SmokingPhase 2/3NCT01615380
Exercise to Enhance Smoking Cessation for Women at the YMCA
A Phase 2/3 study testing CBT+ Contact and CBT+ Exercise in people with Smoking, run by The Miriam Hospital at 1 site in United States.
Trial summary
Approximately 21% of women continue to smoke cigarettes despite the increased risk of cancer and cardiovascular disease associated with cigarette smoking. Exercise has been shown to be an efficacious treatment component in combating nicotine dependence, especially among women for whom concerns about weight gain during… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- CBT+ Contact and CBT+ Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Apr 2012
- Phase
- Phase 2/3
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy female smokers
- ages 18 - 65
- Read and write English
- Regularly smoke 5 or more cigarettes a day
- Sedentary, or not exercising greater than 20 minutes of vigorous exercise more than once a week or greater than 30 minutes of moderate exercise 2 times per week.
Who cannot join
- known history of cardiovascular
- pulmonary or metabolic disease such as coronary artery disease, stroke, hypertension, chronic bronchitis, asthma, emphysema, and diabetes
- Any musculoskeletal problems that would limit exercise training such as knee or hip osteoarthritis or any other serious medical condition that might make exercise unsafe or unwise.
- The current use of smokeless tobacco, nicotine replacement therapy or other smoking cessation treatment, and currently using prescription medication that might impair exercise performance or tolerance, specifically beta-blockers or medications used for the treatment of hypertension
- Pregnant or planning to become pregnant within the next 12 months.
- Women hospitalized for a psychiatric disorder
- Receiving treatment for bipolar disorder or schizophrenia
- Current alcohol abuse or psychological problems when quitting in the past that required treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using a YMCA Exercise Program to Enhance Nicotine Dependence Treatment for Women
Approximately 21% of women continue to smoke cigarettes despite the increased risk of cancer and cardiovascular disease associated with cigarette smoking. Exercise has been shown to be an efficacious treatment component in combating nicotine dependence, especially among women for whom concerns about weight gain during smoking cessation are an obstacle to successful quitting. In previous trials of women smokers, the investigators program of cognitive behavioral smoking cessation treatment (CBT) plus regular aerobic exercise was more efficacious than CBT plus equal contact time. Recognizing the program's successes, Commit to Quit (CTQ) was recently designated an Effective Program by the Substance Abuse and Mental Health Services Administration's (SAMHSA) National Registry of Effective Programs. Thus, the Commit to Quit program is well poised for a larger trial in a community setting where it has the potential to reach a large number of female smokers in a setting in which it can be sustained. In response to PA-03-126, Behavioral Therapies Development Program, the investigators propose a Stage III study in which they will conduct a trial to test the investigators CTQ smoking cessation program in the community setting of the local YMCAs. As stated in the PA, Stage III research is aimed at understanding if and how an efficacious therapy may be transported to the community. The investigators propose a randomized controlled clinical trial to take place in the YMCA setting and delivered by YMCA staff. The trial will compare CBT smoking cessation treatment plus a program of regular exercise to CBT smoking cessation treatment plus contact control. In order to promote transportability to the YMCA, the investigators will use the YMCA's existing Personal Fitness Program, which is similar to the investigators CTQ exercise program, in that it is guided by trained staff and requires participants to exercise 3 times per week. If the exercise condition is found to be more efficacious than contact control when delivered at the YMCA by YMCA staff, then the investigators will be well positioned to partner with the YMCA to pursue widespread, national dissemination of this program.
Read the detailed description
We propose a randomized controlled clinical trial to take place in the YMCA setting and to be delivered by YMCA staff. The trial will compare CBT smoking cessation treatment plus a program of regular exercise (CBT + EXERCISE) to CBT smoking cessation treatment plus an equal staff contact control (CBT + CONTACT). In order to promote transportability to the YMCA, the exercise program will be the YMCA's existing Personal Fitness Program, which like our CTQ exercise program, is guided by trained staff and requires participants to exercise at least 3 times per week.
