NCT01633567

Brief Summary

For the approximately 4.6 million LGBT persons in the U.S., smoking rates among those living in urban areas are roughly twice that of heterosexuals. Targeted interventions have shown great promise in reducing health risk behaviors across a variety of behaviors and population groups by enhancing the relevance of the health information. The primary aim of this study is to test the efficacy of a culturally targeted group-based smoking cessation intervention (vs. a non-targeted intervention) on smoking outcomes among lesbian, gay, bisexual, and transgender (LGBT) smokers. The investigators anticipate that the culturally targeted intervention will be more effective at helping LGBT smokers to successfully stop smoking than will the non-targeted intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2012

Longer than P75 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

Study Start

First participant enrolled

May 1, 2012

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

May 30, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 4, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2017

Enrollment Period

3.7 years

First QC Date

May 30, 2012

Last Update Submit

May 3, 2017

Conditions

Keywords

Smoking CessationCigarette SmokingTobaccoLGBTLGBTQ

Outcome Measures

Primary Outcomes (4)

  • 7-Day Point Prevalence Smoking Quit Rates 1 Month Post Quit Date

    7-Day point prevalence smoking quit rates will serve as the main outcome measure and will be obtained from Time Line Follow-Back (TLFB) interviews.

    Assessed 1 month after quit date

  • 7-Day Point Prevalence Smoking Quit Rates 3 Months Post Quit Date

    7-Day point prevalence smoking quit rates will serve as the main outcome measure and will be obtained from Time Line Follow-Back (TLFB) interviews.

    Assessed 3 months after quit date

  • 7-Day Point Prevalence Smoking Quit Rates 6 Months Post Quit Date

    7-Day point prevalence smoking quit rates will serve as the main outcome measure and will be obtained from Time Line Follow-Back (TLFB) interviews.

    Assessed 6 months after quit date

  • 7-Day Point Prevalence Smoking Quit Rates 12 Months Post Quit Date

    7-Day point prevalence smoking quit rates will serve as the main outcome measure and will be obtained from Time Line Follow-Back (TLFB) interviews.

    Assessed 12 months after quit date

Study Arms (2)

Culturally Targeted Cessation Program

EXPERIMENTAL

The culturally targeted program will include the same cognitive and behavioral approaches and smoking education content that is used in the standard program. As such, we will maintain the integrity of the core program. However, cultural targeting of that program has been informed by local LGBT focus group input and testing, the available literature on LGBT smoking rates and behaviors, feedback from a panel of LGBT health experts, and data collected as part of a previous study.

Behavioral: Culturally Targeted Cessation Program

Non-Targeted Cessation Program

ACTIVE COMPARATOR

Non-culturally targeted program with cognitive and behavioral approaches and smoking education content.

Behavioral: Non-Targeted Cessation Program

Interventions

The culturally targeted version of the behavioral counseling intervention will consist of six group-based smoking cessation counseling sessions. Each smoking cessation therapy session will last approximately 90 minutes and will begin two weeks before the quit date. In addition, participants will be provided nicotine replacement therapy and peer support sessions will occur between the group sessions.

Culturally Targeted Cessation Program

Behavioral counseling intervention will consist of six group-based smoking cessation counseling sessions. Each smoking cessation therapy session will last approximately 90 minutes and will begin two weeks before the quit date. In addition, participants will be provided nicotine replacement therapy and peer support sessions will occur between the group sessions.

Non-Targeted Cessation Program

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self identify as lesbian, gay, bisexual, or transgender
  • Age 18-65
  • Current cigarette smoker
  • Desire to quit smoking (self-report rating of interest in quitting)

You may not qualify if:

  • Agree to attend behavioral counseling sessions, be randomized, and be followed-up
  • Agrees to use nicotine patch and has no prior adverse reactions to patch
  • Has stable residence and telephone and can provide the name of an outside household collateral family member or close friend for contact and follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Howard Brown Health Center

Chicago, Illinois, 60613, United States

Location

Related Publications (1)

  • Matthews AK, McConnell EA, Li CC, Vargas MC, King A. Design of a comparative effectiveness evaluation of a culturally tailored versus standard community-based smoking cessation treatment program for LGBT smokers. BMC Psychol. 2014 May 30;2(1):12. doi: 10.1186/2050-7283-2-12. eCollection 2014.

Related Links

MeSH Terms

Conditions

Cigarette SmokingSmoking Cessation

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorTobacco UseHealth Behavior

Study Officials

  • Alicia K Matthews, Ph.D.

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 30, 2012

First Posted

July 4, 2012

Study Start

May 1, 2012

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

May 4, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations