Curbing Tobacco Use in Suburban and Rural Schools

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00513097
Recruitment Status : Completed
First Posted : August 8, 2007
Last Update Posted : November 6, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Tobacco Use Cessation Behavioral: Smoking Prevention Program Behavioral: Focus Group Behavioral: Survey Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1289 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Curbing Tobacco Use in Suburban and Rural Schools
Actual Study Start Date : July 25, 2006
Actual Primary Completion Date : October 18, 2017
Actual Study Completion Date : October 18, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: Smoking Prevention & Cessation Program Behavioral: Smoking Prevention Program
Interactive internet, computer-based activities (like games) with questions about thoughts on smoking and tobacco.

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

Behavioral: Survey
On-line evaluations and questionnaires

Primary Outcome Measures :
  1. Reductions in smoking initiation [ Time Frame: Baseline, 6-month, 12-month, and 18-month ]

Secondary Outcome Measures :
  1. Smoking cessation [ Time Frame: Baseline, 6-month, 12-month, and 18-month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00513097

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Alex Prokhorov, MD, PhD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00513097     History of Changes
Other Study ID Numbers: 2005-0914
NCI-2011-02826 ( Registry Identifier: NCI CTRP )
2R01CA081934-05A1 ( U.S. NIH Grant/Contract )
First Posted: August 8, 2007    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017

Keywords provided by M.D. Anderson Cancer Center:
Cancer Prevention
Smoking Cessation
Smoking Prevention
Focus Groups