NCT05470621

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
294

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 22, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

August 22, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

February 5, 2024

Status Verified

February 1, 2024

Enrollment Period

1.4 years

First QC Date

July 18, 2022

Last Update Submit

February 1, 2024

Conditions

Keywords

Physical ActivitySchools

Outcome Measures

Primary Outcomes (21)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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 Outcomes (5)

  • Mean perceived implementation appropriateness

    Post-intervention (approximately 6 months)

  • Mean perceived implementation feasibility

    Post-intervention (approximately 6 months)

  • Mean observed implementation fidelity

    Monthly post-intervention through end of school year

  • Mean observed implementation sustainability

    Post-intervention (approximately 12 months)

  • Mean observed implementation sustainability

    Post-intervention (approximately 18 months)

Study Arms (2)

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

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

Interventions

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

Playground Curriculum Arm

Eligibility Criteria

Age7 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Students enrolled an after-school program in Mesa Public Schools

You may not qualify if:

  • Students in grades kindergarten or first grade will be excluded due to their young age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mesa Public Schools

Mesa, Arizona, 85201, United States

Location

Related Publications (4)

  • 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.

    PMID: 34904920BACKGROUND
  • 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.

    PMID: 9085394BACKGROUND
  • 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.

    PMID: 25393191BACKGROUND
  • 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.

Related Links

MeSH Terms

Conditions

Sedentary BehaviorSocial SkillsChild BehaviorMotor Activity

Condition Hierarchy (Ancestors)

BehaviorSocial Behavior

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2022

First Posted

July 22, 2022

Study Start

August 22, 2022

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

February 5, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

All IPD that underlie results in a publication will be de-identified and available

Shared Documents
STUDY PROTOCOL
Time Frame
Data will become available 6 months after publication and remain available as stored in repository
Access Criteria
A link to an open-access data repository will be included in all publications. Interested parties can also contact the principal investigators of the study for data access.

Locations