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Efficacy of a Smoke-Free Homes Intervention

Randomized Controlled Trial to Test the Efficacy of a Smoke-Free Homes Intervention in Promoting Cessation

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04547686
Acronym
SFH 5A RCT
Enrollment
916
Registered
2020-09-14
Start date
2020-11-11
Completion date
2025-07-27
Last updated
2026-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cessation, Smoking

Keywords

Smoke-Free, Home Intervention, Cessation

Brief 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. 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.

Interventions

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.

BEHAVIORALQuitline

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.

Sponsors

Emory University
Lead SponsorOTHER
National Institutes of Health (NIH)
CollaboratorNIH
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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 * pregnant women * prisoners * cognitively impaired or Individuals with Impaired Decision-Making Capacity * not able to clearly understand English * community participation

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Achieving Smoking Cessation/Abstinence12 monthsSmoking 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.

Secondary

MeasureTime frameDescription
Number of Participants Self-reporting 30-day Abstinence6 months, 12 monthsParticipants self-report abstinence from smoking during the prior 30 days.
Number of Cigarettes Smoked Per Day on Smoking Days6 months,12 monthsParticipants are asked to report the number of cigarettes smoked per day, for daily smokers, on days that they smoked.
Number of Quit Attempts6 months, 12 monthsParticipants 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.
Number of Participants With Smoke-free Home Rules6 months, 12 monthsParticipants 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.
Number of Participants Smoke-free Vehicle Rules6 months, 12 monthsParticipants 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.
Number of Cigarettes Smoked in the Home6 months,12 monthsParticipants were asked to report the number of cigarettes smoked inside the home on a typical day, during the last 7 days.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMichelle Kegler, DrPH

Emory University

Participant flow

Recruitment details

Participants were referred by primary care providers of participating Federally Qualified Health Centers (FQHC) in Georgia, USA. Participant enrollment began November 11, 2020 and all follow-up assessments were completed by July 27, 2025.

Baseline characteristics

Characteristic
Age, Continuous50.6 years
STANDARD_DEVIATION 12.75
Education
College graduate
50 Participants
Education
High School/General Educational Development (GED)
187 Participants
Education
Less than High School/some High School
129 Participants
Education
Vocational-technical school/some college
97 Participants
Household size
1 Person Living in Household
104 Participants
Household size
2 People Living in Household
131 Participants
Household size
3 People Living in Household
103 Participants
Household size
4 People Living in Household
72 Participants
Household size
5 or More People Living in Household
122 Participants
Household size
Missing
1 Participants
Race/Ethnicity, Customized
Hispanic
13 Participants
Race/Ethnicity, Customized
More than one race
11 Participants
Race/Ethnicity, Customized
Non-Hispanic Black
580 Participants
Race/Ethnicity, Customized
Non-Hispanic White
137 Participants
Race/Ethnicity, Customized
Other
2 Participants
Race/Ethnicity, Customized
Unknown or not reported
7 Participants
Region of Enrollment
United States
449 Participants
Sex/Gender, Customized
Female
297 Participants
Sex/Gender, Customized
Male
150 Participants
Sex/Gender, Customized
Other
1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
2 / 4670 / 449
other
Total, other adverse events
0 / 4670 / 449
serious
Total, serious adverse events
0 / 4670 / 449

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 19, 2026