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An Extended Facebook Intervention for Young Sexual and Gender Minority Smokers (POP-6)

Primary Purpose

Tobacco Use, Smoking, Tobacco Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
POP-6:
TSP-6:
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Use focused on measuring Tobacco, Gender Identity Minority, Sexual Identity Minority, Cessation, Intervention, Young Adults, Social Media, Internet, Cigarette

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of California San Francisco Department of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

The Put It Out Project (POP-6):

Tobacco Status Project (TSP-6):

Arm Description

a culturally tailored intervention developed for sexual and gender minority (SGM) young adults on Facebook

the original TSP intervention (non-tailored) delivered to groups of only SGM participants on Facebook

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Reduction in cigarettes smoked by at least 50%
Reduction will be assessed at 3 and 6 month follow-ups
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.
Readiness to quit tobacco
Proportion of participants ready to quit smoking in the next month assessed at 3 and 6 months.
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.

Full Information

First Posted
May 30, 2018
Last Updated
October 14, 2020
Sponsor
University of California, San Francisco
Collaborators
Tobacco Related Disease Research Program
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1. Study Identification

Unique Protocol Identification Number
NCT03553992
Brief Title
An Extended Facebook Intervention for Young Sexual and Gender Minority Smokers
Acronym
POP-6
Official Title
An Extended Facebook Intervention for Young Sexual and Gender Minority Smokers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
October 29, 2018 (Actual)
Primary Completion Date
July 7, 2019 (Actual)
Study Completion Date
July 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Tobacco Related Disease Research Program

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
Detailed Description
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. 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 nicotine test kits that will be mailed to participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use, Smoking, Tobacco Dependence, Tobacco Use Disorder, Tobacco Use Cessation, Tobacco Smoking, Smoking Cessation, Smoking, Cigarette, Smoking, Tobacco
Keywords
Tobacco, Gender Identity Minority, Sexual Identity Minority, Cessation, Intervention, Young Adults, Social Media, Internet, Cigarette

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
173 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The Put It Out Project (POP-6):
Arm Type
Experimental
Arm Description
a culturally tailored intervention developed for sexual and gender minority (SGM) young adults on Facebook
Arm Title
Tobacco Status Project (TSP-6):
Arm Type
Experimental
Arm Description
the original TSP intervention (non-tailored) delivered to groups of only SGM participants on Facebook
Intervention Type
Behavioral
Intervention Name(s)
POP-6:
Intervention Description
90 days of Facebook messaging, weekly live sessions targeting tobacco use and tailored to SGM young adults Drug: nicotine patch 14-day supply of nicotine patch
Intervention Type
Behavioral
Intervention Name(s)
TSP-6:
Intervention Description
90 days of Facebook messaging, weekly live sessions targeting tobacco use Drug: nicotine patch 14-day supply of nicotine patch
Primary Outcome Measure Information:
Title
7-day point prevalence abstinence at 3 months
Description
Reports of no smoking in the 7 days prior to the 3 month assessment. Biochemical verification of abstinence will also be recorded.
Time Frame
3 months post baseline
Title
7-day point prevalence abstinence at 6 months
Description
Reports of no smoking in the 7 days prior to the 6 month assessment. Biochemical verification of abstinence will also be recorded.
Time Frame
6 months post baseline
Secondary Outcome Measure Information:
Title
Reduction in cigarettes smoked by at least 50%
Description
Reduction will be assessed at 3 and 6 month follow-ups
Time Frame
3 and 6 months post baseline
Title
Tobacco use quit attempts
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.
Time Frame
3 and 6 months post baseline
Title
Readiness to quit tobacco
Description
Proportion of participants ready to quit smoking in the next month assessed at 3 and 6 months.
Time Frame
3 and 6 months post baseline
Title
Thoughts About Tobacco Abstinence
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.
Time Frame
3 and 6 months post baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary L. Humfleet, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco Department of Psychiatry
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26721211
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.
Results Reference
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PubMed Identifier
26561529
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.
Results Reference
background
PubMed Identifier
26374203
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.
Results Reference
background
PubMed Identifier
25045624
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.
Results Reference
background
PubMed Identifier
24575728
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.
Results Reference
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An Extended Facebook Intervention for Young Sexual and Gender Minority Smokers

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