Childhood ObesityNCT03890913

Painted Playgrounds Aim 1

An observational study of Childhood Obesity, run by Pennington Biomedical Research Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Childhood Obesity
How many people: 51 participants
Where: 1 siteUnited States
Study dates: 1 Sep 2017to 30 Jun 2019
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Study population: Four licensed DOE Class A or B childcare centers will be selected from a list of all DOE licensed childcare centers in East Baton Rouge Parish.

Who may be able to join

Licensed by DOE as a Class A or Class B childcare center
Current childcare enrollment of at least 20 children between the ages of 3-6 years
Has a playground/play area with adequate space for stenciling

Who cannot join

Childcare center and/or childcare center director are unwilling to participate

Trial locations and contacts

1 site in 1 country.

United States1 site

Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808

Other trials in United States

About this study

Official title: Painted Playgrounds: A Scalable Approach to Increasing Physical Activity and Motor Skills in Louisiana Preschool Aged Children. Aim 1: Observation

Painted Playgrounds Aim 1: Observation will examine the physical environment of licensed childcare centers before and after painting stencil activities (hopscotch, foursquare, fun trails, etc.) on playgrounds. The stencils are a promising intervention to help decrease obesity and sedentary behaviors in preschool aged children because they are cost-effective and easily scalable. Observations will be held at follow-ups by video recording during recess and using a modified behavioral observation method, called SOPLAY. Surveys will be administered to childcare center directors to report further on their physical activity environment and how much they are interacting with the stencils.

Read the detailed description

Preschool is a critical period during which children develop fundamental motor skills, build confidence in their movement, and start a physical activity trajectory that follows through adolescence and beyond. Unfortunately, few sustainable interventions have succeeded in increasing preschool children's physical activity, and subsequently children are developing obesity at alarming rates. A simple, low-cost strategy is the addition of colorful markings (i.e. hopscotch, foursquare, fun trails) to existing playgrounds or open spaces. These "painted playgrounds" have been shown to be effective to increase physical activity in older school-aged children but remain understudied in preschool children. The proposed project will examine the physical activity environment of licensed childcare centers before and after the implementation of a promising (cost-effective, easily scalable) playground stenciling intervention.

The project aim will be achieved through a prospective observational epidemiological approach before and after a stenciling intervention is implemented. Among 4 childcare centers licensed in East Baton Rouge Parish (EBR), the investigators will first observe the playground environment to assess the equipment, space, ground material, etc. to provide a baseline measure of the physical activity environment prior to stenciling and ensure that intervention and control centers have similar playground environments. A modified behavioral observation method, the System for Observing Play and Leisure Activity in Youth (SOPLAY), will be used during recess to identify changes in physical activity after the stencils are added and which stencils are generating the biggest changes in physical activity. Surveys will be administered to center directors to further understand the physical activity environment (i.e. policies, additional PA support, etc.) in each center. This project will examine how a promising (cost-effective, easily scalable) playground stenciling intervention changes the physical activity landscape of childcare centers in order to provide evidence for the need for dissemination to numerous childcare centers across Louisiana. Ultimately, this pilot may launch an innovative strategy that has the potential to disrupt negative trends in obesity and sedentary behavior among Louisiana preschoolers.

Conditions: Childhood Obesity
Medical subject headings: Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03890913
Study group	Role	What they receive
Observation		All childcare centers enrolled to Aim 1 will be observed. The physical activity environment will be examined before and after the implementation of playground stencils.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Children's Physical Activity Levels During Recess
The investigators will observe the number of children participating in physical activity during recess before and after the implementation of a playground stenciling intervention to asses for change. The observation will be performed using a modified version of the System for Observing Play and Leisure Activity in Youth (SOPLAY). SOPLAY is an observational tool designed to assess physical activity levels \& environmental conditions in settings where youth are engaged in play and leisure. SOPLAY is typically used to capture data on physical activity levels, the type of activity, and environmental factors that may influence youth activity. SOPLAY does not produce a single cumulative "score" but instead provides a detailed record of activity levels and environmental conditions. The data is typically analyzed to assess patterns, identify factors that promote or inhibit physical activity, and guide interventions to improve youth physical activity engagement.
Measured: Children will be examined at follow up (6-8 weeks after receiving the stencils)

Secondary outcomes (3)

Childcare Center Physical Activity Environment
Childcare center directors will complete a survey assessing the physical activity environment (e.g. policies for outdoor play and screen time, available equipment, teacher engagement in physical activity, etc.) of their childcare center.
Measured: Baseline
Satisfaction With Playground Stencils
Intervention Childcare center directors will complete a survey to measure their satisfaction and perceptions of teacher's satisfaction with the playground stencils.
Measured: 6-8 weeks after receiving the playground stencils.
Childcare Center Resources for Physical Activity
Project staff will evaluate the availability of resources (i.e. playground space, equipment, etc.) at each childcare center.
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 201730 Jun 2019

