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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

Titles & IDs
Public title
Eating Disorders Genetics Initiative 2
Scientific title
Eating Disorders Genetics Initiative 2
Secondary ID [1] 0 0
R01MH136149
Secondary ID [2] 0 0
23-2887
Universal Trial Number (UTN)
Trial acronym
EDGI2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anorexia Nervosa 0 0
Bulimia Nervosa 0 0
Binge-Eating Disorder 0 0
Avoidant Restrictive Food Intake Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Eating disorders
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Identified with an Eating Disorder Diagnosis by Category
Timepoint [1] 0 0
Baseline
Primary outcome [2] 0 0
Age of eating disorder onset
Timepoint [2] 0 0
Baseline
Secondary outcome [1] 0 0
Current Disordered Eating Symptoms
Timepoint [1] 0 0
Baseline
Secondary outcome [2] 0 0
Mental Health and Behavior
Timepoint [2] 0 0
Baseline
Secondary outcome [3] 0 0
Mood - Lifetime history of mood and anxiety disorders
Timepoint [3] 0 0
Baseline
Secondary outcome [4] 0 0
Self-Violence
Timepoint [4] 0 0
Baseline
Secondary outcome [5] 0 0
Lifetime Substance Use
Timepoint [5] 0 0
Baseline
Secondary outcome [6] 0 0
Life-Events
Timepoint [6] 0 0
Baseline
Secondary outcome [7] 0 0
Eating Disorder Quality of Life
Timepoint [7] 0 0
Baseline
Secondary outcome [8] 0 0
Compulsive Exercise Test
Timepoint [8] 0 0
Baseline
Secondary outcome [9] 0 0
Perfectionism
Timepoint [9] 0 0
Baseline

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)
Minimum age
12 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* History of subthreshold disordered eating behaviors.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/10/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2027
Actual
Sample size
Target
20000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
QIMR Berghofer - Brisbane
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
North Carolina
Country [2] 0 0
Mexico
State/province [2] 0 0
Monterrey
Country [3] 0 0
New Zealand
State/province [3] 0 0
Canterbury
Country [4] 0 0
Sweden
State/province [4] 0 0
Stockholm

Funding & Sponsors
Primary sponsor type
Other
Name
University of North Carolina, Chapel Hill
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Queensland Institute of Medical Research
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Karolinska Institutet
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Government body
Name [3] 0 0
National Institute of Mental Health (NIMH)
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
University of Otago
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
University of Aarhus
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Yale University
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Comenzar de Nuevo A.C.
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
University of Sydney
Address [8] 0 0
Country [8] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Cynthia Bulik, PhD
Address 0 0
University of North Carolina, Chapel Hill
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Laura M Thornton, PhD
Address 0 0
Country 0 0
Phone 0 0
804-690-3079
Fax 0 0
Email 0 0
laura_thornton@med.unc.edu
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Informed consent form (ICF)
When will data be available (start and end dates)?
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).
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://nda.nih.gov/nda/access-data-info.html


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