Effects of Yoga and Cardiovascular Exercise on Smoking Motivation

Sponsor
H. Lee Moffitt Cancer Center and Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT01423578
Collaborator
(none)
79
1
3
118
0.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Hatha Yoga (HY)
  • Behavioral: Cardiovascular Exercise (CE)
  • Behavioral: Smoking Cessation Counseling
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
79 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Effects of Yoga and Cardiovascular Exercise on Smoking Motivation
Actual Study Start Date :
Aug 21, 2007
Actual Primary Completion Date :
May 2, 2011
Actual Study Completion Date :
Jun 20, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Hatha Yoga (HY)

Exercise and Smoking Cessation Counseling

Behavioral: Hatha Yoga (HY)
3 Sessions of yoga instruction
Other Names:
  • yoga
  • Behavioral: Smoking Cessation Counseling
    4 smoking cessation counseling visits.
    Other Names:
  • control group
  • Experimental: Cardiovascular Exercise (CE)

    Exercise and Smoking Cessation Counseling

    Behavioral: Cardiovascular Exercise (CE)
    3 sessions of cardiovascular exercise
    Other Names:
  • exercise
  • Behavioral: Smoking Cessation Counseling
    4 smoking cessation counseling visits.
    Other Names:
  • control group
  • Other: Smoking Cessation Counseling Only

    Control Group - Smoking Cessation Counseling

    Behavioral: Smoking Cessation Counseling
    4 smoking cessation counseling visits.
    Other Names:
  • control group
  • Outcome Measures

    Primary Outcome Measures

    1. The Number of Participants Reporting Post Intervention Effects [Average of 6 Months]

      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).

    Secondary Outcome Measures

    1. Number of Participants Reporting Behavior Changes Post Intervention [Average of 6 Months]

      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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Smoke at least 10 cigarettes per day

    • Smoked regularly at least 2 years

    • Carbon monoxide reading at least 8 ppm

    • Interest in quitting smoking

    • Able to read and understand the consent form and questionnaires

    • Not currently practicing yoga

    Exclusion Criteria:
    • Current Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) (American Psychiatric Association, 1994) psychosis

    • Major depressive episode, manic episode, or panic disorder

    • Current DSM-IV psychoactive substance dependence or use

    • Current medication use that might affect physiological responses

    • Current use of bupropion, varenicline, or nicotine-containing products other than cigarettes

    • Significant health problems that might compromise physiological data collection or be contraindicated for moderate physical exercise or yoga

    • Significant hearing or visual impairment; pregnant as determined by urine human chorionic gonadotropin (hCG) test or nursing females

    • Body mass index (BMI) 35 or greater

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 H. Lee Moffitt Cancer Center and Research Institute Tampa Florida United States 33612

    Sponsors and Collaborators

    • H. Lee Moffitt Cancer Center and Research Institute

    Investigators

    • Principal Investigator: David J. Drobes, Ph.D., H. Lee Moffitt Cancer Center and Research Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    H. Lee Moffitt Cancer Center and Research Institute
    ClinicalTrials.gov Identifier:
    NCT01423578
    Other Study ID Numbers:
    • MCC-15245
    First Posted:
    Aug 26, 2011
    Last Update Posted:
    Jun 26, 2017
    Last Verified:
    Jun 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by H. Lee Moffitt Cancer Center and Research Institute
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 26, 2017