Community-Centered eHealth Smoking Cessation Intervention Based on the "Smoking Rationalization Beliefs" Framework for Chinese Male Smokers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Biochemically verified continuous smoking abstinence at 3 month
研究概览
简要总结
Recent findings regarding why Chinese male smokers are reluctant to quit have offered insight for a possible new solution. Consistent with the Cognitive Dissonance Theory, "smoking rationalization beliefs" are a set of beliefs by smokers to rationalize their smoking behavior and avoid quitting. These beliefs have been well studied by global researchers, and a "smoking rationalization beliefs" scale was recently developed and validated for Chinese male smokers. The six dimensions of these beliefs are: smoking functional beliefs, risk generalization beliefs, social acceptability beliefs, safe smoking beliefs, self-exempting beliefs, and quitting is harmful beliefs. Studies on smoking rationalization in China have primarily been observational. Investigators propose to develop a Community-Centered eHealth Smoking Cessation Intervention (CCeSCI). The trinity of CCeSCI are the triangular unity of "smoking rationalization beliefs" framework, the non-physician community workers, and the eHealth technologies. The latter two were previously proven effective in interventional studies (including three conducted by the PI) but not yet widely used in smoking cessation. With the adoption of smoking rationalization beliefs framework aiming to address the cognitive causes of phycological addition to smoking and supported by the community-based behavioral interventions and the use of eHealth, CCeSCI is designed to overcome previous challenges with the principles of people-centeredness, convenience, and personalization.
详细描述
Investigators will firstly evaluate the feasibility of CCeSCI. Once CCeSCI is ready to deploy, investigators will recruit 60 smokers (male, 25-64 years old) in two communities in Qingpu to conduct a pilot non-blinded randomized controlled trial. They will be randomized in a 1:1 ratio into either the intervention group to receive CCeSCI or the control group to receive the traditional "smoking is harmful" education video. Investigators will also use qualitative research methods (one on one interviews) to conduct process evaluations at 4th, 8th, and 12th weeks according to the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework. At the end of the 12th week after the participants joined the RCT, saliva samples will be collected by community workers and quitting outcomes will be biochemically verified by a third party lab.
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
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male, current cigarette smokers who are willing to quit
- •Citizens who currently reside in Qingpu District, Shanghai, China
- •Smoking index greater than or equal to 100 (smoking index = average number of cigarettes smoked per day × years of smoking)
- •Able to understand mandarin Chinese
- •Willing to provide informed consent to participate in the study
排除标准
- •Ever or currently on pharmacologic treatments, including various forms of NRT formulations such as gum, transdermal patch, nasal spray, oral inhaler, lozenge, Bupropion, Varenicline and newly emerged precision medicine
- •Currently participating in other individual-based cessation program(s), such as psychological counseling, behavioral therapy etc.
- •Currently under treatment of life-threatening medical conditions or critically ill
- •Unable to make commitment of a consecutive 4-hour video viewing
- •Plan to move out of the community in the next 3 month
研究组 & 干预措施
Traditional "smoking is harmful" education group
The control group to receive the traditional "smoking is harmful" education.
干预措施: Traditional "smoking is harmful" education (Other)
Community-Centered eHealth Smoking Cessation Intervention (CCeSCI) group
The intervention group will receive Community-Centered eHealth Smoking Cessation Intervention(CCeSCI).
干预措施: Community-Centered eHealth Smoking Cessation Intervention (CCeSCI) (Other)
结局指标
主要结局
Biochemically verified continuous smoking abstinence at 3 month
时间窗: 3 month
Investigators will use cotinine to measure the smoking abstinence. Cotinine is a good biomarker for nicotine with a longer half-life (16-18h), and lab test for saliva is highly sensitive, convenient, and cost-effective. measured by cotinine saliva tests (\<10ng•mL-1)
次要结局
- Fagerstrom Test For Nicotine Dependence (FTND) Score(Change from baseline to 3-month follow up)
- Smoking Rationalization Scale(Change from baseline to 3-month follow up)
- Patient Health Questionnaire-9(Change from baseline to 3-month follow up)
- Self-reported 7-day point smoking status(3-month follow up)
- Self-reported continuous abstinence at 3 month(3-month follow up)
- Self-reported average number of cigarettes(Change from baseline to 3-month follow up)
- Questionnaire about community health workers' Knowledge, Attitude and Practices (KAP)(3-month follow up)
- Weight in kilograms(Change from baseline to 3-month follow up)
- Blood Pressure(Change from baseline to 3-month follow up)
- Waist Circumference(Change from baseline to 3-month follow up)