 weeks
measure: Change in Delay Discounting Area Under the Curve (Normalized)
timeFrame: Baseline, 8 weeks, 16 weeks, and 24 weeks
Secondary outcomes:
measure: Perceived Treatment Effectiveness
timeFrame: 8 weeks, 16 weeks, and 24 weeks
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Fralin Biomedical Research Institute
state: Virginia
Study officials:
affiliation: Virginia Tech Carilion School of Medicine and Research Institute
name: Jeff S Stein, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Carilion Clinic
name: John W Epling, MD
role: PRINCIPAL_INVESTIGATOR
References: