Eating Disorders Genetics Initiative 2 (EDGI2)

July 6, 2026 updated by: University of North Carolina, Chapel Hill
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Casey MacDermod, BA
  • Phone Number: 984-974-3798
  • Email: edgi2@unc.edu

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

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.

Description

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:

  • History of subthreshold disordered eating behaviors.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Anorexia nervosa
Individuals with a self-reported lifetime history of anorexia nervosa.
Other: 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.
Bulimia nervosa
Individuals with a self-reported lifetime history of bulimia nervosa.
Other: 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.
Binge-eating disorder
Individuals with a self-reported lifetime history of binge-eating disorder.
Other: 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.
ARFID
Individuals with a self-reported lifetime history of avoidant restrictive food intake disorder.
Other: 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.
Control
Individuals with no history of disordered eating behaviors or symptoms
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Current Disordered Eating Symptoms
Time Frame: Baseline
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.
Baseline
Mental Health and Behavior
Time Frame: Baseline
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
Baseline
Mood - Lifetime history of mood and anxiety disorders
Time Frame: Baseline
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.
Baseline
Self-Violence
Time Frame: Baseline
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.
Baseline
Lifetime Substance Use
Time Frame: Baseline
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.
Baseline
Life-Events
Time Frame: Baseline
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.
Baseline
Eating Disorder Quality of Life
Time Frame: Baseline
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.
Baseline
Compulsive Exercise Test
Time Frame: Baseline
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.
Baseline
Perfectionism
Time Frame: Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of North Carolina, Chapel Hill

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)
Karolinska Institutet
Yale University
University of Aarhus
University of Otago
University of Sydney
Queensland Institute of Medical Research
Comenzar de Nuevo, AC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cynthia Bulik, PhD, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 28, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23-2887
  • R01MH136149 (U.S. NIH Grant/Contract)
  • R01MH136157 (U.S. NIH Grant/Contract)
  • R01MH136156 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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).

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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