First posted26 Mar 2019
Study start1 Sep 2017
Primary completion30 Jun 2019
Study completion30 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Childhood ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03890913
Sponsor's protocol ID: PBRC 2017-034
Status last verified: Jan 2025
First submitted: 29 Jan 2019
Last updated: 3 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Webster EK, Kepper MM, Saha S, Beyl RA, Kracht CL, Romain JS, Staiano AE. Painted playgrounds for preschoolers' physical activity and fundamental motor skill improvement: a randomized controlled pilot trial of effectiveness. BMC Pediatr. 2023 Sep 9;23(1):455. doi: 10.1186/s12887-023-04260-2.
PubMed 37689622

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Childhood Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Painted Playgrounds: A Scalable Approach to Increasing Physical Activity and Motor Skills in Louisiana Preschool Aged Children. Aim 1: Observation
ClinicalTrials.gov ID: NCT03890913
Acronym / sponsor ID: PBRC 2017-034
Conditions: Childhood Obesity
Study type: Observational
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Pennington Biomedical Research CenterUniversity, hospital or other
Collaborators: Blue Cross Blue Shield
Study start: 1 Sep 2017 (actual)
Primary completion: 30 Jun 2019 (actual)
Study completion: 30 Jun 2019 (actual)
First posted: 26 Mar 2019 (actual)
Results: Posted 3 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Observation	–	–All childcare centers enrolled to Aim 1 will be observed. The physical activity environment will be examined before and after the implementation of playground stencils.

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
Study population: Four licensed DOE Class A or B childcare centers will be selected from a list of all DOE licensed childcare centers in East Baton Rouge Parish.

Key inclusion criteria (3 listed)

Licensed by DOE as a Class A or Class B childcare center
Current childcare enrollment of at least 20 children between the ages of 3-6 years
Has a playground/play area with adequate space for stenciling

Key exclusion criteria (1 listed)

Childcare center and/or childcare center director are unwilling to participate

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Change in Children's Physical Activity Levels During Recess
Time frame: Children will be examined at follow up (6-8 weeks after receiving the stencils)
The investigators will observe the number of children participating in physical activity during recess before and after the implementation of a playground stenciling intervention to asses for change. The observation will be performed using a modified version of the System for Observing Play and Leisure Activity in Youth (SOPLAY). SOPLAY is an observational tool designed to assess physical activity levels \& environmental conditions in settings where youth are engaged in play and leisure. SOPLAY is typically used to capture data on physical activity levels, the type of activity, and environmental factors that may influence youth activity. SOPLAY does not produce a single cumulative "score" but instead provides a detailed record of activity levels and environmental conditions. The data is typically analyzed to assess patterns, identify factors that promote or inhibit physical activity, and guide interventions to improve youth physical activity engagement.

3 secondary outcomes

Childcare Center Physical Activity Environment
Time frame: Baseline
Satisfaction With Playground Stencils
Time frame: 6-8 weeks after receiving the playground stencils.
Childcare Center Resources for Physical Activity
Time frame: Baseline

Results and safety

Results posted to the registry on 3 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention Centers	32	32
Wait-List Control	19	19

Primary outcome: Change in Children's Physical Activity Levels During Recess

Time frame: Children will be examined at follow up (6-8 weeks after receiving the stencils). Mean (Standard Deviation). Unit: count of participants

Measure	Children Enrolled in Participating Child Care Centers - Control n = 19	Children Enrolled in Participating Child Care Centers - Intervention n = 26
Light physical activity	2.3 (3.3)	4.3 (2.9)
Moderate physical activity	3.5 (3.6)	0.5 (3.2)
Vigorous PA	2.6 (1.2)	.9 (1.1)
Moderate-to-Vigorous Physical Activity	6.2 (4.1)	1.4 (3.7)
Sedentary Behavior	-8.5 (6.8)	-5.6 (6.1)

Population analysed: A total number of 45 children were observed playing in either the intervention or control playgrounds. When the numbers listed below does not match with the over number of participants analyzed (51), that means the children not represented DID NOT use the stencils at their center. Reminder that the participants listed below are children who were students at the 4 sites within this aim.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Children Enrolled in Participating Child Care Centers - Control	0 of 19 (0%)	0 of 19 (0%)	0 of 19
Children Enrolled in Participating Child Care Centers - Intervention	0 of 32 (0%)	0 of 32 (0%)	0 of 32

Limitations and caveats (from the sponsor): Limitations include the small sample for this pilot study. Only four schools were examined in one region of the United States, so results may only be generalizable to this area or to programs with similar characteristics. The limited access to concrete space in most ECE centers is a limitation that must be considered for the expansion of this intervention. Finally, intervention fidelity was not measured, nor was PA measured immediately after introducing the markings on the playground.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 37689622Webster EK, Kepper MM, Saha S, Beyl RA, Kracht CL, Romain JS, Staiano AE. Painted playgrounds for preschoolers' physical activity and fundamental motor skill improvement: a randomized controlled pilot trial of effectiveness. BMC Pediatr. 2023 Sep 9;23(1):455. doi: 10.1186/s12887-023-04260-2.
Individual participant dataSharing planned: No

Related trials for Childhood Obesity

RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Recruiting
Cities for Better Health Childhood Obesity Prevention Initiative in JAPAN
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Amanda Staiano, PhD principal investigator

Pennington Biomedical

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Childhood Obesity, run by Pennington Biomedical Research Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Children's Physical Activity Levels During Recess (time frame: Children will be examined at follow up (6-8 weeks after receiving the stencils)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03890913, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.