Getting Physical on Cigarettes - Smoking Cessation & Relapse Prevention

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Western Ontario, Canada.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Canadian Cancer Society Research Institute (CCSRI)
Information provided by (Responsible Party):
University of Western Ontario, Canada
ClinicalTrials.gov Identifier:
NCT01305447
First received: February 25, 2011
Last updated: June 25, 2012
Last verified: June 2012
  Purpose

Adult female smokers will participate in an exercise-aided smoking cessation program, and will then be randomized into one of four cessation maintenance conditions: (a) Exercise Maintenance only (b) Exercise Maintenance + Relapse Prevention Booklets(c) Relapse Prevention Booklets + Contact and (d) Contact Control. Primary follow-up outcome is smoking behaviour. Secondary outcomes include exercise behaviour, Physiological measures (body composition (Dual-emission X-ray absorptiometry; DXA), vascular health (stiffness, endothelial function, carotid plaque volume), physical fitness), and Psychological measures (self-regulatory cognitions related to exercise adherence [exercise, scheduling, barrier, relapse, and concurrent self-regulatory self-efficacy]).

The hypotheses detailed below are specific to the randomization of participants into the following 4 groups:

  1. Exercise Maintenance only
  2. Exercise Maintenance + Relapse Prevention Booklets
  3. Relapse Prevention Booklets + Contact
  4. Contact Control

Hypothesis 1: Compared to quitters in the contact control condition, quitters exposed to a home-based lifestyle exercise maintenance intervention (Exercise Maintenance only and Exercise Maintenance + Relapse Prevention Booklets) will demonstrate significantly greater exercise adherence and fitness levels, as well as significantly less weight gain and smoking relapse rates following exercise-aided smoking cessation program termination.

Hypothesis 2: Compared to quitters in the contact control condition, quitters exposed to relapse information only (Relapse Prevention Booklets + Contact) will experience significantly less smoking relapse following exercise-aided smoking cessation program termination.

Due to the novelty and exploratory nature of the respective prevention programs, no hypotheses are specified with respect to which prevention program (exercise maintenance or relapse prevention information) will be superior to the other, or whether the additive benefits (i.e., exercise maintenance plus relapse prevention information) will be superior to one prevention program alone.


Condition Intervention Phase
Cancer
Behavioral: Exercise Behaviour Maintenance
Behavioral: Smoking Relapse prevention booklets
Behavioral: Contact control
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Getting Physical on Cigarettes: Exercise and Smoking Cessation - Preventing Relapse

Resource links provided by NLM:


Further study details as provided by University of Western Ontario, Canada:

Primary Outcome Measures:
  • Smoking Behaviour [ Time Frame: 56 weeks post participant start date ] [ Designated as safety issue: No ]
    Continuous smoking behaviour will be measured from week 4-week 14, week26, week 56 (one year following quit). Smoking behaviour will be measured via self-report, breath Carbon Monoxide less than 6 parts per million, saliva cotinine.


Secondary Outcome Measures:
  • Exercise Behaviour [ Time Frame: for 56 weeks post participant start ] [ Designated as safety issue: No ]
    Exercise behaviour will be measured via Actical accelerometer at baseline, week 14, week 26 and week 56.


Estimated Enrollment: 420
Study Start Date: October 2009
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise Maintenance

Randomization and Group-Mediated Cognitive Behavioural therapy (GMCB) sessions will begin on week 8 of the program. Topics of self-regulation related to exercise (Social cognitive theory of self-regulation, Albert Bandura, 1991) will be discussed: monitoring, scheduling, goal setting, coping, overcoming barriers, rewards, social support.

Following the termination of the 14 week exercise aided smoking cessation program, trained exercise facilitators will deliver 15 minute biweekly (for the first month), monthly (for the next 2 months), and then bimonthly (for last 8 months) intervention strategies over the phone to continue to enhance the GMCB principles on how to maintain exercise behavior.

Behavioral: Exercise Behaviour Maintenance
Following the termination of the 14 week exercise aided smoking cessation program, trained exercise facilitators will deliver 15 minute biweekly (for the first month), monthly (for the next 2 months), and then bimonthly (for last 8 months) phone calls to remind the participants of the self-regulatory skills they learned during group discussion.
Other Name: Physical Activity
Experimental: Ex. Maintenance + relapse prevention

The same topics of self-regulation related to exercise maintenance(Social cognitive theory of self-regulation, Albert Bandura, 1991) will be discussed: monitoring, scheduling, goal setting, coping, overcoming barriers, rewards, social support.

