Anorexia NervosaEDGI2NCT06594913
Eating Disorders Genetics Initiative 2
An observational study of Anorexia Nervosa and Bulimia Nervosa, run by University of North Carolina, Chapel Hill at 5 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder
- What is being tested?
- Eating disorder diagnosis group
- How many people
- 20,000 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 28 Oct 2024to 1 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Interested individuals from the United States, Mexico, Australia, New Zealand, and Sweden who meet criteria may participate within their respective country.
Who may be able to join
- 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)
Who cannot join
- History of subthreshold disordered eating behaviors.
Trial locations and contacts
5 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 5 countries
United States1 site, 1 recruiting
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7160
Laura M Thornton, PhD, 804-690-3079, laura_thornton@med.unc.edu
Australia1 site, 1 recruiting
- Recruiting
QIMR Berghofer
Brisbane, Queensland
Richard Parker, richard.parker@qimeberghofer.edu.au
Mexico1 site, 1 recruiting
- Recruiting
Comenzar de Nuevo
Monterrey
Anid Cortes Morales, anid.cortes@comenzardenuevo.net
New Zealand1 site, 1 recruiting
- Recruiting
University of Otago
Christchurch, Canterbury
Jennifer Jordan, jenny.jordan@otago.ac.nz
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Institutet
Stockholm
Lisa Dinkler, PhD, lisa.dinkler@ki.se
About this study
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.
- Conditions
- Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder, Avoidant Restrictive Food Intake Disorder
- Being tested
- Eating disorder diagnosis group
- Keywords
- severe and enduring eating disorder, genetics, mental health, disordered eating, environmental factors
- Medical subject headings
- Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder, Avoidant Restrictive Food Intake Disorder, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eating disorder diagnosis groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Anorexia nervosa | Individuals with a self-reported lifetime history of anorexia nervosa. Receives: Other: Eating disorder diagnosis group | |
| Bulimia nervosa | Individuals with a self-reported lifetime history of bulimia nervosa. Receives: Other: Eating disorder diagnosis group | |
| Binge-eating disorder | Individuals with a self-reported lifetime history of binge-eating disorder. Receives: Other: Eating disorder diagnosis group | |
| ARFID | Individuals with a self-reported lifetime history of avoidant restrictive food intake disorder. Receives: Other: Eating disorder diagnosis group | |
| Control | Individuals with no history of disordered eating behaviors or symptoms Receives: Other: Eating disorder diagnosis group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Secondary outcomes (9)
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.
Measured: Baseline
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
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start28 Oct 2024
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Cynthia Bulik, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594913
- Sponsor's protocol ID
- 23-2887
- Other IDs
- R01MH136149, R01MH136157, R01MH136156
- Acronym
- EDGI2
- Status last verified
- Jul 2026
- First submitted
- 10 Sep 2024
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eating Disorders Genetics Initiative 2
- ClinicalTrials.gov ID
- NCT06594913
- Acronym / sponsor ID
- EDGI2 / 23-2887
- Conditions
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- 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
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Anorexia nervosa | – | Other: Eating disorder diagnosis groupIndividuals with a self-reported lifetime history of anorexia nervosa. |
| Bulimia nervosa | – | Other: Eating disorder diagnosis groupIndividuals with a self-reported lifetime history of bulimia nervosa. |
| Binge-eating disorder | – | Other: Eating disorder diagnosis groupIndividuals with a self-reported lifetime history of binge-eating disorder. |
| ARFID | – | Other: Eating disorder diagnosis groupIndividuals with a self-reported lifetime history of avoidant restrictive food intake disorder. |
| Control | – | Other: Eating disorder diagnosis groupIndividuals with no history of disordered eating behaviors or symptoms |
Who may qualify
- Ages
- 12 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Interested individuals from the United States, Mexico, Australia, New Zealand, and Sweden who meet criteria may participate within their respective country.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- History of subthreshold disordered eating behaviors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eating disorder diagnosis groupThis 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. | Other | ARFID, Anorexia nervosa, Binge-eating disorder, Bulimia nervosa, Control |
Primary outcome
Number of Participants Identified with an Eating Disorder Diagnosis by Category
Time frame: Baseline
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.
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 ED100Kv4 questionnaire (ED100K). Age of onset will be reported for each eating disorder group.
9 secondary outcomes
Current Disordered Eating Symptoms
Time frame: Baseline
Mental Health and Behavior
Time frame: Baseline
Mood - Lifetime history of mood and anxiety disorders
Time frame: Baseline
Self-Violence
Time frame: Baseline
Lifetime Substance Use
Time frame: Baseline
Life-Events
Time frame: Baseline
Eating Disorder Quality of Life
Time frame: Baseline
Compulsive Exercise Test
Time frame: Baseline
Perfectionism
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Derived from this study: PubMed 40419993Berthold 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cynthia Bulik, PhD principal investigator
University of North Carolina, Chapel Hill
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa and Bulimia Nervosa, run by University of North Carolina, Chapel Hill at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Australia, Mexico, New Zealand, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura M Thornton, PhD (804-690-3079, laura_thornton@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Identified with an Eating Disorder Diagnosis by Category (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06594913, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.