- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02817412
Food Response Training for Binge Eating
Study Overview
Status
Conditions
Detailed Description
Binge eating disorder is the most prevalent eating disorder and affects both men and women at comparable rates unlike anorexia nervosa and bulimia nervosa. Given that binge eating and obesity are strongly associated, binge eating treatments should aim to reduce binge eating as well as weight. However, most binge eating interventions do not produce lasting weight loss. Recent research has shown computer-based response inhibition training with high-calorie foods reduces reward region response to and attentional bias for the training foods, decreases training food intake, increases inhibitory control, and produces weight loss in overweight adults. There is evidence that the weight loss effects from such response training persist through 6-month follow-up. Further, binge eating has been associated with increased food-related impulsivity and increased activation in a reward-processing brain region to high-calorie foods. Prior research suggests that food response training may be an effective intervention for binge eating that teaches automatic self-control in response to high-calorie foods which in turn, reduces binge eating and produces weight loss. This study will examine the effectiveness of food response training interventions in reducing binge eating and weight among adults engaged in binge eating.
The goals of this study are to: (1) test the hypothesis that adults who complete the food response trainings will show significantly greater reductions in binge eating frequency and in body mass index (BMI) compared to generic response training from pretest to posttest and at 3-month follow up, (2) to determine whether one of the food response trainings is more effective in binge eating frequency and reducing BMI from pretest to posttest and at 3-month follow up, and (3) test whether a reduction in valuation of the high-calorie versus low-calorie foods (willingness to pay for the pictured foods) and/or behavioral improvement of inhibitory control during the training tasks mediate the effects of the various trainings on reductions in binge frequency and body mass index.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60607
- Sylvia Herbozo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Engages in objective binge episodes as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and meets one of the following frequency and duration criteria: 1) at least two objective binge episodes per month for at least 3 months; or 3) at least six objective binge episodes over a shorter period
Exclusion Criteria:
- Illicit drug use and excessive alcohol use
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Go/No-Go Training
In the go/no go training, participants are shown images in which high-calorie foods are shown on one side of the screen and low-calorie foods on the other.
They are told to press response keys as quickly as possible to indicate the side of presentation (go-trials).
On half of the trials, the rectangular frame surrounding the image is not solid but hatched, which is a signal for them to withhold their response (no-go trials).
This training is divided into 4 blocks of 50 trials.
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Experimental: Stop-Signal Training
In the stop signal training, participants are shown images in either a dark blue or light gray border.
They are told to press the space bar as quickly as possible when the border is blue (go trials) and to withhold a response when the border is gray (no-go trials).
This training is divided into 20 blocks of 32 trials.
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Experimental: Dot-Probe Training
In the dot-probe training, participants are shown images in which high-calorie foods are shown on one side of the screen and low-calorie foods on the other.
Immediately after the images disappear, a small dot probe appears in the location of one of the images.
Participants are told to press response keys as quickly as possible to indicate whether a visual probe appeared behind the left or right image during the trials.
The probe appears in the location occupied by a high-calorie food image 10% of the time and in the location occupied by a low-calorie food image 90% of the time.
This training is divided into 6 blocks of 40 trials.
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Placebo Comparator: Generic Training
In the generic training, participants complete a generic go/no-go training that uses images of flowers and office supplies instead of the images of high-calorie and low-calorie food images.
This generic go/no go training is identical in duration and contact time to the go/no-go food training.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Binge Eating Frequency
Time Frame: Post-intervention (at 4 months)
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Number of times engaged in binge eating (self-report)
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Post-intervention (at 4 months)
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Binge Eating Frequency
Time Frame: 3-month follow-up (at 7 months)
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Number of times engaged in binge eating (self-report)
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3-month follow-up (at 7 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Mass Index
Time Frame: Post-intervention (at 4 months)
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Weight in kilograms divided by height in meters squared.
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Post-intervention (at 4 months)
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Body Mass Index
Time Frame: 3-month follow-up (at 7 months)
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Weight in kilograms divided by height in meters squared.
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3-month follow-up (at 7 months)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sylvia Herbozo, Ph.D., University of Illinois at Chicago
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5160020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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