Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT01497158
Status:
COMPLETED
Last Update Posted:
2014-08-22
First Post:
2011-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Promoting Home Smoking Restrictions: Biomarker Feedback to Smoking and Non-Smoking Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D020340', 'term': 'Tobacco Use Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-21', 'studyFirstSubmitDate': '2011-12-20', 'studyFirstSubmitQcDate': '2011-12-21', 'lastUpdatePostDateStruct': {'date': '2014-08-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of Self-Reported Home Smoking Restrictions - Active Counseling', 'timeFrame': 'From baseline to week 12', 'description': 'Received self-help brochure and biomarker feedback from urine collected from non-smoking adult in home. Outcome criteria categorized into 3 areas: establishment of a complete ban (defined as no one allowed to smoke anywhere, ever), some restrictions (smoking allowed in some places or some time), and no restrictions (smoking permitted anywhere, no rules).'}, {'measure': 'Comparison of Self-Reported Home Smoking Restrictions - Control Group', 'timeFrame': 'From baseline to week 12', 'description': 'Received only self-help brochure on home ETS exposure. Outcome criteria categorized into 3 areas: establishment of a complete ban (defined as no one allowed to smoke anywhere, ever), some restrictions (smoking allowed in some places or some time), and no restrictions (smoking permitted anywhere, no rules).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tobacco cessation'], 'conditions': ['Smoking Cessation', 'Tobacco Use Disorder']}, 'descriptionModule': {'briefSummary': 'This study is directed at decreasing home environmental tobacco smoking (ETS) exposure with a novel approach of adoption of home smoking restrictions. This will be done by providing the cohabitating smoker and non-smoker with biomarker feedback documenting exposure to ETS. The intent is to identify an intervention strategy(ies) to reduce ETS exposure.', 'detailedDescription': 'This is a two-group interventional trial targeting cohabitating smokers and non-smokers. Participants will be randomized to the control condition or biomarker feedback group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be at least 18 years of age\n* Cohabitating Non-Smoker (control) and smoker (active)\n* Smoker must test \\> 6ppm on carbon dioxide (CO) test and non-smoker \\< 6ppm\n* General good health\n* Written informed consent\n* Live within Twin Cities 7 county metropolitan area (Minnesota)\n* Plan to live in same home for 6 months and be willing for researchers to come to their home\n\nExclusion Criteria:\n\n* Individuals that live in a treatment facility or shelter\n* Individuals endorsing current domestic violence'}, 'identificationModule': {'nctId': 'NCT01497158', 'briefTitle': 'Promoting Home Smoking Restrictions: Biomarker Feedback to Smoking and Non-Smoking Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Promoting Home Smoking Restrictions: Biomarker Feedback to Cohabitating Smoking and Non-Smoking Adults', 'orgStudyIdInfo': {'id': '2007NT053'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Participants who received only self-help brochure regarding environmental tobacco smoking (ETS) exposure in the home.', 'interventionNames': ['Other: Self-help brochure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Group', 'description': 'Participants who received self-help brochure regarding environmental tobacco smoking (ETS) exposure in the home and biomarker feedback from the urine of cohabitating adult non-smoker in the home.', 'interventionNames': ['Other: Self-help brochure', 'Other: Biomarker feedback']}], 'interventions': [{'name': 'Self-help brochure', 'type': 'OTHER', 'description': 'Self help brochure given at baseline visit.', 'armGroupLabels': ['Active Group', 'Control Group']}, {'name': 'Biomarker feedback', 'type': 'OTHER', 'description': 'Biomarker feedback from urine of adult non-smoker in the home.', 'armGroupLabels': ['Active Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': "55455'", 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Janet Thomas, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}