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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01522274
First Posted: January 31, 2012
Last Update Posted: August 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
David M. Williams, Brown University
  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
Cigarette Smoking Behavioral: Moderate intensity exercise Behavioral: Health education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 David M. Williams, Brown University:

Primary Outcome Measures:
  • Smoking Cessation [ Time Frame: 7-Day Point Prevalence at 3, 6, 9 and 1-year follow-ups ]
    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 ]
    E-diary use will collect daily cognitive and affective data from each participant in order to reveal mechanisms of treatment outcomes.


Enrollment: 113
Study Start Date: January 2012
Study Completion Date: July 2017
Primary Completion Date: July 2017 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01522274


Locations
United States, Rhode Island
Public Health Building @ 121 South Main St
Providence, Rhode Island, United States, 02912
Sponsors and Collaborators
Brown University
National Cancer Institute (NCI)
Investigators
Principal Investigator: David Williams, PhD Brown University
  More Information

Additional Information:
Responsible Party: David M. Williams, Assistant Professor, Brown University
ClinicalTrials.gov Identifier: NCT01522274     History of Changes
Other Study ID Numbers: CA155381
R01CA155381 ( U.S. NIH Grant/Contract )
First Submitted: January 18, 2012
First Posted: January 31, 2012
Last Update Posted: August 1, 2017
Last Verified: July 2017