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Physical Activity and Screen-Time Regulations in Childcare Centers - Aim 2 (Pause and Play)

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ClinicalTrials.gov Identifier: NCT02751814
Recruitment Status : Completed
First Posted : April 26, 2016
Last Update Posted : September 7, 2018
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Amanda Staiano, Pennington Biomedical Research Center

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.

Condition or disease
Childhood Obesity

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.

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Study Type : Observational
Actual Enrollment : 175 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Physical Activity and Screen-Time Regulations in Childcare Centers: Influence on Young Children's Health Behaviors (Pause & Play) - Aim 2
Actual Study Start Date : April 2016
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  1. 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).

  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. Fundamental motor skills [ Time Frame: 1 year ]
    Cross-sectional and longitudinal associations among sedentary behavior (by screen-time observation/self-report and by accelerometry), physical activity (by accelerometry), and fundamental motor skills.



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Ages Eligible for Study:   3 Years to 4 Years   (Child)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751814


Locations
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United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: Amanda E Staiano, PhD PBRC Assistant Professor

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Responsible Party: Amanda Staiano, PBRC Assistant Professor, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT02751814     History of Changes
Other Study ID Numbers: PBRC 2015-038
U54MD008602-P02UAB ( Other Grant/Funding Number: UAB )
U54MD008602 ( U.S. NIH Grant/Contract )
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Amanda Staiano, Pennington Biomedical Research Center:
Childcare Center Regulations
Physical Activity
Sedentary Behavior
Screen-time Behavior

Additional relevant MeSH terms:
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Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms