Biological Risk Factors for Onset of Binge Eating and Compensatory Behaviors

Eating Disorder Clinical Trial

Official title:

Biological Risk Factors for Onset of Binge Eating and Compensatory Behaviors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03687346
• Other study ID #: BioRF Pilot
• Status: Completed
• Start date: August 3, 2017
• Est. completion date: October 1, 2021

Study information

• Verified date: November 2021
• Source: Oregon Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 of problematic eating (bingeing and purging) in female adolescents.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 16 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Bulimia
• Eating Disorder
• Feeding and Eating Disorders

Locations

Country	Name	City	State
United States	Oregon Research Institute	Eugene	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in binge eating behaviors using the EDDI	Eating Disorder Diagnostic Interview (EDDI)	6 months, 1 year, 2 year, and 3 year follow-up
Primary	Change in compensatory behaviors using the EDDI	Eating Disorder Diagnostic Interview (EDDI)	6 months, 1 year, 2 year, and 3 year follow-up