ARFIDNCT05105308
Chompions! A Treatment Study for Childhood Avoidant/Restrictive Food Intake Disorder (ARFID)
A study testing Family Assisted Diet (FAD) and Feeling and Body Investigator_ARFID Division (FBI-ARFID) in people with ARFID and Picky Eating, run by Duke University at 1 site in United States.
Trial summary
Avoidant Restrictive Food Intake Disorder (ARFID) is a disorder that affects toddlers, children, adolescents, and adults. Individuals with ARFID are not able to consume an adequate amount or variety of food to a degree that it affects their mental and/or physical health. Read more about this study
- Who is it for?
- Ages 60 to 119 months
- Conditions the study is for
- ARFID, Picky Eating, Eating Disorders in Children
- What is being tested?
- Family Assisted Diet (FAD) and Feeling and Body Investigator_ARFID Division (FBI-ARFID)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2022to 29 Sep 2025
- Phase
- Interventional
- 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 60 to 119 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child is between 60 and 119 months (5 years and up to 9 years, 11 months)
- English Speaking
- Consent given by parent and assent by child
- And any one or more of the following:
- Score of 29 or above on the Child Food Neophobia Scale
- Underweight
Show all 9Show fewer
- Current diagnosis of ARFID
- Dependent on nutritional supplements to achieve sufficient calories for optimal growth
- Avoiding activities due to eating rated at least almost always
Who cannot join
- Child is known to have a severe intellectual disability based on medical chart review
- Meets diagnostic criteria for anorexia nervosa or bulimia nervosa
- Is currently enrolled in a treatment study or receiving active treatment for ARFID
- Taking medications known to affect appetite
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Avoidant Restrictive Food Intake Disorder (ARFID) is a disorder that affects toddlers, children, adolescents, and adults. Individuals with ARFID are not able to consume an adequate amount or variety of food to a degree that it affects their mental and/or physical health. ARFID often begins in early childhood so it is important to treat children in early in life as possible to prevent any negative consequences of poor nutrition. There are currently no treatments for young children with ARFID. The investigators have developed two different study programs and the purpose of this study is to test them out and see if they help children with ARFID and to learn more about how these study programs work.
- Conditions
- ARFID, Picky Eating, Eating Disorders in Children
- Being tested
- Family Assisted Diet (FAD), Feeling and Body Investigator_ARFID Division (FBI-ARFID)
- Keywords
- FBI-ARFID, Eating Disorder, Avoidant Restrictive Food Intake Disorder, Food Neophobia, Treatment for Children, Sensory Sensitivity, Picky Eating, Low Weight, Nutritional Deficiencies
- Medical subject headings
- Avoidant Restrictive Food Intake Disorder, Food Fussiness, Feeding and Eating Disorders, Thinness, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Assisted Diet (FAD)Behavioural
Also called FAD
A behavioral intervention consisting of helping parents renourish their child and conduct food exposures with new foods.
Feeling and Body Investigator_ARFID Division (FBI-ARFID)Behavioural
Also called FBI-ARFID
A sensory and somatic focused intervention that educates children about feelings and bodily sensations, in-session exposures to body and food sensations, different strategies to improve generalization while at home, and strategies to help them understand and track experiences exploring food.
| Study group | Role | What they receive |
|---|---|---|
| Family Assisted Diet (FAD) | Active comparator | This is a 20-session intervention with a child and the child's parents that consists of helping parents set goals around their child's renourishment; consider barriers to implementing proposed plans; thinking through strategies to avoid barriers; and providing ongoing support for plan implementation. Receives: Behavioral: Family Assisted Diet (FAD) |
| Feeling and Body Investigator_ARFID Division (FBI-ARFID) | Experimental | This is a 20-session intervention with a child and the child's parents that consists of 4 components: 1) psychoeducation of somatic body sensations and sensory features of foods using playful characters (e.g., Aftertaste Anthony); 2) in-session exercises that expose family members to different body and food sensations so they can learn something new about their body and food; 3) body brainstorm worksheets that help them generalize what they learn in session to outside of treatment; and 4) Decision-tree practice worksheets that help them map body sensations to meanings and actions and to track explorations with food. Receives: Behavioral: Feeling and Body Investigator_ARFID Division (FBI-ARFID) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of clinically severe symptoms of Avoidant Restrictive Food Intake Disorder (ARFID) as measured by the PARDI (Pica, ARFID, and Rumination Diagnostic Interview)
The 17-item PARDI measures symptoms including body mass index, diet quality, dependence on supplement use for sufficient calories, and psychosocial impairment. Each item assesses a symptom on a 0 - 6 scale, with scores above 4 indicating that it is a clinically severe symptom.
