Painted Playgrounds: Aim 2: Assessments

November 5, 2024 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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
51

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 6 years (Child)

Accepts Healthy Volunteers

Yes

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other: Playground Stencils
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.
Other: Playground Stencils
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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. The main outcome variable will be percentage of recess time spent in MVPA, measured objectively using a physical activity monitor (i.e. accelerometer).
Baseline and follow-up (6 to 8 weeks after playground stenciling)
Change in Fundamental Motor Skill Development
Time Frame: Baseline and follow-up (6 to 8 weeks after playground stenciling)
The Test of Gross Motor Development, 3rd edition (TGMD-3) was utilized to assess fundamental motor skills. The test consists of a total of 13 skills which are designed to assess locomotor (6 skills) and ball (7 skills). Children complete two trials, and if they meet the specified performance criteria, they are scored a 1. If they fail to meet the criteria, they are scored a zero. Trials 1 and 2 are added to get the raw scores of locomotor and ball skill. For locomotor, this range is from 0-46; for ball skills, children can score from 0-54. Raw scores are then converted to scaled scores based on the TGMD-3 age and gender charts. The scaled scores are added to determine a total scaled score. The total scaled score has a percentile ranking to determine what percentile the child is in (<1,>99). The post-TGMD-3 total percentile was subtracted for the change score from the baseline percentile. A positive value indicates an improvement in fundamental motor skills, where
Baseline and follow-up (6 to 8 weeks after playground stenciling)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pennington Biomedical Research Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Blue Cross Blue Shield

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Maura Kepper, PhD, Pennington Biomedical Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 21, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PBRC 2017-040

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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