- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02751814
Physical Activity and Screen-Time Regulations in Childcare Centers - Aim 2 (Pause and Play)
March 27, 2024 updated by: Amanda Staiano, Pennington Biomedical Research Center
Physical Activity and Screen-Time Regulations in Childcare Centers: Influence on Young Children's Health Behaviors (Pause & Play) - Aim 2
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
175
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Louisiana
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Baton Rouge, Louisiana, United States, 70808
- Pennington Biomedical Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 4 years (Child)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Ten licensed DOE Class A or B childcare centers will be randomly selected from a list of all DOE licensed childcare centers in East Baton Rouge Parish (EBR).
From the ten centers, 266 children and their parent(s) will be recruited to complete additional measures of physical activity and screen-time behaviors.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Objective Child Physical Activity
Time Frame: 1 Year
|
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.
|
1 Year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Classroom Observation of Child Screen-time
Time Frame: 1 year
|
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.
|
1 year
|
|
Parent Reports of Child Screen Time
Time Frame: 1 Year
|
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.
|
1 Year
|
|
Sedentary Behavior and Physical Activity
Time Frame: 1 year
|
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.
|
1 year
|
|
Fundamental Motor Skills
Time Frame: 1 year
|
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.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Amanda E Staiano, PhD, PBRC Assistant Professor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Joseph ED, Kracht CL, St Romain J, Allen AT, Barbaree C, Martin CK, Staiano AE. Young Children's Screen Time and Physical Activity: Perspectives of Parents and Early Care and Education Center Providers. Glob Pediatr Health. 2019 Jul 24;6:2333794X19865856. doi: 10.1177/2333794X19865856. eCollection 2019.
- Kracht CL, Webster EK, Staiano AE. A natural experiment of state-level physical activity and screen-time policy changes early childhood education (ECE) centers and child physical activity. BMC Public Health. 2020 Mar 24;20(1):387. doi: 10.1186/s12889-020-08533-8.
- Staiano AE, Webster EK, Allen AT, Jarrell AR, Martin CK. Screen-Time Policies and Practices in Early Care and Education Centers in Relationship to Child Physical Activity. Child Obes. 2018 Aug/Sep;14(6):341-348. doi: 10.1089/chi.2018.0078.
- Staiano AE, Allen AT, Fowler W, Gustat J, Kepper MM, Lewis L, Martin CK, Romain JS, Webster EK. State Licensing Regulations on Screen Time in Childcare Centers: An Impetus for Participatory Action Research. Prog Community Health Partnersh. 2018;12(1S):101-109. doi: 10.1353/cpr.2018.0025.
- Webster EK, Martin CK, Staiano AE. Fundamental motor skills, screen-time, and physical activity in preschoolers. J Sport Health Sci. 2019 Mar;8(2):114-121. doi: 10.1016/j.jshs.2018.11.006. Epub 2018 Nov 24.
- Martins, C., Webster, E. K., Bandeira, P. F. R., & Staiano, A. E. (2022). Identifying Fundamental Motor Skills Building Blocks in Preschool Children From Brazil and the United States: A Network Analysis. Journal of Motor Learning and Development, 10(1), 96-115. Retrieved Mar 27, 2024, from https://doi.org/10.1123/jmld.2021-0022
- Kracht CL, Webster EK, Staiano AE. Relationship between the 24-Hour Movement Guidelines and fundamental motor skills in preschoolers. J Sci Med Sport. 2020 Dec;23(12):1185-1190. doi: 10.1016/j.jsams.2020.06.021. Epub 2020 Jul 5.
- Kracht CL, Webster EK, Staiano AE. Sociodemographic Differences in Young Children Meeting 24-Hour Movement Guidelines. J Phys Act Health. 2019 Oct 1;16(10):908-915. doi: 10.1123/jpah.2019-0018. Epub 2019 Sep 6.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2016
Primary Completion (Actual)
June 1, 2018
Study Completion (Actual)
June 1, 2018
Study Registration Dates
First Submitted
April 19, 2016
First Submitted That Met QC Criteria
April 21, 2016
First Posted (Estimated)
April 26, 2016
Study Record Updates
Last Update Posted (Actual)
March 29, 2024
Last Update Submitted That Met QC Criteria
March 27, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PBRC 2015-038
- U54MD008602-P02UAB (Other Grant/Funding Number: UAB)
- U54MD008602 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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