Clinical trial NCT06594913: Eating Disorders Genetics Initiative 2
Official title: Eating Disorders Genetics Initiative 2
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anorexia Nervosa
Bulimia Nervosa
Binge-Eating Disorder
Avoidant Restrictive Food Intake Disorder
Keywords: severe and enduring eating disorder
genetics
mental health
disordered eating
environmental factors
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Queensland Institute of Medical Research
name: Karolinska Institutet
name: National Institute of Mental Health (NIMH)
name: University of Otago
name: University of Aarhus
name: Yale University
name: Comenzar de Nuevo A.C.
name: University of Sydney
First posted: 2024-09-19
Enrollment: 20000
Sex: ALL
Minimum age (years): 12
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Interested individuals from the United States, Mexico, Australia, New Zealand, and Sweden who meet criteria may participate within their respective country.

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.


Eligibility criteria: 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)

Exclusion Criteria:

* History of subthreshold disordered eating behaviors.

Primary outcomes:
measure: Number of Participants Identified with an Eating Disorder Diagnosis by Category
timeFrame: Baseline
measure: Age of eating disorder onset
timeFrame: Baseline
Secondary outcomes:
measure: Current Disordered Eating Symptoms
timeFrame: Baseline
measure: Mental Health and Behavior
timeFrame: Baseline
measure: Mood - Lifetime history of mood and anxiety disorders
timeFrame: Baseline
measure: Self-Violence
timeFrame: Baseline
measure: Lifetime Substance Use
timeFrame: Baseline
measure: Life-Events
timeFrame: Baseline
measure: Eating Disorder Quality of Life
timeFrame: Baseline
measure: Compulsive Exercise Test
timeFrame: Baseline
measure: Perfectionism
timeFrame: Baseline
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Brisbane
country: Australia
facility: QIMR Berghofer
state: Queensland
city: Monterrey
country: Mexico
facility: Comenzar de Nuevo
city: Christchurch
country: New Zealand
facility: University of Otago
state: Canterbury
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Cynthia Bulik, PhD
role: PRINCIPAL_INVESTIGATOR
References: