Clinical trial NCT00513097: Curbing Tobacco Use in Suburban and Rural Schools
Official title: Curbing Tobacco Use in Suburban and Rural Schools
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tobacco Use Cessation
Keywords: Epidemiology
Cancer Prevention
Smoking Cessation
Smoking Prevention
Focus Groups
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-08-08
Enrollment: 1289
Sex: ALL
Minimum age (years): 14
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1) Disruptive individuals who are not able to work with the program

Primary outcomes:
measure: Reductions in smoking initiation
timeFrame: Baseline, 6-month, 12-month, and 18-month
Secondary outcomes:
measure: Smoking cessation
timeFrame: Baseline, 6-month, 12-month, and 18-month
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Alex Prokhorov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: