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OpenTrials
Completed

NCT Number: NCT01522274

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

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.

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Key information

Conditions

Cigarette Smoking Behavior Smoking Tobacco Smoking Tobacco Use

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Public Health Building @ 121 South Main St

Providence, Rhode Island, 02912, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Current smoker

Exclusion criteria

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

Treatment and study plan

Moderate Intensity Exercise

Behavioral

Brisk walking on a treadmill for 56 minutes 3x per week.

Health Education

Behavioral

Videos

Primary outcomes

  1. Smoking Cessation

    Time frame: 7-Day Point Prevalence at 3, 6, 9 and 1-year follow-ups

    Verified by saliva cotinine

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: QFH

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Jan 31, 2012
Registry last updated
Aug 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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