Following the termination of the 14 week exercise aided smoking cessation program, trained exercise facilitators will deliver 15 minute biweekly (for the first month), monthly (for the next 2 months), and then bimonthly (for last 8 months) intervention strategies over the phone to continue to enhance the Group-Mediated Cognitive Behavioural therapy (GMCB) principles on how to maintain exercise behavior.

Participants in this arm will also receive the Brandon et al. (2004) Forever Free smoking relapse prevention booklets.

Behavioral: Exercise Behaviour Maintenance
Following the termination of the 14 week exercise aided smoking cessation program, trained exercise facilitators will deliver 15 minute biweekly (for the first month), monthly (for the next 2 months), and then bimonthly (for last 8 months) phone calls to remind the participants of the self-regulatory skills they learned during group discussion.
Other Name: Physical Activity
Behavioral: Smoking Relapse prevention booklets
Participants will be given Brandon et al. (2000, 2004) smoking relapse prevention booklets following exercise program.
Other Name: Educational material, relapse prevention, Forever Free
Active Comparator: relapse prevention

Randomization and group discussion sessions will begin on week 8 of the program. Topics of women's health, unrelated to exercise will be discussed (control).

Following the termination of the 14 week exercise aided smoking cessation program, trained exercise facilitators will deliver 15 minute biweekly (for the first month), monthly (for the next 2 months), and then bimonthly (for last 8 months) phone calls to continue to maintain contact time.

Participants in this arm will also receive the Brandon et al. (2004) Forever Free smoking relapse prevention booklets.

Behavioral: Smoking Relapse prevention booklets
Participants will be given Brandon et al. (2000, 2004) smoking relapse prevention booklets following exercise program.
Other Name: Educational material, relapse prevention, Forever Free
Active Comparator: Contact Control

Randomization and group discussion sessions will begin on week 8 of the program. Topics of women's health, unrelated to exercise will be discussed (control).

Following the termination of the 14 week exercise aided smoking cessation program, trained exercise facilitators will deliver 15 minute biweekly (for the first month), monthly (for the next 2 months), and then bimonthly (for last 8 months) phone calls to continue to maintain contact time.

Behavioral: Contact control
No treatment, but equal contact time as the other intervention arms. Topics of women's health, unrelated to exercise will be discussed in group-mediated sessions(control).
Other Name: Control

  Hide Detailed Description

Detailed Description:

Adding exercise to cognitive behaviour therapy (CBT) has been shown to aid smoking cessation and lessen some of the negative consequences of withdrawal symptoms (Marcus et al., 1999; Ussher, 2005). Recently, Prapavessis and colleagues (2007) demonstrated that their 12-week program, consisting of supervised vigorous intensity exercise as an adjunct to nicotine replacement therapy (NRT), facilitates smoking cessation, improves physical fitness, and delays weight gain in women smokers. However, a smoking relapse effect was shown post-intervention, illustrating a trend where, as abstinence decreased, physical fitness showed a corresponding decrease and an increase in weight (also see, Marcus et al.). These results suggest that exercise needs to be maintained if it is to be an effective aid to smoking cessation.

In practice, long-term supervised and structured vigorous exercise regimes are beyond the scope of smoking cessation services. Therefore, it is important to determine whether an exercise intervention program can be developed to maintain weight and physical fitness after program termination, and thus prevent (or reduce) smoking relapse. Teaching smokers the necessary self-regulatory skills needed to abstain from smoking and adhere to exercise independently may be a promising avenue through which to ensure lasting health behaviour changes.

The Getting Physical on Cigarettes program will begin in January 2010. The main purpose of this project is to examine whether an inexpensive, home-based lifestyle exercise maintenance intervention can demonstrate sustained health benefits in terms of weight gain and physical fitness benefits following an exercise and Nicotine Replacement Therapy (NRT) aided smoking cessation program. In addition, this trial seeks to examine previously unexplored topics of interest in the smoking abstinence literature; specifically, we are interested in whether the nicotine metabolite ratio (3-HC/Cotinine: Schnoll et al., 2009) is a useful biomarker for determining cessation success in relation to exercise and Nicotine Replacement Therapy (NRT) treatment, and whether the interactive effects of exercise and smoking cessation improve vascular health and lung function.

