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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04378101
Registration number
NCT04378101
Ethics application status
Date submitted
4/05/2020
Date registered
7/05/2020
Date last updated
6/06/2023
Titles & IDs
Public title
Eating Disorders Genetics Initiative
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Scientific title
Eating Disorders Genetics Initiative (EDGI)
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Secondary ID [1]
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R01MH120170
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Secondary ID [2]
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19-1378
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Universal Trial Number (UTN)
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Trial acronym
EDGI
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Anorexia Nervosa
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Bulimia Nervosa
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Binge-Eating Disorder
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Condition category
Condition code
Mental Health
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Eating disorders
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Diet and Nutrition
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Other diet and nutrition disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Other interventions - Eating disorder diagnosis group
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.
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.
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.
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.
Other interventions: 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.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants Identified with an Eating Disorder Diagnosis by Category
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline
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Primary outcome [2]
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Age of eating disorder onset
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline
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Secondary outcome [1]
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Current eating disorder self-report total sum scores
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline
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Secondary outcome [2]
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Eating disorder-related quality of life scores
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline
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Secondary outcome [3]
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Health-related quality of life scores
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline
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Secondary outcome [4]
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Current depressive symptoms sum score
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline
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Secondary outcome [5]
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Prevalence of life-time history of major depression
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline
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Secondary outcome [6]
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Current anxiety symptoms sum scores
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline
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Secondary outcome [7]
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Prevalence of generalized anxiety disorder
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline
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Eligibility
Key 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
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Minimum age
15
Years
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Maximum age
99
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- History of subthreshold disordered eating behaviors
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Study design
Purpose
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Duration
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Selection
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Timing
Retrospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/06/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/05/2023
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Sample size
Target
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Accrual to date
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Final
17991
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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QIMR Berghofer - Brisbane
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Recruitment postcode(s) [1]
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- Brisbane
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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North Carolina
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Country [2]
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New Zealand
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State/province [2]
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Canterbury
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of North Carolina, Chapel Hill
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Address
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Other collaborator category [1]
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Government body
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Name [1]
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National Institute of Mental Health (NIMH)
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Address [1]
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Other collaborator category [2]
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Other
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Name [2]
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University of Otago
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Address [2]
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Other collaborator category [3]
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Other
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Name [3]
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University of Aarhus
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Address [3]
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Other collaborator category [4]
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Other
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Name [4]
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QIMR Berghofer Medical Research Institute
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Address [4]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04378101
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Cynthia M Bulik, PhD
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Address
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University of North Carolina, Chapel Hill
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04378101
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