Preschoolers Learning and Active in PLAY (PLAY Extension)

Sponsor
Seattle Children's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04772638
Collaborator
(none)
200
1
2
32.1
6.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: PLAY
  • Other: Wait list control
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Cluster RCT with a waitlist controlCluster RCT with a waitlist control
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
PLAY 2 - Preschoolers Learning and Active in PLAY (PLAY Extension)
Actual Study Start Date :
Feb 26, 2021
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: PLAY intervention

The PLAY intervention with educators, parents and children

Behavioral: 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.

Placebo Comparator: Wait list control

Other: Wait list control
not an active intervention

Outcome Measures

Primary Outcome Measures

  1. Post-intervention physical activity [6 Month after baseline assessment]

    Accelerometer measured

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 5 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seattle Childrens Seattle Washington United States 98101

Sponsors and Collaborators

  • Seattle Children's Hospital

Investigators

  • Principal Investigator: Pooja Tandon, MD MPH, Seattle Childrens

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pooja Tandon, Principal Investigator, Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT04772638
Other Study ID Numbers:
  • 00000628
First Posted:
Feb 26, 2021
Last Update Posted:
May 9, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pooja Tandon, Principal Investigator, Seattle Children's Hospital

Study Results

No Results Posted as of May 9, 2022