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

    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center

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

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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