Smoking CessationNCT01574560
P60 Program Project Grant-Outreach for Smoke-Free Homes
A study testing Brochure and Counseling in people with Smoking Cessation and Tobacco Cessation, run by University of Minnesota at 1 site in United States.
Trial summary
Smoking is widely accepted to cause an increase in an individual's likelihood of developing cancer and heart disease. The effects of tobacco smoke are not limited to smokers. Secondhand smoke inhaled by a non-smoker has also been associated with the development of several illnesses. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Tobacco Cessation
- What is being tested?
- Brochure and Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Apr 2013
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Female
- Smoked ≥ 1 cigarettes per day for at least the past 6 months
- Smoked on 20 days or more in the last month
- Smoking status confirmed via cotinine verification strips
- Resides with a child ≤ 10 years of age in the role of the child's parent or caregiver
Show all 14Show fewer
- Will agree to provide a urine sample at study enrollment
- Will also agree to the child providing a urine sample at study enrollment and at follow-up visits (for children who are not toilet trained, a diaper sample will be collected in lieu of the urine sample)
- Has a home address
- Has a functioning home phone or cell phone
- Provides written informed consent
- < or = 10 years of age
- Non-smoker -no cigarette use within prior 30 days to enrollment; however experimentation with smoking (a puff) will not exclude the child
- Lives in the primary home with the adult study participant at least 5 days a week
Who cannot join
- Current or past 7 day use of Nicotine Replacement Therapy (NRT) or pharmacotherapy for smoking cessation
- Planning to move outside of Minnesota within the next 3 months
- Have complete home smoking restrictions currently in place verified by the nicotine dosimeter
- Currently pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Community Outreach and Biomarker Feedback for Smoke-Free Homes
Smoking is widely accepted to cause an increase in an individual's likelihood of developing cancer and heart disease. The effects of tobacco smoke are not limited to smokers. Secondhand smoke inhaled by a non-smoker has also been associated with the development of several illnesses. This study focuses on learning how to make your home smoke-free.
Read the detailed description
This study will be conducted in two phases. Phase 1 will be qualitative focus groups/pilot study with the purpose to develop a motivationally enhanced biomarker feedback counseling protocol and all printed materials to be used in Phase 2. After investigators develop a good working treatment protocol, an active intervention in smoking homes who live with a child in their home will be carried out.
Those randomized to the Control Group will receive health education in the form of brochures detailing the health effects of secondhand smoke and how to make their home smoke free. Participants randomized to the Treatment Group will receive tobacco-specific biomarker feedback and personalized motivationally enhanced counseling.
- Conditions
- Smoking Cessation, Tobacco Cessation
- Being tested
- Brochure, Counseling
- Keywords
- smoke-free, tobacco exposure, biomarker feedback, nicotine, cotinine, secondhand smoke
- Medical subject headings
- Smoking Cessation, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrochureBehavioural
Information regarding secondhand smoke and creating a healthy home environment.
CounselingBehavioural
Receives brochure and counseling sessions focusing on changing smoking behaviors and/or other health behaviors.
| Study group | Role | What they receive |
|---|---|---|
| Control Group - Health Education | Active comparator | This group is provided with information regarding secondhand smoke and creating a healthy home environment. Receives: Behavioral: Brochure |
| Treatment Group - Counseling | Active comparator | This group is provided with biomarker feedback on child exposure to secondhand smoke. Active participants receive 5 counseling sessions from a trained research counselor; 3 sessions in the home and 2 by phone. The counseling sessions focus on changing smoking behaviors and/or other behaviors that impact smoking. Receives: Behavioral: Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Home Secondhand Smoke levels
Measured by nicotine dosimeter - a passive "badge" hung in the home that measures free floating airborne nicotine particles.
Measured: From Baseline to Week 26 Follow-Up
Secondary outcomes (2)
Comparison of Child Cotinine Levels in Urine
Cotinine is an alkaloid found in tobacco and is also a metabolite of nicotine. Cotinine is used as a biomarker for exposure to tobacco smoke. Child (non-smoker) cotinine will be used as an objective measure of secondhand smoke exposure at baseline and again at end of study (week 26).
