CHW Support for Quitting Smoking During Pregnancy

(SFHOPE Trial)

Recruiting at 1 trial location

Overseen By Pramil Singh

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Loma Linda University

Must not be taking: Nicotine Replacement Therapy

Disqualifiers: Severe mental health problems, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 10 months

105 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to help pregnant smokers quit by integrating a new support program into their prenatal care. Participants will receive visits from a Community Health Worker (CHW) who provides a brief tobacco cessation intervention. This approach, called HCP-CHW Integration into Prenatal Care for Smoking Cessation, is compared to standard care to determine which is more effective for quitting smoking. Pregnant women who are less than 24 weeks along, currently smoke, and want to quit soon might be a good fit. Participants must receive prenatal care at either Loma Linda University Health or Riverside University Health System.

As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance prenatal care and support for pregnant smokers.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that you cannot be on Nicotine Replacement Therapy (NRT) or enrolled in another cessation program within 30 days before joining.

What prior data suggests that this behavioral program is safe for pregnant smokers?

Research has shown that smoking cessation programs for pregnant women, such as the one in this study, are safe. These programs often use self-help methods and are easy to follow. They aim to help pregnant women quit smoking without risking their health or their baby's health.

In this trial, community health workers (CHWs) are included in prenatal care to assist women in stopping smoking. Studies have found that this type of support does not cause harm, making it a safe choice for pregnant women who want to quit smoking. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the integration of Community Health Workers (CHWs) into prenatal care for smoking cessation during pregnancy because it offers a personalized, supportive approach that traditional methods often lack. Unlike standard treatments like nicotine replacement therapy or counseling, this intervention involves direct interaction with CHWs who provide tailored guidance and motivation to expectant mothers. This method not only aims to help women quit smoking effectively but also enhances the overall prenatal care experience, potentially leading to better health outcomes for both the mother and baby.

What evidence suggests that this program is effective for quitting smoking during pregnancy?

Research shows that involving community health workers (CHWs) in prenatal care can help pregnant women stop smoking. In this trial, participants in the Integrated HCP-CHW Intervention Arm will receive a CHW visit with a brief tobacco cessation intervention. Studies have found that CHWs provide effective support by working closely with healthcare teams. This method offers personalized advice and ongoing encouragement to expectant mothers who want to quit smoking. Some evidence suggests that these efforts lead to more pregnant women successfully quitting smoking. While more research is needed, early signs are promising for this new way of offering support. ^{1 2 4 5 6}

Who Is on the Research Team?

Anne Berit Petersen, PhD

Principal Investigator

Loma Linda University

Are You a Good Fit for This Trial?

This trial is for pregnant smokers in San Bernardino County who are interested in quitting smoking. Specific eligibility criteria have not been provided, but typically participants would need to be of legal age for consent and willing to follow the study procedures.

Inclusion Criteria

< 24 weeks pregnant

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)

Enrolled in prenatal care at Loma Linda University Health (LLUH) or Riverside University Health System (RUHS)

Exclusion Criteria

I started using nicotine replacement or joined a quitting program in the last 30 days.

I am not willing to participate in recorded interviews or groups.

Severe mental health problems that prevent informed consent and/or CHW intervention

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a tobacco cessation intervention with eight home visits by community health workers (CHWs) integrated into prenatal care

10 months

8 home visits by CHWs

Follow-up

Participants are monitored for tobacco abstinence and satisfaction with the intervention

1 month postpartum

What Are the Treatments Tested in This Trial?

Interventions

• HCP-CHW Integration into Prenatal Care for Smoking Cessation

Trial Overview The trial is testing a new behavioral tobacco cessation program designed specifically for pregnant women. Participants will either receive this specialized support from community health workers integrated into their prenatal care or be placed in a control group without this additional intervention.

How Is the Trial Designed?

Group I: Integrated HCP-CHW Intervention Arm Experimental Treatment 1 Intervention

CHW visit with brief tobacco cessation intervention.

Group II: Control arm Experimental Treatment 1 Intervention

Standard of Care

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials

322

Recruited

267,000+

Riverside University Health System Medical Center

Collaborator

Trials

10

Recruited

19,300+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

Published Research Related to This Trial

In a randomized clinical trial involving 242 pregnant women, a prenatal self-help smoking cessation program led to a significant increase in quitting rates, with 22.2% of participants quitting compared to only 8.6% in the control group.

The study demonstrated that this low-cost intervention, primarily using printed materials, effectively helps pregnant women stop smoking, which is crucial for improving maternal and child health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of a serialized self-help smoking cessation program for pregnant women in an HMO. Ershoff, DH., Mullen, PD., Quinn, VP.[2019]

A smoking cessation program for pregnant women could prevent approximately 5,876 low birthweight infants and 338 perinatal deaths, demonstrating significant potential for improving maternal and infant health outcomes.

The program is cost-effective, saving over $77 million in neonatal care costs, and offers a return of more than $6 for every $1 spent when considering long-term care for infants affected by low birthweight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cost-benefit/cost-effectiveness analysis of smoking cessation for pregnant women. Marks, JS., Koplan, JP., Hogue, CJ., et al.[2017]

Non-pharmacological interventions, particularly various forms of counseling, have been shown to help pregnant women who smoke quit smoking and improve birth weight and reduce prematurity risks.

Financial incentives are effective for smoking cessation among pregnant women and may also positively impact neonatal outcomes, while self-help interventions and health education are recommended as supportive strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[N on-pharmacological management of smoking cessation during pregnancy- CNGOF-SFT Expert Report and Guidelines for Smoking Management during Pregnancy]. Peyronnet, V., Koch, A., Rault, E., et al.[2023]

Over 50% of healthcare providers (HCPs) inquire about smoking status and advise pregnant smokers to quit, but less than 50% assess readiness to change or provide follow-up support, indicating gaps in comprehensive smoking cessation (SC) care.

System-level and training initiatives have shown promise in improving HCP engagement in SC for pregnant smokers, although the sustainability of these effects remains uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health care providers' engagement in smoking cessation with pregnant smokers. Okoli, CTC., Greaves, L., Bottorff, JL., et al.[2022]

Tobacco use during pregnancy poses significant health risks, but nurses can play a crucial role in helping pregnant women quit smoking by using specific tobacco control guidelines and tailored counseling.

The article discusses the Smoke Free Families program, which is designed for pregnant women and includes support for managing second-hand smoke, highlighting effective strategies for integrating smoking cessation into prenatal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoke free families: a tobacco control program for pregnant women and their families. Pletsch, PK., Morgan, S.[2019]

In a study of pregnant women who quit smoking before starting prenatal care, 41% were identified as 'spontaneous quitters', who generally had lighter smoking habits and a stronger belief in the dangers of smoking during pregnancy.

Despite the positive trend, 21% of these spontaneous quitters relapsed before delivery, highlighting the need for targeted interventions during prenatal care to support those at risk of relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Women who stop smoking spontaneously prior to prenatal care and predictors of relapse before delivery. Quinn, VP., Mullen, PD., Ershoff, DH.[2019]

Smoking during pregnancy doubles the risk of low birthweight babies and significantly increases perinatal mortality, with an average birthweight reduction of 200 grams for infants of smoking mothers.

Effective interventions can help 8.1% more pregnant women quit smoking, but healthcare providers often struggle to implement these strategies, highlighting the need for better support, especially since nicotine replacement therapy's efficacy in pregnancy remains unproven.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quitting smoking in pregnancy. Walsh, RA., Lowe, JB., Hopkins, PJ.[2020]

Health providers face significant challenges in delivering effective smoking cessation care to pregnant women due to role confusion, lack of training, and insufficient resources, which can hinder their capability and motivation to help.

Pregnant women are more likely to respond positively to smoking cessation advice when it is tailored to their psychological state and accompanied by resources, peer support, and encouragement, highlighting the need for comprehensive support systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health providers' and pregnant women's perspectives about smoking cessation support: a COM-B analysis of a global systematic review of qualitative studies. Kumar, R., Stevenson, L., Jobling, J., et al.[2021]

Active and passive tobacco smoke exposure during pregnancy is a major preventable cause of negative health outcomes for mothers and infants in France, highlighting the urgent need for effective smoking cessation strategies.

The article outlines low-intensity interventions, such as CO monitoring and the 5 A's approach, that can be easily integrated into routine prenatal care to support pregnant women in quitting smoking, emphasizing the importance of tailored support in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Health Professionals' Interventions for promoting smoking cessation during pregnancy: a review of the evidence]. Stoebner-Delbarre, A., Letourmy, F.[2017]

The Fax-to-Quit program in West Virginia successfully engaged pregnant smokers by connecting them with cessation services, with 25.9% of referred women enrolling in Quitline services, indicating a feasible approach to support smoking cessation during pregnancy.

The program highlights the importance of provider involvement and communication in facilitating referrals, suggesting that structured support can enhance access to quitting resources for pregnant women who smoke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Encouraging smoking cessation during pregnancy in West Virginia: using Fax-to-Quit as a cessation strategy. Tworek, C., Horn, KA., Anderson, RH., et al.[2013]

Pregnant women are more likely to quit smoking, making pregnancy a crucial time for healthcare providers to offer support for cessation, which benefits both maternal and fetal health.

Non-pharmacological support is the primary recommendation for helping pregnant smokers quit, with options like counseling and behavioral interventions, while nicotine replacement therapy can be used cautiously if necessary, focusing on oral formulations and shorter treatment durations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Medical support of cessation for pregnant smokers]. Watti, J., Pócs, D., Tari, G., et al.[2023]

One-third of pregnant women who smoke quit spontaneously, but many seek help for smoking cessation, highlighting the need for healthcare providers to actively support these women during pregnancy.

A comprehensive smoking cessation program was implemented in a level 1 maternity facility, involving training for staff and collaboration among healthcare professionals, which aims to improve perinatal outcomes and support smoking mothers effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Smoking and pregnancy: the role of the gynecologist-obstetrician and the obstetrical team]. Bertrand, ML., Vegezzi, MP., Ecoe, R., et al.[2017]

The prenatal self-help smoking cessation program significantly increased the likelihood of women quitting smoking during pregnancy, with a cessation rate of 22.2% compared to 8.6% in the control group.

The program also led to better birth outcomes, with infants born to participants weighing an average of 57 grams more and a 45% reduction in the likelihood of low birth weight, demonstrating both efficacy and positive health impacts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pregnancy and medical cost outcomes of a self-help prenatal smoking cessation program in a HMO. Ershoff, DH., Quinn, VP., Mullen, PD., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06438549

Integrating CHWs Into Prenatal Care for Maternal Smoking ... This study seeks to address the disparities in the maternal smoking cessation outcomes of previous research by developing an innovative maternal tobacco ...

2. medrxiv.org medrxiv.org/content/10.1101/2025.10.26.25338756v1.full

Protocol for a Pilot Feasibility RCT Integrating CHWs into ... In this context, the CHW-led intervention allows us to add a brief advice tobacco and nicotine cessation intervention to the overall dashboard ...

3. medrxiv.org medrxiv.org/content/10.1101/2025.10.26.25338756v1.full.pdf

Protocol for a Pilot Feasibility RCT Integrating CHWs The integrated CHW coordinates closely with the prenatal care team, typically a social worker and/or public health nurse, to ensure continuity.

4. researchgate.net researchgate.net/publication/397011311_Smoke-Free_Household_and_Parent_Program_Smoke-Free_HOPE_Protocol_for_a_Pilot_Feasibility_RCT_Integrating_CHWs_into_Prenatal_Care_for_Maternal_Tobacco_Cessation

Protocol for a Pilot Feasibility RCT Integrating CHWs into ... Background: Tobacco use remains the most common form of substance use during pregnancy. Persistent disparities in maternal tobacco use exist ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11523498/

Effectiveness of smoking cessation interventions in ... The interventions may have increased smoking cessation rates in pregnant women; however, it cannot be determined if the increase was attributable to the ...

6. withpower.com withpower.com/trial/phase-tobacco-use-5-2024-8f9d4

CHW Support for Quitting Smoking During Pregnancy The research on smoking cessation programs for pregnant women, which includes self-help interventions, shows no safety concerns and suggests these programs can ...