Measured: Baseline, Post-Treatment (up to 30 weeks), 3-Months Post-Treatment
Secondary outcomes (11)
Nutrition Quantity as measured by 3-day 24-hour dietary recalls
Nutrition Quantity is measured by two weekdays and one weekend day assisted dietary recall with the parent of the child. Using the Harris-Benedict equation to determine a child's nutritional needs, the following will be measured: 1) Child unable to meet daily energy requirements without supplement and/or 2) Child's dietary intake is below energy needs on all 3 days.
Measured: Baseline
Nutrition Quantity as measured by 3-day 24-hour dietary recalls
Nutrition Quantity is measured by two weekdays and one weekend day assisted dietary recall with the parent of the child. Using the Harris-Benedict equation to determine a child's nutritional needs, the following outcomes will be measured: 1) Child unable to meet daily energy requirements without supplement and/or 2) Child's dietary intake is below energy needs on all 3 days.
Measured: Post-Treatment (up to 30 weeks)
Psychosocial Functioning as measured by items on the PARDI
Psychosocial functioning is measured by items on the PARDI indicating that the child does not avoid social events due to eating/food and less than or equal to 1 indicating that the child is able to remain at the table and demonstrate age-appropriate behaviors.
Measured: Baseline
Psychosocial Functioning as measured by items on the PARDI
Psychosocial functioning is measured by items on the PARDI indicating that the child does not avoid social events due to eating/food and less than or equal to 1 indicating that the child is able to remain at the table and demonstrate age-appropriate behaviors.
Measured: Post-Treatment (up to 30 weeks)
Psychosocial Functioning as measured by items on the PARDI
Psychosocial functioning is measured by items on the PARDI indicating that the child does not avoid social events due to eating/food and less than or equal to 1 indicating that the child is able to remain at the table and demonstrate age-appropriate behaviors.
Measured: 3-Months Post-Treatment
Nutrition Quality as measured by 3-day 24-hour dietary recalls
Nutrition Quality is measured by the average macronutrient and micronutrient assessment from two weekdays and one weekend day assisted dietary recall with the parent of the child.
Measured: Baseline
Nutrition Quality as measured by 3-day 24-hour dietary recalls
Nutrition Quality is measured by the average macronutrient and micronutrient assessment from two weekdays and one weekend day assisted dietary recall with the parent of the child.
Measured: Post-Treatment (up to 30 weeks)
Body Mass Index (BMI) as measured by height and weight
BMI will be measured by parents at home with scales and tape measures provided to them.
Measured: Baseline
Body Mass Index (BMI) as measured by height and weight
BMI will be measured by parents at home with scales and tape measures provided to them.
Measured: Weekly (up to 30 weeks)
Body Mass Index (BMI) as measured by height and weight
BMI will be measured by parents at home with scales and tape measures provided to them.
Measured: Post-Treatment (up to 30 weeks)
Body Mass Index (BMI) as measured by height and weight
BMI will be measured by parents at home with scales and tape measures provided to them.
