Using a YMCA Exercise Program to Enhance Nicotine Dependence Treatment for Women
We propose a randomized controlled clinical trial to take place in the YMCA setting and to
be delivered by YMCA staff. The trial will compare CBT smoking cessation treatment plus a
program of regular exercise (CBT + EXERCISE) to CBT smoking cessation treatment plus an
equal staff contact control (CBT + CONTACT). In order to promote transportability to the
YMCA, the exercise program will be the YMCA's existing Personal Fitness Program, which like
our CTQ exercise program, is guided by trained staff and requires participants to exercise
at least 3 times per week.
If CBT + EXERCISE is found to be more efficacious than CBT + CONTACT when delivered at the
YMCA by YMCA staff, then we will be well positioned to partner with the YMCA's initiative of
Y Total Health to pursue widespread, national dissemination of this program. The proposed
testing of the efficacy of the CTQ program in the YMCA setting is a necessary intermediate
step in the eventual dissemination of the CTQ program.
Primary Aim. To determine the efficacy of CBT + EXERCISE compared with CBT + CONTACT when
delivered in the YMCAs by YMCA staff to enhance the achievement and maintenance (3, 6, and
12 months follow-up) of smoking cessation (continuous abstinence) among healthy adult female
Hypothesis. Participants in the CBT + EXERCISE condition will have significantly greater
continuous abstinence rates than those in the CBT + CONTACT condition at end-of-treatment,
3, 6, and 12 months follow-up.
Additional Questions of Interest.
1. To perform process-to-outcome analyses on the intermediate variables which influence the
achievement and maintenance of smoking cessation among healthy female smokers.
Specifically, to determine if exercise affects weight and/or weight concerns, negative
affect associated with nicotine withdrawal, and/or self-efficacy and to determine if these
hypothesized mediators affect the achievement and maintenance of smoking cessation.
To explore potential moderators of the treatment, such as baseline demographic and
psychological characteristics (e.g., age, baseline mood) on smoking cessation outcomes.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Saliva will be collected at the 12 month follow-up visit and sent to a laboratory for analysis of cotinine, a biomarker of nicotine.
12 months posttreatment
Bess H Marcus, PhD
The Miriam Hospital
United States: Institutional Review Board
|The Mriam Hospital||Providence, Rhode Island 02903|