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Completed

NCT Number: NCT02751814

Physical Activity and Screen-Time Regulations in Childcare Centers - 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.

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Key information

Age range

3 year–4 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

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

Acronym: Pause and Play

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 26, 2016
Registry last updated
Mar 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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