Clinical trial NCT01915810: Physical Activity in Promoting Smoking Cessation in African Americans
Official title: Using Physical Activity to Facilitate Smoking Cessation Among African American Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Current Smoker
Healthy Subject
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-08-05
Enrollment: 45
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment feasibility, defined as >= 75% of eligible/screened participants choose to enroll in the study
timeFrame: Up to 8 weeks
measure: 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)
timeFrame: Up to 8 weeks
measure: Post intervention focus group analysis
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: Mechanisms underlying smoking cessation (e.g., stress, positive and negative affect, depression, smoking urges, self-efficacy, motivation, PA enjoyment, and heart rate variability)
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Lorna McNeill
role: PRINCIPAL_INVESTIGATOR
References: