NCT03885518

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
5.5 years until next milestone

Results Posted

Study results publicly available

December 24, 2024

Completed
Last Updated

December 24, 2024

Status Verified

November 1, 2024

Enrollment Period

7 months

First QC Date

January 29, 2019

Results QC Date

July 5, 2023

Last Update Submit

November 5, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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. 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

    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)

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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

Wait-List

PLACEBO COMPARATOR

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

Interventions

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.

InterventionWait-List

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (1)

  • 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.

    PMID: 37689622BACKGROUND

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

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.

Results Point of Contact

Title
Dr. Amanda Staiano
Organization
LSU's Pennington Biomedical Research Center

Study Officials

  • Maura Kepper, PhD

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 29, 2019

First Posted

March 21, 2019

Study Start

December 15, 2018

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

December 24, 2024

Results First Posted

December 24, 2024

Record last verified: 2024-11

Locations