Curbing Tobacco Use in Suburban and Rural Schools

Tobacco Use Cessation Clinical Trial

Official title:

Curbing Tobacco Use in Suburban and Rural Schools

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00513097
• Other study ID #: 2005-0914
• Secondary ID: NCI-2011-028262R
• Status: Completed
• Phase: Phase 1
• First received: August 6, 2007
• Last updated: October 31, 2017
• Start date: July 25, 2006
• Est. completion date: October 18, 2017

Study information

• Verified date: October 2017
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1289
• Est. completion date: October 18, 2017
• Est. primary completion date: October 18, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Use Cessation

Intervention

Behavioral:
• Smoking Prevention Program
Interactive internet, computer-based activities (like games) with questions about thoughts on smoking and tobacco.
• Focus Group
A total of 24 focus groups will be held relating to the topics of smoking prevention and cessation.
• Survey
On-line evaluations and questionnaires

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reductions in smoking initiation		Baseline, 6-month, 12-month, and 18-month
Secondary	Smoking cessation		Baseline, 6-month, 12-month, and 18-month

External Links

•   University of Texas MD Anderson Cancer Center Website