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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04378101




Registration number
NCT04378101
Ethics application status
Date submitted
4/05/2020
Date registered
7/05/2020

Titles & IDs
Public title
Eating Disorders Genetics Initiative
Scientific title
Eating Disorders Genetics Initiative (EDGI)
Secondary ID [1] 0 0
R01MH120170
Secondary ID [2] 0 0
19-1378
Universal Trial Number (UTN)
Trial acronym
EDGI
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
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 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.
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 eating disorder self-report total sum scores
Timepoint [1] 0 0
Baseline
Secondary outcome [2] 0 0
Eating disorder-related quality of life scores
Timepoint [2] 0 0
Baseline
Secondary outcome [3] 0 0
Health-related quality of life scores
Timepoint [3] 0 0
Baseline
Secondary outcome [4] 0 0
Current depressive symptoms sum score
Timepoint [4] 0 0
Baseline
Secondary outcome [5] 0 0
Prevalence of life-time history of major depression
Timepoint [5] 0 0
Baseline
Secondary outcome [6] 0 0
Current anxiety symptoms sum scores
Timepoint [6] 0 0
Baseline
Secondary outcome [7] 0 0
Prevalence of generalized anxiety disorder
Timepoint [7] 0 0
Baseline

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
Minimum age
15 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
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/06/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/05/2023
Sample size
Target
Accrual to date
Final
17991
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
New Zealand
State/province [2] 0 0
Canterbury

Funding & Sponsors
Primary sponsor type
Other
Name
University of North Carolina, Chapel Hill
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institute of Mental Health (NIMH)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Otago
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University of Aarhus
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
QIMR Berghofer Medical Research Institute
Address [4] 0 0
Country [4] 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 M 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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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 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.

Supporting document/s available: Study protocol
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/NCT04378101