Trial Outcomes & Findings for Physical Activity and Screen-Time Regulations in Childcare Centers - Aim 2 (NCT NCT02751814)
NCT ID: NCT02751814
Last Updated: 2024-03-29
Results Overview
Physical activity will be measured with a 7 day accelerometer at baseline and 1 year, including minutes/day MVPA in childcare center, minutes/day MVPA total. Physical activity and time spent in moderate to vigorous physical activity will be measured by a triaxial accelerometer (Actigraph GT3X+, Actigraph of Ft. Walton Beach, FL). Children will be measured on 7 full days during the baseline and follow-up periods.The Actigraph is one of the most common accelerometers used for scientific purposes, and the GT3X+ version provides extensive data on steps/day and time spent in various activity intensities. The research team will ask the parents to have the children wear the accelerometer for additional days (to a maximum of 14 days) to ensure that minimal data requirements are met.
COMPLETED
175 participants
1 Year
2024-03-29
Participant Flow
Children were recruited from 10 local preschool centers. Parents were not recruited or enrolled in this study, but they did complete surveys to assess for efficacy.
Participant milestones
| Measure |
ECE Center Changes Between Baseline and Follow-up
Assessed differences in total EPAO score at baseline, follow-up, and overall change by policy engagement category (no engagement, some engagement, high engagement).
|
|---|---|
|
Overall Study
STARTED
|
175
|
|
Overall Study
Completed Baseline Assessments
|
112
|
|
Overall Study
COMPLETED
|
130
|
|
Overall Study
NOT COMPLETED
|
45
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Physical Activity and Screen-Time Regulations in Childcare Centers - Aim 2
Baseline characteristics by cohort
| Measure |
ECE Center Changes Between Baseline and Follow-up
n=49 Participants
Assessed differences in total EPAO score at baseline, follow-up, and overall change by policy engagement category (no engagement, some engagement, high engagement).
|
|---|---|
|
Age, Categorical
<=18 years
|
49 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
37 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · African American
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 YearPhysical activity will be measured with a 7 day accelerometer at baseline and 1 year, including minutes/day MVPA in childcare center, minutes/day MVPA total. Physical activity and time spent in moderate to vigorous physical activity will be measured by a triaxial accelerometer (Actigraph GT3X+, Actigraph of Ft. Walton Beach, FL). Children will be measured on 7 full days during the baseline and follow-up periods.The Actigraph is one of the most common accelerometers used for scientific purposes, and the GT3X+ version provides extensive data on steps/day and time spent in various activity intensities. The research team will ask the parents to have the children wear the accelerometer for additional days (to a maximum of 14 days) to ensure that minimal data requirements are met.
Outcome measures
| Measure |
ECE Center Changes Between Baseline and Follow-up
n=49 Participants
Assessed differences in total EPAO score at baseline, follow-up, and overall change by policy engagement category (no engagement, some engagement, high engagement).
|
Follow-up
Parent screen report.
|
|---|---|---|
|
Changes in Objective Child Physical Activity
Active Opportunities
|
3.3 minutes
Standard Deviation 4.1
|
—
|
|
Changes in Objective Child Physical Activity
Sedentary Opportunities
|
-0.4 minutes
Standard Deviation 2.6
|
—
|
|
Changes in Objective Child Physical Activity
Sedentary Opportunities - Revised
|
1.1 minutes
Standard Deviation 4.7
|
—
|
|
Changes in Objective Child Physical Activity
Sedentary Environment
|
0.0 minutes
Standard Deviation 4.7
|
—
|
|
Changes in Objective Child Physical Activity
Portable Play Environment
|
1.9 minutes
Standard Deviation 4.0
|
—
|
|
Changes in Objective Child Physical Activity
Fixed Play Environment
|
-1.0 minutes
Standard Deviation 4.0
|
—
|
SECONDARY outcome
Timeframe: 1 yearClassroom observation of child screen-time will be measured with the Environment and Policy Assessment and Observation (EPAO) method to quantify average minutes/day screen-time in childcare center. Screen time will be assessed using classroom observation at the childcare center (from the EPAO observation in Aim 1). Results are reflecting changes in screen-time.
