PE Audit and Feedback Pilot Study

Cardiovascular Diseases Clinical Trial

Official title:

Increasing Compliance With Physical Education Laws to Reduce Health Inequities

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05509803
• Other study ID #: 1K01HL151805
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: February 8, 2026

Study information

• Verified date: May 2024
• Source: University of California, Berkeley
• Contact: Hannah R Thompson, PhD, MPH
• Phone: (510) 643-0881
• Email: ThompsonH[@]Berkeley.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

School physical education (PE) is one of the most valuable tools for increasing physical activity and fitness among youth of all backgrounds; however, compliance with existing PE laws is low (and differential by school race/ethnic and family-income composition, contributing to health disparities), and best practices for increasing compliance remain unknown. This study proposes to examine a novel approach for increasing PE law compliance by testing a PE audit and feedback tool (adapted from a tool used by the New York City Department of Education) in Oakland, California schools to determine the effectiveness, adaptability, and scalability of this potential cost-effective approach for increasing PE law compliance and student physical activity.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: February 8, 2026
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Elementary school in the Oakland Unified School District

• >50% of students in the school qualify for free or reduced-price meals

• >80% of students non-white

Exclusion Criteria:

• Having a PE program known by the PE Director to be well-established and/or meet/exceed district expectations for PE

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Physical Inactivity

Intervention

Behavioral:
• PE Audit and Feedback Tool
The intervention consists of a Physical Education (PE) Audit and Feedback tool, which was adapted from work done through the PE Works program in the New York City Department of Education. A district-level PE program leader in Oakland Unified School District will deliver the tool, which consists of auditing the current status of PE in intervention schools, providing feedback on the status to help improve PE, and providing technical assistance to bring schools up to code and ensure support for PE programming.

Locations

Country	Name	City	State
United States	UC Berkeley	Berkeley	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Berkeley

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness	We will examine differences in changes between intervention and control schools from baseline in Fall 2020 to follow-up in Fall 2023 in 1) continuous estimated minutes of PE/week; and 2) binary meeting the California PE minute mandate of 200 minutes of PE/10 days for elementary students. We will calculate the estimated minutes of PE class-time students receive per week using the number of PE minutes scheduled per week, the proportion of scheduled PE classes that did not occur on days we randomly arrived to observe class, and actual observed PE class length from System for Observing Fitness Instruction Time (SOFIT) observations. Differences in changes in calculated minutes of PE/week and meeting the California PE minute mandate will be determined using adjusted linear and logistic mixed effects models with a time by group interaction term and random effects on teachers nested within school.	Baseline (12 weeks); Follow-up (12 weeks)
Primary	Adoption	To determine critical adoption issues, we will conduct 20-30 minute interviews with all observed teachers teaching PE and school principals after SOFIT observations are complete in the Fall of 2023. We will code all interview transcripts using a thematic analysis approach, using predefined themes based on the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) literature (e.g. commitment of principals and teachers; communication about the tool; impediments/facilitators to adoption, structural embedding of the tool into practice and policy, etc.).	20-30 minutes
Primary	Implementation	To determine critical implementation issues, we will conduct 20-30 minute interviews with all observed teachers teaching PE and school principals after SOFIT observations are complete in the Fall of 2023. We will code all interview transcripts using a thematic analysis approach, using predefined themes based on the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) literature (e.g. commitment of principals and teachers; communication about the tool; impediments/facilitators to implementation, structural embedding of the tool into practice and policy, etc.).	20-30 minutes
Primary	Maintenance	To determine critical maintenance issues, we will conduct 20-30 minute interviews with all observed teachers teaching PE and school principals after SOFIT observations are complete in the Fall of 2023. We will code all interview transcripts using a thematic analysis approach, using predefined themes based on the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) literature (e.g. commitment of principals and teachers; communication about the tool; impediments/facilitators to maintenance, structural embedding of the tool into practice and policy, etc.).	20-30 minutes