Financial incentives for smoking cessation in pregnancy: multicentre randomised controlled trial

ObjectiveTo evaluate the efficacy of financial incentives dependent on continuous smoking abstinence on smoking cessation and birth outcomes among pregnant smokers.DesignSingle blind, randomised controlled trial.SettingFinancial Incentive for Smoking Cessation in Pregnancy (FISCP) trial in 18 maternity wards in France.Participants460 pregnant smokers aged at least 18 years who smoked ≤5 cigarettes/day or ≤3 roll-your-own cigarettes/day and had a pregnancy gestation of <18 weeks were randomised to a financial incentives group (n=231) or a control group (n=229).InterventionsParticipants in the financial incentives group received a voucher equivalent to €20 (£17; $23), and further progressively increasing vouchers at each study visit if they remained abstinent. Participants in the control group received no financial incentive for abstinence. All participants received a €20 show-up fee at each of six visits.Main outcome measuresThe main outcome measure was continuous smoking abstinence from the first post-quit date visit to visit 6, before delivery. Secondary outcomes in the mothers were point prevalence abstinence, time to smoking relapse, withdrawal symptoms, blood pressure, and alcohol and cannabis use in past 30 days. Secondary outcomes in the babies were gestational age at birth, birth characteristics (birth weight, length, head circumference, Apgar score), and a poor neonatal outcome—a composite measure of transfer to the neonatal unit, congenital malformation, convulsions, or perinatal death.ResultsMean age was 29 years. In the financial incentives and control groups, respectively, 137 (59%) and 148 (65%) were employed, 163 (71%) and 171 (75%) were in a relationship, and 41 (18%) and 31 (13%) were married. The participants had smoked a median of 60 cigarettes in the past seven days. The continuous abstinence rate was significantly higher in the financial incentives group (16%, 38/231) than control group (7%, 17/229): odds ratio 2.45 (95% confidence interval 1.34 to 4.49), P=0.004). The point prevalence abstinence rate was higher (4.61, 1.41 to 15.01, P=0.011), the median time to relapse was longer (visit 5 (interquartile range 3-6) and visit 4 (3-6), P<0.001)), and craving for tobacco was lower (β=−1.81, 95% confidence interval −3.55 to −0.08, P=0.04) in the financial incentives group than control group. Financial incentives were associated with a 7% reduction in the risk of a poor neonatal outcome: 4 babies (2%) in the financial incentives group and 18 babies (9%) in the control group: mean difference 14 (95% confidence interval 5 to 23), P=0.003. Post hoc analyses suggested that more babies in the financial incentives group had birth weights ≥2500 g than in the control group: unadjusted odds ratio 1.95 (95% confidence interval 0.99 to 3.85), P=0.055; sex adjusted odds ratio 2.05 (1.03 to 4.10), P=0.041; and sex and prematurity adjusted odds ratio 2.06 (0.90 to 4.71), P=0.086. As these are post hoc analyses, the results should be interpreted with caution.ConclusionsFinancial incentives to reward smoking abstinence compared with no financial incentives were associated with an increased abstinence rate in pregnant smokers. Financial incentives dependent on smoking abstinence could be implemented as a safe and effective intervention to help pregnant smokers quit smoking.Trial registrationClinicalTrials.gov NCT02606227.

Investigating N-3 Fatty Acids to prevent Neonatal Tobacco-related outcomeS (INFANTS): study protocol for a double-blind, randomized, placebo-controlled parallel clinical trial of n-3 polyunsaturated fatty acids in pregnant smokers

Background Tobacco use during pregnancy is the most important modifiable risk factor associated with adverse pregnancy outcomes, increasing the risk of preterm birth, intrauterine growth restriction and sudden infant death syndrome. Fewer than half of pregnant smokers can quit on their own. Identifying safe and effective therapies to prevent tobacco-related adverse pregnancy outcomes and/or increase smoking cessation in pregnant women would have a substantial public health impact. Cigarette smoking is associated with a relative deficiency in circulating n-3 long-chain polyunsaturated fatty acid (n-3 LCPUFA) levels. A recent analysis found that smokers taking n-3 LCPUFAs during pregnancy had a reduction in preterm labor risk when compared to non-smokers. Studies have shown that supplemental n-3 LCPUFAs may also reduce nicotine cravings and daily cigarette use. Thus, smokers may benefit from supplemental n-3 LCPUFAs by lowering the risk of preterm labor and/or increased smoking cessation. To address important remaining knowledge gaps, we propose the Investigating N-3 Fatty Acids to prevent Neonatal Tobacco related outcomeS (INFANTS). Methods The INFANTS study is a multicenter, randomized, double-blind, placebo-controlled study that will randomize 400 pregnant smokers to either supplemental n-3 LCPUFAs or placebo. Participants will be enrolled between 12 and 24 weeks’ gestation and followed until 6 weeks after delivery. We will recruit from clinical centers throughout Middle Tennessee. We will assess smoking behavior after 12 weeks of supplementation using self-report and validated biomarkers of tobacco exposure. We will measure response to supplementation using biological markers of n-3 LCPUFA status. Our primary endpoint will be preterm labor as reflected by gestational age at delivery. Our secondary endpoint will be change from baseline in cigarettes per day at 12 weeks. Discussion This study tests the hypothesis that smoking-induced n-3 LCPUFA deficiencies contribute to tobacco-related adverse pregnancy outcomes and that supplementation of n-3 LCPUFAs in pregnant smokers may prevent these complications. If our study demonstrates that supplemental n-3 LCPUFAs are effective at reducing the risk of tobacco-related adverse neonatal outcomes and/or reducing tobacco use during pregnancy, our results could have an immediate and major impact on pregnancy care and neonatal outcomes. Trial registration ClinicalTrials.gov NCT04417595. Registered on April 21, 2020

