- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05470621
A Playground Training to Improve Children's Health After-school and During Recess: The PLAYground Project
A Cluster Randomized Controlled Trial of an After-school Playground Intervention to Improve Children's Physical, Social, and Emotional Health: The PLAYground Project
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Arizona
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Mesa, Arizona, United States, 85201
- Mesa Public Schools
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Students enrolled an after-school program in Mesa Public Schools
Exclusion Criteria:
- Students in grades kindergarten or first grade will be excluded due to their young age.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Playground Curriculum Arm
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
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A staff and student training to implement a playground curriculum in after-school and recess settings
|
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No Intervention: Program As Usual
Staff and students receive no training and participate in after-school programs and recess as usual
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline (month 0) and Post-intervention (approximately 6 months)
|
|
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.
|
Baseline (month 0) and Post-intervention (approximately 12 months)
|
|
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.
|
Baseline (month 0) and Post-intervention (approximately 18 months)
|
|
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).
|
Baseline (month 0) and Post-intervention (approximately 6 months)
|
|
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.
|
Baseline (month 0) and Post-intervention (approximately 6 months)
|
|
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.
|
Baseline (month 0) and Post-intervention (approximately 6 months)
|
|
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.
|
Baseline (month 0) and Post-intervention (approximately 6 months)
|
|
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.
|
Baseline (month 0) and Post-intervention (approximately 6 months)
|
|
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).
|
Baseline (month 0) and Post-intervention (approximately 12 months)
|
|
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.
|
Baseline (month 0) and Post-intervention (approximately 12 months)
|
|
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.
|
Baseline (month 0) and Post-intervention (approximately 12 months)
|
|
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.
|
Baseline (month 0) and Post-intervention (approximately 12 months)
|
|
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.
|
Baseline (month 0) and Post-intervention (approximately 12 months)
|
|
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).
|
Baseline (month 0) and Post-intervention (approximately 18 months)
|
|
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.
|
Baseline (month 0) and Post-intervention (approximately 18 months)
|
|
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.
|
Baseline (month 0) and Post-intervention (approximately 18 months)
|
|
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.
|
Baseline (month 0) and Post-intervention (approximately 18 months)
|
|
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.
|
Baseline (month 0) and Post-intervention (approximately 18 months)
|
|
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
|
Baseline (month 0) and Post-intervention (approximately 6 months)
|
|
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
|
Baseline (month 0) and Post-intervention (approximately 12 months)
|
|
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
|
Baseline (month 0) and Post-intervention (approximately 18 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean perceived implementation appropriateness
Time Frame: Post-intervention (approximately 6 months)
|
Staff-reported appropriateness and feasibility of intervention collected through questionnaire with Intervention Appropriateness Measure (IAM).
|
Post-intervention (approximately 6 months)
|
|
Mean perceived implementation feasibility
Time Frame: Post-intervention (approximately 6 months)
|
Staff-reported appropriateness and feasibility of intervention collected through questionnaire with Feasibility of Intervention Measure (FIM).
|
Post-intervention (approximately 6 months)
|
|
Mean observed implementation fidelity
Time Frame: Monthly post-intervention through end of school year
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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.
|
Monthly post-intervention through end of school year
|
|
Mean observed implementation sustainability
Time Frame: Post-intervention (approximately 12 months)
|
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.
|
Post-intervention (approximately 12 months)
|
|
Mean observed implementation sustainability
Time Frame: Post-intervention (approximately 18 months)
|
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.
|
Post-intervention (approximately 18 months)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Allison Poulos, PhD, Assistant Professor, College of Health Solutions, Arizona State University
- Principal Investigator: Pamela Kulinna, PhD, Professor, Mary Lou Fulton Teachers College, Arizona State University
Publications and helpful links
General Publications
- Saunders 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.
- Jackson 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.
- Poulos 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- STUDY00015985
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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