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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06594913
Registration number
NCT06594913
Ethics application status
Date submitted
10/09/2024
Date registered
19/09/2024
Date last updated
31/05/2025
Titles & IDs
Public title
Eating Disorders Genetics Initiative 2
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Scientific title
Eating Disorders Genetics Initiative 2
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Secondary ID [1]
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R01MH136149
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Secondary ID [2]
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23-2887
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Universal Trial Number (UTN)
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Trial acronym
EDGI2
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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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Avoidant Restrictive Food Intake 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 - Individuals with a self-reported lifetime history of anorexia nervosa.
Bulimia nervosa - Individuals with a self-reported lifetime history of bulimia nervosa.
Binge-eating disorder - Individuals with a self-reported lifetime history of binge-eating disorder.
ARFID - Individuals with a self-reported lifetime history of avoidant restrictive food intake disorder.
Control - Individuals with no history of disordered eating behaviors or symptoms
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 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.
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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 ED100Kv4 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 Disordered Eating Symptoms
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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), 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.
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Timepoint [1]
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Baseline
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Secondary outcome [2]
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Mental Health and Behavior
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Assessment method [2]
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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
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Timepoint [2]
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Baseline
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Secondary outcome [3]
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Mood - Lifetime history of mood and anxiety disorders
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline
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Secondary outcome [4]
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Self-Violence
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline
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Secondary outcome [5]
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Lifetime Substance Use
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline
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Secondary outcome [6]
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Life-Events
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline
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Secondary outcome [7]
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Eating Disorder Quality of Life
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline
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Secondary outcome [8]
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Compulsive Exercise Test
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline
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Secondary outcome [9]
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Perfectionism
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline
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Eligibility
Key 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)
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Minimum age
12
Years
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Maximum age
99
Years
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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
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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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
28/10/2024
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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
1/08/2027
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Actual
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Sample size
Target
20000
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Accrual to date
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Final
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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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Mexico
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State/province [2]
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Monterrey
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Country [3]
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New Zealand
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State/province [3]
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Canterbury
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Country [4]
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Sweden
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State/province [4]
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Stockholm
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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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Country
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Other collaborator category [1]
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Other
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Name [1]
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Queensland Institute of Medical Research
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Karolinska Institutet
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Address [2]
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Country [2]
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Other collaborator category [3]
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Government body
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Name [3]
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National Institute of Mental Health (NIMH)
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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University of Otago
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Address [4]
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Other collaborator category [5]
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Other
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Name [5]
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University of Aarhus
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Address [5]
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Country [5]
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Other collaborator category [6]
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Other
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Name [6]
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Yale University
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Address [6]
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Country [6]
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Other collaborator category [7]
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Other
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Name [7]
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Comenzar de Nuevo A.C.
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Address [7]
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Country [7]
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Other collaborator category [8]
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Other
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Name [8]
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University of Sydney
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Address [8]
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Country [8]
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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 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.
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Trial website
https://clinicaltrials.gov/study/NCT06594913
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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 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
Name
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Laura M Thornton, PhD
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Address
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Country
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Phone
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804-690-3079
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06594913
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