Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Roanoke, Virginia 24016


Purpose:

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 summary:

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, 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 we 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).


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 - Inellectual impairment - Unmanaged medical or psychiatric disorder - Abnormal glucose related to medications (e.g, glucocorticoids)


NCT ID:

NCT03732209


Primary Contact:

Principal Investigator
Jeff S Stein, PhD
Virginia Tech Carilion Research Institute

Jeff S Stein, PhD
Phone: 540-526-2124
Email: jstein1@vtc.vt.edu


Backup Contact:

Email: kmgatch@vtc.vt.edu
Kirstin Gatchalian, BS
Phone: 540-526-2071


Location Contact:

Roanoke, Virginia 24016
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.