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Eating Disorders Genetics Initiative (EDGI)

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ClinicalTrials.gov Identifier: NCT04378101
Recruitment Status : Recruiting
First Posted : May 7, 2020
Last Update Posted : June 30, 2021
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
University of Otago
University of Aarhus
QIMR Berghofer Medical Research Institute
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Description
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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.

Condition or disease Intervention/treatment
Anorexia Nervosa Bulimia Nervosa Binge-Eating Disorder Other: Eating disorder diagnosis group

Study Design
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Study Type : Observational
Estimated Enrollment : 16000 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Eating Disorders Genetics Initiative (EDGI)
Actual Study Start Date : June 12, 2020
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : July 1, 2023
Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Other: 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.
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.
 Other: 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.
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.
 Other: 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.
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: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants Identified with an Eating Disorder Diagnosis by Category [ Time Frame: Baseline ]
    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.

  2. Age of eating disorder onset [ Time Frame: Baseline ]
    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.


Secondary Outcome Measures :
  1. Current eating disorder self-report total sum scores [ Time Frame: Baseline ]
    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.

  2. Eating disorder-related quality of life scores [ Time Frame: Baseline ]
    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.

  3. Health-related quality of life scores [ Time Frame: Baseline ]
    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.

  4. Current depressive symptoms sum score [ Time Frame: Baseline ]
    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.

  5. Prevalence of life-time history of major depression [ Time Frame: Baseline ]
    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.

  6. Current anxiety symptoms sum scores [ Time Frame: Baseline ]
    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.

  7. Prevalence of generalized anxiety disorder [ Time Frame: Baseline ]
    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.


Biospecimen Retention:   Samples With DNA

Participants from the United States, Australia, and New Zealand will be asked to submit a saliva sample using standard industry collection tubes. DNA will be isolated from these samples.

DNA will be isolated from blood spots obtained at birth from participants in Denmark.


Eligibility Criteria
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Ages Eligible for Study:   15 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Interested individuals from the United States, Australia, and New Zealand who meet criteria may participate within their respective country.
Criteria

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

Exclusion Criteria:

  • History of subthreshold disordered eating behaviors
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04378101


Contacts
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Contact: Casey MacDermod 1-984-974-3798 edgi@unc.edu
Contact: Laura Thornton, PhD 1-804-690-3079 laura_thornton@med.unc.edu

Locations
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United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599-7160
Contact: Laura M Thornton, PhD    804-690-3079    laura_thornton@med.unc.edu   
Australia, Queensland
QIMR Berghofer Recruiting
Brisbane, Queensland, Australia
Contact: Richard Parker       Richard.Parker@qimrberghofer.edu.au   
New Zealand
University of Otago Recruiting
Christchurch, Canterbury, New Zealand
Contact: Jennifer Jordan       jenny.jordan@otago.ac.nz   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH)
University of Otago
University of Aarhus
QIMR Berghofer Medical Research Institute
Investigators
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Principal Investigator: Cynthia M Bulik, PhD University of North Carolina, Chapel Hill
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT04378101    
Other Study ID Numbers: 19-1378
R01MH120170 ( U.S. NIH Grant/Contract )
First Posted: May 7, 2020    Key Record Dates
Last Update Posted: June 30, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Time Frame: 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).
Access Criteria: 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.
URL: https://nda.nih.gov/get/access-data.html

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of North Carolina, Chapel Hill:
Anorexia Nervosa
Bulimia Nervosa
Binge-Eating Disorder
Additional relevant MeSH terms:
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Disease
Anorexia
Bulimia
Feeding and Eating Disorders
Anorexia Nervosa
Binge-Eating Disorder
 Bulimia Nervosa
Pathologic Processes
Mental Disorders
Signs and Symptoms, Digestive
Hyperphagia