Effects of Yoga and Cardiovascular Exercise on Smoking Motivation
| Tracking Information | |||||
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| First Received Date ICMJE | August 24, 2011 | ||||
| Last Updated Date | April 26, 2013 | ||||
| Start Date ICMJE | August 2007 | ||||
| Estimated Primary Completion Date | November 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The Number of Participants Reporting Post Intervention Effects [ Time Frame: Average of 6 Months ] [ Designated as safety issue: No ] Intervention effects on measures of craving, mood, cue reactivity, and smoking behavior will be analyzed with mixed-design analysis of variance (ANOVA), with Intervention as the between-group factor (HY vs. CE vs. NA), and Time as a within-subject factor (pre vs. post-intervention). Analyses for cue reactivity variables will include the additional within-subject factor of Cue Type (smoking vs. neutral), and analyses for craving and mood self-report will include the additional within-subject factor of Session (1 vs. 2 vs. 3). |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01423578 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Number of Participants Reporting Behavior Changes Post Intervention [ Time Frame: Average of 6 Months ] [ Designated as safety issue: No ] In order to determine whether intervention effects on smoking behavior are mediated by changes in craving, mood, and/or cue reactivity, we will conduct Sobel tests (e.g., Preacher & Leonardelli, 2001), supplemented by mediation analyses using methods of Baron & Kenny (1986). |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of Yoga and Cardiovascular Exercise on Smoking Motivation | ||||
| Official Title ICMJE | Effects of Yoga and Cardiovascular Exercise on Smoking Motivation | ||||
| Brief Summary | The overall purpose of this pilot study is to examine effects of Hatha yoga and cardiovascular exercise on craving, mood, cue reactivity, and smoking behavior. Our preliminary study indicated that a single session of either form of activity intervention improved mood, and the yoga intervention appeared to decrease cravings to smoke. The proposed study will extend this preliminary research in several ways. |
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| Detailed Description | First, the investigators will expand the exercise-based interventions from one to three sessions, which will more closely resemble how these interventions may be used in the context of smoking cessation. Second, the investigators will recruit smokers who are motivated to quit smoking, further increasing the clinical relevance of the research. Finally, the investigators will examine the effects of the interventions on actual smoking behavior within and outside of the laboratory setting. This may appropriately be considered a "proof of concept" study, as the investigators will not be powered to detect treatment outcome (smoking cessation) differences, nor are the interventions designed to maximize clinical smoking cessation outcomes. Participants will be randomized to receive 3-sessions of yoga instruction, 3-sessions of cardiovascular exercise, or to a no activity control group. Sessions will be scheduled to occur approximately 7 days apart, with a minimum of 4 between sessions. Mood and craving will be assessed before and after each session, and smoking behavior will be assessed following each session. Finally, a detailed cue reactivity assessment will be conducted prior to the first session and following the last session. Analyses will examine intervention effects on craving, mood, cue reactivity, and smoking behavior. In addition, the investigators will examine several potential mediators and moderators of intervention effects on smoking behavior. Finally, the investigators will continue to examine the feasibility and potential acceptability of each active intervention, to assist in developing future clinical applications of these techniques in the context of smoking cessation. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Tobacco Dependence | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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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 | ||||
| Enrollment ICMJE | 79 | ||||
| Estimated Completion Date | November 2013 | ||||
| Estimated Primary Completion Date | November 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 55 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 | NCT01423578 | ||||
| Other Study ID Numbers ICMJE | MCC-15245 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | H. Lee Moffitt Cancer Center and Research Institute | ||||
| Study Sponsor ICMJE | H. Lee Moffitt Cancer Center and Research Institute | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | H. Lee Moffitt Cancer Center and Research Institute | ||||
| Verification Date | April 2013 | ||||
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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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