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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05470621
Other study ID # STUDY00015985
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 22, 2022
Est. completion date December 30, 2023

Study information

Verified date February 2024
Source Arizona State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 294
Est. completion date December 30, 2023
Est. primary completion date December 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 13 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
PlayOn! playground curriculum
A staff and student training to implement a playground curriculum in after-school and recess settings

Locations

Country Name City State
United States Mesa Public Schools Mesa Arizona

Sponsors (1)

Lead Sponsor Collaborator
Arizona State University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline (month 0) and Post-intervention (approximately 6 months)
Primary 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. Baseline (month 0) and Post-intervention (approximately 12 months)
Primary 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. Baseline (month 0) and Post-intervention (approximately 18 months)
Primary 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). Baseline (month 0) and Post-intervention (approximately 6 months)
Primary 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. Baseline (month 0) and Post-intervention (approximately 6 months)
Primary 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. Baseline (month 0) and Post-intervention (approximately 6 months)
Primary 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. Baseline (month 0) and Post-intervention (approximately 6 months)
Primary 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. Baseline (month 0) and Post-intervention (approximately 6 months)
Primary 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). Baseline (month 0) and Post-intervention (approximately 12 months)
Primary 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. Baseline (month 0) and Post-intervention (approximately 12 months)
Primary 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. Baseline (month 0) and Post-intervention (approximately 12 months)
Primary 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. Baseline (month 0) and Post-intervention (approximately 12 months)
Primary 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. Baseline (month 0) and Post-intervention (approximately 12 months)
Primary 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). Baseline (month 0) and Post-intervention (approximately 18 months)
Primary 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. Baseline (month 0) and Post-intervention (approximately 18 months)
Primary 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. Baseline (month 0) and Post-intervention (approximately 18 months)
Primary 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. Baseline (month 0) and Post-intervention (approximately 18 months)
Primary 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. Baseline (month 0) and Post-intervention (approximately 18 months)
Primary Change in number of school-reported behavioral incidents from baseline to 6 months School-reported number of children referred to administrators for behavioral incidents Baseline (month 0) and Post-intervention (approximately 6 months)
Primary Change in number of school-reported behavioral incidents from baseline to 12 months School-reported number of children referred to administrators for behavioral incidents Baseline (month 0) and Post-intervention (approximately 12 months)
Primary Change in number of school-reported behavioral incidents from baseline to 18 months School-reported number of children referred to administrators for behavioral incidents Baseline (month 0) and Post-intervention (approximately 18 months)
Secondary Mean perceived implementation appropriateness Staff-reported appropriateness and feasibility of intervention collected through questionnaire with Intervention Appropriateness Measure (IAM). Post-intervention (approximately 6 months)
Secondary Mean perceived implementation feasibility Staff-reported appropriateness and feasibility of intervention collected through questionnaire with Feasibility of Intervention Measure (FIM). Post-intervention (approximately 6 months)
Secondary 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. Monthly post-intervention through end of school year
Secondary 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. Post-intervention (approximately 12 months)
Secondary 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. Post-intervention (approximately 18 months)
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