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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01522274
Acronym
QFH
Enrollment
113
Registered
2012-01-31
Start date
2012-01-31
Completion date
2017-07-31
Last updated
2017-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cigarette Smoking

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).

Interventions

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

BEHAVIORALHealth education

Videos

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Brown University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* Current smoker

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Smoking Cessation7-Day Point Prevalence at 3, 6, 9 and 1-year follow-upsVerified by saliva cotinine

Secondary

MeasureTime frameDescription
Cognitive and Affective Mechanisms of TreatmentDaily assessments completed throughout the day at random and scheduled times from baseline to 3 monthsE-diary use will collect daily cognitive and affective data from each participant in order to reveal mechanisms of treatment outcomes.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026