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

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.

Study Overview

• Status: Completed
• Conditions: Diet Modification
• Intervention / Treatment: Device: Mobile Health Intervention

Detailed Description

Autism spectrum disorder (ASD) is the fastest growing developmental disability affecting more than 2 million US children and tens of millions worldwide. Children with ASD are 5 times more likely to have mealtime challenges and be picky eaters, which in part has been attributed to restrictive and ritualistic behaviors and heightened sensory sensitivity. These nutritional difficulties pose significant every day challenges for caregivers when it comes to child feeding and daily eating routines and call for new and innovative ways to promote healthy eating in children affected by ASD. The use of mobile technologies is rapidly increasing in children across all age groups. Children with ASD, in particular, often engage with mobile devices on a daily basis and mobile health (mHealth) technology has been shown to be an effective tool for improving behavioral, social, and communication skills in children with ASD. The investigators aim to harness the lure of technology and develop and test, for the first time, the feasibility and acceptability of an interactive mHealth nutrition intervention for children with ASD. This intervention will build upon core behavior change strategies that have been empirically tested in family-based nutrition research for over 3 decades. A second aim of this project is to test, in a 3-month randomized controlled trial, the efficacy of the mHealth intervention on changing consumption of targeted healthy and less healthy foods and beverages in 6- to 10-year-old children with ASD who are picky eaters. Primary outcomes of this proof-of-concept trial will include 3-month changes in children's daily intake of fruits and vegetables, salty and sugary snacks, and sugar-sweetened beverages. Secondary outcomes will include parent and child engagement with the mHealth technology, motivation, user friendliness and ease of use. If successful, the use of this innovative mHealth nutrition intervention will offer new and powerful targets for intervention in improving dietary intake and the fight against childhood obesity in this especially vulnerable population of children.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Center for Weight and Eating Disorders

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Includes core behavior change strategies and behavioral skills training designed to promote healthy eating behaviors.	Device: Mobile Health Intervention; Mobile health intervention to promote healthy eating.
No Intervention: Control Group; Information provided will mimic what families may receive during a routine well-child visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intake of Target Foods	24-hour dietary recalls	Change from baseline intake of target foods and beverages at 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of mHealth intervention - Technology Engagement	Review of automatic log from technology of all user activities	3 months
Evaluation of mHealth intervention - User Evaluation	Conduct of semi-structured interviews with study participants	3 months

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Emily Kuschner, Ph.D., Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2018
• Primary Completion (Actual): August 31, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: January 10, 2018
• First Submitted That Met QC Criteria: January 31, 2018
• First Posted (Actual): February 7, 2018

Study Record Updates

• Last Update Posted (Actual): September 29, 2020
• Last Update Submitted That Met QC Criteria: September 28, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: 827786

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No