Physical Activity in Promoting Smoking Cessation in African Americans

NCT ID: NCT01915810

Last Updated: 2026-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-29

Study Completion Date

2027-01-31

Brief Summary

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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

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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.

Conditions

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Current Smoker Healthy Subject

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Exercise Intervention

Intervention Type BEHAVIORAL

Complete SCwPA intervention

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Nicotine Patch

Intervention Type DRUG

Receive nicotine patch

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Tobacco Cessation Counseling

Intervention Type OTHER

Receive smoking cessation counseling

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.

Group Type EXPERIMENTAL

Exercise Intervention

Intervention Type BEHAVIORAL

Complete SCwPA intervention

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Nicotine Patch

Intervention Type DRUG

Receive nicotine patch

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Tobacco Cessation Counseling

Intervention Type OTHER

Receive smoking cessation counseling

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.

Group Type ACTIVE_COMPARATOR

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Nicotine Patch

Intervention Type DRUG

Receive nicotine patch

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Tobacco Cessation Counseling

Intervention Type OTHER

Receive smoking cessation counseling

Interventions

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Exercise Intervention

Complete SCwPA intervention

Intervention Type BEHAVIORAL

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Nicotine Patch

Receive nicotine patch

Intervention Type DRUG

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Tobacco Cessation Counseling

Receive smoking cessation counseling

Intervention Type OTHER

Other Intervention Names

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NicoDerm CQ Nicotine Skin Patch Nicotine Transdermal Patch

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lorna McNeill

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

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NCI-2015-01057

Identifier Type: REGISTRY

Identifier Source: secondary_id

2013-0183

Identifier Type: OTHER

Identifier Source: secondary_id

2013-0183

Identifier Type: -

Identifier Source: org_study_id

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