Integrating CHWs Into Prenatal Care for Maternal Smoking Cessation

NCT ID: NCT06438549

Last Updated: 2025-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-24

Study Completion Date

2026-08-31

Brief Summary

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

Detailed Description

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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

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Tobacco Use Tobacco Use Cessation Tobacco Use in Childbirth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Integrated HCP-CHW Intervention Arm

CHW visit with brief tobacco cessation intervention.

Group Type EXPERIMENTAL

HCP-CHW Integration into Prenatal Care for Smoking Cessation

Intervention Type BEHAVIORAL

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.

Control arm

Standard of Care

Group Type OTHER

Control Arm

Intervention Type OTHER

Standard of Care which provides referrals to community-based smoking cessation resources.

Interventions

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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.

Intervention Type BEHAVIORAL

Control Arm

Standard of Care which provides referrals to community-based smoking cessation resources.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role collaborator

Riverside University Health System Medical Center

OTHER

Sponsor Role collaborator

Loma Linda University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne Berit Petersen, PhD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University

Locations

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Loma Linda University Medical Center

Loma Linda, California, United States

Site Status RECRUITING

Riverside University Health Systems

Moreno Valley, California, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Central Contacts

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Anne Berit Petersen

Role: CONTACT

909 558 1000 ext. 42846

Pramil Singh

Role: CONTACT

Facility Contacts

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Courtney Martin, DO

Role: primary

909-558-1000 ext. 15504

Bryan Oshiro, MD

Role: primary

Related Links

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Other Identifiers

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T32KT4784

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

5220112

Identifier Type: -

Identifier Source: org_study_id

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