Outcome measures
| Measure |
ECE Center Changes Between Baseline and Follow-up
n=49 Participants
Assessed differences in total EPAO score at baseline, follow-up, and overall change by policy engagement category (no engagement, some engagement, high engagement).
|
Follow-up
Parent screen report.
|
|---|---|---|
|
Changes in Classroom Observation of Child Screen-time
Total screen-time
|
-20.9 minutes/day
Standard Deviation 39.2
|
—
|
|
Changes in Classroom Observation of Child Screen-time
Television viewing
|
-2.8 minutes/day
Standard Deviation 8.3
|
—
|
|
Changes in Classroom Observation of Child Screen-time
Non-television screen-time
|
-18.1 minutes/day
Standard Deviation 32.7
|
—
|
SECONDARY outcome
Timeframe: 1 YearPopulation: 110 parents completed the screen time survey in year 1. In Year 2 this dropped to 36. Some questions only one or two parents did not answer. All questions
Parent reports of child screen time to quantify minutes/day screen-time total. Parents will complete a survey adapted to provide information about the child's screen-time (separately for TV, computer, games console and smartphone) on weekdays and weekend days. For each item the parent will be asked to report the time the child spent using it for (a) a normal weekday and (b) a normal weekend day, with response options: none; 1 to 30 minutes; 31 minutes to 1 hour; 1 to 2 hours; 2 to 3 hours; 3 to 4 hours; 4 hours or more. The assessment of TV viewing using parental report has been shown to correlate moderately (r=0.60) with 10 days of TV diaries among young children.
Outcome measures
| Measure |
ECE Center Changes Between Baseline and Follow-up
n=110 Participants
Assessed differences in total EPAO score at baseline, follow-up, and overall change by policy engagement category (no engagement, some engagement, high engagement).
|
Follow-up
n=36 Participants
Parent screen report.
|
|---|---|---|
|
Parent Reports of Child Screen Time
Monthly average of smartphone use hours/day outside of school. · 5 hours
|
3 Participants
|
1 Participants
|
|
Parent Reports of Child Screen Time
Monthly average of tv hours/day outside of school. · Less than 1 hour
|
18 Participants
|
4 Participants
|
|
Parent Reports of Child Screen Time
Monthly average of tv hours/day outside of school. · 1 hour
|
27 Participants
|
12 Participants
|
|
Parent Reports of Child Screen Time
Monthly average of tv hours/day outside of school. · 2 hours
|
30 Participants
|
12 Participants
|
|
Parent Reports of Child Screen Time
Monthly average of tv hours/day outside of school. · 3 hours
|
24 Participants
|
6 Participants
|
|
Parent Reports of Child Screen Time
Monthly average of tv hours/day outside of school. · 4 hours
|
2 Participants
|
1 Participants
|
|
Parent Reports of Child Screen Time
Monthly average of tv hours/day outside of school. · 5 hours
|
8 Participants
|
1 Participants
|
|
Parent Reports of Child Screen Time
Monthly average of tv hours/day outside of school. · More than 5 hours
|
0 Participants
|
0 Participants
|
|
Parent Reports of Child Screen Time
Monthly average of tv hours/day outside of school. · None, my child does not watch TV or videos
|
1 Participants
|
0 Participants
|
|
Parent Reports of Child Screen Time
Monthly average of computer hours/day outside of school. · Less than 1 hour
|
37 Participants
|
9 Participants
|
|
Parent Reports of Child Screen Time
Monthly average of computer hours/day outside of school. · 1 hour
|
9 Participants
|
4 Participants
|
|
Parent Reports of Child Screen Time
Monthly average of computer hours/day outside of school. · 2 hours
|
10 Participants
|
1 Participants
|
|
Parent Reports of Child Screen Time
Monthly average of computer hours/day outside of school. · 3 hours
|
7 Participants
|
0 Participants
|
|
Parent Reports of Child Screen Time
Monthly average of computer hours/day outside of school. · 4 hours
|
3 Participants
|
0 Participants
|
|
Parent Reports of Child Screen Time
Monthly average of computer hours/day outside of school. · 5 hours
|
2 Participants
|
1 Participants
|
|
Parent Reports of Child Screen Time
Monthly average of computer hours/day outside of school. · More than 5 hours
|
0 Participants
|
0 Participants
|
|
Parent Reports of Child Screen Time
Monthly average of computer hours/day outside of school. · None, my child does not watch TV or videos
|
42 Participants
|
21 Participants
|
|
Parent Reports of Child Screen Time
Monthly average of video games outside of school. · Less than 1 hour
|
35 Participants
|
10 Participants
|
|
Parent Reports of Child Screen Time
Monthly average of video games outside of school. · 1 hour
|
8 Participants
|
1 Participants
|
|
Parent Reports of Child Screen Time
Monthly average of video games outside of school. · 2 hours
|
8 Participants
|
1 Participants
|
|
Parent Reports of Child Screen Time
Monthly average of video games outside of school. · 3 hours
|
2 Participants
|
1 Participants
|
|
Parent Reports of Child Screen Time
Monthly average of video games outside of school. · 4 hours
|
2 Participants
|
0 Participants
|
|
Parent Reports of Child Screen Time
Monthly average of video games outside of school. · 5 hours
|
1 Participants
|
1 Participants
|
|
Parent Reports of Child Screen Time
Monthly average of video games outside of school. · More than 5 hours
|
0 Participants
|
0 Participants
|
|
Parent Reports of Child Screen Time
Monthly average of video games outside of school. · None, my child does not watch TV or videos
|
54 Participants
|
22 Participants
|
|
Parent Reports of Child Screen Time
Monthly average of smartphone use hours/day outside of school. · Less than 1 hour
|
41 Participants
|
19 Participants
|
|
Parent Reports of Child Screen Time
Monthly average of smartphone use hours/day outside of school. · 1 hour
|
20 Participants
|
4 Participants
|
|
Parent Reports of Child Screen Time
Monthly average of smartphone use hours/day outside of school. · 2 hours
|
10 Participants
|
2 Participants
|
|
Parent Reports of Child Screen Time
Monthly average of smartphone use hours/day outside of school. · 3 hours
|
5 Participants
|
1 Participants
|
|
Parent Reports of Child Screen Time
Monthly average of smartphone use hours/day outside of school. · 4 hours
|
3 Participants
|
0 Participants
|
|
Parent Reports of Child Screen Time
Monthly average of smartphone use hours/day outside of school. · More than 5 hours
|
0 Participants
|
0 Participants
|
|
Parent Reports of Child Screen Time
Monthly average of smartphone use hours/day outside of school. · None, my child does not watch TV or videos
|
28 Participants
|
8 Participants
|
|
Parent Reports of Child Screen Time
Monthly average of ipad/tablet use hours/day outside of school. · Less than 1 hour
|
35 Participants
|
14 Participants
|
|
Parent Reports of Child Screen Time
Monthly average of ipad/tablet use hours/day outside of school. · 1 hour
|
19 Participants
|
5 Participants
|
|
Parent Reports of Child Screen Time
Monthly average of ipad/tablet use hours/day outside of school. · 2 hours
|
16 Participants
|
2 Participants
|
|
Parent Reports of Child Screen Time
Monthly average of ipad/tablet use hours/day outside of school. · 3 hours
|
6 Participants
|
2 Participants
|
|
Parent Reports of Child Screen Time
Monthly average of ipad/tablet use hours/day outside of school. · 4 hours
|
5 Participants
|
0 Participants
|
|
Parent Reports of Child Screen Time
Monthly average of ipad/tablet use hours/day outside of school. · 5 hours
|
5 Participants
|
2 Participants
|
|
Parent Reports of Child Screen Time
Monthly average of ipad/tablet use hours/day outside of school. · More than 5 hours
|
0 Participants
|
0 Participants
|
|
Parent Reports of Child Screen Time
Monthly average of ipad/tablet use hours/day outside of school. · None, my child does not watch TV or videos
|
24 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: 107 participants had complete physical activity and screen-time data sets at Baseline. Researchers followed up a year later- at this follow-up time, 53 participants had complete data sets at baseline and follow-up. "Cross-sectional" arm presents the mean number of hours participants spent in light physical activity, moderate-to-vigorous physical activity, and screen time - at baseline. The "Longitudinal" arm presents means at follow-up.
