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Physical Activity and Screen-Time Regulations in Childcare Centers - Aim 1 (Pause and Play)

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ClinicalTrials.gov Identifier: NCT02751788
Recruitment Status : Completed
First Posted : April 26, 2016
Last Update Posted : August 28, 2019
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Amanda Staiano, Pennington Biomedical Research Center

Tracking Information
First Submitted Date April 19, 2016
First Posted Date April 26, 2016
Last Update Posted Date August 28, 2019
Actual Study Start Date April 2016
Actual Primary Completion Date June 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 10, 2016)
Change in EPAO score and EPAO subscales. [ Time Frame: 1 year ]
The EPAO instrument will be used, which is a comprehensive, day-long observation that objectively defines the nutrition and physical activity environmental characteristics of child care centers. To address the specific aim, only the EPAO variables related to physical activity and screen-time will be included in the assessment. Means, standard deviations, and Pearson correlations will be calculated to describe the sample and examine relationships among the environment subscales at baseline and follow-up. Differences in center characteristics (i.e. racial distribution) will be tested using t-tests and chi-square tests. Repeated measures analysis of covariance (ANCOVAs) will be used to examine change in the EPAO score overall.
Original Primary Outcome Measures
 (submitted: April 21, 2016)
Change in EPAO score and EPAO subscales. [ Time Frame: 1 year ]
We will use the EPAO instrument, which is a comprehensive, day-long observation that objectively defines the nutrition and physical activity environmental characteristics of child care centers. To address the specific aim, only the EPAO variables related to physical activity and screen-time will be included in the assessment. Means, standard deviations, and Pearson correlations will be calculated to describe the sample and examine relationships among the environment subscales at baseline and follow-up. Differences in center characteristics (i.e. racial distribution) will be tested using t-tests and chi-square tests. Repeated measures analysis of covariance (ANCOVAs) will be used to examine change in the EPAO score overall.
Change History Complete list of historical versions of study NCT02751788 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 21, 2016)
Changes in practice-based survey items based on childcare director responses. [ Time Frame: 1 Year ]
A survey will be administered to the director of each childcare center to determine the following: awareness of the new policy; structured programs and/or field trips that allow children to be physically active (including number of times per day or week); if one or more community organizations support or provide physical activity programs at the center; whether or not the childcare center has policies regarding television viewing and computer use; amount of time allowed for free play; and amount of time spent outside.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Physical Activity and Screen-Time Regulations in Childcare Centers - Aim 1
Official Title Physical Activity and Screen-Time Regulations in Childcare Centers: Influence on Young Children's Health Behaviors (Pause & Play) - Aim 1
Brief Summary The goal of this project is to examine the physical activity and screen-time environment of licensed childcare centers before and after the enactment of new state regulations.
Detailed Description Pause and Play will take a prospective observational epidemiological approach before and after enactment of new regulations. 10 childcare centers licensed in East Baton Rouge Parish will be randomly selected and standardized behavioral observation scales will be used to objectively quantify the physical activity and screen-time environment of the centers and the children's behaviors both in and outside the center. These assessments will be collected twice during the 2-year grant period to capture potential changes after the policies are implemented.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method 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)
Condition Childhood Obesity
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 21, 2016)
10
Original Estimated Enrollment Same as current
Actual Study Completion Date June 1, 2018
Actual Primary Completion Date June 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Licensed by DOE as a Class A or Class B childcare center
  • Located in East Baton Rouge Parish
  • Current childcare enrollment of at least 18 children between the ages of 3-4 years

Exclusion Criteria:

  • Childcare center and/or childcare center director unwilling to participate
Sex/Gender
Sexes Eligible for Study: All
Ages 3 Years to 4 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02751788
Other Study ID Numbers PBRC 2015-044
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Amanda Staiano, Pennington Biomedical Research Center
Study Sponsor Pennington Biomedical Research Center
Collaborators National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
Principal Investigator: Amanda E Staiano, PhD PBRC Assistant Professor
PRS Account Pennington Biomedical Research Center
Verification Date August 2019