Preschoolers Learning and Active in PLAY (PLAY Extension)

NCT04772638 | Completed

• 1 other identifier: 00000628
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

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.

Conditions

Activity, Motor

Keywords

children; physical activity; early childhood education

Outcome Measures

Primary Outcomes (1)

• Post-intervention physical activity

  Accelerometer measured

  6 Month after baseline assessment

Study Arms (2)

PLAY intervention

EXPERIMENTAL

The PLAY intervention with educators, parents and children

Behavioral: PLAY

Wait list control

PLACEBO COMPARATOR

Other: Wait list control

Interventions

PLAY 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.

PLAY intervention

Wait list control OTHER

not an active intervention

Wait list control

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• \- family based child care homes

Sponsors & Collaborators

• Seattle Children's Hospital: lead

Study Sites (1)

Seattle Childrens

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Pooja Tandon, MD MPH

  Seattle Childrens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Cluster RCT with a waitlist control

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: February 26, 2021
• Study Start: February 26, 2021
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)