NCT03424811

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 7, 2018

Completed
10 months until next milestone

Study Start

First participant enrolled

December 10, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

January 3, 2025

Completed
Last Updated

January 3, 2025

Status Verified

November 1, 2024

Enrollment Period

1.7 years

First QC Date

January 10, 2018

Results QC Date

September 19, 2023

Last Update Submit

November 11, 2024

Conditions

Diet Modification

Outcome Measures

Primary Outcomes (3)

  • 3-month Fruit and Vegetable Intake

    24-hour dietary recalls to assess fruit and vegetable intake

    Change from baseline intake of fruits and vegetables at 3 months

  • 3-month Snack Intake

    24-hour dietary recalls

    Change from baseline intake to end of intervention (3 months)

  • 3-month Sugar-sweetened Beverage Intake

    24-hour dietary recalls to assess sugar-sweetened beverage intake.

    Change from baseline to end of intervention (3 months)

Secondary Outcomes (2)

  • Evaluation of mHealth Intervention - User Evaluation

    3 months

  • Evaluation of mHealth Intervention - Technology Engagement

    3 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Device: Mobile Health Intervention

Control Group

NO INTERVENTION

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

Interventions

Mobile Health InterventionDEVICE

Mobile health intervention to promote healthy eating.

Intervention Group

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Weight and Eating Disorders

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

  • 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.

    PMID: 39248190DERIVED

  • 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.

    PMID: 36873654DERIVED

Limitations and Caveats

The coronavirus pandemic significantly interfered with the conduct of the study. All home visits had to be stopped in March of 2020.

Results Point of Contact

Title
Tanja Kral
Organization
University of Pennsylvania
tkral@nursing.upenn.edu
(215) 573-7512

Study Officials

  • Emily Kuschner, Ph.D.

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2018

First Posted

February 7, 2018

Study Start

December 10, 2018

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

January 3, 2025

Results First Posted

January 3, 2025

Record last verified: 2024-11

Locations

US(1)