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ARFID Therapies for Picky Eating
N/A
Waitlist Available
Led By Nancy L Zucker, PhD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Underweight
Child is between 60 and 119 months (5 years and up to 9 years, 11 months)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, post-treatment (up to 30 weeks), 3-months post-treatment
Awards & highlights
Study Summary
This trial is testing out two possible treatments for ARFID in young children to see if they help and to learn more about how they work.
Who is the study for?
This trial is for children aged 5 to almost 10 years with ARFID, who rely on supplements for calories and show significant picky eating. They must be English-speaking and not taking appetite-affecting meds, have no severe intellectual disability or other eating disorders like anorexia or bulimia, and not be in another ARFID treatment study.Check my eligibility
What is being tested?
The study tests two programs: Family Assisted Diet (FAD) and Feeling & Body Investigator_ARFID Division, designed to help young kids with ARFID eat better. It aims to find out if these treatments can improve the variety of foods they eat without causing stress.See study design
What are the potential side effects?
Since this trial involves dietary interventions rather than medication, side effects may include initial resistance to new foods or mealtime stress but are expected to be minimal compared to drug-related trials.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am considered underweight for my height.
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My child is between 5 and 9 years old.
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I have been diagnosed with ARFID.
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I speak English.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, post-treatment (up to 30 weeks), 3-months post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, post-treatment (up to 30 weeks), 3-months post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.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)
Secondary outcome measures
Body Mass Index (BMI) as measured by height and weight
Nutrition Quality as measured by 3-day 24-hour dietary recalls
Nutrition Quantity as measured by 3-day 24-hour dietary recalls
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Feeling and Body Investigator_ARFID Division (FBI-ARFID)Experimental Treatment1 Intervention
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.
Group II: Family Assisted Diet (FAD)Active Control1 Intervention
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.
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Who is running the clinical trial?
Duke UniversityLead Sponsor
2,381 Previous Clinical Trials
3,427,510 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,798 Previous Clinical Trials
2,660,715 Total Patients Enrolled
Nancy L Zucker, PhDPrincipal InvestigatorDuke University
1 Previous Clinical Trials
18 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am considered underweight for my height.I have been diagnosed with anorexia nervosa or bulimia nervosa.I am currently in a study or receiving treatment for ARFID.I am on medication that affects my appetite.My child is between 5 and 9 years old.I have been diagnosed with ARFID.I speak English.
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