Trial Summary
What is the purpose of this trial?This develops a novel behavioral tobacco cessation program for pregnant smokers in San Bernardino County.
What data supports the idea that CHW Support for Quitting Smoking During Pregnancy is an effective treatment?The available research shows that CHW Support for Quitting Smoking During Pregnancy is effective. For example, a study on a self-help program found that women who participated were more likely to quit smoking for most of their pregnancy compared to those who did not participate (22.2% vs. 8.6%). Additionally, their babies weighed more at birth, and they were less likely to have low birth weight infants. This suggests that such programs can be beneficial in helping pregnant women quit smoking and improve health outcomes for their babies.1291011
What safety data exists for the smoking cessation program during pregnancy?The research does not directly address safety data for the CHW Support for Quitting Smoking During Pregnancy program. However, it provides evidence that smoking cessation programs, including self-help interventions, are effective in reducing smoking rates among pregnant women and improving birth outcomes, such as reducing the incidence of low birth weight infants. These programs are also cost-effective, suggesting they are beneficial for both health and economic reasons. The studies emphasize the importance of including smoking cessation programs in prenatal care, but specific safety data for the CHW Support program is not detailed in the provided research.12345
Is the treatment HCP-CHW Integration into Prenatal Care for Smoking Cessation a promising treatment for helping pregnant women quit smoking?Yes, the treatment is promising because it helps pregnant women quit smoking, which is important for the health of both the mother and the baby. Health professionals and community health workers working together can provide better support and guidance, making it easier for pregnant women to stop smoking. This approach can lead to healthier pregnancies and reduce risks for both mothers and their babies.6781213
Do I have to stop taking my current medications to join the trial?The trial protocol does not specify if you need to stop taking your current medications. However, if you are using Nicotine Replacement Therapy, you cannot join the trial.
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
I am older than 18 years.
Treatment Details
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.
2Treatment groups
Experimental Treatment
Group I: Integrated HCP-CHW Intervention ArmExperimental Treatment1 Intervention
CHW visit with brief tobacco cessation intervention.
Group II: Control armExperimental Treatment1 Intervention
Standard of Care
Find a clinic near you
Research locations nearbySelect from list below to view details:
Riverside University Health SystemsMoreno Valley, CA
Loma Linda University Medical CenterLoma Linda, CA
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Who is running the clinical trial?
Loma Linda UniversityLead Sponsor
Riverside University Health System Medical CenterCollaborator
University of California, San FranciscoCollaborator
References
Women who stop smoking spontaneously prior to prenatal care and predictors of relapse before delivery. [2019]This study explores the experience of pregnant women who quit smoking prior to initiating prenatal care. These "spontaneous quitters" comprised 41% of a socioeconomically and ethnically diverse population of prepregnancy smokers enrolled in a health maintenance organization. Compared to women who were smoking at the start of prenatal care, spontaneous quitters had been lighter smokers, were less likely to have another smoker in their household, indicated a stronger belief in the harmful effect of maternal smoking, had a history of fewer miscarriages, and entered prenatal care earlier. Biochemical validation of smoking status over the course of pregnancy found that 21% of the spontaneous quitters relapsed prior to delivery. Characteristics reported at the first prenatal visit that were associated with maintenance included having achieved cessation for a longer period of time without smoking even a puff, higher self-efficacy for maintenance, stronger belief in the harmful effect of maternal smoking, primigravida, and greater frequency of nausea. The identification of spontaneous quitters and selected intervention for those at greatest risk of relapse is recommended for inclusion in routine prenatal care.
Pregnancy and medical cost outcomes of a self-help prenatal smoking cessation program in a HMO. [2018]The results of a randomized clinical trial of a prenatal self-help smoking cessation program are reported in terms of the pregnancy and cost outcomes. The study population were the socioeconomically and ethnically diverse members of a large health maintenance organization (HMO) who reported that they were smoking at the time of their first prenatal visit. The intervention consisted predominantly of printed materials received through the mail. Compared with the usual care control group, women assigned to the self-help program were more likely to achieve cessation for the majority of their pregnancy (22.2 percent versus 8.6 percent), gave birth to infants weighing on average 57 grams more, and were 45 percent less likely to deliver a low birth weight infant. An economic evaluation of the self-help program was conducted from the perspective of the sponsoring HMO. Based upon the expenditures associated with the neonates' initial hospital episode, the intervention had a benefit-cost ratio of 2.8:1. These findings provide strong evidence to support widespread incorporation of smoking cessation interventions as a standard component of prenatal care.
A cost-benefit/cost-effectiveness analysis of smoking cessation for pregnant women. [2017]Research has shown that pregnant women who smoke cigarettes increase their risk of having low birthweight (LBW) infants. Recent randomized trials indicate that women who quit smoking early in pregnancy reduce their risk of delivering a LBW infant. Using various sources, we estimated the cost-effectiveness of a smoking cessation program for preventing LBW and perinatal mortality. Assuming the program would cost $30 a participant and that 15% of the participants would quit smoking, we determined that a program offered to all pregnant smokers would shift 5,876 LBW infants to normal birthweight and would cost about $4,000 for each LBW infant prevented. Since infants born to smokers are at 20% greater risk for a perinatal death, a smoking cessation program could prevent 338 deaths at a cost of $69,542 for each perinatal death averted. Compared with the costs of caring for these LBW infants in a neonatal intensive care unit (NICU), smoking cessation programs would save $77,807,054, or $3.31 per $1 spent. The ratio of savings to costs increases to more than six to one when we include reducing long-term care for infants with disabilities secondary to LBW in the benefits from smoking cessation programs. These findings argue for routinely including smoking cessation programs in prenatal care for smokers.
A randomized trial of a serialized self-help smoking cessation program for pregnant women in an HMO. [2019]We report the results of a population-based randomized clinical trial that tested the effectiveness of a prenatal self-help smoking cessation program. The intervention consisted predominantly of printed materials received through the mail. The population (n = 242) consisted of a socioeconomically and ethnically diverse group of pregnant women enrolled in a large health maintenance organization (HMO) who reported they were smoking at the time of their first prenatal visit. Biochemical confirmation of continuous abstinence achieved prior to the 20th completed week of pregnancy and lasting through delivery revealed 22.2 per cent of the women in the eight-week serialized program quit versus 8.6 per cent of controls with usual care. The adjusted odds ratio was 2.80 (95 per cent CI = 1.17, 6.69). We conclude that a low-cost prenatal self-help intervention can significantly affect the public health problem of smoking during pregnancy and its associated risks for maternal and child health.
Short-term health and economic benefits of smoking cessation: low birth weight. [2019]To estimate excess direct medical costs of low birth weight from maternal smoking and short-term cost savings from smoking cessation programs before or during the first trimester of pregnancy.
Smoke free families: a tobacco control program for pregnant women and their families. [2019]Tobacco use during pregnancy continues to cause health problems for women and children. Nurses can facilitate smoking cessation during pregnancy through the use of tobacco control guidelines and counseling tailored to pregnant women. In this article, the Treating Tobacco Use and Dependence: Clinical Practice Guideline is reviewed; the Smoke Free Families program, which is tailored for pregnancy, stage matched, and includes second-hand smoke control assistance, is described; and two models for integrating smoking cessation counseling into prenatal services are offered.
[Smoking and pregnancy: the role of the gynecologist-obstetrician and the obstetrical team]. [2017]Pregnancy is a particular period of life which changes the woman's smoking behavior. One-third of smoking women stop smoking spontaneously during this period and a large proportion request help with smoking cessation. Gynecologist-obstetricians who are concerned by the technical aspects of the pregnancy and other classical risk factors (gestational diabetes, hypertension) play an indispensable role, but together with the entire obstetrical team they must become more involved to fully take into account this toxic disease in their everyday practice. We report the experience of a level 1 maternity supported by the Lorrain Perinatal Network, the Association for Perinatal Prevention, Research and Information, and the work of our midwife anti-smoking team. The first step was better awareness. We shared our knowledge about the profile of the smoking mother and her expectations and about the usefulness of CO monitoring (prenatal consultations, hospital stay, delivery room). We then established a strategy for our entire healthcare facility involving minimal training for all categories of personnel, definition of screening and prevention modalities, and obstetrical care for smoking mothers. We also organized a smoking cessation supportive care program. Applied during outpatient consultations and hospital stays and in the delivery room, the program also included a smoking-cessation consultation with two midwives in the unit in cooperation with a physician and a dietitian working with smoking patients. A survey conducted in 24 maternity wards participating in the Lorrain Perinatal Network and five Perinatal Care Centers enabled an assessment of their participation in the smoking-cessation program and to evaluate their needs. Perinatal indicators are not satisfactory in France and it will be interesting to observe what changes can be achieved in each maternity ward after application of the smoking cessation care and support program.
[Health Professionals' Interventions for promoting smoking cessation during pregnancy: a review of the evidence]. [2017]Active and passive exposure to tobacco smoke during pregnancy is the most serious and preventable cause of adverse maternal, fetal, and infant outcomes in France. The clinical and economic benefits of cessation have been documented. The objective of this article is to review the evidence base addressing smoking cessation in pregnant women. The article describes how best to assist the pregnant smoker in clinical practice or hospital to quit during pregnancy. The following low intensity interventions designed to be integrated into routine prenatal care are detailed: expired air CO measures, practice of the evidence-based 5 A's smoking cessation intervention for pregnant women, use of pregnant woman's self-help guide to quit smoking, relapse prevention, health professionals' training, participation to community program.
Health care providers' engagement in smoking cessation with pregnant smokers. [2022]To review how health care providers' (HCPs) engage in smoking cessation (SC) with pregnant smokers, and to examine the effect of system-level approaches and training initiatives to promote SC provision by HCPs.
Encouraging smoking cessation during pregnancy in West Virginia: using Fax-to-Quit as a cessation strategy. [2013]Despite known dangers of smoking, a majority of pregnant women continue to smoke or relapse following delivery. West Virginia women have high unmet needs for smoking cessation, and the prenatal period presents a critical and unique opportunity for education and quitting assistance. West Virginia's Fax-to-Quit program uses provider-faxed referrals to the Quitline to engage smokers and connect them with cessation services. A 12-month feasibility evaluation of this Fax-to-Quit program for pregnant women was conducted. In February 2009, providers and staff from three OB/GYN clinics in three adjoining West Virginia counties were recruited. All participating sites received an intensive half-day training program. Adult pregnant smokers receiving prenatal care in these OB/GYN clinic sites were eligible to participate. Recruitment sites screened pregnant women for smoking; assessed readiness-to-quit; and enrolled consenting participants in the Fax-to-Quit Program. The Quitline measured cessation attempts with six-month follow-up of enrolled participants. Between March-December 2009, 58 referrals were made at these OB/GYN clinic sites, with 15 women (25.9%) enrolling in Quitline services. These enrolled women account for approximately one-quarter of calls from pregnant smokers to the West Virginia Quitline in the past 12 months. Contact, communication, and cooperation with office staff were relevant and important to successful project implementation. Findings indicate that Fax-to-Quit is feasible to engage providers and pregnant smokers with the West Virginia Quitline. Successful referrals and enrollment demonstrate Fax-to-Quit may support cessation by increasing Quitline use and connecting pregnant women who smoke with quitting services through provider-faxed referrals to the West Virginia Quitline.
[N on-pharmacological management of smoking cessation during pregnancy- CNGOF-SFT Expert Report and Guidelines for Smoking Management during Pregnancy]. [2023]To assess the benefit of non-pharmacological intervention promoting on smoking cessation, obstetric and neonatal outcomes, to offer pregnant women who smoke (PWS) optimal care.
Health providers' and pregnant women's perspectives about smoking cessation support: a COM-B analysis of a global systematic review of qualitative studies. [2021]Smoking cessation in pregnancy has unique challenges. Health providers (HP) may need support to successfully implement smoking cessation care (SCC) for pregnant women (PW). We aimed to synthesize qualitative data about views of HPs and PW on SCC during pregnancy using COM-B (Capability, Opportunity, Motivation, Behaviour) framework.
[Medical support of cessation for pregnant smokers]. [2023]Female smokers are most likely to quit using tobacco products during pregnancy. This period is an excellent chance for the health sector to achieve dual - maternal and fetal - health benefits with the professional support of the cessation attempt. In our review, we collected the practicalities of this specific cessation support. This review is based on publications available in the PubMed database as well as domestic and international guidelines and summaries, which were selected based on their practical importance. Quitting smoking during pregnancy is really important for both the foetus and the mother. Reframing the obstetric, neonatal and pediatric complications of smoking during pregnancy positively, and focusing on the benefits of quitting are recommended. Minimal intervention is advised to be complemented with counselling relating to the gestational age, referral to specialised care service and cessation support for the pregnant mother's partner. Non-pharmacological support is the primary recommended therapy for pregnant smokers. If it is not possible, or is unsatisfactory, the use of nicotine replacement therapy may be reasonable. Nicotine replacement therapy for pregnant smokers differs from the general nicotine replacement treatments in the following: use of oral formulations over transdermal nicotine intake; more cautious titration period; shorter treatment duration. Using behaviour interventions is also advised to support smoking cessation during pregnancy. The emphasis is on stress management, emotion regulation, behavioural and biological feedback, self-reward and use of external incentives. These methods are based on the cognitive behavioural therapy model and motivational interviewing techniques. Practical examples are presented in this summary. Orv Hetil. 2023; 164(30): 1194-1203.