NCT02817412

Brief Summary

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

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2018

Completed
Last Updated

November 25, 2019

Status Verified

November 1, 2019

Enrollment Period

1.9 years

First QC Date

June 23, 2016

Last Update Submit

November 21, 2019

Conditions

Keywords

binge eatingobesityovereating

Outcome Measures

Primary Outcomes (2)

  • Binge Eating Frequency

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

    Post-intervention (at 4 months)

  • Binge Eating Frequency

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

    3-month follow-up (at 7 months)

Secondary Outcomes (2)

  • Body Mass Index

    Post-intervention (at 4 months)

  • Body Mass Index

    3-month follow-up (at 7 months)

Study Arms (4)

Go/No-Go Training

EXPERIMENTAL

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

Stop-Signal Training

EXPERIMENTAL

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

Dot-Probe Training

EXPERIMENTAL

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

Generic Training

PLACEBO COMPARATOR

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

Interventions

Go/No-TrainingBEHAVIORAL
Go/No-Go Training
Stop-Signal Training
Dot-Probe Training
Generic Training

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Illicit drug use and excessive alcohol use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sylvia Herbozo

Chicago, Illinois, 60607, United States

Location

MeSH Terms

Conditions

BulimiaObesityHyperphagia

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Study Officials

  • Sylvia Herbozo, Ph.D.

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 23, 2016

First Posted

June 29, 2016

Study Start

June 1, 2016

Primary Completion

April 24, 2018

Study Completion

April 24, 2018

Last Updated

November 25, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations