N/A
N=132
An Integrated Nutrition Intervention to Promote Healthy Eating Habits for Children With ASD
Autism Spectrum Disorder
Bottom Line
View on ClinicalTrials.gov: NCT05194345 ↗Enrolled (actual)
132
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Change in Fruit and Vegetable Intake From Baseline, as Measured by the Daily Amount of Fruit and Vegetables Consumed by Children — 0.313; -0.045; 0.549; -0.077 cup equivalents
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Autism Eats nutrition intervention (Behavioral); We Can! enhanced usual care (Behavioral)
- Age
- Pediatric
- Sex
- All
- Sponsor
- University of South Florida
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Fruit and Vegetable Intake From Baseline, as Measured by the Daily Amount of Fruit and Vegetables Consumed by Children |
0.313; -0.045; 0.549; -0.077 | — |
| PRIMARY Change in Food Variety From Baseline, as Measured by the Daily Food Counts Consumed by Children |
0.856; -0.362; -0.031; -0.726 | — |
| PRIMARY Change in Diet Quality From Baseline, as Measured by Mean Healthy Eating Index (HEI) Score From the Food Records. HEI Score Ranges From 0 to 100. |
-2.179; -0.510; -1.079; -0.589 | — |
| PRIMARY Change in Mealtime Behaviors, as Measured by Total Score of the Brief Autism Mealtime Behavior Inventory (Score Ranges 5-90). |
-5.151; -4.268; -3.413; -4.267; -0.499; -2.269 | — |
| SECONDARY Change in Child's Weight-for-length/BMI Percentile (Calculated With Height & Weight), as Measured by Percentile on the CDC Weight-for-length/BMI-for-age Growth Chart. |
-10.475; -2.653 | — |
| SECONDARY Change in Child Feeding Practices, as Measured in Mean on the Child Feeding Questionnaire Using a 5-point Scale. |
-0.214; 0.034; -0.299; -0.484; 0.088; 0.433 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT05194345). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.