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Smoke-free Air Coalitions in Georgia and Armenia

Smoke-free Air Coalitions in Georgia and Armenia: A Community Randomized Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03447912
Enrollment
2924
Registered
2018-02-27
Start date
2018-10-01
Completion date
2022-06-30
Last updated
2023-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking

Keywords

Behavioral intervention, Social intervention, Public health, Smoking behavior

Brief summary

This is a matched-pairs community randomized controlled trial (CRCT) to examine the impact of coalitions promoting smoke-free air policies on individual secondhand smoke exposure (SHSe). This proposal will build the capacity of Georgia (GE) and Armenia (AM) researchers to conduct high-quality mixed methods tobacco research and test the Community Coalition Action Theory (CCAT) as a framework for impacting local community-driven policy change to inform such processes for the region more broadly. Researchers from the GE National Center for Disease Control (NCDC) and AM National Institute of Health (NIH) will collaborate with Emory to execute the proposed research, train tobacco control researchers within their organizations and partnering universities, and train practitioners within local communities to build local coalitions for tobacco control policy. Twenty-eight communities (14 per country) will participate in the population-level tobacco survey at baseline and follow-up. Within each country, 7 communities will be randomized to the intervention condition and 7 to the control condition (14 communities per condition). In the intervention communities, public health center staff will form a coalition by recruiting partner organizations from civil society and other government sectors (e.g., health care, education), conduct situational assessment, and develop and implement action plans to promote the adoption and enforcement of smoke-free policies primarily in indoor and outdoor public places (e.g., worksites, hospitality). The GE NCDC and AM NIH will establish subcontracts with the local public health centers in the randomly selected communities to provide funding for local staff to develop local coalitions and to support program activities. The 14 communities assigned as controls will participate in the population-level survey and be provided with a site-specific summary of findings but will not participate in any aspects of the intervention. Additionally, to examine potential contamination in the control communities, a follow-up interview will be conducted with public health center leaders to assess any local coalition or grassroots actions regarding tobacco control that may have naturally occurred or be influenced by coalition activity in other communities.

