Physical Activity in Promoting Smoking Cessation in African Americans

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Healthy Subject; Current Smoker

Treatments: Other: Questionnaire Administration; Other: Laboratory Biomarker Analysis; Drug: Nicotine Patch; Behavioral: Exercise Intervention; Other: Tobacco Cessation Counseling

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01915810

NCI-2015-01057 (Registry Identifier)

2013-0183 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Arm I (pre-quit physical activity)

Experimental group

Description:

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.

Treatment:

Other: Tobacco Cessation Counseling

Behavioral: Exercise Intervention

Drug: Nicotine Patch

Other: Laboratory Biomarker Analysis

Other: Questionnaire Administration

Arm II (quit day physical activity)

Experimental group

Description:

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.

Treatment:

Other: Tobacco Cessation Counseling

Behavioral: Exercise Intervention

Drug: Nicotine Patch

Other: Laboratory Biomarker Analysis

Other: Questionnaire Administration

Arm III (no physical activity)

Active Comparator group

Description:

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.

Treatment:

Other: Tobacco Cessation Counseling

Drug: Nicotine Patch

Other: Laboratory Biomarker Analysis

Other: Questionnaire Administration