Clinical trial

Using Physical Activity to Facilitate Smoking Cessation Among African American Adults

Name
2013-0183
Description
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.
Trial arms
Trial start
2014-01-29
Estimated PCD
2026-01-31
Trial end
2027-01-31
Status
Active (not recruiting)
Treatment
Exercise Intervention
Complete SCwPA intervention
Arms:
Arm I (pre-quit physical activity), Arm II (quit day physical activity)
Laboratory Biomarker Analysis
Correlative studies
Arms:
Arm I (pre-quit physical activity), Arm II (quit day physical activity), Arm III (no physical activity)
Nicotine Patch
Receive nicotine patch
Arms:
Arm I (pre-quit physical activity), Arm II (quit day physical activity), Arm III (no physical activity)
Other names:
NicoDerm CQ, Nicotine Skin Patch, Nicotine Transdermal Patch
Questionnaire Administration
Ancillary studies
Arms:
Arm I (pre-quit physical activity), Arm II (quit day physical activity), Arm III (no physical activity)
Tobacco Cessation Counseling
Receive smoking cessation counseling
Arms:
Arm I (pre-quit physical activity), Arm II (quit day physical activity), Arm III (no physical activity)
Size
45
Primary endpoint
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
Up to 8 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 45, 'type': 'ESTIMATED'}}
Updated at
2024-03-20

1 organization

1 product

2 indications

Product
Nicotine
Indication
Smoking
Indication
Healthy Subject