Integrating CHWs Into Prenatal Care for Maternal Smoking Cessation

Not Applicable

Recruiting

• Conditions: Tobacco Use in Childbirth; Tobacco Use; Tobacco Use Cessation
• Interventions: Behavioral: HCP-CHW Integration into Prenatal Care for Smoking Cessation; Other: Control Arm

• Registration Number: NCT06438549
• Lead Sponsor: Loma Linda University

Brief 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.

Study Timeline

• Study First Submitted: 2024-04-18
• Study Start: 2024-05-24
• Study First Submitted QC: 2024-05-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-02
• Study First Posted: 2024-06-03
• Last Update Posted: 2024-06-04
• Primary Completion: 2025-05
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 105

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Integrated HCP-CHW Intervention Arm	HCP-CHW Integration into Prenatal Care for Smoking Cessation	CHW visit with brief tobacco cessation intervention.
Control arm	Control Arm	Standard of Care

Primary Outcome Measures

Name	Time	Method
Self-Report Tobacco Abstinence	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

Secondary Outcome Measures

Name	Time	Method
Carbon Monoxide Level	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+
Arm 1 Satisfaction with CHW visit	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.

Trial Locations

Locations (2)

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States

Riverside University Health Systems; 🇺🇸 Moreno Valley, California, United States