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

Cigarette Smoking Clinical Trial

— QFH  

Official title:

Efficacy of Brisk Walking as a Smoking Cessation Treatment Adjunct Among Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01522274
• Other study ID #: CA155381
• Secondary ID: R01CA155381
• Status: Completed
• Phase: N/A
• First received: January 18, 2012
• Last updated: July 28, 2017
• Start date: January 2012
• Est. completion date: July 2017

Study information

• Verified date: July 2017
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Current smoker

Exclusion Criteria:

• Ineligible after telephone screen.

• Each participant's personal physician/clinic determines it is unsafe to participate.

Related Conditions & MeSH terms

• Cigarette Smoking

Intervention

Behavioral:
• Moderate intensity exercise
Brisk walking on a treadmill for 56 minutes 3x per week.
• Health education
Videos

Locations

Country	Name	City	State
United States	Public Health Building @ 121 South Main St	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking Cessation	Verified by saliva cotinine	7-Day Point Prevalence at 3, 6, 9 and 1-year follow-ups
Secondary	Cognitive and Affective Mechanisms of Treatment	E-diary use will collect daily cognitive and affective data from each participant in order to reveal mechanisms of treatment outcomes.	Daily assessments completed throughout the day at random and scheduled times from baseline to 3 months

External Links

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