Detailed description

Public health efforts in low- and middle-income countries (LMICs) could be catalyzed by bolstering ways to optimally leverage local talents and resources, such as civil society. Developing effective models for aligning civil society and governmental public health at the local level in LMICs has the potential to impact a range of chronic diseases and risk factors, including tobacco use. Local coalitions have been a dominant strategy in tobacco control in the US, with well-documented success in establishing smoke-free policies specifically. However, this approach has not been widely leveraged or well-studied in LMICs or those with less democratic traditions than the US. Instead, in many LMICs, smoke-free policy progress is largely initiated at the national level. Parallel civil society movements at the local level may be needed to build support for and compliance with policies. Given their sociopolitical histories and high tobacco use and secondhand smoke exposure (SHSe) rates, Georgia (GE) and Armenia (AM) are two strategic settings for the proposed work. The smoking prevalence is 57.7% and 52.3% in men (6th and 11th highest in the world) and 5.7% and 1.5% in women, respectively. Moreover, previous findings indicate extremely high rates of SHSe. However, there is also documented high receptivity to public smoke-free policies despite high use rates. In this matched-pairs community randomized controlled trial (CRCT), the impact of coalitions promoting smoke-free air policies on individual secondhand smoke exposure (SHSe) will be examined. The Emory team will lead the oversight of the research design and execution of all components of the research. This proposal will build the capacity of Georgia (GE) and Armenia (AM) researchers to conduct high-quality mixed methods tobacco research and test the Community Coalition Action Theory (CCAT) as a framework for impacting local community-driven policy change to inform such processes for the region more broadly. Researchers from the GE National Center for Disease Control (NCDC) and AM National Institute of Health (NIH) will collaborate with Emory to execute the proposed research, train tobacco control researchers within their organizations and partnering universities (Tbilisi State Medical University, American University of Armenia), and train practitioners within local communities to build local coalitions for tobacco control policy. This study aims to: 1. conduct a matched-pair community randomized controlled trial in 28 municipalities in GE and AM to examine the impact of local coalitions promoting the adoption of smoke-free policies in public places, with the primary outcome of changes in SHSe over time; 2. assess how community context and coalition factors influence adoption of organizational and municipal smoke-free policies to provide an evidence-base for public health practice; 3. disseminate research findings regarding both the effectiveness and the process of establishing and maintaining coalitions, and consequently increasing smoke-free policies and reducing SHSe, to key stakeholders in GE and AM; and 4. capitalize on the proposed research and dissemination opportunities to build tobacco control research capacity within the GE NCDC, AM NIH, and partnering universities, as well as practice capacity within local public health centers and their civil society partners. Twenty-eight communities (14 per country) will participate in the population-level tobacco survey at baseline and follow-up. Within each country, 7 communities will be randomized to the intervention condition and 7 to the control condition (14 communities per condition). In the intervention communities, public health center staff will form a coalition by recruiting partner organizations from civil society and other government sectors (e.g., health care, education), conduct situational assessment, and develop and implement action plans to promote the adoption and enforcement of smoke-free policies in primarily in indoor and outdoor public places (e.g., worksites, hospitality). The GE NCDC and AM NIH will establish subcontracts with the local public health centers in the randomly selected communities to provide funding for local staff to develop local coalitions and to support program activities. The 14 communities assigned as controls will participate in the population-level survey and be provided with a site-specific summary of findings but will not participate in any aspects of the intervention. Additionally, to examine potential contamination in the control communities, a follow-up interview will be conducted with public health center leaders to assess any local coalition or grassroots actions regarding tobacco control that may have naturally occurred or be influenced by coalition activity in other communities. The GE NCDC and AM NIH will conduct cross-sectional population-level surveys in Year 1 (baseline) and in Years 4/5 (follow-up) in the intervention and control communities. A multi-stage, clustered sample design will be used to select 50 participants within each municipality. The most recent census data for each country and the respective municipalities will be used to establish the sampling frame.

Interventions

The intervention approach will be informed by the Community Coalition Action Theory (CCAT) developed by Butterfoss and Kegler. CCAT posits that coalitions form due to a threat, opportunity, or mandate. Public health center staff will form a coalition by recruiting partner organizations from civil society and other government sectors (e.g., health care, education), conduct situational assessment, and develop and implement action plans to promote the adoption and enforcement of smoke-free policies in public indoor and and outdoor spaces.

Sponsors

Fogarty International Center of the National Institute of Health
CollaboratorNIH
Emory University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

This is a matched-pairs community randomized controlled trial. 14 communities will receive the behavioral intervention and 14 will serve as control communities. Enrollment is on the community level rather than individual level.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

Community Level Inclusion Criteria: * Population size ranging from approximately 6,000 to 90,000

Exclusion criteria

* Lack of interest of local health care center director

Design outcomes

Primary

MeasureTime frameDescription
Secondhand Smoke ExposureBaseline, Follow-up (approximately 44 months post-baseline)The frequency of secondhand smoke (SHS) exposure in the past 30 days was assessed by asking the respondent to report the number of days they were exposed to SHS.

