Genetic Architecture of Avoidant/Restrictive Food Intake Disorder (ARFID-GEN)

The goal of this observational study is to rapidly accelerate knowledge about the biology of avoidant and restrictive food intake disorder or ARFID in children ages 7-17 and in adults. The investigators will be evaluating the genetic and environmental origins of ARFID. Participants will be asked to answer questionnaires online and to submit a saliva sample for DNA using a kit that will be mailed to their home.

Study Overview

• Status: Completed
• Conditions: Eating Disorders; ARFID; Eating Disorders in Children; Eating, Picky

• Study Type: Observational
• Enrollment (Actual): 5076

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 99 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Parents of children with ARFID and adults with ARFID will self-select into the study. Because the study is conducted online, participants can join from across the United States

Description

Inclusion Criteria:

• Meet study criteria for ARFID
• Be willing to submit a saliva sample
• Have a US mailing address
• English-speaking

Exclusion Criteria:

• Potential other eating disorders

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cases; Participants will self-select into the study. All enrolled will meet study specific criteria and be considered cases.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Case definitions	Number of enrolled individuals who meet the case definition	Baseline

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute of Mental Health (NIMH); Psychiatric Center Ballerup
• Investigators: Principal Investigator: Cynthia M Bulik, PhD, University of North Carolina

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2023
• Primary Completion (Actual): August 1, 2024
• Study Completion (Actual): August 1, 2024

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: November 1, 2022
• First Posted (Actual): November 4, 2022

Study Record Updates

• Last Update Posted (Actual): October 29, 2024
• Last Update Submitted That Met QC Criteria: October 25, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Avoidant Restrictive Food Intake Disorder; Feeding and Eating Disorders
• Other Study ID Numbers: 22-1524; R56MH129437 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The specimens (saliva and DNA) and data (from questionnaires) may be shared with researchers at UNC or other institutions, such as the National Institutes of Health (NIH), and will eventually be included in the NIH data repository without additional consent. Research studies may be done at many places at the same time. No personal, identifying information will be sent to other researchers or included in the data repository. To secure the data, the NIH data repository will include multiple tiers of data security such as sequential firewalls, independent networks, and encryption based on the content and level of risk associated with the data. All data and information will be submitted to a high security network within NIH through a secure transmission process.

No participant will be identified in any report or publication about research using their specimens.

• IPD Sharing Time Frame: Questionnaire data and saliva samples will be submitted to NIMH repositories within 6 months after end of study. Genetic results will be submitted within one year after initial publication. All data will be available after the respective embargo periods.
• IPD Sharing Access Criteria: https://dbgap.ncbi.nlm.nih.gov/aa/dbgap_request_process.pdf https://nda.nih.gov/nda/access-data-info.html
• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No