Piloting a complex intervention to promote a tobacco and alcohol-free pregnancy: the Smoke and Alcohol Free with EHealth and Rewards (SAFER) pregnancy study.

BACKGROUND: Tobacco smoking and alcohol consumption before and during pregnancy increase the risk of adverse health outcomes for mother and child. Interventions to address smoking and drinking before and during pregnancy have the potential to reduce early-life health inequalities. In the Smoke and Alcohol Free with EHealth and Rewards (SAFER) pilot study we aimed to evaluate the acceptability, feasibility and effectiveness of a complex intervention supporting women in smoking and alcohol cessation before and during pregnancy. METHODS: From February 2019 till March 2021, we piloted the SAFER pregnancy intervention among pregnant women and women planning pregnancy in South-West Netherlands in an uncontrolled before-after study. Participants were supported in smoking and alcohol cessation via up to six group sessions and an online platform. In addition, biochemically validated cessation was rewarded with incentives (i.e. shopping vouchers) amounting up to 185 euros. We aimed to include 66 women. The primary outcome was smoking and/or alcohol cessation at 34-38 weeks of gestation (if pregnant) or after six group sessions (if not pregnant). Quantitative data were analysed using descriptive statistics. Focus group interviews among those involved in the study were conducted at the end of the study to explore their experiences. Qualitative data was analysed using thematic analysis. RESULTS: Thirty-nine women who smoked were included; no women who consumed alcohol were referred to the study. Unemployment (51%), financial problems (36%) and a smoking partner (72%) were common. Thirteen women (33%) dropped out, often due to other problems impeding smoking cessation or 'being too busy' to participate in the group sessions. Eleven women (28%) had quit smoking at the study's endpoint. The personal and positive approach was highly valued and biochemical validation was felt to be helpful. CONCLUSION: The SAFER pregnancy intervention seems appropriate for women in need of extra support for smoking cessation before and during pregnancy. Its impact on alcohol cessation could not be studied due to recruitment issues. Recruitment and prevention of early dropout need attention in further development of this intervention. TRIAL REGISTRATION: Netherlands Trial Register: NL7493. Date registered: 04/02/2019.

Change in Lifestyle Behaviors After Preconception Care: A Prospective Cohort Study.

PURPOSE: To evaluate the effects of preconception care (PCC) consultations by change in lifestyle behaviors. SETTING AND INTERVENTION: Women in deprived neighborhoods of 14 Dutch municipalities were encouraged to visit a general practitioner or midwife for PCC. SAMPLE: The study included women aged 18 to 41 years who had a PCC consultation. DESIGN: In this community-based prospective cohort study, we assessed initiation of folic acid supplementation, cessation of smoking, alcohol consumption, and illicit drug use. MEASURES: Self-reported and biomarker data on behavioral changes were obtained at baseline and 3 months later. ANALYSIS: The changes in prevalence were assessed with the McNemar test. RESULTS: Of the 259 included participants, paired analyses were available in 177 participants for self-reported outcomes and in 82 for biomarker outcomes. Baseline self-reported prevalence of no folic acid use was 36%, smoking 12%, weekly alcohol use 22%, and binge drinking 17%. Significant changes in prevalence toward better lifestyle during follow-up were seen for folic acid use (both self-reported, P < .001; and biomarker-confirmed, P = .008) and for self-reported binge drinking (P = .007). CONCLUSION: Our study suggests that PCC contributes to initiation of folic acid supplementation and cessation of binge drinking in women who intend to become pregnant. Although based on a small sample, the study adds to the limited body of evidence regarding the benefits of PCC in improving periconception health.

Effectiveness of general preconception care accompanied by a recruitment approach: protocol of a community-based cohort study (the Healthy Pregnancy 4 All study).

INTRODUCTION: Promotion of healthy pregnancies has gained high priority in the Netherlands because of the relative unfavourable perinatal outcomes. In response, a nationwide study Healthy Pregnancy 4 All (HP4ALL) has been initiated. One of the substudies within HP4ALL focuses on preconception care (PCC). PCC is an opportunity to detect and eliminate risk factors before conception to optimise health before organogenesis and placentation. The main objectives of the PCC substudy are (1) to assess the effectiveness of a recruitment strategy for the PCC health services and (2) to assess the effectiveness of individual PCC consultations. METHODS/ANALYSIS: Prospective cohort study in neighbourhoods of 14 municipalities with perinatal mortality and morbidity rates exceeding the nation's average. The theoretical framework of the PCC substudy is based on Andersen's model of healthcare utilisation (a model that evaluates the utilisation of healthcare services from a sociological perspective). Women aged 18 up to and including 41 years are targeted for utilisation of the PCC health service by a four armed recruitment strategy. The PCC health service consists of an individual PCC consultation consisting of (1) initial risk assessment and risk management and (2) a follow-up consultation to assess adherence to the management plan. The primary outcomes regarding the effectiveness of consultations is behavioural change regarding folic acid supplementation, smoking cessation, cessation of alcohol consumption and illicit substance use. The primary outcome regarding the effectiveness of the recruitment strategy is the number of women successfully recruited and the outreach in terms of which population is reached in comparison to the approached population. Data collection consists of registration in the database of women that enrol for a visit to the individual PCC consultations (women successfully recruited), and preconsultation and postconsultation measurements among the included study population (by questionnaires, anthropometric measurements and biomarkers). Sample size calculation resulted in a sample size of n=839 women. ETHICS AND DISSEMINATION: Approval for this study has been obtained from the Medical Ethical Committee of the Erasmus Medical Center of Rotterdam (MEC 2012-425). Results will be published and presented at international conferences.