Cessation, SmokingSFH 5A RCTNCT04547686
Efficacy of a Smoke-Free Homes Intervention
A study testing Smoke-Free Homes Intervention and Quitline in people with Cessation, Smoking, run by Emory University at 1 site in United States.
Trial summary
The purpose of this study is to test whether the integration of a smoke-free homes intervention into the clinical guidelines for tobacco cessation can encourage sustained smoking cessation in low-income primary care patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cessation, Smoking
- What is being tested?
- Smoke-Free Homes Intervention and Quitline
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 916 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2020to 27 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age and older
- referred by primary care physician or provider of a participating Federally Qualified Health Center (FQHC) in Georgia
- have smoked at least one cigarette in the past 30 days
- has ability to speak and understand English
- be the only patient per household to be enrolled in the study
- not currently be enrolled in a cessation program
Who cannot join
- non-smoker
- unable to speak or understand English
- under 18 years of age
- have another family or household member participating in the research
- vulnerable special populations will not be enrolled, including:
- adults unable to consent
Show all 11Show fewer
- pregnant women
- prisoners
- cognitively impaired or Individuals with Impaired Decision-Making Capacity
- not able to clearly understand English
- community participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Rollins School of Public Health, Emory University
Atlanta, Georgia, 30322
About this study
Official title: Randomized Controlled Trial to Test the Efficacy of a Smoke-Free Homes Intervention in Promoting Cessation
The purpose of this study is to test whether the integration of a smoke-free homes intervention into the clinical guidelines for tobacco cessation can encourage sustained smoking cessation in low-income primary care patients. The intervention consists of five components, three interactive mailings and two coaching calls, focused on creating home and vehicle(s) smoking bans among smokers.
Read the detailed description
Tobacco use remains the top preventable cause of death and disease in the U.S., is a major cause of cancer and cardiovascular disease, and is responsible for 480,000 deaths per year. Recent prevalence estimates show that 15.1% of adults (36.5 million) smoke cigarettes, with significant disparities in rates by socio-economic status and race/ethnicity. Among those living below poverty, 26.1% smoked in 2015, in contrast to 13.9% living above the poverty threshold. Smoking rates are also higher among those on Medicaid (27.8%), uninsured persons (27.4%) and those living in rural areas, particularly in the South. Quitting smoking reduces premature mortality and is beneficial to health across the lifespan. The majority (68.8%) of smokers would like to quit and over half try to quit in any given year. Unfortunately, of those who try to quit, a relatively small proportion succeed. Of significance to this study, just 7% to 20% plan to quit within the next 30 days.
Low-income populations, such as those served by a Federally Qualified Health Center (FQHC), are less likely to have a Smoke-Free Home (SFH). Nationally, in 2012-2013, among combustible-only tobacco users, 53.7% reported a SFH. Among those with an annual household income <$20,000, just 37.0% had a SFH. It increased to 48.5% for smokers with an annual household income between $20,000 and $49,999, and 63% for those with annual household incomes between $50,000 and $100,000. Given that the majority of FQHC patients live in poverty, we anticipate that over 60% of FQHC patients who smoke will not yet have a SFH.
This study is a randomized controlled trial with smokers from Federally Qualified Health Centers (FQHCs) in Georgia which will compare the efficacy of adding a smoke-free homes intervention to the currently recommended clinical guidelines on tobacco cessation. Participants in the intervention condition will receive the expanded Smoke-Free Homes intervention coupled with a connection to the quitline, if they are interested (the quitline is a free cessation counseling offered to all Georgia residents by the state of Georgia). The usual care/control arm will receive mailed information on the quitline immediately following the baseline interview and a connection to the quitline at their request. Follow-up will be at six and twelve months, including saliva cotinine validation for reported 7-day cessation.
- Conditions
- Cessation, Smoking
- Being tested
- Smoke-Free Homes Intervention, Quitline
- Keywords
- Smoke-Free, Home Intervention, Cessation
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoke-Free Homes InterventionBehavioural
The adapted smoke-free homes intervention consists of five components, three interactive mailings and two coaching calls, focused on creating home and vehicle(s) smoking bans among smokers. The intervention is based on principles of Social Cognitive Theory and the Transtheoretical Model's stages of change. The rationale underlying the intervention is that creation of additional smoke-free environments will reduce situational and environmental cues to smoke, reduce opportunities and places to smoke, increase self-efficacy for quitting and increase motivation to quit. The intervention uses persuasion, role modeling, behavioral contracting and goal setting to move smokers through behavioral capability, outcome expectations and self-efficacy for strict smoke-free rules, creation of and compliance/enforcement with smoke-free rules, reduced cigarettes smoked per day, increased motivation to quit, increased quit attempts, and successful cessation.
