Increasing Physical Activity as Part of a Smoking Cessation Program

June 30, 2008 updated by: National Heart, Lung, and Blood Institute (NHLBI)

Increasing Physical Activity to Aid Smoking Cessation

Cigarette smoking is the most common risk factor for lung cancer, and it increases the risk of developing other cancers, chronic lung disease, and heart disease. A smoking cessation program that incorporates physical activity may be beneficial in improving long-term smoking cessation rates. This study will evaluate the effectiveness of a community-based physical activity program, in combination with nicotine replacement therapy and a behavioral smoking cessation program, at improving cessation rates among sedentary smokers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Tobacco use is the single most preventable cause of death in the United States, with cigarette smoking accounting for nearly one-third of all cancer deaths each year. While a number of inexpensive and effective smoking cessation methods exist, including the nicotine patch and nicotine gum, smoking rates have not declined in the past few years. Individuals who engage in regular exercise, in addition to participating in a smoking cessation program, are often successful at quitting smoking and reducing post-cessation weight gain. However, past studies on this topic have consisted of highly structured, supervised physical activity, which made study recruitment and long-term adherence difficult. Additionally, these studies generally have had low long-term quit rates, which may be attributed to the lack of a nicotine replacement component. The purpose of this study is to evaluate the effectiveness of a community-based physical activity intervention, in combination with a behavioral smoking cessation program and nicotine replacement, at increasing smoking cessation rates among sedentary adult smokers.

This 7-week study will enroll sedentary or minimally active cigarette smokers. All participants will take part in a behavioral smoking cessation program and will wear a nicotine patch. In addition, they will be randomly assigned to take part in either a community-based physical activity intervention or a wellness control group intervention. All participants will attend sixteen 60- to 90-minute face-to-face counseling sessions and twelve 20-minute telephone counseling sessions. They will also receive twelve informational mailings. Participants in the physical activity intervention will focus on increasing physical activity; the general wellness control group will receive information on general health topics. Outcome measures, including smoking status, physical activity levels, and body mass index, will be assessed at the end of the intervention and at 6- and 12-month follow-up visits.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38152
        • University of Memphis Center for Community Health
      • Memphis, Tennessee, United States
        • Department of Preventive Medicine, University of Tennessee Health Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Smokes five or more cigarettes each day in the year prior to study entry
  • Sedentary or minimally active physical activity level
  • Willing to be randomly assigned to either intervention group
  • Willing to use the nicotine patch

Exclusion Criteria:

  • Pregnant, breastfeeding, or planning to become pregnant in the year following study entry
  • Planning to move out of the area in the year following study entry
  • Blood pressure greater than 160/95 mm Hg
  • Body weight greater than 140% of ideal body weight
  • History of heart attack, stroke, unstable angina, coronary artery bypass grafting, angioplasty, or stent in the 6 months prior to study entry
  • Symptomatic peripheral artery disease
  • History of congestive heart failure (New York Heart Association [NYHA] Class III or IV)
  • Electrocardiogram (EKG) evidence of 2nd or 3rd degree atrioventricular (AV) block
  • History of a serious illness that might limit longevity (e.g., significant kidney disease, liver disease, cancer)
  • Current substance abuse
  • Current alcohol use of more than 21 drinks per week
  • Uncontrolled arrhythmia or hyperthyroidism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Smoking status (measured immediately post-intervention and at 6- and 12-month follow-up visits)

Secondary Outcome Measures

Outcome Measure
Changes in self-reported and objective physical activity
Body mass index
Percentage of body fat
Waist circumference (all measured immediately post-intervention and at 6- and 12-month follow-up visits)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Kenneth D. Ward, PhD, University of Memphis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Study Registration Dates

First Submitted

November 22, 2006

First Submitted That Met QC Criteria

November 22, 2006

First Posted (ESTIMATE)

November 23, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

July 2, 2008

Last Update Submitted That Met QC Criteria

June 30, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 381
  • R01HL068569 (NIH)

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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