Eating Disorders Genetics Initiative

Completed

• Conditions: Binge-Eating Disorder; Bulimia Nervosa; Anorexia Nervosa
• Interventions: Other: Eating disorder diagnosis group

• Registration Number: NCT04378101
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-04
• Study First Submitted QC: 2020-05-06
• Study First Posted: 2020-05-07
• Study Start: 2020-06-12
• Status Verified: 2023-04
• Primary Completion: 2023-05-31
• Study Completion: 2023-05-31
• Last Update Submitted: 2023-06-02
• Last Update Posted: 2023-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17991

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

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Exclusion Criteria

• History of subthreshold disordered eating behaviors

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bulimia Nervosa Case	Eating disorder diagnosis group	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	Eating disorder diagnosis group	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.
Anorexia Nervosa Case	Eating disorder diagnosis group	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.
Control	Eating disorder diagnosis group	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Identified with an Eating Disorder Diagnosis by Category	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.
Age of eating disorder onset	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

Name	Time	Method
Current eating disorder self-report total sum scores	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.
Eating disorder-related quality of life scores	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.
Health-related quality of life scores	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.
Prevalence of life-time history of major depression	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.
Prevalence of generalized anxiety disorder	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.
Current depressive symptoms sum score	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.
Current anxiety symptoms sum scores	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.

Trial Locations

Locations (3)

University of Otago; 🇳🇿 Christchurch, Canterbury, New Zealand

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

QIMR Berghofer; 🇦🇺 Brisbane, Queensland, Australia