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Completed

NCT Number: NCT03732209

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Fralin Biomedical Research Institute

Roanoke, Virginia, 24016, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Episodic Future Thinking

Behavioral

Participants will engage in episodic future thinking, prompted via text-based cues, when making decisions about dietary, exercise, and medication adherence choices.

Control Thinking

Behavioral

Participants will engage in non-future-oriented control thinking, prompted via text-based cues, when making decisions about dietary, exercise, and medication adherence choices.

Primary outcomes

  1. Change in Glycosylated Hemoglobin

    Time frame: Baseline, 8 weeks, 16 weeks, and 24 weeks

    Glycemic control will be assessed by change in glycosylated hemoglobin (hemoglobin A1C, or HbA1c), a standardized diagnostic measure for type 2 diabetes.

    Negative change scores indicate a reduction in percentage of glycosylated hemoglobin (improved glycemic control); positive scores indicate an increase in percentage of glycosylated hemoglobin (worsened glycemic control)

  2. Change in kg/m^2 (Body Mass Index)

    Time frame: Baseline, 8 weeks, 16 weeks, and 24 weeks

    Change in kg/m^2 (body mass index) will be measures using a digital scale

    Negative scores indicate reductions in kg/m^2; positive scores indicate increases in BMI.

  3. Change in Delay Discounting Area Under the Curve (Normalized)

    Time frame: Baseline, 8 weeks, 16 weeks, and 24 weeks

    Delay discounting will be assessed using a computerized task that assess participants' indifference points, or the objective amount of a smaller, immediate reward that is subjectively equivalent to a delayed, larger reward ($100), across a range of delays (1 month, 3 months, 6 months, 1 year, 3 years, 5 years, and 12 years). Indifference points will be expressed as a proportion of the larger reward (0 to 1). This delay discounting curve (indifference points as a function of delay) will be summarized using area under the curve (AUC), calculated using subjective value of the delayed reward (0 to 1) as the y-axis unit and delay as the x-axis unit. Individual delays are converted to ordinal units (1-7) prior to analysis. AUC is expressed as a proportion of the maximum possible AUC. This normalized measure of AUC varies from 0 (maximum discounting) to 1 (minimum discounting).

    Positive scores indicate reductions in delay discounting (i.e., increases in AUC across time); negative sco

Secondary outcomes

  1. Perceived Treatment Effectiveness

    Time frame: 8 weeks, 16 weeks, and 24 weeks

    Perceived treatment effectiveness for the EFT and control conditions will be measured using a 5-point scale, ranging from 1 (not at all) to 5 (extremely).

    Higher scores reflect greater perceived effectiveness.

Sponsors and collaborators

Lead sponsor

Virginia Polytechnic Institute and State University

Other

Collaborators

  • Carilion Clinic
  • National Institute of Nursing Research (NINR)
  • University at Buffalo

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 6, 2018
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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