Physical InactivityNCT05509803

PE Audit and Feedback Pilot Study

A study testing PE Audit and Feedback Tool in people with Physical Inactivity and Cardiovascular Diseases, run by University of California, Berkeley at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Physical Inactivity, Cardiovascular Diseases
What is being tested?: PE Audit and Feedback Tool
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteUnited States
Study dates: 1 Apr 2022to 30 Jun 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

UC Berkeley
Berkeley, California, 94720

Other trials in United States

About this study

Official title: Increasing Compliance With Physical Education Laws to Reduce Health Inequities

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.

Conditions: Physical Inactivity, Cardiovascular Diseases
Being tested: PE Audit and Feedback Tool
Medical subject headings: Sedentary Behavior, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PE Audit and Feedback ToolBehavioural
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.

Study groups in NCT05509803
Study group	Role	What they receive
PE Audit and Feedback Intervention	Experimental	Schools in this arm will receive a PE audit and feedback tool delivered by the school district's teacher on special assignment for PE, which will consist of an audit of the school's existing PE program; Feedback on ways to improve the PE program; and technical assistance to help improve the PE program. Receives: Behavioral: PE Audit and Feedback Tool
PE Support as Usual	No intervention	Schools in this arm will receive district-level support for PE as is typically provided by the school district.

What is being measured

The primary outcome is the main question the study is designed to answer.

Scheduled Minutes of Physical Education/Week
Linear mixed effects models with random effects for school and grade were used to determine within group difference in change between baseline and follow up in scheduled minutes of physical education/week
Measured: Change from baseline (spring of year 1) to follow-up (spring of year 2)
Estimated Minutes of Physical Education/Week
Linear mixed effects models with random effects for school and grade were used to determine within group difference in change between baseline and follow up in estimated minutes of physical education/week based on data collected with the System for Observing Fitness Instruction Time
Measured: Change from baseline (spring of year 1) to follow-up (spring of year 2)
% of PE Lesson Time in Moderate to Vigorous Physical Activity
Linear mixed effects models with random effects for school and grade were used to determine within group difference in change between baseline and follow up in proportion of PE class time in MVPA based on data collected with the System for Observing Fitness Instruction Time
Measured: Change from baseline (spring of year 1) to follow-up (spring of year 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 202230 Jun 2024

First posted22 Aug 2022
Study start1 Apr 2022
Primary completion30 Jun 2024
Study completion30 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Physical InactivityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: This will be a 2-group cluster-randomized clinical trial, with the school being the unit of assignment and randomization. 5 schools will receive an intervention and 5 schools will serve as controls.
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05509803
Sponsor's protocol ID: 1K01HL151805
Status last verified: Mar 2026
First submitted: 15 Aug 2022
Last updated: 27 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Thompson HR, Nguyen C, McKenzie TL, Dzewaltowski DA, Madsen KA. A pilot cluster-randomized controlled trial of an audit, feedback, and coaching intervention on compliance with elementary physical education laws and student physical activity during lesson time. Prev Med Rep. 2025 Mar 19;53:103037. doi: 10.1016/j.pmedr.2025.103037. eCollection 2025 May.
PubMed 40212560

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Physical Inactivity trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Increasing Compliance With Physical Education Laws to Reduce Health Inequities
ClinicalTrials.gov ID: NCT05509803
Acronym / sponsor ID: 1K01HL151805
Conditions: Physical Inactivity, Cardiovascular Diseases
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: University of California, BerkeleyUniversity, hospital or other
Study start: 1 Apr 2022 (actual)
Primary completion: 30 Jun 2024 (actual)
Study completion: 30 Jun 2024 (actual)
First posted: 22 Aug 2022 (actual)
Results: Posted 27 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: This will be a 2-group cluster-randomized clinical trial, with the school being the unit of assignment and randomization. 5 schools will receive an intervention and 5 schools will serve as controls.

