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PreDiabetesMINDD4NCT03670602

Weight Loss for Prediabetes Using Episodic Future Thinking

A study testing Episodic Future Thinking and Daily Check in in people with PreDiabetes, run by State University of New York at Buffalo at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
PreDiabetes
What is being tested?
Episodic Future Thinking and Daily Check in
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
64 participants
Where
2 sitesUnited States
Study dates
17 Jan 2019to 30 Jun 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Type 2 Diabetes
  • Use of diabetic drugs
  • Pregnancy
  • Not ambulatory
  • Intellectual impairment
  • Unmanaged mood disorders
Show all 9Show fewer
  • Current substance use disorder (excluding nicotine and caffeine)
  • History of eating disorders (Except binge eating disorder)
  • Abnormal blood glucose related to medications

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • University at Buffalo, Department of Pediatrics, Division of Behavioral Medicine

    Buffalo, New York, 14214

  • Fralin Biomedical Research Institute, Virginia Tech Carilion

    Roanoke, Virginia, 24016

Other trials in United States

About this study

Official title: Delay Discounting as a Target for Self-Regulation in Prediabetes

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.

Read the 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.

Conditions
PreDiabetes
Being tested
Episodic Future Thinking, Daily Check in
Keywords
Weight loss, delay discounting
Medical subject headings
Prediabetic State, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Episodic Future ThinkingBehavioural

    Also called EFT

    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 inBehavioural

    Also called DCI

    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.

Study groups in NCT03670602
Study groupRoleWhat they receive
Episodic Future Thinking (EFT)ExperimentalParticipants will generate positive future cues that will be accessed via an electronic app to engage in EFT.
Receives: Behavioral: Episodic Future Thinking
Daily Check in (DCI)Placebo comparatorParticipants will be asked to access an electronic app daily, but will receive no cues.
Receives: Behavioral: Daily Check in

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. Change From Baseline in Weight

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

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

  3. 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.

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

Secondary outcomes (4)
  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2018
  2. Study start17 Jan 2019
  3. Primary completion30 Jun 2021
  4. Study completion30 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Outcomes assessor
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03670602
Sponsor's protocol ID
5UH3DK109543-05
Other IDs
5UH3DK109543-05
Acronym
MINDD4
Status last verified
Nov 2022
First submitted
7 Sep 2018
Last updated
9 Dec 2022
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Episodic Future Thinking and Daily Check in in people with PreDiabetes, run by State University of New York at Buffalo at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Delay Discounting (time frame: Baseline (0 weeks), 12 weeks and 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2022.

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