NCT03901300

Brief Summary

The goal of "PLAY" is to adapt and test a developmentally appropriate intervention delivered on a mobile app to parents, with the goal of teaching fundamental motor skill (FMS) proficiency to their preschool-aged children (ages 3 to 5 y). Seventy-two children (3 to 5 y of age) were randomized. Of these children, 36 parents were randomized to use the FMS app and 36 were randomized to use a version of the app that promotes unstructured PA as a comparator group. Parents in the FMS condition accessed instructional lessons, peer modeling videos, and activity breaks to deliver 720 minutes of targeted, structured FMS instruction time to their child over a 12-week period. Parents in the comparator arm used a version of the app that provides instructional lessons to promote the equivalent amount of unstructured PA for their child. Parents were asked to guide the intervention, as parental support, modeling, and co-participation predict children's engagement in PA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

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

April 1, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2019

Completed
28 days until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2020

Completed
2 years until next milestone

Results Posted

Study results publicly available

February 9, 2022

Completed
Last Updated

March 29, 2024

Status Verified

March 1, 2024

Enrollment Period

10 months

First QC Date

April 1, 2019

Results QC Date

December 14, 2021

Last Update Submit

March 27, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • App Adherence

    Adherence to the app intervention based on number of activity breaks completed over the 12 week intervention

    From date of randomization until completion of the 12 weeks of intervention

Secondary Outcomes (1)

  • Change in Test of Gross Motor Development (TGMD-3) Percentile Rank Between Baseline and Week 12

    baseline and 12 weeks (primary outcome)

Study Arms (2)

Fundamental Motor Skills (FMS)

EXPERIMENTAL

The FMS group will utilize the PLAY FMS app that provides instructional lessons, peer modeling videos, and activity breaks to deliver 720 minutes of targeted, structured FMS instruction time to the child over a 12 week period.

Behavioral: Fundamental Motor Skills App

Unstructured Physical Activity

ACTIVE COMPARATOR

The active comparator group will use a version of the PLAY app that provides instructional lessons to promote the equivalent dosage of unstructured physical activity for the child.

Behavioral: Unstructured Physical Activity App

Interventions

Lessons will be provided over the app each week with notifications sent 5 days/week over 12 weeks specific to randomized experimental group.

Fundamental Motor Skills (FMS)

Lessons will be provided over the app each week with notifications sent 5 days/week over 12 weeks specific to randomized active comparator group.

Unstructured Physical Activity

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • years of age
  • Physically capable of exercise
  • Has no parent-reported mobility limitations that impairs performance of fundamental motor skills

You may not qualify if:

  • Gross Motor Quotient at "gifted or very advanced" based on the Test of Gross Motor Development (TGMD-3)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (3)

  • Webster EK, Kracht CL, Newton RL Jr, Beyl RA, Staiano AE. Intervention to Improve Preschool Children's Fundamental Motor Skills: Protocol for a Parent-Focused, Mobile App-Based Comparative Effectiveness Trial. JMIR Res Protoc. 2020 Oct 20;9(10):e19943. doi: 10.2196/19943.

    PMID: 33079066BACKGROUND
  • Staiano AE, Newton RL, Beyl RA, Kracht CL, Hendrick CA, Viverito M, Webster EK. mHealth Intervention for Motor Skills: A Randomized Controlled Trial. Pediatrics. 2022 May 1;149(5):e2021053362. doi: 10.1542/peds.2021-053362.

  • Staiano AE, Saha S, Beyl RA, Kracht CL, Newton RL Jr, Webster EK. Parental engagement and implementation fidelity in a mHealth motor skills intervention for young children. Phys Educ Sport Pedagogy. 2025;30(4):390-402. doi: 10.1080/17408989.2023.2235394. Epub 2023 Jul 15.

MeSH Terms

Conditions

Motor ActivitySelf-Control

Condition Hierarchy (Ancestors)

BehaviorSocial Behavior

Results Point of Contact

Title
Dr. Amanda Staiano
Organization
LSU's Pennington Biomedical Research Center

Study Officials

  • Amanda Staiano, PhD

    Pennington Biomedical Study Director

    PRINCIPAL INVESTIGATOR
  • E. Kipling Webster, PhD

    Augusta University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 1, 2019

First Posted

April 3, 2019

Study Start

May 1, 2019

Primary Completion

February 10, 2020

Study Completion

February 10, 2020

Last Updated

March 29, 2024

Results First Posted

February 9, 2022

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations