Chronic DiseaseNCT01868672
Brief Intervention to Create Smoke-Free Homes Policies in Low-Income Households: North Carolina Effectiveness Trial
A study testing Educational print materials and coaching call in people with Chronic Disease, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The burden of tobacco use falls disproportionately on low-income populations, through high rates of primary smoking and exposure to secondhand smoke. The remarkable progress in creating smoke-free environments in the U.S. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Educational print materials and coaching call
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Jul 2014
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be 18 years of age or older.
- Must speak and understand English.
- Must smoke and live with at least one other non-smoking person OR be a non-smoker who lives with a smoker(s).
- Must not have a total smoking ban in their home.
Who cannot join
- All participants who are not in immediate crisis will be invited to participate in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
The burden of tobacco use falls disproportionately on low-income populations, through high rates of primary smoking and exposure to secondhand smoke. The remarkable progress in creating smoke-free environments in the U.S. over the past two decades has left smoker's homes as one of the primary sources of exposure to secondhand smoke for both children and nonsmoking adults. Intervention research that identifies effective and practical strategies for reaching the minority of households that still allow smoking in the home has considerable potential to reduce smoke exposure, but suitable channels to reach low-income families are limited.
The proposed research will systematically test an intervention designed to create smoke-free homes in low income households among 2-1-1 callers. During this randomized control trial, researchers will disseminate and evaluate a brief smoke-free homes intervention through the established infrastructure of a North Carolina 2-1-1 call center. 2-1-1 is a nationally designated 3-digit telephone exchange, similar to 9-1-1 for emergencies or 4-1-1 for directory assistance, that links callers to community-based health and social services. The main hypothesis to be tested is that a higher proportion of households in the intervention group will establish and maintain a smoke-free home than in the measures-only control group.
- Conditions
- Chronic Disease
- Being tested
- Educational print materials and coaching call
- Keywords
- Secondhand smoke exposure, Smoke-free homes, Smoke-free home bans
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational print materials and coaching callBehavioural
Intervention group participants receive three sets of mailed educational materials about making their home smoke-free and one coaching call.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participant receives usual care. |
| Intervention | Experimental | Educational print materials and coaching call: Intervention group participants receive three sets of mailed educational materials about making their home smoke-free and one coaching call. Receives: Behavioral: Educational print materials and coaching call |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of a total home smoking ban
Measured: Change from baseline in reported total home smoking bans at 3-month and 6-month follow-up
Secondary outcomes (5)
Weekly secondhand smoke exposure for non-smokers
Measured: Change from baseline in reported secondhand smoke exposure fro non-smokers at 3-month and 6-month follow-up
Cessation attempts (for smokers)
Measured: Change from baseline in reported cessation attempts (for smokers) at 3-month and 6-month follow-up
Number of cigarettes smoked (for smokers)
Measured: Change from baseline in reported number of cigarettes smoked (for smokers) at 3-month and 6-month follow-up
Stage of change to quit smoking (for smokers)
Measured: Change from baseline in stage of change to quit smoking (for smokers) at 3-month and 6-month follow-up
Successful cessation (for smokers)
Measured: Change from baseline in successful cessation (for smokers) at 3-month and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Emory University, The University of Texas Health Science Center, Houston, Washington University School of Medicine
- Responsible party
- Sponsor
- Investigators
- Rebecca S Williams, MHS, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868672
- Sponsor's protocol ID
- 13-1808
- Other IDs
- U01CA154282
- Status last verified
- Aug 2014
- First submitted
- 30 May 2013
- Last updated
- 4 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kegler MC, Escoffery C, Bundy L, Berg CJ, Haardorfer R, Yembra D, Schauer G. Pilot study results from a brief intervention to create smoke-free homes. J Environ Public Health. 2012;2012:951426. doi: 10.1155/2012/951426. Epub 2012 May 17.
PubMed 22675374Escoffery C, Bundy L, Carvalho M, Yembra D, Haardorfer R, Berg C, Kegler MC. Third-hand smoke as a potential intervention message for promoting smoke-free homes in low-income communities. Health Educ Res. 2013 Oct;28(5):923-30. doi: 10.1093/her/cyt056. Epub 2013 May 13.
