Getting Physical on Cigarettes - Smoking Cessation & Relapse Prevention
NCT ID: NCT01305447
Last Updated: 2014-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
413 participants
INTERVENTIONAL
2009-10-31
2014-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
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.
Smoking Relapse prevention booklets
Participants will be given Brandon et al. (2000, 2004) smoking relapse prevention booklets following exercise program.
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.
Smoking Relapse prevention booklets
Participants will be given Brandon et al. (2000, 2004) smoking relapse prevention booklets following exercise program.
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.
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Smoking Relapse prevention booklets
Participants will be given Brandon et al. (2000, 2004) smoking relapse prevention booklets following exercise program.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Exclusion Criteria
* 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)
18 Years
65 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Canadian Cancer Society (CCS)
OTHER
University of Western Ontario, Canada
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Harry Prapavessis, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
The University of Western Ontario
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Exercise and Health Psychology Laboratory - The University of Western Ontario
London, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Brandon TH, Collins BN, Juliano LM, Lazev AB. Preventing relapse among former smokers: a comparison of minimal interventions through telephone and mail. J Consult Clin Psychol. 2000 Feb;68(1):103-13. doi: 10.1037//0022-006x.68.1.103.
Brandon TH, Meade CD, Herzog TA, Chirikos TN, Webb MS, Cantor AB. Efficacy and cost-effectiveness of a minimal intervention to prevent smoking relapse: dismantling the effects of amount of content versus contact. J Consult Clin Psychol. 2004 Oct;72(5):797-808. doi: 10.1037/0022-006X.72.5.797.
Marcus BH, Albrecht AE, King TK, Parisi AF, Pinto BM, Roberts M, Niaura RS, Abrams DB. The efficacy of exercise as an aid for smoking cessation in women: a randomized controlled trial. Arch Intern Med. 1999 Jun 14;159(11):1229-34. doi: 10.1001/archinte.159.11.1229.
Prapavessis H, Cameron L, Baldi JC, Robinson S, Borrie K, Harper T, Grove JR. The effects of exercise and nicotine replacement therapy on smoking rates in women. Addict Behav. 2007 Jul;32(7):1416-32. doi: 10.1016/j.addbeh.2006.10.005. Epub 2006 Nov 9.
Schnoll RA, Patterson F, Wileyto EP, Tyndale RF, Benowitz N, Lerman C. Nicotine metabolic rate predicts successful smoking cessation with transdermal nicotine: a validation study. Pharmacol Biochem Behav. 2009 Mar;92(1):6-11. doi: 10.1016/j.pbb.2008.10.016. Epub 2008 Oct 31.
Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.
Prapavessis H, De Jesus S, Fitzgeorge L, Rollo S. Anthropometric and body composition changes in smokers vs abstainers following an exercise-aided pharmacotherapy smoking cessation trial for women. Addict Behav. 2018 Oct;85:125-130. doi: 10.1016/j.addbeh.2018.06.003. Epub 2018 Jun 7.
Related Links
Access external resources that provide additional context or updates about the study.
Exercise and Health Psychology Laboratory
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Prapavessis NCIC RCT
Identifier Type: -
Identifier Source: org_study_id