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Completed

NCT Number: NCT03901300

An Intervention to Improve Motor Skills in Young Children

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.

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Key information

Conditions

Physical Activity Behavior Development, Child Fundamental Motor Skills Motor Activity Self-Control Self-regulation Social Behavior

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

Preschoolers spend 4 hours/day in front of a screen, while fewer than one-quarter engage in the recommended two hours of daily physical activity (PA). The decline in PA, increase in screen-based behaviors, and onset of obesity during preschool years have been linked to lifetime risk of obesity and related comorbidities. However, emerging evidence indicates that "screen time" can actually be leveraged as a tool to increase children's PA and promote healthy weight. Specifically, PA interventions delivered over digital devices can provide real-time encouragement for children to be physically active. Prior interventions delivered over mobile devices were effective in increasing PA levels, including our own P-Mobile study that provided behavioral strategies to parents of children aged 6 to 10 years.

When considering how to support and motivate parents whose children are preschool-aged, teaching and modeling fundamental motor skills (FMS) are critical to enable children's PA. FMS like running, jumping, or throwing a ball, are basic, goal-directed movement patterns developed in early childhood that provide a foundation for children to be physically active and competent movers. These skills enable a child to function independently in their surrounding environment, engage with peers, and contribute to their ability to be physically active. Evidence has shown that children must establish a minimal level of FMS proficiency to continue participating in PA opportunities as they age. FMS and PA behaviors have a dynamic and reciprocal relationship. Children with higher levels of FMS are more physically active both during childhood and into adolescence. Therefore, a PA intervention for preschoolers should focus on developing FMS competence.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 3-5 years of age
  • Physically capable of exercise
  • Has no parent-reported mobility limitations that impairs performance of fundamental motor skills

Exclusion criteria

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

Treatment and study plan

Fundamental Motor Skills App

Behavioral

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

Unstructured Physical Activity App

Behavioral

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

Primary outcomes

  1. App Adherence

    Time frame: 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

Secondary outcomes

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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

PLAY: An Intervention to Improve Motor Skills in Young Children

Acronym: PLAY

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 3, 2019
Registry last updated
Mar 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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