Quit and Fit: Teen Smoking Cessation

This study has been completed.
Sponsor:
Collaborator:
Penn State University
Information provided by:
West Virginia University
ClinicalTrials.gov Identifier:
NCT01242657
First received: November 11, 2010
Last updated: December 9, 2010
Last verified: December 2010
  Purpose

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.


Condition Intervention
Tobacco Use Cessation
Behavioral: Physical Activity Module
Behavioral: Not On Tobacco (N-O-T) Program

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: Quit and Fit: Exploring the Effects of Physical Activity on Teen Smoking Cessation

Resource links provided by NLM:


Further study details as provided by West Virginia University:

Primary Outcome Measures:
  • Smoking cessation: quit and reduction rates [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The primary aim of the current research project is to reduce smoking among West Virginia teens.


Secondary Outcome Measures:
  • Participants´ physical activity behavior [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Increase participants´ physical activity behavior by supplementing the intervention with a physical activity component.

  • Impact of physical activity on cessation outcomes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Assess the mediating/moderating impact of physical activity on cessation outcomes.


Enrollment: 236
Study Start Date: October 2006
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Brief Advice
Standard of care arm with no intervention; includes standard communication regarding youth tobacco cessation such as a brief discussion and printed materials
Active Comparator: Not On Tobacco (N-O-T) Program
Teens randomized to this arm participated in the N-O-T program, a proven teen cessation program.
Behavioral: Not On Tobacco (N-O-T) Program
Not On Tobacco (N-O-T) Program, a proven teen smoking cessation program
Experimental: Quit & Fit
Teens randomized to this arm participated in the Not On Tobacco (N-O-T) program with an added physical activity module.
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".
Behavioral: Not On Tobacco (N-O-T) Program
Not On Tobacco (N-O-T) Program, a proven teen smoking cessation program

  Eligibility

Ages Eligible for Study:   14 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01242657

Locations
United States, West Virginia
West Virginia University
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
West Virginia University
Penn State University
Investigators
Principal Investigator: Kimberly Horn, EdD West Virginia University
Study Director: Melissa Taylor, MA West Virginia University
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kimberly Horn, EdD, West Virginia University Community Medicine
ClinicalTrials.gov Identifier: NCT01242657     History of Changes
Other Study ID Numbers: CDCU48/CCU310821
Study First Received: November 11, 2010
Last Updated: December 9, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by West Virginia University:
Tobacco Use Cessation
Youth Tobacco Use
Physical Activity
Smoking Cessation Intervention

Additional relevant MeSH terms:
Smoking
Tobacco Use Disorder
Habits
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014