NCT00513097

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. 1.Smoking Prevention (primary): Does the intervention result in a lower incidence of smoking initiation compared to standard care?
  2. 2.Smoking Cessation (primary): Does the intervention result in higher rates of smoking cessation compared to standard care?
  3. 3.Reduction of Spit Tobacco Use (secondary): Does the intervention have an impact on spit tobacco use compared to standard care?
  4. 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. 5.Mediating Variables (tertiary): How are mediating variables associated with tobacco-use onset and cessation?
  6. 6.Testing Predictors: Investigate established and recently elucidated predictors of susceptibility to smoking at baseline and 12-month follow-up.
  7. 7.Develop/Validate Spit Tobacco Measures: Investigate predictors of susceptibility of spit tobacco use at baseline and 12-month follow-up
  8. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,289

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2006

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 25, 2006

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 6, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2007

Completed
10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2017

Completed
Last Updated

November 6, 2017

Status Verified

October 1, 2017

Enrollment Period

11.2 years

First QC Date

August 6, 2007

Last Update Submit

October 31, 2017

Conditions

Keywords

EpidemiologyCancer PreventionSmoking CessationSmoking PreventionFocus Groups

Outcome Measures

Primary Outcomes (1)

  • Reductions in smoking initiation

    Baseline, 6-month, 12-month, and 18-month

Secondary Outcomes (1)

  • Smoking cessation

    Baseline, 6-month, 12-month, and 18-month

Study Arms (1)

Smoking Prevention & Cessation Program

EXPERIMENTAL
Behavioral: Smoking Prevention ProgramBehavioral: Focus GroupBehavioral: Survey

Interventions

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

Smoking Prevention & Cessation Program
Focus GroupBEHAVIORAL

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

Smoking Prevention & Cessation Program
SurveyBEHAVIORAL

On-line evaluations and questionnaires

Smoking Prevention & Cessation Program

Eligibility Criteria

Age14 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Tobacco Use CessationSmoking Cessation

Interventions

Focus GroupsSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Alex Prokhorov, MD, PhD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2007

First Posted

August 8, 2007

Study Start

July 25, 2006

Primary Completion

October 18, 2017

Study Completion

October 18, 2017

Last Updated

November 6, 2017

Record last verified: 2017-10

Locations