Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2026-02-01 @ 5:23 PM
Study NCT ID:
NCT03553992
Status:
COMPLETED
Last Update Posted:
2020-10-19
First Post:
2018-05-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Extended Facebook Intervention for Young Sexual and Gender Minority Smokers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064424', 'term': 'Tobacco Use'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D020340', 'term': 'Tobacco Use Cessation'}, {'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D000073865', 'term': 'Cigarette Smoking'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D015438', 'term': 'Health Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000612025', 'term': 'POP6 protein, S cerevisiae'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 173}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-14', 'studyFirstSubmitDate': '2018-05-30', 'studyFirstSubmitQcDate': '2018-05-30', 'lastUpdatePostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '7-day point prevalence abstinence at 3 months', 'timeFrame': '3 months post baseline', 'description': 'Reports of no smoking in the 7 days prior to the 3 month assessment. Biochemical verification of abstinence will also be recorded.'}, {'measure': '7-day point prevalence abstinence at 6 months', 'timeFrame': '6 months post baseline', 'description': 'Reports of no smoking in the 7 days prior to the 6 month assessment. Biochemical verification of abstinence will also be recorded.'}], 'secondaryOutcomes': [{'measure': 'Reduction in cigarettes smoked by at least 50%', 'timeFrame': '3 and 6 months post baseline', 'description': 'Reduction will be assessed at 3 and 6 month follow-ups'}, {'measure': 'Tobacco use quit attempts', 'timeFrame': '3 and 6 months post baseline', 'description': 'A Smoking Questionnaire will assess the presence and number of 24 hr quit attempts since the last assessment, used to calculate presence of at least one quit attempt (y/n) in the assessment time period. This questionnaire has good internal consistency and construct validity, and is routinely used in smoking treatment research.'}, {'measure': 'Readiness to quit tobacco', 'timeFrame': '3 and 6 months post baseline', 'description': 'Proportion of participants ready to quit smoking in the next month assessed at 3 and 6 months.'}, {'measure': 'Thoughts About Tobacco Abstinence', 'timeFrame': '3 and 6 months post baseline', 'description': 'The 4-item Thoughts About Abstinence Form, will measure thoughts about abstinence (desire to quit, abstinence self-efficacy, and perceived difficulty of quitting) on a scale from 1 ("least") to 10("most"), and abstinence goal as no goal, intermediary goal (e.g., reduced smoking), or total abstinence.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tobacco', 'Gender Identity Minority', 'Sexual Identity Minority', 'Cessation', 'Intervention', 'Young Adults', 'Social Media', 'Internet', 'Cigarette'], 'conditions': ['Tobacco Use', 'Smoking', 'Tobacco Dependence', 'Tobacco Use Disorder', 'Tobacco Use Cessation', 'Tobacco Smoking', 'Smoking Cessation', 'Smoking, Cigarette', 'Smoking, Tobacco']}, 'referencesModule': {'references': [{'pmid': '26721211', 'type': 'BACKGROUND', 'citation': 'Ramo DE, Thrul J, Chavez K, Delucchi KL, Prochaska JJ. Feasibility and Quit Rates of the Tobacco Status Project: A Facebook Smoking Cessation Intervention for Young Adults. J Med Internet Res. 2015 Dec 31;17(12):e291. doi: 10.2196/jmir.5209.'}, {'pmid': '26561529', 'type': 'BACKGROUND', 'citation': 'Thrul J, Klein AB, Ramo DE. Smoking Cessation Intervention on Facebook: Which Content Generates the Best Engagement? J Med Internet Res. 2015 Nov 11;17(11):e244. doi: 10.2196/jmir.4575.'}, {'pmid': '26374203', 'type': 'BACKGROUND', 'citation': 'Ramo DE, Thrul J, Delucchi KL, Ling PM, Hall SM, Prochaska JJ. The Tobacco Status Project (TSP): Study protocol for a randomized controlled trial of a Facebook smoking cessation intervention for young adults. BMC Public Health. 2015 Sep 15;15:897. doi: 10.1186/s12889-015-2217-0.'}, {'pmid': '25045624', 'type': 'BACKGROUND', 'citation': 'Ramo DE, Rodriguez TM, Chavez K, Sommer MJ, Prochaska JJ. Facebook Recruitment of Young Adult Smokers for a Cessation Trial: Methods, Metrics, and Lessons Learned. Internet Interv. 