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Using a YMCA Exercise Program to Enhance Nicotine Dependence Treatment for Women

Phase 2/Phase 3
18 Years
65 Years
Not Enrolling

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Trial Information

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.

Inclusion Criteria:

- Healthy female smokers

- ages 18 - 65

- Read and write English

- Regularly smoke 5 or more cigarettes a day

- Sedentary, or not exercising greater than 20 minutes of vigorous exercise more than
once a week or greater than 30 minutes of moderate exercise 2 times per week.

Exclusion Criteria:

- known history of cardiovascular

- pulmonary or metabolic disease such as coronary artery disease, stroke, hypertension,
chronic bronchitis, asthma, emphysema, and diabetes

- Any musculoskeletal problems that would limit exercise training such as knee or hip
osteoarthritis or any other serious medical condition that might make exercise unsafe
or unwise.

- The current use of smokeless tobacco, nicotine replacement therapy or other smoking
cessation treatment, and currently using prescription medication that might impair
exercise performance or tolerance, specifically beta-blockers or medications used for
the treatment of hypertension

- Pregnant or planning to become pregnant within the next 12 months.

- Women hospitalized for a psychiatric disorder

- Receiving treatment for bipolar disorder or schizophrenia

- Current alcohol abuse or psychological problems when quitting in the past that
required treatment

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Salivary Cotinine

Outcome Description:

Saliva will be collected at the 12 month follow-up visit and sent to a laboratory for analysis of cotinine, a biomarker of nicotine.

Outcome Time Frame:

12 months posttreatment

Safety Issue:


Principal Investigator

Bess H Marcus, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Miriam Hospital


United States: Institutional Review Board

Study ID:




Start Date:

September 2006

Completion Date:

April 2012

Related Keywords:

  • Smoking
  • smoking cessation
  • Aerobic Exercise
  • Women
  • YMCA
  • Tobacco Use Disorder
  • Smoking



The Mriam Hospital Providence, Rhode Island  02903