Activity, MotorPLAYNCT04772638
Preschoolers Learning and Active in PLAY (PLAY Extension)
A study testing PLAY in people with Activity, Motor, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
The PLAY 2 Study is the continuation of an R21 pilot PLAY study. In the R21, we tested the acceptability, feasibility and initial efficacy of three early childhood education setting- based, multi-level interventions to promote preschoolers' physical activity using wearable technology and additional behavior change… Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Activity, Motor
- What is being tested?
- PLAY
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 133 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2021to 28 Feb 2024
- 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
- Children ages 3-5 who attend participating preschools and their parents s are eligible.
- Teachers and staff who work at participating preschools are eligible.
- Participating preschools:
- child care centers that offer full day child care
- at least 1 classroom for children ages 3-5
Who cannot join
- family based child care homes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PLAY 2 - Preschoolers Learning and Active in PLAY (PLAY Extension)
The PLAY 2 Study is the continuation of an R21 pilot PLAY study. In the R21, we tested the acceptability, feasibility and initial efficacy of three early childhood education setting- based, multi-level interventions to promote preschoolers' physical activity using wearable technology and additional behavior change techniques to engage educators and parents. We have selected one of these 3 as the main intervention for the R33 portion of the grant. The intervention will contain components of teacher wellness, parent engagement, and activity level monitoring.
Read the detailed description
Physical activity in early childhood is important for numerous aspects of children's health and development. Preschoolers are thought to be very active but previous studies have shown that they are sedentary for the majority of time and not getting adequate opportunities to engage in active play. Experts have recommended strategies to promote physical activity in early learning settings and to involve parents in efforts to promote active living from a young age. Through early learning settings, we may be able to change behaviors in large groups of children and particularly benefit more vulnerable children who have fewer opportunities for outdoor play and physical activity at home or in their neighborhoods. However, meaningful engagement from families is also important and research suggests that there is gap in communication and perhaps alignment between educators and parents on the topic of preschoolers' physical activity. This research uses wearable technology to monitor physical activity in children, motivate parents and educators to help create active play opportunities, and create a platform for communication and shared accountability about this important health behavior. We will focus particularly on children from lower income backgrounds who suffer from disparities in both health and educational outcomes. Our primary outcome of interest is accelerometer measured physical activity. We will also explore how changes in preschooler's physical activity relate to behavioral indicators, which are topics of great significance to early childhood educators, policy makers and parents.
- Conditions
- Activity, Motor
- Being tested
- PLAY, Wait list control
- Keywords
- children, physical activity, early childhood education
- 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
This intervention focuses on promoting physical activity in preschoolers and the adults (parents and teachers) in their lives. It consists of 1) Teacher training 2) Activity trackers for children, teachers and parents and 3) text messaging with content and individualized goal setting.
Wait list controlOther
not an active intervention
| Study group | Role | What they receive |
|---|---|---|
| PLAY intervention | Experimental | The PLAY intervention with educators, parents and children Receives: Behavioral: PLAY |
| Wait list control | Placebo comparator | Not described Receives: Other: Wait list control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-intervention physical activity
Accelerometer measured
Measured: 6 Month after baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start26 Feb 2021
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Activity, MotorStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
- 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
- Single group
- Model description
- Cluster RCT with a waitlist control
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pooja Tandon, Seattle Children's Hospital
- Investigators
- Pooja Tandon, MD MPH, Principal investigator, Seattle Childrens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772638
- Sponsor's protocol ID
- 00000628
- Acronym
- PLAY
- Status last verified
- Apr 2024
- First submitted
- 24 Feb 2021
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PLAY 2 - Preschoolers Learning and Active in PLAY (PLAY Extension)
- ClinicalTrials.gov ID
- NCT04772638
- Acronym / sponsor ID
- PLAY / 00000628
- Conditions
- Activity, Motor
- Keywords
- children, physical activity, early childhood education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- 26 Feb 2021 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 26 Feb 2021 (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 PLAY 2 Study is the continuation of an R21 pilot PLAY study. In the R21, we tested the acceptability, feasibility and initial efficacy of three early childhood education setting- based, multi-level interventions to promote preschoolers' physical activity using wearable technology and additional behavior change techniques to engage educators and parents. We have selected one of these 3 as the main intervention for the R33 portion of the grant. The intervention will contain components of teacher wellness, parent engagement, and activity level monitoring.
Detailed description
Physical activity in early childhood is important for numerous aspects of children's health and development. Preschoolers are thought to be very active but previous studies have shown that they are sedentary for the majority of time and not getting adequate opportunities to engage in active play. Experts have recommended strategies to promote physical activity in early learning settings and to involve parents in efforts to promote active living from a young age. Through early learning settings, we may be able to change behaviors in large groups of children and particularly benefit more vulnerable children who have fewer opportunities for outdoor play and physical activity at home or in their neighborhoods. However, meaningful engagement from families is also important and research suggests that there is gap in communication and perhaps alignment between educators and parents on the topic of preschoolers' physical activity. This research uses wearable technology to monitor physical activity in children, motivate parents and educators to help create active play opportunities, and create a platform for communication and shared accountability about this important health behavior. We will focus particularly on children from lower income backgrounds who suffer from disparities in both health and educational outcomes. Our primary outcome of interest is accelerometer measured physical activity. We will also explore how changes in preschooler's physical activity relate to behavioral indicators, which are topics of great significance to early childhood educators, policy makers and parents.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster RCT with a waitlist control
| Arm | Type | Receives |
|---|---|---|
| PLAY intervention | Experimental | Behavioral: PLAYThe PLAY intervention with educators, parents and children |
| Wait list control | Placebo comparator | Other: Wait list control |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children ages 3-5 who attend participating preschools and their parents s are eligible.
- Teachers and staff who work at participating preschools are eligible.
- child care centers that offer full day child care
- at least 1 classroom for children ages 3-5
Key exclusion criteria (1 listed)
- family based child care homes
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 |
|---|---|---|
| PLAYThis intervention focuses on promoting physical activity in preschoolers and the adults (parents and teachers) in their lives. It consists of 1) Teacher training 2) Activity trackers for children, teachers and parents and 3) text messaging with content and individualized goal setting. | Behavioural | PLAY intervention |
| Wait list controlnot an active intervention | Other | Wait list control |
Primary outcome
Post-intervention physical activity
Time frame: 6 Month after baseline assessment
Accelerometer measured
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 22 Apr 2024.
- Individual participant dataSharing planned: No
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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 MPH principal investigator
Seattle Childrens
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 in people with Activity, Motor, 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 5 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 22 Apr 2024. 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. Some participants in this study may receive a placebo. 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 (time frame: 6 Month after baseline assessment). 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 22 Apr 2024.