Trial Outcomes & Findings for Smoke-free Air Coalitions in Georgia and Armenia (NCT NCT03447912)
NCT ID: NCT03447912
Last Updated: 2023-10-17
Results Overview
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.
COMPLETED
NA
2924 participants
Baseline, Follow-up (approximately 44 months post-baseline)
2023-10-17
Participant Flow
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.
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.
Unit of analysis: communities
Participant milestones
| Measure |
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.
The intervention approach was 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 indoor and outdoor public spaces.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
1481 14
|
1443 14
|
|
Overall Study
Community Members Who Completed the Baseline Survey
|
732 14
|
724 14
|
|
Overall Study
Community Members Who Completed the Follow-up Survey
|
749 14
|
719 14
|
|
Overall Study
COMPLETED
|
1481 14
|
1443 14
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Smoke-free Air Coalitions in Georgia and Armenia
Baseline characteristics by cohort
| Measure |
Intervention Condition
n=732 Participants
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.
|
Control Condition
n=724 Participants
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.
|
Total
n=1456 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.52 years
STANDARD_DEVIATION 13.71 • n=5 Participants
|
44.19 years
STANDARD_DEVIATION 13.22 • n=7 Participants
|
43.35 years
STANDARD_DEVIATION 13.49 • n=5 Participants
|
|
Sex: Female, Male
Female
|
429 Participants
n=5 Participants
|
452 Participants
n=7 Participants
|
881 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
303 Participants
n=5 Participants
|
272 Participants
n=7 Participants
|
575 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
732 Participants
n=5 Participants
|
724 Participants
n=7 Participants
|
1456 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
732 Participants
n=5 Participants
|
724 Participants
n=7 Participants
|
1456 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Armenia
|
351 Participants
n=5 Participants
|
354 Participants
n=7 Participants
|
705 Participants
n=5 Participants
|
|
Region of Enrollment
Georgia
|
381 Participants
n=5 Participants
|
370 Participants
n=7 Participants
|
751 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Intervention Condition
n=1481 Participants
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.
|
Control Condition
n=1443 Participants
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.
|
|---|---|---|
|
Secondhand Smoke Exposure
Follow-up
|
10.86 days with SHS exposure
Standard Deviation 11.77
|
10.51 days with SHS exposure
Standard Deviation 11.92
|
|
Secondhand Smoke Exposure
Baseline
|
11.70 days with SHS exposure
Standard Deviation 12.14
|
12.08 days with SHS exposure
Standard Deviation 12.35
|
SECONDARY outcome
Timeframe: 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.
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".
Outcome measures
| Measure |
Intervention Condition
n=1481 Participants
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.
|
Control Condition
n=1443 Participants
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.
|
|---|---|---|
|
Attitude Regarding Secondhand Smoke Exposure
Baseline
|
2.53 score on a scale
Standard Deviation 0.70
|
2.53 score on a scale
Standard Deviation 0.68
|
|
Attitude Regarding Secondhand Smoke Exposure
Follow-up
|
3.44 score on a scale
Standard Deviation 0.81
|
3.37 score on a scale
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Intervention Condition
n=1481 Participants
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.
|
Control Condition
n=1443 Participants
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.