If CBT + EXERCISE is found to be more efficacious than CBT + CONTACT when delivered at the YMCA by YMCA staff, then we will be well positioned to partner with the YMCA's initiative of Y Total Health to pursue widespread, national dissemination of this program. The proposed testing of the efficacy of the CTQ program in the YMCA setting is a necessary intermediate step in the eventual dissemination of the CTQ program.
Primary Aim. To determine the efficacy of CBT + EXERCISE compared with CBT + CONTACT when delivered in the YMCAs by YMCA staff to enhance the achievement and maintenance (3, 6, and 12 months follow-up) of smoking cessation (continuous abstinence) among healthy adult female smokers.
Hypothesis. Participants in the CBT + EXERCISE condition will have significantly greater continuous abstinence rates than those in the CBT + CONTACT condition at end-of-treatment, 3, 6, and 12 months follow-up.
Additional Questions of Interest.
- To perform process-to-outcome analyses on the intermediate variables which influence the achievement and maintenance of smoking cessation among healthy female smokers. Specifically, to determine if exercise affects weight and/or weight concerns, negative affect associated with nicotine withdrawal, and/or self-efficacy and to determine if these hypothesized mediators affect the achievement and maintenance of smoking cessation.
To explore potential moderators of the treatment, such as baseline demographic and psychological characteristics (e.g., age, baseline mood) on smoking cessation outcomes.
- Conditions
- Smoking
- Being tested
- CBT+ Contact, CBT+ Exercise
- Keywords
- smoking cessation, Aerobic Exercise, Women, YMCA
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT+ ContactBehavioural
In addition to the smoking cessation program, those in the CBT + CONTACT condition will enroll in a Wellness Program and will receive weekly wellness materials to read as well as receiving 4 sessions with a health educator in weeks 1, 4, 8 and 12 to discuss the wellness materials.
CBT+ ExerciseBehavioural
Participants will receive an identical 12-week cognitive behavioral smoking cessation program delivered by YMCA staff and monitored by members of the research team to ensure fidelity of treatment delivery. In addition to the smoking cessation program, those in the CBT + EXERCISE condition will enroll in the 12-week YMCA Personal Fitness Program (PFP) where they will receive 4 sessions with a personal trainer in weeks 1, 4, 8 and 12 and will engage in aerobic exercise at least 3 times per week either in the PFP facilities or in other programs offered at the YMCA, such as aerobics classes.
| Study group | Role | What they receive |
|---|---|---|
| CBT+ Contact | Active comparator | In addition to the smoking cessation program, those in the CBT + CONTACT condition will enroll in a Wellness Program and will receive weekly wellness materials to read as well as receiving 4 sessions with a health educator in weeks 1, 4, 8 and 12 to discuss the wellness materials. Receives: Behavioral: CBT+ Contact |
| CBT+ Exercise | Experimental | Participants will receive an identical 12-week cognitive behavioral smoking cessation program delivered by YMCA staff and monitored by members of the research team to ensure fidelity of treatment delivery. In addition to the smoking cessation program, those in the CBT + EXERCISE condition will enroll in the 12-week YMCA Personal Fitness Program (PFP) where they will receive 4 sessions with a personal trainer in weeks 1, 4, 8 and 12 and will engage in aerobic exercise at least 3 times per week either in the PFP facilities or in other programs offered at the YMCA, such as aerobics classes. Receives: Behavioral: CBT+ Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary Cotinine
Saliva will be collected at the 12 month follow-up visit and sent to a laboratory for analysis of cotinine, a biomarker of nicotine.
Measured: 12 months posttreatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startSep 2006
- Primary completionSep 2010
- Study completionApr 2012
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 SmokingStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Bess H Marcus, PhD, Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615380
- Sponsor's protocol ID
- R01DA021729
- Other IDs
- R01DA021729
- Status last verified
- Jun 2012
- First submitted
- 18 May 2012
- Last updated
- 8 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Whiteley JA, Williams DM, Dunsiger S, Jennings EG, Ciccolo JT, Bock BC, Albrecht A, Parisi A, Linke SE, Marcus BH. YMCA commit to quit: randomized trial outcomes. Am J Prev Med. 2012 Sep;43(3):256-62. doi: 10.1016/j.amepre.2012.05.025.
PubMed 22898118
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a YMCA Exercise Program to Enhance Nicotine Dependence Treatment for Women
- ClinicalTrials.gov ID
- NCT01615380
- Acronym / sponsor ID
- R01DA021729
- Conditions
- Smoking
- Keywords
- smoking cessation, Aerobic Exercise, Women, YMCA
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2006
- Primary completion
- Sep 2010 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 8 Jun 2012 (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.
Approximately 21% of women continue to smoke cigarettes despite the increased risk of cancer and cardiovascular disease associated with cigarette smoking. Exercise has been shown to be an efficacious treatment component in combating nicotine dependence, especially among women for whom concerns about weight gain during smoking cessation are an obstacle to successful quitting. In previous trials of women smokers, the investigators program of cognitive behavioral smoking cessation treatment (CBT) plus regular aerobic exercise was more efficacious than CBT plus equal contact time. Recognizing the program's successes, Commit to Quit (CTQ) was recently designated an Effective Program by the Substance Abuse and Mental Health Services Administration's (SAMHSA) National Registry of Effective Programs. Thus, the Commit to Quit program is well poised for a larger trial in a community setting where it has the potential to reach a large number of female smokers in a setting in which it can be sustained. In response to PA-03-126, Behavioral Therapies Development Program, the investigators propose a Stage III study in which they will conduct a trial to test the investigators CTQ smoking cessation program in the community setting of the local YMCAs. As stated in the PA, Stage III research is aimed at understanding if and how an efficacious therapy may be transported to the community. The investigators propose a randomized controlled clinical trial to take place in the YMCA setting and delivered by YMCA staff. The trial will compare CBT smoking cessation treatment plus a program of regular exercise to CBT smoking cessation treatment plus contact control. In order to promote transportability to the YMCA, the investigators will use the YMCA's existing Personal Fitness Program, which is similar to the investigators CTQ exercise program, in that it is guided by trained staff and requires participants to exercise 3 times per week. If the exercise condition is found to be more efficacious than contact control when delivered at the YMCA by YMCA staff, then the investigators will be well positioned to partner with the YMCA to pursue widespread, national dissemination of this program.
Detailed description
We propose a randomized controlled clinical trial to take place in the YMCA setting and to be delivered by YMCA staff. The trial will compare CBT smoking cessation treatment plus a program of regular exercise (CBT + EXERCISE) to CBT smoking cessation treatment plus an equal staff contact control (CBT + CONTACT). In order to promote transportability to the YMCA, the exercise program will be the YMCA's existing Personal Fitness Program, which like our CTQ exercise program, is guided by trained staff and requires participants to exercise at least 3 times per week.
If CBT + EXERCISE is found to be more efficacious than CBT + CONTACT when delivered at the YMCA by YMCA staff, then we will be well positioned to partner with the YMCA's initiative of Y Total Health to pursue widespread, national dissemination of this program. The proposed testing of the efficacy of the CTQ program in the YMCA setting is a necessary intermediate step in the eventual dissemination of the CTQ program.
Primary Aim. To determine the efficacy of CBT + EXERCISE compared with CBT + CONTACT when delivered in the YMCAs by YMCA staff to enhance the achievement and maintenance (3, 6, and 12 months follow-up) of smoking cessation (continuous abstinence) among healthy adult female smokers.
Hypothesis. Participants in the CBT + EXERCISE condition will have significantly greater continuous abstinence rates than those in the CBT + CONTACT condition at end-of-treatment, 3, 6, and 12 months follow-up.
Additional Questions of Interest.
- To perform process-to-outcome analyses on the intermediate variables which influence the achievement and maintenance of smoking cessation among healthy female smokers. Specifically, to determine if exercise affects weight and/or weight concerns, negative affect associated with nicotine withdrawal, and/or self-efficacy and to determine if these hypothesized mediators affect the achievement and maintenance of smoking cessation.
