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Physical Activity in Promoting Smoking Cessation in African Americans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01915810
Recruitment Status : Active, not recruiting
First Posted : August 5, 2013
Last Update Posted : June 25, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Current Smoker Healthy Subject Behavioral: Exercise Intervention Other: Laboratory Biomarker Analysis Drug: Nicotine Patch Other: Questionnaire Administration Other: Tobacco Cessation Counseling Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Using Physical Activity to Facilitate Smoking Cessation Among African American Adults
Actual Study Start Date : January 29, 2014
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 31, 2021


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.
Behavioral: Exercise Intervention
Complete SCwPA intervention

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Nicotine Patch
Receive nicotine patch
Other Names:
  • NicoDerm CQ
  • Nicotine Skin Patch
  • Nicotine Transdermal Patch

Other: Questionnaire Administration
Ancillary studies

Other: Tobacco Cessation Counseling
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.
Behavioral: Exercise Intervention
Complete SCwPA intervention

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Nicotine Patch
Receive nicotine patch
Other Names:
  • NicoDerm CQ
  • Nicotine Skin Patch
  • Nicotine Transdermal Patch

Other: Questionnaire Administration
Ancillary studies

Other: Tobacco Cessation Counseling
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.
Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Nicotine Patch
Receive nicotine patch
Other Names:
  • NicoDerm CQ
  • Nicotine Skin Patch
  • Nicotine Transdermal Patch

Other: Questionnaire Administration
Ancillary studies

Other: Tobacco Cessation Counseling
Receive smoking cessation counseling




Primary Outcome Measures :
  1. Recruitment feasibility, defined as >= 75% of eligible/screened participants choose to enroll in the study [ Time Frame: Up to 8 weeks ]
  2. 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 ]
  3. Post intervention focus group analysis [ Time Frame: Up to 8 weeks ]
    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.


Secondary Outcome Measures :
  1. 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 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01915810


Locations
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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Lorna McNeill M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01915810    
Other Study ID Numbers: 2013-0183
NCI-2015-01057 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2013-0183 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: August 5, 2013    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action