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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03732209
• Other study ID #: 2696
• Secondary ID: 1R21NR018349-01
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 1, 2019
• Est. completion date: August 31, 2021

Study information

• Verified date: October 2021
• Source: Virginia Polytechnic Institute and State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Fralin Biomedical Research Institute	Roanoke	Virginia

Sponsors (4)

Lead Sponsor	Collaborator
Virginia Polytechnic Institute and State University	Carilion Clinic, National Institute of Nursing Research (NINR), University at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Perceived treatment effectiveness and ease of use	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.	8 weeks, 16 weeks, and 24 weeks
Primary	Change in glycemic control	Glycemic control will be assessed by hemoglobin A1C (HbA1c), a standardized diagnostic measure for type 2 diabetes.	Baseline, 8 weeks, 16 weeks, and 24 weeks
Primary	Change in weight	Body weight will be measured using a digital scale.	Baseline, 8 weeks, 16 weeks, and 24 weeks
Primary	Change in delay discounting	Delay discounting will be assessed using computerized behavioral tasks.	Baseline, 8 weeks, 16 weeks, and 24 weeks
Secondary	Change in dietary intake	Dietary intake will be assessed by 24-hour food recall, using the Automated Self-Administered 24 (ASA-24) food recalls.	Baseline, 8 weeks, 16 weeks, and 24 weeks
Secondary	Change in medication adherence	Medication adherence to oral glucose-lowering medication (e.g., metformin) will be assessed by direct observation (pill counts) and by self-report.	Baseline, 8 weeks, 16 weeks, and 24 weeks
Secondary	Change in physical activity	Duration of physical activity (in minutes) will be measured using an Actigraph accelerometer	Baseline, 8 weeks, 16 weeks, and 24 weeks
Secondary	Change in blood pressure	Blood pressure will be measured using an automated blood pressure device.	Baseline, 8 weeks, 16 weeks, and 24 weeks
Secondary	Change in waist and hip circumference	Waist and hip circumference will be assessed by measuring tape.	Baseline, 8 weeks, 16 weeks, and 24 weeks