Viewing Study NCT00403312



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Study NCT ID: NCT00403312
Status: COMPLETED
Last Update Posted: 2008-07-02
First Post: 2006-11-22

Brief Title: Increasing Physical Activity as Part of a Smoking Cessation Program
Sponsor: National Heart Lung and Blood Institute NHLBI
Organization: National Heart Lung and Blood Institute NHLBI

Study Overview

Official Title: Increasing Physical Activity to Aid Smoking Cessation
Status: COMPLETED
Status Verified Date: 2008-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R01HL068569 NIH None httpsreporternihgovquickSearchR01HL068569