ARFIDARFID-GENNCT05605067
Genetic Architecture of Avoidant/Restrictive Food Intake Disorder
An observational study of ARFID and Eating Disorders, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 99 years
- Conditions the study is for
- ARFID, Eating Disorders, Eating Disorders in Children
- How many people
- 5,076 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2023to 1 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- Meet study criteria for ARFID
- Be willing to submit a saliva sample
- Have a US mailing address
- English-speaking
Who cannot join
- Potential other eating disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
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.
- Conditions
- ARFID, Eating Disorders, Eating Disorders in Children, Eating, Picky
- Medical subject headings
- Avoidant Restrictive Food Intake Disorder, Feeding and Eating Disorders, Food Fussiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Participants will self-select into the study. All enrolled will meet study specific criteria and be considered cases. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Case definitions
Number of enrolled individuals who meet the case definition
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start5 Jan 2023
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ARFIDStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 5,076 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Psychiatric Center Ballerup
- Responsible party
- Sponsor
- Investigators
- Cynthia M Bulik, PhD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05605067
- Sponsor's protocol ID
- 22-1524
- Other IDs
- R56MH129437
- Acronym
- ARFID-GEN
- Status last verified
- Aug 2024
- First submitted
- 26 Oct 2022
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Aguilar MV, Giulumian GK, Rodriguez I, Baker JH, Surti PP, Dinkler L, Guintivano J, Johnson JS, MacDermod CM, Ortiz SN, Pisetsky EM, White JP, Micali N, Bulik CM, Thornton LM, Wu YK. Associations Between Avoidant/Restrictive Food Intake Disorder Dimensions and Obsessive-Compulsive Symptomatology. Eur Eat Disord Rev. 2026 Sep;34(5):1327-1335. doi: 10.1002/erv.70122. Epub 2026 Apr 26.
PubMed 42037051Bulik 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.
PubMed 37990202Bulik 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.
PubMed 37693386
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Architecture of Avoidant/Restrictive Food Intake Disorder
- ClinicalTrials.gov ID
- NCT05605067
- Acronym / sponsor ID
- ARFID-GEN / 22-1524
- Conditions
- ARFID, Eating Disorders, Eating Disorders in Children, Eating, Picky
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,076 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Psychiatric Center Ballerup
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 4 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Participants will self-select into the study. All enrolled will meet study specific criteria and be considered cases. |
Who may qualify
- Ages
- 7 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- Meet study criteria for ARFID
- Be willing to submit a saliva sample
- Have a US mailing address
- English-speaking
Key exclusion criteria (1 listed)
- Potential other eating disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Case definitions
Time frame: Baseline
Number of enrolled individuals who meet the case definition
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Derived from this study: PubMed 42037051Aguilar MV, Giulumian GK, Rodriguez I, Baker JH, Surti PP, Dinkler L, Guintivano J, Johnson JS, MacDermod CM, Ortiz SN, Pisetsky EM, White JP, Micali N, Bulik CM, Thornton LM, Wu YK. Associations Between Avoidant/Restrictive Food Intake Disorder Dimensions and Obsessive-Compulsive Symptomatology. Eur Eat Disord Rev. 2026 Sep;34(5):1327-1335. doi: 10.1002/erv.70122. Epub 2026 Apr 26.
- Derived from this study: PubMed 37990202Bulik 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.
- Derived from this study: PubMed 37693386Bulik 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.
- Individual participant dataSharing planned: Yes. 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.
Related trials for ARFID
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Parent-Based Intervention for Childhood Avoidant/Restrictive Food Intake Disorder (ARFID)
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Cognitive-behavioral Therapy vs. Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder Part II
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Sensory Feeding and Parent Coaching for Children With ARFID
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia M Bulik, PhD principal investigator
University of North Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ARFID and Eating Disorders, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Case definitions (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05605067, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.