Anorexia NervosaEDGINCT04378101
Eating Disorders Genetics Initiative
An observational study of Anorexia Nervosa and Bulimia Nervosa, run by University of North Carolina, Chapel Hill at 3 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 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
- 17,991 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 12 Jun 2020to 31 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 15 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Interested individuals from the United States, Australia, and New Zealand 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, or no history of any disordered eating behavior
- Age 15-99 years
Who cannot join
- History of subthreshold disordered eating behaviors
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27599-7160
About this study
Official title: Eating Disorders Genetics Initiative (EDGI)
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.
- Conditions
- Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder
- Being tested
- Eating disorder diagnosis group
- Keywords
- Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder
- Medical subject headings
- Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder
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 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. Receives: Other: Eating disorder diagnosis group | |
| 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. Receives: Other: Eating disorder diagnosis group | |
| 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. Receives: Other: Eating disorder diagnosis group | |
| 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. 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 ED100K 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, 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 ED100K questionnaire (ED100K). Age of onset will be reported for each eating disorder group.
Measured: Baseline
Secondary outcomes (7)
Current eating disorder self-report total sum scores
Current eating disorder symptoms will be determined by self-report responses on the Eating Disorder Examination Questionnaire (EDEQ). Items ask about eating disorder symptoms over the past 28 days. There are four subscales of the EDEQ--Restraint, Eating Concern, Shape Concern, and Weight Concern--with scores for each ranging from 0-6. Subscales are averaged to compute a total score. Higher scores indicate more eating disorder pathology. Total and subscale sores will be reported to each eating disorder group.
Measured: Baseline
Eating disorder-related quality of life scores
Eating disorder quality of life will be 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
Health-related quality of life scores
Quality of life will be measured with the Short Form Health Survey 12 (SF-12) self-report questionnaire. The SF-12 asks 12 items assessing physical and mental health scores range from 0 to 100, with higher scores indicating better quality of life. Scores will be reported for each eating disorder group and for controls.
Measured: Baseline
Current depressive symptoms sum score
Current depressive symptoms will be measured using the Patient Health Questionnaire (PHQ). The PHQ asks 9 items about symptoms of depression over the past 2 weeks. Response options range from 0 (not at all) to 3 (nearly every day). Items are summed for a total score, ranging between 0-27 with higher scores indicating more depressive symptoms. Scores will be reported for each eating disorder group and for controls.
Measured: Baseline
Prevalence of life-time history of major depression
The prevalence of a history of major depression will be compared between eating disorder groups. Participants will complete a self-report questionnaire with items linked to the diagnostic criteria for major depression. Those individuals who indicate the presence of all the criterion required for a major depression diagnosis will be considered to have a history of major depression. Prevalence of life-time history of major depression will be reported for each eating disorder group and for controls.
Measured: Baseline
Current anxiety symptoms sum scores
Current anxiety symptoms will be measured using the Generalized Anxiety Disorder 7 (GAD7) self report questionnaire. GAD7 is a questionnaire for screening and severity measuring of generalized anxiety disorder. GAD7 consists of a total score for the seven items ranging from 0 to 21. Higher scores indicate higher levels of generalized anxiety. Scores will be reported for each eating disorder group and for controls.
Measured: Baseline
Prevalence of generalized anxiety disorder
The prevalence of a history of a generalized anxiety disorder will be compared between eating disorder groups. Participants will complete a self-report questionnaire with items linked to the diagnostic criteria for an anxiety disorder. Those individuals who indicate the presence of all the criterion required for generalized anxiety disorder diagnosis will be considered to have a history of generalized anxiety disorder. The prevalence of generalized anxiety disorder will be reported for each eating disorder group and for controls.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start12 Jun 2020
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Retrospective
- Enrolment
- 17,991 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Otago, University of Aarhus, QIMR Berghofer Medical Research Institute
- Responsible party
- Sponsor
- Investigators
- Cynthia M Bulik, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04378101
- Sponsor's protocol ID
- 19-1378
- Other IDs
- R01MH120170
- Acronym
- EDGI
- Status last verified
- Apr 2023
- First submitted
- 4 May 2020
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 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.
Publications
Schaumberg K, Watson HJ, Thornton LM, Kennedy HL, Ong SH, Roche P, Costello K, Barnhart WR, Pauley-Gadd SB, 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, Morancie NA, Bulik CM. Assessment of Maladaptive Exercise History Among Individuals With Eating Disorders: Validation of a Brief, Self-Report Measure. Eur Eat Disord Rev. 2026 Jul;34(4):1003-1015. doi: 10.1002/erv.70084. Epub 2026 Feb 15.
PubMed 41693143Watson 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. 2026 Jan;59(1):190-204. doi: 10.1002/eat.24563. Epub 2025 Oct 20.
PubMed 41115789Bulik 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.
PubMed 33947359
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eating Disorders Genetics Initiative (EDGI)
- ClinicalTrials.gov ID
- NCT04378101
- Acronym / sponsor ID
- EDGI / 19-1378
- Conditions
- Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder
- Keywords
- Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17,991 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Otago, University of Aarhus, QIMR Berghofer Medical Research Institute
- Study start
- 12 Jun 2020 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 7 May 2020 (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 (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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Anorexia Nervosa Case | – | Other: Eating disorder diagnosis groupParticipants 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. |
| Bulimia Nervosa Case | – | Other: Eating disorder diagnosis groupParticipants 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. |
| Binge-Eating Disorder Case | – | Other: Eating disorder diagnosis groupParticipants 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. |
| Control | – | Other: Eating disorder diagnosis groupParticipants 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. |
Who may qualify
- Ages
- 15 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Interested individuals from the United States, Australia, and New Zealand 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, or no history of any disordered eating behavior
- Age 15-99 years
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 | Anorexia Nervosa Case, Binge-Eating Disorder Case, Bulimia Nervosa Case, Control |
Primary outcome
Number of Participants Identified with an Eating Disorder Diagnosis by Category
Time frame: Baseline
The ED100K 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, 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 ED100K questionnaire (ED100K). Age of onset will be reported for each eating disorder group.
7 secondary outcomes
Current eating disorder self-report total sum scores
Time frame: Baseline
Eating disorder-related quality of life scores
Time frame: Baseline
Health-related quality of life scores
Time frame: Baseline
Current depressive symptoms sum score
Time frame: Baseline
Prevalence of life-time history of major depression
Time frame: Baseline
Current anxiety symptoms sum scores
Time frame: Baseline
Prevalence of generalized anxiety disorder
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
- Derived from this study: PubMed 41693143Schaumberg K, Watson HJ, Thornton LM, Kennedy HL, Ong SH, Roche P, Costello K, Barnhart WR, Pauley-Gadd SB, 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, Morancie NA, Bulik CM. Assessment of Maladaptive Exercise History Among Individuals With Eating Disorders: Validation of a Brief, Self-Report Measure. Eur Eat Disord Rev. 2026 Jul;34(4):1003-1015. doi: 10.1002/erv.70084. Epub 2026 Feb 15.
- Derived from this study: PubMed 41115789Watson 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. 2026 Jan;59(1):190-204. doi: 10.1002/eat.24563. Epub 2025 Oct 20.
- Derived from this study: PubMed 33947359Bulik 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.
- 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 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.
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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. This study is not recruiting at the moment.
Cynthia M Bulik, PhD principal investigator
University of North Carolina, Chapel Hill
3 sites in 3 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 3 sites in 3 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: finished, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Australia, New Zealand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 NCT04378101, which also lists 3 linked publications.
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 6 Jun 2023; AzTrials last refreshed its copy on 29 Oct 2026.