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

July 28, 2017 updated by: David M. Williams, Brown University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

113

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02912
        • Public Health Building @ 121 South Main St

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Current smoker

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Videos

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Smoking Cessation
Time Frame: 7-Day Point Prevalence at 3, 6, 9 and 1-year follow-ups
Verified by saliva cotinine
7-Day Point Prevalence at 3, 6, 9 and 1-year follow-ups

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Daily assessments completed throughout the day at random and scheduled times from baseline to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brown University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: David Williams, PhD, Brown University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

January 18, 2012

First Submitted That Met QC Criteria

January 27, 2012

First Posted (Estimate)

January 31, 2012

Study Record Updates

Last Update Posted (Actual)

August 1, 2017

Last Update Submitted That Met QC Criteria

July 28, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • CA155381
  • R01CA155381 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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