- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03885518
Painted Playgrounds: Aim 2: Assessments
August 25, 2022 updated by: Amanda Staiano, Pennington Biomedical Research Center
Painted Playgrounds: A Scalable Approach to Increasing Physical Activity and Motor Skills in Louisiana Preschool Aged Children. Aim 2: Assessments
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70808
- Pennington Biomedical Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 6 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Intervention
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
|
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.
|
PLACEBO_COMPARATOR: Wait-List
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Moderate to Vigorous Activity (MVPA) during recess
Time Frame: Baseline and follow-up (6 to 8 weeks after playground stenciling)
|
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.
|
Baseline and follow-up (6 to 8 weeks after playground stenciling)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in fundamental motor skill development
Time Frame: Baseline and follow-up (6 to 8 weeks after playground stenciling)
|
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.
|
Baseline and follow-up (6 to 8 weeks after playground stenciling)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 15, 2018
Primary Completion (ACTUAL)
June 30, 2019
Study Completion (ACTUAL)
June 30, 2019
Study Registration Dates
First Submitted
January 29, 2019
First Submitted That Met QC Criteria
March 19, 2019
First Posted (ACTUAL)
March 21, 2019
Study Record Updates
Last Update Posted (ACTUAL)
August 26, 2022
Last Update Submitted That Met QC Criteria
August 25, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-040-PBRC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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