Effects of Yoga and Cardiovascular Exercise on Smoking Motivation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT01423578
First received: August 24, 2011
Last updated: April 26, 2013
Last verified: April 2013

August 24, 2011
April 26, 2013
August 2007
November 2013   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01423578 on ClinicalTrials.gov Archive Site
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).
Same as current
Not Provided
Not Provided
 
Effects of Yoga and Cardiovascular Exercise on Smoking Motivation
Effects of Yoga and Cardiovascular Exercise on Smoking Motivation

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Tobacco Dependence
  • Behavioral: Hatha Yoga (HY)
    3 Sessions of yoga instruction
    Other Name: yoga
  • Behavioral: Cardiovascular Exercise (CE)
    3 sessions of cardiovascular exercise
    Other Name: exercise
  • Behavioral: Smoking Cessation Counseling
    4 smoking cessation counseling visits.
    Other Name: control group
  • Active Comparator: Hatha Yoga (HY)
    Exercise and Smoking Cessation Counseling
    Interventions:
    • Behavioral: Hatha Yoga (HY)
    • Behavioral: Smoking Cessation Counseling
  • Experimental: Cardiovascular Exercise (CE)
    Exercise and Smoking Cessation Counseling
    Interventions:
    • Behavioral: Cardiovascular Exercise (CE)
    • Behavioral: Smoking Cessation Counseling
  • Smoking Cessation Counseling Only
    Control Group - Smoking Cessation Counseling
    Intervention: Behavioral: Smoking Cessation Counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
79
November 2013
November 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01423578
MCC-15245
No
H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
Not Provided
Principal Investigator: David J. Drobes, Ph.D. H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP