Physical InactivityNCT05470621
A Playground Training to Improve Children's Health After-school and During Recess: The PLAYground Project
A study testing PlayOn! playground curriculum in people with Physical Inactivity and Social Skills, run by Arizona State University at 1 site in United States.
Trial summary
Schools are critical settings to foster children's health. The purpose of this two-year cluster-randomized trial is to enhance both the after-school and recess settings to provide children with knowledge and skills to facilitate active and inclusive play. Read more about this study
- Who is it for?
- Ages 7 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity, Social Skills, Behavior, Child
- What is being tested?
- PlayOn! playground curriculum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2022to 30 Dec 2023
- 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 7 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Students enrolled an after-school program in Mesa Public Schools
Who cannot join
- Students in grades kindergarten or first grade will be excluded due to their young age.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cluster Randomized Controlled Trial of an After-school Playground Intervention to Improve Children's Physical, Social, and Emotional Health: The PLAYground Project
Schools are critical settings to foster children's health. The purpose of this two-year cluster-randomized trial is to enhance both the after-school and recess settings to provide children with knowledge and skills to facilitate active and inclusive play. The primary aim of the project is to assess the impact of a playground curriculum intervention on children's physical, social, emotional, and behavioral health. The secondary aim of the project to understand the appropriateness, feasibility, fidelity, and sustainability of implementing a playground curriculum in after-school and recess settings.
Read the detailed description
Physical, social, and emotional health are critical for children and predict good health later in life. Schools are essential settings to foster children's health as they provide access to the majority of children during crucial stages of development. In particular, recess and before/after school programming are critical sources of children's health and well-being, and core components of a whole school approach to health and wellness. The purpose of this two-year cluster-randomized trial is to enhance the quality of these existing settings through the integration of a playground curriculum designed to promote active and inclusive play.
Based on Social Cognitive Theory aligned with the Theory of Expanded, Extended, and Enhanced Opportunities, it is hypothesized that active and inclusive play through a playground curriculum intervention will improve enjoyment, knowledge, and self-efficacy (personal conditions), social and emotional learning (behavioral conditions), and the development of peer relationships (environmental conditions) among children, leading to increased physical activity and reduced behavioral incidents. The implementation (appropriateness, feasibility, fidelity, and sustainability) of the playground curriculum intervention to improve children's health will be assessed as a secondary outcome.
Participants will be recruited from elementary schools in Mesa Public Schools (Arizona) that offer after-school programming (N=14). The intervention includes the delivery of a curriculum aimed at providing students with knowledge and skills to initiate activities using playground structures. Trainings will be delivered to staff (after-school staff, recess aides, and Physical Education teachers) and students in the after-school setting. Students attending the after-school program will become Play Leaders to transfer the knowledge and skills they learn from PlayOn! to the recess setting.
The impact of the playground curriculum intervention on children's physical, social, emotional, and behavioral health after school and during recess will be measured using surveys, observations, interviews, physical activity devices, and de-identified school behavioral information. Data will be collected at all 14 school sites each fall and spring semester. In year one, seven schools will receive the intervention. Schools will be stratified to either the intervention or control group by Title 1 status - an indicator of school-level income. In year two, the seven control schools will receive the intervention to allow all schools the opportunity to benefit from the project.
- Conditions
- Physical Inactivity, Social Skills, Behavior, Child
- Being tested
- PlayOn! playground curriculum
- Keywords
- Physical Activity, Schools
- Medical subject headings
- Sedentary Behavior, Social Skills, Child Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlayOn! playground curriculumBehavioural
A staff and student training to implement a playground curriculum in after-school and recess settings
| Study group | Role | What they receive |
|---|---|---|
| Playground Curriculum Arm | Experimental | Staff (after-school staff, recess aides, and physical education teachers) receive training to implement a playground curriculum in an after-school program; children receive a training to use the curriculum during recess Receives: Behavioral: PlayOn! playground curriculum |
| Program As Usual | No intervention | Staff and students receive no training and participate in after-school programs and recess as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in accelerometer-derived physical activity from baseline to six months
Accelerometer counts of sedentary, light-, and moderate-to-vigorous physical activity levels will be segmented and processed separately to determine physical activity during recess, during school, during after-school programming, out of school, and on weekends.
Measured: Baseline (month 0) and Post-intervention (approximately 6 months)
Mean change in accelerometer-derived physical activity from baseline to 12 months
Accelerometer counts of sedentary, light-, and moderate-to-vigorous physical activity levels will be segmented and processed separately to determine physical activity during recess, during school, during after-school programming, out of school, and on weekends.
Measured: Baseline (month 0) and Post-intervention (approximately 12 months)
Mean change in accelerometer-derived physical activity from baseline to 18 months
Accelerometer counts of sedentary, light-, and moderate-to-vigorous physical activity levels will be segmented and processed separately to determine physical activity during recess, during school, during after-school programming, out of school, and on weekends.
Measured: Baseline (month 0) and Post-intervention (approximately 18 months)
Mean change in student-reported personal (emotional) health from baseline to 6 months
Child-reported personal health (enjoyment, knowledge, and self-efficacy) will be collected through questionnaire with Discrete Emotions in Physical Education Scale (DEPES).
Measured: Baseline (month 0) and Post-intervention (approximately 6 months)
Mean change in student-reported personal (self-efficacy) health from baseline to 6 months
Child-reported personal health (enjoyment, knowledge, and self-efficacy) will be collected through questionnaire with Metacognitive Process in Physical Education Questionnaire.
Measured: Baseline (month 0) and Post-intervention (approximately 6 months)
Mean change in student-reported personal (social) health from baseline to 6 months
Child-reported personal health (enjoyment, knowledge, and self-efficacy) will be collected through questionnaire with Saunders psychosocial influences on physical activity scale.
Measured: Baseline (month 0) and Post-intervention (approximately 6 months)
Mean change in student-reported environmental health from baseline to 6 months
Child-reported environmental health (peer relationships) will be collected through questionnaire with the ECLS-K peer relationship scale.
Measured: Baseline (month 0) and Post-intervention (approximately 6 months)
Mean change in student-reported behavioral health from baseline to 6 months
Child-reported behavioral health (social and emotional learning) will be collected through questionnaire with the Social and Emotional Learning module of the California Healthy Kids Survey.
Measured: Baseline (month 0) and Post-intervention (approximately 6 months)
Mean change in student-reported personal (emotional) health from baseline to 12 months
Child-reported personal health indicators (enjoyment, knowledge, and self-efficacy) will be collected through questionnaire with Discrete Emotions in Physical Education Scale (DEPES).
Measured: Baseline (month 0) and Post-intervention (approximately 12 months)
Mean change in student-reported personal (self-efficacy) health from baseline to 12 months
Child-reported personal health indicators (enjoyment, knowledge, and self-efficacy) will be collected through questionnaire with Metacognitive Process in Physical Education Questionnaire.
Measured: Baseline (month 0) and Post-intervention (approximately 12 months)
Mean change in student-reported personal (social) health from baseline to 12 months
Child-reported personal health indicators (enjoyment, knowledge, and self-efficacy) will be collected through questionnaire with Saunders psychosocial influences on physical activity scale.
Measured: Baseline (month 0) and Post-intervention (approximately 12 months)
Mean change in student-reported environmental health from baseline to 12 months
Child-reported environmental health (peer relationships) will be collected through questionnaire with the ECLS-K peer relationship scale.
Measured: Baseline (month 0) and Post-intervention (approximately 12 months)
Mean change in student-reported behavioral health from baseline to 12 months
Child-reported behavioral health (social and emotional learning) will be collected through questionnaire with the Social and Emotional Learning module of the California Healthy Kids Survey.
Measured: Baseline (month 0) and Post-intervention (approximately 12 months)
Mean change in student-reported personal (emotional) health from baseline to 18 months
Child-reported personal health indicators (enjoyment, knowledge, and self-efficacy) collected through questionnaire with Discrete Emotions in Physical Education Scale (DEPES).
Measured: Baseline (month 0) and Post-intervention (approximately 18 months)
Mean change in student-reported personal (self-efficacy) health from baseline to 18 months
Child-reported personal health indicators (enjoyment, knowledge, and self-efficacy) collected through questionnaire with Metacognitive Process in Physical Education Questionnaire.
Measured: Baseline (month 0) and Post-intervention (approximately 18 months)
Mean change in student-reported personal (social) health from baseline to 18 months
Child-reported personal health indicators (enjoyment, knowledge, and self-efficacy) collected through questionnaire with Saunders psychosocial influences on physical activity scale.
Measured: Baseline (month 0) and Post-intervention (approximately 18 months)
Mean change in student-reported environmental health from baseline to 18 months
Child-reported environmental health (peer relationships) will be collected through questionnaire with the ECLS-K peer relationship scale.
Measured: Baseline (month 0) and Post-intervention (approximately 18 months)
Mean change in student-reported behavioral health from baseline to 18 months
Child-reported behavioral health (social and emotional learning) will be collected through questionnaire with the Social and Emotional Learning module of the California Healthy Kids Survey.
Measured: Baseline (month 0) and Post-intervention (approximately 18 months)
Change in number of school-reported behavioral incidents from baseline to 6 months
School-reported number of children referred to administrators for behavioral incidents
Measured: Baseline (month 0) and Post-intervention (approximately 6 months)
Change in number of school-reported behavioral incidents from baseline to 12 months
School-reported number of children referred to administrators for behavioral incidents
Measured: Baseline (month 0) and Post-intervention (approximately 12 months)
Change in number of school-reported behavioral incidents from baseline to 18 months
School-reported number of children referred to administrators for behavioral incidents
Measured: Baseline (month 0) and Post-intervention (approximately 18 months)
Secondary outcomes (5)
Mean perceived implementation appropriateness
Staff-reported appropriateness and feasibility of intervention collected through questionnaire with Intervention Appropriateness Measure (IAM).
Measured: Post-intervention (approximately 6 months)
Mean perceived implementation feasibility
Staff-reported appropriateness and feasibility of intervention collected through questionnaire with Feasibility of Intervention Measure (FIM).
Measured: Post-intervention (approximately 6 months)
Mean observed implementation fidelity
Researcher-reported fidelity of intervention (adherence, exposure/dose, quality of delivery, component differentiation, and participant involvement) collected using researcher-developed protocol for monthly systematic observations.
Measured: Monthly post-intervention through end of school year
Mean observed implementation sustainability
Researcher-reported fidelity of intervention (adherence, exposure/dose, quality of delivery, component differentiation, and participant involvement) collected using researcher-developed protocol for monthly systematic observations.
Measured: Post-intervention (approximately 12 months)
Mean observed implementation sustainability
Researcher-reported fidelity of intervention (adherence, exposure/dose, quality of delivery, component differentiation, and participant involvement) collected using researcher-developed protocol for monthly systematic observations.
Measured: Post-intervention (approximately 18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start22 Aug 2022
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Allison Poulos, PhD, Principal investigator, Assistant Professor, College of Health Solutions, Arizona State UniversityPamela Kulinna, PhD, Principal investigator, Professor, Mary Lou Fulton Teachers College, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05470621
- Sponsor's protocol ID
- STUDY00015985
- Status last verified
- Feb 2024
- First submitted
- 18 Jul 2022
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be de-identified and available
Publications
Simonton KL, Garn AC, Mercier KJ. Expanding the Discrete Emotions in Physical Education Scale (DEPES): Evaluating Emotions With Behavior and Learning. Res Q Exerc Sport. 2023 Mar;94(1):35-44. doi: 10.1080/02701367.2021.1935434. Epub 2021 Dec 14.
PubMed 34904920Saunders RP, Pate RR, Felton G, Dowda M, Weinrich MC, Ward DS, Parsons MA, Baranowski T. Development of questionnaires to measure psychosocial influences on children's physical activity. Prev Med. 1997 Mar-Apr;26(2):241-7. doi: 10.1006/pmed.1996.0134.
