Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-02-06 @ 8:41 PM
Study NCT ID:
NCT00617266
Status:
UNKNOWN
Last Update Posted:
2008-02-15
First Post:
2008-02-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tobacco Control Among Business Process Outsourcing (BPO) Employees
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2009-03-25', 'releaseDate': '2009-03-03'}, {'resetDate': '2009-07-09', 'releaseDate': '2009-05-19'}, {'resetDate': '2009-09-16', 'releaseDate': '2009-08-26'}, {'resetDate': '2011-02-10', 'releaseDate': '2011-01-12'}, {'resetDate': '2011-07-12', 'releaseDate': '2011-06-15'}], 'estimatedResultsFirstSubmitDate': '2009-03-03'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020340', 'term': 'Tobacco Use Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-02', 'completionDateStruct': {'date': '2009-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-02-14', 'studyFirstSubmitDate': '2008-02-04', 'studyFirstSubmitQcDate': '2008-02-14', 'lastUpdatePostDateStruct': {'date': '2008-02-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the post-intervention knowledge, attitudes and practices regarding tobacco addiction and the change as compared with the pre-intervention records by analysing the outcome with respect to different intervention strategies.', 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'measure': 'The prevalence of tobacco and alcohol addiction among the BPO employees.', 'timeFrame': '10 months'}, {'measure': 'The prevalence of addiction to different forms of tobacco products.', 'timeFrame': '10 months'}, {'measure': 'Analysis of the factors responsible for initiation and continuation of tobacco habit.', 'timeFrame': '10 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['tobacco, cessation, BPO, RCT, KAP'], 'conditions': ['Tobacco Use Cessation']}, 'descriptionModule': {'briefSummary': 'The Business Process Outsourcing BPO industry has been rapidly expanding in India over the last 10 years. There is a concern regarding issues of health and safety that are unique to this new and developing industry. The lack of reliable and relevant information on which to base the response to this concern poses a challenge for safeguarding the health of BPO employees. Elevated stress levels, shift duties, high work targets, lofty income may force many towards addictions to keep them going.\n\nUse of tobacco, which is very common addiction in India, is associated with several health hazards. Anecdotal evidence suggests that smoking and other forms of addictions are at its peak in the BPO industries. We are conducting a research on the tobacco habits among Business Process Outsourcing (BPO) employees to understand the prevalence of different forms of tobacco addiction and the reasons for initiation and continuation of the habit. We will also offer different interventions as a measure of tobacco cessation.', 'detailedDescription': 'This is a four arm randomized controlled trial among Business Process Outsourcing (BPO) employees working in four different BPO units. The trial is undertaken with the objective to explore the prevalence of tobacco use in its various forms along with factors responsible for initiation and continuation of the habit. This trial also aims to study the change in the knowledge, attitudes and practices among BPO employees after intervention with different tobacco cessation strategies.\n\nFour BPO units with work force of approximately 200 employees each, with the management and employees that consent to participate in the study will be selected for the trial. The aim and purpose of the study will be explained and a written informed consent form in English will be offered. The employees who are willing to participate in the trial, will be recruited after signing the informed consent form.\n\nThe subjects involved in the research will be expected to answer a few questions about their socio-demographic, occupational, medical, risk factor history and some questions to assess their knowledge, attitude and practice regarding tobacco use. Following this the tobacco users will be offered one of the tobacco cessation interventions to help them quit tobacco.\n\nRegular follow-up visits will be conducted through out the period of the study. The same questionnaire as the pre intervention will be repeated post intervention, ten months later to assess change in their knowledge, attitude and practice regarding tobacco use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The study participants will be apparently healthy males and females above 18 years of age working in the selected BPO units in Mumbai.\n\nExclusion Criteria:\n\n* There will be no minors.'}, 'identificationModule': {'nctId': 'NCT00617266', 'briefTitle': 'Tobacco Control Among Business Process Outsourcing (BPO) Employees', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tata Memorial Hospital'}, 'officialTitle': 'Tobacco Control Among Business Process Outsourcing (BPO) Employees', 'orgStudyIdInfo': {'id': '351'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1 Control Group', 'description': 'Distribution of pamphlets containing information on the hazards of tobacco', 'interventionNames': ['Other: Tobacco cessation intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': 'Active Health Education sessions (harmful effects of tobacco addiction) followed by focus group discussion for all BPO employees', 'interventionNames': ['Other: Tobacco cessation intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3', 'description': 'Active Health Education and Tobacco Cessation Programme for tobacco users using Behavioural Therapy only', 'interventionNames': ['Other: tobacco cessation intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 4', 'description': 'Active Health Education and Tobacco Cessation Programme for tobacco users using Behavioural and Pharmaco-therapy', 'interventionNames': ['Other: Tobacco cessation intervention']}], 'interventions': [{'name': 'tobacco cessation intervention', 'type': 'OTHER', 'description': 'Active Health Education and Tobacco Cessation Programme for tobacco users using Behavioural Therapy only', 'armGroupLabels': ['Arm 3']}, {'name': 'Tobacco cessation intervention', 'type': 'OTHER', 'description': 'Active Health Education and Tobacco Cessation Programme for tobacco users using Behavioural and Pharmaco-therapy', 'armGroupLabels': ['Arm 4']}, {'name': 'Tobacco cessation intervention', 'type': 'OTHER', 'description': 'Distribution of pamphlets containing information on the hazards of tobacco', 'armGroupLabels': ['Arm 1 Control Group']}, {'name': 'Tobacco cessation intervention', 'type': 'OTHER', 'description': 'Active Health Education sessions (harmful effects of tobacco addiction) followed by focus group discussion for all BPO employees', 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400012', 'city': 'Mumbai', 'state': 'Maharashtra', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Gauravi A Mishra, MD', 'role': 'CONTACT', 'email': 'gauravi2005@yahoo.co.in', 'phone': '+91-22-4157532'}, {'name': 'Gauravi A Mishra, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tata Memorial Hospital', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}], 'centralContacts': [{'name': 'Gauravi A Mishra, MD', 'role': 'CONTACT', 'email': 'gauravi2005@yahoo.co.in', 'phone': '+91-22-24157532'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tata Memorial Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Gauravi Ashish Mishra', 'oldOrganization': 'Tata Memorial Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2009-03-03', 'type': 'RELEASE'}, {'date': '2009-03-25', 'type': 'RESET'}, {'date': '2009-05-19', 'type': 'RELEASE'}, {'date': '2009-07-09', 'type': 'RESET'}, {'date': '2009-08-26', 'type': 'RELEASE'}, {'date': '2009-09-16', 'type': 'RESET'}, {'date': '2011-01-12', 'type': 'RELEASE'}, {'date': '2011-02-10', 'type': 'RESET'}, {'date': '2011-06-15', 'type': 'RELEASE'}, {'date': '2011-07-12', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Tata Memorial Hospital (Gauravi Ashish Mishra)'}}}}