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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21HD095035-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
• Gross Motor Quotient at "gifted or very advanced" based on the Test of Gross Motor Development (TGMD-3)
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| Name | Affiliation | Role |
|---|---|---|
| Amanda Staiano, PhD | Pennington Biomedical Study Director | Principal Investigator |
| E. Kipling Webster, PhD | Augusta University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33079066 | Background | 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. | |
| 35415743 | Result | 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. |
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A convenience sample was recruited using flyers at local childcare centers, email listserv, social media, and community health fairs.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Only children were enrolled as study participants in the trial.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | App Adherence | Adherence to the app intervention based on number of activity breaks completed over the 12 week intervention | Posted | Mean | Full Range | percentage of activity breaks | From date of randomization until completion of the 12 weeks of intervention |
|
24 weeks
Only the children were enrolled study participants, so AEs were only collected for the children.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amanda Staiano | LSU's Pennington Biomedical Research Center | 2257632500 | amanda.staiano@pbrc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 24, 2020 | Dec 14, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 30, 2019 | Dec 14, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D000068356 | Self-Control |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D012919 | Social Behavior |
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| 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. |
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| 40777185 | Result | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Fundamental Motor Skills (TGMD-3 Total Percentile Rank) | The percentile rank can vary from 1st to 99th percentile, with 1st indicating lowest motor skills and 99th indicating highest (best) motor skills. | Mean | Standard Deviation | percentile |
|
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.
|
|
| 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). | Delta in TGMD-3 Total Percentile Rank between baseline to Week 12 | Posted | Mean | Standard Deviation | percentile | baseline and 12 weeks (primary outcome) |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | 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. | 0 | 37 | 0 | 37 | 0 | 37 |
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