Clinical trial NCT04772638: Preschoolers Learning and Active in PLAY (PLAY Extension)
Official title: PLAY 2 - Preschoolers Learning and Active in PLAY (PLAY Extension)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Activity, Motor
Keywords: children
physical activity
early childhood education
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 133
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Cluster RCT with a waitlist control
Primary purpose: OTHER

Brief summary: The PLAY 2 Study is the continuation of an R21 pilot PLAY study. In the R21, we tested the acceptability, feasibility and initial efficacy of three early childhood education setting- based, multi-level interventions to promote preschoolers' physical activity using wearable technology and additional behavior change techniques to engage educators and parents. We have selected one of these 3 as the main intervention for the R33 portion of the grant. The intervention will contain components of teacher wellness, parent engagement, and activity level monitoring.

Detailed description: Physical activity in early childhood is important for numerous aspects of children's health and development. Preschoolers are thought to be very active but previous studies have shown that they are sedentary for the majority of time and not getting adequate opportunities to engage in active play. Experts have recommended strategies to promote physical activity in early learning settings and to involve parents in efforts to promote active living from a young age. Through early learning settings, we may be able to change behaviors in large groups of children and particularly benefit more vulnerable children who have fewer opportunities for outdoor play and physical activity at home or in their neighborhoods. However, meaningful engagement from families is also important and research suggests that there is gap in communication and perhaps alignment between educators and parents on the topic of preschoolers' physical activity. This research uses wearable technology to monitor physical activity in children, motivate parents and educators to help create active play opportunities, and create a platform for communication and shared accountability about this important health behavior. We will focus particularly on children from lower income backgrounds who suffer from disparities in both health and educational outcomes. Our primary outcome of interest is accelerometer measured physical activity. We will also explore how changes in preschooler's physical activity relate to behavioral indicators, which are topics of great significance to early childhood educators, policy makers and parents.

Eligibility criteria: Inclusion Criteria:

* Children ages 3-5 who attend participating preschools and their parents s are eligible.
* Teachers and staff who work at participating preschools are eligible.

Participating preschools:

1. child care centers that offer full day child care
2. at least 1 classroom for children ages 3-5

Exclusion Criteria:

- family based child care homes

Primary outcomes:
measure: Post-intervention physical activity
timeFrame: 6 Month after baseline assessment
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Childrens
state: Washington
Study officials:
affiliation: Seattle Childrens
name: Pooja Tandon, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: