N/A N=38 Randomized Double-blind Treatment

Mobile Health (mHealth) Nutrition Intervention for Children With Autism Spectrum Disorder

Diet Modification

Bottom Line

View on ClinicalTrials.gov: NCT03424811 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2025

Primary outcome: Primary: 3-month Fruit and Vegetable Intake — 2.16; 3.01 Servings per day

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Mobile Health Intervention (Device)
Age: Pediatric · 6+ yrs
Sex: All
Sponsor: University of Pennsylvania
Primary completion: Aug 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY 3-month Fruit and Vegetable Intake	2.16; 3.01	—
PRIMARY 3-month Snack Intake	420.8; 385.7	—
PRIMARY 3-month Sugar-sweetened Beverage Intake	7.6; 7.3	—
SECONDARY Evaluation of mHealth Intervention - User Evaluation	4; 2	—
SECONDARY Evaluation of mHealth Intervention - Technology Engagement	7; 4	—

Summary

The high prevalence of mealtime difficulties and obesity among children with autism spectrum disorder (ASD) calls for new and innovative ways to promote healthy eating and weight development in this population. This project aims to develop and test an interactive mobile health (mHealth) nutrition intervention, which incorporates core behavior change strategies that have been empirically tested in family-based nutrition research and behavioral interventions with children with ASD. The feasibility and efficacy of this mHealth intervention to improve dietary outcomes in children with ASD will be tested in a proof-of-concept randomized controlled trial.

Eligibility Criteria

Inclusion Criteria

6 to 10 years;
fluent in English;
have an ASD diagnosis;
cognitive skills within average (or higher) range with IQ ≥ 80;
above or standardized receptive language scores.

Exclusion Criteria

moderate-severe hearing/visual or motor impairment;
taking antipsychotic medications;
on special diet;
are underweight (BMI-for-age < 5th percentile).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03424811). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.