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

NCT ID: NCT03424811

Last Updated: 2025-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-10
• Study Completion Date: 2020-08-31

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.

Conditions

Diet Modification

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention Group

Includes core behavior change strategies and behavioral skills training designed to promote healthy eating behaviors.

Group Type: EXPERIMENTAL

Mobile Health Intervention

Intervention Type: DEVICE

Mobile health intervention to promote healthy eating.

Control Group

Information provided will mimic what families may receive during a routine well-child visit.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mobile Health Intervention

Mobile health intervention to promote healthy eating.

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emily Kuschner, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

Center for Weight and Eating Disorders

Philadelphia, Pennsylvania, United States

Countries

United States

References

Slater CN, Schroeder K, Fultz A, Kuschner ES, O'Malley L, Johnson K, Benvenuti T, Chittams J, Quinn RJ, Graham Thomas J, Pinto-Martin J, Levy SE, Kral TVE. Insights from user experience and evaluation of a mobile health nutrition intervention for children with autism: A qualitative study. J Hum Nutr Diet. 2024 Dec;37(6):1439-1453. doi: 10.1111/jhn.13365. Epub 2024 Sep 9.

Reference Type: DERIVED

PMID: 39248190 (View on PubMed)

Kral TVE, O'Malley L, Johnson K, Benvenuti T, Chittams J, Quinn RJ, Thomas JG, Pinto-Martin JA, Levy SE, Kuschner ES. Effects of a mobile health nutrition intervention on dietary intake in children who have autism spectrum disorder. Front Pediatr. 2023 Feb 15;11:1100436. doi: 10.3389/fped.2023.1100436. eCollection 2023.

Reference Type: DERIVED

PMID: 36873654 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

827786

Identifier Type: -

Identifier Source: org_study_id