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临床试验/NCT04009590
NCT04009590已完成不适用

Quit4Health: Expanding the Reach of an Innovative Tobacco Control Program for Young Adults

M.D. Anderson Cancer Center2 个研究点 分布在 1 个国家目标入组 579 人开始时间: 2018年12月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
579
试验地点
2
主要终点
Abstinence from tobacco

研究概览

简要总结

This trial studies how well Quit4Health intervention works in supporting smoking cessation and preventing smoking initiation in young adults. Quit4Health intervention may help young adults learn more about the risks of tobacco use and may help them to quit smoking.

详细描述

PRIMARY OBJECTIVES:

I. To evaluate whether smokers randomized to Quit4Health are more likely to quit smoking and remain tobacco-free at 6 months than subjects randomized to the education only control group.

II. To evaluate whether non-smokers who are randomized to Quit4Health are less likely to initiate tobacco usage and remain tobacco-free at 6 months than non-smokers randomized to the education only control group.

SECONDARY OBJECTIVES:

I. To evaluate whether well-established predictors of susceptibility and barriers to cessation (e.g. self-efficacy, knowledge about associated risks, normative beliefs, attitudes, resistance skills, peer pressure) and recently identified predictors of tobacco use (e.g., depression, nicotine dependence, alcohol use, risk-taking propensity) will mediate the effect of the intervention on both onset (for non-smokers) and cessation (for smokers) of tobacco use.

研究设计

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

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Be enrolled in at least one class at Houston Community College (HCC) Central campus, West Loop campus or Spring Branch campus (cessation and prevention/advocacy groups)
  • Speak and read English (cessation and prevention/advocacy groups)
  • Own an Android or iOS smartphone (cessation and prevention/advocacy groups)
  • Provide current and relevant contact information (cessation and prevention/advocacy groups)
  • Smoked at least one cigarette (or more) in the past 30 days (cessation group)
  • Have data and wifi capabilities on their mobile device (cessation and prevention/advocacy groups)
  • Evidence of smoking susceptibility as defined by the Smoking Susceptibility Scale (prevention/advocacy groups)

排除标准

  • People who score 16 or above on the Center for Epidemiologic Studies Depression (CESD) thus showing evidence of major depressive disorder (cessation and prevention/advocacy groups)

结局指标

主要结局

Abstinence from tobacco

时间窗: At 6 months

Any abstinence is defined as "subjective reports of abstinence from tobacco for at least 24 hours or more in the past 30 days", the 7-day point prevalence of abstinence at follow-ups will be verified by measurement of saliva cotinine. The primary analysis will compare the abstinence rates at 6 months in the control and treatment group using a 2-sample test of proportion for all smokers. A secondary analysis will involve a simple post-test analysis among smokers using logistic regression.

Susceptibility to tobacco initiation

时间窗: At 6 months

Will assess susceptibility to smoking using the measure proposed by Pierce and colleagues. Will employ similar analytic methods as in primary objective 1 to evaluate the prevalence of susceptibility at the 6-month follow-up in subjects randomized to the experimental intervention condition with respect to subjects assigned to the control condition.

次要结局

  • Mediation effect of predictors of smoking and recently identified predictors of tobacco use(Up to 6 months)
  • Behavior modification(Up to 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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