Trials Today

Integrating CHWs Into Prenatal Care for Maternal Smoking Cessation

Purpose

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

Conditions

Tobacco Use
Tobacco Use Cessation
Tobacco Use in Childbirth

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: Female
Accepts Healthy Volunteers: No

Inclusion Criteria

< 24 weeks pregnant - age > 18 years, - current smokers (100 cigarettes in their lifetime and >3 cigarettes per day in the last 7 days; including poly-tobacco use, combining cigarettes with non-combustible products) confirmed by expired carbon monoxide (CO) - willing to quit smoking and set a quit date in the next 2 weeks upon enrolling - enrolled in prenatal care at Loma Linda University Health (LLUH) or Riverside University Health System (RUHS)

Exclusion Criteria

severe mental health problems that prevent informed consent and/or CHW intervention - women who were on Nicotine Replacement Therapy (NRT) or enrolled in a cessation program within 30 days - unwillingness to participate in audio-recorded key informant interviews or focus groups

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The model compares the integration of CHW Home visits into healthcare provider-directed clinical care and a schedule of CHW home visits to provide behavioral smoking cessation for pregnant people and adult household members before, during, and after a quit date vs Standard of Care.
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Integrated HCP-CHW Intervention Arm	CHW visit with brief tobacco cessation intervention.	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	Other: Control Arm Standard of Care which provides referrals to community-based smoking cessation resources.

Recruiting Locations

Loma Linda University Medical Center
Loma Linda, California 92350

Contact:
Courtney Martin, DO
909-558-1000
COUMartin@llu.edu

More Details

NCT ID: NCT06438549
Status: Recruiting
Sponsor: Loma Linda University

Study Contact

Anne Berit Petersen
909 558 1000
abpetersen@llu.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.