Physical ActivityPLAYNCT03901300
An Intervention to Improve Motor Skills in Young Children
A study testing Fundamental Motor Skills App and Unstructured Physical Activity App in people with Physical Activity and Fundamental Motor Skills, run by Pennington Biomedical Research Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Fundamental Motor Skills, Development, Child
- What is being tested?
- Fundamental Motor Skills App and Unstructured Physical Activity App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 10 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 3-5 years of age
- Physically capable of exercise
- Has no parent-reported mobility limitations that impairs performance of fundamental motor skills
Who cannot join
- Gross Motor Quotient at "gifted or very advanced" based on the Test of Gross Motor Development (TGMD-3)
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: PLAY: 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.
Read the 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.
- Being tested
- Fundamental Motor Skills App, Unstructured Physical Activity App
- Medical subject headings
- Motor Activity, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fundamental Motor Skills AppBehavioural
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 AppBehavioural
Lessons will be provided over the app each week with notifications sent 5 days/week over 12 weeks specific to randomized active comparator group.
| Study group | Role | What they receive |
|---|---|---|
| Fundamental Motor Skills (FMS) | Experimental | 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. Receives: Behavioral: Fundamental Motor Skills App |
| Unstructured Physical Activity | Active comparator | 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. Receives: Behavioral: Unstructured Physical Activity App |
What is being measured
The primary outcome is the main question the study is designed to answer.
App Adherence
Adherence to the app intervention based on number of activity breaks completed over the 12 week intervention
Measured: From date of randomization until completion of the 12 weeks of intervention
Secondary outcomes (1)
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).
Measured: baseline and 12 weeks (primary outcome)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start1 May 2019
- Primary completion10 Feb 2020
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Amanda Staiano, Pennington Biomedical Research Center
- Investigators
- Amanda Staiano, PhD, Principal investigator, Pennington Biomedical Study DirectorE. Kipling Webster, PhD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901300
- Sponsor's protocol ID
- PBRC 2018-041
- Other IDs
- 1R21HD095035-01A1
- Acronym
- PLAY
- Status last verified
- Mar 2024
- First submitted
- 1 Apr 2019
- Last updated
- 29 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33079066Staiano 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.
PubMed 35415743Staiano 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.
PubMed 40777185
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PLAY: An Intervention to Improve Motor Skills in Young Children
- ClinicalTrials.gov ID
- NCT03901300
- Acronym / sponsor ID
- PLAY / PBRC 2018-041
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 May 2019 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 3 Apr 2019 (actual)
- Results
- Posted 9 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fundamental Motor Skills (FMS) | Experimental | Behavioral: Fundamental Motor Skills AppThe 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. |
| Unstructured Physical Activity | Active comparator | Behavioral: Unstructured Physical Activity AppThe 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. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 3-5 years of age
- Physically capable of exercise
- Has no parent-reported mobility limitations that impairs performance of fundamental motor skills
Key exclusion criteria (1 listed)
- Gross Motor Quotient at "gifted or very advanced" based on the Test of Gross Motor Development (TGMD-3)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fundamental Motor Skills AppLessons will be provided over the app each week with notifications sent 5 days/week over 12 weeks specific to randomized experimental group. | Behavioural | Fundamental Motor Skills (FMS) |
| Unstructured Physical Activity AppLessons will be provided over the app each week with notifications sent 5 days/week over 12 weeks specific to randomized active comparator group. | Behavioural | Unstructured Physical Activity |
Primary outcome
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
1 secondary outcome
Change in Test of Gross Motor Development (TGMD-3) Percentile Rank Between Baseline and Week 12
Time frame: baseline and 12 weeks (primary outcome)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33079066Webster 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.
- Results publication: PubMed 35415743Staiano 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.
- Results publication: PubMed 40777185Staiano 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.
- Individual participant dataSharing planned: No
Related trials for Physical Activity
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda Staiano, PhD principal investigator
Pennington Biomedical Study Director
E. Kipling Webster, PhD principal investigator
Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fundamental Motor Skills App and Unstructured Physical Activity App in people with Physical Activity and Fundamental Motor Skills, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
App Adherence (time frame: From date of randomization until completion of the 12 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03901300, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2024.