Autism Eats nutrition intervention for Autism

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of South Florida, Tampa, FLAutism+1 MoreAutism Eats nutrition intervention - Behavioral
Eligibility
< 18
All Sexes
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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.

Eligible Conditions
  • Autism

Treatment Effectiveness

Study Objectives

3 Primary · 2 Secondary · Reporting Duration: baseline, post-intervention (10 weeks from baseline), and 5-month follow-up

Baseline
demographic characteristics
reach/participation, as measured in number of people reached and percent participation
Baseline, 5-month follow-up
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 child feeding practices, as measured in mean on the Child Feeding Questionnaire using a 5-point scale.
parent BMI, as measured in kg/m² calculated from height (m) and weight (kg).
Week 10
Change in mealtime behaviors, as measured by total score of the Brief Autism Mealtime Behavior Inventory (score ranges 5-90).
End of study (5-month follow-up)
attrition, in percentage
compatibility, as measured in a 5-point scale of the provider exit survey/interview
fidelity, as measured in a 5-point scale
intervention completion, in percentage
Week 10
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

Trial Safety

Trial Design

2 Treatment Groups

We Can! enhanced usual care control
1 of 2
Autism Eats nutrition intervention
1 of 2

Active Control

Experimental Treatment

48 Total Participants · 2 Treatment Groups

Primary Treatment: Autism Eats nutrition intervention · No Placebo Group · N/A

Autism Eats nutrition intervention
Behavioral
Experimental Group · 1 Intervention: Autism Eats nutrition intervention · Intervention Types: Behavioral
We Can! enhanced usual care control
Behavioral
ActiveComparator Group · 1 Intervention: We Can! enhanced usual care · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, post-intervention (10 weeks from baseline), and 5-month follow-up

Who is running the clinical trial?

University of South FloridaLead Sponsor
377 Previous Clinical Trials
102,384 Total Patients Enrolled
Heewon L Gray, PhD, RDNPrincipal InvestigatorUniversity of South Florida

Eligibility Criteria

Age < 18 · All Participants · 3 Total Inclusion Criteria

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Who else is applying?

What state do they live in?
Pennsylvania50.0%
Florida25.0%
New York25.0%
How old are they?
< 1850.0%
18 - 6550.0%
What site did they apply to?
University of South Florida100.0%
What portion of applicants met pre-screening criteria?
Met criteria50.0%
Did not meet criteria50.0%
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.