An Integrated Nutrition Intervention to Promote Healthy Eating Habits for Children With ASD

NCT05194345 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2025-11-19

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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 in Autism Eats and those in the EUC groups at post-intervention and 5-month follow-up from baseline.

Conditions

Interventions

BEHAVIORAL

Autism Eats nutrition intervention

The Autism Eats intervention group will spend about 8.5 hours over 5 months (baseline, post intervention, and 5-month follow-up assessments are 30 minutes each, 25-30 minutes weekly sessions for up to 10 weeks, two 25-30 minutes monthly booster sessions, and a 60-minute exit interview). The Autism Eats intervention group EI provider will spend about 12 hours over 5 months (two 90-minutes training sessions, 25-30 minutes weekly sessions for up to 10 weeks, two 25-30 minutes monthly booster sessions, 10-minute fidelity checklist completion after each session, and a 60-minute exit interview).

BEHAVIORAL

We Can! enhanced usual care

We Can! EUC control group will spend about 3 hours over 5 months (baseline, post intervention, and 5-month follow-up assessments are 30 minutes each, one 25-30 minute nutrition session, and a 60-minute exit interview). We Can! EUC control group EI provider will spend about 4.5 hours over 5 months (two 90-minutes training sessions, one 25-30 minutes session, 1-2-minute written material distribution at their 9 weekly EI sessions, and a 60-minute exit interview).

Sponsors & Collaborators

  • University of South Florida

    lead OTHER

Principal Investigators

  • Heewon L Gray, PhD, RDN · University of South Florida

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
36 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-27
Primary Completion
2024-05-24
Completion
2024-05-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05194345 on ClinicalTrials.gov