Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2025-12-29 @ 2:24 PM
Study NCT ID:
NCT01588392
Status:
COMPLETED
Last Update Posted:
2023-06-08
First Post:
2012-04-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short bouTs of Exercise for Preschool-age Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 323}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-07', 'studyFirstSubmitDate': '2012-04-25', 'studyFirstSubmitQcDate': '2012-04-26', 'lastUpdatePostDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-05-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in Physical activity levels at 6-month', 'timeFrame': 'Baseline, 3-month and 6-month after study initiation', 'description': 'Physical activity levels will be assessed with accelerometer and direct observation system'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Physical activity', 'preschoolers'], 'conditions': ['Physical Activity']}, 'referencesModule': {'references': [{'pmid': '22853642', 'type': 'DERIVED', 'citation': 'Alhassan S, Nwaokelemeh O, Mendoza A, Shitole S, Whitt-Glover MC, Yancey AK. Design and baseline characteristics of the Short bouTs of Exercise for Preschoolers (STEP) study. BMC Public Health. 2012 Aug 1;12:582. doi: 10.1186/1471-2458-12-582.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine if short bouts of structured physical activity implemented within the classroom setting as part of designated gross-motor playtime will increase preschool-age children during-school physical activity level.', 'detailedDescription': "Most preschool centers provide two 30-minute sessions of gross-motor/outdoor playtime per preschool day. Within this time frame, children accumulate most of their activity within the first 10 minutes. This study is a cluster randomized controlled study designed to examine the effects of short bouts of structured physical activity implemented within the classroom setting as part of designated gross-motor playtime on during-school physical activity in preschoolers. Results from this intervention could provide evidence that a physical activity policy that exposes preschoolers to shorter bouts of structured physical activity throughout the preschool day could potentially increase preschooler's physical activity levels."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Attend one of 10 participating preschool centers\n* Attend preschool full-time\n* Children between 2.9 - 5 years of age on the date of baseline assessment\n\nExclusion Criteria:\n\n* Did not have a condition limiting their participation in routine gross-motor playtime at preschool\n* Unable to wear the activity monitor'}, 'identificationModule': {'nctId': 'NCT01588392', 'acronym': 'STEP', 'briefTitle': 'Short bouTs of Exercise for Preschool-age Children', 'organization': {'class': 'OTHER', 'fullName': 'University of Massachusetts, Amherst'}, 'officialTitle': 'Effects of Short Bouts of Physical Activity in Low-income Preschool-age Children', 'orgStudyIdInfo': {'id': '2010-0817'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Short bouts of structured activity', 'interventionNames': ['Behavioral: Short bouts of structured physical activity']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Unstructured physical activity', 'interventionNames': ['Behavioral: Unstructured physical activity']}], 'interventions': [{'name': 'Short bouts of structured physical activity', 'type': 'BEHAVIORAL', 'otherNames': ['Instant Recess for preschoolers'], 'description': 'Short bouts of structured physical activity preschools will be asked to implement age-appropriate 10 minute structured physical activity routines within the classroom setting followed by 20 minutes of usual unstructured playtime activities. Intervention will be implemented for a total of 30 minutes during both morning and afternoon gross motor playtime 5 days/week for 6 months.', 'armGroupLabels': ['Short bouts of structured activity']}, {'name': 'Unstructured physical activity', 'type': 'BEHAVIORAL', 'otherNames': ['Free playtime'], 'description': 'Unstructured physical activity intervention will consist of 30 minutes of supervised unstructured free playtime twice. intervention will be delivered during both morning and afternoon gross motor playtime for 5 days/week for 6 months.', 'armGroupLabels': ['Unstructured physical activity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01103', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Preschool centers in Springfield, MA', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}], 'overallOfficials': [{'name': 'Sofiya Alhassan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Massachusetts, Amherst'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Massachusetts, Amherst', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Sofiya Alhassan', 'investigatorAffiliation': 'University of Massachusetts, Amherst'}}}}