Tobacco Use CessationNCT03845413
Gender-Relevant Tobacco Cessation Among Women in Brazil
A study testing 12-home visits by the Community Health Worker + referring to an appointment for the participant to attend the tobacco cessation program in people with Tobacco Use Cessation, run by University of Alabama at Birmingham.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Cessation
- What is being tested?
- 12-home visits by the Community Health Worker + referring to an appointment for the participant to attend the tobacco cessation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 338 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2012to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Woman
- Current tobacco user
- 18 years of age
- Living in the randomized neighborhood
Who cannot join
- -
About this study
Official title: Tobacco Control Network Among Women in Parana, Brazil - II
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.
Read the 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
- Being tested
- Control, 12-home visits by the Community Health Worker + referring to an appointment for the participant to attend the tobacco cessation program
- Keywords
- tobacco cessation, women, capacity building
- Medical subject headings
- Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlBehavioural
Schedule an appointment to attend tobacco cessation at Basic Health Unit
12-home visits by the Community Health Worker + referring to an appointment for the participant to attend the tobacco cessation programBehavioural
12-home visits by the Community Health Worker + referring to an appointment for the participant to attend the tobacco cessation program
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | 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. Receives: Behavioral: 12-home visits by the Community Health Worker + referring to an appointment for the participant to attend the tobacco cessation program |
| Control | Active comparator | 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. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tobacco Cessation
Our outcome at follow-up, smoking status, was obtained from responses to the question, "Do you smoke any tobacco product?" Respondents could indicate they smoked daily, less than daily, or that they did not smoke. Those who indicated they smoked daily or less than daily were labeled as 'smokers' while those who indicated they did not smoke were labeled 'non-smokers' confirmed by exhaled carbon monoxide level
Measured: 7 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start20 Jun 2012
- Primary completion30 Jul 2018
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use CessationStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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. The intervention arm consisted of 12-home visits by the Community Health Worker
- Masking
- None (open label)
- Enrolment
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Pontifícia Universidade Católica do Paraná, Universidade Estadual de Londrina, University of Massachusetts, Worcester
- Responsible party
- Principal investigator, Isabel Scarinci, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03845413
- Sponsor's protocol ID
- IRB-120606001
- Status last verified
- Nov 2019
- First submitted
- 15 Feb 2019
- Last updated
- 5 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: de-identified data may be shared in the future
Publications
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.
PubMed 35580140
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tobacco Control Network Among Women in Parana, Brazil - II
- ClinicalTrials.gov ID
- NCT03845413
- Acronym / sponsor ID
- IRB-120606001
- Conditions
- Tobacco Use Cessation
- Keywords
- tobacco cessation, women, capacity building
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 338 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Pontifícia Universidade Católica do Paraná, Universidade Estadual de Londrina, University of Massachusetts, Worcester
- Study start
- 20 Jun 2012 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 19 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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. The intervention arm consisted of 12-home visits by the Community Health Worker
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: 12-home visits by the Community Health Worker + referring to an appointment for the participant to attend the tobacco cessation programThe 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. |
| Control | Active comparator | Behavioral: ControlThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Woman
- Current tobacco user
- 18 years of age
- Living in the randomized neighborhood
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlSchedule an appointment to attend tobacco cessation at Basic Health Unit | Behavioural | Control |
| 12-home visits by the Community Health Worker + referring to an appointment for the participant to attend the tobacco cessation program12-home visits by the Community Health Worker + referring to an appointment for the participant to attend the tobacco cessation program | Behavioural | Intervention |
Primary outcome
Tobacco Cessation
Time frame: 7 months follow-up
Our outcome at follow-up, smoking status, was obtained from responses to the question, "Do you smoke any tobacco product?" Respondents could indicate they smoked daily, less than daily, or that they did not smoke. Those who indicated they smoked daily or less than daily were labeled as 'smokers' while those who indicated they did not smoke were labeled 'non-smokers' confirmed by exhaled carbon monoxide level
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- Derived from this study: PubMed 35580140Scarinci 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.
- Individual participant dataSharing planned: Undecided. de-identified data may be shared in the future
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 12-home visits by the Community Health Worker + referring to an appointment for the participant to attend the tobacco cessation program in people with Tobacco Use Cessation, run by University of Alabama at Birmingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tobacco Cessation (time frame: 7 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03845413, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2019.