Binge EatingNCT03429114
Emotion Regulation in Binge Eating and Purging Among Adolescents
An observational study of Binge Eating and Purging (Eating Disorders), run by Stanford University at 1 site in United States.
Trial summary
The study will examine the neural and behavioral correlates of emotion regulation in adolescents engaging in binge eating and/or purging and healthy adolescents. Furthermore, it will look at the influence of executive function on emotion regulation in this population. Read more about this study
- Who is it for?
- Ages 14 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Binge Eating, Purging (Eating Disorders)
- What is being tested?
- Magnetic resonance imaging
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2017to 1 Sep 2022
- 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 14 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Female adolescents between ages 14-18.
Who may be able to join
- Female
- Ages 14-18
- with or without current binge eating and/or purging behaviors
Who cannot join
- We exclude patients of clinically significant low weight (<85% ideal body weight using CDC norms for height, age, and gender) and those with contraindications for MRI (e.g., orthodontia, metallic implants). Participants also will be without evidence of current or past major neurological (e.g., seizures, psychosis, head trauma) or major sensory deficit.
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: Neural Correlates of Emotion Regulation and Executive Function in Binge Eating and Purging Among Adolescents
The study will examine the neural and behavioral correlates of emotion regulation in adolescents engaging in binge eating and/or purging and healthy adolescents. Furthermore, it will look at the influence of executive function on emotion regulation in this population. This study will allow us to gain further understanding of the neural basis of emotion regulation in this age group. Moreover, this study supports the need to develop new treatment approaches based on a better understanding of the brain processes associated with eating disorders.
- Conditions
- Binge Eating, Purging (Eating Disorders)
- Being tested
- Magnetic resonance imaging
- Medical subject headings
- Bulimia, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imagingOther
We will conduct MRI and fMRI brain scans to compare brain function between groups.
| Study group | Role | What they receive |
|---|---|---|
| Binge eating/purging | Adolescents engaging in recurrent binge eating and/or purging behavior. Receives: Other: Magnetic resonance imaging | |
| Healthy comparison | Adolescents who do not have a history of eating disorders Receives: Other: Magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 emotion regulation
Functional magnetic resonance imaging will be used to measure brain activity during a task where participants attempt to regulate emotional responses.
Measured: Baseline
Brain activity during cognitive control and emotion response
Functional magnetic resonance imaging will be used to measure brain activity during a task where participants engage in cognitive control and respond to emotional stimuli.
Measured: Baseline
Secondary outcomes (3)
Behavioral performance on emotion conflict task
Response times will be used as behavioral measure on the emotion conflict task
Measured: Baseline
Behavioral performance on emotion regulation task
Emotion ratings will be used as behavioral measure on the emotion regulation task
Measured: Baseline
Behavioral performance on cognitive control and emotion regulation task
Emotion ratings will be used as behavioral measure on the cognitive control and emotion regulation task
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start15 Oct 2017
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cara Bohon, PhD, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429114
- Sponsor's protocol ID
- 40075
- Status last verified
- Dec 2022
- First submitted
- 2 Feb 2018
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Correlates of Emotion Regulation and Executive Function in Binge Eating and Purging Among Adolescents
- ClinicalTrials.gov ID
- NCT03429114
- Acronym / sponsor ID
- 40075
- Conditions
- Binge Eating, Purging (Eating Disorders)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 15 Oct 2017 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 12 Feb 2018 (actual)
- 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 study will examine the neural and behavioral correlates of emotion regulation in adolescents engaging in binge eating and/or purging and healthy adolescents. Furthermore, it will look at the influence of executive function on emotion regulation in this population. This study will allow us to gain further understanding of the neural basis of emotion regulation in this age group. Moreover, this study supports the need to develop new treatment approaches based on a better understanding of the brain processes associated with eating disorders.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Binge eating/purging | – | Other: Magnetic resonance imagingAdolescents engaging in recurrent binge eating and/or purging behavior. |
| Healthy comparison | – | Other: Magnetic resonance imagingAdolescents who do not have a history of eating disorders |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Female adolescents between ages 14-18.
Key inclusion criteria (3 listed)
- Female
- Ages 14-18
- with or without current binge eating and/or purging behaviors
Key exclusion criteria (1 listed)
- We exclude patients of clinically significant low weight (<85% ideal body weight using CDC norms for height, age, and gender) and those with contraindications for MRI (e.g., orthodontia, metallic implants). Participants also will be without evidence of current or past major neurological (e.g., seizures, psychosis, head trauma) or major sensory deficit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic resonance imagingWe will conduct MRI and fMRI brain scans to compare brain function between groups. | Other | Binge eating/purging, Healthy comparison |
Primary outcome
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 emotion regulation
Time frame: Baseline
Functional magnetic resonance imaging will be used to measure brain activity during a task where participants attempt to regulate emotional responses.
Brain activity during cognitive control and emotion response
Time frame: Baseline
Functional magnetic resonance imaging will be used to measure brain activity during a task where participants engage in cognitive control and respond to emotional stimuli.
3 secondary outcomes
Behavioral performance on emotion conflict task
Time frame: Baseline
Behavioral performance on emotion regulation task
Time frame: Baseline
Behavioral performance on cognitive control and emotion regulation task
Time frame: Baseline
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 6 Dec 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Purging (Eating Disorders), 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 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: finished, as of the sponsor's last update on 6 Dec 2022. 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 emotion conflict (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 6 Dec 2022.