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NCT05194345 · ClinicalTrials.gov registry record · NA
An Integrated Nutrition Intervention to Promote Healthy Eating Habits for Children With ASD
A NA study of Autism Spectrum Disorder, sponsored by University of South Florida.
- Completed
- Registry status
- NA
- Development phase
- 132
- Enrollment target
- 1
- Study location
NCT05194345 is a NA study of Autism Spectrum Disorder that has completed, run by University of South Florida. The registered enrollment target is 132 participants, roughly in line with the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target. The trial reports 1 study location across 1 state.
The verdict
NCT05194345, a NA study of Autism Spectrum Disorder, has completed, sponsored by University of South Florida.
- COMPLETED
- Registry status
- NA
- Development phase
- 132 participants
- Enrollment target
- 1
- Study location
Study 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 chronic health conditions. Children with ASD tend to consume few fruit and vegetables and mainly high-energy dense foods, including sugar-sweetened beverages and processed snacks. Obesity prevalence in children with ASD is up to 40% higher than in typically developing children, and recent studies show significantly elevated risks of hyperlipidemia and hypertension among individuals with ASD, regardless of using psychotropic medications. Our interdisciplinary team conducted a preliminary study to examine diet quality and mealtime behaviors among diverse children with ASD in Florida (34% Hispanic/Latino) and parental preferences for nutrition interventions. Based on the study findings, we developed the manual for our nutrition intervention, Autism Eats, for children with ASD enrolled in the Part C of Individuals with Disabilities Education Act (IDEA) Early Intervention (EI) services. Our Autism Eats manual and parent materials are based on ASD-specific feeding strategies such as food chaining combined with behaviorally-focused nutrition intervention strategies such as goal setting and weekly meal planning to promote healthy eating. Among children with ASD enrolled in Part C EI services in Florida, we will conduct a randomized controlled trial (RCT) with the nutrition intervention program, Autism Eats, and the enhanced usual care (EUC) comparison program. The Autism Eats intervention is to prevent problematic mealtime behaviors and promote development of healthy eating habits. We expect that implementing the Autism Eats will be feasible and the intervention will be well-received by EI providers and parent-child dyads. We will examine differences in children's food intakes (fruit and vegetables), food variety, diet quality, and problematic mealtime behaviors between children
Conditions Studied
Interventions
- BEHAVIORAL Autism Eats nutrition intervention
- BEHAVIORAL We Can! enhanced usual care
Study Locations (1)
Florida
- University of South Florida - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2022-01-27 |
| Est. Completion | 2024-05-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05194345
The ClinicalTrials.gov registry entry for NCT05194345 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target. The listed sponsor is University of South Florida, which has 252 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 2 interventions - of which Autism Eats nutrition intervention is the first listed.
NCT05194345 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT05194345 about?
NCT05194345 is a clinical study titled "An Integrated Nutrition Intervention to Promote Healthy Eating Habits for Children With ASD". 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 chronic health conditions. Children with ASD tend to consume few fruit and vegetables and mainly high...
What is the current status of trial NCT05194345?
This trial is currently completed. It is a NA study. The enrollment target is 132 participants. The study started on 2022-01-27. Estimated completion is 2024-05-31.
What conditions does trial NCT05194345 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder.
What interventions are being tested in trial NCT05194345?
The interventions under investigation include: Autism Eats nutrition intervention (BEHAVIORAL), We Can! enhanced usual care (BEHAVIORAL).
Who is sponsoring clinical trial NCT05194345?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05194345 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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