跳至主要内容
临床试验/NCT03670602
NCT03670602已完成不适用

Delay Discounting as a Target for Self-Regulation in Prediabetes

State University of New York at Buffalo2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2019年1月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
2
主要终点
Change From Baseline in Delay Discounting

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Research personnel who will be conducting assessment sessions, including weight measurements, will not be informed of participant's group assignment

入排标准

年龄范围
18 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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

研究组 & 干预措施

Episodic Future Thinking (EFT)

Experimental

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

干预措施: Episodic Future Thinking (Behavioral)

Daily Check in (DCI)

Placebo Comparator

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

干预措施: Daily Check in (Behavioral)

结局指标

主要结局

Change From Baseline in Delay Discounting

时间窗: Baseline (0 weeks), 12 weeks and 24 weeks

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.

Change From Baseline in Weight

时间窗: Baseline (0 weeks), 12 weeks, and 24 weeks

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

Change From Baseline in Glycemic Control

时间窗: Baseline (0 weeks), 12 weeks and 24 weeks

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.

次要结局

  • Change in Total Calories(Baseline (0 weeks), 12 weeks and 24 weeks)
  • Changes in Working Memory(Baseline (0 weeks), 12 weeks and 24 weeks)
  • Change in Medication Adherence(Baseline (0 weeks), 12 weeks and 24 weeks)
  • Changes in Physical Activity(Baseline (0 weeks), 12 weeks and 24 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Leonard Epstein

Principal Investigator

State University of New York at Buffalo

研究点 (2)

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