PubMed 23669213
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Intervention to Create Smoke-Free Homes Policies in Low-Income Households: North Carolina Effectiveness Trial
- ClinicalTrials.gov ID
- NCT01868672
- Acronym / sponsor ID
- 13-1808
- Conditions
- Chronic Disease
- Keywords
- Secondhand smoke exposure, Smoke-free homes, Smoke-free home bans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Emory University, The University of Texas Health Science Center, Houston, Washington University School of Medicine
- Study start
- Jun 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 4 Jun 2013 (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.
The burden of tobacco use falls disproportionately on low-income populations, through high rates of primary smoking and exposure to secondhand smoke. The remarkable progress in creating smoke-free environments in the U.S. over the past two decades has left smoker's homes as one of the primary sources of exposure to secondhand smoke for both children and nonsmoking adults. Intervention research that identifies effective and practical strategies for reaching the minority of households that still allow smoking in the home has considerable potential to reduce smoke exposure, but suitable channels to reach low-income families are limited.
The proposed research will systematically test an intervention designed to create smoke-free homes in low income households among 2-1-1 callers. During this randomized control trial, researchers will disseminate and evaluate a brief smoke-free homes intervention through the established infrastructure of a North Carolina 2-1-1 call center. 2-1-1 is a nationally designated 3-digit telephone exchange, similar to 9-1-1 for emergencies or 4-1-1 for directory assistance, that links callers to community-based health and social services. The main hypothesis to be tested is that a higher proportion of households in the intervention group will establish and maintain a smoke-free home than in the measures-only control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participant receives usual care. |
| Intervention | Experimental | Behavioral: Educational print materials and coaching callEducational print materials and coaching call: Intervention group participants receive three sets of mailed educational materials about making their home smoke-free and one coaching call. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be 18 years of age or older.
- Must speak and understand English.
- Must smoke and live with at least one other non-smoking person OR be a non-smoker who lives with a smoker(s).
- Must not have a total smoking ban in their home.
Key exclusion criteria (1 listed)
- All participants who are not in immediate crisis will be invited to participate in the study.
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 |
|---|---|---|
| Educational print materials and coaching callIntervention group participants receive three sets of mailed educational materials about making their home smoke-free and one coaching call. | Behavioural | Intervention |
Primary outcome
Presence of a total home smoking ban
Time frame: Change from baseline in reported total home smoking bans at 3-month and 6-month follow-up
5 secondary outcomes
Weekly secondhand smoke exposure for non-smokers
Time frame: Change from baseline in reported secondhand smoke exposure fro non-smokers at 3-month and 6-month follow-up
Cessation attempts (for smokers)
Time frame: Change from baseline in reported cessation attempts (for smokers) at 3-month and 6-month follow-up
Number of cigarettes smoked (for smokers)
Time frame: Change from baseline in reported number of cigarettes smoked (for smokers) at 3-month and 6-month follow-up
Stage of change to quit smoking (for smokers)
Time frame: Change from baseline in stage of change to quit smoking (for smokers) at 3-month and 6-month follow-up
Successful cessation (for smokers)
Time frame: Change from baseline in successful cessation (for smokers) at 3-month and 6-month follow-up
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 4 Aug 2014.
- Background: PubMed 22675374Kegler MC, Escoffery C, Bundy L, Berg CJ, Haardorfer R, Yembra D, Schauer G. Pilot study results from a brief intervention to create smoke-free homes. J Environ Public Health. 2012;2012:951426. doi: 10.1155/2012/951426. Epub 2012 May 17.
- Background: PubMed 23669213Escoffery C, Bundy L, Carvalho M, Yembra D, Haardorfer R, Berg C, Kegler MC. Third-hand smoke as a potential intervention message for promoting smoke-free homes in low-income communities. Health Educ Res. 2013 Oct;28(5):923-30. doi: 10.1093/her/cyt056. Epub 2013 May 13.
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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.
Rebecca S Williams, MHS, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational print materials and coaching call in people with Chronic Disease, run by University of North Carolina, Chapel Hill 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 4 inclusion and 1 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 4 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?
Presence of a total home smoking ban (time frame: Change from baseline in reported total home smoking bans at 3-month and 6-month follow-up). 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 NCT01868672, which also lists 2 linked publications.
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 4 Aug 2014.