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An Intervention to Improve Motor Skills in Young Children

PLAY: An Intervention to Improve Motor Skills in Young Children

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03901300
Acronym
PLAY
Enrollment
72
Registered
2019-04-03
Start date
2019-05-01
Completion date
2020-02-10
Last updated
2024-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Detailed 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.

Interventions

BEHAVIORALFundamental 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.

BEHAVIORALUnstructured 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.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
App AdherenceFrom date of randomization until completion of the 12 weeks of interventionAdherence to the app intervention based on number of activity breaks completed over the 12 week intervention

Secondary

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

Countries

United States

Participant flow

Recruitment details

A convenience sample was recruited using flyers at local childcare centers, email listserv, social media, and community health fairs.

Participants by arm

ArmCount
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. 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.
35
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. 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.
37
Total72

Baseline characteristics

CharacteristicFundamental Motor Skills (FMS)Unstructured Physical ActivityTotal
Age, Continuous3.8 years
STANDARD_DEVIATION 0.8
4.1 years
STANDARD_DEVIATION 0.8
4.0 years
STANDARD_DEVIATION 0.8
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants1 Participants3 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
33 Participants36 Participants69 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Fundamental Motor Skills (TGMD-3 Total Percentile Rank)18.6 percentile
STANDARD_DEVIATION 2.3
14.9 percentile
STANDARD_DEVIATION 2.1
16.7 percentile
STANDARD_DEVIATION 2.2
Race/Ethnicity, Customized
Race
African American
8 Participants11 Participants19 Participants
Race/Ethnicity, Customized
Race
Other
6 Participants2 Participants8 Participants
Race/Ethnicity, Customized
Race
White
21 Participants24 Participants45 Participants
Region of Enrollment
United States
35 participants37 participants72 participants
Sex: Female, Male
Female
15 Participants16 Participants31 Participants
Sex: Female, Male
Male
20 Participants21 Participants41 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 350 / 37
other
Total, other adverse events
0 / 350 / 37
serious
Total, serious adverse events
0 / 350 / 37

Outcome results

Primary

App Adherence

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

Time frame: From date of randomization until completion of the 12 weeks of intervention

ArmMeasureValue (MEAN)
Fundamental Motor Skills (FMS)App Adherence71 percentage of activity breaks
Unstructured Physical ActivityApp Adherence87 percentage of activity breaks
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).

Time frame: baseline and 12 weeks (primary outcome)

Population: Delta in TGMD-3 Total Percentile Rank between baseline to Week 12

ArmMeasureValue (MEAN)Dispersion
Fundamental Motor Skills (FMS)Change in Test of Gross Motor Development (TGMD-3) Percentile Rank Between Baseline and Week 127.1 percentileStandard Deviation 1.4
Unstructured Physical ActivityChange in Test of Gross Motor Development (TGMD-3) Percentile Rank Between Baseline and Week 12-5.5 percentileStandard Deviation 1.3

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026