NCT05605067

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,076

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 4, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

January 5, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

October 29, 2024

Status Verified

August 1, 2024

Enrollment Period

1.6 years

First QC Date

October 26, 2022

Last Update Submit

October 25, 2024

Conditions

ARFIDEating DisordersEating Disorders in ChildrenEating, Picky

Outcome Measures

Primary Outcomes (1)

  • Case definitions

    Number of enrolled individuals who meet the case definition

    Baseline

Study Arms (1)

Cases

Participants will self-select into the study. All enrolled will meet study specific criteria and be considered cases.

Eligibility Criteria

Age7 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • Potential other eating disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (2)

  • Bulik CM, Micali N, MacDermod CM, Qi B, Munn-Chernoff MA, Thornton LM, White J, Dinkler L, Pisetsky EM, Johnson J, Devine KR, Ortiz SN, Silverman AE, Berthold N, Dumain A, Guintivano J, Halvorsen M, Crowley JJ. ARFID Genes and Environment (ARFID-GEN): study protocol. BMC Psychiatry. 2023 Nov 21;23(1):863. doi: 10.1186/s12888-023-05266-x.

    PMID: 37990202DERIVED

  • Bulik CM, Micali N, MacDermod CM, Qi B, Munn-Chernoff MA, Thornton LM, White J, Dinkler L, Pisetsky EM, Johnson J, Devine KR, Ortiz SN, Silverman AE, Berthold N, Dumain A, Guintivano J, Halvorsen M, James J. Arfid Genes and Environment (ARFID-GEN): Study Protocol. Res Sq [Preprint]. 2023 Aug 31:rs.3.rs-3186174. doi: 10.21203/rs.3.rs-3186174/v1.

    PMID: 37693386DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Saliva samples from participants for DNA extraction

MeSH Terms

Conditions

Avoidant Restrictive Food Intake DisorderFeeding and Eating DisordersFood Fussiness

Condition Hierarchy (Ancestors)

Mental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsFeeding BehaviorBehavior

Study Officials

  • Cynthia M Bulik, PhD

    University of North Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2022

First Posted

November 4, 2022

Study Start

January 5, 2023

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

October 29, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
ICF
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.
Access Criteria
https://dbgap.ncbi.nlm.nih.gov/aa/dbgap\ request\ process.pdf https://nda.nih.gov/nda/access-data-info.html

Locations

US(1)