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

Not Applicable

Completed

• Conditions: Cigarette Smoking
• Interventions: Behavioral: Moderate intensity exercise; Behavioral: Health education

• Registration Number: NCT01522274
• Lead Sponsor: Brown University

Brief 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.

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).

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-18
• Study First Submitted QC: 2012-01-27
• Study First Posted: 2012-01-31
• Status Verified: 2017-07
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Last Update Submitted: 2017-07-28
• Last Update Posted: 2017-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 113

Inclusion Criteria

• Current smoker

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moderate intensity exercise	Moderate intensity exercise	Brisk walk on treadmill for 56 minutes 3x per week.
Health education	Health education	Attend health education sessions 3x per week.

Primary Outcome Measures

Name	Time	Method
Smoking Cessation	7-Day Point Prevalence at 3, 6, 9 and 1-year follow-ups	Verified by saliva cotinine

Secondary Outcome Measures

Name	Time	Method
Cognitive and Affective Mechanisms of Treatment	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.

Trial Locations

Locations (1)

Public Health Building @ 121 South Main St; 🇺🇸 Providence, Rhode Island, United States