NCT03901300: PLAY

An Intervention to Improve Motor Skills in Young Children

Completed NA Results posted Last updated 29 March 2024

What this trial tests

NA trial testing Fundamental Motor Skills App in Physical Activity in 72 participants. Completed in 10 February 2020.

Timeline

1 May 2019

Primary endpoint
10 February 2020

10 February 2020

Quick facts

Lead sponsor	Pennington Biomedical Research Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	72
Start date	1 May 2019
Primary completion	10 February 2020
Estimated completion	10 February 2020
Sites	1 location across United States

Drugs / interventions tested

• Fundamental Motor Skills App
• Unstructured Physical Activity App

Conditions studied

• Physical Activity — all drugs for Physical Activity →
• Fundamental Motor Skills — all drugs for Fundamental Motor Skills →
• Development, Child — all drugs for Development, Child →
• Self-regulation — all drugs for Self-regulation →

Sponsor

Pennington Biomedical Research Center — full company profile →

Who can join

Adults 3 to 5, any sex, with Physical Activity or Fundamental Motor Skills. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

App Adherence Primary · From date of randomization until completion of the 12 weeks of intervention

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

Group	Value	95% CI
Fundamental Motor Skills (FMS)	71	8 – 100
Unstructured Physical Activity	87	8 – 100

Change in Test of Gross Motor Development (TGMD-3) Percentile Rank Between Baseline and Week 12 Secondary · baseline and 12 weeks (primary outcome)

A validated, reliable observation assessment to evaluate fundamental motor skills performance. Percentile ranks range from 1st (lowest) to 99th (highest/best).

Group	Value	95% CI
Fundamental Motor Skills (FMS)	7.1	± 1.4
Unstructured Physical Activity	-5.5	± 1.3

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.