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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
Date last updated
6/06/2023

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
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.
Trial website
https://clinicaltrials.gov/study/NCT04378101
Trial related presentations / publications
Bulik CM, Thornton LM, Parker R, Kennedy H, Baker JH, MacDermod C, Guintivano J, Cleland L, Miller AL, Harper L, Larsen JT, Yilmaz Z, Grove J, Sullivan PF, Petersen LV, Jordan J, Kennedy MA, Martin NG. The Eating Disorders Genetics Initiative (EDGI): study protocol. BMC Psychiatry. 2021 May 4;21(1):234. doi: 10.1186/s12888-021-03212-3.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04378101