An Intervention to Improve Motor Skills in Young Children

Physical Activity Clinical Trial

— PLAY  

Official title:

PLAY: An Intervention to Improve Motor Skills in Young Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03901300
• Other study ID #: PBRC 2018-041
• Secondary ID: 1R21HD095035-01A
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: February 10, 2020

Study information

• Verified date: March 2024
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 10, 2020
• Est. primary completion date: February 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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)

Related Conditions & MeSH terms

• Development, Child
• Fundamental Motor Skills
• Physical Activity
• Self-regulation

Intervention

Behavioral:
• Fundamental Motor Skills App
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
Lessons will be provided over the app each week with notifications sent 5 days/week over 12 weeks specific to randomized active comparator group.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

Staiano AE, Saha S, Beyl RA, Kracht CL, Newton, Jr RL, Webster EK. Parental engagement and implementation fidelity through a mHealth motor skills intervention for young children. Physical Education and Sport Pedagogy Journal. 2023. ePub online. Doi: 10.10

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Test of Gross Motor Development (TGMD-3) Percentile Rank Between Baseline and Week 12	A validated, reliable observation assessment to evaluate fundamental motor skills performance. Percentile ranks range from 1st (lowest) to 99th (highest/best).	baseline and 12 weeks (primary outcome)