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Binge EatingNCT02817412

Food Response Training for Binge Eating

A study testing Go/No-Training, Stop-Signal Training and Dot-Probe Paradigm in people with Binge Eating, run by Loma Linda University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Binge Eating
What is being tested?
Go/No-Training, Stop-Signal Training and Dot-Probe Paradigm
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
35 participants
Where
1 siteUnited States
Study dates
Jun 2016to 24 Apr 2018
Phase
Interventional
Are there results?
None posted in the registry

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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • Illicit drug use and excessive alcohol use

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Sylvia Herbozo

    Chicago, Illinois, 60607

Other trials in United States

About this study

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

Read the 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.

Conditions
Binge Eating
Being tested
Go/No-Training, Stop-Signal Training, Dot-Probe Paradigm, Generic Response Training
Keywords
binge eating, obesity, overeating
Medical subject headings
Bulimia, Obesity, Hyperphagia

What participants receive

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

  • Go/No-TrainingBehavioural

  • Stop-Signal TrainingBehavioural

  • Dot-Probe ParadigmBehavioural

  • Generic Response TrainingBehavioural

Study groups in NCT02817412
Study groupRoleWhat they receive
Go/No-Go TrainingExperimentalIn 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.
Receives: Behavioral: Go/No-Training
Stop-Signal TrainingExperimentalIn 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.
Receives: Behavioral: Stop-Signal Training
Dot-Probe TrainingExperimentalIn 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.
Receives: Behavioral: Dot-Probe Paradigm
Generic TrainingPlacebo comparatorIn 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.
Receives: Behavioral: Generic Response Training

What is being measured

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

  1. Binge Eating Frequency

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

    Measured: Post-intervention (at 4 months)

  2. Binge Eating Frequency

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

    Measured: 3-month follow-up (at 7 months)

Secondary outcomes (2)
  1. Body Mass Index

    Weight in kilograms divided by height in meters squared.

    Measured: Post-intervention (at 4 months)

  2. Body Mass Index

    Weight in kilograms divided by height in meters squared.

    Measured: 3-month follow-up (at 7 months)

Timeline

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

  1. First posted29 Jun 2016 (estimated)
  2. Study startJun 2016
  3. Primary completion24 Apr 2018
  4. Study completion24 Apr 2018

Why it stopped: Principle investigator (Sylvia Herbozo) left the university.

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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02817412
Sponsor's protocol ID
5160020
Status last verified
Nov 2019
First submitted
23 Jun 2016
Last updated
25 Nov 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Go/No-Training, Stop-Signal Training and Dot-Probe Paradigm in people with Binge Eating, run by Loma Linda University at 1 site 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study was stopped early (reason given: Principle investigator (Sylvia Herbozo) left the university.). Results are not available in the source record.

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?

Binge Eating Frequency (time frame: Post-intervention (at 4 months)). The study lists 2 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 25 Nov 2019; AzTrials last refreshed its copy on 30 Oct 2026.

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