search
Back to results

Painted Playgrounds: Aim 2: Assessments

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Playground Stencils
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Childhood Obesity

Eligibility Criteria

3 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • A child who attends a childcare center enrolled to Aim 1.
  • A child who is ≥ 3 years and ≤ 6 years old
  • Your child will continue to attend this same childcare center for the duration of the study.

Exclusion Criteria:

• Parent/legal guardian is unwilling to provide written informed consent

Sites / Locations

  • Pennington Biomedical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention

Wait-List

Arm Description

Participants attending the childcare centers randomized to this arm will receive the stencil activities after baseline assessments have been completed. We will follow-up with assessments after 6-8 weeks

Participants attending the childcare centers randomized to this arm will receive the stencil activities approximately 8 weeks after enrolling, after baseline and follow-up assessments have been completed.

Outcomes

Primary Outcome Measures

Change in Moderate to Vigorous Activity (MVPA) during recess
To test the effectiveness of a promising (cost-effective, easily scalable) playground stenciling intervention to increase physical activity, change in MVPA during recess will be measured using accelerometers.

Secondary Outcome Measures

Change in fundamental motor skill development
To test the effectiveness of a promising (cost-effective, easily scalable) playground stenciling intervention to change fundamental motor skills, Tests of Gross Motor Development (TGMDs) will be performed at baseline and follow-up.

Full Information

First Posted
January 29, 2019
Last Updated
August 25, 2022
Sponsor
Pennington Biomedical Research Center
Collaborators
Blue Cross Blue Shield
search

1. Study Identification

Unique Protocol Identification Number
NCT03885518
Brief Title
Painted Playgrounds: Aim 2: Assessments
Official Title
Painted Playgrounds: A Scalable Approach to Increasing Physical Activity and Motor Skills in Louisiana Preschool Aged Children. Aim 2: Assessments
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 15, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center
Collaborators
Blue Cross Blue Shield

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The Painted Playgrounds Aim 2 (Assessment) project will examine the effects of a stenciling intervention aimed at increasing physical activity and improving fundamental motor skill functioning of preschool aged children. 72 children from local licensed childcare centers will participate in individual assessments at baseline and follow-up 6-8 weeks later. Assessments include height/weight, surveys and wearing a physical activity monitor (accelerometer) for 7 days. A parent/legal guardian will provide consent for their child to participate and will also complete a brief survey about their child's lifestyle and habits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Participants attending the childcare centers randomized to this arm will receive the stencil activities after baseline assessments have been completed. We will follow-up with assessments after 6-8 weeks
Arm Title
Wait-List
Arm Type
Placebo Comparator
Arm Description
Participants attending the childcare centers randomized to this arm will receive the stencil activities approximately 8 weeks after enrolling, after baseline and follow-up assessments have been completed.
Intervention Type
Other
Intervention Name(s)
Playground Stencils
Intervention Description
The stencils (hopscotch, agility trail, foursquare, bullseye, etc.) will be painted on the playgrounds at each childcare center. A toolkit and training video will be distributed to staff at each center to aid in instructing the children on how to perform the tasks.
Primary Outcome Measure Information:
Title
Change in Moderate to Vigorous Activity (MVPA) during recess
Description
To test the effectiveness of a promising (cost-effective, easily scalable) playground stenciling intervention to increase physical activity, change in MVPA during recess will be measured using accelerometers.
Time Frame
Baseline and follow-up (6 to 8 weeks after playground stenciling)
Secondary Outcome Measure Information:
Title
Change in fundamental motor skill development
Description
To test the effectiveness of a promising (cost-effective, easily scalable) playground stenciling intervention to change fundamental motor skills, Tests of Gross Motor Development (TGMDs) will be performed at baseline and follow-up.
Time Frame
Baseline and follow-up (6 to 8 weeks after playground stenciling)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: A child who attends a childcare center enrolled to Aim 1. A child who is ≥ 3 years and ≤ 6 years old Your child will continue to attend this same childcare center for the duration of the study. Exclusion Criteria: • Parent/legal guardian is unwilling to provide written informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maura Kepper, PhD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Painted Playgrounds: Aim 2: Assessments

We'll reach out to this number within 24 hrs