Skip to content

Eating Disorders Genetics Initiative

Eating Disorders Genetics Initiative (EDGI)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04378101
Acronym
EDGI
Enrollment
17991
Registered
2020-05-07
Start date
2020-06-12
Completion date
2023-05-31
Last updated
2023-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorexia Nervosa, Binge-Eating Disorder, Bulimia Nervosa

Keywords

Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder

Brief 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. 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.

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.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of Otago
CollaboratorOTHER
University of Aarhus
CollaboratorOTHER
QIMR Berghofer Medical Research Institute
CollaboratorOTHER
University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

* A lifetime history of anorexia nervosa, bulimia nervosa, binge-eating disorder, or no history of any disordered eating behavior * Age 15-99 years

Exclusion criteria

* History of subthreshold disordered eating behaviors

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Identified with an Eating Disorder Diagnosis by CategoryBaselineThe 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 onsetBaselineAge 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.

Secondary

MeasureTime frameDescription
Health-related quality of life scoresBaselineQuality 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.
Current depressive symptoms sum scoreBaselineCurrent 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.
Current eating disorder self-report total sum scoresBaselineCurrent 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.
Current anxiety symptoms sum scoresBaselineCurrent 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.
Prevalence of generalized anxiety disorderBaselineThe 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.
Prevalence of life-time history of major depressionBaselineThe 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.
Eating disorder-related quality of life scoresBaselineEating 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.

Countries

Australia, New Zealand, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026