RecruitingNot Applicable

Integrating CHWs Into Prenatal Care for Maternal Smoking Cessation

United States105 participantsStarted 2024-05-24

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Self-Report Tobacco Abstinence

Timeframe: Change between baseline enrollment and 1 month postpartum visit, typically ten months

Trial details

NCT IDNCT06438549

SponsorLoma Linda University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05

Contact for this trial

Anne Berit Petersen

909 558 1000 abpetersen@llu.edu

View on ClinicalTrials.gov More Tobacco Use trials