Weight Loss for Prediabetes Using Episodic Future Thinking
Condition: PreDiabetes
MeSH terms: Prediabetic State; Glucose Intolerance
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Episodic Future Thinking; Daily Check in
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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 name(s): EFT; DCI
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Weight loss, delay discounting