NCT03259360

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 23, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

April 23, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
Last Updated

January 30, 2025

Status Verified

January 1, 2025

Enrollment Period

12 months

First QC Date

August 21, 2017

Last Update Submit

January 27, 2025

Conditions

Keywords

TobaccoGender Identity MinoritySexual Identity MinorityCessationInterventionYoung AdultsSocial MediaInternetCigarette

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Reduction in cigarettes smoked by at least 50%

    3 and 6 months post baseline

  • Tobacco use quit attempts

    3 and 6 months post baseline

  • Readiness to quit tobacco

    3 and 6 months post baseline

  • Thoughts About Tobacco Abstinence

    3 and 6 months post baseline

Study Arms (2)

The Put It Out Project (POP):

EXPERIMENTAL

a culturally tailored intervention developed for SGM young adults on Facebook

Behavioral: POP:

Tobacco Status Project (TSP):

EXPERIMENTAL

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

Behavioral: TSP:

Interventions

POP:BEHAVIORAL

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

The Put It Out Project (POP):
TSP:BEHAVIORAL

90 days of Facebook messaging, weekly live sessions targeting tobacco use

Tobacco Status Project (TSP):

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco Department of Psychiatry

San Francisco, California, 94143, United States

Location

Related Publications (6)

  • 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: 26721211BACKGROUND
  • 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: 26561529BACKGROUND
  • 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: 26374203BACKGROUND
  • 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: 25045624BACKGROUND
  • 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.

    PMID: 24575728BACKGROUND
  • Vogel EA, Ramo DE, Meacham MC, Prochaska JJ, Delucchi KL, Humfleet GL. The Put It Out Project (POP) Facebook Intervention for Young Sexual and Gender Minority Smokers: Outcomes of a Pilot, Randomized, Controlled Trial. Nicotine Tob Res. 2020 Aug 24;22(9):1614-1621. doi: 10.1093/ntr/ntz184.

    PMID: 31562765BACKGROUND

MeSH Terms

Conditions

Tobacco UseSmokingTobacco Use DisorderTobacco Use CessationTobacco SmokingSmoking CessationCigarette Smoking

Condition Hierarchy (Ancestors)

BehaviorSubstance-Related DisordersChemically-Induced DisordersMental DisordersHealth Behavior

Study Officials

  • Gary L. Humfleet, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2017

First Posted

August 23, 2017

Study Start

April 23, 2018

Primary Completion

April 20, 2019

Study Completion

February 28, 2020

Last Updated

January 30, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations