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Physical Activity and Screen-Time Regulations in Childcare Centers - Aim 2

Physical Activity and Screen-Time Regulations in Childcare Centers: Influence on Young Children's Health Behaviors (Pause & Play) - Aim 2

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02751814
Acronym
Pause and Play
Enrollment
175
Registered
2016-04-26
Start date
2016-04-30
Completion date
2018-06-30
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

Childhood Obesity

Keywords

Childcare Center Regulations, Physical Activity, Sedentary Behavior, Screen-time Behavior

Brief summary

Objective is to examine the physical activity and screen-time behaviors of children enrolled in licensed childcare centers before and after the enactment of new state regulations.

Detailed description

Pause and Play aims to enroll 266 children. Each child will participate in the study for approximately 1 year. Surveys, anthropometric measures, and screen-time observations will take approximately 1 day each to complete, and the child will be given an accelerometer to wear at home for 7 days at both baseline and 1 year follow-up. Fundamental motor skill assessments will take place at baseline and 1 year follow-up after the 7 days of accelerometer wear. Staff members will spend approximately 2 weeks at each childcare center at baseline and 1 year follow-up to complete study procedures with each child.

Interventions

None listed

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH
Pennington Biomedical Research Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Years to 4 Years
Healthy volunteers
Yes

Inclusion criteria

* A child who is 3 or 4 years old * Child spends at least 6 hours per day, 5 days per week at a participating childcare center * Child will continue to attend the same childcare center for the next year

Exclusion criteria

* Parent/legal guardian is unwilling to provide written informed consent

Design outcomes

Primary

MeasureTime frameDescription
Changes in Objective Child Physical Activity1 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.

Secondary

MeasureTime frameDescription
Changes in Classroom Observation of Child Screen-time1 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.
Parent Reports of Child Screen Time1 YearParent 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.
Sedentary Behavior and Physical Activity1 yearCross-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.
Fundamental Motor Skills1 yearCross-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.

Countries

United States

Participant flow

Recruitment details

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.

Participants by arm

ArmCount
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).
49
Total49

Baseline characteristics

CharacteristicECE Center Changes Between Baseline and Follow-up
Age, Categorical
<=18 years
49 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Race/Ethnicity, Customized
Race
African American
7 Participants
Race/Ethnicity, Customized
Race
Other
5 Participants
Race/Ethnicity, Customized
Race
White
37 Participants
Sex: Female, Male
Female
24 Participants
Sex: Female, Male
Male
25 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 112
other
Total, other adverse events
0 / 112
serious
Total, serious adverse events
0 / 112

Outcome results

Primary

Changes in Objective Child Physical Activity

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.

Time frame: 1 Year

ArmMeasureGroupValue (MEAN)Dispersion
ECE Center Changes Between Baseline and Follow-upChanges in Objective Child Physical ActivityActive Opportunities3.3 minutesStandard Deviation 4.1
ECE Center Changes Between Baseline and Follow-upChanges in Objective Child Physical ActivitySedentary Opportunities-0.4 minutesStandard Deviation 2.6
ECE Center Changes Between Baseline and Follow-upChanges in Objective Child Physical ActivitySedentary Opportunities - Revised1.1 minutesStandard Deviation 4.7
ECE Center Changes Between Baseline and Follow-upChanges in Objective Child Physical ActivitySedentary Environment0.0 minutesStandard Deviation 4.7
ECE Center Changes Between Baseline and Follow-upChanges in Objective Child Physical ActivityPortable Play Environment1.9 minutesStandard Deviation 4
ECE Center Changes Between Baseline and Follow-upChanges in Objective Child Physical ActivityFixed Play Environment-1.0 minutesStandard Deviation 4
Secondary

Changes in Classroom Observation of Child Screen-time

Classroom 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.

Time frame: 1 year

ArmMeasureGroupValue (MEAN)Dispersion
ECE Center Changes Between Baseline and Follow-upChanges in Classroom Observation of Child Screen-timeTotal screen-time-20.9 minutes/dayStandard Deviation 39.2
ECE Center Changes Between Baseline and Follow-upChanges in Classroom Observation of Child Screen-timeTelevision viewing-2.8 minutes/dayStandard Deviation 8.3
ECE Center Changes Between Baseline and Follow-upChanges in Classroom Observation of Child Screen-timeNon-television screen-time-18.1 minutes/dayStandard Deviation 32.7
Secondary

Fundamental Motor Skills

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.

