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

Not Applicable

Completed

• Conditions: Diet Modification
• Interventions: Device: Mobile Health Intervention

• Registration Number: NCT03424811
• Lead Sponsor: University of Pennsylvania

Brief 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.

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 Timeline

• Study First Submitted: 2018-01-10
• Study First Submitted QC: 2018-01-31
• Study First Posted: 2018-02-07
• Study Start: 2018-12-10
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31
• Results First Submitted: 2023-09-19
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-11
• Last Update Submitted: 2024-11-11
• Results First Posted: 2025-01-03
• Last Update Posted: 2025-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Mobile Health Intervention	Includes core behavior change strategies and behavioral skills training designed to promote healthy eating behaviors.

Primary Outcome Measures

Name	Time	Method
3-month Fruit and Vegetable Intake	Change from baseline intake of fruits and vegetables at 3 months	24-hour dietary recalls to assess fruit and vegetable intake
3-month Snack Intake	Change from baseline intake to end of intervention (3 months)	24-hour dietary recalls
3-month Sugar-sweetened Beverage Intake	Change from baseline to end of intervention (3 months)	24-hour dietary recalls to assess sugar-sweetened beverage intake.

Secondary Outcome Measures

Name	Time	Method
Evaluation of mHealth Intervention - User Evaluation	3 months	The study aimed to better understand participant experiences with motivation, user-friendliness, ease of use of the mobile health technology.
Evaluation of mHealth Intervention - Technology Engagement	3 months	Parents in the intervention group will be asked to complete a semi-structured interview, which will ask them about parent and child engagement with the technology.

Trial Locations

Locations (1)

Center for Weight and Eating Disorders; 🇺🇸 Philadelphia, Pennsylvania, United States