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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: Completed NA study of Autism Spectrum Disorder, sponsored by University of South Florida.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

Change in daily fruit and vegetable intake based on 3-day food records. Daily amount (in cup equivalent) of fruit and vegetable intake from each child participant will be estimated based on parent report 3-day food records. The change amount of fruit and vegetable intake at post- from the baseline and at 5-month follow-up from the baseline will be compared between the intervention and the enhanced usual care (EUC) control groups.

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

FieldValue
Enrollment Target 132 participants
Start Date 2022-01-27
Est. Completion 2024-05-31
Phase NA
University of South Florida

252 total trials

What the finished NCT05194345 record still lists

NCT05194345 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target.

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 a single indexed study location in 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.

Similar trials for Autism Spectrum Disorder

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05194345's enrollment target sits among peer trials

132 64th of 224 higher than 160 of 224 other Autism Spectrum Disorder trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Autism Spectrum Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05194345, the US trial registry maintained by the National Library of Medicine. NCT05194345 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.