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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
970

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • School of Kinesiology, University of Michigan

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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:

  1. 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,
  2. students do not submit the survey on time (within a week),
  3. if a student only submit one survey either at baseline or at the post-intervention,
  4. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Smart-QPE
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Moderate-to-vigorous physical activity (MVPA)
Time Frame: During the Smart-QPE intervention period (up to two months).
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.
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.
Baseline test and post-intervention test (up to 4 months).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Baseline and post-intervention test (up to 4 months).
The Physical Activity Questionnaire for Children
Time Frame: Baseline and post-intervention test (up to 4 months).
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.
Baseline and post-intervention test (up to 4 months).
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Michigan

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 8, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 19, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Smart-Quality Physical Education

Clinical Trials on Smart-QPE

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings