Quit Smoking With Nicotine Patch and Exercise/Health Education (Females Only) (QFH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2012 by Brown University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David M. Williams, Brown University
ClinicalTrials.gov Identifier:
NCT01522274
First received: January 18, 2012
Last updated: January 27, 2012
Last verified: January 2012
  Purpose

This research study is for FEMALE cigarette smokers who want to quit smoking.

Participants will be provided with brief quit-smoking education at the beginning of the study and will receive the nicotine patch for 10 weeks, free of charge.

Participants will be assigned to either an exercise program or a general health education program. The exercise and health education programs will take place over 14 weeks, with follow-up appointments 3, 6, and 12 months after the end of the 14-week program.

There is no fee for any part of this study and participants will be compensated for their time.


Condition Intervention Phase
Cigarette Smoking
Behavioral: Moderate intensity exercise
Behavioral: Health education
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Efficacy of Brisk Walking as a Smoking Cessation Treatment Adjunct Among Women

Resource links provided by NLM:


Further study details as provided by Brown University:

Primary Outcome Measures:
  • Smoking Cessation [ Time Frame: 7-Day Point Prevalence at 3, 6, 9 and 1-year follow-ups ] [ Designated as safety issue: No ]
    Verified by saliva cotinine


Secondary Outcome Measures:
  • Cognitive and Affective Mechanisms of Treatment [ Time Frame: Daily assessments completed throughout the day at random and scheduled times from baseline to 3 months ] [ Designated as safety issue: No ]
    E-diary use will collect daily cognitive and affective data from each participant in order to reveal mechanisms of treatment outcomes.


Estimated Enrollment: 164
Study Start Date: January 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Moderate intensity exercise
Brisk walk on treadmill for 56 minutes 3x per week.
Behavioral: Moderate intensity exercise
Brisk walking on a treadmill for 56 minutes 3x per week.
Active Comparator: Health education
Attend health education sessions 3x per week.
Behavioral: Health education
Videos

Detailed Description:

Participants must complete telephone screening process first.

All eligible participants must attend an orientation session when the investigators will explain the study in detail. After this session, interested participants will complete a consent form and the investigators will collect blood pressure, resting heart rate, body mass index (height/weight), and a carbon monoxide sample to confirm eligibility. The investigators will then explain the physician consent process (all eligible and interested participants must obtain consent from a physician or clinic that they have seen in the past year to confirm that it is safe for them to participate).

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Current smoker

Exclusion Criteria:

  • Ineligible after telephone screen.
  • Each participant's personal physician/clinic determines it is unsafe to participate.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01522274

Contacts
Contact: Fred Holloway, BA 401-863-6664 QuitForHealth@Brown.edu

Locations
United States, Rhode Island
Public Health Building @ 121 South Main St Recruiting
Providence, Rhode Island, United States, 02912
Contact: Fred    401-863-6664      
Sponsors and Collaborators
Brown University
Investigators
Principal Investigator: David Williams, PhD Brown University
  More Information

Additional Information:
No publications provided

Responsible Party: David M. Williams, Assistant Professor, Brown University
ClinicalTrials.gov Identifier: NCT01522274     History of Changes
Other Study ID Numbers: CA155381, R01CA155381
Study First Received: January 18, 2012
Last Updated: January 27, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 18, 2014