Cigarette SmokingQFHNCT01522274
Quit Smoking With Nicotine Patch and Exercise/Health Education (Females Only)
A study testing Moderate intensity exercise and Health education in people with Cigarette Smoking, run by Brown University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- Moderate intensity exercise and Health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Current smoker
Who cannot join
- Ineligible after telephone screen.
- Each participant's personal physician/clinic determines it is unsafe to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
Public Health Building @ 121 South Main St
Providence, Rhode Island, 02912
About this study
Official title: 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.
Read the 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).
- Conditions
- Cigarette Smoking
- Being tested
- Moderate intensity exercise, Health education
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate intensity exerciseBehavioural
Brisk walking on a treadmill for 56 minutes 3x per week.
Health educationBehavioural
Videos
| Study group | Role | What they receive |
|---|---|---|
| Moderate intensity exercise | Active comparator | Brisk walk on treadmill for 56 minutes 3x per week. Receives: Behavioral: Moderate intensity exercise |
| Health education | Active comparator | Attend health education sessions 3x per week. Receives: Behavioral: Health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Cessation
Verified by saliva cotinine
Measured: 7-Day Point Prevalence at 3, 6, 9 and 1-year follow-ups
Secondary outcomes (1)
Cognitive and Affective Mechanisms of Treatment
E-diary use will collect daily cognitive and affective data from each participant in order to reveal mechanisms of treatment outcomes.
Measured: Daily assessments completed throughout the day at random and scheduled times from baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, David M. Williams, Brown University
- Investigators
- David Williams, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522274
- Sponsor's protocol ID
- CA155381
- Other IDs
- R01CA155381
- Acronym
- QFH
- Status last verified
- Jul 2017
- First submitted
- 18 Jan 2012
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36455006
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Brisk Walking as a Smoking Cessation Treatment Adjunct Among Women
- ClinicalTrials.gov ID
- NCT01522274
- Acronym / sponsor ID
- QFH / CA155381
- Conditions
- Cigarette Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2012
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 31 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate intensity exercise | Active comparator | Behavioral: Moderate intensity exerciseBrisk walk on treadmill for 56 minutes 3x per week. |
| Health education | Active comparator | Behavioral: Health educationAttend health education sessions 3x per week. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Current smoker
Key exclusion criteria (2 listed)
- Ineligible after telephone screen.
- Each participant's personal physician/clinic determines it is unsafe to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate intensity exerciseBrisk walking on a treadmill for 56 minutes 3x per week. | Behavioural | Moderate intensity exercise |
| Health educationVideos | Behavioural | Health education |
Primary outcome
Smoking Cessation
Time frame: 7-Day Point Prevalence at 3, 6, 9 and 1-year follow-ups
Verified by saliva cotinine
1 secondary outcome
Cognitive and Affective Mechanisms of Treatment
Time frame: Daily assessments completed throughout the day at random and scheduled times from baseline to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Derived from this study: PubMed 36455006LaRowe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Williams, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate intensity exercise and Health education in people with Cigarette Smoking, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking Cessation (time frame: 7-Day Point Prevalence at 3, 6, 9 and 1-year follow-ups). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01522274, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017; AzTrials last refreshed its copy on 8 Nov 2026.