To explore potential moderators of the treatment, such as baseline demographic and psychological characteristics (e.g., age, baseline mood) on smoking cessation outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT+ Contact | Active comparator | Behavioral: CBT+ ContactIn addition to the smoking cessation program, those in the CBT + CONTACT condition will enroll in a Wellness Program and will receive weekly wellness materials to read as well as receiving 4 sessions with a health educator in weeks 1, 4, 8 and 12 to discuss the wellness materials. |
| CBT+ Exercise | Experimental | Behavioral: CBT+ ExerciseParticipants will receive an identical 12-week cognitive behavioral smoking cessation program delivered by YMCA staff and monitored by members of the research team to ensure fidelity of treatment delivery. In addition to the smoking cessation program, those in the CBT + EXERCISE condition will enroll in the 12-week YMCA Personal Fitness Program (PFP) where they will receive 4 sessions with a personal trainer in weeks 1, 4, 8 and 12 and will engage in aerobic exercise at least 3 times per week either in the PFP facilities or in other programs offered at the YMCA, such as aerobics classes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy female smokers
- ages 18 - 65
- Read and write English
- Regularly smoke 5 or more cigarettes a day
- Sedentary, or not exercising greater than 20 minutes of vigorous exercise more than once a week or greater than 30 minutes of moderate exercise 2 times per week.
Key exclusion criteria (8 listed)
- known history of cardiovascular
- pulmonary or metabolic disease such as coronary artery disease, stroke, hypertension, chronic bronchitis, asthma, emphysema, and diabetes
- Any musculoskeletal problems that would limit exercise training such as knee or hip osteoarthritis or any other serious medical condition that might make exercise unsafe or unwise.
- The current use of smokeless tobacco, nicotine replacement therapy or other smoking cessation treatment, and currently using prescription medication that might impair exercise performance or tolerance, specifically beta-blockers or medications used for the treatment of hypertension
- Pregnant or planning to become pregnant within the next 12 months.
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 |
|---|---|---|
| CBT+ ContactIn addition to the smoking cessation program, those in the CBT + CONTACT condition will enroll in a Wellness Program and will receive weekly wellness materials to read as well as receiving 4 sessions with a health educator in weeks 1, 4, 8 and 12 to discuss the wellness materials. | Behavioural | CBT+ Contact |
| CBT+ ExerciseParticipants will receive an identical 12-week cognitive behavioral smoking cessation program delivered by YMCA staff and monitored by members of the research team to ensure fidelity of treatment delivery. In addition to the smoking cessation program, those in the CBT + EXERCISE condition will enroll in the 12-week YMCA Personal Fitness Program (PFP) where they will receive 4 sessions with a personal trainer in weeks 1, 4, 8 and 12 and will engage in aerobic exercise at least 3 times per week either in the PFP facilities or in other programs offered at the YMCA, such as aerobics classes. | Behavioural | CBT+ Exercise |
Primary outcome
Salivary Cotinine
Time frame: 12 months posttreatment
Saliva will be collected at the 12 month follow-up visit and sent to a laboratory for analysis of cotinine, a biomarker of nicotine.
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 8 Jun 2012.
- Derived from this study: PubMed 22898118Whiteley JA, Williams DM, Dunsiger S, Jennings EG, Ciccolo JT, Bock BC, Albrecht A, Parisi A, Linke SE, Marcus BH. YMCA commit to quit: randomized trial outcomes. Am J Prev Med. 2012 Sep;43(3):256-62. doi: 10.1016/j.amepre.2012.05.025.
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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.
Bess H Marcus, PhD principal investigator
The Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing CBT+ Contact and CBT+ Exercise in people with Smoking, run by The Miriam Hospital at 1 site 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 5 inclusion and 8 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 8 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Salivary Cotinine (time frame: 12 months posttreatment). 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 NCT01615380, 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 8 Jun 2012.