An Integrated Nutrition Intervention to Promote Healthy Eating Habits for Children With ASD

NCT05194345 | Completed Results DMC

• 1 other identifier: STUDY002968
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder; Nutrition; Children; Feeding strategies; Intervention

Outcome Measures

Primary Outcomes (4)

• Change in Fruit and Vegetable Intake From Baseline, as Measured by the Daily Amount of Fruit and Vegetables Consumed by Children

  Change in daily fruit and vegetable intake based on 3-day food records. Daily amount (in cup equivalent) of fruit and vegetable intake from each child participant will be estimated based on parent report 3-day food records. The change amount of fruit and vegetable intake at post- from the baseline and at 5-month follow-up from the baseline will be compared between the intervention and the enhanced usual care (EUC) control groups.

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

• Change in Food Variety From Baseline, as Measured by the Daily Food Counts Consumed by Children

  Change in daily food counts based on 3-day food records. Daily number of food items from each child participant will be estimated based on parent report 3-day food records. The change in number of daily food items at post- from the baseline and at 5-month follow-up from the baseline will be compared between the intervention and the enhanced usual care (EUC) control groups.

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

• 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 HEI score based on 3-day food records. Daily mean HEI score from each child participant will be estimated based on parent report 3-day food records. The change in HEI score at post- from the baseline and at 5-month follow-up from the baseline will be compared between the intervention and the enhanced usual care (EUC) control groups. HEI score ranges 0-100, and higher values represent a better outcome (better diet quality).

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

• Change in Mealtime Behaviors, as Measured by Total Score of the Brief Autism Mealtime Behavior Inventory (Score Ranges 5-90).

  The Brief Autism Mealtime Behavior Inventory (BAMBI), which is validated and used in many previous research studies to assess children with ASD's problematic mealtime behaviors. Parents completed the survey via REDCap. The BAMBI contains 18 questions using a 5-point scale, with response options ranging from 1 (Never) to 5 (Almost every meal), for reporting the frequency of a behavior. The total score ranges from 18-90. The higher the score indicated more problematic mealtime behaviors (worse). Each question also has a yes or no option for parents to indicate if they perceive the behaviors as problematic (score range 0-18). There are subscales: Limited Variety, Food Refusal, and Features of Autism. The Limited Variety scale includes 8 items, with a score range of 8-40. The Food Refusal scale has 5 items, with a 5-25 score range. The Features of Autism includes 5 items with a 5-25 score range. The total score is the sum of all scores. The survey takes about 5 minutes to complete.

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

Secondary Outcomes (2)

• 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.

  Baseline, 5-month follow-up

• Change in Child Feeding Practices, as Measured in Mean on the Child Feeding Questionnaire Using a 5-point Scale.

  Baseline, 5-month follow-up

Other Outcomes (1)

• Parent BMI, as Measured in kg/m² Calculated From Height (m) and Weight (kg).

  Baseline, 5-month follow-up

Study Arms (2)

Autism Eats nutrition intervention

EXPERIMENTAL

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.

Behavioral: Autism Eats nutrition intervention

We Can! enhanced usual care control

ACTIVE COMPARATOR

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).

Behavioral: We Can! enhanced usual care

Interventions

Autism Eats nutrition intervention BEHAVIORAL

The Autism Eats intervention group will spend about 8.5 hours over 5 months (baseline, post intervention, and 5-month follow-up assessments are 30 minutes each, 25-30 minutes weekly sessions for up to 10 weeks, two 25-30 minutes monthly booster sessions, and a 60-minute exit interview). The Autism Eats intervention group EI provider will spend about 12 hours over 5 months (two 90-minutes training sessions, 25-30 minutes weekly sessions for up to 10 weeks, two 25-30 minutes monthly booster sessions, 10-minute fidelity checklist completion after each session, and a 60-minute exit interview).

Autism Eats nutrition intervention

We Can! enhanced usual care BEHAVIORAL

We Can! EUC control group will spend about 3 hours over 5 months (baseline, post intervention, and 5-month follow-up assessments are 30 minutes each, one 25-30 minute nutrition session, and a 60-minute exit interview). We Can! EUC control group EI provider will spend about 4.5 hours over 5 months (two 90-minutes training sessions, one 25-30 minutes session, 1-2-minute written material distribution at their 9 weekly EI sessions, and a 60-minute exit interview).

We Can! enhanced usual care control

Eligibility Criteria

• Age: Up to 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

University of South Florida

Tampa, Florida, 33612, United States

Location

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• Gray HL, Jimenez C, Pang T, Kim E, Shaffer-Hudkins E, Agazzi H, Rosado A, Klinger A, Young C, Kandil J, Won S, Perez A, Sayre WD, Waters KA, Miltenberger RG, Stern M. Recruitment feasibility and dietary and behavioral patterns in toddlers with ASD: Preliminary results from the Autism Eats program. Contemp Clin Trials. 2024 Nov;146:107688. doi: 10.1016/j.cct.2024.107688. Epub 2024 Sep 11.

  PMID: 39270747 DERIVED

• Gray HL, Pang T, Agazzi H, Shaffer-Hudkins E, Kim E, Miltenberger RG, Waters KA, Jimenez C, Harris M, Stern M. A nutrition education intervention to improve eating behaviors of children with autism spectrum disorder: Study protocol for a pilot randomized controlled trial. Contemp Clin Trials. 2022 Aug;119:106814. doi: 10.1016/j.cct.2022.106814. Epub 2022 Jun 4.

  PMID: 35671902 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Heewon Gray
• Organization: University of South Florida

hlgray@usf.edu

(813) 974-9881

Study Officials

• Heewon L Gray, PhD, RDN

  University of South Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data collectors/outcomes assessors will be masked on whether the participants are in the intervention or the control (enhanced usual care) group. 51 parent-child dyads completed the baseline assessments, 50 dyads enrolled (100 individuals) in the intervention/control condition, and 32 providers enrolled to implement the intervention/control. The total number of participants who are considered enrolled is 132 (individuals).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: January 18, 2022
• Study Start: January 27, 2022
• Primary Completion: May 24, 2024
• Study Completion: May 31, 2024
• Last Updated: November 19, 2025
• Results First Posted: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: A study protocol manuscript has been submitted for publication in Feb 2022, and all deidentified data will be submitted to the NIH/NIMH NDA system at the end of the study and within a year after the project ends.
• Access Criteria: Publication on study protocol will be available to public through the journal. Analytic code and deidentified data will be available to those researchers who have permission to use data related to autism spectrum disorder through NIH/NIMH.

Locations

US (1)