Remote Patient Monitoring and Incentives to Support Smoking Cessation Among Pregnant and Postpartum Medicaid Members: Three Randomized Controlled Pilot Studies

Background Smoking rates among low-income individuals, including those eligible for Medicaid, have not shown the same decrease that is observed among high-income individuals. The rate of smoking among pregnant women enrolled in Medicaid is almost twice that among privately insured women, which leads to significant disparities in birth outcomes and a disproportionate cost burden placed on Medicaid. Several states have identified maternal smoking as a key target for improving birth outcomes and reducing health care expenditures; however, efficacious, cost-effective, and feasible cessation programs have been elusive. Objective This study aims to examine the feasibility, acceptability, and effectiveness of a smartwatch-enabled, incentive-based smoking cessation program for Medicaid-eligible pregnant smokers. Methods Pilot 1 included a randomized pilot study of smartwatch-enabled remote monitoring versus no remote monitoring for 12 weeks. Those in the intervention group also received the SmokeBeat program. Pilot 2 included a randomized pilot study of pay-to-wear versus pay-to-quit for 4 weeks. Those in a pay-to-wear program could earn daily incentives for wearing the smartwatch, whereas those in pay-to-quit program could earn daily incentives if they wore the smartwatch and abstained from smoking. Pilot 3, similar to pilot 2, had higher incentives and a duration of 3 weeks. Results For pilot 1 (N=27), self-reported cigarettes per week among the intervention group declined by 15.1 (SD 27) cigarettes over the study; a similar reduction was observed in the control group with a decrease of 17.2 (SD 19) cigarettes. For pilot 2 (N=8), self-reported cigarettes per week among the pay-to-wear group decreased by 43 cigarettes (SD 12.6); a similar reduction was seen in the pay-to-quit group, with an average of 31 (SD 45.6) fewer cigarettes smoked per week. For pilot 3 (N=4), one participant in the pay-to-quit group abstained from smoking for the full study duration and received full incentives. Conclusions Decreases in smoking were observed in both the control and intervention groups during all pilots. The use of the SmokeBeat program did not significantly improve cessation. The SmokeBeat program, remote cotinine testing, and remote delivery of financial incentives were considered feasible and acceptable. Implementation challenges remain for providing evidence-based cessation incentives to low-income pregnant smokers. The feasibility and acceptability of the SmokeBeat program were moderately high. Moreover, the feasibility and acceptability of remote cotinine testing and the remotely delivered contingent financial incentives were successful. Trial Registration ClinicalTrials.gov NCT03209557; https://clinicaltrials.gov/ct2/show/NCT03209557.

The Development and Testing of a Perinatal Tobacco, Attitudes, and Behaviors Survey (PTABS)

Background and PurposeAccurate assessment of tobacco use in pregnant smokers is key to effective nursing intervention. There is a lack of valid and reliable tools easily integrated into prenatal care. Therefore, the purpose of this study was to develop and test a perinatal survey, guided by the Health Promotion Model (HPM).MethodsThe survey was tested with 107 pregnant women via iPad. Urine cotinine assays and a process evaluation were conducted.ResultsReliability yielded a Cronbach's alpha of .873 for the ever-smoker sample and .835 for the total sample. Factors dovetailed with HPM constructs.ConclusionsPerinatal Tobacco, Attitudes, and Behaviors Survey (PTABS) exhibits high reliability and validity and is easily utilized. Updates need to include questions on all nicotine products and to be streamlined. With accurate identification of nicotine users nurses can provide targeted interventions early in pregnancy.

