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NCT Number: NCT06583148

A Smoke-Free Home Intervention in Tribal Communities

This clinical trial evaluates a smoke-free home intervention for reducing exposure to secondhand smoke from commercial tobacco in homes of participants who live in rural tribal communities. Smoke-free homes are an innovative and relatively untapped strategy for cancer prevention in rural tribal communities. Smoke-free policies, including those that target homes, can reduce exposure to secondhand smoke and support smoking cessation. Rural and racial/ethnic inequities intersect to increase tobacco-related harms among Indigenous populations. A smoke-free home program may improve the health of the household as well as impact smoking behavior among the family unit by reducing secondhand smoke exposure.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location status: Recruiting

Location contact

Michelle Kegler, DrPH, MPH

CONTACT

[email protected]

404-712-9957

Michelle Kegler, DrPH, MPH

PRINCIPAL_INVESTIGATOR

About this study

PRIMARY OBJECTIVE:

I. To assess the effectiveness of a smoke-free homes intervention for tribal communities.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I: Participants receive the smoke-free home program, consisting of mailed educational information about smoke-free homes at enrollment and in weeks 4 and 6, and attend one coaching call in week 2.

GROUP II: Participants receive usual care on study. Participants may optionally receive the smoke-free home program following the 6 months follow-up.

After completion of study intervention, participants are followed up at 3 and 6 months.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age and older
  • Self-report as being a smoker or living with a smoker
  • Indicate that they do not reside in a smoke-free home
  • Identify as living in an American Indian household

Exclusion criteria

  • Children under the age of 18 will not be included

Treatment and study plan

Best Practice

Other

Receive usual care

Other names: standard of care, standard therapy

Smoking Cessation Intervention

Behavioral

Receive the smoke-free home program

Other names: Smoking and Tobacco Use Cessation Interventions

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. Self-Reported Smoke-Free Home

    Time frame: At 3 and 6 months

    Which statement best describes rules about smoking inside your home? There are no rules about smoking inside your home? Smoking is not allowed anywhere inside your home? Smoking is allowed in some places or at some times in your home? Smoking is allowed anywhere inside your home? Those answering that smoking is not allowed anywhere inside their home are classified as having a smoke-free home. It will be self-reported & measured using air nicotine monitor from a subset of 20% participants to assess validity of the self-report, adjusting for possible traditional uses of tobacco and use of electronic cigarettes. Receiver-operator curve analysis to determine the optimal thresholds for a smoke-free home & complete case data, two-level logistic multilevel models accounting for nesting of participants in tribal communities with group assignment predicting a binary smoke-free home status (full ban/no full ban).

Secondary outcomes

  1. Smoke-Free Vehicles Assessed Via Telephone Interview

    Time frame: At 3 and 6 months

    Smoke-Free Vehicles will be assessed via telephone interview using a measure adapted from the Centers for Disease Control and Prevention (CDC)'s National Adult Tobacco Survey, 2009-2010. What about smoking cigarettes in your vehicle(s) (including cars, SUVs, and trucks) - would you say: There are no rules about smoking in the vehicle(s), smoking is sometimes allowed in the/some vehicle(s), smoking is never allowed in the/any vehicle, no car, don't know. Those answering smoking is never allowed in the/any vehicle are classified as having a smoke-free vehicle rule. We will use 3-level logistic growth curve models using Statistical Analysis System (SAS) procedure (PROC) Bayesian Generalized Linear Mixed Modeling (BGLIMM) to model all of the collected data. Data cleaning, descriptive analyses, as well as bivariate and multilevel modeling, will be conducted using Statistical Analysis System (SAS) version 9.4. Mediation analyses will be conducted in Mplus statistical software version 8.5.

  2. Secondhand Smoke (SHS) Exposure In The Home Assessed via Telephone Interview

    Time frame: At 3 and 6 months

    SHS exposure in the home will be assessed via telephone interview using a measure adapted from the Centers for Disease Control and Prevention (CDC)'s National Youth Tobacco Survey, 2023. During the past 7 days, how many days have people smoked in your home in your presence? Response options 0 to 7. We will use 3-level logistic growth curve models using Statistical Analysis System (SAS) procedure (PROC) Bayesian Generalized Linear Mixed Modeling (BGLIMM) to model all of the collected data. Data cleaning, descriptive analyses, as well as bivariate and multilevel modeling will be conducted using Statistical Analysis System (SAS) 9.4. Mediation analyses will be conducted in Mplus statistical software version 8.5.

  3. Number of Cigarettes Smoked In the Home

    Time frame: At 3 and 6 months

    Will use 3-level logistic growth curve models using Statistical Analysis System (SAS) procedure (PROC) Bayesian Generalized Linear Mixed Modeling (BGLIMM) to model all of the collected data. Data cleaning, descriptive analyses, as well as bivariate and multilevel modeling will be conducted using Statistical Analysis System (SAS) version 9.4. Mediation analyses will be conducted in Mplus statistical software version 8.5.

  4. Public Support for Smoke-Free Tribal Housing Assessed Via Telephone Interview

    Time frame: At 3 and 6 months

    To what extent do you support or oppose a complete cigarette smoking ban in the following settings: tribally owned multi-unit housing. Response options include a range from 1 (strongly oppose) to 4 (strongly support).

Study contacts

Contact information is provided by the study sponsor or research team.

Josh Kaufmann

CONTACT

[email protected]

404-727-7718

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

Assessing the Effectiveness of a Smoke-Free Home Program in Tribal Communities

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Sep 3, 2024
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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