Quit Smoking With Nicotine Patch and Exercise/Health Education (Females Only) (QFH)
|ClinicalTrials.gov Identifier: NCT01522274|
Recruitment Status : Completed
First Posted : January 31, 2012
Last Update Posted : August 1, 2017
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 or disease||Intervention/treatment|
|Cigarette Smoking||Behavioral: Moderate intensity exercise Behavioral: Health education|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||113 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Brisk Walking as a Smoking Cessation Treatment Adjunct Among Women|
|Study Start Date :||January 2012|
|Primary Completion Date :||July 2017|
|Study Completion Date :||July 2017|
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
- Smoking Cessation [ Time Frame: 7-Day Point Prevalence at 3, 6, 9 and 1-year follow-ups ]Verified by saliva cotinine
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01522274
|United States, Rhode Island|
|Public Health Building @ 121 South Main St|
|Providence, Rhode Island, United States, 02912|
|Principal Investigator:||David Williams, PhD||Brown University|