Chompions! A Treatment Study for Childhood Avoidant/Restrictive Food Intake Disorder (ARFID)

February 12, 2026 updated by: Duke University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

203

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 9 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Behavioral: Family Assisted Diet (FAD)
A behavioral intervention consisting of helping parents renourish their child and conduct food exposures with new foods.
Other Names:
  • FAD
Experimental: 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.
Behavioral: Feeling and Body Investigator_ARFID Division (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.
Other Names:
  • FBI-ARFID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Post-Treatment (up to 30 weeks), 3-Months Post-Treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutrition Quantity as measured by 3-day 24-hour dietary recalls
Time Frame: Baseline
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.
Baseline
Nutrition Quantity as measured by 3-day 24-hour dietary recalls
Time Frame: Post-Treatment (up to 30 weeks)
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.
Post-Treatment (up to 30 weeks)
Psychosocial Functioning as measured by items on the PARDI
Time Frame: Baseline
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.
Baseline
Psychosocial Functioning as measured by items on the PARDI
Time Frame: Post-Treatment (up to 30 weeks)
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.
Post-Treatment (up to 30 weeks)
Psychosocial Functioning as measured by items on the PARDI
Time Frame: 3-Months Post-Treatment
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.
3-Months Post-Treatment
Nutrition Quality as measured by 3-day 24-hour dietary recalls
Time Frame: Baseline
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.
Baseline
Nutrition Quality as measured by 3-day 24-hour dietary recalls
Time Frame: Post-Treatment (up to 30 weeks)
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.
Post-Treatment (up to 30 weeks)
Body Mass Index (BMI) as measured by height and weight
Time Frame: Baseline
BMI will be measured by parents at home with scales and tape measures provided to them.
Baseline
Body Mass Index (BMI) as measured by height and weight
Time Frame: Weekly (up to 30 weeks)
BMI will be measured by parents at home with scales and tape measures provided to them.
Weekly (up to 30 weeks)
Body Mass Index (BMI) as measured by height and weight
Time Frame: Post-Treatment (up to 30 weeks)
BMI will be measured by parents at home with scales and tape measures provided to them.
Post-Treatment (up to 30 weeks)
Body Mass Index (BMI) as measured by height and weight
Time Frame: 3-Months Post-Treatment
BMI will be measured by parents at home with scales and tape measures provided to them.
3-Months Post-Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Nancy L Zucker, PhD, Duke University
  • Principal Investigator: Guillermo Sapiro, PhD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2022

Primary Completion (Actual)

September 29, 2025

Study Completion (Actual)

September 29, 2025

Study Registration Dates

First Submitted

October 22, 2021

First Submitted That Met QC Criteria

October 22, 2021

First Posted (Actual)

November 3, 2021

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00103645
  • 1R33MH121549-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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