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RecruitingNCT06594913EDGI2Updated Jul 8, 2026

Eating Disorders Genetics Initiative 2

An observational study in Anorexia Nervosa, Bulimia Nervosa and Binge-Eating Disorder, sponsored by University of North Carolina, Chapel Hill. Recruiting at 5 sites in 5 countries. Open to participants aged 12 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-08.

Sponsored by University of North Carolina, Chapel Hill · Observational

From the registry’s dates

  • Started Oct 2024; still recruiting 1 year 11 months later.
Study type
Observational
Model
Case-control
Time perspective
Other
Enrollment
20,000
Ages
12 Years to 99 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Anorexia Nervosa
  • Bulimia Nervosa
  • Binge-Eating Disorder
  • Avoidant Restrictive Food Intake Disorder

Keywords

  • severe and enduring eating disorder
  • genetics
  • mental health
  • disordered eating
  • environmental factors
03

In context

Anorexia Nervosa

455 studies on the registry are indexed under Anorexia Nervosa; 126 are open to participants now.

This study's planned enrollment of 20,000 is above the median of 72 across 135 observational studies indexed under Anorexia Nervosa.

Browse Anorexia Nervosa studies →

Lead sponsor

University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.

Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • History of subthreshold disordered eating behaviors.
05

Study design

Observational model
Case-control
Time perspective
Other
Enrollment
20,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Anorexia nervosa

    Individuals with a self-reported lifetime history of anorexia nervosa.

    Other: Eating disorder diagnosis group

  • Bulimia nervosa

    Individuals with a self-reported lifetime history of bulimia nervosa.

    Other: Eating disorder diagnosis group

  • Binge-eating disorder

    Individuals with a self-reported lifetime history of binge-eating disorder.

    Other: Eating disorder diagnosis group

  • ARFID

    Individuals with a self-reported lifetime history of avoidant restrictive food intake disorder.

    Other: Eating disorder diagnosis group

  • Control

    Individuals with no history of disordered eating behaviors or symptoms

    Other: Eating disorder diagnosis group

Interventions

  • OtherEating 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: Baseline

Secondary outcomes

  1. Current Disordered Eating Symptoms

    Current eating disorder symptoms will be determined by self-report responses on the Eating Disorder Examination Questionnaire (EDEQ), the Binge Eating Disorder Screener-(BEDS7), the Nine Item ARFID Screen (NIAS), Muscle Dysmorphic Disorder Inventory (MDDI), the Drive for Muscularity Scale (DMS), and food insecurity. Items in all assessments ask about current symptoms related to eating disorders. The assessments sum scores to create subscales where higher scores indicate more eating disorder pathology and the scores taken together reveal the current disordered eating status of participants. Subscale sores will be reported for the total sample.

    Time frame: Baseline

  2. Mental Health and Behavior

    Current mental health symptoms (depression, anxiety, obsessive-compulsive disorder, autism, and attention-deficit/hyperactivity disorder \[ADHD\]) are assessed using the Patient Health Questionnaire (PHQ), Generalized Anxiety Disorder 7 (GAD7), Obsessional Compulsive Inventory - Revised (OCI-R), Autism Spectrum Quotient (AQ10), and Adult ADHD Self-Report Scale (ASRS).The assessments sum scores to create subscales where higher scores indicate more mental health symptoms and the scores taken together provide insight to current comorbidity of participants. Subscale sores will be reported for the entire sample

    Time frame: Baseline

  3. Mood - Lifetime history of mood and anxiety disorders

    The GLAD questionnaire asks about lifetime history of mood and anxiety symptoms. Algorithms based on Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) criteria will be applied to data to report lifetime history of mood and anxiety disorders.

    Time frame: Baseline

  4. Self-Violence

    A series of questions will be asked about suicidality and self-harm. The number and percent of participants indicating suicidality and self-harm will be reported.

    Time frame: Baseline

  5. Lifetime Substance Use

    Adapted to lifetime use, Alcohol Use Disorders Identification Test (AUDIT; 10 times) and the Drug Use Disorders Identification Test (DUDIT) are administered along with the heaviness of smoking and and questions about vaping. The AUDIT, DUDIT, and heaviness of smoking are scored using published algorithms. The prevalence of lifetime substance use will be reported for each eating disorder group.

    Time frame: Baseline

  6. Life-Events

    A modified version of Life Events Checklist for DSM-5 (LEC-5) is administered to collect information about 20 adverse events experienced, the age those events were first experienced, and the degree of trauma that resulted from the life events. The number and percent of each life event experienced will be reported for each eating disorder group.

    Time frame: Baseline

  7. Eating Disorder Quality of Life

    Eating disorder quality of life is measured with the Eating Disorder Quality of Life (EDQL) self-report questionnaire. The EDQL asks 25 items about the psychological, physical, financial, and work/school impact of an eating disorder over the past 30 days. Items are scored never (0), rarely (1), sometimes (2), often (3), or always (4). Items are summed for a total score ranging from 0-100, representing the overall impact of an eating disorder on life quality. Higher scores indicate a more significant impact of the eating disorder on life quality. Scores will be reported for each eating disorder group.

    Time frame: Baseline

  8. Compulsive Exercise Test

    Maladaptive exercise is evaluated using the Compulsive Exercise Test. A total of 24 questions ask about excessive or problematic exercise. Response options are on a 6-point Likert scale. There are 5 subscales, which are scored according to published criteria. Higher scores indicate greater pathology. Scores will be reported for each eating disorder group.

    Time frame: Baseline

  9. Perfectionism

    A shortened version (12 items) of the Multidimensional Perfectionism Scale (MPS) is used to assess 3 features of perfectionism: doubts about actions, concern over mistakes, and personal standards. Response options are on a 5-point Likert scale. Greater scores indicate higher perfectionism. Scores will be reported for each eating disorder group.

    Time frame: Baseline

07

Study locations

5 of 5 sites recruiting
08

References and documents

Publications

  • 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. PubMed 40419993 ↗

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Icf

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06594913
Lead sponsor
University of North Carolina, Chapel Hill
Collaborators
Queensland Institute of Medical Research, Karolinska Institutet, National Institute of Mental Health (NIMH), University of Otago, University of Aarhus, Yale University, Comenzar de Nuevo, AC, University of Sydney
Responsible party
Sponsor
First posted
Sep 19, 2024
Start date
Oct 28, 2024
Primary completion
Sep 1, 2027 (estimated)
Completion
Sep 1, 2027 (estimated)
Last update
Jul 8, 2026

Study contacts

Laura M Thornton, PhD
Contact
laura_thornton@med.unc.edu
804-690-3079
Casey MacDermod, BA
Contact
edgi2@unc.edu
984-974-3798
Cynthia Bulik, PhD
principal investigator · University of North Carolina, Chapel Hill

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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