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.
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
- Conditions the study is for
- Focus on Physical Activity, Recess, and Play
- 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
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 group | Role | What they receive |
|---|---|---|
| Playworks | Experimental | Playworks was implemented during the entire school year, and outcome measures were collected in spring of the school year. Receives: Other: Playworks |
| Control | No intervention | Playworks was not implemented at these schools. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Number of Accelerometer Intensity Counts Recorded Per Minute During Recess
Measured: 8 weeks
Mean Number of Steps Taken Per Minute During Recess
Measured: 8 weeks
Mean Percentage of Accelerometer Wear Time During Recess Spent in Sedentary Activity
Measured: 8 weeks
Mean Percentage of Accelerometer Wear Time During Recess Spent in Light Activity
Measured: 8 weeks
Mean Percentage of Accelerometer Wear Time During Recess Spent in Moderately Intense Activity
Measured: 8 weeks
Mean Percentage of Accelerometer Wear Time During Recess Spent in Vigorously Intense Activity
Measured: 8 weeks
Secondary outcomes (4)
Percentage of Students Who Participate in Recess Activities That Make Them Sweat and Breathe Hard "Sometimes" or "A Lot"
Measured: 8 weeks
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
Percentage of Students Who Participated in a Sports Team After School or on the Weekend During the School Year
Measured: 8 weeks
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.
- First posted16 Jul 2014 (estimated)
- Study startMar 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus on Physical Activity, Recess, and PlayStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mathematica Policy Research, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susanne James-Burdumy, Principal investigator, Mathematica Policy ResearchMartha Bleeker, Study director, Mathematica Policy Research
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Experiment of Playworks
- ClinicalTrials.gov ID
- NCT02192281
- Acronym / sponsor ID
- MPR-06758
- Keywords
- Physical activity, Recess, Accelerometer, Play
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,278 participants (actual)
- Lead sponsor
- Mathematica Policy Research, Inc.University, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 16 Jul 2014 (estimated)
- 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 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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Playworks | Experimental | Other: PlayworksPlayworks was implemented during the entire school year, and outcome measures were collected in spring of the school year. |
| Control | No intervention | –Playworks was not implemented at these schools. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| PlayworksThe Playworks program places full-time coaches in low-income schools to provide opportunities for organized play during recess and throughout the school day. | Other | Playworks |
Primary outcome
Mean Number of Accelerometer Intensity Counts Recorded Per Minute During Recess
Time frame: 8 weeks
Mean Number of Steps Taken Per Minute During Recess
Time frame: 8 weeks
Mean Percentage of Accelerometer Wear Time During Recess Spent in Sedentary Activity
Time frame: 8 weeks
Mean Percentage of Accelerometer Wear Time During Recess Spent in Light Activity
Time frame: 8 weeks
Mean Percentage of Accelerometer Wear Time During Recess Spent in Moderately Intense Activity
Time frame: 8 weeks
Mean Percentage of Accelerometer Wear Time During Recess Spent in Vigorously Intense Activity
Time frame: 8 weeks
4 secondary outcomes
Percentage of Students Who Participate in Recess Activities That Make Them Sweat and Breathe Hard "Sometimes" or "A Lot"
Time frame: 8 weeks
Percentage of Teachers Who "Agree" or "Strongly Agree" That Their Students Participate in Physical Activities That Make Them Sweat and Breathe Hard During Recess
Time frame: 8 weeks
Percentage of Students Who Participated in a Sports Team After School or on the Weekend During the School Year
Time frame: 8 weeks
Percentage of Students Who Participated in Dance, Gymnastics or Martial Arts Lessons After School or on the Weekend During the School Year
Time frame: 8 weeks
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 16 Jul 2014.
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.
Susanne James-Burdumy principal investigator
Mathematica Policy Research
Martha Bleeker study director
Mathematica Policy Research
1 site in 1 country: see every site and its status.
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.