Trial Outcomes & Findings for An Intervention to Improve Motor Skills in Young Children (NCT NCT03901300)
NCT ID: NCT03901300
Last Updated: 2024-03-29
Results Overview
Adherence to the app intervention based on number of activity breaks completed over the 12 week intervention
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
72 participants
Primary outcome timeframe
From date of randomization until completion of the 12 weeks of intervention
Results posted on
2024-03-29
Participant Flow
A convenience sample was recruited using flyers at local childcare centers, email listserv, social media, and community health fairs.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
37
|
|
Overall Study
COMPLETED
|
32
|
37
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Intervention to Improve Motor Skills in Young Children
Baseline characteristics by cohort
| Measure |
Fundamental Motor Skills (FMS)
n=35 Participants
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.
|
Unstructured Physical Activity
n=37 Participants
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.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
3.8 years
STANDARD_DEVIATION 0.8 • n=5 Participants
|
4.1 years
STANDARD_DEVIATION 0.8 • n=7 Participants
|
4.0 years
STANDARD_DEVIATION 0.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
21 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · African American
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
37 participants
n=7 Participants
|
72 participants
n=5 Participants
|
|
Fundamental Motor Skills (TGMD-3 Total Percentile Rank)
|
18.6 percentile
STANDARD_DEVIATION 2.3 • n=5 Participants
|
14.9 percentile
STANDARD_DEVIATION 2.1 • n=7 Participants
|
16.7 percentile
STANDARD_DEVIATION 2.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: From 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
Outcome measures
| Measure |
Fundamental Motor Skills (FMS)
n=35 Participants
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.
|
Unstructured Physical Activity
n=37 Participants
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.
|
|---|---|---|
|
App Adherence
|
71 percentage of activity breaks
Interval 8.0 to 100.0
|
87 percentage of activity breaks
Interval 8.0 to 100.0
|
SECONDARY outcome
Timeframe: baseline and 12 weeks (primary outcome)Population: Delta in TGMD-3 Total Percentile Rank between baseline to Week 12
A validated, reliable observation assessment to evaluate fundamental motor skills performance. Percentile ranks range from 1st (lowest) to 99th (highest/best).
Outcome measures
| Measure |
Fundamental Motor Skills (FMS)
n=32 Participants
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.
|
Unstructured Physical Activity
n=36 Participants
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.
|
|---|---|---|
|
Change in Test of Gross Motor Development (TGMD-3) Percentile Rank Between Baseline and Week 12
|
7.1 percentile
Standard Deviation 1.4
|
-5.5 percentile
Standard Deviation 1.3
|
Adverse Events
Fundamental Motor Skills (FMS)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Unstructured Physical Activity
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Amanda Staiano
LSU's Pennington Biomedical Research Center
Phone: 2257632500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place