Preschoolers Learning and Active in PlaY

Physical Activity Clinical Trial

— PLAY  

Official title:

Preschoolers Learning and Active in PlaY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03279926
• Other study ID #: STUDY00000628
• Secondary ID: 1R21CA218592-01
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: October 15, 2019

Study information

• Verified date: September 2020
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: October 15, 2019
• Est. primary completion date: October 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Physical Activity

Intervention

Behavioral:
• PLAY
Activity trackers + curriculum information
• PLAY Parents
Enhanced parental engagement
• PLAY Teachers
Enhanced teacher engagement with active living initiates for the teachers

Locations

Country	Name	City	State
United States	Seattle Children's Research Institute	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Children's Hospital	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	activity tracker wear	amount of days activity tracker is worn by participant	Month 1
Other	activity tracker wear	amount of days the activity tracker is worn by participant	Month 6
Primary	Post-intervention physical activity (children)	accelerometer measured	Month 6 compared to baseline
Primary	Post-intervention physical activity (children)	accelerometer measured	Month 1 compared to baseline
Secondary	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