Eating Disorders Genetics Initiative

NCT ID: NCT04378101

Last Updated: 2023-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

17991 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-12

Study Completion Date

2023-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anorexia Nervosa Bulimia Nervosa Binge-Eating Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Eating disorder diagnosis group

Intervention Type OTHER

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.

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.

Eating disorder diagnosis group

Intervention Type OTHER

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.

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.

Eating disorder diagnosis group

Intervention Type OTHER

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.

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.

Eating disorder diagnosis group

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Eating disorder diagnosis group

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

15 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Otago

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role collaborator

QIMR Berghofer Medical Research Institute

OTHER

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Cynthia M Bulik, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

QIMR Berghofer

Brisbane, Queensland, Australia

Site Status

University of Otago

Christchurch, Canterbury, New Zealand

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Australia New Zealand

References

Explore related publications, articles, or registry entries linked to this study.

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. 2025 Oct 20. doi: 10.1002/eat.24563. Online ahead of print.

Reference Type DERIVED
PMID: 41115789 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33947359 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01MH120170

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-1378

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Early Genetic Identification of Obesity
NCT06239064 ACTIVE_NOT_RECRUITING
Initiative for Clinical Long-read Sequencing
NCT06060184 NOT_YET_RECRUITING NA
Rare and Undiagnosed Disease Research Biorepository
NCT04703179 ENROLLING_BY_INVITATION
Personalized Genomic Research
NCT01294345 COMPLETED
The Informed Genetics Annotated Patient Registry
NCT04419896 ENROLLING_BY_INVITATION