PubMed 9085394Jackson SL, Cunningham SA. Social Competence and Obesity in Elementary School. Am J Public Health. 2015 Jan;105(1):153-158. doi: 10.2105/AJPH.2014.302208.
PubMed 25393191Poulos A, Kulinna PH. A cluster randomized controlled trial of an after-school playground curriculum intervention to improve children's physical, social, and emotional health: study protocol for the PLAYground project. BMC Public Health. 2022 Sep 1;22(1):1658. doi: 10.1186/s12889-022-13991-3.
PubMed 36050657
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomized Controlled Trial of an After-school Playground Intervention to Improve Children's Physical, Social, and Emotional Health: The PLAYground Project
- ClinicalTrials.gov ID
- NCT05470621
- Acronym / sponsor ID
- STUDY00015985
- Conditions
- Physical Inactivity, Social Skills, Behavior, Child
- Keywords
- Physical Activity, Schools
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 22 Jul 2022 (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.
Schools are critical settings to foster children's health. The purpose of this two-year cluster-randomized trial is to enhance both the after-school and recess settings to provide children with knowledge and skills to facilitate active and inclusive play. The primary aim of the project is to assess the impact of a playground curriculum intervention on children's physical, social, emotional, and behavioral health. The secondary aim of the project to understand the appropriateness, feasibility, fidelity, and sustainability of implementing a playground curriculum in after-school and recess settings.
Detailed description
Physical, social, and emotional health are critical for children and predict good health later in life. Schools are essential settings to foster children's health as they provide access to the majority of children during crucial stages of development. In particular, recess and before/after school programming are critical sources of children's health and well-being, and core components of a whole school approach to health and wellness. The purpose of this two-year cluster-randomized trial is to enhance the quality of these existing settings through the integration of a playground curriculum designed to promote active and inclusive play.
Based on Social Cognitive Theory aligned with the Theory of Expanded, Extended, and Enhanced Opportunities, it is hypothesized that active and inclusive play through a playground curriculum intervention will improve enjoyment, knowledge, and self-efficacy (personal conditions), social and emotional learning (behavioral conditions), and the development of peer relationships (environmental conditions) among children, leading to increased physical activity and reduced behavioral incidents. The implementation (appropriateness, feasibility, fidelity, and sustainability) of the playground curriculum intervention to improve children's health will be assessed as a secondary outcome.
Participants will be recruited from elementary schools in Mesa Public Schools (Arizona) that offer after-school programming (N=14). The intervention includes the delivery of a curriculum aimed at providing students with knowledge and skills to initiate activities using playground structures. Trainings will be delivered to staff (after-school staff, recess aides, and Physical Education teachers) and students in the after-school setting. Students attending the after-school program will become Play Leaders to transfer the knowledge and skills they learn from PlayOn! to the recess setting.
The impact of the playground curriculum intervention on children's physical, social, emotional, and behavioral health after school and during recess will be measured using surveys, observations, interviews, physical activity devices, and de-identified school behavioral information. Data will be collected at all 14 school sites each fall and spring semester. In year one, seven schools will receive the intervention. Schools will be stratified to either the intervention or control group by Title 1 status - an indicator of school-level income. In year two, the seven control schools will receive the intervention to allow all schools the opportunity to benefit from the project.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Playground Curriculum Arm | Experimental | Behavioral: PlayOn! playground curriculumStaff (after-school staff, recess aides, and physical education teachers) receive training to implement a playground curriculum in an after-school program; children receive a training to use the curriculum during recess |
| Program As Usual | No intervention | –Staff and students receive no training and participate in after-school programs and recess as usual |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Students enrolled an after-school program in Mesa Public Schools
Key exclusion criteria (1 listed)
- Students in grades kindergarten or first grade will be excluded due to their young age.
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 |
|---|---|---|
| PlayOn! playground curriculumA staff and student training to implement a playground curriculum in after-school and recess settings | Behavioural | Playground Curriculum Arm |
Primary outcome
Mean change in accelerometer-derived physical activity from baseline to six months
Time frame: Baseline (month 0) and Post-intervention (approximately 6 months)
Accelerometer counts of sedentary, light-, and moderate-to-vigorous physical activity levels will be segmented and processed separately to determine physical activity during recess, during school, during after-school programming, out of school, and on weekends.
