Biological Risk Factors for Onset of Binge Eating and Compensatory Behaviors

• ClinicalTrials.gov Identifier: NCT03687346
• Recruitment Status: Completed
• First Posted: September 27, 2018
• Last Update Posted: November 3, 2021
• Sponsor: Oregon Research Institute
• Information provided by (Responsible Party): Oregon Research Institute

Study Description

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.

Condition or disease
Eating Disorder

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

• Study Type: Observational
• Actual Enrollment: 88 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
• Actual Primary Completion Date: October 1, 2021
• Actual Study Completion Date: October 1, 2021

Groups and Cohorts

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

Outcome Measures

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)

Eligibility Criteria

• Ages Eligible for Study: 13 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 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

Contacts and Locations

Locations

United States, Oregon

Oregon Research Institute

Eugene, Oregon, United States, 97403

Sponsors and Collaborators

Oregon Research Institute

Investigators

• Principal Investigator: Eric Stice, Ph.D.; Stanford University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Oregon Research Institute
• ClinicalTrials.gov Identifier: NCT03687346
• Other Study ID Numbers: BioRF Pilot
• First Posted: September 27, 2018
• Last Update Posted: November 3, 2021
• Last Verified: November 2021

• 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:

Bulimia; Feeding and Eating Disorders; Mental Disorders; Hyperphagia; Signs and Symptoms, Digestive