Development and Pilot Evaluation of the Path2Quit Tobacco Intervention Targeting African Americans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- Proportion of participants who abstain from smoking
研究概览
简要总结
The purpose of this research is to study a smoking cessation program for adult smokers in Northeast Ohio. The study will also look at how different people respond to the program.
The study includes completing surveys and receiving text messages to help participants become tobacco free.
详细描述
OBJECTIVES Specific Aim 1: Translate a culturally specific video-based tobacco use intervention into a scalable mobile health (mhealth) format.
Specific Aim 2: Conduct a pilot study of the video-text intervention.
Study Design:
2-arm semi-pragmatic randomized design among current tobacco users
Cuyahoga Metropolitan Housing Authority residents will be randomly assigned to receive (1) the newly translated Path2Quit or (2) SmokeFreeText (NCI's publicly available, standard text messaging program) combined with brief behavioral counseling session plus 2 weeks of nicotine replacement therapy (NRT). Primary outcomes will include intervention evaluations (content and format), acceptability, coping strategies, engagement, and NRT adherence. Secondary variables will include 24-hour quit attempts and biochemically verified tobacco use abstinence at the 1-month follow-up. Exploratory mediational analyses will examine the roles of urban hassles, acculturation, neighborhood environment, ethnic discrimination, and psychological distress in intervention effects.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Self-identify as African American
- •Either smoke at least 1 cigarettes/day or have a carbon monoxide (CO) reading of at least 4 ppm
- •Consistent with SmokefreeTXT, be willing to set a quit date within the next 14 days.
- •Recruited from Cleveland metropolitan housing authority or who report low income based on federal guidelines
排除标准
- •Does not meet all of the above inclusion criteria
研究组 & 干预措施
Path2Quit
Culturally specific text message intervention
干预措施: Path2Quit (Behavioral)
SmokeFreeText
The National Cancer Institute's publicly available, standard text messaging program for tobacco cessation
干预措施: SmokeFreeText (Behavioral)
结局指标
主要结局
Proportion of participants who abstain from smoking
时间窗: At 1-month follow-up
Abstinence will be coded as a binary variable. Analysis will be conducted with an intent to treat approach
次要结局
- 24-Hour quit attempts(At 1-month follow-up)
- Average score of smoking urges(Up to 1-month follow-up)
- Average score of Intervention Evaluation (IRQ)(At 1-month follow-up)
- Changes in carbon monoxide breath levels from baseline to followup(At 1-month follow-up)
- Number of missed nicotine replacement therapy doses(Up to 1-month follow-up)
- Changes in Contemplation ladder score(From baseline to up to 1-month follow-up)