Time frame: 1 year

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
ECE Center Changes Between Baseline and Follow-upFundamental Motor SkillsLocomotor Skills34.9 Raw ScoreStandard Deviation 22.8
ECE Center Changes Between Baseline and Follow-upFundamental Motor SkillsBall Skills52.5 Raw ScoreStandard Deviation 24.2
ECE Center Changes Between Baseline and Follow-upFundamental Motor SkillsTotal TGMD-341.7 Raw ScoreStandard Deviation 22.5
Follow-upFundamental Motor SkillsLocomotor Skills35.0 Raw ScoreStandard Deviation 24.3
Follow-upFundamental Motor SkillsBall Skills50.9 Raw ScoreStandard Deviation 26.9
Follow-upFundamental Motor SkillsTotal TGMD-341.4 Raw ScoreStandard Deviation 23.8
Secondary

Parent Reports of Child Screen Time

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.

Time frame: 1 Year

Population: 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

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
ECE Center Changes Between Baseline and Follow-upParent Reports of Child Screen TimeMonthly average of computer hours/day outside of school.1 hour9 Participants
ECE Center Changes Between Baseline and Follow-upParent Reports of Child Screen TimeMonthly average of video games outside of school.4 hours2 Participants
ECE Center Changes Between Baseline and Follow-upParent Reports of Child Screen TimeMonthly average of tv hours/day outside of school.4 hours2 Participants
ECE Center Changes Between Baseline and Follow-upParent Reports of Child Screen TimeMonthly average of video games outside of school.5 hours1 Participants
ECE Center Changes Between Baseline and Follow-upParent Reports of Child Screen TimeMonthly average of computer hours/day outside of school.2 hours10 Participants
ECE Center Changes Between Baseline and Follow-upParent Reports of Child Screen TimeMonthly average of video games outside of school.More than 5 hours0 Participants
ECE Center Changes Between Baseline and Follow-upParent Reports of Child Screen TimeMonthly average of tv hours/day outside of school.1 hour27 Participants
ECE Center Changes Between Baseline and Follow-upParent Reports of Child Screen TimeMonthly average of video games outside of school.None, my child does not watch TV or videos54 Participants
ECE Center Changes Between Baseline and Follow-upParent Reports of Child Screen TimeMonthly average of computer hours/day outside of school.3 hours7 Participants
ECE Center Changes Between Baseline and Follow-upParent Reports of Child Screen TimeMonthly average of smartphone use hours/day outside of school.Less than 1 hour41 Participants
ECE Center Changes Between Baseline and Follow-upParent Reports of Child Screen TimeMonthly average of tv hours/day outside of school.5 hours8 Participants
ECE Center Changes Between Baseline and Follow-upParent Reports of Child Screen TimeMonthly average of smartphone use hours/day outside of school.1 hour20 Participants
ECE Center Changes Between Baseline and Follow-upParent Reports of Child Screen TimeMonthly average of computer hours/day outside of school.4 hours3 Participants
ECE Center Changes Between Baseline and Follow-upParent Reports of Child Screen TimeMonthly average of smartphone use hours/day outside of school.2 hours10 Participants
ECE Center Changes Between Baseline and Follow-upParent Reports of Child Screen TimeMonthly average of tv hours/day outside of school.2 hours30 Participants
ECE Center Changes Between Baseline and Follow-upParent Reports of Child Screen TimeMonthly average of computer hours/day outside of school.5 hours2 Participants
ECE Center Changes Between Baseline and Follow-upParent Reports of Child Screen TimeMonthly average of smartphone use hours/day outside of school.4 hours3 Participants
ECE Center Changes Between Baseline and Follow-upParent Reports of Child Screen TimeMonthly average of tv hours/day outside of school.More than 5 hours0 Participants
ECE Center Changes Between Baseline and Follow-upParent Reports of Child Screen TimeMonthly average of smartphone use hours/day outside of school.5 hours3 Participants
ECE Center Changes Between Baseline and Follow-upParent Reports of Child Screen TimeMonthly average of computer hours/day outside of school.More than 5 hours0 Participants
ECE Center Changes Between Baseline and Follow-upParent Reports of Child Screen TimeMonthly average of smartphone use hours/day outside of school.More than 5 hours0 Participants
ECE Center Changes Between Baseline and Follow-upParent Reports of Child Screen TimeMonthly average of tv hours/day outside of school.Less than 1 hour18 Participants
