Integrating CHWs Into Prenatal Care for Maternal Smoking Cessation

Tobacco Use Clinical Trial

— SFHOPE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06438549
• Other study ID #: 5220112
• Secondary ID: T32KT4784
• Status: Recruiting
• Phase: N/A
• Start date: May 24, 2024
• Est. completion date: August 2025

Study information

• Verified date: June 2024
• Source: Loma Linda University
• Contact: Anne Berit Petersen
• Phone: 909 558 1000
• Email: abpetersen[@]llu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: August 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

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 which provides referrals to community-based smoking cessation resources.

Locations

Country	Name	City	State
United States	Loma Linda University Medical Center	Loma Linda	California
United States	Riverside University Health Systems	Moreno Valley	California

Sponsors (3)

Lead Sponsor	Collaborator
Loma Linda University	Riverside University Health System Medical Center, University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-Report Tobacco Abstinence	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	Carbon Monoxide Level	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
Secondary	Arm 1 Satisfaction with CHW visit	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.

External Links

•   Study website