Mean change in accelerometer-derived physical activity from baseline to 12 months
Time frame: Baseline (month 0) and Post-intervention (approximately 12 months)
Accelerometer counts of sedentary, light-, and moderate-to-vigorous physical activity levels will be segmented and processed separately to determine physical activity during recess, during school, during after-school programming, out of school, and on weekends.
Mean change in accelerometer-derived physical activity from baseline to 18 months
Time frame: Baseline (month 0) and Post-intervention (approximately 18 months)
Accelerometer counts of sedentary, light-, and moderate-to-vigorous physical activity levels will be segmented and processed separately to determine physical activity during recess, during school, during after-school programming, out of school, and on weekends.
Mean change in student-reported personal (emotional) health from baseline to 6 months
Time frame: Baseline (month 0) and Post-intervention (approximately 6 months)
Child-reported personal health (enjoyment, knowledge, and self-efficacy) will be collected through questionnaire with Discrete Emotions in Physical Education Scale (DEPES).
Mean change in student-reported personal (self-efficacy) health from baseline to 6 months
Time frame: Baseline (month 0) and Post-intervention (approximately 6 months)
Child-reported personal health (enjoyment, knowledge, and self-efficacy) will be collected through questionnaire with Metacognitive Process in Physical Education Questionnaire.
Mean change in student-reported personal (social) health from baseline to 6 months
Time frame: Baseline (month 0) and Post-intervention (approximately 6 months)
Child-reported personal health (enjoyment, knowledge, and self-efficacy) will be collected through questionnaire with Saunders psychosocial influences on physical activity scale.
Mean change in student-reported environmental health from baseline to 6 months
Time frame: Baseline (month 0) and Post-intervention (approximately 6 months)
Child-reported environmental health (peer relationships) will be collected through questionnaire with the ECLS-K peer relationship scale.
Mean change in student-reported behavioral health from baseline to 6 months
Time frame: Baseline (month 0) and Post-intervention (approximately 6 months)
Child-reported behavioral health (social and emotional learning) will be collected through questionnaire with the Social and Emotional Learning module of the California Healthy Kids Survey.
Mean change in student-reported personal (emotional) health from baseline to 12 months
Time frame: Baseline (month 0) and Post-intervention (approximately 12 months)
Child-reported personal health indicators (enjoyment, knowledge, and self-efficacy) will be collected through questionnaire with Discrete Emotions in Physical Education Scale (DEPES).
Mean change in student-reported personal (self-efficacy) health from baseline to 12 months
Time frame: Baseline (month 0) and Post-intervention (approximately 12 months)
Child-reported personal health indicators (enjoyment, knowledge, and self-efficacy) will be collected through questionnaire with Metacognitive Process in Physical Education Questionnaire.
Mean change in student-reported personal (social) health from baseline to 12 months
Time frame: Baseline (month 0) and Post-intervention (approximately 12 months)
Child-reported personal health indicators (enjoyment, knowledge, and self-efficacy) will be collected through questionnaire with Saunders psychosocial influences on physical activity scale.
Mean change in student-reported environmental health from baseline to 12 months
Time frame: Baseline (month 0) and Post-intervention (approximately 12 months)
Child-reported environmental health (peer relationships) will be collected through questionnaire with the ECLS-K peer relationship scale.
Mean change in student-reported behavioral health from baseline to 12 months
Time frame: Baseline (month 0) and Post-intervention (approximately 12 months)
Child-reported behavioral health (social and emotional learning) will be collected through questionnaire with the Social and Emotional Learning module of the California Healthy Kids Survey.
Mean change in student-reported personal (emotional) health from baseline to 18 months
Time frame: Baseline (month 0) and Post-intervention (approximately 18 months)
Child-reported personal health indicators (enjoyment, knowledge, and self-efficacy) collected through questionnaire with Discrete Emotions in Physical Education Scale (DEPES).
