Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-27 @ 1:30 AM
Study NCT ID:
NCT00122993
Status:
COMPLETED
Last Update Posted:
2019-11-01
First Post:
2005-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Worksite Program to Prevent Weight Gain Among Bus Drivers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003132', 'term': 'Commerce'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D004777', 'term': 'Environment'}], 'ancestors': [{'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D055669', 'term': 'Ecological and Environmental Phenomena'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-30', 'studyFirstSubmitDate': '2005-07-20', 'studyFirstSubmitQcDate': '2005-07-21', 'lastUpdatePostDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in body weight', 'timeFrame': 'Measured at Year 2'}], 'secondaryOutcomes': [{'measure': 'Changes in energy intake and physical activity', 'timeFrame': 'Measured at Year 2'}, {'measure': 'Health claims cost', 'timeFrame': 'Measured at Year 2'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Obesity', 'Cardiovascular Diseases', 'Heart Diseases']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to implement and evaluate a two-year multi-component environmental intervention to prevent weight gain among city bus drivers at four bus garages.\n\nIt is hypothesized that transit employees in the intervention garages will gain less weight compared to the transit employees in the control garages.', 'detailedDescription': 'BACKGROUND:\n\nEnvironmental influences that support less healthful food choices and sedentary behaviors have contributed to the epidemic increase in overweight and obesity among U.S. adults. Worksite settings are an effective channel through which to reach adults with interventions designed to prevent excess weight gain and obesity.\n\nDESIGN NARRATIVE:\n\nThis study will implement and evaluate a multi-component environmental intervention to prevent excess weight gain among 1200 bus drivers working in four garages in a major metropolitan area. Four garages will be randomized to the intervention or control group for a two-year period. The environmental interventions are based on a social ecological framework and target four worksite environmental areas: 1) food availability and incentives; 2) physical activity opportunities and incentives; 3) the social environment; and 4) media/promotion related to health food choices, physical activity, and body weight.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Employed as a bus driver\n\nExclusion criteria:\n\n* Not employed as a bus operator at one of the four participating garages'}, 'identificationModule': {'nctId': 'NCT00122993', 'briefTitle': 'Worksite Program to Prevent Weight Gain Among Bus Drivers', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Worksite Environmental Interventions for Weight Control', 'orgStudyIdInfo': {'id': '0409S63606'}, 'secondaryIdInfos': [{'id': 'R01HL079478', 'link': 'https://reporter.nih.gov/quickSearch/R01HL079478', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Multi-component environmental intervention to prevent excess weight gain among bus drivers', 'interventionNames': ['Behavioral: Healthful eating and food choices behavior change programs and changes in worksite food availability and prices', 'Behavioral: Physical Activity', 'Behavioral: Environment']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'Control group'}], 'interventions': [{'name': 'Healthful eating and food choices behavior change programs and changes in worksite food availability and prices', 'type': 'BEHAVIORAL', 'description': 'Food choices and eating behavior programs and environmental changes will be implemented for 18 months in intervention garages.', 'armGroupLabels': ['1']}, {'name': 'Physical Activity', 'type': 'BEHAVIORAL', 'description': 'Physical activity programs are offered at the intervention garages for an 18 month period.', 'armGroupLabels': ['1']}, {'name': 'Environment', 'type': 'BEHAVIORAL', 'description': 'Changes in the food and physical activity environment are made for an 18 month period in intervention garages. These include improving the healthfulness of the foods available in vending machines, and improving the fitness rooms at the garages.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55454', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Simone French', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}