Smoking CessationNCT00403312
Increasing Physical Activity as Part of a Smoking Cessation Program
A study testing Smoking Cessation Behavioral Program, Nicotine Patch and Physical Activity in people with Smoking Cessation, run by National Heart, Lung, and Blood Institute (NHLBI) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Smoking Cessation Behavioral Program, Nicotine Patch and Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 400 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2003to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Memphis Center for Community Health
Memphis, Tennessee, 38152
Department of Preventive Medicine, University of Tennessee Health Science Center
Memphis, Tennessee
About this study
Official title: 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.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- Smoking Cessation Behavioral Program, Nicotine Patch, Physical Activity
- Keywords
- Physical Activity, Wellness Programs, Pharmacological Smoking Cessation
- Medical subject headings
- Smoking Cessation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking Cessation Behavioral ProgramBehavioural
Nicotine PatchDrug
Physical ActivityBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking status (measured immediately post-intervention and at 6- and 12-month follow-up visits)
Secondary outcomes (4)
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2006 (estimated)
- Study startJan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Kenneth D. Ward, PhD, Principal investigator, University of Memphis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00403312
- Sponsor's protocol ID
- 381
- Other IDs
- R01HL068569
- Status last verified
- Jun 2008
- First submitted
- 22 Nov 2006
- Last updated
- 2 Jul 2008
- Results posted
- No
Publications
Stockton MB, Ward KD, McClanahan BS, Vander Weg MW, Coday M, Wilson N, Relyea G, Read MC, Connelly S, Johnson KC. The Efficacy of Individualized, Community-Based Physical Activity to Aid Smoking Cessation: A Randomized Controlled Trial. J Smok Cessat. 2023 May 26;2023:5535832. doi: 10.1155/2023/5535832. eCollection 2023.
PubMed 37273658
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Physical Activity to Aid Smoking Cessation
- ClinicalTrials.gov ID
- NCT00403312
- Acronym / sponsor ID
- 381
- Conditions
- Smoking Cessation
- Keywords
- Physical Activity, Wellness Programs, Pharmacological Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jan 2003
- First posted
- 23 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking Cessation Behavioral Program | Behavioural | – |
| Nicotine Patch | Drug | – |
| Physical Activity | Behavioural | – |
Primary outcome
Smoking status (measured immediately post-intervention and at 6- and 12-month follow-up visits)
4 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2008.
- Derived from this study: PubMed 37273658Stockton MB, Ward KD, McClanahan BS, Vander Weg MW, Coday M, Wilson N, Relyea G, Read MC, Connelly S, Johnson KC. The Efficacy of Individualized, Community-Based Physical Activity to Aid Smoking Cessation: A Randomized Controlled Trial. J Smok Cessat. 2023 May 26;2023:5535832. doi: 10.1155/2023/5535832. eCollection 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth D. Ward, PhD principal investigator
University of Memphis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking Cessation Behavioral Program, Nicotine Patch and Physical Activity in people with Smoking Cessation, run by National Heart, Lung, and Blood Institute (NHLBI) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking status (measured immediately post-intervention and at 6- and 12-month follow-up visits). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00403312, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2008.