Helping pregnant women quit smoking with community health workers
Official title: Integrating CHWs Into Prenatal Care for Maternal Smoking Cessation: A Pilot Feasibility Study
Run by Loma Linda University · NCT06438549 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 105 (estimated) |
| Sponsor | Loma Linda University Academic / other |
| Locations | 2 sites (Loma Linda, California and 1 other locations) |
| Status | Recruiting |
| Started | May 24, 2024 |
| Main results expected | May 2027 |
| Study ends | August 2027 |
| Registry record updated | June 8, 2026 |
| Trial ID | NCT06438549 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with severe mental health issues that prevent informed consent or participation in the intervention may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown success with community health worker interventions in smoking cessation, indicating a promising approach for this population.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This study is testing new ways to help people living in poverty in Utah quit smoking by using support tools and strategies in their healthcare clinics.
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This study is testing if taking cannabidiol (CBD) can help people who smoke more than 10 cigarettes a day quit smoking and feel better during withdrawal.
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One extra structured CBT session to help cancer patients quit smoking
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.