Measured: 3-Months Post-Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start10 Feb 2022
- Primary completion29 Sep 2025
- Study completion29 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ARFIDStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The design is a two-group (n=70 per group) randomized controlled trial. Primary outcomes including ARFID symptoms and secondary outcomes (e.g., responder status of weight gain) will be assessed at baseline, posttreatment, and 3-month follow-up, while abbreviated measures will be assessed every session.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Nancy L Zucker, PhD, Principal investigator, Duke UniversityGuillermo Sapiro, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105308
- Sponsor's protocol ID
- Pro00103645
- Other IDs
- 1R33MH121549-01A1
- Status last verified
- May 2025
- First submitted
- 22 Oct 2021
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zucker N, Mauro C, Craske M, Wagner HR, Datta N, Hopkins H, Caldwell K, Kiridly A, Marsan S, Maslow G, Mayer E, Egger H. Acceptance-based interoceptive exposure for young children with functional abdominal pain. Behav Res Ther. 2017 Oct;97:200-212. doi: 10.1016/j.brat.2017.07.009. Epub 2017 Jul 29.
PubMed 28826066Zucker NL, LaVia MC, Craske MG, Foukal M, Harris AA, Datta N, Savereide E, Maslow GR. Feeling and body investigators (FBI): ARFID division-An acceptance-based interoceptive exposure treatment for children with ARFID. Int J Eat Disord. 2019 Apr;52(4):466-472. doi: 10.1002/eat.22996. Epub 2018 Dec 31.
PubMed 30597590
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chompions! A Treatment Study for Childhood Avoidant/Restrictive Food Intake Disorder (ARFID)
- ClinicalTrials.gov ID
- NCT05105308
- Acronym / sponsor ID
- Pro00103645
- Conditions
- ARFID, Picky Eating, Eating Disorders in Children
- Keywords
- FBI-ARFID, Eating Disorder, Avoidant Restrictive Food Intake Disorder, Food Neophobia, Treatment for Children, Sensory Sensitivity, Picky Eating, Low Weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 29 Sep 2025 (actual)
- Study completion
- 29 Sep 2025 (actual)
- First posted
- 3 Nov 2021 (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.
Avoidant Restrictive Food Intake Disorder (ARFID) is a disorder that affects toddlers, children, adolescents, and adults. Individuals with ARFID are not able to consume an adequate amount or variety of food to a degree that it affects their mental and/or physical health. ARFID often begins in early childhood so it is important to treat children in early in life as possible to prevent any negative consequences of poor nutrition. There are currently no treatments for young children with ARFID. The investigators have developed two different study programs and the purpose of this study is to test them out and see if they help children with ARFID and to learn more about how these study programs work.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The design is a two-group (n=70 per group) randomized controlled trial. Primary outcomes including ARFID symptoms and secondary outcomes (e.g., responder status of weight gain) will be assessed at baseline, posttreatment, and 3-month follow-up, while abbreviated measures will be assessed every session.
| Arm | Type | Receives |
|---|---|---|
| Family Assisted Diet (FAD) | Active comparator | Behavioral: Family Assisted Diet (FAD)This is a 20-session intervention with a child and the child's parents that consists of helping parents set goals around their child's renourishment; consider barriers to implementing proposed plans; thinking through strategies to avoid barriers; and providing ongoing support for plan implementation. |
| Feeling and Body Investigator_ARFID Division (FBI-ARFID) | Experimental | Behavioral: Feeling and Body Investigator_ARFID Division (FBI-ARFID)This is a 20-session intervention with a child and the child's parents that consists of 4 components: 1) psychoeducation of somatic body sensations and sensory features of foods using playful characters (e.g., Aftertaste Anthony); 2) in-session exercises that expose family members to different body and food sensations so they can learn something new about their body and food; 3) body brainstorm worksheets that help them generalize what they learn in session to outside of treatment; and 4) Decision-tree practice worksheets that help them map body sensations to meanings and actions and to track explorations with food. |
Who may qualify
- Ages
- 60 to 119 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Child is between 60 and 119 months (5 years and up to 9 years, 11 months)
- English Speaking
- Consent given by parent and assent by child
- Score of 29 or above on the Child Food Neophobia Scale
- Underweight
Key exclusion criteria (4 listed)
- Child is known to have a severe intellectual disability based on medical chart review
- Meets diagnostic criteria for anorexia nervosa or bulimia nervosa
- Is currently enrolled in a treatment study or receiving active treatment for ARFID
- Taking medications known to affect appetite
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Assisted Diet (FAD)Also: FADA behavioral intervention consisting of helping parents renourish their child and conduct food exposures with new foods. | Behavioural | Family Assisted Diet (FAD) |
| Feeling and Body Investigator_ARFID Division (FBI-ARFID)Also: FBI-ARFIDA sensory and somatic focused intervention that educates children about feelings and bodily sensations, in-session exposures to body and food sensations, different strategies to improve generalization while at home, and strategies to help them understand and track experiences exploring food. | Behavioural | Feeling and Body Investigator_ARFID Division (FBI-ARFID) |
Primary outcome
Change in the number of clinically severe symptoms of Avoidant Restrictive Food Intake Disorder (ARFID) as measured by the PARDI (Pica, ARFID, and Rumination Diagnostic Interview)
Time frame: Baseline, Post-Treatment (up to 30 weeks), 3-Months Post-Treatment
The 17-item PARDI measures symptoms including body mass index, diet quality, dependence on supplement use for sufficient calories, and psychosocial impairment. Each item assesses a symptom on a 0 - 6 scale, with scores above 4 indicating that it is a clinically severe symptom.
11 secondary outcomes
Nutrition Quantity as measured by 3-day 24-hour dietary recalls
Time frame: Baseline
Nutrition Quantity as measured by 3-day 24-hour dietary recalls
Time frame: Post-Treatment (up to 30 weeks)
Psychosocial Functioning as measured by items on the PARDI
Time frame: Baseline
Psychosocial Functioning as measured by items on the PARDI
Time frame: Post-Treatment (up to 30 weeks)
Psychosocial Functioning as measured by items on the PARDI
Time frame: 3-Months Post-Treatment
Nutrition Quality as measured by 3-day 24-hour dietary recalls
Time frame: Baseline
Nutrition Quality as measured by 3-day 24-hour dietary recalls
Time frame: Post-Treatment (up to 30 weeks)
Body Mass Index (BMI) as measured by height and weight
Time frame: Baseline
Body Mass Index (BMI) as measured by height and weight
Time frame: Weekly (up to 30 weeks)
Body Mass Index (BMI) as measured by height and weight
Time frame: Post-Treatment (up to 30 weeks)
Body Mass Index (BMI) as measured by height and weight
Time frame: 3-Months Post-Treatment
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 17 Feb 2026.
- Background: PubMed 28826066Zucker N, Mauro C, Craske M, Wagner HR, Datta N, Hopkins H, Caldwell K, Kiridly A, Marsan S, Maslow G, Mayer E, Egger H. Acceptance-based interoceptive exposure for young children with functional abdominal pain. Behav Res Ther. 2017 Oct;97:200-212. doi: 10.1016/j.brat.2017.07.009. Epub 2017 Jul 29.
- Background: PubMed 30597590Zucker NL, LaVia MC, Craske MG, Foukal M, Harris AA, Datta N, Savereide E, Maslow GR. Feeling and body investigators (FBI): ARFID division-An acceptance-based interoceptive exposure treatment for children with ARFID. Int J Eat Disord. 2019 Apr;52(4):466-472. doi: 10.1002/eat.22996. Epub 2018 Dec 31.
- Individual participant dataSharing planned: No
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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.
Nancy L Zucker, PhD principal investigator
Duke University
Guillermo Sapiro, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Assisted Diet (FAD) and Feeling and Body Investigator_ARFID Division (FBI-ARFID) in people with ARFID and Picky Eating, run by Duke University 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 9 inclusion and 4 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 17 Feb 2026. 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?
Change in the number of clinically severe symptoms of Avoidant Restrictive Food Intake Disorder (ARFID) as measured by the PARDI (Pica, ARFID, and Rumination Diagnostic Interview) (time frame: Baseline, Post-Treatment (up to 30 weeks), 3-Months Post-Treatment). 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 NCT05105308, which also lists 2 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 17 Feb 2026.