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

Brown University

Status: Completed

Conditions: Cigarette Smoking

Treatments: Behavioral: Moderate intensity exercise; Behavioral: Health education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01522274

R01CA155381 (U.S. NIH Grant/Contract)

CA155381

Details and patient eligibility

About

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.

Full 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).

Enrollment: 113 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Current smoker

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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113 participants in 2 patient groups

Moderate intensity exercise

Active Comparator group

Description:

Brisk walk on treadmill for 56 minutes 3x per week.

Treatment:

Behavioral: Moderate intensity exercise

Health education

Active Comparator group

Description:

Attend health education sessions 3x per week.

Treatment:

Behavioral: Health education