Smoke-Free Homes Intervention for Smoking Cessation

(SFH 5A RCT Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Non-smoker, Pregnant, Prisoners, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help people quit smoking by integrating a smoke-free homes intervention into standard smoking cessation guidelines. The approach includes interactive mailings and coaching calls to encourage bans on smoking in homes and vehicles. It targets smokers who have had a cigarette in the past 30 days, are connected with a primary care provider in Georgia, and are not part of another quitting program. Researchers will check participants at six and twelve months to confirm smoking cessation using a saliva test. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative smoking cessation strategies.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Smoke-Free Homes intervention is safe for smoking cessation?

Research has shown that making homes smoke-free is generally well-received by participants. One study found that when homes are smoke-free, people tend to smoke fewer cigarettes each day, indicating that these interventions are usually safe and can help people quit smoking.

Another study found that people who set smoke-free rules at home tried to quit smoking more often and were less likely to start again, demonstrating more attempts to stop smoking and fewer relapses. Additionally, strong support exists for creating smoke-free environments, indicating that people find this approach acceptable.

Overall, these findings suggest that the Smoke-Free Homes intervention is a safe way to help people stop smoking. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Smoke-Free Homes intervention because it offers a comprehensive approach to smoking cessation by targeting the home environment. Unlike standard treatments that primarily focus on individual behavior change, this intervention involves creating a smoke-free living space and connects participants to quitline support, enhancing accountability and motivation. This dual approach not only helps individuals quit smoking but also protects non-smokers in the household from secondhand smoke, providing a more holistic benefit. By validating outcomes through saliva cotinine levels, the intervention also ensures accurate assessment of smoking cessation, making it a promising alternative to conventional methods.

What evidence suggests that the Smoke-Free Homes intervention is effective for smoking cessation?

Research has shown that the Smoke-Free Homes program helps create smoke-free environments in homes and cars. One study found that more participants in the program reported completely banning smoking in their homes compared to those not in the program, with 30.4% versus 14.9% after three months. Other studies have also found that more participants in the program made their homes smoke-free than those who didn't join. Participants in this trial will receive the expanded Smoke-Free Homes intervention, which has led to bigger drops in daily smoking and more attempts to quit. These results suggest that this program can help smokers quit by encouraging smoke-free living spaces. ^{3 6 7 8 9}

Who Is on the Research Team?

Michelle Kegler, PhD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for adult smokers referred by a primary care physician from a participating health center in South Georgia, who have smoked recently but aren't in another cessation program. Participants must speak and understand English, be the only person from their household to join, and not be pregnant or unable to consent.

Inclusion Criteria

There is no specific criterion provided. Please provide more context or information to help me better understand what you mean by "community participation".

You are pregnant.

You have smoked a cigarette within the last 30 days.

Exclusion Criteria

You do not smoke cigarettes.

have another family or household member participating in the research

You do not understand or speak English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the Smoke-Free Homes intervention, including interactive mailings and coaching calls, and may connect to the quitline

6 months

3 mailings, 2 coaching calls

Follow-up

Participants are monitored for smoking cessation and smoke-free home establishment at six and twelve months

12 months

2 follow-up assessments (6 and 12 months)

What Are the Treatments Tested in This Trial?

Interventions

• Smoke-Free Homes intervention
• Smoke-Free Homes Intervention

Trial Overview The study tests if adding a smoke-free homes intervention into tobacco quitting guidelines helps people stop smoking. It includes three mailings and two coaching calls aimed at creating no-smoking rules at home and in cars.

How Is the Trial Designed?

Group I: Smoke-Free Homes Intervention Experimental Treatment 2 Interventions

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.

Group II: Control Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Michelle C. Kegler

Lead Sponsor

Trials

1

Recruited

920+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Creating a smoke-free home (SFH) significantly increases the likelihood of quitting smoking among low-income smokers, with effects observed at both 3-month and 6-month follow-ups in a study involving 941 participants.

For smokers who did not quit, those with a SFH reported a greater reduction in daily cigarette consumption and more frequent quit attempts compared to those without a SFH, indicating that SFHs can support smoking reduction efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cessation and reduction in smoking behavior: impact of creating a smoke-free home on smokers. Haardörfer, R., Kreuter, M., Berg, CJ., et al.[2020]

A study involving 36 residents in permanent supportive housing revealed that while support for indoor smoking bans was modest (33.1%), a significant majority (77.8%) would not move due to a smoking ban, indicating potential feasibility for smoke-free policies.

