Skip to main content
OpenTrials
Completed

NCT Number: NCT05105308

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

ARFID Avoidant Restrictive Food Intake Disorder Behavior Body Weight Eating Disorders in Children Feeding Behavior Feeding and Eating Disorders Food Fussiness Malnutrition Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Picky Eating Signs and Symptoms Signs and Symptoms, Digestive Thinness

Age range

60 month–119 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Family Assisted Diet (FAD)

Behavioral

A behavioral intervention consisting of helping parents renourish their child and conduct food exposures with new foods.

Other names: FAD

Feeling and Body Investigator_ARFID Division (FBI-ARFID)

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 3, 2021
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.