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Clinical Trials/NCT04378101
NCT04378101CompletedNot Applicable

Eating Disorders Genetics Initiative (EDGI)

University of North Carolina, Chapel Hill3 sites in 3 countries17,991 target enrollmentStarted: June 12, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
17,991
Locations
3
Primary Endpoint
Number of Participants Identified with an Eating Disorder Diagnosis by Category

Study Overview

Brief Summary

The overarching intention of the Eating Disorder Genetics Initiative (EDGI) is to lay the foundation for all future genomic discovery in eating disorders--anorexia nervosa (AN), bulimia nervosa (BN), and binge-eating disorder (BED)--by exploring both genetic and behavioral factors. To do this, information will be collected from 4000 people who have provided DNA samples for the Anorexia Nervosa Genetics Initiative (ANGI) and the same information and DNA will be collected from an additional 16,000 people. The goal is to better understand eating disorders and how they relate to each other so that better treatments can be developed.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Retrospective

Eligibility Criteria

Ages
15 Years to 99 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • A lifetime history of anorexia nervosa, bulimia nervosa, binge-eating disorder, or no history of any disordered eating behavior
  • Age 15-99 years

Exclusion Criteria

  • History of subthreshold disordered eating behaviors

Outcomes

Primary Outcomes

Number of Participants Identified with an Eating Disorder Diagnosis by Category

Time Frame: Baseline

The ED100K is a web-based diagnostic questionnaire, based on the Structured Clinical Interview for Axis 1 Disorders, that applies algorithms to participant responses. The number of participants with each diagnosis (AN, BN, BED, and control) will be reported.

Age of eating disorder onset

Time Frame: Baseline

Age of eating disorder onset will be considered as the age of first eating disorder symptom as self-reported in the ED100K questionnaire (ED100K). Age of onset will be reported for each eating disorder group.

Secondary Outcomes

  • Current eating disorder self-report total sum scores(Baseline)
  • Eating disorder-related quality of life scores(Baseline)
  • Health-related quality of life scores(Baseline)
  • Prevalence of life-time history of major depression(Baseline)
  • Prevalence of generalized anxiety disorder(Baseline)
  • Current depressive symptoms sum score(Baseline)
  • Current anxiety symptoms sum scores(Baseline)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (3)

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