Physical ActivityPLAYNCT03279926
Preschoolers Learning and Active in PlaY
A study testing PLAY, PLAY Parents and PLAY Teachers in people with Physical Activity, run by Seattle Children's Hospital at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- PLAY, PLAY Parents and PLAY Teachers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 15 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- attends preschool in a child care center participating in this study
- no physical/health restrictions on participating in physical activities
Who cannot join
- unable to participate in all physical activities
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Research Institute
Seattle, Washington, 98145
About this study
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
- Being tested
- PLAY, PLAY Parents, PLAY Teachers
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLAYBehavioural
Activity trackers + curriculum information
PLAY ParentsBehavioural
Enhanced parental engagement
PLAY TeachersBehavioural
Enhanced teacher engagement with active living initiates for the teachers
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: PLAY; Behavioral: PLAY Teachers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-intervention physical activity (children)
accelerometer measured
Measured: Month 6 compared to baseline
Post-intervention physical activity (children)
accelerometer measured
Measured: 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)
Measured: Month 6 compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start1 Oct 2017
- Primary completion15 Oct 2019
- Study completion15 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Pooja Tandon, Seattle Children's Hospital
- Investigators
- Pooja Tandon, MD, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279926
- Sponsor's protocol ID
- STUDY00000628
- Other IDs
- 1R21CA218592-01
- Acronym
- PLAY
- Status last verified
- Sep 2020
- First submitted
- 8 Sep 2017
- Last updated
- 7 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preschoolers Learning and Active in PlaY
- ClinicalTrials.gov ID
- NCT03279926
- Acronym / sponsor ID
- PLAY / STUDY00000628
- Conditions
- Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 15 Oct 2019 (actual)
- First posted
- 12 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PLAY | Experimental | Behavioral: PLAYPreschoolers \& 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. |
| PLAY Parents | Experimental | Behavioral: PLAY, Behavioral: PLAY ParentsEverything 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. |
| PLAY Teachers | Experimental | Behavioral: PLAY, Behavioral: PLAY TeachersEverything in Arm 1 plus an enhanced focus on teacher wellness, specifically with regard to active lifestyles for them. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- attends preschool in a child care center participating in this study
- no physical/health restrictions on participating in physical activities
Key exclusion criteria (1 listed)
- unable to participate in all physical activities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLAYActivity trackers + curriculum information | Behavioural | PLAY, PLAY Parents, PLAY Teachers |
| PLAY ParentsEnhanced parental engagement | Behavioural | PLAY Parents |
| PLAY TeachersEnhanced teacher engagement with active living initiates for the teachers | Behavioural | PLAY Teachers |
Primary outcome
Post-intervention physical activity (children)
Time frame: Month 6 compared to baseline
accelerometer measured
Post-intervention physical activity (children)
Time frame: Month 1 compared to baseline
accelerometer measured
1 secondary outcome
Active play opportunities at child care
Time frame: Month 6 compared to baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
Related trials for Physical Activity
Not yet recruitingPhase 1/2
A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
Active, not recruitingPhase 2
A Pilot Study to Investigate the Safety and Clinical Activity of Avelumab (MSB0010718C) in Thymoma and Thymic Carcinoma After Progression on Platinum-Based Chemotherapy
Thymoma, Thymic Carcinoma
Recruiting
Stress Modulation and Dynamic Balance
Stress
Recruiting
Outpatient Physiotherapy vs. mHealth Exercise and Self-Management for Knee Osteoarthritis (MOKneeTOR)
Knee Osteoarthristis
RecruitingPhase 1
Imatinib to Increase RUNX1 Activity in Participants With Germline RUNX1 Deficiency
Inherited Bone Marrow Failure Syndrome, Familial Platelet Disorder With Predisposition to Myeloid Malignancies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pooja Tandon, MD principal investigator
Seattle Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PLAY, PLAY Parents and PLAY Teachers in people with Physical Activity, run by Seattle Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-intervention physical activity (children) (time frame: Month 6 compared to baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2020.