Eating Disorders Genetics Initiative 2

Recruiting

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

• Registration Number: NCT06594913
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

The overarching intention of the Eating Disorder Genetics Initiative 2 (EDGI2) is to increase sample size, diversity, and eating disorder phenotypes. The investigators are enrolling 20,000 new participants with anorexia nervosa (AN), bulimia nervosa (BN), binge-eating disorder (BED), avoidant/restrictive food intake disorder (ARFID), and controls in the US, Mexico, Australia, New Zealand, Sweden, and Denmark. A primary study goal is to enroll at least 30% of participants from underrepresented groups. Participants are asked to complete a series of questionnaires and submit a saliva sample for genotyping. 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: 2024-09-10
• Study First Submitted QC: 2024-09-10
• Study First Posted: 2024-09-19
• Status Verified: 2024-10
• Study Start: 2024-10-28
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-13
• Primary Completion: 2027-08-01
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20000

Inclusion Criteria

• A lifetime history of anorexia nervosa, bulimia nervosa, binge-eating disorder, avoidant restrictive food intake disorders or no history of any disordered eating behavior, based on DSM-5 criteria algorithms
• Age 12-99 years, depending on country. (US enrollment age is 18-99)

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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
Anorexia nervosa	Eating disorder diagnosis group	Individuals with a self-reported lifetime history of anorexia nervosa.
Bulimia nervosa	Eating disorder diagnosis group	Individuals with a self-reported lifetime history of bulimia nervosa.
Binge-eating disorder	Eating disorder diagnosis group	Individuals with a self-reported lifetime history of binge-eating disorder.
ARFID	Eating disorder diagnosis group	Individuals with a self-reported lifetime history of avoidant restrictive food intake disorder.
Control	Eating disorder diagnosis group	Individuals with no history of disordered eating behaviors or symptoms

Primary Outcome Measures

Name	Time	Method
Number of Participants Identified with an Eating Disorder Diagnosis by Category	Baseline	The ED100Kv4 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, ARFID, 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 ED100Kv4 questionnaire (ED100K). Age of onset will be reported for each eating disorder group.

Secondary Outcome Measures

Name	Time	Method
Current Disordered Eating Symptoms	Baseline	Current eating disorder symptoms will be determined by self-report responses on the Eating Disorder Examination Questionnaire (EDEQ), the Binge Eating Disorder Screener-(BEDS7), the Nine Item ARFID Screen (NIAS), Muscle Dysmorphic Disorder Inventory (MDDI), the Drive for Muscularity Scale (DMS), and food insecurity. Items in all assessments ask about current symptoms related to eating disorders. The assessments sum scores to create subscales where higher scores indicate more eating disorder pathology and the scores taken together reveal the current disordered eating status of participants. Subscale sores will be reported for the total sample.
Mental Health and Behavior	Baseline	Current mental health symptoms (depression, anxiety, obsessive-compulsive disorder, autism, and attention-deficit/hyperactivity disorder \[ADHD\]) are assessed using the Patient Health Questionnaire (PHQ), Generalized Anxiety Disorder 7 (GAD7), Obsessional Compulsive Inventory - Revised (OCI-R), Autism Spectrum Quotient (AQ10), and Adult ADHD Self-Report Scale (ASRS).The assessments sum scores to create subscales where higher scores indicate more mental health symptoms and the scores taken together provide insight to current comorbidity of participants. Subscale sores will be reported for the entire sample
Mood - Lifetime history of mood and anxiety disorders	Baseline	The GLAD questionnaire asks about lifetime history of mood and anxiety symptoms. Algorithms based on Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) criteria will be applied to data to report lifetime history of mood and anxiety disorders.
Self-Violence	Baseline	A series of questions will be asked about suicidality and self-harm. The number and percent of participants indicating suicidality and self-harm will be reported.
Lifetime Substance Use	Baseline	Adapted to lifetime use, Alcohol Use Disorders Identification Test (AUDIT; 10 times) and the Drug Use Disorders Identification Test (DUDIT) are administered along with the heaviness of smoking and and questions about vaping. The AUDIT, DUDIT, and heaviness of smoking are scored using published algorithms. The prevalence of lifetime substance use will be reported for each eating disorder group.
Life-Events	Baseline	A modified version of Life Events Checklist for DSM-5 (LEC-5) is administered to collect information about 20 adverse events experienced, the age those events were first experienced, and the degree of trauma that resulted from the life events. The number and percent of each life event experienced will be reported for each eating disorder group.
Eating Disorder Quality of Life	Baseline	Eating disorder quality of life is 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.
Compulsive Exercise Test	Baseline	Maladaptive exercise is evaluated using the Compulsive Exercise Test. A total of 24 questions ask about excessive or problematic exercise. Response options are on a 6-point Likert scale. There are 5 subscales, which are scored according to published criteria. Higher scores indicate greater pathology. Scores will be reported for each eating disorder group.
Perfectionism	Baseline	A shortened version (12 items) of the Multidimensional Perfectionism Scale (MPS) is used to assess 3 features of perfectionism: doubts about actions, concern over mistakes, and personal standards. Response options are on a 5-point Likert scale. Greater scores indicate higher perfectionism. Scores will be reported for each eating disorder group.

Trial Locations

Locations (5)

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

QIMR Berghofer; 🇦🇺 Brisbane, Queensland, Australia

Comenzar de Nuevo; 🇲🇽 Monterrey, Mexico

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

Karolinska Institutet; 🇸🇪 Stockholm, Sweden