Eating Disorders Genetics Initiative 2
EDGI2
4 other identifiers
observational
20,000
5 countries
5
Brief Summary
The overarching intention of the Eating Disorder Genetics Initiative 2 (EDGI2) is to increase sample size, diversity, and eating disorder phenotypes. The investigators are enrolling 20,000 new participants with anorexia nervosa (AN), bulimia nervosa (BN), binge-eating disorder (BED), avoidant/restrictive food intake disorder (ARFID), and controls in the US, Mexico, Australia, New Zealand, Sweden, and Denmark. A primary study goal is to enroll at least 30% of participants from underrepresented groups. Participants are asked to complete a series of questionnaires and submit a saliva sample for genotyping. The goal is to better understand eating disorders and how they relate to each other so that better treatments can be developed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2024
Typical duration for all trials
5 active sites
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
September 10, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedStudy Start
First participant enrolled
October 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
May 31, 2025
May 1, 2025
2.8 years
September 10, 2024
May 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants Identified with an Eating Disorder Diagnosis by Category
The ED100Kv4 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, ARFID, 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 ED100Kv4 questionnaire (ED100K). Age of onset will be reported for each eating disorder group.
Baseline
Secondary Outcomes (9)
Current Disordered Eating Symptoms
Baseline
Mental Health and Behavior
Baseline
Mood - Lifetime history of mood and anxiety disorders
Baseline
Self-Violence
Baseline
Lifetime Substance Use
Baseline
- +4 more secondary outcomes
Study Arms (5)
Anorexia nervosa
Individuals with a self-reported lifetime history of anorexia nervosa.
Bulimia nervosa
Individuals with a self-reported lifetime history of bulimia nervosa.
Binge-eating disorder
Individuals with a self-reported lifetime history of binge-eating disorder.
ARFID
Individuals with a self-reported lifetime history of avoidant restrictive food intake disorder.
Control
Individuals with no history of disordered eating behaviors or symptoms
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.
Eligibility Criteria
Interested individuals from the United States, Mexico, Australia, New Zealand, and Sweden who meet criteria may participate within their respective country.
You may qualify if:
- A lifetime history of anorexia nervosa, bulimia nervosa, binge-eating disorder, avoidant restrictive food intake disorders or no history of any disordered eating behavior, based on DSM-5 criteria algorithms
- Age 12-99 years, depending on country. (US enrollment age is 18-99)
You may not qualify if:
- History of subthreshold disordered eating behaviors.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of North Carolina, Chapel Hilllead
- Queensland Institute of Medical Researchcollaborator
- Karolinska Institutetcollaborator
- National Institute of Mental Health (NIMH)collaborator
- University of Otagocollaborator
- University of Aarhuscollaborator
- Yale Universitycollaborator
- Comenzar de Nuevo, ACcollaborator
- University of Sydneycollaborator
Study Sites (5)
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7160, United States
QIMR Berghofer
Brisbane, Queensland, Australia
Comenzar de Nuevo
Monterrey, Mexico
University of Otago
Christchurch, Canterbury, New Zealand
Karolinska Institutet
Stockholm, Sweden
Related Publications (1)
Berthold N, MacDermod CM, Thornton LM, Parker R, Morales SAC, Hog L, Kennedy HL, Guintivano J, Sullivan PF, Crowley JJ, Johnson JS, Birgegard A, Fundin BT, Frans E, Xu J, Ngati Pukenga MP, Miller AL, Aguilar MV, Barakat S, Abdulkadir M, White JP, Larsen JT, Trujillo E, Winterman B, Zhang R, Lawson R, Wonderlich S, Wonderlich J, Schaefer LM, Mehler PS, Oakes J, Foster M, Gaudiani J, Vacuan ETC, Compte EJ, Petersen LV, Yilmaz Z, Micali N, Jordan J, Kennedy MA, Maguire S, Huckins LM, Lu Y, Dinkler L, Martin NG, Bulik CM. The Eating Disorders Genetics Initiative 2 (EDGI2): study protocol. BMC Psychiatry. 2025 May 26;25(1):532. doi: 10.1186/s12888-025-06777-5.
PMID: 40419993DERIVED
Biospecimen
Saliva samples will be collected for DNA extraction. Both saliva samples and DNA will be retained in biorepositories.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cynthia Bulik, PhD
University of North Carolina, Chapel Hill
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2024
First Posted
September 19, 2024
Study Start
October 28, 2024
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
May 31, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- 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.
Anonymized data and scripts will be made available to the general scientific community at the conclusion of the investigation. Specifically, phenotype data from the United States, Mexico, Australia, and New Zealand 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. Data from Sweden will be made available on the Federated European Genome-phenome Archive.