Preschoolers Learning and Active in PlaY (PLAY)

The overall aim of this proposal is to develop and test early childhood education setting-based physical activity (PA) interventions that are innovative by using wearable technology to facilitate monitoring, feedback and motivation for physical activity across multiple levels (child, parent, educator). We posit that our intervention strategies will promote behavior changes in parents and educators, leading to greater awareness and communication about physical activity, more active play opportunities, and ultimately more physical activity for preschoolers. In the R21, we will test the acceptability, feasibility and initial efficacy of three 6 month early childhood education setting- based, multi-level interventions to promote preschoolers' PA using wearable technology and additional behavior change techniques to engage educators and parents. The results of this study will inform a larger intervention trial.

Study Overview

• Status: Completed
• Conditions: Physical Activity
• Intervention / Treatment: Behavioral: PLAY; Behavioral: PLAY Parents; Behavioral: PLAY Teachers

• Study Type: Interventional
• Enrollment (Actual): 181
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98145
      • Seattle Children's Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• attends preschool in a child care center participating in this study
• no physical/health restrictions on participating in physical activities

Exclusion Criteria:

• unable to participate in all physical activities

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PLAY; Preschoolers & their teachers will get activity trackers and the child care program/providers will get some basic information on the use of the trackers and how to integrate their use in the curriculum. A PLAY Champion will be identified to help support PLAY related activities.	Behavioral: PLAY; Activity trackers + curriculum information
Experimental: PLAY Parents; Everything in Arm 1 plus one parent per child will receive an activity tracker and will get reports to help with physical activity goal setting for the family.	Behavioral: PLAY; Activity trackers + curriculum information; Behavioral: PLAY Parents; Enhanced parental engagement
Experimental: PLAY Teachers; Everything in Arm 1 plus an enhanced focus on teacher wellness, specifically with regard to active lifestyles for them.	Behavioral: PLAY; Activity trackers + curriculum information; Behavioral: PLAY Teachers; Enhanced teacher engagement with active living initiates for the teachers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-intervention physical activity (children)	accelerometer measured	Month 6 compared to baseline
Post-intervention physical activity (children)	accelerometer measured	Month 1 compared to baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Active play opportunities at child care	Using an observation tool, a trained research assistant will note opportunities for active play (including teacher led, child-initiated, outdoor and indoor)	Month 6 compared to baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
activity tracker wear	amount of days activity tracker is worn by participant	Month 1
activity tracker wear	amount of days the activity tracker is worn by participant	Month 6

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Pooja Tandon, MD, Seattle Children's

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): October 15, 2019
• Study Completion (Actual): October 15, 2019

Study Registration Dates

• First Submitted: September 8, 2017
• First Submitted That Met QC Criteria: September 8, 2017
• First Posted (Actual): September 12, 2017

Study Record Updates

• Last Update Posted (Actual): September 7, 2020
• Last Update Submitted That Met QC Criteria: September 4, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00000628; 1R21CA218592-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No