|
|---|---|---|
|
Attitude Regarding Smoke-Free Environments
Baseline - Parks and beaches
|
2.93 score on a scale
Standard Deviation 1.04
|
2.91 score on a scale
Standard Deviation 1.09
|
|
Attitude Regarding Smoke-Free Environments
Baseline - Other public outdoor areas, such as open stadiums
|
2.86 score on a scale
Standard Deviation 1.11
|
2.77 score on a scale
Standard Deviation 1.18
|
|
Attitude Regarding Smoke-Free Environments
Follow-up - In restaurants, cafes, and cafeterias
|
3.36 score on a scale
Standard Deviation 0.98
|
3.33 score on a scale
Standard Deviation 1.00
|
|
Attitude Regarding Smoke-Free Environments
Baseline - In restaurants, cafes, and cafeterias
|
3.36 score on a scale
Standard Deviation 0.88
|
3.32 score on a scale
Standard Deviation 1.02
|
|
Attitude Regarding Smoke-Free Environments
Baseline - On the outdoor terrace of restaurants, cafes, and cafeterias
|
2.39 score on a scale
Standard Deviation 1.12
|
2.60 score on a scale
Standard Deviation 1.21
|
|
Attitude Regarding Smoke-Free Environments
Baseline - In bars, pubs, or nightclubs
|
3.05 score on a scale
Standard Deviation 1.05
|
3.08 score on a scale
Standard Deviation 1.17
|
|
Attitude Regarding Smoke-Free Environments
Baseline - On the outdoor terrace of bars, pubs, or nightclubs
|
2.33 score on a scale
Standard Deviation 1.14
|
2.49 score on a scale
Standard Deviation 1.24
|
|
Attitude Regarding Smoke-Free Environments
Baseline - Indoor common areas of apartment or condominium complexes (hallways, lobbies, stairwells)
|
3.26 score on a scale
Standard Deviation 0.96
|
3.21 score on a scale
Standard Deviation 1.05
|
|
Attitude Regarding Smoke-Free Environments
Baseline - Outdoor common areas of apartment or condominium complexes (playgrounds, park benches)
|
3.10 score on a scale
Standard Deviation 0.98
|
3.04 score on a scale
Standard Deviation 1.07
|
|
Attitude Regarding Smoke-Free Environments
Baseline - Within individual apartment or condo units within a complex
|
3.17 score on a scale
Standard Deviation 1.00
|
3.06 score on a scale
Standard Deviation 1.14
|
|
Attitude Regarding Smoke-Free Environments
Baseline - Private vehicles when children under age 18 are present
|
3.84 score on a scale
Standard Deviation 0.47
|
3.77 score on a scale
Standard Deviation 0.61
|
|
Attitude Regarding Smoke-Free Environments
Follow-up - On the outdoor terrace of restaurants, cafes, and cafeterias
|
2.59 score on a scale
Standard Deviation 1.15
|
2.49 score on a scale
Standard Deviation 1.12
|
|
Attitude Regarding Smoke-Free Environments
Follow-up - In bars, pubs, or nightclubs
|
3.26 score on a scale
Standard Deviation 1.04
|
3.32 score on a scale
Standard Deviation 1.00
|
|
Attitude Regarding Smoke-Free Environments
Follow-up - On the outdoor terrace of bars, pubs, or nightclubs
|
2.59 score on a scale
Standard Deviation 1.16
|
2.49 score on a scale
Standard Deviation 1.12
|
|
Attitude Regarding Smoke-Free Environments
Follow-up -Indoor common areas of apartment or condominium complexes (hallways, lobbies, stairwells)
|
3.24 score on a scale
Standard Deviation 1.01
|
3.17 score on a scale
Standard Deviation 1.04
|
|
Attitude Regarding Smoke-Free Environments
Follow-up - Outdoor common areas of apartment or condominium complexes (playgrounds, park benches)
|
2.97 score on a scale
Standard Deviation 1.10
|
2.92 score on a scale
Standard Deviation 1.08
|
|
Attitude Regarding Smoke-Free Environments
Follow-up - Within individual apartment or condo units within a complex
|
3.06 score on a scale
Standard Deviation 1.14
|
2.96 score on a scale
Standard Deviation 1.20
|
|
Attitude Regarding Smoke-Free Environments
Follow-up - Private vehicles when children under age 18 are present
|
3.62 score on a scale
Standard Deviation 0.79
|
3.62 score on a scale
Standard Deviation 0.80
|
|
Attitude Regarding Smoke-Free Environments
Follow-up - Parks and beaches
|
2.74 score on a scale
Standard Deviation 1.08
|
2.64 score on a scale
Standard Deviation 1.07
|
|
Attitude Regarding Smoke-Free Environments
Follow-up - Other public outdoor areas, such as open stadiums
|
2.82 score on a scale
Standard Deviation 1.09
|
2.68 score on a scale
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Intervention Condition
n=1481 Participants
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.
|
Control Condition
n=1443 Participants
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.
|
|---|---|---|
|
Count of Participants Agreeing With Certain Home Policies
Follow-up · There are no rules about smoking in the home
|
88 Participants
|
124 Participants
|
|
Count of Participants Agreeing With Certain Home Policies
Baseline · Smoking is allowed
|
91 Participants
|
110 Participants
|
|
Count of Participants Agreeing With Certain Home Policies
Baseline · Smoking is not allowed but there are exceptions
|
209 Participants
|
177 Participants
|
|
Count of Participants Agreeing With Certain Home Policies
Baseline · Smoking is never allowed
|
298 Participants
|
263 Participants
|
|
Count of Participants Agreeing With Certain Home Policies
Baseline · There are no rules about smoking in the home
|
131 Participants
|
172 Participants
|
|
Count of Participants Agreeing With Certain Home Policies
Baseline · No response
|
3 Participants
|
2 Participants
|
|
Count of Participants Agreeing With Certain Home Policies
Follow-up · Smoking is allowed
|
95 Participants
|
90 Participants
|
|
Count of Participants Agreeing With Certain Home Policies
Follow-up · Smoking is not allowed but there are exceptions
|
147 Participants
|
136 Participants
|
|
Count of Participants Agreeing With Certain Home Policies
Follow-up · Smoking is never allowed
|
418 Participants
|
369 Participants
|
|
Count of Participants Agreeing With Certain Home Policies
Follow-up · No response
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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.
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."
Outcome measures
| Measure |
Intervention Condition
n=682 Participants
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.
|
Control Condition
n=600 Participants
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.
|
|---|---|---|
|
Count of Participants With Certain Workplace Policies
Follow-up · Smoking is allowed only in some indoor areas
|
46 Participants
|
42 Participants
|
|
Count of Participants With Certain Workplace Policies
Follow-up · Smoking is not allowed in any indoor areas
|
266 Participants
|
233 Participants
|
|
Count of Participants With Certain Workplace Policies
Follow-up · There is no policy
|
21 Participants
|
11 Participants
|
|
Count of Participants With Certain Workplace Policies
Baseline · Smoking is allowed anywhere
|
32 Participants
|
38 Participants
|
|
Count of Participants With Certain Workplace Policies
Baseline · Smoking is allowed only in some indoor areas
|
51 Participants
|
28 Participants
|
|
Count of Participants With Certain Workplace Policies
Baseline · Smoking is not allowed in any indoor areas
|
217 Participants
|
173 Participants
|
|
Count of Participants With Certain Workplace Policies
Baseline · There is no policy
|
40 Participants
|
68 Participants
|
|
Count of Participants With Certain Workplace Policies
Follow-up · Smoking is allowed anywhere
|
9 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline, Follow-up (approximately 44 months post-baseline)Population: This item was not administered at either study time point.
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?"
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
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
Outcome measures
| Measure |
Intervention Condition
n=1481 Participants
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.
|
Control Condition
n=1443 Participants
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.
|
|---|---|---|
|
Secondhand Smoke Exposure in Various Locations
Follow-up - Exposure in outdoor public areas
|
6.78 days with SHS exposure
Standard Deviation 9.68
|
6.49 days with SHS exposure
Standard Deviation 9.02
|
|
Secondhand Smoke Exposure in Various Locations
Baseline - Exposure in the home
|
6.83 days with SHS exposure
Standard Deviation 11.48
|
7.18 days with SHS exposure
Standard Deviation 11.53
|
|
Secondhand Smoke Exposure in Various Locations
Baseline - Exposure in vehicles
|
3.87 days with SHS exposure
Standard Deviation 8.15
|
3.93 days with SHS exposure
Standard Deviation 8.36
|
|
Secondhand Smoke Exposure in Various Locations
Baseline - Exposure in indoor work areas
|
4.16 days with SHS exposure
Standard Deviation 8.66
|
4.44 days with SHS exposure
Standard Deviation 8.85
|
|
Secondhand Smoke Exposure in Various Locations
Baseline - Exposure in indoor public areas
|
1.74 days with SHS exposure
Standard Deviation 4.71
|
2.00 days with SHS exposure
Standard Deviation 5.17
|
|
Secondhand Smoke Exposure in Various Locations
Baseline - Exposure in outdoor public areas
|
5.34 days with SHS exposure
Standard Deviation 8.86
|
4.83 days with SHS exposure
Standard Deviation 8.79
|
|
Secondhand Smoke Exposure in Various Locations
Follow-up - Exposure in the home
|
4.88 days with SHS exposure
Standard Deviation 9.83
|
4.72 days with SHS exposure
Standard Deviation 9.83
|
|
Secondhand Smoke Exposure in Various Locations
Follow-up - Exposure in vehicles
|
4.43 days with SHS exposure
Standard Deviation 8.27
|
4.74 days with SHS exposure
Standard Deviation 9.27
|
|
Secondhand Smoke Exposure in Various Locations
Follow-up - Exposure in indoor work areas
|
2.91 days with SHS exposure
Standard Deviation 7.70
|
3.06 days with SHS exposure
Standard Deviation 7.68
|
|
Secondhand Smoke Exposure in Various Locations
Follow-up - Exposure in indoor public areas
|
1.66 days with SHS exposure
Standard Deviation 5.21
|
1.15 days with SHS exposure
Standard Deviation 3.89
|
Adverse Events
Intervention Condition
Control Condition
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place