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Design and study protocol of the maternal smoking cessation during pregnancy study, (M-SCOPE).

ABSTRACT: Maternal smoking is the most significant cause of preventable complications during pregnancy, with smoking cessation during pregnancy shown to increase birth weight and reduce preterm birth among pregnant women who quit smoking. Taking into account the fact that the number of women who smoke in Greece has increased steadily throughout the previous decade and that the prevalence of smoking among Greek females is one of the highest in the world, smoking cessation should be a top priority among Greek health care professionals.The Maternal Smoking Cessation during Pregnancy Study (M-SCOPE), is a Randomized Control Trial (RCT) that aims to test whether offering Greek pregnant smokers a high intensity intervention increases smoking cessation during the third trimester of pregnancy, when compared to a low intensity intervention. Prospective participants will be pregnant smokers of more than 5 cigarettes per week, recruited up to the second trimester of pregnancy. Urine samples for biomarker analysis of cotinine will be collected at three time points: at baseline, at around the 32nd week of gestation and at six months post partum. The control group/low intensity intervention will include: brief advice for 5 minutes and a short leaflet, while the experimental group/intensive intervention will include: 30 minutes of individualized cognitive-behavioural intervention provided by a trained health professional and a self-help manual especially tailored for smoking cessation during pregnancy, while counselling will be based on the ''5 As.'' After childbirth, the infants' birth weight, gestational age and any other health related complications during pregnancy will be recorded. A six months post-partum a follow up will be performed in order to re-assess the quitters smoking status.If offering pregnant smokers a high intensity intervention for smoking cessation increases the rate of smoking cessation in comparison to a usual care low intensity intervention in Greek pregnant smokers, such a scheme if beneficial could be implemented successfully within clinical practice in Greece.ClinicalTrials.gov Identifier NCT01210118.

SUBMITTER: Loukopoulou AN

PROVIDER: S-EPMC3260439 | biostudies-literature | 2011 Dec

REPOSITORIES: biostudies-literature

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Design and study protocol of the maternal smoking cessation during pregnancy study, (M-SCOPE).

Loukopoulou Andriani N AN Vardavas Constantine I CI Farmakides George G Rossolymos Christos C Chrelias Charalambos C Tzatzarakis Manolis N MN Tsatsakis Aristidis A Lymberi Maria M Connolly Gregory N GN Behrakis Panagiotis K PK

BMC public health 20111206

<h4>Background</h4>Maternal smoking is the most significant cause of preventable complications during pregnancy, with smoking cessation during pregnancy shown to increase birth weight and reduce preterm birth among pregnant women who quit smoking. Taking into account the fact that the number of women who smoke in Greece has increased steadily throughout the previous decade and that the prevalence of smoking among Greek females is one of the highest in the world, smoking cessation should be a top ...[more]

PMID: 22145828

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Project description:BackgroundSmoking prevalence during and after pregnancy remains high among socioeconomically disadvantaged women. Mobile health (mHealth) apps with game and social support elements seem promising to support smoking cessation.ObjectiveThis study aims to describe the user-centered design and usability evaluation of Kindle, an mHealth app with game and social support elements, to support disadvantaged young women during and after pregnancy through the first stages of smoking cessation.MethodsDisadvantaged women (n=9), members of their social networks (n=4), and nurses supporting these women (n=51) were informants throughout the iterative prototype development of Kindle according to the International Organization for Standardization 9241-11:2018. Specific phases included understanding the context of use through secondary analysis of qualitative interview data (phase 1), establishing the user and organizational requirements (phase 2), production of design solutions (phase 3), and usability inspection of the prototype through a heuristic evaluation (3 experts) along with user testing by a think aloud method (5 disadvantaged women and 5 nurses; phase 4). Usability problems were categorized according to the principles of the Healthcare Information and Management Systems Society.ResultsPhase 1 resulted in an understanding of the VoorZorg program and the needs of VoorZorg nurses and clients (eg, focus on early stages of change and building new supportive networks to aid clients in smoking cessation). In phase 2, we established requirements (n=22; eg, mHealth app, secure communication between nurses and clients, easy-to-use interfaces, inclusion of game elements, and tailoring at early stages of change in smoking cessation). Phase 3 resulted in a prototype of Kindle, combining the interface for nurses and clients, including the following functionalities: personal goal setting with earning points; secured chat function between nurses and other clients; and tips, diary, and profile creation. The heuristic evaluation and thinking aloud method in phase 4 revealed 78 usability problems in the interfaces. Most usability problems concerned simplicity (eg, unclear clickable button) and naturalness (eg, unclear icon).ConclusionsThe user-centered design and usability testing of the mHealth app Kindle yielded useful insights. The involvement of end users, specifically socioeconomically disadvantaged women during and after their pregnancy, resulted in a prototype that met their needs and requirements (eg, mHealth app, secure communication between nurses and clients, easy-to-use interfaces, inclusion of game elements, and tailoring to the early stages of change in smoking cessation) to achieve readiness for smoking cessation. Moreover, the usability evaluation by end users and experts revealed unique usability problems for this population. These insights allow for further optimization of Kindle and encourage future studies to engage disadvantaged populations in all phases of mHealth intervention design and usability testing.

