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Adaptation and Evaluation of a Tobacco Cessation Program: An Integrated mHealth Approach

NCT04865276 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 431

Last updated 2026-06-18

No results posted yet for this study

Summary

We developed and established the efficacy of a theory-based, culturally- and gender-relevant Community Health Worker (CHW) intervention for low-income Brazilian women that augments the tobacco cessation program offered through the public health system. This study seeks to adapt this CHW-delivered tobacco cessation program to be integrated with mHealth support through mobile devices (App). During phase I we will make the adaptations and determine feasibility of a CHW-delivered intervention that is integrated with a mHealth tobacco cessation application (interactive App for participants and tracking system for CHWs) through formative assessments among all involved stakeholders, pretesting, and pilot testing of the intervention. In phase II we will assess the effectiveness of the integrated CHW-mHealth tobacco cessation intervention through a group randomized trial with towns as the unit of randomization (8 towns, N=344). The comparison group will consist of a home visit by a CHW during which the participant is scheduled to attend the tobacco cessation program at the neighborhood public health clinic). We hypothesize that at 6-months, women smokers who receive the integrated CHW-mHealth intervention will have significantly higher 7-day point prevalence abstinence (defined as no cigarettes in the past 7 days) than women smokers in the control condition. If shown to be effective, this approach could be utilized as a model for a population-based intervention in low-resource settings, including rural and disadvantaged women in the U.S.

Conditions

  • Tobacco Cessation

Interventions

BEHAVIORAL

Integrated tobacco cessation intervention delivered by Community Health Workers with the support of an App (mHealth) + Tobacco cessation program at the public health system

Integrated tobacco cessation intervention delivered by Community Health Workers with the support of an App (mHealth) + Tobacco cessation program at the public health system

Sponsors & Collaborators

  • Universidade Estadual de Londrina

    collaborator OTHER

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Isabel C Scarinci, PhD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2026-12-31
Completion
2027-08-31

Countries

  • Brazil

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04865276 on ClinicalTrials.gov