NCT04378101

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
17,991

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

Geographic Reach
3 countries

3 active sites

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

First Submitted

Initial submission to the registry

May 4, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 7, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

June 12, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

June 6, 2023

Status Verified

April 1, 2023

Enrollment Period

3 years

First QC Date

May 4, 2020

Last Update Submit

June 2, 2023

Conditions

Keywords

Anorexia NervosaBulimia NervosaBinge-Eating Disorder

Outcome Measures

Primary Outcomes (2)

  • Number of Participants Identified with an Eating Disorder Diagnosis by Category

    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.

    Baseline

  • Age of eating disorder onset

    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.

    Baseline

Secondary Outcomes (7)

  • Current eating disorder self-report total sum scores

    Baseline

  • Eating disorder-related quality of life scores

    Baseline

  • Health-related quality of life scores

    Baseline

  • Current depressive symptoms sum score

    Baseline

  • Prevalence of life-time history of major depression

    Baseline

  • +2 more secondary outcomes

Study Arms (4)

Anorexia Nervosa Case

Participants in this group have a life-time history of anorexia nervosa as determined by an algorithm applied to their responses to an eating disorders screening questionnaire (ED100K) that is based on the Structured Clinical Interview for Axis 1 Disorders.

Other: Eating disorder diagnosis group

Bulimia Nervosa Case

Participants in this group have a life-time history of bulimia nervosa as determined by an algorithm applied to their responses to an eating disorders screening questionnaire (ED100K) that is based on the Structured Clinical Interview for Axis 1 Disorders. These participants do not have a history of anorexia nervosa.

Other: Eating disorder diagnosis group

Binge-Eating Disorder Case

Participants in this group have a life-time history of binge-eating disorder as determined by an algorithm applied to their responses to an eating disorders screening questionnaire (ED100K) that is based on the Structured Clinical Interview for Axis 1 Disorders. These participants do not have a history of anorexia nervosa or bulimia nervosa.

Other: Eating disorder diagnosis group

Control

Participants in this group have no history of disordered eating behaviors as determined by an algorithm applied to their responses to an eating disorders screening questionnaire (ED100K) that is based on the Structured Clinical Interview for Axis 1 Disorders.

Other: Eating disorder diagnosis group

Interventions

This is an observational study, no active intervention is applied. Participants are assigned to an eating disorder diagnosis group based on their lifetime history of disordered eating behaviors and symptoms.

Anorexia Nervosa CaseBinge-Eating Disorder CaseBulimia Nervosa CaseControl

Eligibility Criteria

Age15 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Interested individuals from the United States, Australia, and New Zealand who meet criteria may participate within their respective country.

You may qualify if:

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

You may not qualify if:

  • History of subthreshold disordered eating behaviors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of North Carolina

Chapel Hill, North Carolina, 27599-7160, United States

Location

QIMR Berghofer

Brisbane, Queensland, Australia

Location

University of Otago

Christchurch, Canterbury, New Zealand

Location

Related Publications (2)

  • Watson HJ, Schaumberg K, Thornton LM, Kennedy HL, Ong SH, Roche P, Barnhart WR, Pauley-Gadd SB, Costello K, Flatt RE, Birgegard A, Dinkler L, Abbaspour A, Mantilla EF, Monell E, Frans EM, Barakat S, Pettie MA, Parker R, Maguire S, Jordan J, Kennedy MA, Bulik CM. Maladaptive Exercise in People With a Lifetime History of Eating Disorders: A Multicountry Observational Study. Int J Eat Disord. 2026 Jan;59(1):190-204. doi: 10.1002/eat.24563. Epub 2025 Oct 20.

  • Bulik CM, Thornton LM, Parker R, Kennedy H, Baker JH, MacDermod C, Guintivano J, Cleland L, Miller AL, Harper L, Larsen JT, Yilmaz Z, Grove J, Sullivan PF, Petersen LV, Jordan J, Kennedy MA, Martin NG. The Eating Disorders Genetics Initiative (EDGI): study protocol. BMC Psychiatry. 2021 May 4;21(1):234. doi: 10.1186/s12888-021-03212-3.

Biospecimen

Retention: SAMPLES WITH DNA

Participants from the United States, Australia, and New Zealand will be asked to submit a saliva sample using standard industry collection tubes. DNA will be isolated from these samples. DNA will be isolated from blood spots obtained at birth from participants in Denmark.

MeSH Terms

Conditions

Anorexia NervosaBulimia NervosaBinge-Eating Disorder

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • Cynthia M Bulik, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2020

First Posted

May 7, 2020

Study Start

June 12, 2020

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

June 6, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

Anonymized data and scripts will be made available to the general scientific community at the conclusion of the investigation. Specifically, phenotype data will be submitted to the database of Genotypes and Phenotypes (dbGaP) and National Institute of Mental Health Repository \& Genetics Resource (NRGR) and genotype data to dbGaP.

Shared Documents
STUDY PROTOCOL
Time Frame
Assessment phenotype data will be submitted within 6 months after the end of the study. Genotype data will be submitted after the first set of analyses with these data are complete. All data will be available as long as the repositories maintain the datasets (indefinitely).
Access Criteria
The databases are controlled-access meaning that individuals who wish to have access to the data must apply to the respective repository and meet all of their criteria.
More information

Locations