Secondary

MeasureTime frameDescription
Attitude Regarding Smoke-Free EnvironmentsBaseline, Follow-up (approximately 44 months post-baseline)To assess attitudes regarding smoke-free environments, respondents were asked whether they think smoking should or should not be allowed in places such as workplaces, indoor areas on school grounds, outdoor events, restaurants, and bars. Participants indicated how much the supported or opposed complete cigarette smoking bans on a 4-point scale where 1 = strongly oppose and 4 = strongly support.
Count of Participants Agreeing With Certain Home PoliciesBaseline, Follow-up (approximately 44 months post-baseline)Smoke-free home policies at baseline and follow-up were assessed by asking about rules about smoking inside of the participant's home. Possible responses included: smoking is allowed, smoking is not allowed but there are exceptions, smoking is never allowed, or there are no rules about smoking in the home.
Attitude Regarding Secondhand Smoke ExposureBaseline, Follow-up (approximately 44 months post-baseline)Attitudes regarding Secondhand Smoke Exposure (SHSe) were examined by assessing the degree to which the respondent believes that smoke causes illnesses. Participants were asked Based on what you know or believe, does breathing other people's smoke cause serious illness in non-smokers? Possible responses are 1 = not at all, 2 = a little, 3 = somewhat, or 4 = a lot.
Enforcement of Smoke-Free PoliciesBaseline, Follow-up (approximately 44 months post-baseline)Changes in enforcement of smoke-free policies in various settings will be measured by asking, In the past 7 days, how many times have you seen someone using tobacco in a location where it is prohibited?
Secondhand Smoke Exposure in Various LocationsBaseline, Follow-up (approximately 44 months post-baseline)The frequency of secondhand smoke (SHS) exposure in the past 30 days will be assessed by asking the respondent to report the number of days they were exposed to SHS in the home, in vehicles, at work, in indoor public places, and in outdoor public places. The frequency of exposures is evaluated as the number of days in the past 30 days the participant was exposed to SHS in the home, in vehicles, at work, in indoor public places, and in outdoor public places
Count of Participants With Certain Workplace PoliciesBaseline, Follow-up (approximately 44 months post-baseline)Among participants employed in a workplace with an indoor setting, workplace policies at baseline and follow-up were measured by asking, Which of the following best describes the indoor smoking policy where you work? Smoking is allowed anywhere, smoking is allowed only in some indoor areas, smoking is not allowed in any indoor areas, or there is no policy.

Countries

Armenia, Georgia

Participant flow

Recruitment details

Participants were from communities in Tbilisi, Georgia and Yerevan, Armenia. Community member participation began October 1, 2018 and the follow-up assessments occurred in Spring and Summer of 2022 (approximately 44 months after the start of community member participation in the baseline surveys). Follow-up assessments were completed by June 30, 2022.

Pre-assignment details

Fourteen communities delivered the study intervention and 14 continued as usual to serve as a control group. In this repeated cross-sectional study design, surveys were administered at baseline and follow-up (approximately 44 months after baseline) to community members. Individual community members were only assessed once, participating in either the baseline or follow-up time points.

Participants by arm

ArmCount
Intervention Condition
Community members in communities assigned to an intervention promoting the adoption and enforcement of smoke-free policies primarily in indoor and outdoor public places (e.g., worksites, hospitality) to reduce secondhand smoke exposure.
732
Control Condition
Community members in communities assigned to the control condition which participated in population-level surveys but did not participate in any aspects of the intervention.
724
Total1,456

Baseline characteristics

CharacteristicIntervention ConditionTotalControl Condition
Age, Continuous42.52 years
STANDARD_DEVIATION 13.71
43.35 years
STANDARD_DEVIATION 13.49
44.19 years
STANDARD_DEVIATION 13.22
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
732 Participants1456 Participants724 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
732 Participants1456 Participants724 Participants
Region of Enrollment
Armenia
351 Participants705 Participants354 Participants
Region of Enrollment
Georgia
381 Participants751 Participants370 Participants
Sex: Female, Male
Female
429 Participants881 Participants452 Participants
Sex: Female, Male
Male
303 Participants575 Participants272 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1,4810 / 1,443
other
Total, other adverse events
0 / 1,4810 / 1,443
serious
Total, serious adverse events
0 / 1,4810 / 1,443

Outcome results

Primary

Secondhand Smoke Exposure

The frequency of secondhand smoke (SHS) exposure in the past 30 days was assessed by asking the respondent to report the number of days they were exposed to SHS.

Time frame: Baseline, Follow-up (approximately 44 months post-baseline)

Population: This analysis includes community members who completed the Baseline or Follow-up assessments. Community members at each time point are distinct groups who participated in the study only once rather than at both time points.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention ConditionSecondhand Smoke ExposureBaseline11.70 days with SHS exposureStandard Deviation 12.14
Intervention ConditionSecondhand Smoke ExposureFollow-up10.86 days with SHS exposureStandard Deviation 11.77
Control ConditionSecondhand Smoke ExposureBaseline12.08 days with SHS exposureStandard Deviation 12.35
Control ConditionSecondhand Smoke ExposureFollow-up10.51 days with SHS exposureStandard Deviation 11.92
Secondary

Attitude Regarding Secondhand Smoke Exposure

Attitudes regarding Secondhand Smoke Exposure (SHSe) were examined by assessing the degree to which the respondent believes that smoke causes illnesses. Participants were asked Based on what you know or believe, does breathing other people's smoke cause serious illness in non-smokers? Possible responses are 1 = not at all, 2 = a little, 3 = somewhat, or 4 = a lot.

Time frame: Baseline, Follow-up (approximately 44 months post-baseline)

Population: This analysis includes community members who completed the Baseline or Follow-up assessments. Community members at each time point are distinct groups who participated in the study only once rather than at both time points.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention ConditionAttitude Regarding Secondhand Smoke ExposureBaseline2.53 score on a scaleStandard Deviation 0.7
Intervention ConditionAttitude Regarding Secondhand Smoke ExposureFollow-up3.44 score on a scaleStandard Deviation 0.81
Control ConditionAttitude Regarding Secondhand Smoke ExposureBaseline2.53 score on a scaleStandard Deviation 0.68
Control ConditionAttitude Regarding Secondhand Smoke ExposureFollow-up3.37 score on a scaleStandard Deviation 0.82
Secondary

Attitude Regarding Smoke-Free Environments

To assess attitudes regarding smoke-free environments, respondents were asked whether they think smoking should or should not be allowed in places such as workplaces, indoor areas on school grounds, outdoor events, restaurants, and bars. Participants indicated how much the supported or opposed complete cigarette smoking bans on a 4-point scale where 1 = strongly oppose and 4 = strongly support.

Time frame: Baseline, Follow-up (approximately 44 months post-baseline)

Population: This analysis includes community members who completed the Baseline or Follow-up assessments. Community members at each time point are distinct groups who participated in the study only once rather than at both time points.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention ConditionAttitude Regarding Smoke-Free EnvironmentsFollow-up - In restaurants, cafes, and cafeterias3.36 score on a scaleStandard Deviation 0.98
Intervention ConditionAttitude Regarding Smoke-Free EnvironmentsBaseline - In restaurants, cafes, and cafeterias3.36 score on a scaleStandard Deviation 0.88
Intervention ConditionAttitude Regarding Smoke-Free EnvironmentsBaseline - On the outdoor terrace of restaurants, cafes, and cafeterias2.39 score on a scaleStandard Deviation 1.12
Intervention ConditionAttitude Regarding Smoke-Free EnvironmentsBaseline - In bars, pubs, or nightclubs3.05 score on a scaleStandard Deviation 1.05
Intervention ConditionAttitude Regarding Smoke-Free EnvironmentsBaseline - On the outdoor terrace of bars, pubs, or nightclubs2.33 score on a scaleStandard Deviation 1.14
Intervention ConditionAttitude Regarding Smoke-Free EnvironmentsBaseline - Indoor common areas of apartment or condominium complexes (hallways, lobbies, stairwells)3.26 score on a scaleStandard Deviation 0.96
Intervention ConditionAttitude Regarding Smoke-Free EnvironmentsBaseline - Outdoor common areas of apartment or condominium complexes (playgrounds, park benches)3.10 score on a scaleStandard Deviation 0.98
Intervention ConditionAttitude Regarding Smoke-Free EnvironmentsBaseline - Within individual apartment or condo units within a complex3.17 score on a scaleStandard Deviation 1
Intervention ConditionAttitude Regarding Smoke-Free EnvironmentsBaseline - Private vehicles when children under age 18 are present3.84 score on a scaleStandard Deviation 0.47
Intervention ConditionAttitude Regarding Smoke-Free EnvironmentsBaseline - Parks and beaches2.93 score on a scaleStandard Deviation 1.04
Intervention ConditionAttitude Regarding Smoke-Free EnvironmentsBaseline - Other public outdoor areas, such as open stadiums2.86 score on a scaleStandard Deviation 1.11
Intervention ConditionAttitude Regarding Smoke-Free EnvironmentsFollow-up - On the outdoor terrace of restaurants, cafes, and cafeterias2.59 score on a scaleStandard Deviation 1.15
Intervention ConditionAttitude Regarding Smoke-Free EnvironmentsFollow-up - In bars, pubs, or nightclubs3.26 score on a scaleStandard Deviation 1.04
Intervention ConditionAttitude Regarding Smoke-Free EnvironmentsFollow-up - On the outdoor terrace of bars, pubs, or nightclubs2.59 score on a scaleStandard Deviation 1.16
Intervention ConditionAttitude Regarding Smoke-Free EnvironmentsFollow-up -Indoor common areas of apartment or condominium complexes (hallways, lobbies, stairwells)3.24 score on a scaleStandard Deviation 1.01
Intervention ConditionAttitude Regarding Smoke-Free EnvironmentsFollow-up - Outdoor common areas of apartment or condominium complexes (playgrounds, park benches)2.97 score on a scaleStandard Deviation 1.1
Intervention ConditionAttitude Regarding Smoke-Free EnvironmentsFollow-up - Within individual apartment or condo units within a complex3.06 score on a scaleStandard Deviation 1.14
Intervention ConditionAttitude Regarding Smoke-Free EnvironmentsFollow-up - Private vehicles when children under age 18 are present3.62 score on a scaleStandard Deviation 0.79
Intervention ConditionAttitude Regarding Smoke-Free EnvironmentsFollow-up - Parks and beaches2.74 score on a scaleStandard Deviation 1.08
Intervention ConditionAttitude Regarding Smoke-Free EnvironmentsFollow-up - Other public outdoor areas, such as open stadiums2.82 score on a scaleStandard Deviation 1.09
Control ConditionAttitude Regarding Smoke-Free EnvironmentsFollow-up - Private vehicles when children under age 18 are present3.62 score on a scaleStandard Deviation 0.8
Control ConditionAttitude Regarding Smoke-Free EnvironmentsFollow-up - In restaurants, cafes, and cafeterias3.33 score on a scaleStandard Deviation 1
Control ConditionAttitude Regarding Smoke-Free EnvironmentsBaseline - Other public outdoor areas, such as open stadiums2.77 score on a scaleStandard Deviation 1.18
Control ConditionAttitude Regarding Smoke-Free EnvironmentsBaseline - In restaurants, cafes, and cafeterias3.32 score on a scaleStandard Deviation 1.02
Control ConditionAttitude Regarding Smoke-Free EnvironmentsFollow-up - Outdoor common areas of apartment or condominium complexes (playgrounds, park benches)2.92 score on a scaleStandard Deviation 1.08
Control ConditionAttitude Regarding Smoke-Free EnvironmentsBaseline - On the outdoor terrace of restaurants, cafes, and cafeterias2.60 score on a scaleStandard Deviation 1.21
Control ConditionAttitude Regarding Smoke-Free EnvironmentsFollow-up - On the outdoor terrace of restaurants, cafes, and cafeterias2.49 score on a scaleStandard Deviation 1.12
Control ConditionAttitude Regarding Smoke-Free EnvironmentsBaseline - In bars, pubs, or nightclubs3.08 score on a scaleStandard Deviation 1.17
Control ConditionAttitude Regarding Smoke-Free EnvironmentsFollow-up - Other public outdoor areas, such as open stadiums2.68 score on a scaleStandard Deviation 1.08
Control ConditionAttitude Regarding Smoke-Free EnvironmentsBaseline - On the outdoor terrace of bars, pubs, or nightclubs2.49 score on a scaleStandard Deviation 1.24
Control ConditionAttitude Regarding Smoke-Free EnvironmentsFollow-up - In bars, pubs, or nightclubs3.32 score on a scaleStandard Deviation 1
Control ConditionAttitude Regarding Smoke-Free EnvironmentsBaseline - Indoor common areas of apartment or condominium complexes (hallways, lobbies, stairwells)3.21 score on a scaleStandard Deviation 1.05
Control ConditionAttitude Regarding Smoke-Free EnvironmentsFollow-up - Within individual apartment or condo units within a complex2.96 score on a scaleStandard Deviation 1.2
Control ConditionAttitude Regarding Smoke-Free EnvironmentsBaseline - Outdoor common areas of apartment or condominium complexes (playgrounds, park benches)3.04 score on a scaleStandard Deviation 1.07
Control ConditionAttitude Regarding Smoke-Free EnvironmentsFollow-up - On the outdoor terrace of bars, pubs, or nightclubs2.49 score on a scaleStandard Deviation 1.12
Control ConditionAttitude Regarding Smoke-Free EnvironmentsBaseline - Within individual apartment or condo units within a complex3.06 score on a scaleStandard Deviation 1.14
Control ConditionAttitude Regarding Smoke-Free EnvironmentsFollow-up - Parks and beaches2.64 score on a scaleStandard Deviation 1.07
Control ConditionAttitude Regarding Smoke-Free EnvironmentsBaseline - Private vehicles when children under age 18 are present3.77 score on a scaleStandard Deviation 0.61
Control ConditionAttitude Regarding Smoke-Free EnvironmentsFollow-up -Indoor common areas of apartment or condominium complexes (hallways, lobbies, stairwells)3.17 score on a scaleStandard Deviation 1.04
Control ConditionAttitude Regarding Smoke-Free EnvironmentsBaseline - Parks and beaches2.91 score on a scaleStandard Deviation 1.09
Secondary