ECE Center Changes Between Baseline and Follow-upParent Reports of Child Screen TimeMonthly average of smartphone use hours/day outside of school.None, my child does not watch TV or videos28 Participants
ECE Center Changes Between Baseline and Follow-upParent Reports of Child Screen TimeMonthly average of computer hours/day outside of school.None, my child does not watch TV or videos42 Participants
ECE Center Changes Between Baseline and Follow-upParent Reports of Child Screen TimeMonthly average of ipad/tablet use hours/day outside of school.Less than 1 hour35 Participants
ECE Center Changes Between Baseline and Follow-upParent Reports of Child Screen TimeMonthly average of tv hours/day outside of school.None, my child does not watch TV or videos1 Participants
ECE Center Changes Between Baseline and Follow-upParent Reports of Child Screen TimeMonthly average of ipad/tablet use hours/day outside of school.1 hour19 Participants
ECE Center Changes Between Baseline and Follow-upParent Reports of Child Screen TimeMonthly average of video games outside of school.Less than 1 hour35 Participants
ECE Center Changes Between Baseline and Follow-upParent Reports of Child Screen TimeMonthly average of ipad/tablet use hours/day outside of school.2 hours16 Participants
ECE Center Changes Between Baseline and Follow-upParent Reports of Child Screen TimeMonthly average of tv hours/day outside of school.3 hours24 Participants
ECE Center Changes Between Baseline and Follow-upParent Reports of Child Screen TimeMonthly average of ipad/tablet use hours/day outside of school.3 hours6 Participants
ECE Center Changes Between Baseline and Follow-upParent Reports of Child Screen TimeMonthly average of video games outside of school.1 hour8 Participants
ECE Center Changes Between Baseline and Follow-upParent Reports of Child Screen TimeMonthly average of ipad/tablet use hours/day outside of school.4 hours5 Participants
ECE Center Changes Between Baseline and Follow-upParent Reports of Child Screen TimeMonthly average of computer hours/day outside of school.Less than 1 hour37 Participants
ECE Center Changes Between Baseline and Follow-upParent Reports of Child Screen TimeMonthly average of ipad/tablet use hours/day outside of school.5 hours5 Participants
ECE Center Changes Between Baseline and Follow-upParent Reports of Child Screen TimeMonthly average of video games outside of school.2 hours8 Participants
ECE Center Changes Between Baseline and Follow-upParent Reports of Child Screen TimeMonthly average of ipad/tablet use hours/day outside of school.More than 5 hours0 Participants
ECE Center Changes Between Baseline and Follow-upParent Reports of Child Screen TimeMonthly average of smartphone use hours/day outside of school.3 hours5 Participants
ECE Center Changes Between Baseline and Follow-upParent Reports of Child Screen TimeMonthly average of ipad/tablet use hours/day outside of school.None, my child does not watch TV or videos24 Participants
ECE Center Changes Between Baseline and Follow-upParent Reports of Child Screen TimeMonthly average of video games outside of school.3 hours2 Participants
Follow-upParent Reports of Child Screen TimeMonthly average of ipad/tablet use hours/day outside of school.None, my child does not watch TV or videos11 Participants
Follow-upParent Reports of Child Screen TimeMonthly average of tv hours/day outside of school.Less than 1 hour4 Participants
Follow-upParent Reports of Child Screen TimeMonthly average of tv hours/day outside of school.2 hours12 Participants
Follow-upParent Reports of Child Screen TimeMonthly average of tv hours/day outside of school.3 hours6 Participants
Follow-upParent Reports of Child Screen TimeMonthly average of tv hours/day outside of school.4 hours1 Participants
Follow-upParent Reports of Child Screen TimeMonthly average of tv hours/day outside of school.5 hours1 Participants
Follow-upParent Reports of Child Screen TimeMonthly average of tv hours/day outside of school.More than 5 hours0 Participants
Follow-upParent Reports of Child Screen TimeMonthly average of tv hours/day outside of school.None, my child does not watch TV or videos0 Participants
Follow-upParent Reports of Child Screen TimeMonthly average of computer hours/day outside of school.Less than 1 hour9 Participants
Follow-upParent Reports of Child Screen TimeMonthly average of computer hours/day outside of school.1 hour4 Participants
Follow-upParent Reports of Child Screen TimeMonthly average of computer hours/day outside of school.2 hours1 Participants
Follow-upParent Reports of Child Screen TimeMonthly average of computer hours/day outside of school.3 hours0 Participants
Follow-upParent Reports of Child Screen TimeMonthly average of computer hours/day outside of school.4 hours0 Participants
Follow-upParent Reports of Child Screen TimeMonthly average of computer hours/day outside of school.5 hours1 Participants
Follow-upParent Reports of Child Screen TimeMonthly average of computer hours/day outside of school.More than 5 hours0 Participants
Follow-upParent Reports of Child Screen TimeMonthly average of computer hours/day outside of school.None, my child does not watch TV or videos21 Participants
Follow-upParent Reports of Child Screen TimeMonthly average of video games outside of school.Less than 1 hour10 Participants
Follow-upParent Reports of Child Screen TimeMonthly average of video games outside of school.1 hour1 Participants
Follow-upParent Reports of Child Screen TimeMonthly average of video games outside of school.2 hours1 Participants
Follow-upParent Reports of Child Screen TimeMonthly average of video games outside of school.3 hours1 Participants
Follow-upParent Reports of Child Screen TimeMonthly average of video games outside of school.4 hours0 Participants
Follow-upParent Reports of Child Screen TimeMonthly average of video games outside of school.5 hours1 Participants
Follow-upParent Reports of Child Screen TimeMonthly average of video games outside of school.More than 5 hours0 Participants
Follow-upParent Reports of Child Screen TimeMonthly average of video games outside of school.None, my child does not watch TV or videos22 Participants
Follow-upParent Reports of Child Screen TimeMonthly average of smartphone use hours/day outside of school.Less than 1 hour19 Participants
Follow-upParent Reports of Child Screen TimeMonthly average of smartphone use hours/day outside of school.1 hour4 Participants
Follow-upParent Reports of Child Screen TimeMonthly average of smartphone use hours/day outside of school.2 hours2 Participants
Follow-upParent Reports of Child Screen TimeMonthly average of smartphone use hours/day outside of school.3 hours1 Participants
Follow-upParent Reports of Child Screen TimeMonthly average of smartphone use hours/day outside of school.4 hours0 Participants
Follow-upParent Reports of Child Screen TimeMonthly average of smartphone use hours/day outside of school.5 hours1 Participants
Follow-upParent Reports of Child Screen TimeMonthly average of smartphone use hours/day outside of school.More than 5 hours0 Participants
Follow-upParent Reports of Child Screen TimeMonthly average of smartphone use hours/day outside of school.None, my child does not watch TV or videos8 Participants
Follow-upParent Reports of Child Screen TimeMonthly average of ipad/tablet use hours/day outside of school.Less than 1 hour14 Participants
Follow-upParent Reports of Child Screen TimeMonthly average of ipad/tablet use hours/day outside of school.1 hour5 Participants
Follow-upParent Reports of Child Screen TimeMonthly average of ipad/tablet use hours/day outside of school.2 hours2 Participants
Follow-upParent Reports of Child Screen TimeMonthly average of ipad/tablet use hours/day outside of school.3 hours2 Participants
Follow-upParent Reports of Child Screen TimeMonthly average of ipad/tablet use hours/day outside of school.4 hours0 Participants
Follow-upParent Reports of Child Screen TimeMonthly average of ipad/tablet use hours/day outside of school.5 hours2 Participants
Follow-upParent Reports of Child Screen TimeMonthly average of ipad/tablet use hours/day outside of school.More than 5 hours0 Participants
Follow-upParent Reports of Child Screen TimeMonthly average of tv hours/day outside of school.1 hour12 Participants
Secondary

Sedentary Behavior and Physical Activity

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.

Time frame: 1 year

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
ECE Center Changes Between Baseline and Follow-upSedentary Behavior and Physical ActivityModerate-Vigorous Physical Activity (MVPA)1.7 hours per dayStandard Deviation 0.6
ECE Center Changes Between Baseline and Follow-upSedentary Behavior and Physical ActivityLight Physical Activity (LPA)4.2 hours per dayStandard Deviation 0.6
ECE Center Changes Between Baseline and Follow-upSedentary Behavior and Physical ActivityScreen-time4.5 hours per dayStandard Deviation 3.3
Follow-upSedentary Behavior and Physical ActivityLight Physical Activity (LPA)4.1 hours per dayStandard Deviation 0.5
Follow-upSedentary Behavior and Physical ActivityModerate-Vigorous Physical Activity (MVPA)1.7 hours per dayStandard Deviation 0.5
Follow-upSedentary Behavior and Physical ActivityScreen-time3.8 hours per dayStandard Deviation 3.5

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026