Physical Inactivity Clinical Trial
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
Verified date | February 2024 |
Source | Arizona State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Mesa Public Schools | Mesa | Arizona |
Lead Sponsor | Collaborator |
---|---|
Arizona State University |
United States,
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
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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