Smoke-Free Homes Intervention for Secondhand Smoke

(SFHAMGE Trial)

Recruiting at 1 trial location

Overseen By Carla Berg

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: George Washington University

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

Compensation: Varies

Number of Visits: 6

550 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to reduce secondhand smoke exposure and tobacco use in homes in Armenia and Georgia. It will test an intervention using educational materials and coaching calls to promote smoke-free homes. Participants will either receive these resources or join a control group with no intervention. People who smoke indoors and live with a child or non-smoker, or non-smokers living with smokers, may be suitable for this trial. The goal is to create healthier home environments and reduce health disparities related to tobacco use.

As an unphased trial, this study allows participants to contribute to important research that could lead to healthier living conditions.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this smoke-free homes intervention is safe?

Research has shown that programs encouraging smoke-free homes are generally safe for participants. These programs effectively reduce exposure to secondhand smoke, which causes health problems, particularly affecting the lungs and heart. For instance, a study in Scotland found that similar efforts led to fewer hospital visits for children due to secondhand smoke.

Participants in related studies have strongly supported adopting smoke-free home policies. In trials involving about 500 households each, many homes remained smoke-free after the program. These results suggest that the program is well-received and can lead to better health outcomes without causing harm. ^{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 fresh approach to reducing secondhand smoke exposure. Unlike typical methods that might focus on smoking cessation programs or public smoking bans, this intervention uses a combination of educational materials and motivational interviewing delivered through mailed packages and coaching calls. This personalized and proactive strategy aims to empower individuals to create smoke-free environments at home, which could lead to significant health benefits for non-smokers, especially children. By targeting behavior change directly in the home setting, the intervention has the potential to make a tangible impact on family health and well-being.

What evidence suggests that the smoke-free homes intervention is effective for reducing secondhand smoke exposure?

Research has shown that programs encouraging smoke-free homes can successfully reduce exposure to secondhand smoke. In this trial, participants in the intervention arm will receive a theory-based intervention with educational materials and a coaching call. Studies have found that such programs significantly increase the number of households adopting no-smoking rules. In trials with about 500 participants each, 38% to 63% of households maintained smoke-free homes six months later. Additionally, family-focused programs have led to a noticeable decrease in daily cigarette use and more attempts to quit smoking. These findings suggest that smoke-free home programs can help create healthier living spaces by reducing secondhand smoke exposure. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 18 in Armenia and Georgia who either smoke at home with a child or non-smoker present, or are non-smokers living with someone who smokes indoors. Participants must speak Armenian or Georgian and reside in selected communities.

Inclusion Criteria

Live in a selected community

Smoke in the home and have a child and/or nonsmoker in the home, or be a non-smoker and live with someone who smokes in the home

I speak Armenian or Georgian.

Exclusion Criteria

N/A

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Theory-based intervention involving 3 mailed sets of educational materials and a brief coaching call using motivational interviewing, delivered over a 6-week period

6 weeks

3 mailed sets, 1 coaching call

Follow-up

Participants are monitored for smoke-free home adoption and other outcomes

6 months

Assessments at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Smoke-free homes intervention

Trial Overview The study is testing an intervention designed to create smoke-free homes (SFHs) to reduce secondhand smoke exposure. It's being conducted as a hybrid effectiveness-implementation randomized controlled trial (RCT) across selected communities.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Theory-based intervention involving 3 mailed sets of educational materials and a brief coaching call using motivational interviewing, delivered over a 6-week period

Group II: Control Active Control 1 Intervention

Assessment-only control

Who Is Running the Clinical Trial?

George Washington University

Lead Sponsor

Trials

263

Recruited

476,000+

Citations

1. 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 ...

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

Smoke-Free Homes Our main outcome was the implementation of smoking bans in the homes and the related reduction in secondhand smoke exposure. Data were collected at baseline, ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2589537025003529

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

4. stacks.cdc.gov stacks.cdc.gov/view/cdc/22743/cdc_22743_DS1.pdf

Research Article Pilot Study Results from a Brief ... The baseline survey included questions related to smoking history, secondhand smoke exposure, cigarette consumption, cessation attempts, household com- position ...

5. tobaccopreventioncessation.com tobaccopreventioncessation.com/Smoke-free-homes-The-final-frontier,142772,0,2.html

Smoke-free homes: The final frontier An urgent need to reduce exposure to SHS in women and children through implementing effective, affordable, inclusive, feasible and sustainable solutions.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11601997/

A Systematic Review of the Impact of Secondhand Smoke ... Exposure to SHS has been thoroughly linked to detrimental health outcomes, particularly in the respiratory and cardiovascular systems [5]. In ...

7. thelancet.com thelancet.com/journals/lanpub/article/PIIS2468-2667(20)30178-X/fulltext

Associations between a smoke-free homes intervention ... In summary, we found that two initiatives aimed at reducing harm to children from second-hand smoke in Scotland were associated with decreases in hospital ...

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. amchp.org amchp.org/wp-content/uploads/2022/02/LC-28_ExposureSecondhand_Final_8-6-2014.pdf

Life course indicator: Exposure to secondhand smoke ... Children suffer from serious health risks due to second hand smoke exposure including new cases of asthma and exacerbation of asthma symptoms, Sudden Infant ...