NCT03752008

Brief Summary

The aim of this study was to develop, test, and compare two approaches to increasing physical activity (PA) and decreasing sedentary time among young children at child care centers, one which focused on a teacher-led PA curriculum (AP=Active Play!) and the other on increasing outdoor free play time (OP=Outdoor Play!).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 4, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2014

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 23, 2018

Completed
Last Updated

November 26, 2018

Status Verified

November 1, 2018

Enrollment Period

1.4 years

First QC Date

November 20, 2018

Last Update Submit

November 21, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • Pre to post change in preschoolers Physical Activity

    Physical Activity levels measured by actigraphy monitors

    baseline and 12 weeks after intervention

  • Pre to post change in Physical Activity Opportunities

    Minutes where students could be physically active by observation (RA observed and wrote down times for when children were engaged in various activities and categorized them as active play opportunities or non active play opportunities. Total minutes in each category were calculated.

    baseline and 12 weeks after intervention

Secondary Outcomes (1)

  • pre to post Teacher Physical Activity

    baseline and 12 weeks after intervention

Study Arms (2)

Active Play (AP)

EXPERIMENTAL

This arm received the Active Play curriculum intervention (described in following section).

Behavioral: Active Play (AP)

Outdoor Play (OP)

EXPERIMENTAL

This arm received the Outdoor Play curriculum intervention (described in following section).

Behavioral: Outdoor Play (OP)

Interventions

This intervention focused on promoting PA in preschoolers through structured, teacher-led activities that could be incorporated into daily curriculum. Teachers attended a 3-hour workshop that included presentation and discussion of 1) the importance of daily physical activity for children's health and development, 2) teachers' beliefs and barriers to promoting PA, and 3) the Active Play! Intervention materials. Teachers were introduced to and given the Active Play! Fun Physical Activities for Young Children Book and Digital Video Disk (DVD), which promotes PA and fundamental movement skills in young children. Clips of the DVD demonstrating various activities were shown and activities were modeled. Examples of activities include jumping on bubble wrap, hula hoop limbo and an indoor obstacle course. The end of the book has a suggested curriculum that teachers could follow. Centers in the Active Play! intervention also received a set of portable toys needed for the suggested activities.

Active Play (AP)

This intervention focused on promoting outdoor time in preschoolers as a means to increasing their PA, using both child initiated and teacher-led activities. The training and materials were designed to emphasize the teacher's own connection with nature, the benefits of outdoor time for children and adults, and problem solving around barriers encountered. Teachers at participating centers attended one 3-hour workshop (delivered at the childcare center) that focused on having participants recognize their own connection with the natural world and how to transmit that to the next generation. Teachers were given hats and gloves for themselves, a set of rain jackets and boots for the preschoolers, and ideas on what children could do outdoors to be active.

Outdoor Play (OP)

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Teachers/Staff
  • be a teacher/staff member in a participating childcare center
  • Students
  • be 3 - 5 years old
  • be a full day student in the classroom where data collection was occurring

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Pooja Tandon, MD MPH

    Seattle Chidlren's

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 10 childcare centers were cluster-randomized to receive either a physical activity or outdoor free play curriculum.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 20, 2018

First Posted

November 23, 2018

Study Start

December 4, 2012

Primary Completion

April 24, 2014

Study Completion

April 24, 2014

Last Updated

November 26, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share