Increasing Physical Activity as Part of a Smoking Cessation Program

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00403312
First received: November 22, 2006
Last updated: June 30, 2008
Last verified: June 2008
  Purpose

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.


Condition Intervention
Smoking Cessation
Behavioral: Smoking Cessation Behavioral Program
Drug: Nicotine Patch
Behavioral: Physical Activity

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Increasing Physical Activity to Aid Smoking Cessation

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Smoking status (measured immediately post-intervention and at 6- and 12-month follow-up visits)

Secondary Outcome Measures:
  • 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)

Estimated Enrollment: 400
Study Start Date: January 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403312

Locations
United States, Tennessee
Department of Preventive Medicine, University of Tennessee Health Science Center
Memphis, Tennessee, United States
University of Memphis Center for Community Health
Memphis, Tennessee, United States, 38152
Sponsors and Collaborators
Investigators
Principal Investigator: Kenneth D. Ward, PhD University of Memphis
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00403312     History of Changes
Other Study ID Numbers: 381, R01 HL068569
Study First Received: November 22, 2006
Last Updated: June 30, 2008
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Physical Activity
Wellness Programs
Pharmacological Smoking Cessation

ClinicalTrials.gov processed this record on October 23, 2014