- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03687346
Biological Risk Factors for Onset of Binge Eating and Compensatory Behaviors
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Oregon
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Eugene, Oregon, United States, 97403
- Oregon Research Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Female
- Aged 13-16 years
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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High Risk Group
Parental history of eating pathology
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Low Risk Group
No parental history of eating pathology
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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6 months, 1 year, 2 year, and 3 year follow-up
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Change in compensatory behaviors using the EDDI
Time Frame: 6 months, 1 year, 2 year, and 3 year follow-up
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Eating Disorder Diagnostic Interview (EDDI)
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6 months, 1 year, 2 year, and 3 year follow-up
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eric Stice, Ph.D., Stanford University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BioRF Pilot
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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