Weight Loss for Prediabetes Using Episodic Future Thinking

NCT03670602 | Completed Results

• 1 other identifier: 5UH3DK109543-05
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

Brief Summary

The goals of the UH3 are to assess the effectiveness of adding Episodic Future Thinking (EFT) to the investigators standard behavioral weight control program to improve weight loss, delay discounting (DD), working memory, glycemic control (HbA1c) and behavioral medication adherence over a 6 month period in persons with prediabetes and comorbid hypertension and/or hyperlipidemia. This will be accomplished by a randomized trial (N = 71 randomized) comparing the effects of EFT versus control that matches attention and use of technology.

Conditions

PreDiabetes

Keywords

Weight loss, delay discounting

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in Delay Discounting

  Delay Discounting will be assessed using an adjusting amount task where choices will be present between a larger, delayed amount of money ($100) and a smaller, immediate amount. The smaller, immediate amount will begin at $50 on the first trial and will be adjusted following each trial. Participants cues created during treatment will be displayed during the task. To calculate discount rates hyperbolic discounting model will be used V=A/1+kD where V is discounted value, A is reward amount, D is delay and k is a free parameter that indexes the rate of discounting. k values are transformed using natural log. Higher scores indicate more choices for immediate reward. Change is assessed using repeated measures.

  Baseline (0 weeks), 12 weeks and 24 weeks

• Change From Baseline in Weight

  Weight measured in kilograms. Change is assessed using repeated measures.

  Baseline (0 weeks), 12 weeks, and 24 weeks

• Change From Baseline in Glycemic Control

  Glycemic control will be measured as hemoglobin A1c (HbA1c), which is the percentage of glycated hemoglobin within total hemoglobin. Change is assessed using repeated measures.

  Baseline (0 weeks), 12 weeks and 24 weeks

Secondary Outcomes (4)

• Change in Medication Adherence

  Baseline (0 weeks), 12 weeks and 24 weeks

• Changes in Physical Activity

  Baseline (0 weeks), 12 weeks and 24 weeks

• Change in Total Calories

  Baseline (0 weeks), 12 weeks and 24 weeks

• Changes in Working Memory

  Baseline (0 weeks), 12 weeks and 24 weeks

Other Outcomes (1)

• Changes in Relative Reinforcing Efficacy of Unhealthy Food

  Baseline (0 weeks), 12 weeks and 24 weeks

Study Arms (2)

Episodic Future Thinking (EFT)

EXPERIMENTAL

Participants will generate positive future cues that will be accessed via an electronic app to engage in EFT.

Behavioral: Episodic Future Thinking

Daily Check in (DCI)

PLACEBO COMPARATOR

Participants will be asked to access an electronic app daily, but will receive no cues.

Behavioral: Daily Check in

Interventions

Episodic Future Thinking BEHAVIORAL

Participants will practice using these cues when making decisions about health choices. Participants will implement EFT while using The Traffic Light Diet, The Traffic Light Activity Program, and a variety of behavioral techniques including stimulus control, self-monitoring, goal setting, problem solving, resetting rewarding mechanisms by reducing need for immediate gratification, finding behavioral substitutes for highly reinforcing food.

Also known as: EFT

Episodic Future Thinking (EFT)

Daily Check in BEHAVIORAL

Participants will be asked to access the electronic app at the same rate as the experimental group (e.g. daily). Participants will receive behavioral weight loss treatment including The Traffic Light Diet, The Traffic Light Activity Program, and a variety of behavioral techniques including stimulus control, self-monitoring, goal setting, problem solving, and finding behavioral substitutes for highly reinforcing food.

Also known as: DCI

Daily Check in (DCI)

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Overweight or obese (BMI ≥ 25)
• Prediabetes (HbA1c between 5.7 - 6.4%; 39-40 mmol/mol)

You may not qualify if:

• Type 2 Diabetes
• Use of diabetic drugs
• Pregnancy
• Not ambulatory
• Intellectual impairment
• Unmanaged mood disorders
• Current substance use disorder (excluding nicotine and caffeine)
• History of eating disorders (Except binge eating disorder)
• Abnormal blood glucose related to medications

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• Virginia Polytechnic Institute and State University: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

University at Buffalo, Department of Pediatrics, Division of Behavioral Medicine

Buffalo, New York, 14214, United States

Location

Fralin Biomedical Research Institute, Virginia Tech Carilion

Roanoke, Virginia, 24016, United States

Location

MeSH Terms

Conditions

Prediabetic State; Weight Loss

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Leonard H. Epstein
• Organization: University at Buffalo

lhenet@buffalo.edu

716-829-3400

Study Officials

• Leonard H Epstein, PhD

  State University of New York at Buffalo

  PRINCIPAL INVESTIGATOR

• Warren K Bickel, PhD

  Virginia Polytechnic Institute and State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research personnel who will be conducting assessment sessions, including weight measurements, will not be informed of participant's group assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will engage in EFT or control while using The Traffic Light Diet, The Traffic Light Activity Program, and a variety of behavioral techniques including stimulus control, self-monitoring, goal setting, problem solving, resetting rewarding mechanisms by reducing need for immediate gratification, finding behavioral substitutes for highly reinforcing food.

Study Record Dates

• First Submitted: September 7, 2018
• First Posted: September 13, 2018
• Study Start: January 17, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: December 9, 2022
• Results First Posted: December 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)