Status:
COMPLETED
An Integrated Nutrition Intervention to Promote Healthy Eating Habits for Children With ASD
Lead Sponsor:
University of South Florida
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
Up to 36 years
Phase:
NA
Brief Summary
There is an unmet need for nutrition interventions that address both autism spectrum disorder (ASD) specific feeding challenges and unbalanced eating habits among children with ASD to prevent future c...
Detailed Description
The aim of the study is to evaluate the feasibility and preliminary efficacy of Autism Eats in improving dietary intake and mealtime behaviors of children with ASD. We will enroll 30 early interventio...
Eligibility Criteria
Inclusion
- Children should be enrolled in the early intervention (EI) service and diagnosed with ASD determined by clinical assessment such as the Autism Diagnostic Observation Schedule (ADOS) or another validated evaluation tool (e.g., Gilliam Autism Rating Scale, GARS-3), if available, or be at-risk/monitored for ASD with a pending diagnosis at the time of screening. Children birth to 36 months are eligible for the EI services, and therefore, age of our research participants will range from birth to 36 months. The ASD diagnosis verification process occurs in two steps: (1) during screening; and (2) at the 5-month follow up assessment, taking into consideration the pending diagnosis at screening and potential changes in diagnosis status due to the young age of the children.
- Both the child and the parent should be available during the EI service time.
- Parents should be 18 years or older and speak fluent English and/or Spanish
Exclusion
- Children who are on exclusive breastfeeding, medicines that may interact with appetite and food consumption, having severe GI conditions such as irritable bowel syndrome, diagnosed with feeding disorders or severe food selectivity (consuming fewer than 5 food items), or other serious medical comorbidities such as cancer.
- Children who are receiving the EI service at a daycare setting or other than home setting.
- Parent and child with ASD who have previously participated in a similar nutrition intervention study will also be excluded.
- Parent's first language is not English or Spanish.
Key Trial Info
Start Date :
January 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2024
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT05194345
Start Date
January 27 2022
End Date
May 31 2024
Last Update
November 19 2025
Active Locations (1)
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1
University of South Florida
Tampa, Florida, United States, 33612