ClinicalTrials.gg
CompletedNCT03279926PLAYUpdated Sep 7, 2020

Preschoolers Learning and Active in PlaY

An interventional study of PLAY and PLAY Parents in Physical Activity, sponsored by Seattle Children's Hospital. Completed at 1 site in United States. Open to participants aged 3 Years to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-07.

Sponsored by Seattle Children's Hospital · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
181
Allocation
Randomized
Ages
3 Years to 5 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 16 studies in Motor Activity by Seattle Children's Hospital — none open to participants now, 1 under way, none of them phase 3. Motor Activity · Seattle Children's Hospital.

Enrollment
6th of 15
181 · median 133
Started
2017
with 1 other
No phase
15 of 16
none open now
Registered
9th of 16
by date

Among the 16 studies in Motor Activity by Seattle Children's Hospital, this one is the 6th largest by enrollment of the 15 interventional ones that give a count, is one of 2 that started in 2017, is one of 15 with no phase, and was the 9th registered.

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

Browse Motor Activity studies →

Open to participants now

None of the 16 studies in Motor Activity by Seattle Children's Hospital is open now.

Where they have run

Who these studies take

Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.

This study: 3 Years to 5 Years · all sexes · healthy volunteers too.

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Download CSVNarrow it in search →With an account: the 16 studies in Motor Activity by Seattle Children's Hospital as a file.
02

Study 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.

03

Conditions studied

  • Physical Activity

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04

Who can participate

Ages eligible
3 Years to 5 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • unable to participate in all physical activities
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
181 participants (actual)

Study arms

  • 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

  • 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 · Behavioral: PLAY Parents

  • Experimental
    PLAY Teachers

    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

  • BehavioralPLAY

    Activity trackers + curriculum information

  • BehavioralPLAY Parents

    Enhanced parental engagement

  • BehavioralPLAY Teachers

    Enhanced teacher engagement with active living initiates for the teachers

06

What researchers measure

Primary outcomes

  1. Post-intervention physical activity (children)

    accelerometer measured

    Time frame: Month 6 compared to baseline

  2. Post-intervention physical activity (children)

    accelerometer measured

    Time frame: Month 1 compared to baseline

Secondary outcomes

  1. 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)

    Time frame: Month 6 compared to baseline

Other outcomes

  1. activity tracker wear

    amount of days activity tracker is worn by participant

    Time frame: Month 1

  2. activity tracker wear

    amount of days the activity tracker is worn by participant

    Time frame: Month 6

07

Study locations

1 site
  • Seattle Children's Research Institute
    Seattle, Washington 98145, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2017 to primary completion in Oct 2019, 24 months.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 24 months is above that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 8, 2017
First posted
Sep 12, 2017
StartActual
Oct 1, 2017
Primary completionActual
Oct 15, 2019
CompletionActual
Oct 15, 2019
Last update
Sep 7, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03279926
Responsible party
Pooja Tandon (Assistant Professor, Seattle Children's Hospital) — Principal investigator
First posted
Sep 12, 2017
Start date
Oct 1, 2017
Primary completion
Oct 15, 2019
Completion
Oct 15, 2019
Last update
Sep 7, 2020

Study contacts

Pooja Tandon, MD
principal investigator · Seattle Children's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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