NCT06438549

Integrating CHWs Into Prenatal Care for Maternal Smoking Cessation

Integrating CHWs Into Prenatal Care for Maternal Smoking Cessation: A Pilot Feasibility Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: Loma Linda University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This develops a novel behavioral tobacco cessation program for pregnant smokers in San Bernardino County.

Detailed description

This study seeks to address the disparities in the maternal smoking cessation outcomes of previous research by developing an innovative maternal tobacco cessation program that expands the outreach by integrating home visits by community health workers (CHW) into the prenatal healthcare model. The overall aim is to conduct a pilot randomized control trial to test the feasibility, acceptability, and efficacy of a Healthcare Provider-Community Health Worker (HCP-CHW) intervention model that expands outreach by adding eight home visits by CHWs to provide tobacco cessation support services before and after the quit date.

Conditions

• Tobacco Use
• Tobacco Use Cessation
• Tobacco Use in Childbirth

Interventions

Type	Name	Description
BEHAVIORAL	HCP-CHW Integration into Prenatal Care for Smoking Cessation	CHWs will be integrated into primary care, and subjects will receive CHW home visits (up to 8) that will provide brief behavioral smoking cessation interventions before, during, and after a quit date. This brief behavioral intervention will include watching a video and reviewing self-help materials.
OTHER	Control Arm	Standard of Care which provides referrals to community-based smoking cessation resources.

Timeline

• Start date: 2024-05-24
• Primary completion: 2026-05-01
• Completion: 2026-08-01
• First posted: 2024-06-03
• Last updated: 2025-06-05

Locations

2 sites across 1 country: United States