Nonsmokers Helping Smokers Quit (Project BEST)
2020年2月11日 更新者:Shu-Hong Zhu、University of California, San Diego
Mail Campaigns That Target Smokers or Nonsmokers Who Live With Smokers
This study examines whether nonsmokers can be mobilized to help smokers quit.
We will test, via mail campaign, whether targeting nonsmokers can be equally effective in increasing smokers' quit rate as targeting smokers directly.
The hypothesis is that both targeted interventions will lead to a higher quit rate than a control group, which receives one set of self-help materials.
Each of the targeted intervention groups receives 10 mailings.
Smoking status of all three groups will be measured at 3 and 7 months post randomization.
研究概览
详细说明
This study examines the potential of enlisting nonsmokers to help smokers quit smoking.
Nonsmokers are the majority of the society.
If an intervention can be designed to mobilize nonsmokers to help smokers quit, then it has strong implications for increasing smoking cessation at the population level.
The conventional approach in smoking cessation is to target smokers directly.
This study aims to test whether targeting nonsmokers can be equally effective.
The study employs a three arm randomized design, in which a smoker-nonsmoker pair in the same household will be randomized into one of the three groups.
One group receives materials targeting the smoker in the household, one group receives materials targeting the nonsmoker, and the third group serve as a control group.
The intervention consists of mailed materials which include postcards, informational materials, CDs, DVDs, coupons for cessation-related incentives such as nicotine patches, and links to secured websites.
The mail campaign is augmented with brief phone calls to ensure receipt of mailings and to reinforce targeted messages.The mail campaign is augmented with brief phone calls to ensure receipt of mailings and to reinforce targeted messages.
At 3 and 7 months post randomization, project staff contact all participants to assess their smoking status.
研究类型
介入性
注册 (实际的)
3125
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
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California
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San Diego、California、美国、92111
- University of California San Diego
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 18 years or older
- A household with at least one smoker and one nonsmoker
- Valid contact information
- English proficiency, both speaking and reading
Exclusion Criteria:
- Insufficient contact information
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Messages targeting nonsmokers
Messages targeting nonsmokers include 10 mailings for nonsmokers sent over 10 weeks.
The mailed materials include postcards, informational materials, CDs, DVDs, coupons for cessation-related incentives such as nicotine patches, and links to secured websites.
The mail campaign is augmented with brief phone calls to ensure receipt of mailings and to reinforce targeted messages.
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|
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实验性的:Messages targeting smokers
Messages targeting smokers include 10 mailings for smokers sent over 10 weeks.
The mailed materials include postcards, informational materials, CDs, DVDs, coupons for cessation-related incentives such as nicotine patches, and links to secured websites.
The mail campaign is augmented with brief phone calls to ensure receipt of mailings and to reinforce targeted messages.
|
|
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无干预:Usual care
one time mailing with a self-help quit kit
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants Reporting 30-day Abstinence
大体时间:7-months post enrollment
|
Assessment interview is conducted over the phone at 7-months post enrollment to determine 30-day abstinence.
The interview will cover, as appropriate, tobacco use, use of quitting aids, and pattern of quitting (including slips and relapse situations).
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7-months post enrollment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Support for Quitting
大体时间:At intake
|
The number of participants who felt they had "a lot" of support for quitting or staying quit.
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At intake
|
|
Number of Participants Reporting 30-day Abstinence
大体时间:3-months post enrollment
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Assessment interview is conducted over the phone at 3-months post enrollment to determine 30-day abstinence.
The interview will cover, as appropriate, tobacco use, use of quitting aids, and pattern of quitting (including slips and relapse situations).
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3-months post enrollment
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Counseling
大体时间:7-months post enrollment
|
Did participants receive counseling
|
7-months post enrollment
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年12月1日
初级完成 (实际的)
2016年1月1日
研究完成 (实际的)
2016年1月1日
研究注册日期
首次提交
2013年12月2日
首先提交符合 QC 标准的
2013年12月9日
首次发布 (估计)
2013年12月13日
研究记录更新
最后更新发布 (实际的)
2020年2月13日
上次提交的符合 QC 标准的更新
2020年2月11日
最后验证
2020年2月1日
更多信息
与本研究相关的术语
其他研究编号
- UO1 CA154280 IRB #130764
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.