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临床试验/NCT01633567
NCT01633567已完成不适用

A Culturally Targeted and Individually Tailored Smoking Cessation Intervention for LGBT Smokers

University of Illinois at Chicago2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2012年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
400
试验地点
2
主要终点
7-Day Point Prevalence Smoking Quit Rates 6 Months Post Quit Date

研究概览

简要总结

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.

详细描述

In Phase 1 of this study we used focus groups to establish the cultural appropriateness and acceptability of the targeted elements of the intervention for the LGBT population. For Phase 2 of this study, we seek to enroll 400 participants in a randomized controlled trial of the targeted intervention vs. a non-targeted, comparison condition. Both conditions will consist of group counseling sessions combined with nicotine replacement therapy and peer support. We expect that quit rates, stage of readiness, perceived benefits, self-efficacy, and treatment adherence will be higher among those who received the targeted intervention than those in the non-targeted intervention. Furthermore, we expect that a stronger LGBT cultural identification and salience of that identity will be associated with more satisfaction and adherence to the targeted intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)
  • Relatively healthy, with no medical conditions that would adversely interact with study parameters (see exclusion criteria for specific details)
  • 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.

排除标准

  • 未提供

结局指标

主要结局

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

时间窗: Assessed 6 months after 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.

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

时间窗: Assessed 12 months after 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.

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

时间窗: Assessed 1 month after 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.

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

时间窗: Assessed 3 months after 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alicia Matthews

Associate Professor

University of Illinois at Chicago

研究点 (2)

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