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Curbing Tobacco Use in Suburban and Rural Schools

NCT ID: NCT00513097

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

1289 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-25

Study Completion Date

2017-10-18

Brief Summary

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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

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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.

Conditions

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Tobacco Use Cessation

Keywords

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Epidemiology Cancer Prevention Smoking Cessation Smoking Prevention Focus Groups

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Smoking Prevention & Cessation Program

Group Type EXPERIMENTAL

Smoking Prevention Program

Intervention Type BEHAVIORAL

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

Focus Group

Intervention Type BEHAVIORAL

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

Survey

Intervention Type BEHAVIORAL

On-line evaluations and questionnaires

Interventions

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Smoking Prevention Program

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

Intervention Type BEHAVIORAL

Focus Group

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

Intervention Type BEHAVIORAL

Survey

On-line evaluations and questionnaires

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alex Prokhorov, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

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NCI-2011-02826

Identifier Type: REGISTRY

Identifier Source: secondary_id

2R01CA081934-05A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2005-0914

Identifier Type: -

Identifier Source: org_study_id