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

• ClinicalTrials.gov Identifier: NCT05105308
• Recruitment Status: Recruiting
• First Posted: November 3, 2021
• Last Update Posted: December 19, 2022
• Sponsor: Duke University
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Duke University

Tracking Information

• First Submitted Date: October 22, 2021
• First Posted Date: November 3, 2021
• Last Update Posted Date: December 19, 2022
• Actual Study Start Date: February 10, 2022
• Estimated Primary Completion Date: November 1, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 22, 2021)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 22, 2021)

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Chompions! A Treatment Study for Childhood Avoidant/Restrictive Food Intake Disorder (ARFID)
• Official Title: Chompions! A Treatment Study for Childhood Avoidant/Restrictive Food Intake Disorder (ARFID)
• Brief 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. 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Outcomes Assessor)
Masking Description:

Individuals who conduct the diagnostic interview will not be informed of the intervention arm to which a child is randomized.

Primary Purpose: Treatment

Condition

• ARFID
• Picky Eating
• Eating Disorders in Children

Intervention

• Behavioral: Family Assisted Diet (FAD)
  A behavioral intervention consisting of helping parents renourish their child and conduct food exposures with new foods.
• Behavioral: Feeling and Body Investigator_ARFID Division
  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 Name: FBI-ARFID

Study Arms

• 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.
  Intervention: Behavioral: Family Assisted Diet (FAD)
• Experimental: Feeling and Body Investigator_ARFID Division
  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.
  Intervention: Behavioral: Feeling and Body Investigator_ARFID Division

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.
• Zucker 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 22, 2021): 170
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 1, 2025
• Estimated Primary Completion Date: November 1, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 60 Months to 119 Months (Child)
• Accepts Healthy Volunteers: No

Contacts

Contact: Nancy L Zucker, PhD; 919-385-0828; zucke001@mc.duke.edu

Contact: Ilana R Pilato, PhD; 919-660-7649; ilana.pilato@duke.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05105308
• Other Study ID Numbers: Pro00103645; 1R33MH121549-01A1 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Duke University
• Original Responsible Party: Same as current
• Current Study Sponsor: Duke University
• Original Study Sponsor: Same as current
• Collaborators: National Institute of Mental Health (NIMH)

Investigators

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

• PRS Account: Duke University
• Verification Date: December 2022