- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01915810
Physical Activity in Promoting Smoking Cessation in African Americans
Using Physical Activity to Facilitate Smoking Cessation Among African American Adults
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77030
- M D Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Correlative studies
Ancillary studies
Receive nicotine patch
Other Names:
Complete SCwPA intervention
Receive smoking cessation counseling
|
Experimental: 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.
|
Correlative studies
Ancillary studies
Receive nicotine patch
Other Names:
Complete SCwPA intervention
Receive smoking cessation counseling
|
Active Comparator: 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.
|
Correlative studies
Ancillary studies
Receive nicotine patch
Other Names:
Receive smoking cessation counseling
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recruitment feasibility, defined as >= 75% of eligible/screened participants choose to enroll in the study
Time Frame: Up to 8 weeks
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Up to 8 weeks
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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)
Time Frame: Up to 8 weeks
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Up to 8 weeks
|
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Post intervention focus group analysis
Time Frame: Up to 8 weeks
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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.
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Up to 8 weeks
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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)
Time Frame: Up to 8 weeks
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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.
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Up to 8 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lorna McNeill, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-0183 (Other Identifier: M D Anderson Cancer Center)
- NCI-2015-01057 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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