Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02751788
Recruitment Status : Completed
First Posted : April 26, 2016
Last Update Posted : September 25, 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:
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.

Condition or disease
Childhood Obesity

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 10 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 1
Actual Study Start Date : April 2016
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
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

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): NCT02751788


Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Amanda E Staiano, PhD PBRC Assistant Professor

Layout table for additonal information
Responsible Party: Amanda Staiano, PBRC Assistant Professor, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT02751788     History of Changes
Other Study ID Numbers: PBRC 2015-044
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: September 25, 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:
Layout table for MeSH terms
Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms