Weight Loss for Prediabetes Using Episodic Future Thinking
NCT ID: NCT03670602
Last Updated: 2022-12-09
Study Results
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View full resultsBasic Information
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COMPLETED
NA
64 participants
INTERVENTIONAL
2019-01-17
2021-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Episodic Future Thinking (EFT)
Participants will generate positive future cues that will be accessed via an electronic app to engage in EFT.
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 (DCI)
Participants will be asked to access an electronic app daily, but will receive no cues.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Prediabetes (HbA1c between 5.7 - 6.4%; 39-40 mmol/mol)
Exclusion Criteria
* 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
18 Years
74 Years
ALL
No
Sponsors
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Virginia Polytechnic Institute and State University
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
State University of New York at Buffalo
OTHER
Responsible Party
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Leonard Epstein
Principal Investigator
Principal Investigators
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Leonard H Epstein, PhD
Role: PRINCIPAL_INVESTIGATOR
State University of New York at Buffalo
Warren K Bickel, PhD
Role: PRINCIPAL_INVESTIGATOR
Virginia Polytechnic Institute and State University
Locations
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University at Buffalo, Department of Pediatrics, Division of Behavioral Medicine
Buffalo, New York, United States
Fralin Biomedical Research Institute, Virginia Tech Carilion
Roanoke, Virginia, United States
Countries
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Provided Documents
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