A Smoke-Free Home Intervention in Tribal Communities

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Children under the age of 18 will not be included

Trial design

Design model

Parallel

Treatments tested in this trial

  • Best Practice

    Other intervention

    Receive usual care

  • Smoking Cessation Intervention

    Behavioral

    Receive the smoke-free home program

  • Survey Administration

    Other intervention

    Ancillary studies

Treatment groups

575 Participants
are divided into 2 treatment groups
Group A: Group I (smoke-free home program)Experimental treatment 2 interventions
Group B: Group II (waitlist control)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

Self-Reported Smoke-Free Home

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).

Time frame
At 3 and 6 months

Secondary outcomes

1

Smoke-Free Vehicles Assessed Via Telephone Interview

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.

Time frame
At 3 and 6 months
2

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

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.

Time frame
At 3 and 6 months
3

Number of Cigarettes Smoked In the Home

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.

Time frame
At 3 and 6 months
4

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

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).

Time frame
At 3 and 6 months

Other outcomes

Sponsors and contacts

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Emory University

Lead sponsor

National Cancer Institute (NCI)

Collaborator

National Institutes of Health (NIH)

Collaborator