QuitlineBehavioural
The quitline is a phone number that people can call that offers free smoking cessation counseling to all Georgia residents by the state of Georgia.
| Study group | Role | What they receive |
|---|---|---|
| Smoke-Free Homes Intervention | Experimental | Participants in the intervention condition will receive the expanded Smoke-Free Homes intervention coupled with a connection to the quitline. Follow-up will be at six and twelve months, including saliva cotinine validation for reported 7-day cessation. Receives: Behavioral: Smoke-Free Homes Intervention; Behavioral: Quitline |
| Control | Active comparator | The usual care/control arm will receive mailed information on the quitline and a connection to the quitline at their request. Follow-up will be at six and twelve months, including saliva cotinine validation for reported 7-day cessation. Receives: Behavioral: Quitline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Achieving Smoking Cessation/Abstinence
Smoking cessation/abstinence is assessed as cotinine-validated 7-day point-prevalence abstinence at 12 months. Saliva samples were collected via mail from participants who report 7-day (and/or 30-day) point-prevalence abstinence at 12-month follow-up in order to examine cotinine levels to verify self-reported abstinence. A standard cut point for cotinine of 15 ng/ml is used to determine abstinence.
Measured: 12 months
Secondary outcomes (6)
Number of Participants Self-reporting 30-day Abstinence
Participants self-report abstinence from smoking during the prior 30 days.
Measured: 6 months, 12 months
Number of Cigarettes Smoked Per Day on Smoking Days
Participants are asked to report the number of cigarettes smoked per day, for daily smokers, on days that they smoked.
Measured: 6 months,12 months
Number of Quit Attempts
Participants were asked "How many times during the past 6 months have you stopped smoking for more than one day because you were trying to quit smoking?" to assess the number of attempts to quit smoking.
Measured: 6 months, 12 months
Number of Participants With Smoke-free Home Rules
Participants were asked to describe the rules about cigarette smoking inside their home. Possible responses are: There are no rules about smoking inside the home; Smoking is not allowed anywhere inside the home; Smoking is allowed in some places or at sometimes; Smoking is allowed anywhere inside the home. Responses are categorized as the home being smoke-free or not.
Measured: 6 months, 12 months
Number of Participants Smoke-free Vehicle Rules
Participants were asked to describe the rules about cigarette smoking inside their vehicle. Possible responses are: There are no rules about smoking inside vehicles; Smoking is sometimes allowed in some vehicles; Smoking is never allowed in any vehicle; No vehicle. Responses are categorized as vehicles being smoke-free or not.
Measured: 6 months, 12 months
Number of Cigarettes Smoked in the Home
Participants were asked to report the number of cigarettes smoked inside the home on a typical day, during the last 7 days.
Measured: 6 months,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start11 Nov 2020
- Primary completion27 Jul 2025
- Study completion27 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cessation, SmokingStudies of the same condition, open and under way.
- More trials run by Emory 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
- 916 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Michelle C. Kegler, Emory University
- Investigators
- Michelle Kegler, DrPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04547686
- Sponsor's protocol ID
- STUDY00001085
- Other IDs
- R01CA235721, 2025P013504
- Acronym
- SFH 5A RCT
- Status last verified
- Jul 2026
- First submitted
- 8 Sep 2020
- Last updated
- 18 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from the quantitative surveys at baseline and follow-up (6 and 12 month) will be made available for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Test the Efficacy of a Smoke-Free Homes Intervention in Promoting Cessation
- ClinicalTrials.gov ID
- NCT04547686
- Acronym / sponsor ID
- SFH 5A RCT / STUDY00001085
- Conditions
- Cessation, Smoking
- Keywords
- Smoke-Free, Home Intervention, Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 916 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- 27 Jul 2025 (actual)
- Study completion
- 27 Jul 2025 (actual)
- First posted
- 14 Sep 2020 (actual)
- Results
- Posted 18 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test whether the integration of a smoke-free homes intervention into the clinical guidelines for tobacco cessation can encourage sustained smoking cessation in low-income primary care patients. The intervention consists of five components, three interactive mailings and two coaching calls, focused on creating home and vehicle(s) smoking bans among smokers.
Detailed description
Tobacco use remains the top preventable cause of death and disease in the U.S., is a major cause of cancer and cardiovascular disease, and is responsible for 480,000 deaths per year. Recent prevalence estimates show that 15.1% of adults (36.5 million) smoke cigarettes, with significant disparities in rates by socio-economic status and race/ethnicity. Among those living below poverty, 26.1% smoked in 2015, in contrast to 13.9% living above the poverty threshold. Smoking rates are also higher among those on Medicaid (27.8%), uninsured persons (27.4%) and those living in rural areas, particularly in the South. Quitting smoking reduces premature mortality and is beneficial to health across the lifespan. The majority (68.8%) of smokers would like to quit and over half try to quit in any given year. Unfortunately, of those who try to quit, a relatively small proportion succeed. Of significance to this study, just 7% to 20% plan to quit within the next 30 days.
Low-income populations, such as those served by a Federally Qualified Health Center (FQHC), are less likely to have a Smoke-Free Home (SFH). Nationally, in 2012-2013, among combustible-only tobacco users, 53.7% reported a SFH. Among those with an annual household income <$20,000, just 37.0% had a SFH. It increased to 48.5% for smokers with an annual household income between $20,000 and $49,999, and 63% for those with annual household incomes between $50,000 and $100,000. Given that the majority of FQHC patients live in poverty, we anticipate that over 60% of FQHC patients who smoke will not yet have a SFH.
This study is a randomized controlled trial with smokers from Federally Qualified Health Centers (FQHCs) in Georgia which will compare the efficacy of adding a smoke-free homes intervention to the currently recommended clinical guidelines on tobacco cessation. Participants in the intervention condition will receive the expanded Smoke-Free Homes intervention coupled with a connection to the quitline, if they are interested (the quitline is a free cessation counseling offered to all Georgia residents by the state of Georgia). The usual care/control arm will receive mailed information on the quitline immediately following the baseline interview and a connection to the quitline at their request. Follow-up will be at six and twelve months, including saliva cotinine validation for reported 7-day cessation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smoke-Free Homes Intervention | Experimental | Behavioral: Smoke-Free Homes Intervention, Behavioral: QuitlineParticipants in the intervention condition will receive the expanded Smoke-Free Homes intervention coupled with a connection to the quitline. Follow-up will be at six and twelve months, including saliva cotinine validation for reported 7-day cessation. |
| Control | Active comparator | Behavioral: QuitlineThe usual care/control arm will receive mailed information on the quitline and a connection to the quitline at their request. Follow-up will be at six and twelve months, including saliva cotinine validation for reported 7-day cessation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age and older
- referred by primary care physician or provider of a participating Federally Qualified Health Center (FQHC) in Georgia
- have smoked at least one cigarette in the past 30 days
- has ability to speak and understand English
- be the only patient per household to be enrolled in the study
Key exclusion criteria (11 listed)
- non-smoker
- unable to speak or understand English
- under 18 years of age
- have another family or household member participating in the research
- vulnerable special populations will not be enrolled, including:
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 |
|---|---|---|
| Smoke-Free Homes InterventionThe adapted smoke-free homes intervention consists of five components, three interactive mailings and two coaching calls, focused on creating home and vehicle(s) smoking bans among smokers. The intervention is based on principles of Social Cognitive Theory and the Transtheoretical Model's stages of change. The rationale underlying the intervention is that creation of additional smoke-free environments will reduce situational and environmental cues to smoke, reduce opportunities and places to smoke, increase self-efficacy for quitting and increase motivation to quit. The intervention uses persuasion, role modeling, behavioral contracting and goal setting to move smokers through behavioral capability, outcome expectations and self-efficacy for strict smoke-free rules, creation of and compliance/enforcement with smoke-free rules, reduced cigarettes smoked per day, increased motivation to quit, increased quit attempts, and successful cessation. | Behavioural | Smoke-Free Homes Intervention |
| QuitlineThe quitline is a phone number that people can call that offers free smoking cessation counseling to all Georgia residents by the state of Georgia. | Behavioural | Control, Smoke-Free Homes Intervention |
Primary outcome
Number of Participants Achieving Smoking Cessation/Abstinence
Time frame: 12 months
Smoking cessation/abstinence is assessed as cotinine-validated 7-day point-prevalence abstinence at 12 months. Saliva samples were collected via mail from participants who report 7-day (and/or 30-day) point-prevalence abstinence at 12-month follow-up in order to examine cotinine levels to verify self-reported abstinence. A standard cut point for cotinine of 15 ng/ml is used to determine abstinence.
6 secondary outcomes
Number of Participants Self-reporting 30-day Abstinence
Time frame: 6 months, 12 months
Number of Cigarettes Smoked Per Day on Smoking Days
Time frame: 6 months,12 months
Number of Quit Attempts
Time frame: 6 months, 12 months
Number of Participants With Smoke-free Home Rules
Time frame: 6 months, 12 months
Number of Participants Smoke-free Vehicle Rules
Time frame: 6 months, 12 months
Number of Cigarettes Smoked in the Home
Time frame: 6 months,12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data from the quantitative surveys at baseline and follow-up (6 and 12 month) will be made available for sharing.
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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.
Michelle Kegler, DrPH principal investigator
Emory 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 Smoke-Free Homes Intervention and Quitline in people with Cessation, Smoking, run by Emory 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 6 inclusion and 11 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 18 Aug 2026. 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?
Yes. Results are posted in the registry (first posted 18 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Achieving Smoking Cessation/Abstinence (time frame: 12 months). 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 18 Aug 2026.