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

918 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the Smoke-Free Homes treatment for smoking cessation?

The Smoke-Free Homes Program has been shown to be effective in promoting smoke-free environments in low-income populations, as evidenced by its successful implementation in 2-1-1 call centers. Additionally, interventions that combine smoke-free policies with tobacco dependence treatments are noted to be more effective, suggesting that the Smoke-Free Homes intervention could support smoking cessation efforts. ^{1 2 3 4 5}

Is the Smoke-Free Homes Intervention safe for humans?

The available research on the Smoke-Free Homes Intervention does not report any safety concerns for humans. The studies focus on promoting smoke-free environments and reducing smoking behavior, which are generally considered safe and beneficial for health. ^{2 4 6 7 8}

How is the Smoke-Free Homes intervention treatment different from other smoking cessation treatments?

The Smoke-Free Homes intervention is unique because it focuses on creating smoke-free environments in homes, particularly in low-income and supportive housing settings, rather than directly targeting individual smoking habits. This approach aims to reduce secondhand smoke exposure and encourage voluntary adoption of smoke-free policies, which can indirectly support smoking cessation. ^{1 2 4 9 10}

Research Team

Michelle Kegler, PhD

Principal Investigator

Emory University

Eligibility Criteria

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.

I am younger than 18 years old.

have another family or household member participating in the research

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2022]

2. England 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Factors associated with smoke-free homes in NSW: results from the 1998 NSW Health Survey. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Smoke-Free or Not: Attitudes Toward Indoor Smoke-Free Policies Among Permanent Supportive Housing Residents. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Smoke-Free Homes and Youth Smoking Behavior in Italy: Findings From the SIDRIAT Longitudinal Study. [2018]

7. Iran 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. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Cessation and reduction in smoking behavior: impact of creating a smoke-free home on smokers. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Smoke-Free Home Intervention in Permanent Supportive Housing: A Multifaceted Intervention Pilot. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Pilot study results from a brief intervention to create smoke-free homes. [2023]