Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-25 @ 8:15 PM
Study NCT ID:
NCT07227935
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-11-13
First Post:
2025-10-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sustaining Quality Physical Education for Healthy Kids
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'During the Smart-Quality Physical Education (PE) intervention, the PE teacher will integrate the Heart Zone Moves System into teaching each PE lessons, where students will wear the heart rate monitor on his/her forearm to self-monitor his/her real time engagement in moderate-to-vigorous physical activity (MVPA).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 970}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-11', 'studyFirstSubmitDate': '2025-10-19', 'studyFirstSubmitQcDate': '2025-11-11', 'lastUpdatePostDateStruct': {'date': '2025-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Moderate-to-vigorous physical activity (MVPA)', 'timeFrame': 'During the Smart-QPE intervention period (up to two months).', 'description': "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."}, {'measure': 'PACER test', 'timeFrame': 'Baseline test and post-intervention test (up to 4 months).', 'description': 'The PE teacher will administer the PACER test to students for measuring their cardiorespiratory fitness will be assessed during a regular PE lesson.'}], 'secondaryOutcomes': [{'measure': 'Assessing Social Emotional Learning Skills Questionnaire', 'timeFrame': 'Baseline and post-intervention test (up to 4 months).', 'description': "Students' social emotional learning skills will be assessed by completing the Qualtrics Survey. This is online platform survey includes this social emotional learning outcome."}, {'measure': 'The Physical Activity Questionnaire for Children', 'timeFrame': 'Baseline and post-intervention test (up to 4 months).', 'description': '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.'}, {'measure': 'Mental Health and Well-Being questionnaire', 'timeFrame': 'Baseline and post-intervention test (up to 4 months).', 'description': 'Students will complete the Qualtrics Survey, including mental health and mental well-being questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Quality Physical Education, Heart Zone Moves System'], 'conditions': ['Smart-Quality Physical Education']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '8 Years', 'genderBased': True, 'genderDescription': 'All students including boys and girls and self-identified genders were invited to participate.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* students are 4rd-7th grade students aged 8-14 years old;\n* enroll in the school offered physical education classes;\n* being able to read and write in English;\n* 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\n* students can stop the aerobic fitness test at the baseline and the post-intervention\n\nExclusion Criteria:\n\n1. 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,\n2. students do not submit the survey on time (within a week),\n3. if a student only submit one survey either at baseline or at the post-intervention,\n4. 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."}, 'identificationModule': {'nctId': 'NCT07227935', 'briefTitle': 'Sustaining Quality Physical Education for Healthy Kids', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Sustaining Quality Physical Education for Healthy Kids', 'orgStudyIdInfo': {'id': 'HUM00241100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Smart-Quality Physical Education', 'description': '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.', 'interventionNames': ['Behavioral: Smart-QPE']}], 'interventions': [{'name': 'Smart-QPE', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Smart-Quality Physical Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'School of Kinesiology, University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'In the IRB-approved consent form, we did not indicate that we will share IPD with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Weiyun Chen', 'investigatorAffiliation': 'University of Michigan'}}}}