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NCT Number: NCT06438549

Integrating CHWs Into Prenatal Care for Maternal Smoking Cessation

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

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Key information

Conditions

Tobacco Use Behavior Health Behavior Tobacco Use Cessation Tobacco Use in Childbirth

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University Medical Center, Loma Linda, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HCP-CHW Integration into Prenatal Care for Smoking Cessation

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

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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+

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Berit Petersen

CONTACT

[email protected]

909 558 1000 ext. 42846

Pramil Singh

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: SFHOPE

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 3, 2024
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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