Helping pregnant women quit smoking with community health workers
Integrating CHWs Into Prenatal Care for Maternal Smoking Cessation: A Pilot Feasibility Study
This study is testing a new program that uses community health workers to help pregnant women in San Bernardino County quit smoking by providing support through home visits.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 105 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Loma Linda University Academic / other |
| Locations | 2 sites (Loma Linda, California and 1 other locations) |
| Trial ID | NCT06438549 on ClinicalTrials.gov |
What this trial studies
This study develops a novel behavioral tobacco cessation program specifically for pregnant smokers in San Bernardino County. It aims to improve maternal smoking cessation outcomes by integrating community health workers (CHWs) into the prenatal care model, providing support through home visits. The pilot randomized control trial will assess the feasibility, acceptability, and efficacy of this Healthcare Provider-Community Health Worker (HCP-CHW) intervention model, which includes eight home visits to assist women in quitting smoking before and after their designated quit date.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women under 24 weeks, over 18 years old, who are current smokers and willing to quit.
Not a fit: Patients with severe mental health issues that prevent informed consent or participation in the intervention may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve smoking cessation rates among pregnant women, leading to better health outcomes for both mothers and their babies.
How similar studies have performed: Other studies have shown success with community health worker interventions in smoking cessation, indicating a promising approach for this population.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Loma Linda, California and 1 other locations
- Loma Linda University Medical Center — Loma Linda, California, United States (Recruiting)
- Riverside University Health Systems — Moreno Valley, California, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Anne Berit Petersen, PhD — Loma Linda University
- Study coordinator: Anne Berit Petersen
- Email: abpetersen@llu.edu
- Phone: 909 558 1000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.