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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
Sponsor:
Collaborators:
Carilion Clinic
University at Buffalo
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Jeffrey Stein, Virginia Polytechnic Institute and State University

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Episodic future thinking Behavioral: Control Thinking Phase 1 Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. Change in weight [ Time Frame: Baseline, 8 weeks, 16 weeks, and 24 weeks ]
    Body weight will be measured using a digital scale.

  3. Change in delay discounting [ Time Frame: Baseline, 8 weeks, 16 weeks, and 24 weeks ]
    Delay discounting will be assessed using computerized behavioral tasks.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

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


Contacts
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Contact: Jeff S Stein, PhD 540-526-2124 jstein1@vtc.vt.edu
Contact: Kirstin Gatchalian, BS 540-526-2071 kmgatch@vtc.vt.edu

Locations
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United States, Virginia
Fralin Biomedical Research Institute Recruiting
Roanoke, Virginia, United States, 24016
Contact: Jeff Stein, Ph.D.    540-526-2124    jstein1@vtc.vt.edu   
Sponsors and Collaborators
Virginia Polytechnic Institute and State University
Carilion Clinic
University at Buffalo
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Jeff S Stein, PhD Virginia Tech Carilion School of Medicine and Research Institute
Principal Investigator: John W Epling, MD Carilion Clinic
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Responsible Party: Jeffrey Stein, Research Assistant Professor, Virginia Polytechnic Institute and State University
ClinicalTrials.gov Identifier: NCT03732209    
Other Study ID Numbers: 2696
1R21NR018349-01 ( U.S. NIH Grant/Contract )
First Posted: November 6, 2018    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases