Quit Smoking With Nicotine Patch and Exercise/Health Education (Females Only)
QFH
Efficacy of Brisk Walking as a Smoking Cessation Treatment Adjunct Among Women
2 other identifiers
interventional
113
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 18, 2012
CompletedFirst Posted
Study publicly available on registry
January 31, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedAugust 1, 2017
July 1, 2017
5.5 years
January 18, 2012
July 28, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Smoking Cessation
Verified by saliva cotinine
7-Day Point Prevalence at 3, 6, 9 and 1-year follow-ups
Secondary Outcomes (1)
Cognitive and Affective Mechanisms of Treatment
Daily assessments completed throughout the day at random and scheduled times from baseline to 3 months
Study Arms (2)
Moderate intensity exercise
ACTIVE COMPARATORBrisk walk on treadmill for 56 minutes 3x per week.
Health education
ACTIVE COMPARATORAttend health education sessions 3x per week.
Interventions
Brisk walking on a treadmill for 56 minutes 3x per week.
Eligibility Criteria
You may qualify if:
- Current smoker
You may not qualify if:
- Ineligible after telephone screen.
- Each participant's personal physician/clinic determines it is unsafe to participate.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brown Universitylead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Public Health Building @ 121 South Main St
Providence, Rhode Island, 02912, United States
Related Publications (1)
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.
PMID: 36455006DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Williams, PhD
Brown University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
January 18, 2012
First Posted
January 31, 2012
Study Start
January 1, 2012
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
August 1, 2017
Record last verified: 2017-07