Yoga for Women Attempting Smoking Cessation
Recruitment status was Active, not recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | June 25, 2007 | ||||
| Last Updated Date | July 19, 2010 | ||||
| Start Date ICMJE | August 2007 | ||||
| Primary Completion Date | February 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
smoking cessation: 7-day point prevalence abstinence [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
smoking cessation: 7-day point prevalence abstinence [ Time Frame: 6 months ] | ||||
| Change History | Complete list of historical versions of study NCT00492310 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Acceptability: recruitment, retention, adherence to protocol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Acceptability: recruitment, retention, adherence to protocol [ Time Frame: 12 weeks ] | ||||
| Current Other Outcome Measures ICMJE | |||||
| Original Other Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Yoga for Women Attempting Smoking Cessation | ||||
| Official Title ICMJE | Yoga for Women Attempting Smoking Cessation: an Initial Investigation | ||||
| Brief Summary | The purpose of this study is to examine the feasibility, acceptability and initial effectiveness of adding yoga to a traditional, group-based treatment for smoking cessation for women smokers. |
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| Detailed Description | Smoking is the leading preventable cause of morbidity and mortality among women in the US. Quitting smoking may be especially problematic for women. As a form of exercise, yoga shares many of the same properties as traditional (Western) aerobic exercise which our previous research has shown to be an effective addition to smoking cessation. Yoga may also offer other benefits that may make it an especially effective complimentary treatment for women who are attempting to quit smoking. In this study we will recruit two cohorts of 30 women smokers and provide cognitive-behavioral therapy for smoking cessation once weekly for 12 weeks. In addition, participants will be randomly assigned them to receive either; (1) Yoga or (2) a Wellness program (contact-control), twice weekly during the program. All participants will be assessed for changes in smoking behavior, psychosocial variables relevant to smoking cessation and other psychological constructs that may act as mechanisms of action (mediators) of yoga and smoking cessation. These variables include; weight concerns, perceived stress, mindfulness, self-esteem, quality of life and group cohesion. Interviews will be used to collect qualitative data at the end of each cohort. The proposed study is designed to provide information necessary to establish several research fundamentals necessary to support a full scale efficacy trial. These include: 1) establishing intervention feasibility and acceptability in the target population, 2) piloting recruitment and retention procedures and identifying barriers to participation, 3) obtaining qualitative feedback from participants to enhance treatment content and/or design, 4) establishing anticipated effect size estimates, and 5) identifying likely mechanisms of action that may be responsible for intervention efficacy. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Smoking | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Bock BC, Morrow KM, Becker BM, Williams DM, Tremont G, Gaskins RB, Jennings E, Fava J, Marcus BH. Yoga as a complementary treatment for smoking cessation: rationale, study design and participant characteristics of the Quitting-in-Balance study. BMC Complement Altern Med. 2010 Apr 29;10:14. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 60 | ||||
| Estimated Completion Date | March 2011 | ||||
| Primary Completion Date | February 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Female, Age 18-65, Cigarette smoking 10 or more per day for more than 1 year, sedentary (not exercising more than 2 days per week) Exclusion Criteria: Major depression, Hypertension, Current yoga practice, Current mind/body therapies |
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| Gender | Female | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00492310 | ||||
| Other Study ID Numbers ICMJE | R21 AT003669-01, R21AT003669-01 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Beth Bock, The Miriam Hospital | ||||
| Study Sponsor ICMJE | The Miriam Hospital | ||||
| Collaborators ICMJE | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Investigators ICMJE |
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| Information Provided By | The Miriam Hospital | ||||
| Verification Date | July 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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