Physical Activity in Promoting Smoking Cessation in African Americans

Study Overview
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Brief Summary
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This randomized pilot clinical trial studies the use of physical activity in promoting the discontinuation of the habit of smoking (smoking cessation) in African Americans. Participating in physical activity during an actual smoking quit attempt may work better in helping African Americans stop smoking.

Detailed Description
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PRIMARY OBJECTIVES: I. Evaluate the feasibility of a Smoking Cessation with Physical Activity (SCwPA) intervention among an African American (AA) church-based sample of adult current smokers. II. Conduct post-intervention focus groups to obtain feedback from pilot participants regarding the acceptability of the SCwPA project design and procedures. III. Examine how physical activity (PA) and the timing of PA initiation affects the mechanisms underlying cessation among an AA church-based sample of adult daily smokers who are attempting to quit. OUTLINE: Participants are randomized to 1 of 3 arms. ARM I (PRE-QUIT PHYSICAL ACTIVITY): Participants receive telephone-based cessation counseling over 15-20 minutes 1-2 weeks before assigned quit date and nicotine patch for 6 weeks. Beginning 2 weeks before the assigned quit date, participants receive a Walking Program guide and engage in the SCwPA comprising brisk, self-paced walking with a goal of 150 minutes of exercise activity per week for 5 weeks. ARM II (QUIT DAY PHYSICAL ACTIVITY): Participants receive telephone-based cessation counseling over 15-20 minutes 1-2 weeks before assigned quit date and nicotine patch for 6 weeks. Beginning on the assigned quit date, participants receive a Walking Program guide and engage in the SCwPA comprising brisk, self-paced walking with a goal of 150 minutes of exercise per week for 5 weeks. ARM III (NO PHYSICAL ACTIVITY): Participants quit smoking on an assigned date and receive telephone-based cessation counseling over 15-20 minutes 1-2 weeks before assigned quit date and nicotine patch for 6 weeks.

Official Title
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Using Physical Activity to Facilitate Smoking Cessation Among African American Adults

Conditions
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Current Smoker, Healthy Subject

Intervention / Treatment
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* Behavioral: Exercise Intervention
* Other: Laboratory Biomarker Analysis
* Drug: Nicotine Patch
* Other: Questionnaire Administration
* Other: Tobacco Cessation Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-reported African-American race Current daily smoker (has smoked >= 100 cigarettes in lifetime per self-report, smoked >= 5 cigarettes per day for the last 6 months per self-report) Self-reports motivation to quit smoking within the next 2 weeks Reports willingness to engage in a physical activity-based smoking cessation intervention Has a home address and a functioning home and/or cell phone number Able to engage in moderate intensity physical activity as determined by the Physical Activity Readiness Questionnaire (PAR-Q) or by physicians clearance (letter from physician or nurse practitioner) if currently taking medication for blood pressure or diabetes Willingness to wear the nicotine patches provided in the study as recommended Have an expired carbon monoxide (CO) level > 8 parts per million (ppm) suggestive of current smoking Blood pressure =< 140/90mm or by physicians clearance (letter from physician or nurse practitioner) if blood pressure reading > 140/90mm Hg Exclusion Criteria: Contraindication for nicotine patch use Regular use of tobacco products other than cigarettes in the last 30 days (including black & milds) Current or planned future use of any nicotine replacement or pharmacological product for smoking cessation other than the study patches Pregnancy or lactation Another household member enrolled in the study A schedule not accommodating to the study procedures, or unwillingness to adhere to the procedures

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (pre-quit physical activity)<br>Participants receive telephone-based cessation counseling over 15-20 minutes 1-2 weeks before assigned quit date and nicotine patch for 6 weeks. Beginning 2 weeks before the assigned quit date, participants receive a Walking Program guide and engage in the SCwPA comprising brisk, self-paced walking with a goal of 150 minutes of exercise activity per week for 5 weeks. | Behavioral: Exercise Intervention<br>* Complete SCwPA intervention<br>Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Drug: Nicotine Patch<br>* Receive nicotine patch<br>* Other names: Nicotine Transdermal Patch;Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Tobacco Cessation Counseling<br>* Receive smoking cessation counseling<br>|
| Experimental: Arm II (quit day physical activity)<br>Participants receive telephone-based cessation counseling over 15-20 minutes 1-2 weeks before assigned quit date and nicotine patch for 6 weeks. Beginning on the assigned quit date, participants receive a Walking Program guide and engage in the SCwPA comprising brisk, self-paced walking with a goal of 150 minutes of exercise per week for 5 weeks. | Behavioral: Exercise Intervention<br>* Complete SCwPA intervention<br>Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Drug: Nicotine Patch<br>* Receive nicotine patch<br>* Other names: Nicotine Transdermal Patch;Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Tobacco Cessation Counseling<br>* Receive smoking cessation counseling<br>|
| Active Comparator: Arm III (no physical activity)<br>Participants quit smoking on an assigned date and receive telephone-based cessation counseling over 15-20 minutes 1-2 weeks before assigned quit date and nicotine patch for 6 weeks. | Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Drug: Nicotine Patch<br>* Receive nicotine patch<br>* Other names: Nicotine Transdermal Patch;Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Tobacco Cessation Counseling<br>* Receive smoking cessation counseling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment feasibility, defined as >= 75% of eligible/screened participants choose to enroll in the study |  | Up to 8 weeks | 
| Retention feasibility, defined as an overall retention rate of 80% and if each enrolled participant completes >= 66.7% of study visits (>= 6 of 9 study visits) |  | Up to 8 weeks | 
| Post intervention focus group analysis | Each focus group will use a semi-structured interview guide for consistency, which will consist of approximately 15 open-ended questions. If results do not suggest intervention feasibility, post-intervention focus groups will help to identify why feasibility was not achieved. Focus group transcripts will be imported into a qualitative data analysis software program, such as NVivo, to facilitate data retrieval and analysis and to organize data by themes based on phrases, patterns, relationships, and commonalties or disparities. | Up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanisms underlying smoking cessation (e.g., stress, positive and negative affect, depression, smoking urges, self-efficacy, motivation, PA enjoyment, and heart rate variability) | Validated questionnaires via associated scoring manuals or by convention in the literature will be scored. Descriptive statistics, including mean and variance estimates with 95% confidence intervals, relevant to each of the identified mechanism variables, for each intervention group will be generated. Group*time effects with regard to stress, positive and negative affect, depression, smoking urges, self-efficacy, motivation, and heart rate variability will be examined using repeated measure analyses of variance as the primary analysis technique. | Up to 8 weeks |