Count of Participants Agreeing With Certain Home Policies

Smoke-free home policies at baseline and follow-up were assessed by asking about rules about smoking inside of the participant's home. Possible responses included: smoking is allowed, smoking is not allowed but there are exceptions, smoking is never allowed, or there are no rules about smoking in the home.

Time frame: Baseline, Follow-up (approximately 44 months post-baseline)

Population: This analysis includes community members who completed the Baseline or Follow-up assessments. Community members at each time point are distinct groups who participated in the study only once rather than at both time points.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Intervention ConditionCount of Participants Agreeing With Certain Home PoliciesBaselineNo response3 Participants
Intervention ConditionCount of Participants Agreeing With Certain Home PoliciesBaselineSmoking is allowed91 Participants
Intervention ConditionCount of Participants Agreeing With Certain Home PoliciesFollow-upSmoking is allowed95 Participants
Intervention ConditionCount of Participants Agreeing With Certain Home PoliciesBaselineSmoking is never allowed298 Participants
Intervention ConditionCount of Participants Agreeing With Certain Home PoliciesFollow-upSmoking is not allowed but there are exceptions147 Participants
Intervention ConditionCount of Participants Agreeing With Certain Home PoliciesFollow-upNo response1 Participants
Intervention ConditionCount of Participants Agreeing With Certain Home PoliciesFollow-upSmoking is never allowed418 Participants
Intervention ConditionCount of Participants Agreeing With Certain Home PoliciesBaselineThere are no rules about smoking in the home131 Participants
Intervention ConditionCount of Participants Agreeing With Certain Home PoliciesFollow-upThere are no rules about smoking in the home88 Participants
Intervention ConditionCount of Participants Agreeing With Certain Home PoliciesBaselineSmoking is not allowed but there are exceptions209 Participants
Control ConditionCount of Participants Agreeing With Certain Home PoliciesFollow-upNo response0 Participants
Control ConditionCount of Participants Agreeing With Certain Home PoliciesBaselineSmoking is allowed110 Participants
Control ConditionCount of Participants Agreeing With Certain Home PoliciesBaselineSmoking is not allowed but there are exceptions177 Participants
Control ConditionCount of Participants Agreeing With Certain Home PoliciesBaselineSmoking is never allowed263 Participants
Control ConditionCount of Participants Agreeing With Certain Home PoliciesBaselineThere are no rules about smoking in the home172 Participants
Control ConditionCount of Participants Agreeing With Certain Home PoliciesBaselineNo response2 Participants
Control ConditionCount of Participants Agreeing With Certain Home PoliciesFollow-upSmoking is allowed90 Participants
Control ConditionCount of Participants Agreeing With Certain Home PoliciesFollow-upSmoking is not allowed but there are exceptions136 Participants
Control ConditionCount of Participants Agreeing With Certain Home PoliciesFollow-upSmoking is never allowed369 Participants
Control ConditionCount of Participants Agreeing With Certain Home PoliciesFollow-upThere are no rules about smoking in the home124 Participants
Secondary

