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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03259360
Other study ID # PA-15-263
Secondary ID R21MD011765
Status Completed
Phase N/A
First received
Last updated
Start date April 23, 2018
Est. completion date February 28, 2020

Study information

Verified date May 2020
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The 2-year research plan will test the Put It Out Project (POP) in a pilot randomized trial (N=120) compared to TSP and two historical control conditions. Participants will be young adults who smoke, identify as sexual or gender minorities, and use Facebook. The 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 mos.


Description:

Participants will be randomized to one of two conditions: (1) a Facebook-delivered intervention addressing tobacco use, tailored to SGM young adults; or (2) a 3-month Facebook intervention targeting tobacco use. Both interventions will include 90 days of Facebook-based messages and activities tailored to participants' readiness to quit smoking.

Assessments 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 cotinine test kits that will be mailed to participants.


Recruitment information / eligibility

Status Completed
Enrollment 165
Est. completion date February 28, 2020
Est. primary completion date April 20, 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

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

Study Design


Intervention

Behavioral:
POP:
90 days of Facebook messaging, weekly live sessions targeting tobacco use and tailored to sexual and gender minority young adults
TSP:
90 days of Facebook messaging, weekly live sessions targeting tobacco use

Locations

Country Name City State
United States University of California San Francisco Department of Psychiatry San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
University of California, San Francisco National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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

Outcome

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 Whether a quit attempt was made during the follow-up period at 3 and 6 months post-baseline. 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 Desire to quit, abstinence self-efficacy, perceived difficulty of quitting and abstinence goal 3 and 6 months post baseline
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