Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT04675658
Status:
COMPLETED
Last Update Posted:
2021-06-14
First Post:
2020-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stay Active Physical Activity Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057185', 'term': 'Sedentary Behavior'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-17', 'size': 398609, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-10-20T12:02', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER'], 'maskingDescription': 'Care provider/study staff will be masked to the arm the participant is assigned.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-11', 'studyFirstSubmitDate': '2020-12-08', 'studyFirstSubmitQcDate': '2020-12-15', 'lastUpdatePostDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Daily minutes of PA (physical activity)', 'timeFrame': '3 months', 'description': 'Measured by Garmin device'}, {'measure': 'Daily step count', 'timeFrame': '3 months', 'description': 'Measured by Garmin device'}], 'secondaryOutcomes': [{'measure': 'Parent perceptions of interventions', 'timeFrame': '3 months', 'description': 'Measured via satisfaction surveys'}, {'measure': 'Teacher perceptions of interventions', 'timeFrame': '3 months', 'description': 'Measured via satisfaction interviews'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Physical Activity', 'Exercise'], 'conditions': ['Healthy Lifestyle', 'Sedentary Behavior']}, 'descriptionModule': {'briefSummary': 'The pilot study will create, implement, and evaluate a physical activity program in both the school and home setting during the COVID-19 pandemic.', 'detailedDescription': "This study will compare the impact of two physical activity interventions on student's physical activity."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nClassrooms\n\n* Teacher of a 4th or 5th grade class in the Kansas City area.\n* English speaking only\n\nStudents\n\n* Any student in the selected classrooms\n* A parent or guardian of the student\n* English speaking only\n\nExclusion Criteria:\n\n* Does not meet the required criteria above.'}, 'identificationModule': {'nctId': 'NCT04675658', 'briefTitle': 'Stay Active Physical Activity Program', 'organization': {'class': 'OTHER', 'fullName': "Children's Mercy Hospital Kansas City"}, 'officialTitle': 'Stay Active Physical Activity Program for Teachers, Students, and Families', 'orgStudyIdInfo': {'id': 'STUDY00001495'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Classroom Intervention', 'description': 'Physical activity support is provided by integrating daily structured activities in the classroom delivered by physical activity leaders through a video conferencing platform in partnership with the classroom teacher. Activities last about 10 minutes or less and have the flexibility of being integrated with academic lessons or serving as a break from academics.\n\nThe activities are simple and get kids moving in place. The activities will be delivered by a research staff member via video conferencing (using the schools preferred platform). A combination of live activities led by the research team and pre-recorded videos will be used (see example below). If live videos do not work for the teacher, they will have the option to only use the pre-recorded videos or receive a list of resources to promote CBPA in their classrooms.', 'interventionNames': ['Behavioral: CBPA']}, {'type': 'EXPERIMENTAL', 'label': 'Classroom Intervention plus family support', 'description': 'Same components as the Classroom Intervention Arm plus the following:\n\nFamily Component: A newsletter will be sent to parents or guardians once every two weeks over the semester and posted on the study website. The newsletters include physical activity information related to safety/protection, skills building, motivation, overcoming barriers, and goal setting and monitoring (all newsletters are included as an appendix). As part of the program, children also receive a Garmin wearable physical activity monitor. Parents or guardians will receive text messages with behavior change messages based on the Garmin data (text message content is included as an appendix). Text messages also contain links to website materials.\n\nTexts will be sent out using the Twilio platform.', 'interventionNames': ['Behavioral: CBPA + family support']}], 'interventions': [{'name': 'CBPA + family support', 'type': 'BEHAVIORAL', 'description': 'Classroom Based Physical Activity + family support as described in the Arm', 'armGroupLabels': ['Classroom Intervention plus family support']}, {'name': 'CBPA', 'type': 'BEHAVIORAL', 'description': 'Classroom Based Physical Activity', 'armGroupLabels': ['Classroom Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}], 'overallOfficials': [{'name': 'Jordan Carlson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Faculty'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Mercy Hospital Kansas City", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}