Project description:BackgroundMany women try to stop smoking in pregnancy but fail. One difficulty is that there is insufficient evidence that medications for smoking cessation are effective and safe in pregnancy and thus many women prefer to avoid these. Physical activity (PA) interventions may assist cessation; however, trials examining these interventions have been too small to detect or exclude plausible beneficial effects. The London Exercise And Pregnant smokers (LEAP) trial is investigating whether a PA intervention is effective and cost-effective when used for smoking cessation by pregnant women, and will be the largest study of its kind to date.Methods/designThe LEAP study is a pragmatic, multi-center, two-arm, randomized, controlled trial that will target pregnant women who smoke at least one cigarette a day (and at least five cigarettes a day before pregnancy), and are between 10 and 24 weeks pregnant. Eligible patients are individually randomized to either usual care (that is, behavioral support for smoking cessation) or usual care plus a intervention (entailing supervised exercise on a treadmill plus PA consultations). The primary outcome of the trial is self-reported and biochemically validated continuous abstinence from smoking between a specified quit date and the end of pregnancy. The secondary outcomes, measured at 1 and 4 weeks after the quit date, and at the end of pregnancy and 6 months after childbirth, are PA levels, depression, self-confidence, and cigarette withdrawal symptoms. Smoking status will also be self-reported at 6 months after childbirth. In addition, perinatal measures will be collected, including antenatal complications, duration of labor, mode of delivery, and birth and placental weight. Outcomes will be analyzed on an intention-to-treat basis, and logistic regression models used to compare treatment effects on the primary outcome.DiscussionThis trial will assess whether a PA intervention is effective when used for smoking cessation during pregnancy.Trial registrationISRCTN48600346.

Project description:IntroductionSmoking during pregnancy increases the risk of morbidity and mortality of the mother and child. The inability of the unborn child to protect itself, raises the social and academic responsibility to protect the child from the harmful effects of smoking. Interventions including rewards (incentives) for lifestyle changes are an upcoming trend and can encourage women to quit smoking. However, these incentives can, as we will argue, also have negative consequences, for example the restriction of personal autonomy and encouragement of smoking to become eligible for participation. To prevent these negative consequences, we developed an ethical framework that enables to assess and address unwanted consequences of incentive-based interventions whereby moral permissibility can be evaluated.Aims and methodsThe possible adverse consequences of incentives were identified through an extensive literature search. Subsequently, we developed ethical criteria to identify these consequences based on the biomedical ethical principles of Beauchamp and Childress.ResultsOur framework consists of 12 criteria. These criteria concern (1) effectiveness, (2) support of a healthy lifestyle, (3) motivational for the target population, (4) stimulating unhealthy behavior, (5) negative attitudes, (6) personal autonomy, (7) intrinsic motivation, (8) privacy, (9) fairness, (10) allocation of incentives, (11) cost-effectiveness, and (12) health inequity. Based on these criteria, the moral permissibility of potential interventions can be evaluated.ConclusionsIncentives for smoking cessation are a response to the responsibility to protect the unborn child. But these interventions might have possible adverse effects. This ethical framework aims to identify and address ethical pitfalls in order to avoid these adverse effects.ImplicationsAlthough various interventions to promote smoking cessation during pregnancy exist, many women still smoke during pregnancy. Interventions using incentives for smoking cessation during pregnancy are a promising and upcoming trend but can have unwanted consequences. This ethical framework helps to identify and address ethical pitfalls in order to avoid these adverse effects.It can be a practical tool in the development and evaluation of these interventions and in evaluating the moral permissibility of interventions using incentives for smoking cessation during pregnancy.

Project description:Cigarette smoking during pregnancy increases risk for pregnancy complications, growth restriction, and other adverse health outcomes. The most effective intervention for reducing smoking during pregnancy is financial incentives contingent on biochemically-verified smoking abstinence. The present study examined the efficacy of a smartphone-based intervention whereby smoking monitoring and incentive delivery occurred remotely using a mobile app. If efficacious, this remote intervention would allow pregnant women residing in geographically remote areas to benefit from incentives-based cessation interventions. Sixty U.S. pregnant smokers were recruited between May 2018 to May 2019 via obstetrical clinics, Women, Infants, and Children (WIC) offices, and Facebook. Participants were assigned sequentially to one of two treatments: best practices alone (N = 30) or best practices plus financial incentives (N = 30). Outcomes were analyzed using repeated measures analysis based on generalized estimating equations (GEE). Seven-day point prevalence abstinence rates were greater in the incentives versus best practices arms early- (46.7% vs 20.0%, OR = 3.50, 95%CI = 1.11,11.02) and late-antepartum (36.7% vs 13.3%, OR = 3.76, 95%CI = 1.04,13.65), and four- (36.7% vs 10.0%, OR = 5.21, 95%CI = 1.28,21.24) and eight-weeks postpartum (40.0% vs 6.7%, OR = 9.33, 95%CI = 1.87,46.68), although not at the 12- (23.3% vs 10.0%, OR = 2.74, 95%CI = 0.63,11.82) or 24-week (20.0% vs 6.7%, OR = 3.50, 95%CI = 0.65,18.98) postpartum assessments likely due to this pilot study being underpowered for discerning differences at the later assessments, especially 24-weeks postpartum which was three months after treatment completion. These results support the efficacy of this remote, incentives-based intervention for pregnant smokers. Further research evaluating its efficacy and cost-effectiveness in a well-powered, randomized controlled trial appears warranted.

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Design and study protocol of the maternal smoking cessation during pregnancy study, (M-SCOPE).

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Design and study protocol of the maternal smoking cessation during pregnancy study, (M-SCOPE).

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