Trial results for an integrated nutrition intervention targeting children with Autism Spectrum Disorder were posted on ClinicalTrials.gov on 2025-11-19. The study, which enrolled 132 participants, reported that the intervention group achieved a least squares mean increase of 0.313 cup equivalents in fruit and vegetable intake.
Background
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.
Trial design
This completed study, designated as Phase NA, enrolled 132 participants with Autism Spectrum Disorder. The trial investigated an integrated nutrition intervention, comparing the "Autism Eats Nutrition Intervention" group against a "We Can! Enhanced Usual Care Control" group. The study aimed to promote healthy eating habits for children with ASD.
Key results
The trial reported several key measurements related to dietary changes:
- Change in Fruit and Vegetable Intake From Baseline, as Measured by the Daily Amount of Fruit and Vegetables Consumed by Children (cup equivalents):
- For the Autism Eats Nutrition Intervention group, a least squares mean change of 0.313 cup equivalents was observed.
- For the We Can! Enhanced Usual Care Control group, a least squares mean change of -0.045 cup equivalents was observed.
- Another measurement for the Autism Eats Nutrition Intervention group showed a least squares mean change of 0.549 cup equivalents.
- Another measurement for the We Can! Enhanced Usual Care Control group showed a least squares mean change of -0.077 cup equivalents.
- Change in Food Variety From Baseline, as Measured by the Daily Food Counts Consumed by Children (number of unique food codes per day):
- For the Autism Eats Nutrition Intervention group, a least squares mean change of 0.856 number of unique food codes per day was observed.
- For the We Can! Enhanced Usual Care Control group, a least squares mean change of -0.362 number of unique food codes per day was observed.
- Another measurement for the Autism Eats Nutrition Intervention group showed a least squares mean change of -0.031 number of unique food codes per day.
- Another measurement for the We Can! Enhanced Usual Care Control group showed a least squares mean change of -0.726 number of unique food codes per day.
- 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. (scores on a scale):
- For the Autism Eats Nutrition Intervention group, a least squares mean change of -2.179 scores on a scale was observed.
- For the We Can! Enhanced Usual Care Control group, a least squares mean change of -0.510 scores on a scale was observed.
- Another measurement for the Autism Eats Nutrition Intervention group showed a least squares mean change of -1.079 scores on a scale.
- Another measurement for the We Can! Enhanced Usual Care Control group showed a least squares mean change of -0.589 scores on a scale.
What this means
The results suggest that the "Autism Eats Nutrition Intervention" had a positive impact on increasing fruit and vegetable intake and improving food variety in children with Autism Spectrum Disorder, compared to the enhanced usual care control. While the intervention group showed increases in specific healthy eating habits, both the intervention and control groups experienced a decrease in overall diet quality as measured by the Healthy Eating Index scores. This indicates that while targeted nutritional improvements were observed, broader dietary quality remains a complex challenge for this population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05194345, titled "An Integrated Nutrition Intervention to Promote Healthy Eating Habits for Children With ASD", were posted on 2025-11-19 on clinicaltrials.gov.