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临床试验/NCT00513097
NCT00513097已完成1 期

Curbing Tobacco Use in Suburban and Rural Schools

M.D. Anderson Cancer Center2 个研究点 分布在 1 个国家目标入组 1,289 人开始时间: 2006年7月25日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
1,289
试验地点
2
主要终点
Reductions in smoking initiation

研究概览

简要总结

Primary, secondary, and tertiary specific aims are to answer the following questions about interactive, Internet-based tobacco control intervention directed towards 10th-graders:

  1. Smoking Prevention (primary): Does the intervention result in a lower incidence of smoking initiation compared to standard care?
  2. Smoking Cessation (primary): Does the intervention result in higher rates of smoking cessation compared to standard care?
  3. Reduction of Spit Tobacco Use (secondary): Does the intervention have an impact on spit tobacco use compared to standard care?
  4. Stages of Change (tertiary): Does the intervention have an impact on progression through the stages of smoking and spit tobacco acquisition and cessation compared to standard care?
  5. Mediating Variables (tertiary): How are mediating variables associated with tobacco-use onset and cessation?
  6. Testing Predictors: Investigate established and recently elucidated predictors of susceptibility to smoking at baseline and 12-month follow-up.
  7. Develop/Validate Spit Tobacco Measures: Investigate predictors of susceptibility of spit tobacco use at baseline and 12-month follow-up
  8. Testing Measures Across Race/Ethnicity: Explore predictors of susceptibility to smoking at baseline and 12-month follow-up to determine whether predictors differ among White, African-American, and Hispanic students.

详细描述

The proposed study will test the effectiveness of the Internet-based cigarette smoking and spit tobacco (ST) prevention and cessation in-class curriculum for rural teens. Supplemented by "cyber-support" (chat room and bulletin board), the intervention program also will make use of a human social support environment (via trained school personnel, chat rooms, bulletin boards). The study will use a nested cohort design in which high schools are the unit of design, allocation, and analysis. Tenth-grade students (ages 14-16) within each intervention school will receive a 7-week interactive, Internet-based tobacco prevention and cessation curriculum. Using computerized surveys, study participants will be evaluated at baseline, 6-month, 12-month, and 18-month follow-ups. The study has been designed to permit analyses sensitive enough to detect differences for the two primary hypotheses: reductions in smoking initiation and smoking cessation. Trends in ST use after exposure to the intervention program will also be assessed. The design will also permit analysis of stage-of-change dynamics and mediators for both acquisition and cessation of both forms of tobacco.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
14 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Subjects aged 14-16 years of age (9th and 10th-graders) who speak, read and write English
  • Subjects are students from schools located in suburban and rural communities approximately 200 miles from Houston.
  • Subjects with approved parental consent

排除标准

  • Disruptive individuals who are not able to work with the program

研究组 & 干预措施

Smoking Prevention & Cessation Program

Experimental

干预措施: Smoking Prevention Program (Behavioral)

Smoking Prevention & Cessation Program

Experimental

干预措施: Focus Group (Behavioral)

Smoking Prevention & Cessation Program

Experimental

干预措施: Survey (Behavioral)

结局指标

主要结局

Reductions in smoking initiation

时间窗: Baseline, 6-month, 12-month, and 18-month

次要结局

  • Smoking cessation(Baseline, 6-month, 12-month, and 18-month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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