Clinical trial NCT03424811: Mobile Health (mHealth) Nutrition Intervention for Children With Autism Spectrum Disorder
Official title: Mobile Health (mHealth) Nutrition Intervention for Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet Modification
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2018-02-07
Enrollment: 38
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: 3-month Fruit and Vegetable Intake
timeFrame: Change from baseline intake of fruits and vegetables at 3 months
measure: 3-month Snack Intake
timeFrame: Change from baseline intake to end of intervention (3 months)
measure: 3-month Sugar-sweetened Beverage Intake
timeFrame: Change from baseline to end of intervention (3 months)
Secondary outcomes:
measure: Evaluation of mHealth Intervention - User Evaluation
timeFrame: 3 months
measure: Evaluation of mHealth Intervention - Technology Engagement
timeFrame: 3 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Center for Weight and Eating Disorders
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Emily Kuschner, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: