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Food Response Training for Binge Eating

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ClinicalTrials.gov Identifier: NCT02817412
Recruitment Status : Active, not recruiting
First Posted : June 29, 2016
Last Update Posted : February 27, 2018
Sponsor:
Collaborator:
Oregon Research Institute
Information provided by (Responsible Party):
Sylvia Herbozo, PhD, Loma Linda University

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

Condition or disease Intervention/treatment Phase
Binge Eating Behavioral: Go/No-Training Behavioral: Stop-Signal Training Behavioral: Dot-Probe Paradigm Behavioral: Generic Response Training Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Food Response Training for Binge Eating
Study Start Date : June 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Arm Intervention/treatment
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.
Behavioral: Go/No-Training
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.
Behavioral: Stop-Signal Training
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.
Behavioral: Dot-Probe Paradigm
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.
Behavioral: Generic Response Training



Primary Outcome Measures :
  1. Binge Eating Frequency [ Time Frame: Post-intervention (at 4 months) ]
  2. Binge Eating Frequency [ Time Frame: 3-month follow-up (at 7 months) ]

Secondary Outcome Measures :
  1. Body Mass Index [ Time Frame: Post-intervention (at 4 months) ]
  2. Body Mass Index [ Time Frame: 3-month follow-up (at 7 months) ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02817412


Locations
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United States, Illinois
Sylvia Herbozo
Chicago, Illinois, United States, 60607
Sponsors and Collaborators
Loma Linda University
Oregon Research Institute
Investigators
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Principal Investigator: Sylvia Herbozo, Ph.D. University of Illinois at Chicago

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Responsible Party: Sylvia Herbozo, PhD, Associate Professor, Loma Linda University
ClinicalTrials.gov Identifier: NCT02817412     History of Changes
Other Study ID Numbers: 5160020
First Posted: June 29, 2016    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sylvia Herbozo, PhD, Loma Linda University:
binge eating
obesity
overeating

Additional relevant MeSH terms:
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Binge-Eating Disorder
Bulimia
Feeding and Eating Disorders
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms