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Active, Not Recruiting

NCT Number: NCT01915810

Physical Activity in Promoting Smoking Cessation in African Americans

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Intervention

Behavioral

Complete SCwPA intervention

laboratory biomarker analysis

Other

Correlative studies

Nicotine patch

Drug

Receive nicotine patch

Other names: NicoDerm CQ, Nicotine Skin Patch, Nicotine Transdermal Patch

Questionnaire Administration

Other

Ancillary studies

Tobacco Cessation Counseling

Other

Receive smoking cessation counseling

Primary outcomes

  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 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)

    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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Using Physical Activity to Facilitate Smoking Cessation Among African American Adults

Important dates

Study start
2014
Primary completion
2027
Study completion
2027
First posted
Aug 5, 2013
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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