Arm	Type	Receives
PE Audit and Feedback Intervention	Experimental	Behavioral: PE Audit and Feedback ToolSchools in this arm will receive a PE audit and feedback tool delivered by the school district's teacher on special assignment for PE, which will consist of an audit of the school's existing PE program; Feedback on ways to improve the PE program; and technical assistance to help improve the PE program.
PE Support as Usual	No intervention	–Schools in this arm will receive district-level support for PE as is typically provided by the school district.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PE Audit and Feedback ToolThe 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.	Behavioural	PE Audit and Feedback Intervention

Primary outcome

Scheduled Minutes of Physical Education/Week
Time frame: Change from baseline (spring of year 1) to follow-up (spring of year 2)
Linear mixed effects models with random effects for school and grade were used to determine within group difference in change between baseline and follow up in scheduled minutes of physical education/week
Estimated Minutes of Physical Education/Week
Time frame: Change from baseline (spring of year 1) to follow-up (spring of year 2)
Linear mixed effects models with random effects for school and grade were used to determine within group difference in change between baseline and follow up in estimated minutes of physical education/week based on data collected with the System for Observing Fitness Instruction Time
% of PE Lesson Time in Moderate to Vigorous Physical Activity
Time frame: Change from baseline (spring of year 1) to follow-up (spring of year 2)
Linear mixed effects models with random effects for school and grade were used to determine within group difference in change between baseline and follow up in proportion of PE class time in MVPA based on data collected with the System for Observing Fitness Instruction Time

Results and safety

Results posted to the registry on 27 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention - Physical Education Audits, Feedback, and Coaching (PEAFC)	16	16
Control - PE as Usual	19	19

Primary outcome: Scheduled Minutes of Physical Education/Week

Time frame: Change from baseline (spring of year 1) to follow-up (spring of year 2). Mean (Standard Error). Unit: scheduled minutes of PE per week

Measure	PE Audit and Feedback Intervention n = 5	PE Support as Usual n = 5
Value	-4.0 (6.5)	2.3 (1.8)

Population analysed: 5 schools were randomized to intervention and 5 were randomized to control condition. Data collection on PE schedules took place within each school. Data were aggregated at the school level.

Primary outcome: Estimated Minutes of Physical Education/Week

Time frame: Change from baseline (spring of year 1) to follow-up (spring of year 2). Mean (Standard Error). Unit: Minutes of physical education/week

Measure	PE Audit and Feedback Intervention n = 5	PE Support as Usual n = 5
Value	-1.3 (6.0)	-8.0 (7.2)

Population analysed: 5 schools were randomized to intervention and 5 were randomized to control condition. Data collection on PE schedules took place within each school and PE classes were randomly observed to ensure they were happening according to schedule. Data were aggregated at the school level.

Primary outcome: % of PE Lesson Time in Moderate to Vigorous Physical Activity

Time frame: Change from baseline (spring of year 1) to follow-up (spring of year 2). Mean (Standard Error). Unit: % minutes

Measure	PE Audit and Feedback Intervention n = 5	PE Support as Usual n = 5
Value	9.8 (3.9)	8.5 (3.0)

Adverse events

Time frame: Each school was monitored for 2 academic years, approximately 20 calendar months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PE Audit and Feedback Intervention	0 of 16 (0%)	0 of 16 (0%)	0 of 16
PE Support as Usual	0 of 19 (0%)	0 of 19 (0%)	0 of 19

Limitations and caveats (from the sponsor): The restriction to a single district and a relatively small sample limits generalizability. Further, study randomization did not include presence of a full-time credentialed physical education teacher in the school (which was unknown/uncertain at randomization). In addition, PEAFC was based on a fully funded model initially implemented by NYCDOE. In the current district, PEAFC implementation was unfunded, which limited the physical education Director's ability to adopt NYCDOE's best practices.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 40212560Thompson HR, Nguyen C, McKenzie TL, Dzewaltowski DA, Madsen KA. A pilot cluster-randomized controlled trial of an audit, feedback, and coaching intervention on compliance with elementary physical education laws and student physical activity during lesson time. Prev Med Rep. 2025 Mar 19;53:103037. doi: 10.1016/j.pmedr.2025.103037. eCollection 2025 May.
Individual participant dataSharing planned: No

Related trials for Physical Inactivity

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Wearable Ankle Power Training (WearAPT) for Enhanced Mobility in Aging
Sedentary Behavior / Physical Inactivity, Aged
Active, not recruiting
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PE Audit and Feedback Tool in people with Physical Inactivity and Cardiovascular Diseases, run by University of California, Berkeley at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Scheduled Minutes of Physical Education/Week (time frame: Change from baseline (spring of year 1) to follow-up (spring of year 2)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05509803, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.