Mean change in student-reported personal (self-efficacy) health from baseline to 18 months
Time frame: Baseline (month 0) and Post-intervention (approximately 18 months)
Child-reported personal health indicators (enjoyment, knowledge, and self-efficacy) collected through questionnaire with Metacognitive Process in Physical Education Questionnaire.
Mean change in student-reported personal (social) health from baseline to 18 months
Time frame: Baseline (month 0) and Post-intervention (approximately 18 months)
Child-reported personal health indicators (enjoyment, knowledge, and self-efficacy) collected through questionnaire with Saunders psychosocial influences on physical activity scale.
Mean change in student-reported environmental health from baseline to 18 months
Time frame: Baseline (month 0) and Post-intervention (approximately 18 months)
Child-reported environmental health (peer relationships) will be collected through questionnaire with the ECLS-K peer relationship scale.
Mean change in student-reported behavioral health from baseline to 18 months
Time frame: Baseline (month 0) and Post-intervention (approximately 18 months)
Child-reported behavioral health (social and emotional learning) will be collected through questionnaire with the Social and Emotional Learning module of the California Healthy Kids Survey.
Change in number of school-reported behavioral incidents from baseline to 6 months
Time frame: Baseline (month 0) and Post-intervention (approximately 6 months)
School-reported number of children referred to administrators for behavioral incidents
Change in number of school-reported behavioral incidents from baseline to 12 months
Time frame: Baseline (month 0) and Post-intervention (approximately 12 months)
School-reported number of children referred to administrators for behavioral incidents
Change in number of school-reported behavioral incidents from baseline to 18 months
Time frame: Baseline (month 0) and Post-intervention (approximately 18 months)
School-reported number of children referred to administrators for behavioral incidents
5 secondary outcomes
Mean perceived implementation appropriateness
Time frame: Post-intervention (approximately 6 months)
Mean perceived implementation feasibility
Time frame: Post-intervention (approximately 6 months)
Mean observed implementation fidelity
Time frame: Monthly post-intervention through end of school year
Mean observed implementation sustainability
Time frame: Post-intervention (approximately 12 months)
Mean observed implementation sustainability
Time frame: Post-intervention (approximately 18 months)
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 5 Feb 2024.
- Background: PubMed 34904920Simonton KL, Garn AC, Mercier KJ. Expanding the Discrete Emotions in Physical Education Scale (DEPES): Evaluating Emotions With Behavior and Learning. Res Q Exerc Sport. 2023 Mar;94(1):35-44. doi: 10.1080/02701367.2021.1935434. Epub 2021 Dec 14.
- Background: PubMed 9085394Saunders RP, Pate RR, Felton G, Dowda M, Weinrich MC, Ward DS, Parsons MA, Baranowski T. Development of questionnaires to measure psychosocial influences on children's physical activity. Prev Med. 1997 Mar-Apr;26(2):241-7. doi: 10.1006/pmed.1996.0134.
- Background: PubMed 25393191Jackson SL, Cunningham SA. Social Competence and Obesity in Elementary School. Am J Public Health. 2015 Jan;105(1):153-158. doi: 10.2105/AJPH.2014.302208.
- Derived from this study: PubMed 36050657Poulos A, Kulinna PH. A cluster randomized controlled trial of an after-school playground curriculum intervention to improve children's physical, social, and emotional health: study protocol for the PLAYground project. BMC Public Health. 2022 Sep 1;22(1):1658. doi: 10.1186/s12889-022-13991-3.
- WestEd, California Department of Education. Using CALSCHLS to assess social-emotional learning and health \[Internet\]. San Francisco, CA: WestEd; 2015.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be de-identified and available
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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.
Allison Poulos, PhD principal investigator
Assistant Professor, College of Health Solutions, Arizona State University
Pamela Kulinna, PhD principal investigator
Professor, Mary Lou Fulton Teachers College, Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PlayOn! playground curriculum in people with Physical Inactivity and Social Skills, run by Arizona State University 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 1 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 5 Feb 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. 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 change in accelerometer-derived physical activity from baseline to six months (time frame: Baseline (month 0) and Post-intervention (approximately 6 months)). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05470621, which also lists 4 linked publications.
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 5 Feb 2024.