Quit and Fit: Teen Smoking Cessation

Study Overview
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Brief Summary
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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.

Official Title
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Quit and Fit: Exploring the Effects of Physical Activity on Teen Smoking Cessation

Conditions
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Tobacco Use Cessation

Intervention / Treatment
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* Behavioral: Physical Activity Module
* Behavioral: Not On Tobacco (N-O-T) Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects will be eligible to participate in this study if they: Volunteer to participate Are between the ages of 14-18 Obtain written parental consent• Provide written assent Report smoking on at least 1 day in the past 30 days 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.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Brief Advice<br>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<br>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<br>* Not On Tobacco (N-O-T) Program, a proven teen smoking cessation program<br>|
| Experimental: Quit & Fit<br>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<br>* 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.<br>Behavioral: Not On Tobacco (N-O-T) Program<br>* Not On Tobacco (N-O-T) Program, a proven teen smoking cessation program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants´ physical activity behavior | Increase participants´ physical activity behavior by supplementing the intervention with a physical activity component. | 6 months | 
| Impact of physical activity on cessation outcomes | Assess the mediating/moderating impact of physical activity on cessation outcomes. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tobacco Use Cessation, Youth Tobacco Use, Physical Activity, Smoking Cessation Intervention