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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05605067
Recruitment Status : Recruiting
First Posted : November 4, 2022
Last Update Posted : January 9, 2023
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Psychiatric Center Ballerup
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Description
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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.

Condition or disease
ARFID Eating Disorders Eating Disorders in Children Eating, Picky

Study Design
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Study Type : Observational
Estimated Enrollment : 6000 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Genetic Architecture of Avoidant/Restrictive Food Intake Disorder
Actual Study Start Date : January 5, 2023
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2024
Groups and Cohorts
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Group/Cohort
Cases
Participants will self-select into the study. All enrolled will meet study specific criteria and be considered cases.


Outcome Measures
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Primary Outcome Measures :
  1. Case definitions [ Time Frame: Baseline ]
    Number of enrolled individuals who meet the case definition


Biospecimen Retention:   Samples With DNA
Saliva samples from participants for DNA extraction

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   7 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05605067


Contacts
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Contact: Study Staff 984-974-3798 arfid@unc.edu
Contact: Melissa Munn-Chernoff, PhD melissa_chernoff@med.unc.edu

Locations
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United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Study Team    984-974-3798    arfid@unc.edu   
Contact: Melissa Munn-Chernoff, PhD       melissa_chernoff@med.unc.edu   
Principal Investigator: Cynthia M Bulik, PhD         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH)
Psychiatric Center Ballerup
Investigators
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Principal Investigator: Cynthia M Bulik, PhD University of North Carolina
More Information
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT05605067    
Other Study ID Numbers: 22-1524
R56MH129437 ( U.S. NIH Grant/Contract )
First Posted: November 4, 2022    Key Record Dates
Last Update Posted: January 9, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Informed Consent Form (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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Feeding and Eating Disorders
Avoidant Restrictive Food Intake Disorder
Pathologic Processes
Mental Disorders