Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2026-02-24 @ 5:04 PM
Study NCT ID:
NCT02524132
Status:
COMPLETED
Last Update Posted:
2015-08-14
First Post:
2015-08-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physical Activity Intervention in Preschool Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-13', 'studyFirstSubmitDate': '2015-08-12', 'studyFirstSubmitQcDate': '2015-08-13', 'lastUpdatePostDateStruct': {'date': '2015-08-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical Activity as measured by a Modular Signal Recorder Accelerometer', 'timeFrame': '8 wks'}, {'measure': 'Letter recognition as measured by an Academic Growth Assessment', 'timeFrame': '8 wks'}, {'measure': 'Sound recognition as measured by an Academic Growth Assessment', 'timeFrame': '8 wks'}, {'measure': 'Number recognition as measured by an Academic Growth Assessment', 'timeFrame': '8 wks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'In this research project, the investigators addressed if incorporating physical movements with preschoolers will help increase their ability to retain concepts learned in preschool such as letter, sound and number recognition. Movement plays an important role in the brain. Exercise shows many benefits for the brain to help maintain clearer thought, improve memory, and increase activity in the brain, especially the areas involved in memory, attention, and language. The following research includes an eight week study of the implementation of movement breaks with one preschool class, while using another class as a control group. During the two weeks of baseline data, data was collected from every student in both groups on their letter recognition with both upper and lower case, letter sound identification, and number recognition for numbers 0-10. The group that implemented movement breaks had three-five minute scheduled times to stop for movement. Data was collected and compared between the two groups to find differences in their academic performance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Enrolled preschool student\n\nExclusion Criteria:\n\n* Enrolled in multiple preschool classes'}, 'identificationModule': {'nctId': 'NCT02524132', 'briefTitle': 'Physical Activity Intervention in Preschool Children', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Physical Activity Intervention in Preschool Children', 'orgStudyIdInfo': {'id': '0812015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physical Activity', 'description': '5 minute movement breaks', 'interventionNames': ['Behavioral: Physical Activity']}], 'interventions': [{'name': 'Physical Activity', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Physical Activity']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Hamline University', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hamline University', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'James Levine', 'investigatorAffiliation': 'Mayo Clinic'}}}}