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Focus on Physical Activity, Recess, and PlayNCT02192281

Randomized Experiment of Playworks

A study testing Playworks in people with Focus on Physical Activity, Recess, and Play, run by Mathematica Policy Research, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether Playworks has an impact on student and school outcomes such as physical activity, behavior, and academic performance. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
Playworks
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,278 participants
Where
1 siteUnited States
Study dates
Mar 2011to Jun 2012
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Students in low-income schools in urban areas
  • Students in schools where at least 50 percent of students qualify for free or reduced-price lunch.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Mathematica Policy Research

    Princeton, New Jersey, 08543-2393

Other trials in United States

About this study

The purpose of this study is to determine whether Playworks has an impact on student and school outcomes such as physical activity, behavior, and academic performance.

Read the detailed description

Playworks is a school-based program that places full-time coaches in low-income schools to organize games and activities during recess. The Robert Wood Johnson Foundation (RWJF) contracted with Mathematica Policy Research and its subcontractor, the John W. Gardner Center for Youth and Their Communities (JGC) at Stanford University, to conduct a rigorous evaluation of Playworks. Twenty-nine schools interested in implementing Playworks, across six cities in the United States, were randomly assigned to treatment and control groups during the 2010-2011 (cohort 1) or 2011-2012 (cohort 2) school year. Random assignment was conducted within matched groups of schools within each city. In total, there were 12 blocks of matched schools. For each block, one school was randomly assigned to the control group and the rest to the treatment group.

During the one-year study period for each cohort, treatment schools received Playworks and control schools were not eligible to implement Playworks. Data from student surveys, accelerometers, and teacher surveys were collected from 4th- and 5th-grade students, teachers, and school staff roughly seven months after Playworks was first implemented in treatment schools.

For the student survey, students were asked to complete a 30-minute student survey in the spring of their study year about their experiences at school. A team of experienced survey administration staff administered the survey in the students' classrooms. In addition to the student survey, teachers were asked to complete a teacher survey that asked teachers about their students' experiences at school.

A subsample of students that were asked to complete the student survey also wore accelerometers during one or two school days. During the accelerometer data collection period, the research team arrived at participating classrooms at the beginning of the school day. Team members described the function of the accelerometer and then attached one to each consented student's hip, using an elastic belt. The accelerometer data was then processed with the ActiLife 5 software package.

The impact of Playworks on study outcomes was estimated by comparing the average outcomes in treatment and control schools using regression models customized to the unit of analysis (teacher or student). The regression models used for analysis included indicators for random assignment blocks to account for the blocked design and school-specific random error terms to account for school-specific effects not attributable to the treatment. Covariates were also included in some models to account for significant differences between treatment and control groups in demographic characteristics. Models for continuous and binary outcome variables were fit using least-squares estimation and logistic regression estimation, respectively. Standard errors for the estimated impacts on teacher- and student-level outcomes accounted for clustering at the school level using generalized estimating equations. Model-based p-values and effect sizes were calculated based on the estimated impacts and corresponding standard errors and multiple comparison adjustments accounted for correlations among the multiple tests. Sampling weights were used when estimating impacts. The weights were constructed to account for both the selection probabilities of students and teachers into the sample and nonresponse.

Being tested
Playworks
Keywords
Physical activity, Recess, Accelerometer, Play
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlayworksOther

    The Playworks program places full-time coaches in low-income schools to provide opportunities for organized play during recess and throughout the school day.

Study groups in NCT02192281
Study groupRoleWhat they receive
PlayworksExperimentalPlayworks was implemented during the entire school year, and outcome measures were collected in spring of the school year.
Receives: Other: Playworks
ControlNo interventionPlayworks was not implemented at these schools.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Number of Accelerometer Intensity Counts Recorded Per Minute During Recess

    Measured: 8 weeks

  2. Mean Number of Steps Taken Per Minute During Recess

    Measured: 8 weeks

  3. Mean Percentage of Accelerometer Wear Time During Recess Spent in Sedentary Activity

    Measured: 8 weeks

  4. Mean Percentage of Accelerometer Wear Time During Recess Spent in Light Activity

    Measured: 8 weeks

  5. Mean Percentage of Accelerometer Wear Time During Recess Spent in Moderately Intense Activity

    Measured: 8 weeks

  6. Mean Percentage of Accelerometer Wear Time During Recess Spent in Vigorously Intense Activity

    Measured: 8 weeks

Secondary outcomes (4)
  1. Percentage of Students Who Participate in Recess Activities That Make Them Sweat and Breathe Hard "Sometimes" or "A Lot"

    Measured: 8 weeks

  2. Percentage of Teachers Who "Agree" or "Strongly Agree" That Their Students Participate in Physical Activities That Make Them Sweat and Breathe Hard During Recess

    Measured: 8 weeks

  3. Percentage of Students Who Participated in a Sports Team After School or on the Weekend During the School Year

    Measured: 8 weeks

  4. Percentage of Students Who Participated in Dance, Gymnastics or Martial Arts Lessons After School or on the Weekend During the School Year

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2014 (estimated)
  2. Study startMar 2011
  3. Primary completionJun 2012
  4. Study completionJun 2012

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,278 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02192281
Sponsor's protocol ID
MPR-06758
Other IDs
12-177
Status last verified
Jul 2014
First submitted
14 Jul 2014
Last updated
16 Jul 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Playworks in people with Focus on Physical Activity, Recess, and Play, run by Mathematica Policy Research, Inc. 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 0 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 16 Jul 2014. 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?

Mean Number of Accelerometer Intensity Counts Recorded Per Minute During Recess (time frame: 8 weeks). The study lists 6 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 16 Jul 2014.

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