Cross-sectional and longitudinal associations among sedentary behavior (by screen-time observation/self-report and accelerometry) and physical activity (by accelerometry). The mean and standard deviation for time sedentary behavior and physical activity are presented in the table below.
Outcome measures
| Measure |
ECE Center Changes Between Baseline and Follow-up
n=107 Participants
Assessed differences in total EPAO score at baseline, follow-up, and overall change by policy engagement category (no engagement, some engagement, high engagement).
|
Follow-up
n=53 Participants
Parent screen report.
|
|---|---|---|
|
Sedentary Behavior and Physical Activity
Screen-time
|
4.5 hours per day
Standard Deviation 3.3
|
3.8 hours per day
Standard Deviation 3.5
|
|
Sedentary Behavior and Physical Activity
Light Physical Activity (LPA)
|
4.2 hours per day
Standard Deviation 0.6
|
4.1 hours per day
Standard Deviation 0.5
|
|
Sedentary Behavior and Physical Activity
Moderate-Vigorous Physical Activity (MVPA)
|
1.7 hours per day
Standard Deviation 0.6
|
1.7 hours per day
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 1 yearPopulation: 107 participants had complete physical activity and screen-time data sets at Baseline. Researchers followed up a year later- at this follow-up time, 53 participants had complete data sets at baseline and follow-up. "Cross-sectional" arm presents the mean number of hours participants spent in light physical activity, moderate-to-vigorous physical activity, and screen time - at baseline. The "Longitudinal" arm presents means at follow-up.
Cross-sectional and longitudinal associations among Test of Gross Motor Development, 3rd edition (TGMD-3), and subscales (Ball Skills and Locomotor Skills). The TGMD-3 is a process-oriented assessment designed to assess gross motor performance of young children age 3-10 years. The total score for each item is established by the summation of all performance criteria scores for both trials, which are accumulated to determine the total locomotor and ball skills subtest scores and the overall TGMD-3 raw score for gross motor performance The maximum score a participant can obtain on locomotor is 46, for ball skills its 54, and overall gross motor performance is 100. The minimum score a child can receive is 0. Higher scores indicate better performance. Lower scores help identify delays and deficits in gross motor development in early childhood.
Outcome measures
| Measure |
ECE Center Changes Between Baseline and Follow-up
n=107 Participants
Assessed differences in total EPAO score at baseline, follow-up, and overall change by policy engagement category (no engagement, some engagement, high engagement).
|
Follow-up
n=53 Participants
Parent screen report.
|
|---|---|---|
|
Fundamental Motor Skills
Locomotor Skills
|
34.9 Raw Score
Standard Deviation 22.8
|
35.0 Raw Score
Standard Deviation 24.3
|
|
Fundamental Motor Skills
Ball Skills
|
52.5 Raw Score
Standard Deviation 24.2
|
50.9 Raw Score
Standard Deviation 26.9
|
|
Fundamental Motor Skills
Total TGMD-3
|
41.7 Raw Score
Standard Deviation 22.5
|
41.4 Raw Score
Standard Deviation 23.8
|
Adverse Events
ECE Center Changes Between Baseline and Follow-up
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place