Smoking Cessation Clinical Trial
— POP-6Official title:
An Extended Facebook Intervention for Young Sexual and Gender Minority Smokers
Verified date | October 2020 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 173 |
Est. completion date | July 7, 2019 |
Est. primary completion date | July 7, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 25 Years |
Eligibility | Inclusion Criteria: - read English - between 18 and 25 years of age - indicate they use Facebook "most" (= 4) days per week - have smoked =100 cigarettes in their lives and currently smoke at least 1 cigarette per day on 4 or more days of the week - identifies as SGM - lives in California Exclusion Criteria: - do not read English - are not between 18 and 25 years of age - indicate they do not use Facebook "most" (= 4) days per week - 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 - does not identify as SGM - does not live in California |
Country | Name | City | State |
---|---|---|---|
United States | University of California San Francisco Department of Psychiatry | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | Tobacco Related Disease Research Program |
United States,
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. — View 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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 7-day point prevalence abstinence at 3 months | Reports of no smoking in the 7 days prior to the 3 month assessment. Biochemical verification of abstinence will also be recorded. | 3 months post baseline | |
Primary | 7-day point prevalence abstinence at 6 months | Reports of no smoking in the 7 days prior to the 6 month assessment. Biochemical verification of abstinence will also be recorded. | 6 months post baseline | |
Secondary | Reduction in cigarettes smoked by at least 50% | Reduction will be assessed at 3 and 6 month follow-ups | 3 and 6 months post baseline | |
Secondary | Tobacco use quit attempts | 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. | 3 and 6 months post baseline | |
Secondary | Readiness to quit tobacco | Proportion of participants ready to quit smoking in the next month assessed at 3 and 6 months. | 3 and 6 months post baseline | |
Secondary | Thoughts About Tobacco Abstinence | 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. | 3 and 6 months post baseline |
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