Gender-Relevant Tobacco Cessation Among Women in Brazil

NCT ID: NCT03845413

Last Updated: 2019-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 338 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-20
• Study Completion Date: 2019-07-31

Brief Summary

The overall goal of this renewal is three-fold: (1) to continue to sustain and strengthen the network; (2) to conduct a group randomized controlled trial to assess the efficacy of a theory-based, culturally- and gender-relevant Community Health Worker intervention for Brazilian women "light smokers" that will augment the smoking cessation programs offered through the public health system; and (3) to expand our current Career Development and Research Training Program to the other two major tobacco growing states in order to develop a cadre of well-trained researchers who will continue to develop and implement gender-relevant comprehensive tobacco control strategies at all levels.

Detailed Description

An understanding of women and their tobacco-related issues, as well as the need for the development of gender-relevant tobacco control efforts, have been highlighted as priorities in landmark guiding documents published in the past few years (e.g., WHO Framework Convention on Tobacco Control-WHO FCTC). Brazil is the second largest producer of tobacco in the world, and 95% of the tobacco is produced in the three Southern states (Paraná, Santa Catarina, and Rio Grande do Sul). Although, historically, tobacco use among women in developing countries, particularly Latin America, has been relatively low as compared to men, the smoking epidemic is rapidly spreading to women in developing countries, and these three Southern states have the highest prevalence of women smokers in the country. We have established a Network for Tobacco Control among Women in Paraná, Brazil with the purpose of establishing community and institutional capacity to promote gender-relevant tobacco control efforts among women through Community-Based Participatory Research (CBPR) and training. The goals of the network are to reduce tobacco use and exposure to environmental tobacco smoke (ETS) among women in Paraná, and to develop a cadre of well-trained researchers who will continue to address comprehensive tobacco control strategies at multiple levels. The network conducted an epidemiological survey on the prevalence and factors associated with tobacco use among women across the State of Paraná. Based on the results, the network identified four priorities: (1) to implement policy changes to decrease ETS; (2) to understand the health/social issues of women in tobacco farming; (3) to develop and evaluate a comprehensive, culturally- and gender relevant, school-based smoking prevention program; and (4) to improve access and delivery of smoking cessation programs through the public health system with a particular focus on "light smokers" as 74.8% of women smokers in our study reported smoking 10 or less cigarettes/day. The network is currently addressing the first three priorities, including support for legislation, which resulted in Paraná having the strongest indoor tobacco ban in the country.

The overall goal of this renewal is three-fold: (1) to continue to sustain and strengthen the network; (2) to conduct a group randomized controlled trial to assess the efficacy of a theory-based, culturally- and gender-relevant Community Health Worker intervention for Brazilian women "light smokers" that will augment the smoking cessation programs offered through the public health system; and (3) to expand our current Career Development and Research Training Program to the other two major tobacco growing states in order to develop a cadre of well-trained researchers who will continue to develop and implement gender-relevant comprehensive tobacco control strategies at all levels.

Conditions

Tobacco Use Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention

The intervention arm consisted of 12-home visits by the Community Health Worker + referring to an appointment for the participant to attend the tobacco cessation program at the local Basic Health Unit.

Group Type: ACTIVE_COMPARATOR

12-home visits by the Community Health Worker + referring to an appointment for the participant to attend the tobacco cessation program

Intervention Type: BEHAVIORAL

12-home visits by the Community Health Worker + referring to an appointment for the participant to attend the tobacco cessation program

Control

The control arm consisted of a home visit by the Community Health Worker scheduling an appointment for the participant to attend the tobacco cessation program at the local Basic Health Unit.

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: BEHAVIORAL

Schedule an appointment to attend tobacco cessation at Basic Health Unit

Interventions

Control

Schedule an appointment to attend tobacco cessation at Basic Health Unit

Intervention Type: BEHAVIORAL

12-home visits by the Community Health Worker + referring to an appointment for the participant to attend the tobacco cessation program

12-home visits by the Community Health Worker + referring to an appointment for the participant to attend the tobacco cessation program

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Woman
• Current tobacco user
• 18 years of age
• Living in the randomized neighborhood

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Pontifícia Universidade Católica do Paraná

OTHER

Sponsor Role: collaborator

Universidade Estadual de Londrina

OTHER

Sponsor Role: collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Isabel Scarinci

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Scarinci IC, Kienen N, Wiltenburg TD, Bittencourt L, Person SD. Efficacy of a Gender-Relevant Smoking Cessation Intervention Among Women in Brazil: Findings from a Group Randomized Controlled Trial. J Womens Health (Larchmt). 2022 Nov;31(11):1620-1629. doi: 10.1089/jwh.2021.0443. Epub 2022 May 17.

Reference Type: DERIVED

PMID: 35580140 (View on PubMed)

Other Identifiers

IRB-120606001

Identifier Type: -

Identifier Source: org_study_id