2014 Apr;1(2):58-64. doi: 10.1016/j.invent.2014.05.001.'}, {'pmid': '24575728', 'type': 'BACKGROUND', 'citation': "Ramo DE, Liu H, Prochaska JJ. A mixed-methods study of young adults' receptivity to using Facebook for smoking cessation: if you build it, will they come? Am J Health Promot. 2015 Mar-Apr;29(4):e126-35. doi: 10.4278/ajhp.130326-QUAL-128. Epub 2014 Feb 27."}]}, 'descriptionModule': {'briefSummary': 'The 2-year research plan will test the Extended Put It Out Project (POP-6) in a pilot randomized trial (N=168) compared to TSP-6, as well as comparing POP-6 and TSP-6 to the POP-3 and TSP-3 interventions from a previously-conducted trial. Participants will be young adults who smoke, identify as sexual or gender minorities (SGM), and use Facebook. Primary outcome will be biochemically verified 7-day abstinence from smoking at 3 and 6 months. Secondary outcomes will be a quit attempt (y/n), stage of change, and thoughts about tobacco abstinence at 3 and 6 months.', 'detailedDescription': "Participants will be randomized to one of two conditions: (1) a 6-month Facebook-delivered intervention addressing tobacco use, tailored to SGM young adults; or (2) a 6-month Facebook intervention targeting tobacco use. Both interventions will include 180 days of Facebook-based messages and activities tailored to participants' readiness to quit smoking.\n\nAssessments will occur at baseline, 3, and 6 months follow-up. Assessments will include measures on smoking, thoughts about abstinence, and SGM identity experiences. All participants who report no past 7-day smoking will be asked to give biochemical verification of smoking status with saliva nicotine test kits that will be mailed to participants."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* read English\n* between 18 and 25 years of age\n* indicate they use Facebook "most" (≥ 4) days per week\n* have smoked ≥100 cigarettes in their lives and currently smoke at least 1 cigarette per day on 4 or more days of the week\n* identifies as SGM\n* lives in California\n\nExclusion Criteria:\n\n* do not read English\n* are not between 18 and 25 years of age\n* indicate they do not use Facebook "most" (≥ 4) days per week\n* have not smoked ≥100 cigarettes in their lives and currently smoke at least 1 cigarette per day on 4 or more days of the week\n* does not identify as SGM\n* does not live in California'}, 'identificationModule': {'nctId': 'NCT03553992', 'acronym': 'POP-6', 'briefTitle': 'An Extended Facebook Intervention for Young Sexual and Gender Minority Smokers', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'An Extended Facebook Intervention for Young Sexual and Gender Minority Smokers', 'orgStudyIdInfo': {'id': 'P0520362'}, 'secondaryIdInfos': [{'id': '26IR-0004', 'type': 'OTHER_GRANT', 'domain': 'UC Tobacco-Related Disease Research Pgm'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The Put It Out Project (POP-6):', 'description': 'a culturally tailored intervention developed for sexual and gender minority (SGM) young adults on Facebook', 'interventionNames': ['Behavioral: POP-6:']}, {'type': 'EXPERIMENTAL', 'label': 'Tobacco Status Project (TSP-6):', 'description': 'the original TSP intervention (non-tailored) delivered to groups of only SGM participants on Facebook', 'interventionNames': ['Behavioral: TSP-6:']}], 'interventions': [{'name': 'POP-6:', 'type': 'BEHAVIORAL', 'description': '90 days of Facebook messaging, weekly live sessions targeting tobacco use and tailored to SGM young adults\n\nDrug: nicotine patch 14-day supply of nicotine patch', 'armGroupLabels': ['The Put It Out Project (POP-6):']}, {'name': 'TSP-6:', 'type': 'BEHAVIORAL', 'description': '90 days of Facebook messaging, weekly live sessions targeting tobacco use\n\nDrug: nicotine patch 14-day supply of nicotine patch', 'armGroupLabels': ['Tobacco Status Project (TSP-6):']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco Department of Psychiatry', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Gary L. Humfleet, 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': 'Tobacco Related Disease Research Program', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}