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

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the treatment HCP-CHW Integration into Prenatal Care for Smoking Cessation?

Research shows that integrating smoking cessation programs into prenatal care can be effective. For example, a self-help program increased the likelihood of quitting smoking during pregnancy and improved birth outcomes, while the Fax-to-Quit program successfully connected pregnant women with quitting services, demonstrating the potential benefits of such integrated approaches. ^{1 2 3 4 5}

Is the CHW Support for Quitting Smoking During Pregnancy treatment safe for humans?

The research on smoking cessation programs for pregnant women, which includes self-help interventions, shows no safety concerns and suggests these programs can be beneficial for both mother and baby by reducing risks associated with smoking during pregnancy. ^{3 5 6 7 8}

How is the HCP-CHW Integration into Prenatal Care for Smoking Cessation treatment different from other smoking cessation treatments during pregnancy?

The HCP-CHW Integration into Prenatal Care for Smoking Cessation treatment is unique because it involves integrating community health workers (CHWs) into prenatal care to provide personalized support and counseling for pregnant women trying to quit smoking. This approach emphasizes non-pharmacological support and community involvement, which is different from standard treatments that may rely more on nicotine replacement therapies or minimal interventions. ^{9 10 11 12 13}

Research Team

Anne Berit Petersen, PhD

Principal Investigator

Loma Linda University

Eligibility Criteria

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)

I am willing to quit smoking within the next 2 weeks.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. France 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]. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Encouraging smoking cessation during pregnancy in West Virginia: using Fax-to-Quit as a cessation strategy. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Pregnancy and medical cost outcomes of a self-help prenatal smoking cessation program in a HMO. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Health care providers' engagement in smoking cessation with pregnant smokers. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Women who stop smoking spontaneously prior to prenatal care and predictors of relapse before delivery. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

A randomized trial of a serialized self-help smoking cessation program for pregnant women in an HMO. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

A cost-benefit/cost-effectiveness analysis of smoking cessation for pregnant women. [2017]

8. Australia pubmed.ncbi.nlm.nih.gov

Quitting smoking in pregnancy. [2020]

9. England 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. [2021]

10. Hungary pubmed.ncbi.nlm.nih.gov

[Medical support of cessation for pregnant smokers]. [2023]

11. France pubmed.ncbi.nlm.nih.gov

[Health Professionals' Interventions for promoting smoking cessation during pregnancy: a review of the evidence]. [2017]

12. France pubmed.ncbi.nlm.nih.gov

[Smoking and pregnancy: the role of the gynecologist-obstetrician and the obstetrical team]. [2017]

13. United States pubmed.ncbi.nlm.nih.gov

Smoke free families: a tobacco control program for pregnant women and their families. [2019]