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Food Response Training for Binge Eating

Primary Purpose

Binge Eating

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Go/No-Training
Stop-Signal Training
Dot-Probe Paradigm
Generic Response Training
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Binge Eating focused on measuring binge eating, obesity, overeating

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sylvia Herbozo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Go/No-Go Training

Stop-Signal Training

Dot-Probe Training

Generic Training

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Binge Eating Frequency
Number of times engaged in binge eating (self-report)
Binge Eating Frequency
Number of times engaged in binge eating (self-report)

Secondary Outcome Measures

Body Mass Index
Weight in kilograms divided by height in meters squared.
Body Mass Index
Weight in kilograms divided by height in meters squared.

Full Information

First Posted
June 23, 2016
Last Updated
November 21, 2019
Sponsor
Loma Linda University
Collaborators
Oregon Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02817412
Brief Title
Food Response Training for Binge Eating
Official Title
Food Response Training for Binge Eating
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Why Stopped
Principle investigator (Sylvia Herbozo) left the university.
Study Start Date
June 2016 (Actual)
Primary Completion Date
April 24, 2018 (Actual)
Study Completion Date
April 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loma Linda University
Collaborators
Oregon Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will examine the effectiveness of food response training interventions in reducing binge eating among adults engaged in binge eating.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge Eating
Keywords
binge eating, obesity, overeating

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Go/No-Go Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Stop-Signal Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Dot-Probe Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Generic Training
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Go/No-Training
Intervention Type
Behavioral
Intervention Name(s)
Stop-Signal Training
Intervention Type
Behavioral
Intervention Name(s)
Dot-Probe Paradigm
Intervention Type
Behavioral
Intervention Name(s)
Generic Response Training
Primary Outcome Measure Information:
Title
Binge Eating Frequency
Description
Number of times engaged in binge eating (self-report)
Time Frame
Post-intervention (at 4 months)
Title
Binge Eating Frequency
Description
Number of times engaged in binge eating (self-report)
Time Frame
3-month follow-up (at 7 months)
Secondary Outcome Measure Information:
Title
Body Mass Index
Description
Weight in kilograms divided by height in meters squared.
Time Frame
Post-intervention (at 4 months)
Title
Body Mass Index
Description
Weight in kilograms divided by height in meters squared.
Time Frame
3-month follow-up (at 7 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvia Herbozo, Ph.D.
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sylvia Herbozo
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Food Response Training for Binge Eating

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