PLAY: Preschoolers Learning and Active in PlaY

Sponsor
Seattle Children's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03279926
Collaborator
National Cancer Institute (NCI) (NIH)
181
1
3
24.4
7.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: PLAY
  • Behavioral: PLAY Parents
  • Behavioral: PLAY Teachers
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
181 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Preschoolers Learning and Active in PlaY
Actual Study Start Date :
Oct 1, 2017
Actual Primary Completion Date :
Oct 15, 2019
Actual Study Completion Date :
Oct 15, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Post-intervention physical activity (children) [Month 6 compared to baseline]

    accelerometer measured

  2. Post-intervention physical activity (children) [Month 1 compared to baseline]

    accelerometer measured

Secondary Outcome Measures

  1. Active play opportunities at child care [Month 6 compared to baseline]

    Using an observation tool, a trained research assistant will note opportunities for active play (including teacher led, child-initiated, outdoor and indoor)

Other Outcome Measures

  1. activity tracker wear [Month 1]

    amount of days activity tracker is worn by participant

  2. activity tracker wear [Month 6]

    amount of days the activity tracker is worn by participant

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seattle Children's Research Institute Seattle Washington United States 98145

Sponsors and Collaborators

  • Seattle Children's Hospital
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Pooja Tandon, MD, Seattle Children's

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pooja Tandon, Assistant Professor, Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT03279926
Other Study ID Numbers:
  • STUDY00000628
  • 1R21CA218592-01
First Posted:
Sep 12, 2017
Last Update Posted:
Sep 7, 2020
Last Verified:
Sep 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 7, 2020