- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07227935
Sustaining Quality Physical Education for Healthy Kids
January 29, 2026 updated by: Weiyun Chen, University of Michigan
The purpose of the study is to examine the effects of the technology-enhanced quality physical education (Smart-QPE) lessons on physical activity, cardiorespiratory fitness, social emotional learning (SEL) skills, and mental well-being in school students.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Detailed Description
Students in 4th-7th grades from 17 elementary and middle schools in Michigan are invited to participate in the study.
Students will be assessed with cardiorespiratory fitness, social emotional learning skills, physical activity, and mental well-being at a baseline and the post-intervention tests before and after the Smart-QPE intervention.
The Smart-QPE intervention include that PE teachers integrate the Heart Zone Moves System into their teaching quality physical education lesson in October and November, 2025.
Study Type
Interventional
Enrollment (Estimated)
970
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
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Ann Arbor, Michigan, United States, 48109
- School of Kinesiology, University of Michigan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- students are 4rd-7th grade students aged 8-14 years old;
- enroll in the school offered physical education classes;
- being able to read and write in English;
- students can skip any questions they don't want to answer as they respond to the survey questions at the baseline and the post-intervention; and
- students can stop the aerobic fitness test at the baseline and the post-intervention
Exclusion Criteria:
- students cannot complete the survey, which means that students had difficulty understanding the meaning of each item due to severe cognitive impairment informed by the school nurse/social worker,
- students do not submit the survey on time (within a week),
- if a student only submit one survey either at baseline or at the post-intervention,
- students cannot take the aerobic fitness test, which means that students had difficulty moving their body due to severe physical impairment informed by school nurse/social worker.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Smart-Quality Physical Education
For the Smart-Quality Physical Education (Smart-QPE) intervention, PE teachers integrates the Heart Zone Moves System into teaching quality physical education lessons.
During the Smart-QPE lessons, students wear the heart rate monitors synced to system to self-monitor their heart rates corresponding to light, moderate, and vigorous intensity physical activity.
|
During the Smart-QPE intervention spanning in October - November, 2025, the physical education teacher integrate the Heart Zone Moves System into teaching quality physical education lessons; students wear the heart rate monitor on his/her forearm to self-monitor his/her real time engagement in moderate-to-vigorous physical activity (MVPA) to maximize students MVPA time.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Moderate-to-vigorous physical activity (MVPA)
Time Frame: During the Smart-QPE intervention period (up to two months).
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The MVPA during the Smart-QPE lessons will be objectively measured by using the Heart Zone Moves System, which is synced to each student's heart rate monitor wore on their forearms.
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During the Smart-QPE intervention period (up to two months).
|
|
PACER test
Time Frame: Baseline test and post-intervention test (up to 4 months).
|
The PE teacher will administer the PACER test to students for measuring their cardiorespiratory fitness will be assessed during a regular PE lesson.
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Baseline test and post-intervention test (up to 4 months).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessing Social Emotional Learning Skills Questionnaire
Time Frame: Baseline and post-intervention test (up to 4 months).
|
Students' social emotional learning skills will be assessed by completing the Qualtrics Survey.
This is online platform survey includes this social emotional learning outcome.
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Baseline and post-intervention test (up to 4 months).
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The Physical Activity Questionnaire for Children
Time Frame: Baseline and post-intervention test (up to 4 months).
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Students will complete the Qualtrics Survey, including Physical Activity Questionnaire for Children.
Students will respond to 7 items describing a specific setting to engage in physical activity on 5 point-rating scale.
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Baseline and post-intervention test (up to 4 months).
|
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Mental Health and Well-Being questionnaire
Time Frame: Baseline and post-intervention test (up to 4 months).
|
Students will complete the Qualtrics Survey, including mental health and mental well-being questionnaire.
|
Baseline and post-intervention test (up to 4 months).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 8, 2025
Primary Completion (Actual)
December 19, 2025
Study Completion (Estimated)
August 1, 2026
Study Registration Dates
First Submitted
October 19, 2025
First Submitted That Met QC Criteria
November 11, 2025
First Posted (Actual)
November 13, 2025
Study Record Updates
Last Update Posted (Actual)
February 2, 2026
Last Update Submitted That Met QC Criteria
January 29, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- HUM00241100
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
In the IRB-approved consent form, we did not indicate that we will share IPD with other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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