Eating Disorders Genetics Initiative 2

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-99
SponsorUniversity of North Carolina, Chapel Hill

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

History of subthreshold disordered eating behaviors.

Trial population

Interested individuals from the United States, Mexico, Australia, New Zealand, and Sweden who meet criteria may participate within their respective country.

Trial design

Design model

Case-control

Time perspective

Other

Treatments tested in this trial

  • Eating disorder diagnosis group

    Other intervention

    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.

Treatment groups

20,000 Participants
are divided into 5 treatment groups
Group A: Anorexia nervosa1 intervention
Group B: Bulimia nervosa1 intervention
Group C: Binge-eating disorder1 intervention
Group D: ARFID1 intervention
Group E: Control1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants Identified with an Eating Disorder Diagnosis by Category

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.

Time frame
Baseline
2

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 ED100Kv4 questionnaire (ED100K). Age of onset will be reported for each eating disorder group.

Time frame
Baseline

Secondary outcomes

1

Current Disordered Eating Symptoms

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.

Time frame
Baseline
2

Mental Health and Behavior

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

Time frame
Baseline
3

Mood - Lifetime history of mood and anxiety disorders

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.

Time frame
Baseline
4

Self-Violence

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.

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of North Carolina, Chapel Hill

Lead sponsor

Queensland Institute of Medical Research

Collaborator

Karolinska Institutet

Collaborator

National Institute of Mental Health (NIMH)

Collaborator

University of Otago

Collaborator

University of Aarhus

Collaborator

Yale University

Collaborator

Comenzar de Nuevo, AC

Collaborator

University of Sydney

Collaborator