Preschoolers Learning and Active in PLAY (PLAY Extension)

NCT ID: NCT04772638

Last Updated: 2024-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-26

Study Completion Date

2024-02-28

Brief Summary

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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

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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.

Conditions

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Activity, Motor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Cluster RCT with a waitlist control
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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PLAY intervention

The PLAY intervention with educators, parents and children

Group Type EXPERIMENTAL

PLAY

Intervention Type BEHAVIORAL

This intervention focuses on promoting physical activity in preschoolers and the adults (parents and teachers) in their lives. It consists of 1) Teacher training 2) Activity trackers for children, teachers and parents and 3) text messaging with content and individualized goal setting.

Wait list control

Group Type PLACEBO_COMPARATOR

Wait list control

Intervention Type OTHER

not an active intervention

Interventions

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PLAY

This intervention focuses on promoting physical activity in preschoolers and the adults (parents and teachers) in their lives. It consists of 1) Teacher training 2) Activity trackers for children, teachers and parents and 3) text messaging with content and individualized goal setting.

Intervention Type BEHAVIORAL

Wait list control

not an active intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seattle Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Pooja Tandon

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pooja Tandon, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Seattle Childrens

Locations

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Seattle Childrens

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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00000628

Identifier Type: -

Identifier Source: org_study_id

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