Four hundred and twenty adult female smokers will follow a structured and supervised 14 week exercise-aided smoking cessation program, with the 10 week NRT program beginning at week 4. Participants will be randomized into one of four conditions: a) Exercise Maintenance; b) Exercise Maintenance + Relapse Prevention Booklets; c) Relapse Prevention Booklets + Contact; and d) Contact Control. Starting at week 8, women in the Exercise Maintenance conditions will engage in Group-Mediated Cognitive Behavioural (GMCB) therapy related to maintaining exercise in their home environment, while women in the Contact conditions will partake in group mediated discussions related to other health issues. The "Forever Free" smoking replase prevention book series (Brandon, Collins, Juliano, & Lazev, 2000) will be distributed to participants in the Relapse Prevention Booklets conditions; however, all groups will receive the same amount of supervised exercise sessions and NRT. Following the termination of the 14 week intervention all participants will be contacted by a trained facilitator, who will deliver 15 minute biweekly (for the first month), monthly (for the next 2 months), and then bimonthly (for last 8 months) intervention strategies over the phone to continue to counsel the women according to her particular group-mediated condition.

Primary end points (i.e., smoking abstinence) will be assessed weekly throughout the 14 week program and through follow-ups at 3, 6, and 12 months. Secondary end points (i.e., fitness, vascular health [e.g., endothelial function, carotid plaque volume], lung function, weight and self-regulatory cognitions) will be assessed at baseline and at week 14 as well as at 12 months. Accelerometers (ACTICALÒ) will be used to obtain an objective measure of physical activity at baseline, week 15 (1 week after the 14 week intervention) and at 6 and 12 months.

The Getting Physical on Cigarettes trial will not only contribute to a better understanding of the role exercise plays as an aid to smoking cessation, but will also explore a means of increasing the cost-effectiveness of long-term smoking cessation programs. The findings resulting from this trial may have important implications for improving the quality of life among individuals who wish to stop smoking, which would, in turn, have a significant impact on the cost of health care to the Canadian public.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Participants must meet the following criteria:

  • Between the ages of 18 and 65
  • Smoking greater than 10 cigarettes per day, have done so for the past 2 years, and want to quit
  • Engage in 2 or less 30-minute bouts of moderate or vigorous intensity exercise over the past 6 months
  • Absence of any medical condition that is contraindicative for exercise
  • not pregnant or intending on being pregnant over the course of the study
  • Be able to read and write in English
  • Have a telephone or an email account that we can reach you at

Exclusion criteria include:

  • Contraindication to regular exercise (e.g., disability, unstable angina)
  • Contraindications to using nicotine replacement therapy (NRT)
  • Currently exercise more than twice a week for 30 or more minutes each bout at a moderate to vigorous intensity level and have done so for the past 6 months
  • On medication for physical and/or mental health reasons that would make compliance with the study protocol difficult or dangerous
  • Have substance dependency problems (e.g., alcohol)
  • Are pregnant or are planning on becoming pregnant during the next year
  • No Medical Doctor approval for exercise or NicoDerm patch (Nicotine Replacement Therapy; NRT)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01305447

Contacts
Contact: Harry Prapavessis, Ph.D. 519-661-2111 ext 80173 hprapave@uwo.ca
Contact: Stefanie De Jesus, Ph.D. (c) sdejesus@uwo.ca

Locations
Canada, Ontario
Exercise and Health Psychology Laboratory - The University of Western Ontario Recruiting
London, Ontario, Canada, N6A 5B9
Contact: Harry Prapavessis, Ph.D.    519-661-2111 ext 80173    hprapave@uwo.ca   
Contact: Stefanie De Jesus, Ph.D. (c)    519-661-2111 ext 81189    sdejesus@uwo.ca   
Principal Investigator: Harry Prapavessis, Ph.D.         
Sub-Investigator: Lyndsay A Fitzgeorge, Ph.D.         
Sub-Investigator: Stefanie De Jesus, Ph.D. (c)         
Sponsors and Collaborators
University of Western Ontario, Canada
Canadian Cancer Society Research Institute (CCSRI)
Investigators
Principal Investigator: Harry Prapavessis, Ph.D. University of Western Ontario, Canada
  More Information

Additional Information:
Publications:
Responsible Party: University of Western Ontario, Canada
ClinicalTrials.gov Identifier: NCT01305447     History of Changes
Other Study ID Numbers: Prapavessis NCIC RCT
Study First Received: February 25, 2011
Last Updated: June 25, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Western Ontario, Canada:
smoking cessation
exercise maintenance
preventing relapse
weight gain
group-mediated cognitive behavioural therapy

ClinicalTrials.gov processed this record on September 18, 2014