Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-31 @ 8:37 PM
Study NCT ID:
NCT01698034
Status:
COMPLETED
Last Update Posted:
2012-10-04
First Post:
2012-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Volunteering and Cardiovascular Risk in Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-02', 'studyFirstSubmitDate': '2012-09-21', 'studyFirstSubmitQcDate': '2012-09-27', 'lastUpdatePostDateStruct': {'date': '2012-10-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body mass index', 'timeFrame': 'Baseline-adjusted post-intervention scores at 4 months'}, {'measure': 'C-reactive protein', 'timeFrame': 'Baseline-adjusted post-intervention scores at 4 months'}, {'measure': 'Interleukin-6', 'timeFrame': 'Baseline-adjusted post-intervention scores at 4 months'}, {'measure': 'Total Cholesterol', 'timeFrame': 'Baseline-adjusted post-intervention scores at 4 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['volunteering', 'cardiovascular health'], 'conditions': ['Cardiovascular Risk Factors']}, 'referencesModule': {'references': [{'pmid': '23440253', 'type': 'DERIVED', 'citation': 'Schreier HM, Schonert-Reichl KA, Chen E. Effect of volunteering on risk factors for cardiovascular disease in adolescents: a randomized controlled trial. JAMA Pediatr. 2013 Apr;167(4):327-32. doi: 10.1001/jamapediatrics.2013.1100.'}]}, 'descriptionModule': {'briefSummary': "This study tested whether getting youth engaged in helping others (volunteering) would benefit youth's physical health. 106 predominantly minority and low socioeconomic status (SES) youth were randomized to either volunteer weekly with elementary school children in after school programs or to a wait-list control group. The investigators hypothesized that cardiovascular risk markers of C-reactive protein (CRP), interleukin-6 (IL-6), total cholesterol, and body mass index (BMI) would be lower at post-intervention (4 months after baseline) in the volunteer group compared to the control group. The investigators also hypothesized that the intervention might work through pathways such as reducing negative mood, improving self esteem, and increasing prosocial behaviors (empathy, altruism)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 10th grade high school student\n* English speaking\n* No chronic illnesses\n\nExclusion Criteria:\n\n* Chronic medical illness'}, 'identificationModule': {'nctId': 'NCT01698034', 'briefTitle': 'Volunteering and Cardiovascular Risk in Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'How Volunteer Programs Affect Health and Well-being in Low-income Youth', 'orgStudyIdInfo': {'id': 'H11-00943'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Volunteering', 'description': 'Weekly volunteering with elementary school children in after school programs', 'interventionNames': ['Behavioral: Volunteering']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Wait-list control'}], 'interventions': [{'name': 'Volunteering', 'type': 'BEHAVIORAL', 'description': 'Weekly volunteering with elementary school children in after school programs', 'armGroupLabels': ['Volunteering']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5M1Y5', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Vancouver Technical Secondary School', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Edith Chen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'collaborators': [{'name': 'William T. Grant Foundation', 'class': 'OTHER'}, {'name': 'HopeLab Foundation', 'class': 'OTHER'}, {'name': 'Social Sciences and Humanities Research Council of Canada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}