Residents expressed interest in quitting smoking, but barriers such as co-use of tobacco with other substances and concerns about financial and housing stability need to be addressed to effectively implement smoke-free policies and cessation services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoke-Free or Not: Attitudes Toward Indoor Smoke-Free Policies Among Permanent Supportive Housing Residents. Petersen, AB., Elser, H., Nguyen, T., et al.[2020]

The Smoke-Free Homes (SFH) Program was found to be acceptable and feasible for implementation across multiple 2-1-1 sites, with 70% of staff believing it contributed to more smoke-free homes in their communities.

Despite its perceived effectiveness, challenges such as sustainability, resource demands, and integration into existing workflows were significant barriers to successful implementation, highlighting the need for ongoing support and funding for future tobacco control initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing an Evidence-based Tobacco Control Program at Five 2-1-1 Call Centers: An Evaluation Using the Consolidated Framework for Implementation Research. Thompson, T., Kreuter, MW., Caito, N., et al.[2023]

This study will evaluate the effectiveness of an educational intervention aimed at 136 non-smoker women exposed to second-hand smoke at home, focusing on creating smoke-free environments through women's empowerment and education.

If successful, the intervention could lead to a significant reduction in second-hand smoke exposure at home, suggesting that integrating this educational program into routine care at primary health-care centers could be beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Study Protocol of Women's Education to Create Smoke-free Home on the Basis of Family Ties in Isfahan, Iran. Zamani, A., Golshiri, P., Moqtader, B.[2021]

The 'Staying Free' program is a research-based smoking cessation model specifically designed for hospitalized patients, highlighting the importance of utilizing hospital stays as a chance to promote quitting smoking.

Insights gained from implementing this program suggest a systematic approach is essential for effectively integrating smoking cessation interventions into clinical practice and training for healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating smoking cessation research findings into clinical practice: the "staying free" program. Miller, NH.[2019]

The 'Don't smoke in our home' trial, involving 218 women, showed that while brief counseling did not significantly enhance the implementation of totally smoke-free homes and cars, written materials alone led to modest increases in smoke-free environments among participants.

Despite the intervention, only a small percentage of smokers quit or reduced smoking indoors and in cars, indicating that while awareness and resources can help, more effective strategies are needed to achieve substantial behavior change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The "Don't smoke in our home" randomized controlled trial to protect children from second-hand smoke exposure at home. Chellini, E., Gorini, G., Carreras, G.[2022]

Youths living in smoke-free homes (SFH) were significantly less likely to become established smokers over an 11-year period, with those in non-SFH being nearly twice as likely to start smoking compared to their peers in SFH.

The study found that the protective effect of SFH applied to both children and adolescents, regardless of whether their parents smoked, highlighting the importance of implementing household smoking bans to reduce smoking initiation among youths.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoke-Free Homes and Youth Smoking Behavior in Italy: Findings From the SIDRIAT Longitudinal Study. Gorini, G., Carreras, G., Cortini, B., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4330868/

A Minimal Intervention to Promote Smoke-Free Homes ... Significantly more intervention participants reported a full ban on smoking in the home than control participants 3 months postbaseline (30.4% vs 14.9%; P < .

2. sph.emory.edu sph.emory.edu/eprc/research/smoke-free-homes

Smoke-Free Homes Our results showed that more intervention participants made their home smoke-free than comparison participants. We next conducted an effectiveness trial in ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7368345/

Disseminating a Smoke-free Homes Program to Low ... All three RCTs, with a sample size around 500 per trial, showed significant program effects, with 38%–63% of households reached for follow-up at 6 months ...

4. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(25)00352-9/fulltext

Effectiveness of family-based behavioral intervention for ... Parents receiving family-based behavioral interventions showed greater reductions in daily cigarette consumption, increased quit attempts, improved indoor air ...

5. bmjpublichealth.bmj.com bmjpublichealth.bmj.com/content/2/1/e000843

Comparing acceptance of smoking cessation and ... Results In each arm, 59.7% of participants accepted the quitline offer. In arm 2, among those who declined the quitline offer, 53.1% accepted ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7334872/

Smokefree home rules and cigarette smoking intensity ... The results of the present study suggest that making homes smokefree may encourage reduction in CPD among daily smokers at different stages of smoking cessation ...

7. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-022-14423-y

The smoke-free home study: study protocol for a cluster ... In prior population-based studies, a smoke-free home was associated with reduced consumption, increased quit attempts [16, 17], reduced relapse ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2772724625000460

Cigarette Smoke-free Home Adoption Attempts Among ... One-third of resident participants made smoke-free home adoption attempts. Found substantial support for smoke-free policies among participants.

9. cancercontrol.cancer.gov cancercontrol.cancer.gov/sites/default/files/2023-02/FINAL%20-%20GI_1R01CA248551-01A1.pdf

Establishing smoke-free homes with families involved in child ... The main effect of the intervention will be assessed using self-report of the home smoking rule and air monitor data 8 weeks post-baseline. We will use complete ...