Gender-Relevant Tobacco Cessation Among Women in Brazil

NCT03845413 | Completed DMC

• 1 other identifier: IRB-120606001
• Study Type: interventional
• Target: 338
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tobacco Use Cessation

Keywords

tobacco cessation; women; capacity building

Outcome Measures

Primary Outcomes (1)

• 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

  7 months follow-up

Study Arms (2)

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.

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.

Behavioral: Control

Interventions

Control BEHAVIORAL

Schedule an appointment to attend tobacco cessation at Basic Health Unit

Control

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

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This trial was gender-relevant to include women only
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Pontifícia Universidade Católica do Paraná: collaborator
• Universidade Estadual de Londrina: collaborator
• University of Massachusetts, Worcester: collaborator

Related Publications (1)

• 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.

  PMID: 35580140 DERIVED

MeSH Terms

Conditions

Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: February 19, 2019
• Study Start: June 20, 2012
• Primary Completion: July 30, 2018
• Study Completion: July 31, 2019
• Last Updated: November 5, 2019

Record last verified: 2019-11