Integrating CHWs Into Prenatal Care for Maternal Smoking Cessation (SFHOPE)

June 2, 2025 updated by: Loma Linda University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92350
        • Recruiting
        • Loma Linda University Medical Center
        • Contact:
      • Moreno Valley, California, United States, 92555
        • Not yet recruiting
        • Riverside University Health Systems
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control arm
Standard of Care
Other: Control Arm
Standard of Care which provides referrals to community-based smoking cessation resources.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-Report Tobacco Abstinence
Time Frame: Change between baseline enrollment and 1 month postpartum visit, typically ten months
The 7 Day Point Prevalence Abstinence (PPA) questionnaire will be administered to subjects to assess the following: Tobacco use within past seven days
Change between baseline enrollment and 1 month postpartum visit, typically ten months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Carbon Monoxide Level
Time Frame: Change between baseline and 1 month postpartum visit, typically ten months

Breathalyzer test will be administered to subjects to determine CO level. Subjects will then be classified per CO level as:

Nonsmoker = 0 to 3 Borderline = 4 to 6 Smoker = 7 and above Smoker Low Addiction = 7 to 10 Smoker Moderate Addiction = 11 to 15 Smoker Heavily Addicted = 16 to 25 Smoker Very heavily Addicted = 26+
Change between baseline and 1 month postpartum visit, typically ten months
Arm 1 Satisfaction with CHW visit
Time Frame: Baseline; during the intervention; through study completion, an average of 10 months.
The acceptability of the intervention will be assessed using composite Likert scale measures of process outcomes such as 1) overall patient satisfaction, 2) increasing patient motivation and confidence, and 3) willingness to recommend the program to others. Likert scale interpretations for overall satisfaction: 1=Very Dissatisfied; 2=Dissatisfied; 3=Neutral; 4=Satisfied; 5=Very Satisfied. Likert scale interpretation for patient motivation and confidence: 1=Strongly Disagree (The intervention did not increase motivation/confidence at all); 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree (The intervention significantly increased motivation/confidence). Likert scale interpretation for Willingness to Recommend the Program to Others: 1=Not at all likely; 2=Unlikely; 3=Neutral; 4=Likely; 5=Very Likely.
Baseline; during the intervention; through study completion, an average of 10 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Collaborators

University of California, San Francisco
Riverside University Health System Medical Center

Investigators

  • Principal Investigator: Anne Berit Petersen, PhD, Loma Linda University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

April 18, 2024

First Submitted That Met QC Criteria

May 30, 2024

First Posted (Actual)

June 3, 2024

Study Record Updates

Last Update Posted (Estimated)

June 5, 2025

Last Update Submitted That Met QC Criteria

June 2, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 5220112
  • T32KT4784 (Other Grant/Funding Number: Tobacco-related Disease Research Program (TRDRP))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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