Count of Participants With Certain Workplace Policies

Among participants employed in a workplace with an indoor setting, workplace policies at baseline and follow-up were measured by asking, Which of the following best describes the indoor smoking policy where you work? Smoking is allowed anywhere, smoking is allowed only in some indoor areas, smoking is not allowed in any indoor areas, or there is no policy.

Time frame: Baseline, Follow-up (approximately 44 months post-baseline)

Population: This analysis includes community members who work outside of the home in a workplace with an indoor setting and who completed the Baseline or Follow-up assessments. Community members at each time point are distinct groups who participated in the study only once rather than at both time points.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Intervention ConditionCount of Participants With Certain Workplace PoliciesBaselineSmoking is allowed anywhere32 Participants
Intervention ConditionCount of Participants With Certain Workplace PoliciesBaselineSmoking is allowed only in some indoor areas51 Participants
Intervention ConditionCount of Participants With Certain Workplace PoliciesBaselineSmoking is not allowed in any indoor areas217 Participants
Intervention ConditionCount of Participants With Certain Workplace PoliciesBaselineThere is no policy40 Participants
Intervention ConditionCount of Participants With Certain Workplace PoliciesFollow-upSmoking is allowed anywhere9 Participants
Intervention ConditionCount of Participants With Certain Workplace PoliciesFollow-upSmoking is allowed only in some indoor areas46 Participants
Intervention ConditionCount of Participants With Certain Workplace PoliciesFollow-upSmoking is not allowed in any indoor areas266 Participants
Intervention ConditionCount of Participants With Certain Workplace PoliciesFollow-upThere is no policy21 Participants
Control ConditionCount of Participants With Certain Workplace PoliciesFollow-upThere is no policy11 Participants
Control ConditionCount of Participants With Certain Workplace PoliciesBaselineSmoking is allowed anywhere38 Participants
Control ConditionCount of Participants With Certain Workplace PoliciesFollow-upSmoking is allowed anywhere7 Participants
Control ConditionCount of Participants With Certain Workplace PoliciesBaselineSmoking is allowed only in some indoor areas28 Participants
Control ConditionCount of Participants With Certain Workplace PoliciesFollow-upSmoking is not allowed in any indoor areas233 Participants
Control ConditionCount of Participants With Certain Workplace PoliciesBaselineSmoking is not allowed in any indoor areas173 Participants
Control ConditionCount of Participants With Certain Workplace PoliciesFollow-upSmoking is allowed only in some indoor areas42 Participants
Control ConditionCount of Participants With Certain Workplace PoliciesBaselineThere is no policy68 Participants
Secondary

Enforcement of Smoke-Free Policies

Changes in enforcement of smoke-free policies in various settings will be measured by asking, In the past 7 days, how many times have you seen someone using tobacco in a location where it is prohibited?

Time frame: Baseline, Follow-up (approximately 44 months post-baseline)

Population: This item was not administered at either study time point.

