Preschoolers Learning and Active in PlaY

NCT03279926 | Completed

• 2 other identifiers: STUDY000006281R21CA218592-01
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Activity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Active play opportunities at child care

  Month 6 compared to baseline

Other Outcomes (2)

• activity tracker wear

  Month 1

• activity tracker wear

  Month 6

Study Arms (3)

PLAY

EXPERIMENTAL

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

PLAY Parents

EXPERIMENTAL

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; Behavioral: PLAY Parents

PLAY Teachers

EXPERIMENTAL

Everything in Arm 1 plus an enhanced focus on teacher wellness, specifically with regard to active lifestyles for them.

Behavioral: PLAY; Behavioral: PLAY Teachers

Interventions

PLAY BEHAVIORAL

Activity trackers + curriculum information

PLAY; PLAY Parents; PLAY Teachers

PLAY Parents BEHAVIORAL

Enhanced parental engagement

PLAY Parents

PLAY Teachers BEHAVIORAL

Enhanced teacher engagement with active living initiates for the teachers

PLAY Teachers

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• unable to participate in all physical activities

Sponsors & Collaborators

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

Study Sites (1)

Seattle Children's Research Institute

Seattle, Washington, 98145, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Pooja Tandon, MD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: September 12, 2017
• Study Start: October 1, 2017
• Primary Completion: October 15, 2019
• Study Completion: October 15, 2019
• Last Updated: September 7, 2020

Record last verified: 2020-09

Locations

US (1)