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

Primary Purpose

Diet Modification

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Health Intervention
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diet Modification

Eligibility Criteria

6 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Center for Weight and Eating Disorders

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Intake of Target Foods
24-hour dietary recalls

Secondary Outcome Measures

Evaluation of mHealth intervention - Technology Engagement
Review of automatic log from technology of all user activities
Evaluation of mHealth intervention - User Evaluation
Conduct of semi-structured interviews with study participants

Full Information

First Posted
January 10, 2018
Last Updated
September 28, 2020
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT03424811
Brief Title
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

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
December 10, 2018 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diet Modification

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Includes core behavior change strategies and behavioral skills training designed to promote healthy eating behaviors.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Information provided will mimic what families may receive during a routine well-child visit.
Intervention Type
Device
Intervention Name(s)
Mobile Health Intervention
Intervention Description
Mobile health intervention to promote healthy eating.
Primary Outcome Measure Information:
Title
Intake of Target Foods
Description
24-hour dietary recalls
Time Frame
Change from baseline intake of target foods and beverages at 3 months
Secondary Outcome Measure Information:
Title
Evaluation of mHealth intervention - Technology Engagement
Description
Review of automatic log from technology of all user activities
Time Frame
3 months
Title
Evaluation of mHealth intervention - User Evaluation
Description
Conduct of semi-structured interviews with study participants
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Kuschner, Ph.D.
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Weight and Eating Disorders
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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

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