Weight Loss for Prediabetes Using Episodic Future Thinking

PreDiabetes Clinical Trial

— MINDD4  

Official title:

Delay Discounting as a Target for Self-Regulation in Prediabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03670602
• Other study ID #: 5UH3DK109543-05
• Secondary ID: 5UH3DK109543-05
• Status: Completed
• Phase: N/A
• Start date: January 17, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: November 2022
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Participants in both groups will first attend weekly group meetings followed by monthly group meetings for up to 6 months. They will be provided general information on healthy diet, physical activity and medication adherence that the investigators will develop combining strengths of the investigators well validated family-based behavioral treatment for obesity and the Diabetes Prevention Program (DPP) lifestyle intervention for prediabetes. The behavioral treatment (BT) is a rigorously tested, multi-component intervention that targets diet, activity, and behavioral skills. The treatment will include: 1) a modified version of the Traffic Light Diet, which utilizes RED, YELLOW, 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) 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, and EFT. The investigators have used a traffic light-based intervention in combination with EFT in a pilot study to demonstrate therapeutic effects of EFT on BMI and dietary intake beyond the effects of BT alone.

During treatment meetings, participants will be weighed and have a 30-60 minute group session (up to 20 per group) either preceded or followed by an individualized session with an interventionist. The group sessions review information about weight loss and maintenance and engage in group problem solving for participants who are struggling with behavior change. During the individual meeting with their interventionist, participants are taught behavior change techniques and review and address diet and activity self-monitoring and any barriers to adherence with the weight-loss behaviors. A study website will be developed that will be used to provide information about the intervention, downloadable manuals for the Traffic Light Diet and Activity Program, manage the EFT component of the intervention, and provide tools for cooking, and getting more physical activity. Quizzes to assess mastery of educational materials will be implemented on the study website, with multiple versions of quizzes on each module available to account for those participants who will acquire the information more slowly than others. Participants will have access to traditional paper and pencil self-monitoring, and consistent with current implementation of BT, after self-monitoring skill is acquired, participants can choose to use traditional or technology-based recording. Participants will have access to the study website for feedback, and interventionists will have access to the website to assess patient progress, assist with problem solving and to communicate with participants to structure solutions. The website will also contain password protected sections that are for internal use by study personnel. This section will be a repository for study documents and a communications hub for the study. The website will not contain protected health information.

Participants in both groups will meet with an interventionist to review progress. One group will be trained to implement EFT using the ecological momentary intervention (EMI) computer based program that the investigators have developed. This program can be accessed by smartphone, tablet or computer. This application stores self-generated EFT cues, prompts their use, asks questions about use, and records their use. EFT training will include developing individualized future event cues to use in implementing EFT in the natural environment. In the control group, participants may use non-future cues, recall previous events, and not use prospection.

Cues are stimuli that prompt engaging in EFT. Cues can be signs, reminder cards, audio cues, or physical cues. Subjects will practice using these cues and learn to envision that the "future is now" when making decisions in the laboratory as they are engaged in a variety of DD and food decision training tasks such as the opportunity to have a very enticing snack now or larger portions of healthier food later, earning a small amount of money now or more later, etc. In this way, participants will learn to generate episodic future cues and practice EFT skills in situations where they usually would choose the more immediate reward. Episodic future cues may include audio and written cues that can be accessed during tempting situations in the natural environment. During individual sessions interventionists will review habit changes and medication adherence, and use of EFT. In the control group participants be asked to log into the MAMRT web-app at the same frequency as the EFT group, but will see no cues prior to their daily questions.

Participants in both groups will be weighed at the beginning of each session, and height will also be collected at baseline. Data to be collected at baseline, 3 and 6 months include delay discounting tasks, working memory, measures of medication and behavioral adherence, weight, glycemic control, blood pressure and cholesterol, eating and activity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

Inclusion Criteria:

• Overweight or obese (BMI = 25)

• Prediabetes (HbA1c between 5.7 - 6.4%; 39-40 mmol/mol)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Glucose Intolerance
• PreDiabetes
• Prediabetic State

Intervention

Behavioral:
• Episodic Future Thinking
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.
• Daily Check in
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.

Locations

Country	Name	City	State
United States	University at Buffalo, Department of Pediatrics, Division of Behavioral Medicine	Buffalo	New York
United States	Fralin Biomedical Research Institute, Virginia Tech Carilion	Roanoke	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
State University of New York at Buffalo	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Virginia Polytechnic Institute and State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in Relative Reinforcing Efficacy of Unhealthy Food	Relative Reinforcing efficacy of food is measured with a hypothetical purchasing task, in which number two foods are available and number of portions of food purchased at various prices ($0 - $20) is measured. Foods used were considered unhealthy snack foods, e.g. cookies, potato chips, etc. Intensity, the number of portions of food requested when the price is $0, was used as the outcome measure. Significant non-normality of the data required a log base 10 transformation (log (food portions + 1). Larger numbers represent more food portions, higher intensity and higher reinforcing efficacy. Change is assessed using repeated measures.	Baseline (0 weeks), 12 weeks and 24 weeks
Primary	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
Primary	Change From Baseline in Weight	Weight measured in kilograms. Change is assessed using repeated measures.	Baseline (0 weeks), 12 weeks, and 24 weeks
Primary	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	Change in Medication Adherence	Adherence to prescribed medication for co-morbid hypertension and/or hyperlipidemia will be assessed using pill counts. Experimenter will count pills 2x and record number of pills, medication, dosage and fill date. Adherence percentage is calculated [(Quantity of pills dispensed - remaining)/(quantity prescribed per day*days since last refill)] *100. Change is assessed using repeated measures.	Baseline (0 weeks), 12 weeks and 24 weeks
Secondary	Changes in Physical Activity	Physical activity, as one index of behavioral health and a target of the behavioral weight loss treatment, was measured using an Actigraph Accelerometer. Participants will be asked to wear an Actigraph Accelerometer for at least 10 hours per day for approximately one week. Accelerometer data was filtered using ActiLife, for 90 minutes consecutive non-wear and by participants wear time diaries. The main outcome measure was percent of time engaged in moderate to vigorous activity (MVPA) (MET>3.00). Change is assessed using repeated measures.	Baseline (0 weeks), 12 weeks and 24 weeks
Secondary	Change in Total Calories	Dietary intake, as an index of behavioral health and a target of the treatment, was measured using 3 automated self-administered 24-hour multi-pass food recalls. Total calories were averaged across the three sessions for each timepoint. Change was assessed using repeated measures.	Baseline (0 weeks), 12 weeks and 24 weeks
Secondary	Changes in Working Memory	Visuospatial working memory will be measured using the Backwards Corsi block-tapping task. The total score, or (number of trials completed correctly (out of 14 trials) x longest correctly reported block of items (2 - 8 items) ). Possible scores range from 0 (minimum) - (112) maximum. Higher scores indicate better working memory. Change is assessed using repeated measures	Baseline (0 weeks), 12 weeks and 24 weeks