search
Back to results

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

Primary Purpose

ARFID, Picky Eating, Eating Disorders in Children

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family Assisted Diet (FAD)
Feeling and Body Investigator_ARFID Division
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ARFID focused on measuring FBI-ARFID, Eating Disorder, Avoidant Restrictive Food Intake Disorder, Food Neophobia, Treatment for Children, Sensory Sensitivity, Picky Eating, Low Weight, Nutritional Deficiencies

Eligibility Criteria

60 Months - 119 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Family Assisted Diet (FAD)

Feeling and Body Investigator_ARFID Division

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
October 22, 2021
Last Updated
December 16, 2022
Sponsor
Duke University
Collaborators
National Institute of Mental Health (NIMH)
search

1. Study Identification

Unique Protocol Identification Number
NCT05105308
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2022 (Actual)
Primary Completion Date
November 1, 2025 (Anticipated)
Study Completion Date
November 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, Nutritional Deficiencies

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Individuals who conduct the diagnostic interview will not be informed of the intervention arm to which a child is randomized.
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Family Assisted Diet (FAD)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Feeling and Body Investigator_ARFID Division
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Family Assisted Diet (FAD)
Intervention Description
A behavioral intervention consisting of helping parents renourish their child and conduct food exposures with new foods.
Intervention Type
Behavioral
Intervention Name(s)
Feeling and Body Investigator_ARFID Division
Other Intervention Name(s)
FBI-ARFID
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
Baseline, Post-Treatment (up to 30 weeks), 3-Months Post-Treatment
Secondary Outcome Measure Information:
Title
Nutrition Quantity as measured by 3-day 24-hour dietary recalls
Description
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.
Time Frame
Baseline
Title
Nutrition Quantity as measured by 3-day 24-hour dietary recalls
Description
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.
Time Frame
Post-Treatment (up to 30 weeks)
Title
Psychosocial Functioning as measured by items on the PARDI
Description
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.
Time Frame
Baseline
Title
Psychosocial Functioning as measured by items on the PARDI
Description
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.
Time Frame
Post-Treatment (up to 30 weeks)
Title
Psychosocial Functioning as measured by items on the PARDI
Description
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.
Time Frame
3-Months Post-Treatment
Title
Nutrition Quality as measured by 3-day 24-hour dietary recalls
Description
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.
Time Frame
Baseline
Title
Nutrition Quality as measured by 3-day 24-hour dietary recalls
Description
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.
Time Frame
Post-Treatment (up to 30 weeks)
Title
Body Mass Index (BMI) as measured by height and weight
Description
BMI will be measured by parents at home with scales and tape measures provided to them.
Time Frame
Baseline
Title
Body Mass Index (BMI) as measured by height and weight
Description
BMI will be measured by parents at home with scales and tape measures provided to them.
Time Frame
Weekly (up to 30 weeks)
Title
Body Mass Index (BMI) as measured by height and weight
Description
BMI will be measured by parents at home with scales and tape measures provided to them.
Time Frame
Post-Treatment (up to 30 weeks)
Title
Body Mass Index (BMI) as measured by height and weight
Description
BMI will be measured by parents at home with scales and tape measures provided to them.
Time Frame
3-Months Post-Treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Months
Maximum Age & Unit of Time
119 Months
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nancy L Zucker, PhD
Phone
919-385-0828
Email
zucke001@mc.duke.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ilana R Pilato, PhD
Phone
919-660-7649
Email
ilana.pilato@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy L Zucker, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guillermo Sapiro, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilana B Pilato, PhD
Phone
919-660-7649
Email
ilana.pilato@duke.edu
First Name & Middle Initial & Last Name & Degree
Nancy Zucker, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28826066
Citation
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.
Results Reference
background
PubMed Identifier
30597590
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs