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

NCT ID: NCT01522274

Last Updated: 2017-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2017-07-31

Brief Summary

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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

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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).

Conditions

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Cigarette Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Moderate intensity exercise

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

Group Type ACTIVE_COMPARATOR

Moderate intensity exercise

Intervention Type BEHAVIORAL

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

Health education

Attend health education sessions 3x per week.

Group Type ACTIVE_COMPARATOR

Health education

Intervention Type BEHAVIORAL

Videos

Interventions

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Moderate intensity exercise

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

Intervention Type BEHAVIORAL

Health education

Videos

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Current smoker

Exclusion Criteria

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

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Brown University

OTHER

Sponsor Role lead

Responsible Party

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David M. Williams

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Williams, PhD

Role: PRINCIPAL_INVESTIGATOR

Brown University

Locations

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Public Health Building @ 121 South Main St

Providence, Rhode Island, United States

Site Status

Countries

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United States

References

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LaRowe LR, Dunsiger SI, Williams DM. Acute exercise-induced changes in motivation and behavioral expectation for quitting smoking as predictors of smoking behavior in women. Psychol Addict Behav. 2023 May;37(3):475-482. doi: 10.1037/adb0000901. Epub 2022 Dec 1.

Reference Type DERIVED
PMID: 36455006 (View on PubMed)

Other Identifiers

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R01CA155381

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CA155381

Identifier Type: -

Identifier Source: org_study_id

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