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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01242657
Other study ID # CDCU48/CCU310821
Secondary ID
Status Completed
Phase N/A
First received November 11, 2010
Last updated October 31, 2017
Start date October 2006
Est. completion date March 2009

Study information

Verified date October 2017
Source West Virginia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The long term goal of the study entitled "Quit & Fit" was to revise, evaluate, and disseminate the American Lung Association´s (ALA) teen smoking cessation program called Not On Tobacco (N—O—T), with an added physical activity module. The physical activity module was intended to encourage youth to adopt a more physically active lifestyle. Research showed that physical activity may increase the odds of smoking cessation. The general N—O—T program goals are to help adolescents quit smoking; reduce cigarette use (for participants who are unable to completely quit); increase healthy lifestyle behaviors; and improve life skills such as stress management, decision making, communication, and interpersonal skills. The primary aim of the current research project was to reduce smoking among West Virginia teens. A two—prong secondary aim was to (a) increase participants´ physical activity behavior by supplementing the intervention with a physical activity component and (b) assess the mediating/moderating impact of physical activity on cessation outcomes. If participants quit smoking, the likelihood that they will develop smoking—related diseases is diminished. Participating in this project may aid smoking cessation and therefore improve participants´ health. Research was conducted among 19 of the 123 West Virginia public high schools. 236 teens were recruited to participate in the study over 3 years. This study is a clinical behavioral trial using a 3-group design, with subsequent random assignment.


Recruitment information / eligibility

Status Completed
Enrollment 236
Est. completion date March 2009
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender All
Age group 14 Years to 18 Years
Eligibility Inclusion Criteria:

- Subjects will be eligible to participate in this study if they:

1. Volunteer to participate

2. Are between the ages of 14—18

3. Obtain written parental consent•

4. Provide written assent

5. Report smoking on at least 1 day in the past 30 days

6. Speak and understand English •NOTE: Teens ages 18 or older will provide consent rather than assent. Parental consent will not be required.

Exclusion Criteria:

- WV high schools will be excluded from participating in the research study if school enrollment does not meet or exceed 300 students in grades 9-12.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Physical Activity Module
Participants were provided pedometers in order to track specific "Step Goals", which were defined for male or female participants. In addition, each participant recorded other forms of physical activity in a "Challenge Log".
Not On Tobacco (N-O-T) Program
Not On Tobacco (N-O-T) Program, a proven teen smoking cessation program

Locations

Country Name City State
United States West Virginia University Morgantown West Virginia

Sponsors (2)

Lead Sponsor Collaborator
West Virginia University Penn State University

Country where clinical trial is conducted

United States, 

References & Publications (3)

Branstetter SA, Horn K, Dino G, Zhang J. Beyond quitting: predictors of teen smoking cessation, reduction and acceleration following a school-based intervention. Drug Alcohol Depend. 2009 Jan 1;99(1-3):160-8. doi: 10.1016/j.drugalcdep.2008.07.011. Epub 2008 Sep 19. — View Citation

Dino G, Horn K, Abdulkadri A, Kalsekar I, Branstetter S. Cost-effectiveness analysis of the Not On Tobacco program for adolescent smoking cessation. Prev Sci. 2008 Mar;9(1):38-46. doi: 10.1007/s11121-008-0082-0. Epub 2008 Feb 20. — View Citation

Dino G, Horn K, Goldcamp J, Fernandes A, Kalsekar I, Massey C. A 2-year efficacy study of Not On Tobacco in Florida: an overview of program successes in changing teen smoking behavior. Prev Med. 2001 Dec;33(6):600-5. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Smoking cessation: quit and reduction rates The primary aim of the current research project is to reduce smoking among West Virginia teens. 6 months
Secondary Participants´ physical activity behavior Increase participants´ physical activity behavior by supplementing the intervention with a physical activity component. 6 months
Secondary Impact of physical activity on cessation outcomes Assess the mediating/moderating impact of physical activity on cessation outcomes. 6 months
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