Curbing Tobacco Use in Suburban and Rural Schools

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00513097
First received: August 6, 2007
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Epidemiology
Behavioral: Smoking Prevention Program
Behavioral: Focus Group
Behavioral: Survey
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Curbing Tobacco Use in Suburban and Rural Schools

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Reductions in smoking initiation [ Time Frame: Baseline, 6-month, 12-month, and 18-month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Smoking cessation [ Time Frame: Baseline, 6-month, 12-month, and 18-month ] [ Designated as safety issue: No ]

Estimated Enrollment: 2384
Study Start Date: July 2006
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   14 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00513097

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Alex Prokhorov, MD, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00513097     History of Changes
Other Study ID Numbers: 2005-0914
Study First Received: August 6, 2007
Last Updated: January 30, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 16, 2014