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Trial record 5 of 24 for:    "secondhand smoke" | Recruiting, Not yet recruiting, Available Studies

Smoke-free Air Coalitions in Georgia and Armenia

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ClinicalTrials.gov Identifier: NCT03447912
Recruitment Status : Not yet recruiting
First Posted : February 27, 2018
Last Update Posted : April 9, 2018
Sponsor:
Collaborator:
John E. Fogarty International Center (FIC)
Information provided by (Responsible Party):
Carla Berg, Emory University

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 in worksites and restaurants, settings selected based on general support for smoke-free policies in these settings and the likelihood of impacting population-level SHSe through widespread reach. 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.


Condition or disease Intervention/treatment Phase
Smoking Behavioral: Intervention Condition Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Smoke-free Air Coalitions in Georgia and Armenia: A Community Randomized Trial
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Arm Intervention/treatment
Experimental: Intervention Condition
Fourteen communities will be assigned to the intervention.
Behavioral: Intervention Condition
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 worksites and restaurants.

No Intervention: Control Condition
The 14 communities assigned as controls will participate in the population-level survey and will be provided with a site-specific summary of findings but will not participate in any aspects of the intervention. 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.



Primary Outcome Measures :
  1. Change in Second Hand Smoke Exposure [ Time Frame: Baseline, up to Year 5 ]
    The frequency of second hand smoke (SHS) exposure in the past week 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.


Secondary Outcome Measures :
  1. Change in Attitude Regarding Second Hand Smoke Exposure [ Time Frame: Baseline, up to Year 5 ]
    Attitudes regarding SHSe will be examined by assessing the degree to which the respondent believes that smoke causes illnesses.

  2. Change in Attitude Regarding Smoke-Free Environments [ Time Frame: Baseline, up to Year 5 ]
    To assess attitudes regarding smoke-free environments, respondents will be 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.

  3. Change in Home Policies [ Time Frame: Baseline, up to Year 5 ]
    Changes in home policies will be assessed qualitatively by asking about rules about smoking inside of the participant's home. Possible responses include, 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.

  4. Change in Workplace Policies [ Time Frame: Baseline, up to Year 5 ]
    Changes in workplace policies will be 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."

  5. Change in Enforcement of Smoke-Free Policies [ Time Frame: Baseline, up to Year 5 ]
    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?"



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03447912


Contacts
Contact: Carla Berg, PhD 404-727-7589 cjberg@emory.edu

Locations
Armenia
National Institute of Health Not yet recruiting
Yerevan, Armenia
Contact: Romela Abovyan       rabovyan75@gmail.com   
Georgia
National Center for Disease Control Not yet recruiting
Tbilisi, Georgia
Contact: Marina Topurdize       topuridzemarina@gmail.com   
Sponsors and Collaborators
Emory University
John E. Fogarty International Center (FIC)
Investigators
Principal Investigator: Carla Berg, PhD Emory University

Responsible Party: Carla Berg, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT03447912     History of Changes
Other Study ID Numbers: IRB00097093
R01TW010664 ( U.S. NIH Grant/Contract )
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Carla Berg, Emory University:
Behavioral intervention
Social intervention
Public health
Smoking behavior