Getting Physical on Cigarettes - Smoking Cessation & Relapse Prevention
1 other identifier
interventional
413
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 cancer
Started Oct 2009
Typical duration for phase_2 cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 25, 2011
CompletedFirst Posted
Study publicly available on registry
February 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedDecember 16, 2014
June 1, 2012
4.5 years
February 25, 2011
December 15, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Smoking Behaviour
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.
56 weeks post participant start date
Secondary Outcomes (1)
Exercise Behaviour
for 56 weeks post participant start
Study Arms (4)
Exercise Maintenance
EXPERIMENTALRandomization 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.
Ex. Maintenance + relapse prevention
EXPERIMENTALThe 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.
relapse prevention
ACTIVE COMPARATORRandomization 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.
Contact Control
ACTIVE COMPARATORRandomization 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.
Interventions
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.
Participants will be given Brandon et al. (2000, 2004) smoking relapse prevention booklets following exercise program.
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).
Eligibility Criteria
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Exercise and Health Psychology Laboratory - The University of Western Ontario
London, Ontario, N6A 5B9, Canada
Related Publications (7)
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.
PMID: 10710845BACKGROUNDBrandon 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.
PMID: 15482038BACKGROUNDMarcus 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.
PMID: 10371231BACKGROUNDPrapavessis 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.
PMID: 17097814BACKGROUNDSchnoll 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.
PMID: 19000709BACKGROUNDHartmann-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.
PMID: 34611902DERIVEDPrapavessis 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.
PMID: 29902683DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Harry Prapavessis, Ph.D.
The University of Western Ontario
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2011
First Posted
February 28, 2011
Study Start
October 1, 2009
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
December 16, 2014
Record last verified: 2012-06