Fetal growth and development disorders in smoking pregnant women

BACKGROUND: Due to the increased frequency of smoking in pregnant women, an interest in the study of the mechanisms of the fetoplacental unit in women with tobacco addiction has also been increased all over the world. The effect of low degrees of tobacco addiction of a pregnant woman on the fetus has not been studied in the available literature. AIM: The aim of this study was to identify the growth and developmental abnormalities of the fetus at 30-34 weeks of gestation in smoking pregnant women at the third-trimester ultrasound screening. MATERIALS AND METHODS: Pregnant women, who were observed in the Northern Medical Clinical Center named after N.A. Semashko, Arkhangelsk, Russia were examined during the ultrasound screening. A continuous examination of pregnant women with three ultrasound screenings was carried out, with the third screening performed in 1048 individuals. RESULTS: The survey cohort included 120 pregnant women using the inclusion criteria. Two groups were formed depending on the presence or absence of smoking during pregnancy. The first group contained non-smoking pregnant women (n = 40); the second group comprised smokers during pregnancy (n = 80). Comparison of fetal development parameters in the group of pregnant smokers was carried out in two subgroups: the second a subgroup only consisted of smokers in the first trimester (embryonic period) and the second b subgroup contained smokers throughout pregnancy. All pregnant women who took part in the study signed a Patient Informed Consent form. The study design was observational, cross-sectional (one-step). The main manifestations of fetal growth and development disorders at 30-34 weeks of gestation in pregnant smokers were low estimated fetal weight, low tubular bone length and low head circumference by the gestational age. Low (below the 10th percentile) estimated fetal weight by the gestational age was recorded only in the group of pregnant women who smoke (p = 0.001) and in 90.0% of cases even with a weak degree of tobacco addiction. It was accompanied by low bone sizes and was detected in 10.0% of cases among women who stopped smoking in the first trimester and in 15.0% of cases among those who continued to smoke throughout pregnancy. This result confirmed early symmetrical intrauterine growth restriction of the fetus. Pregnant smokers at 30-34 weeks of gestation had significantly more often low (below the 5th percentile) fetometric parameters characterizing bone growth: femur length (p = 0.01), shinbone length (p = 0.035), shoulder bone length (p = 0.004), biparietal head size (p = 0.006), and head circumference (p = 0.002). Low values of the fetal head circumference were found in 50.0% of cases among pregnant smokers. In the absence of signs of fetal bone growth restriction and the estimated fetal weight in P10-95 values in the group of smoking pregnant women, significantly more often (p = 0.027) than in non-smokers, low (below the 5th percentile) head circumference for gestational age was recorded in 29.8% of cases. In addition, in this group of fetuses of pregnant smokers, elevated ratios of abdominal circumference to head circumference were found, which indicated fetal head growth restriction. The fetometry data obtained were confirmed by anthropometric measurements in the newborns during term delivery, the length of full-term newborns in pregnant smokers being significantly lower (p = 0.040). CONCLUSIONS: Fetuses of pregnant smokers were more likely to have low fetometric parameters by gestational age. Low estimated weights of the fetuses were found in 90.0% of cases with a weak degree of tobacco addiction.

Health providers’ and pregnant women’s perspectives about smoking cessation support: a COM-B analysis of a global systematic review of qualitative studies

Background 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. Methods A systematic search of online databases (MEDLINE, EMBASE, PsycINFO and CINAHL) using PRISMA guidelines. PW’s and HPs’ quotes, as well as the authors’ analysis, were extracted and double-coded (30%) using the COM-B framework. Results Thirty-two studies included research from 5 continents: twelve on HPs’ perspectives, 16 on PW’s perspectives, four papers included both. HPs’ capability and motivation were affected by role confusion and a lack of training, time, and resources to provide interventions. HPs acknowledged that advice should be delivered while taking women’s psychological state (capability) and stressors into consideration. Pregnant women’s physical capabilities to quit (e.g., increased metabolism of nicotine and dependence) was seldom addressed due to uncertainty about nicotine replacement therapy (NRT) use in pregnancy. Improving women’s motivation to quit depended on explaining the risks of smoking versus the safety of quit methods. Women considered advice from HPs during antenatal visits as effective, if accompanied by resources, peer support, feedback, and encouragement. Conclusions HPs found it challenging to provide effective SCC due to lack of training, time, and role confusion. The inability to address psychological stress in women and inadequate use of pharmacotherapy were additional barriers. These findings could aid in designing training programs that address HPs’ and PW’s attitudes and supportive campaigns for pregnant smokers.

Patterns of combustible and electronic cigarette use during pregnancy and associated pregnancy outcomes

Although pregnant smokers may perceive electronic cigarettes (e-cigarettes) as safe alternatives to smoking combustible cigarettes, few studies have evaluated perinatal e-cigarette use and its associated health effects. We analyzed data from the Pregnancy Risk Assessment Monitoring System (PRAMS, 2016–2018) for 16,022 women who recently gave birth and reported smoking combustible cigarettes prior to pregnancy. Using average marginal predictive values from multivariable logistic regression to produce adjusted prevalence ratios (aPRs), we estimated the prevalence of combustible cigarette smoking during pregnancy and adverse birth outcomes associated with e-cigarette use. In total, 14.8% of smoking women reported using e-cigarettes prior to pregnancy. There was no association between e-cigarette use prior to pregnancy and combustible cigarette smoking during pregnancy (aPR 0.95; 95% CI 0.88, 1.02); however, e-cigarette use during pregnancy was associated with higher prevalence of combustible cigarette smoking during pregnancy (aPR 1.65; 95% CI 1.52, 1.80). In this sample, we did not observe evidence to support reduced risk of preterm birth, small-for-gestational age and low birthweight compared to combustible cigarette smoking during pregnancy. The prevalence of LBW was higher for those who used e-cigarettes, even exclusively, compared to women who quit smoking cigarettes entirely. These results suggest that e-cigarettes should not be considered a safe alternative to combustible cigarette smoking during pregnancy.