Getting Physical on Cigarettes - Smoking Cessation & Relapse Prevention - Full Text View

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:

Exercise Maintenance only
Exercise Maintenance + Relapse Prevention Booklets
Relapse Prevention Booklets + Contact
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:

MedlinePlus related topics: Cancer Exercise and Physical Fitness Quitting Smoking Smoking Women's Health

U.S. FDA Resources

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

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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

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

Investigators

Principal Investigator:

Harry Prapavessis, Ph.D.

University of Western Ontario, Canada

More Information

Additional Information:

Exercise and Health Psychology Laboratory This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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.

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. 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. Epub 2008 Oct 31.

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

Additional relevant MeSH terms:

Smoking
Habits

ClinicalTrials.gov processed this record on May 19, 2013