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

Part of paid clinical trials in Tampa, Florida.

Sponsor
University of South Florida
Study ID
NCT05194345
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 36 Months
Healthy Volunteers
Not accepted

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).
  • 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).

Study Details

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.

Key Dates

Start date
Jan 27, 2022
Status verified
Nov 2025
Primary completion
May 24, 2024
Completion
May 31, 2024

Study Design

Enrollment
132 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Autism Eats nutrition 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.
  • Active Comparator: We Can! enhanced usual care control
    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).

Primary Outcome Measure

Change in Fruit and Vegetable Intake From Baseline, as Measured by the Daily Amount of Fruit and Vegetables Consumed by Children [ Time Frame: baseline, post-intervention (10 weeks from baseline), and 5-month follow-up ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of South FloridaTampaFlorida33612-

Find similar trials in Tampa, FL

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
University of South Florida· Tampa, FL

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