Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT01035151
Status:
COMPLETED
Last Update Posted:
2018-12-13
First Post:
2009-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Smoking Cessation Intervention in Public Housing
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073865', 'term': 'Cigarette Smoking'}, {'id': 'D020340', 'term': 'Tobacco Use Cessation'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064424', 'term': 'Tobacco Use'}, {'id': 'D015438', 'term': 'Health Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'j.andrews@sc.edu', 'phone': '803 777 3862', 'title': 'Jeannette Andrews', 'organization': 'University of South Caroina'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 month study period', 'description': 'Collected data on self reported serious adverse events from nicotine patch use, behavioral counseling', 'eventGroups': [{'id': 'EG000', 'title': 'Delayed Control', 'description': 'Women in the delayed control condition received culturally sensitive smoking cessation written materials at week 1, and mailed materials at week 6, 12, and 18. At the end of the study (i.e., after the 12 month data collection), participants were offered counseling, nicotine patches, and community health worker contacts.\n\nControl: Written Cessation Materials', 'otherNumAtRisk': 209, 'deathsNumAtRisk': 209, 'otherNumAffected': 0, 'seriousNumAtRisk': 209, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Experimental', 'description': 'Women in neighborhoods randomized to the S2S received 24-week bundled multi-level intervention. Individual-led strategies were led by paid community health workers (CHWs). The CHWs provided 1:1 contact to reinforce social support, and enhanced self-efficacy with cessation attempts. A certified smoking cessation counselor led behavioral group sessions using the S2S handbook based on the PHS Guidelines. The weekly group sessions were initiated during the 1st week of the intervention, with a total of 6 group sessions over a 6-week period. Transdermal nicotine patches were offered to participants who set a quit date. Within the 24-week study period, the neighborhood tenant association, in partnership with study staff, implemented at least two neighborhood level anti-smoking activities\n\nExperimental: Neighborhood level interventions, peer group (counseling, NRT), and individual level (Coach/CHW)', 'otherNumAtRisk': 200, 'deathsNumAtRisk': 200, 'otherNumAffected': 0, 'seriousNumAtRisk': 200, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Abstinent From Smoking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delayed Control', 'description': 'Women in the delayed control condition received culturally sensitive smoking cessation written materials at week 1, and mailed materials at week 6, 12, and 18. At the end of the study (i.e., after the 12 month data collection), participants were offered counseling, nicotine patches, and community health worker contacts.\n\nControl: Written Cessation Materials'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'Women in neighborhoods randomized to the S2S received 24-week bundled multi-level intervention. Individual-led strategies were led by paid community health workers (CHWs). The CHWs provided 1:1 contact to reinforce social support, and enhanced self-efficacy with cessation attempts. A certified smoking cessation counselor led behavioral group sessions using the S2S handbook based on the PHS Guidelines. The weekly group sessions were initiated during the 1st week of the intervention, with a total of 6 group sessions over a 6-week period. Transdermal nicotine patches were offered to participants who set a quit date. Within the 24-week study period, the neighborhood tenant association, in partnership with study staff, implemented at least two neighborhood level anti-smoking activities\n\nExperimental: Neighborhood level interventions, peer group (counseling, NRT), and individual level (Coach/CHW)'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 month', 'description': 'Reported abstinence validated by exhaled CO and saliva cotinine', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Delayed Control', 'description': 'Women in the delayed control condition received culturally sensitive smoking cessation written materials at week 1, and mailed materials at week 6, 12, and 18. At the end of the study (i.e., after the 12 month data collection), participants were offered counseling, nicotine patches, and community health worker contacts.\n\nControl: Written Cessation Materials'}, {'id': 'FG001', 'title': 'Experimental', 'description': 'Women in neighborhoods randomized to the S2S received 24-week bundled multi-level intervention. Individual-led strategies were led by paid community health workers (CHWs). The CHWs provided 1:1 contact to reinforce social support, and enhanced self-efficacy with cessation attempts. A certified smoking cessation counselor led behavioral group sessions using the S2S handbook based on the PHS Guidelines. The weekly group sessions were initiated during the 1st week of the intervention, with a total of 6 group sessions over a 6-week period. Transdermal nicotine patches were offered to participants who set a quit date. Within the 24-week study period, the neighborhood tenant association, in partnership with study staff, implemented at least two neighborhood level anti-smoking activities\n\nExperimental: Neighborhood level interventions, peer group (counseling, NRT), and individual level (Coach/CHW)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '209'}, {'groupId': 'FG001', 'numSubjects': '200'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '188'}, {'groupId': 'FG001', 'numSubjects': '185'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '15'}]}]}], 'recruitmentDetails': 'Of the 34 subsidized housing neighborhoods in these two regions, the study was implemented in the 14 neighborhoods that met eligibility. Seven matched pairs were formed and randomly assigned one neighborhood in each pair to either the treatment condition or a delayed control condition. 27-32 participants enrolled in each neighborhood.', 'preAssignmentDetails': 'Common reasons for exclusions were not a resident of the neighborhood, not an active smokers.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'BG000'}, {'value': '200', 'groupId': 'BG001'}, {'value': '409', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Delayed Control', 'description': 'Women in the delayed control condition received culturally sensitive smoking cessation written materials at week 1, and mailed materials at week 6, 12, and 18. At the end of the study (i.e., after the 12 month data collection), participants were offered counseling, nicotine patches, and community health worker contacts.\n\nControl: Written Cessation Materials'}, {'id': 'BG001', 'title': 'Experimental', 'description': 'Women in neighborhoods randomized to the S2S received 24-week bundled multi-level intervention. Individual-led strategies were led by paid community health workers (CHWs). The CHWs provided 1:1 contact to reinforce social support, and enhanced self-efficacy with cessation attempts. A certified smoking cessation counselor led behavioral group sessions using the S2S handbook based on the PHS Guidelines. The weekly group sessions were initiated during the 1st week of the intervention, with a total of 6 group sessions over a 6-week period. Transdermal nicotine patches were offered to participants who set a quit date. Within the 24-week study period, the neighborhood tenant association, in partnership with study staff, implemented at least two neighborhood level anti-smoking activities\n\nExperimental: Neighborhood level interventions, peer group (counseling, NRT), and individual level (Coach/CHW)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43', 'spread': '15.6', 'groupId': 'BG000'}, {'value': '41', 'spread': '14.1', 'groupId': 'BG001'}, {'value': '42', 'spread': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '209', 'groupId': 'BG000'}, {'value': '200', 'groupId': 'BG001'}, {'value': '409', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '190', 'groupId': 'BG000'}, {'value': '180', 'groupId': 'BG001'}, {'value': '370', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '192', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '349', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '209', 'groupId': 'BG000'}, {'value': '200', 'groupId': 'BG001'}, {'value': '409', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Nicotine Dependence Score', 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '2.2', 'groupId': 'BG000'}, {'value': '4.7', 'spread': '2.2', 'groupId': 'BG001'}, {'value': '4.7', 'spread': '2.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Fagerstrom Test for Nicotine Dependence was assessed to measure nicotine dependence. The scale ranges from minimum score of 0 to a maximum score of 10. The higher the score, the higher the nicotine dependence.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-09', 'size': 342299, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-11-20T15:10', 'hasProtocol': False}, {'date': '2018-08-09', 'size': 408995, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-11-20T15:16', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 420}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-20', 'studyFirstSubmitDate': '2009-12-17', 'resultsFirstSubmitDate': '2018-05-14', 'studyFirstSubmitQcDate': '2009-12-17', 'lastUpdatePostDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-20', 'studyFirstPostDateStruct': {'date': '2009-12-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Abstinent From Smoking', 'timeFrame': '12 month', 'description': 'Reported abstinence validated by exhaled CO and saliva cotinine'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['randomized cluster design', 'tobacco cessation', 'smoking cessation', 'African American'], 'conditions': ['Cigarette Smoking']}, 'referencesModule': {'references': [{'pmid': '25316192', 'type': 'BACKGROUND', 'citation': 'Andrews JO, Mueller M, Newman SD, Magwood G, Ahluwalia JS, White K, Tingen MS. The association of individual and neighborhood social cohesion, stressors, and crime on smoking status among African-American women in southeastern US subsidized housing neighborhoods. J Urban Health. 2014 Dec;91(6):1158-74. doi: 10.1007/s11524-014-9911-6.'}, {'pmid': '25364473', 'type': 'BACKGROUND', 'citation': "Spruill IJ, Leite RS, Fernandes JK, Kamen DL, Ford ME, Jenkins C, Hunt KJ, Andrews JO. Successes, Challenges and Lessons Learned: Community-engaged research with South Carolina's Gullah population. Gateways. 2013;6:10.5130/ijcre.v6i1.2805. doi: 10.5130/ijcre.v6i1.2805. No abstract available."}, {'pmid': '22289400', 'type': 'BACKGROUND', 'citation': 'Andrews JO, Newman SD, Heath J, Williams LB, Tingen MS. Community-based participatory research and smoking cessation interventions: a review of the evidence. Nurs Clin North Am. 2012 Mar;47(1):81-96. doi: 10.1016/j.cnur.2011.10.013. Epub 2011 Dec 14.'}, {'pmid': '22124619', 'type': 'BACKGROUND', 'citation': 'Andrews JO, Tingen MS, Jarriel SC, Caleb M, Simmons A, Brunson J, Mueller M, Ahluwalia JS, Newman SD, Cox MJ, Magwood G, Hurman C. Application of a CBPR framework to inform a multi-level tobacco cessation intervention in public housing neighborhoods. Am J Community Psychol. 2012 Sep;50(1-2):129-40. doi: 10.1007/s10464-011-9482-6.'}, {'pmid': '23698666', 'type': 'BACKGROUND', 'citation': 'Magwood GS, Andrews JO, Zapka J, Cox MJ, Newman S, Stuart GW. Institutionalization of community partnerships: the challenge for academic health centers. J Health Care Poor Underserved. 2012 Nov;23(4):1512-26. doi: 10.1353/hpu.2012.0161.'}, {'pmid': '21477510', 'type': 'BACKGROUND', 'citation': 'Newman SD, Andrews JO, Magwood GS, Jenkins C, Cox MJ, Williamson DC. Community advisory boards in community-based participatory research: a synthesis of best processes. Prev Chronic Dis. 2011 May;8(3):A70. Epub 2011 Apr 15.'}, {'pmid': '27423320', 'type': 'RESULT', 'citation': 'Andrews JO, Mueller M, Dooley M, Newman SD, Magwood GS, Tingen MS. Effect of a smoking cessation intervention for women in subsidized neighborhoods: A randomized controlled trial. Prev Med. 2016 Sep;90:170-6. doi: 10.1016/j.ypmed.2016.07.008. Epub 2016 Jul 14.'}]}, 'descriptionModule': {'briefSummary': 'The major aim of this study is to test the effectiveness of a bundled, multi-level intervention (Sister to Sister) on smoking cessation outcomes in female smokers residing in public housing neighborhoods.\n\nHypothesis 1.1: As compared to the control group, women receiving the Sister to Sister Intervention will have higher 7-day point prevalence quit rates at 6- and 12-months as validated by salivary cotinine.\n\nHypothesis 1.2: As compared to the control group, women receiving the Sister to Sister Intervention will have higher 6- and 12-month prolonged smoking abstinence as validated by salivary cotinine.', 'detailedDescription': 'This was a cluster randomized controlled study evaluating the effect of a multi-level intervention, Sister to Sister, on the smoking cessation in two Southeastern US metropolitan areas. Fourteen subsidized housing neighborhoods, eight in Charleston, SC and six in Augusta, GA, were pair matched based on size; with one neighborhood in each pair randomized to the intervention to ensure balanced recruitment between groups. Neighborhoods ranged in size from 22 to 33 participants with a total sample size of 409 women; neighborhoods were chosen as the primary sampling unit to prevent contamination of the outcome within neighborhoods, with women in the neighborhoods as secondary sampling unit. All statistical analyses were conducted using SAS 9.2 (SAS Institute, Cary, NC) with statistical significance at an alpha level of 0.05. Comparison between groups at baseline used t-tests for continuous variables and chi-square tests for categorical variables. The primary outcome of interest was smoking status which was dichotomized (smoker/non-smoker) at the 6 and 12 month measurements. Smoking status was determined by cotinine levels in saliva with non-smokers defined as those with cotinine levels of 14 ng/mL or less.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 yrs of age and older,\n* female, resident of public housing, daily smoker\n\nExclusion Criteria:\n\n* pregnant,\n* breastfeeding,\n* no intentions to quit smoking'}, 'identificationModule': {'nctId': 'NCT01035151', 'briefTitle': 'Smoking Cessation Intervention in Public Housing', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'Social Ecological Based Smoking Cessation Intervention in Public Housing Neighborhoods', 'orgStudyIdInfo': {'id': 'MUS08022834'}, 'secondaryIdInfos': [{'id': 'R01HL090951', 'link': 'https://reporter.nih.gov/quickSearch/R01HL090951', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Delayed Control', 'description': 'Women in the delayed control condition received culturally sensitive smoking cessation written materials at week 1, and mailed materials at week 6, 12, and 18. At the end of the study (i.e., after the 12 month data collection), participants were offered counseling, nicotine patches, and community health worker contacts.', 'interventionNames': ['Behavioral: Control']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Women in neighborhoods randomized to the S2S received 24-week bundled multi-level intervention. Individual-led strategies were led by paid community health workers (CHWs). The CHWs provided 1:1 contact to reinforce social support, and enhanced self-efficacy with cessation attempts. A certified smoking cessation counselor led behavioral group sessions using the S2S handbook based on the PHS Guidelines. The weekly group sessions were initiated during the 1st week of the intervention, with a total of 6 group sessions over a 6-week period. Transdermal nicotine patches were offered to participants who set a quit date. Within the 24-week study period, the neighborhood tenant association, in partnership with study staff, implemented at least two neighborhood level anti-smoking activities', 'interventionNames': ['Behavioral: Experimental']}], 'interventions': [{'name': 'Experimental', 'type': 'BEHAVIORAL', 'description': 'Neighborhood level interventions, peer group (counseling, NRT), and individual level (Coach/CHW)', 'armGroupLabels': ['Experimental']}, {'name': 'Control', 'type': 'BEHAVIORAL', 'description': 'Written Cessation Materials', 'armGroupLabels': ['Delayed Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30901', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Medical College of Georgia', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Jeannette Andrews, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Carolina'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Contact the PI'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}