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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
Parents should be 18 years or older and speak fluent English and/or Spanish
Both the child and the parent should be available during the EI service time
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, post-intervention (10 weeks from baseline), and 5-month follow-up
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
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I am over 18 and speak English or Spanish fluently.
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Both my child and I can attend the early intervention service sessions.
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My child is between 0 and 36 months old.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 outcome measures
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

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).

Find a Location

Who is running the clinical trial?

University of South FloridaLead Sponsor
402 Previous Clinical Trials
185,113 Total Patients Enrolled
12 Trials studying Autism Spectrum Disorder
976 Patients Enrolled for Autism Spectrum Disorder
Heewon L Gray, PhD, RDNPrincipal InvestigatorUniversity of South Florida

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum number of participants that are being recruited for this experiment?

"Indeed, clinicaltrials.gov affirms that this clinical trial is presently enrolling participants with its original posting on January 27th 2022 and most recent update occurring May 16th 2022. Currently, the study requires 48 enrollees from a single site."

Answered by AI

Is there currently an open enrollment period for this trial?

"Data hosted on clinicaltrials.gov reveals that this experiment, initially published on January 27th 2022, is actively enrolling participants. The last update was posted May 16th 2022."

Answered by AI

Who else is applying?

What state do they live in?
New York
Florida
Pennsylvania
How old are they?
18 - 65
< 18
What site did they apply to?
University of South Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
~16 spots leftby Mar 2025