Measured: From Baseline to Week 26 Follow-Up
Comparison of Questionnaire Results
Measured by mediators and moderators of effect, including psychosocial and tobacco-related variables.
Measured: Baseline, Week 16 and Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startJan 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janet L. Thomas, Ph.D., Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574560
- Sponsor's protocol ID
- 2009NTLS058
- Status last verified
- Aug 2014
- First submitted
- 5 Apr 2012
- Last updated
- 6 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Outreach and Biomarker Feedback for Smoke-Free Homes
- ClinicalTrials.gov ID
- NCT01574560
- Acronym / sponsor ID
- 2009NTLS058
- Conditions
- Smoking Cessation, Tobacco Cessation
- Keywords
- smoke-free, tobacco exposure, biomarker feedback, nicotine, cotinine, secondhand smoke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 10 Apr 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.
Smoking is widely accepted to cause an increase in an individual's likelihood of developing cancer and heart disease. The effects of tobacco smoke are not limited to smokers. Secondhand smoke inhaled by a non-smoker has also been associated with the development of several illnesses. This study focuses on learning how to make your home smoke-free.
Detailed description
This study will be conducted in two phases. Phase 1 will be qualitative focus groups/pilot study with the purpose to develop a motivationally enhanced biomarker feedback counseling protocol and all printed materials to be used in Phase 2. After investigators develop a good working treatment protocol, an active intervention in smoking homes who live with a child in their home will be carried out.
Those randomized to the Control Group will receive health education in the form of brochures detailing the health effects of secondhand smoke and how to make their home smoke free. Participants randomized to the Treatment Group will receive tobacco-specific biomarker feedback and personalized motivationally enhanced counseling.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group - Health Education | Active comparator | Behavioral: BrochureThis group is provided with information regarding secondhand smoke and creating a healthy home environment. |
| Treatment Group - Counseling | Active comparator | Behavioral: CounselingThis group is provided with biomarker feedback on child exposure to secondhand smoke. Active participants receive 5 counseling sessions from a trained research counselor; 3 sessions in the home and 2 by phone. The counseling sessions focus on changing smoking behaviors and/or other behaviors that impact smoking. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age 18 years or older
- Female
- Smoked ≥ 1 cigarettes per day for at least the past 6 months
- Smoked on 20 days or more in the last month
- Smoking status confirmed via cotinine verification strips
Key exclusion criteria (4 listed)
- Current or past 7 day use of Nicotine Replacement Therapy (NRT) or pharmacotherapy for smoking cessation
- Planning to move outside of Minnesota within the next 3 months
- Have complete home smoking restrictions currently in place verified by the nicotine dosimeter
- Currently pregnant
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 |
|---|---|---|
| BrochureInformation regarding secondhand smoke and creating a healthy home environment. | Behavioural | Control Group - Health Education |
| CounselingReceives brochure and counseling sessions focusing on changing smoking behaviors and/or other health behaviors. | Behavioural | Treatment Group - Counseling |
Primary outcome
Change in Home Secondhand Smoke levels
Time frame: From Baseline to Week 26 Follow-Up
Measured by nicotine dosimeter - a passive "badge" hung in the home that measures free floating airborne nicotine particles.
2 secondary outcomes
Comparison of Child Cotinine Levels in Urine
Time frame: From Baseline to Week 26 Follow-Up
Comparison of Questionnaire Results
Time frame: Baseline, Week 16 and Week 26
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 6 Aug 2014.
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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.
Janet L. Thomas, Ph.D. principal investigator
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brochure and Counseling in people with Smoking Cessation and Tobacco Cessation, run by University of Minnesota 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 14 inclusion and 4 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 6 Aug 2014. 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?
Change in Home Secondhand Smoke levels (time frame: From Baseline to Week 26 Follow-Up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2014; AzTrials last refreshed its copy on 31 Oct 2026.