Current SmokerNCT01915810
Physical Activity in Promoting Smoking Cessation in African Americans
A study testing Exercise Intervention, Laboratory Biomarker Analysis and Nicotine Patch in people with Current Smoker and Healthy Subject, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Current Smoker, Healthy Subject
- What is being tested?
- Exercise Intervention, Laboratory Biomarker Analysis and Nicotine Patch
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2014to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Using Physical Activity to Facilitate Smoking Cessation Among African American Adults
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Current Smoker, Healthy Subject
- Being tested
- Exercise Intervention, Laboratory Biomarker Analysis, Nicotine Patch, Questionnaire Administration, Tobacco Cessation Counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
Complete SCwPA intervention
Laboratory Biomarker AnalysisOther
Correlative studies
Nicotine PatchDrug
Also called NicoDerm CQ, Nicotine Skin Patch, Nicotine Transdermal Patch
Receive nicotine patch
Questionnaire AdministrationOther
Ancillary studies
Tobacco Cessation CounselingOther
Receive smoking cessation counseling
| Study group | Role | What they receive |
|---|---|---|
| Arm I (pre-quit physical activity) | Experimental | 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. Receives: Behavioral: Exercise Intervention; Other: Laboratory Biomarker Analysis; Drug: Nicotine Patch; Other: Questionnaire Administration; Other: Tobacco Cessation Counseling |
| Arm II (quit day physical activity) | Experimental | 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. Receives: Behavioral: Exercise Intervention; Other: Laboratory Biomarker Analysis; Drug: Nicotine Patch; Other: Questionnaire Administration; Other: Tobacco Cessation Counseling |
| Arm III (no physical activity) | Active comparator | 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. Receives: Other: Laboratory Biomarker Analysis; Drug: Nicotine Patch; Other: Questionnaire Administration; Other: Tobacco Cessation Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment feasibility, defined as >= 75% of eligible/screened participants choose to enroll in the study
Measured: 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)
Measured: Up to 8 weeks
Post intervention focus group analysis
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.
Measured: Up to 8 weeks
Secondary outcomes (1)
Mechanisms underlying smoking cessation (e.g., stress, positive and negative affect, depression, smoking urges, self-efficacy, motivation, PA enjoyment, and heart rate variability)
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.
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study start29 Jan 2014
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Current SmokerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lorna McNeill, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01915810
- Sponsor's protocol ID
- 2013-0183
- Other IDs
- NCI-2015-01057, 2013-0183
- Status last verified
- Jul 2026
- First submitted
- 1 Aug 2013
- Last updated
- 16 Jul 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Physical Activity to Facilitate Smoking Cessation Among African American Adults
- ClinicalTrials.gov ID
- NCT01915810
- Acronym / sponsor ID
- 2013-0183
- Conditions
- Current Smoker, Healthy Subject
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 29 Jan 2014 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 5 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I (pre-quit physical activity) | Experimental | Behavioral: Exercise Intervention, Other: Laboratory Biomarker Analysis, Drug: Nicotine Patch, Other: Questionnaire Administration, Other: Tobacco Cessation CounselingParticipants 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) | Experimental | Behavioral: Exercise Intervention, Other: Laboratory Biomarker Analysis, Drug: Nicotine Patch, Other: Questionnaire Administration, Other: Tobacco Cessation CounselingParticipants 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) | Active comparator | Other: Laboratory Biomarker Analysis, Drug: Nicotine Patch, Other: Questionnaire Administration, Other: Tobacco Cessation CounselingParticipants 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise InterventionComplete SCwPA intervention | Behavioural | Arm I (pre-quit physical activity), Arm II (quit day physical activity) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm I (pre-quit physical activity), Arm II (quit day physical activity), Arm III (no physical activity) |
| Nicotine PatchAlso: NicoDerm CQ, Nicotine Skin Patch, Nicotine Transdermal PatchReceive nicotine patch | Drug | Arm I (pre-quit physical activity), Arm II (quit day physical activity), Arm III (no physical activity) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (pre-quit physical activity), Arm II (quit day physical activity), Arm III (no physical activity) |
| Tobacco Cessation CounselingReceive smoking cessation counseling | Other | Arm I (pre-quit physical activity), Arm II (quit day physical activity), Arm III (no physical activity) |
Primary outcome
Recruitment feasibility, defined as >= 75% of eligible/screened participants choose to enroll in the study
Time frame: 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)
Time frame: Up to 8 weeks
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorna McNeill principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention, Laboratory Biomarker Analysis and Nicotine Patch in people with Current Smoker and Healthy Subject, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment feasibility, defined as >= 75% of eligible/screened participants choose to enroll in the study (time frame: Up to 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.