Exercise to Enhance Smoking Cessation for Women at the YMCA

NCT01615380 | Completed Phase 2

• 1 other identifier: R01DA021729
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 1

Brief Summary

Approximately 21% of women continue to smoke cigarettes despite the increased risk of cancer and cardiovascular disease associated with cigarette smoking. Exercise has been shown to be an efficacious treatment component in combating nicotine dependence, especially among women for whom concerns about weight gain during smoking cessation are an obstacle to successful quitting. In previous trials of women smokers, the investigators program of cognitive behavioral smoking cessation treatment (CBT) plus regular aerobic exercise was more efficacious than CBT plus equal contact time. Recognizing the program's successes, Commit to Quit (CTQ) was recently designated an Effective Program by the Substance Abuse and Mental Health Services Administration's (SAMHSA) National Registry of Effective Programs. Thus, the Commit to Quit program is well poised for a larger trial in a community setting where it has the potential to reach a large number of female smokers in a setting in which it can be sustained. In response to PA-03-126, Behavioral Therapies Development Program, the investigators propose a Stage III study in which they will conduct a trial to test the investigators CTQ smoking cessation program in the community setting of the local YMCAs. As stated in the PA, Stage III research is aimed at understanding if and how an efficacious therapy may be transported to the community. The investigators propose a randomized controlled clinical trial to take place in the YMCA setting and delivered by YMCA staff. The trial will compare CBT smoking cessation treatment plus a program of regular exercise to CBT smoking cessation treatment plus contact control. In order to promote transportability to the YMCA, the investigators will use the YMCA's existing Personal Fitness Program, which is similar to the investigators CTQ exercise program, in that it is guided by trained staff and requires participants to exercise 3 times per week. If the exercise condition is found to be more efficacious than contact control when delivered at the YMCA by YMCA staff, then the investigators will be well positioned to partner with the YMCA to pursue widespread, national dissemination of this program.

Conditions

Smoking

Keywords

smoking cessation; Aerobic Exercise; Women; YMCA

Outcome Measures

Primary Outcomes (1)

• Salivary Cotinine

  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

Study Arms (2)

CBT+ Contact

ACTIVE COMPARATOR

In addition to the smoking cessation program, those in the CBT + CONTACT condition will enroll in a Wellness Program and will receive weekly wellness materials to read as well as receiving 4 sessions with a health educator in weeks 1, 4, 8 and 12 to discuss the wellness materials.

Behavioral: CBT+ Contact

CBT+ Exercise

EXPERIMENTAL

Participants will receive an identical 12-week cognitive behavioral smoking cessation program delivered by YMCA staff and monitored by members of the research team to ensure fidelity of treatment delivery. In addition to the smoking cessation program, those in the CBT + EXERCISE condition will enroll in the 12-week YMCA Personal Fitness Program (PFP) where they will receive 4 sessions with a personal trainer in weeks 1, 4, 8 and 12 and will engage in aerobic exercise at least 3 times per week either in the PFP facilities or in other programs offered at the YMCA, such as aerobics classes.

Behavioral: CBT+ Exercise

Interventions

CBT+ Contact BEHAVIORAL

In addition to the smoking cessation program, those in the CBT + CONTACT condition will enroll in a Wellness Program and will receive weekly wellness materials to read as well as receiving 4 sessions with a health educator in weeks 1, 4, 8 and 12 to discuss the wellness materials.

CBT+ Contact

CBT+ Exercise BEHAVIORAL

Participants will receive an identical 12-week cognitive behavioral smoking cessation program delivered by YMCA staff and monitored by members of the research team to ensure fidelity of treatment delivery. In addition to the smoking cessation program, those in the CBT + EXERCISE condition will enroll in the 12-week YMCA Personal Fitness Program (PFP) where they will receive 4 sessions with a personal trainer in weeks 1, 4, 8 and 12 and will engage in aerobic exercise at least 3 times per week either in the PFP facilities or in other programs offered at the YMCA, such as aerobics classes.

CBT+ Exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Miriam Hospital: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

The Mriam Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

• Whiteley JA, Williams DM, Dunsiger S, Jennings EG, Ciccolo JT, Bock BC, Albrecht A, Parisi A, Linke SE, Marcus BH. YMCA commit to quit: randomized trial outcomes. Am J Prev Med. 2012 Sep;43(3):256-62. doi: 10.1016/j.amepre.2012.05.025.

  PMID: 22898118 DERIVED

MeSH Terms

Conditions

Smoking; Smoking Cessation

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Study Officials

• Bess H Marcus, PhD

  The Miriam Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2012
• First Posted: June 8, 2012
• Study Start: September 1, 2006
• Primary Completion: September 1, 2010
• Study Completion: April 1, 2012
• Last Updated: June 8, 2012

Record last verified: 2012-06

Locations

US (1)