← Back to Search

Nutrition Intervention for Autism

N/A

Waitlist Available

Led By Heewon L Gray, PhD, RDN

Research Sponsored by University of South Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Both the child and the parent should be available during the EI service time

Be younger than 18 years old

Must not have

Parent's first language is not English or Spanish

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, post-intervention (10 weeks from baseline), and 5-month follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether the "Autism Eats" nutrition intervention program can help children with ASD develop healthy eating habits, by examining differences in fruit and vegetable intake, diet quality, and problematic mealtime behaviors between children in the intervention group and those in the comparison group.

Who is the study for?

This trial is for children with Autism Spectrum Disorder (ASD) aged birth to 36 months enrolled in early intervention services. Participants must have an ASD diagnosis, and both the child and parent should be available during service times. Parents need to be over 18 and speak English or Spanish fluently.

What is being tested?

The study tests a nutrition program called 'Autism Eats' against enhanced usual care (EUC). The goal is to prevent problematic eating behaviors and promote healthy habits in children with ASD by using strategies like food chaining, goal setting, and meal planning.

What are the potential side effects?

Since this trial focuses on nutritional interventions rather than medications, there are no direct side effects as one would expect from drug trials. However, changes in diet may initially cause mild digestive adjustments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

Both my child and I can attend the early intervention service sessions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My parent's first language is neither English nor Spanish.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, post-intervention (10 weeks from baseline), and 5-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, post-intervention (10 weeks from baseline), and 5-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post-intervention (10 weeks from baseline), and 5-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Change in food variety from baseline, as measured by the daily food counts consumed by children

Change in fruit and vegetable intake from baseline, as measured by the daily amount of fruit and vegetables consumed by children

Secondary study objectives

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.

Change in mealtime behaviors, as measured by total score of the Brief Autism Mealtime Behavior Inventory (score ranges 5-90).

Other study objectives

attrition, in percentage

change in child feeding practices, as measured in mean on the Child Feeding Questionnaire using a 5-point scale.

compatibility, as measured in a 5-point scale of the provider exit survey/interview

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Autism Eats nutrition interventionExperimental Treatment1 Intervention

Autism Eats intervention lessons (10 lessons + 2 booster sessions) integrate ASD-specific feeding strategies such as repeated exposures, food chaining, and making regular mealtime routines and behaviorally-focused nutrition content and activities utilizing goal setting, healthy meal planning, monitoring progress, strategies to overcome barriers, and creating healthy home food environment. The early intervention (EI) providers will be trained to implement the lessons. EI providers are well-trained to use personalized intervention and coaching approach in their EI services, which will be applied to Autism Eats activities as well. Each intervention lesson will take 25-30 minutes within one hour EI services, and parent-child dyads will participate in the intervention as part of their regular EI services. The Autism Eats lesson manual will be provided to the EI providers and the parent handbook will be distributed to the parent participants.

Group II: We Can! enhanced usual care controlActive Control1 Intervention

Enhanced usual care (EUC) control group materials are from the evidence-based materials that are already developed and available online (in both English and Spanish): https://www.nhlbi.nih.gov/health/educational/wecan/index.htm. We will download one to two handouts and email early intervention providers to distribute them to parent-child dyads. Materials will be distributed each week for 10 weeks and additional monthly handouts for two months after the first 10 weeks (parallel to the intervention schedule).

0 / 2Eligibility criteria met