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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00513097
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Completed
Phase Phase 1
Start date July 25, 2006
Completion date October 18, 2017

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