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

NCT03732209 | Completed Phase 1 Results

• 2 other identifiers: 26961R21NR018349-01
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (3)

• Change in Glycosylated Hemoglobin

  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)

  Baseline, 8 weeks, 16 weeks, and 24 weeks

• Change in kg/m^2 (Body Mass Index)

  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.

  Baseline, 8 weeks, 16 weeks, and 24 weeks

• Change in Delay Discounting Area Under the Curve (Normalized)

  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

  Baseline, 8 weeks, 16 weeks, and 24 weeks

Secondary Outcomes (1)

• Perceived Treatment Effectiveness

  8 weeks, 16 weeks, and 24 weeks

Study Arms (2)

Episodic future thinking

EXPERIMENTAL

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

Control thinking

SHAM COMPARATOR

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

Interventions

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.

Episodic future thinking

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.

Control thinking

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead
• Carilion Clinic: collaborator
• University at Buffalo: collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Fralin Biomedical Research Institute

Roanoke, Virginia, 24016, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

The COVID-19 pandemic caused a spike in attrition, with many of the n=59 participants who enrolled in the trial to not reach trial randomization in Week 3 and study completion in Week 24. Likewise, the long-lasting restrictions on in-person assessments and the lack of reliable and feasible methods to collect these measures remotely limited new enrollments. As a result, this trial did not meet its recruitment goals.

Results Point of Contact

• Title: Jeffrey Stein
• Organization: Fralin Biomedical Research Institute at VTC

jstein1@vtc.vt.edu

540-526-2124

Study Officials

• Jeff S Stein, PhD

  Virginia Tech Carilion School of Medicine and Research Institute

  PRINCIPAL INVESTIGATOR

• John W Epling, MD

  Carilion Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Model Details: 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).

Study Record Dates

• First Submitted: November 4, 2018
• First Posted: November 6, 2018
• Study Start: March 1, 2019
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: November 1, 2024
• Results First Posted: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)