A Remotely Delivered Episodic Future Thinking Intervention to Improve Management of Type 2 Diabetes
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|ClinicalTrials.gov Identifier: NCT03732209|
Recruitment Status : Recruiting
First Posted : November 6, 2018
Last Update Posted : April 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Behavioral: Episodic future thinking Behavioral: Control Thinking||Phase 1 Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|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).|
|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.|
|Official Title:||A Remotely Delivered Episodic Future Thinking Intervention to Improve Management of Type 2 Diabetes|
|Actual Study Start Date :||March 1, 2019|
|Estimated Primary Completion Date :||May 31, 2020|
|Estimated Study Completion Date :||July 31, 2020|
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.
- Change in glycemic control [ Time Frame: Baseline, 8 weeks, 16 weeks, and 24 weeks ]Glycemic control will be assessed by hemoglobin A1C (HbA1c), a standardized diagnostic measure for type 2 diabetes.
- Change in weight [ Time Frame: Baseline, 8 weeks, 16 weeks, and 24 weeks ]Body weight will be measured using a digital scale.
- Change in delay discounting [ Time Frame: Baseline, 8 weeks, 16 weeks, and 24 weeks ]Delay discounting will be assessed using computerized behavioral tasks.
- Change in dietary intake [ Time Frame: Baseline, 8 weeks, 16 weeks, and 24 weeks ]Dietary intake will be assessed by 24-hour food recall, using the Automated Self-Administered 24 (ASA-24) food recalls.
- Change in medication adherence [ Time Frame: Baseline, 8 weeks, 16 weeks, and 24 weeks ]Medication adherence to oral glucose-lowering medication (e.g., metformin) will be assessed by direct observation (pill counts) and by self-report.
- Change in physical activity [ Time Frame: Baseline, 8 weeks, 16 weeks, and 24 weeks ]Duration of physical activity (in minutes) will be measured using an Actigraph accelerometer
- Change in blood pressure [ Time Frame: Baseline, 8 weeks, 16 weeks, and 24 weeks ]Blood pressure will be measured using an automated blood pressure device.
- Change in waist and hip circumference [ Time Frame: Baseline, 8 weeks, 16 weeks, and 24 weeks ]Waist and hip circumference will be assessed by measuring tape.
- Perceived treatment effectiveness and ease of use [ Time Frame: 8 weeks, 16 weeks, and 24 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03732209
|Contact: Jeff S Stein, PhDemail@example.com|
|Contact: Kirstin Gatchalian, BSfirstname.lastname@example.org|
|United States, Virginia|
|Fralin Biomedical Research Institute||Recruiting|
|Roanoke, Virginia, United States, 24016|
|Contact: Jeff Stein, Ph.D. 540-526-2124 email@example.com|
|Principal Investigator:||Jeff S Stein, PhD||Virginia Tech Carilion School of Medicine and Research Institute|
|Principal Investigator:||John W Epling, MD||Carilion Clinic|