Eating DisorderNCT03687346
Biological Risk Factors for Onset of Binge Eating and Compensatory Behaviors
An observational study of Eating Disorder, run by Oregon Research Institute at 1 site in United States.
Trial summary
The purpose of this proposed project is to test whether several biological factors (such as elevated brain reward region and attention region response to high-calorie foods, weaker inhibitory region response to high-calorie foods, habitual caloric deprivation, and elevated limbic region responsivity) increase the risk… Read more about this study
- Who is it for?
- Ages 13 to 16 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Eating Disorder
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2017to 1 Oct 2021
- 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 13 to 16 years
- Women only
- Healthy volunteers accepted
- Child
Study population: Community sample
Who may be able to join
- Female
- Aged 13-16 years
Who cannot join
- Adolescents who report functional magnetic resonance imaging (fMRI) contraindications
- Current Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) substance abuse disorder, eating disorder (ED), conduct disorder, attention deficit hyperactivity disorder (ADHD), or bipolar disorder
- Weekly or greater use of psychoactive drugs (e.g., analgesics, cocaine, marijuana)
- Serious medical complications (e.g., cancer, diabetes)
- History of head injury
- Relevant food allergies
- BMI > 35
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this proposed project is to test whether several biological factors (such as elevated brain reward region and attention region response to high-calorie foods, weaker inhibitory region response to high-calorie foods, habitual caloric deprivation, and elevated limbic region responsivity) increase the risk of problematic eating (bingeing and purging) in female adolescents.
Read the detailed description
Participants will be adolescent girls aged 13-16, some of whom will have parental history of eating pathology. Participants will be recruited from the general population but their age, gender, and the presence of parental lifetime eating pathology will create a high-risk sample. The goals of the proposed project are to (1) conduct a prospective high-risk study to test whether proposed biological risk factors predict the future onset of core ED symptoms (e.g., binge eating, compensatory behaviors); (2) test hypotheses regarding how these biological risk factors and established self-report ED risk factors may work together to predict ED behavior onset; (3) examine if certain biological factors account for the effects of certain established self-reported ED risk factors (e.g., elevated brain response to thin models accounts for the effect of questionnaire-measured thin-ideal internalization). The participants will complete a baseline assessment and then follow-ups assessments over a span of three years. In addition, participants will complete one fMRI scan after the first assessment.
During the COVID-19 shelter-at-home order, the investigators will not measure in person only outcomes including fMRI scans, height and weight measurement for BMI calculation nor IAT computer paradigms for all participants that have assessments due during this order.
- Conditions
- Eating Disorder
- Keywords
- fMRI, Eating disorder, adolescent
- Medical subject headings
- Feeding and Eating Disorders
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 |
|---|---|---|
| High Risk Group | Parental history of eating pathology | |
| Low Risk Group | No parental history of eating pathology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in binge eating behaviors using the EDDI
Eating Disorder Diagnostic Interview (EDDI)
Measured: 6 months, 1 year, 2 year, and 3 year follow-up
Change in compensatory behaviors using the EDDI
Eating Disorder Diagnostic Interview (EDDI)
Measured: 6 months, 1 year, 2 year, and 3 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start3 Aug 2017
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eating DisorderStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Stice, Ph.D., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03687346
- Sponsor's protocol ID
- BioRF Pilot
- Status last verified
- Nov 2021
- First submitted
- 21 Sep 2018
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Stice E, Yokum S, Rohde P, Cloud K, Desjardins CD. Comparing healthy adolescent females with and without parental history of eating pathology on neural responsivity to food and thin models and other potential risk factors. J Abnorm Psychol. 2021 Aug;130(6):608-619. doi: 10.1037/abn0000686.
PubMed 34553956
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Risk Factors for Onset of Binge Eating and Compensatory Behaviors
- ClinicalTrials.gov ID
- NCT03687346
- Acronym / sponsor ID
- BioRF Pilot
- Conditions
- Eating Disorder
- Keywords
- fMRI, Eating disorder, adolescent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Study start
- 3 Aug 2017 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 27 Sep 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 purpose of this proposed project is to test whether several biological factors (such as elevated brain reward region and attention region response to high-calorie foods, weaker inhibitory region response to high-calorie foods, habitual caloric deprivation, and elevated limbic region responsivity) increase the risk of problematic eating (bingeing and purging) in female adolescents.
Detailed description
Participants will be adolescent girls aged 13-16, some of whom will have parental history of eating pathology. Participants will be recruited from the general population but their age, gender, and the presence of parental lifetime eating pathology will create a high-risk sample. The goals of the proposed project are to (1) conduct a prospective high-risk study to test whether proposed biological risk factors predict the future onset of core ED symptoms (e.g., binge eating, compensatory behaviors); (2) test hypotheses regarding how these biological risk factors and established self-report ED risk factors may work together to predict ED behavior onset; (3) examine if certain biological factors account for the effects of certain established self-reported ED risk factors (e.g., elevated brain response to thin models accounts for the effect of questionnaire-measured thin-ideal internalization). The participants will complete a baseline assessment and then follow-ups assessments over a span of three years. In addition, participants will complete one fMRI scan after the first assessment.
During the COVID-19 shelter-at-home order, the investigators will not measure in person only outcomes including fMRI scans, height and weight measurement for BMI calculation nor IAT computer paradigms for all participants that have assessments due during this order.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Risk Group | – | –Parental history of eating pathology |
| Low Risk Group | – | –No parental history of eating pathology |
Who may qualify
- Ages
- 13 to 16 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Community sample
Key inclusion criteria (2 listed)
Key exclusion criteria (7 listed)
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
Change in binge eating behaviors using the EDDI
Time frame: 6 months, 1 year, 2 year, and 3 year follow-up
Eating Disorder Diagnostic Interview (EDDI)
Change in compensatory behaviors using the EDDI
Time frame: 6 months, 1 year, 2 year, and 3 year follow-up
Eating Disorder Diagnostic Interview (EDDI)
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 3 Nov 2021.
- Derived from this study: PubMed 34553956Stice E, Yokum S, Rohde P, Cloud K, Desjardins CD. Comparing healthy adolescent females with and without parental history of eating pathology on neural responsivity to food and thin models and other potential risk factors. J Abnorm Psychol. 2021 Aug;130(6):608-619. doi: 10.1037/abn0000686.
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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.
Eric Stice, Ph.D. 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 Eating Disorder, run by Oregon Research Institute 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 2 inclusion and 7 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 3 Nov 2021. 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?
Change in binge eating behaviors using the EDDI (time frame: 6 months, 1 year, 2 year, and 3 year follow-up). 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?
On the ClinicalTrials.gov record for NCT03687346, which also lists 1 linked publication.
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 3 Nov 2021.