Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-25 @ 5:21 PM
Study NCT ID:
NCT01156103
Status:
COMPLETED
Last Update Posted:
2015-05-08
First Post:
2009-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reducing Pediatric Obesity Through After-school Programs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-07', 'studyFirstSubmitDate': '2009-02-17', 'studyFirstSubmitQcDate': '2010-07-01', 'lastUpdatePostDateStruct': {'date': '2015-05-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in BMI z-score', 'timeFrame': 'Baseline (0 months) and 9 months'}], 'secondaryOutcomes': [{'measure': 'Change in Aerobic capacity', 'timeFrame': 'Baseline and 9 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['obesity', 'minority', 'child', 'physical fitness', 'school', 'physical activity'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '23440308', 'type': 'DERIVED', 'citation': 'Madsen K, Thompson H, Adkins A, Crawford Y. School-community partnerships: a cluster-randomized trial of an after-school soccer program. JAMA Pediatr. 2013 Apr;167(4):321-6. doi: 10.1001/jamapediatrics.2013.1071.'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the impact of a national, community-based after-school program promoting physical activity (America SCORES) on obesity, fitness and important cardiovascular risk factors among minority children. The investigators central hypothesis is that established community-based programs, such as America SCORES, can reduce obesity and cardiovascular risk among participants. The 1-year study followed 158 children from 6 public schools, 3 of which were randomized to have SCORES and 3 to "usual care" after-school program. Primary outcomes are change in body mass index (BMI), physical activity (measured by accelerometer), and fitness (aerobic capacity assessed with the 20-meter shuttle test). Cardiovascular outcomes include blood pressure, body composition (assessed using bioelectrical impedance) and waist circumference. The investigators will also measure academic outcomes.', 'detailedDescription': 'Baseline measures were collected in September 2009; midpoint measures were collected in January 2010; and final measures were collected in May 2010. Repeated measures analyses will compare trajectories for BMI, physical activity, and fitness between students in the SCORES and the usual care arms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 3rd-5th grade student enrolled in after-school program in San Francisco Unified School District\n\nExclusion Criteria:\n\n* Uncontrolled asthma\n* Unable to participate in moderate physical activity'}, 'identificationModule': {'nctId': 'NCT01156103', 'briefTitle': 'Reducing Pediatric Obesity Through After-school Programs', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Reducing Pediatric Obesity Through After-school Programs', 'orgStudyIdInfo': {'id': 'H48814-32411-0'}, 'secondaryIdInfos': [{'id': '1K23HD054470-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1K23HD054470-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SCORES', 'description': 'America SCORES, Bay Area, after-school program', 'interventionNames': ['Behavioral: America SCORES, Bay Area']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Standard after-school programming'}], 'interventions': [{'name': 'America SCORES, Bay Area', 'type': 'BEHAVIORAL', 'description': 'After-school program promoting physical activity via soccer 3 days/week', 'armGroupLabels': ['SCORES']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kristine A Madsen, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'San Francisco Unified School District', 'class': 'UNKNOWN'}, {'name': 'America SCORES, Bay Area', 'class': 'UNKNOWN'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}