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Biological Risk Factors for Onset of Binge Eating and Compensatory Behaviors

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ClinicalTrials.gov Identifier: NCT03687346
Recruitment Status : Recruiting
First Posted : September 27, 2018
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Oregon Research Institute

Brief 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 of problematic eating (bingeing and purging) in female adolescents. Participants will be adolescent girls aged 14-16, some of whom will have parental history of eating pathology. They 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, they will complete one fMRI scan after the first assessment.

Condition or disease
Eating Disorder

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biological Risk Factors for Onset of Binge Eating and Compensatory Behaviors
Actual Study Start Date : August 3, 2017
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Group/Cohort
High Risk Group
Parental history of eating pathology
Low Risk Group
No parental history of eating pathology



Primary Outcome Measures :
  1. 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)

  2. 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)



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Ages Eligible for Study:   14 Years to 16 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community sample
Criteria
  • Inclusion Criteria:

    • Female
    • Aged 14-16 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03687346


Contacts
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Contact: Eric Stice, Ph.D. 541-484-2123 ext 2199 estice@ori.org
Contact: Paul Rohde, Ph.D. 541-484-2123 ext 2120 paulr@ori.org

Locations
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United States, Oregon
Oregon Research Institute Recruiting
Eugene, Oregon, United States, 97403
Contact: Eric Stice, Ph.D.    541-484-2123 ext 2199    estice@ori.org   
Contact: Paul Rohde, Ph.D.    541-484-2123 ext 2120    paulr@ori.org   
Sponsors and Collaborators
Oregon Research Institute

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Responsible Party: Oregon Research Institute
ClinicalTrials.gov Identifier: NCT03687346     History of Changes
Other Study ID Numbers: BioRF Pilot
First Posted: September 27, 2018    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Oregon Research Institute:
fMRI
Eating disorder
adolescent
Additional relevant MeSH terms:
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Bulimia
Feeding and Eating Disorders
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms