Ignite Creation Date:
2025-12-24 @ 11:05 PM
Ignite Modification Date:
2025-12-25 @ 8:36 PM
Study NCT ID:
NCT04079569
Status:
COMPLETED
Last Update Posted:
2021-04-08
First Post:
2019-09-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Empower Korean Families to End Tobacco Use & Smoking Exposure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D040242', 'term': 'Risk Reduction Behavior'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062789', 'term': 'Tobacco Products'}], 'ancestors': [{'id': 'D000074602', 'term': 'Smoking Devices'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-05', 'studyFirstSubmitDate': '2019-09-03', 'studyFirstSubmitQcDate': '2019-09-03', 'lastUpdatePostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abstinence', 'timeFrame': '3 months', 'description': 'Biochemically verified 7-day point prevalence of cigarette abstinence at 3-month post baseline assessment (initiation of intervention)'}, {'measure': 'Secondhand smoke (SHS) exposure of non-smokers', 'timeFrame': '3 months', 'description': 'Biochemically verified 7-day point prevalence of SHS exposure at 3-month post baseline assessment (initiation of intervention)'}, {'measure': 'Percent attendance', 'timeFrame': '3-month', 'description': 'Percent of participants who attend at least 3 out of 4 planned contacts'}, {'measure': 'Percentage of participants who rate the intervention as helpful', 'timeFrame': '3 months', 'description': 'Participants will rate their perception as to whether or not they found the intervention to be helpful at the 3 month assessment'}], 'secondaryOutcomes': [{'measure': 'Number of Quit attempts', 'timeFrame': '3 months', 'description': 'Self-report number participants making a quit attempt(s) that lasted at least for 24 hours since baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tobacco', 'smoking cessation', 'Asian Americans'], 'conditions': ['Smoking Cessation', 'Lifestyle Risk Reduction']}, 'descriptionModule': {'briefSummary': 'The goals of the study are to develop a culturally and linguistically appropriate intervention to promote smoking cessation and reduce secondhand smoke exposure for Korean Americans using a family-based intervention approach targeting Korean Americans ages 18 and above in the greater San Francisco Bay Area, CA, and to evaluate efficacy of the proposed intervention. The study is a randomized control trial targeting a total of 8 lay health workers (LHW) and 48 dyads of a daily smoker and a partner who will attend intervention sessions together. The research question is: Can a family-based lay health worker outreach intervention promote smoking cessation and reduce SHS exposure among Korean Americans?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* reside in California, United States\n* for the smoker participants, they must have smoked at least 1 cigarette in the past 30 days, and have smoked either at least 1 cigarette and/or used e-cigarettes in the past 7 days, and self-identified as Korean or Korean American\n* for partner participants, they must be willing to attend intervention session together with a smoker participant\n* provide a valid contact telephone number and email address for pre- and post-intervention assessments'}, 'identificationModule': {'nctId': 'NCT04079569', 'briefTitle': 'Empower Korean Families to End Tobacco Use & Smoking Exposure', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Empower Korean Families to End Tobacco Use & Smoking Exposure', 'orgStudyIdInfo': {'id': 'TRDRP 26IP-0037'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tobacco', 'description': 'Participants will receive education delivered by a lay health worker on "Quit Smoking For a Healthy Family." Participants will receive written information on nutrition and physical activity.', 'interventionNames': ['Behavioral: Tobacco']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy Living', 'description': 'In this comparison arm, participants will receive education delivered by the lay health worker about "Healthy Living" focusing on nutrition and physical activity education. Participants will also receive the Smoking Cessation Resource Handout.', 'interventionNames': ['Behavioral: Healthy Living']}], 'interventions': [{'name': 'Tobacco', 'type': 'BEHAVIORAL', 'description': 'Quit Smoking For a Healthy Family - This is a family-based psycho-education intervention using lay health worker (LHW) outreach. LHW will be trained to recruit smoke-family dyads and provide education and information about tobacco and health, and smoking cessation resources through 2 small-group education sessions and 2 individual phone calls over a 2-month period.', 'armGroupLabels': ['Tobacco']}, {'name': 'Healthy Living', 'type': 'BEHAVIORAL', 'description': 'In this comparison arm, participants will receive the same number of contacts on the same schedule and in the same format (2 small group sessions and 2 telephone calls). The comparison LHWs will receive training about "Healthy Living" focusing on nutrition and physical activity education. Participants will also receive the Smoking Cessation Resource Handout.', 'armGroupLabels': ['Healthy Living']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94577', 'city': 'San Leandro', 'state': 'California', 'country': 'United States', 'facility': 'Korean Community Center of the East Bay', 'geoPoint': {'lat': 37.72493, 'lon': -122.15608}}], 'overallOfficials': [{'name': 'Janice Y Tsoh, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Korean Community Center of the East Bay', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}