Quit Smoking With Nicotine Patch and Exercise/Health Education (Females Only)

Study Overview
=================
Brief Summary
-----------------
This research study is for FEMALE cigarette smokers who want to quit smoking. Participants will be provided with brief quit-smoking education at the beginning of the study and will receive the nicotine patch for 10 weeks, free of charge. Participants will be assigned to either an exercise program or a general health education program. The exercise and health education programs will take place over 14 weeks, with follow-up appointments 3, 6, and 12 months after the end of the 14-week program. There is no fee for any part of this study and participants will be compensated for their time.

Detailed Description
-----------------
Participants must complete telephone screening process first. All eligible participants must attend an orientation session when the investigators will explain the study in detail. After this session, interested participants will complete a consent form and the investigators will collect blood pressure, resting heart rate, body mass index (height/weight), and a carbon monoxide sample to confirm eligibility. The investigators will then explain the physician consent process (all eligible and interested participants must obtain consent from a physician or clinic that they have seen in the past year to confirm that it is safe for them to participate).

Official Title
-----------------
Efficacy of Brisk Walking as a Smoking Cessation Treatment Adjunct Among Women

Conditions
-----------------
Cigarette Smoking

Intervention / Treatment
-----------------
* Behavioral: Moderate intensity exercise
* Behavioral: Health education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current smoker Exclusion Criteria: Ineligible after telephone screen. Each participant's personal physician/clinic determines it is unsafe to participate.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Moderate intensity exercise<br>Brisk walk on treadmill for 56 minutes 3x per week. | Behavioral: Moderate intensity exercise<br>* Brisk walking on a treadmill for 56 minutes 3x per week.<br>|
| Active Comparator: Health education<br>Attend health education sessions 3x per week. | Behavioral: Health education<br>* Videos<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking Cessation | Verified by saliva cotinine | 7-Day Point Prevalence at 3, 6, 9 and 1-year follow-ups | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive and Affective Mechanisms of Treatment | E-diary use will collect daily cognitive and affective data from each participant in order to reveal mechanisms of treatment outcomes. | Daily assessments completed throughout the day at random and scheduled times from baseline to 3 months |