Binge EatingNCT02743000
Food and the Brain
An observational study of Binge Eating, run by Stanford University at 1 site in United States.
Trial summary
The proposed study will examine the role of reward and emotion in women with and without a history of binge eating. It is important to understand how the brain responds to reward and emotion in binge eating in order to identify different pathways toward binge eating and provide individualized targets for treatment. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Binge Eating
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Apr 2020
- Phase
- Observational
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women ages 18-35
Who may be able to join
- Female
- Ages 18-35
- with or without current binge eating behaviors
Who cannot join
- Any contraindication for MRI (orthodontia, vascular stents, metallic ear tubes, metal implants, piercings, etc).
- substance abuse
- traumatic brain injury
- BMI < 18.5
- pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University, Department of Psychiatry
Stanford, California, 94305
About this study
Official title: Emotion and Reward Processing in Binge Eating
The proposed study will examine the role of reward and emotion in women with and without a history of binge eating. It is important to understand how the brain responds to reward and emotion in binge eating in order to identify different pathways toward binge eating and provide individualized targets for treatment. This is particularly important in light of the fact that for many patients, the current treatments for binge eating are not effective.
- Conditions
- Binge Eating
- Keywords
- fMRI, emotion conflict task, monetary incentive delay
- Medical subject headings
- Bulimia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women ages 18-35 | Women ages 18-35 who do and do not engage in binge eating will be included in the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain activity during rest
Functional magnetic resonance imaging will be used to measure brain activity at rest and connectivity between brain regions will be examined.
Measured: Baseline
Brain activity during emotion conflict
Functional magnetic resonance imaging will be used to measure brain activity during a task where participants respond to images of faces with emotional expressions overlaid with an emotion word written in text. We will focus on brain response during this task when emotion face vs word are in conflict.
Measured: Baseline
Brain activity during monetary wins and losses
Functional magnetic resonance imaging will be used to measure brain activity during a game where participants can win or lose money if they respond to a shape on the computer screen. Brain response during wins and losses will be examined.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startJan 2016
- Primary completionApr 2020
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge EatingStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cara Bohon, PhD, Stanford University
- Investigators
- Cara Bohon, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02743000
- Sponsor's protocol ID
- 35204
- Status last verified
- Oct 2020
- First submitted
- 12 Apr 2016
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotion and Reward Processing in Binge Eating
- ClinicalTrials.gov ID
- NCT02743000
- Acronym / sponsor ID
- 35204
- Conditions
- Binge Eating
- Keywords
- fMRI, emotion conflict task, monetary incentive delay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Apr 2020 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study will examine the role of reward and emotion in women with and without a history of binge eating. It is important to understand how the brain responds to reward and emotion in binge eating in order to identify different pathways toward binge eating and provide individualized targets for treatment. This is particularly important in light of the fact that for many patients, the current treatments for binge eating are not effective.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women ages 18-35 | – | –Women ages 18-35 who do and do not engage in binge eating will be included in the study |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women ages 18-35
Key inclusion criteria (3 listed)
- Female
- Ages 18-35
- with or without current binge eating behaviors
Key exclusion criteria (5 listed)
- Any contraindication for MRI (orthodontia, vascular stents, metallic ear tubes, metal implants, piercings, etc).
- substance abuse
- traumatic brain injury
- BMI < 18.5
- pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Brain activity during rest
Time frame: Baseline
Functional magnetic resonance imaging will be used to measure brain activity at rest and connectivity between brain regions will be examined.
Brain activity during emotion conflict
Time frame: Baseline
Functional magnetic resonance imaging will be used to measure brain activity during a task where participants respond to images of faces with emotional expressions overlaid with an emotion word written in text. We will focus on brain response during this task when emotion face vs word are in conflict.
Brain activity during monetary wins and losses
Time frame: Baseline
Functional magnetic resonance imaging will be used to measure brain activity during a game where participants can win or lose money if they respond to a shape on the computer screen. Brain response during wins and losses will be examined.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
Related trials for Binge Eating
Recruiting
Multisensory Processing of Alcohol Cues in Young Adult Binge Drinkers
Drinking, Binge
Active, not recruitingEarly Phase 1
Naltrexone Neuroimaging in Teens With Eating Disorders
Eating Disorders, Binge Eating
RecruitingPhase 4
A Neuropsychobiological Approach to Optimize Patient Selection for GLP-1-based Pharmacotherapy for Weight Management Across the Binge Eating Spectrum
Obesity & Overweight
RecruitingObservational study
Children s Growth and Behavior Study
Obesity, Eating Behaviors
Not yet recruiting
Cognitive and Behavioral Approaches to Reduce Binge Eating and Excess Weight in Adolescents (Online)
Binge Eating, Overweight and Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cara Bohon, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Binge Eating, run by Stanford 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 20 Oct 2020. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Brain activity during rest (time frame: Baseline). The study lists 3 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 20 Oct 2020.