Secondary

Secondhand Smoke Exposure in Various Locations

The frequency of secondhand smoke (SHS) exposure in the past 30 days will be assessed by asking the respondent to report the number of days they were exposed to SHS in the home, in vehicles, at work, in indoor public places, and in outdoor public places. The frequency of exposures is evaluated as the number of days in the past 30 days the participant was exposed to SHS in the home, in vehicles, at work, in indoor public places, and in outdoor public places

Time frame: Baseline, Follow-up (approximately 44 months post-baseline)

Population: This analysis includes community members who completed the Baseline or Follow-up assessments. Community members at each time point are distinct groups who participated in the study only once rather than at both time points.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention ConditionSecondhand Smoke Exposure in Various LocationsBaseline - Exposure in the home6.83 days with SHS exposureStandard Deviation 11.48
Intervention ConditionSecondhand Smoke Exposure in Various LocationsBaseline - Exposure in vehicles3.87 days with SHS exposureStandard Deviation 8.15
Intervention ConditionSecondhand Smoke Exposure in Various LocationsBaseline - Exposure in indoor work areas4.16 days with SHS exposureStandard Deviation 8.66
Intervention ConditionSecondhand Smoke Exposure in Various LocationsBaseline - Exposure in indoor public areas1.74 days with SHS exposureStandard Deviation 4.71
Intervention ConditionSecondhand Smoke Exposure in Various LocationsBaseline - Exposure in outdoor public areas5.34 days with SHS exposureStandard Deviation 8.86
Intervention ConditionSecondhand Smoke Exposure in Various LocationsFollow-up - Exposure in the home4.88 days with SHS exposureStandard Deviation 9.83
Intervention ConditionSecondhand Smoke Exposure in Various LocationsFollow-up - Exposure in vehicles4.43 days with SHS exposureStandard Deviation 8.27
Intervention ConditionSecondhand Smoke Exposure in Various LocationsFollow-up - Exposure in indoor work areas2.91 days with SHS exposureStandard Deviation 7.7
Intervention ConditionSecondhand Smoke Exposure in Various LocationsFollow-up - Exposure in indoor public areas1.66 days with SHS exposureStandard Deviation 5.21
Intervention ConditionSecondhand Smoke Exposure in Various LocationsFollow-up - Exposure in outdoor public areas6.78 days with SHS exposureStandard Deviation 9.68
Control ConditionSecondhand Smoke Exposure in Various LocationsFollow-up - Exposure in indoor work areas3.06 days with SHS exposureStandard Deviation 7.68
Control ConditionSecondhand Smoke Exposure in Various LocationsBaseline - Exposure in the home7.18 days with SHS exposureStandard Deviation 11.53
Control ConditionSecondhand Smoke Exposure in Various LocationsFollow-up - Exposure in the home4.72 days with SHS exposureStandard Deviation 9.83
Control ConditionSecondhand Smoke Exposure in Various LocationsBaseline - Exposure in vehicles3.93 days with SHS exposureStandard Deviation 8.36
Control ConditionSecondhand Smoke Exposure in Various LocationsFollow-up - Exposure in outdoor public areas6.49 days with SHS exposureStandard Deviation 9.02
Control ConditionSecondhand Smoke Exposure in Various LocationsBaseline - Exposure in indoor work areas4.44 days with SHS exposureStandard Deviation 8.85
Control ConditionSecondhand Smoke Exposure in Various LocationsFollow-up - Exposure in vehicles4.74 days with SHS exposureStandard Deviation 9.27
Control ConditionSecondhand Smoke Exposure in Various LocationsBaseline - Exposure in indoor public areas2.00 days with SHS exposureStandard Deviation 5.17
Control ConditionSecondhand Smoke Exposure in Various LocationsFollow-up - Exposure in indoor public areas1.15 days with SHS exposureStandard Deviation 3.89
Control ConditionSecondhand Smoke Exposure in Various LocationsBaseline - Exposure in outdoor public areas4.83 days with SHS exposureStandard Deviation 8.79

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026