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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04378101
Ethics application status
Date submitted
4/05/2020
Date registered
7/05/2020
Date last updated
16/06/2020

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 - 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.
Timepoint [1] 0 0
Baseline
Primary outcome [2] 0 0
Age of eating disorder onset - 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.
Timepoint [2] 0 0
Baseline
Secondary outcome [1] 0 0
Current eating disorder self-report total sum scores - 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.
Timepoint [1] 0 0
Baseline
Secondary outcome [2] 0 0
Eating disorder-related quality of life scores - 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.
Timepoint [2] 0 0
Baseline
Secondary outcome [3] 0 0
Health-related quality of life scores - 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.
Timepoint [3] 0 0
Baseline
Secondary outcome [4] 0 0
Current depressive symptoms sum score - 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.
Timepoint [4] 0 0
Baseline
Secondary outcome [5] 0 0
Prevalence of life-time history of major depression - 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.
Timepoint [5] 0 0
Baseline
Secondary outcome [6] 0 0
Current anxiety symptoms sum scores - 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.
Timepoint [6] 0 0
Baseline
Secondary outcome [7] 0 0
Prevalence of generalized anxiety disorder - 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.
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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
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/show/NCT04378101
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
Casey MacDermod
Address 0 0
Country 0 0
Phone 0 0
1-984-974-3798
Fax 0 0
Email 0 0
edgi@unc.edu
Contact person for scientific queries

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