An Intervention to Improve Motor Skills in Young Children

NCT ID: NCT03901300

Last Updated: 2024-03-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2020-02-10

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Physical Activity Fundamental Motor Skills Development, Child Self-regulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Fundamental Motor Skills (FMS)

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.

Group Type EXPERIMENTAL

Fundamental Motor Skills App

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Unstructured Physical Activity App

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

3 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role collaborator

Pennington Biomedical Research Center

OTHER

Sponsor Role lead

Responsible Party

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Amanda Staiano

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amanda Staiano, PhD

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Study Director

E. Kipling Webster, PhD

Role: PRINCIPAL_INVESTIGATOR

Augusta University

Locations

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Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 33079066 (View on PubMed)

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.

Reference Type RESULT
PMID: 35415743 (View on PubMed)

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.

Reference Type RESULT
PMID: 40777185 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1R21HD095035-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PBRC 2018-041

Identifier Type: -

Identifier Source: org_study_id

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