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Completed

NCT Number: NCT00513097

Curbing Tobacco Use in Suburban and Rural Schools

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.

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Key information

Conditions

Tobacco Use Cessation Behavior Health Behavior Smoking Cessation

Age range

14 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Smoking Prevention Program

Behavioral

Interactive internet, computer-based activities (like games) with questions about thoughts on smoking and tobacco.

Focus Group

Behavioral

A total of 24 focus groups will be held relating to the topics of smoking prevention and cessation.

survey

Behavioral

On-line evaluations and questionnaires

Primary outcomes

  1. Reductions in smoking initiation

    Time frame: Baseline, 6-month, 12-month, and 18-month

Secondary outcomes

  1. Smoking cessation

    Time frame: Baseline, 6-month, 12-month, and 18-month

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2006
Primary completion
2017
Study completion
2017
First posted
Aug 8, 2007
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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