Getting Physical on Cigarettes - Smoking Cessation & Relapse Prevention

NCT01305447 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 413

Last updated 2014-12-16

No results posted yet for this study

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

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.

Conditions

Interventions

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.

BEHAVIORAL

Smoking Relapse prevention booklets

Participants will be given Brandon et al. (2000, 2004) smoking relapse prevention booklets following exercise program.

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).

Sponsors & Collaborators

  • Canadian Cancer Society (CCS)

    collaborator OTHER
  • University of Western Ontario, Canada

    lead OTHER

Principal Investigators

  • Harry Prapavessis, Ph.D. · The University of Western Ontario

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01305447 on ClinicalTrials.gov