NCT03687346

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 3, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 27, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

November 3, 2021

Status Verified

November 1, 2021

Enrollment Period

4.2 years

First QC Date

September 21, 2018

Last Update Submit

November 2, 2021

Conditions

Keywords

fMRIEating disorderadolescent

Outcome Measures

Primary Outcomes (2)

  • Change in binge eating behaviors using the EDDI

    Eating Disorder Diagnostic Interview (EDDI)

    6 months, 1 year, 2 year, and 3 year follow-up

  • Change in compensatory behaviors using the EDDI

    Eating Disorder Diagnostic Interview (EDDI)

    6 months, 1 year, 2 year, and 3 year follow-up

Study Arms (2)

High Risk Group

Parental history of eating pathology

Low Risk Group

No parental history of eating pathology

Eligibility Criteria

Age13 Years - 16 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Community sample

You may qualify if:

  • Female
  • Aged 13-16 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Research Institute

Eugene, Oregon, 97403, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Eric Stice, Ph.D.

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2018

First Posted

September 27, 2018

Study Start

August 3, 2017

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

November 3, 2021

Record last verified: 2021-11

Locations