Study design of a stepped wedge cluster randomized controlled trial to evaluate the effect of a locally tailored approach for preconception care – the APROPOS-II study

Despite major advances in clinical research and medical technology, the prevalence of adverse maternal and neonatal health outcomes, such as pre-eclampsia and preterm birth, have only moderately decreased over the past decade [1]. As the first few weeks of pregnancy are crucial for gametogenesis, organogenesis and placental development, there is growing evidence that exposure to unhealthy lifestyle behaviours before or during pregnancy (such as alcohol consumption, smoking, physical inactivity, excessive weight gain, obesity and poor nutrition), often affect the future health of mothers, their offspring and future generations [2‐4]. In the Netherlands, 85% of all pregnancies are planned pregnancies [5]. However, planning a pregnancy is not always accompanied by appropriate preparation for pregnancy. As such, only half of all pregnant women use folic acid in the correct dose for the correct amount of time and more than 60% of all women with a wish to conceive still use alcohol [5]. A recent study among future fathers showed that the majority of them took no action to improve their lifestyle behaviours before conception [6]. Therefore, it is important to improve awareness among prospective parents regarding (unhealthy) preconceptional lifestyle behaviours and its effect on reproductive outcomes and to encourage prospective parents to actively prepare for pregnancy.

One way to actively prepare for pregnancy is by using preconception care (PCC). PCC is defined as “a set of interventions that aim to identify and modify medical, behavioural and social risks to a woman’s health or pregnancy outcome through prevention and management” [7]. Despite a growing body of evidence showing that PCC can increase the health and well-being of prospective parents, the uptake of PCC-consults remains remarkably low [8]. Even more cause for concern is that vulnerable women, who often have multiple unhealthy lifestyle behaviours, are specifically hard to reach [9]. Previous studies have shown that barriers for the use of PCC are determined by the presence of preconditions, women’s beliefs, perceptions and experiences, given the limited availability and the inadequate infrastructure in which PCC is provided [10, 11]. Previously developed PCC-interventions tend to be clinical and focus on individual-level behaviour change (i.e. counselling women not to engage in risky behaviours) rather than examining social, structural and environmental factors that shape preconception health [12].

A previous feasibility study performed by our group (APROPOS) in one municipality of the Netherlands showed that a locally tailored PCC-approach has the potential to positively affect preconceptional lifestyle behaviours and increases the use of PCC among prospective parents [13]. After being exposed to the intervention, women were more likely to make at least one preconceptional lifestyle behaviour change compared to women who were not exposed to the intervention (adjusted OR 1.56 (95%CI 1.02–2.39)) [13]. However, before this locally tailored intervention can be implemented on an (inter)national level, the feasibility and effectiveness of this intervention needs to be analysed in a larger-scale implementation study. Therefore, we designed a second study (APROPOS-II) with implementation in more municipalities, a larger group of respondents, randomization, and assessment of a more comprehensive set of (clinical) outcomes.

The APROPOS-II study introduces a locally tailored PCC-approach in six municipalities in the Netherlands, that will contribute to current knowledge regarding the implementation and the effectiveness of PCC. Until now there is little data from randomized clinical trials that prove the effectiveness of PCC on maternal and perinatal health outcomes [3, 42, 43]. This evidence is necessary to substantiate the urgency to invest in a comprehensive (inter)national PCC-program. The presented intervention serves the different needs of prospective parents by providing both separate preconception health information and PCC-consultation. This supports the view that most prospective parents will benefit from evidence-based information to prepare themselves for pregnancy, while not every prospective parent will attend a PCC-consult.

Despite the low uptake of PCC-consults, the majority of prospective parents use the internet as their primary source of information regarding preconception health [11]. Women appreciate anonymity and self-management of online information in the privacy of their own home [11, 44]. The aim of the social marketing strategy in this intervention is to trigger women to actively prepare for their pregnancy by guiding them towards a website (www.​wokewomen.​nl) with practical and evidence-based information to help them improve their preconceptional health status. In addition, we encourage these women when there is a need for extra information to visit a healthcare provider for a PCC-consult.

Previous literature on social marketing strategies showed that it has the potential to improve diet, increase exercise and reduce substances-use like tobacco, and alcohol [18]. Creating a social movement could raise awareness on the importance of PCC and could cause a supportive social environment for preconception health. In addition, research shows that healthcare collaborations in health promotion can result in effective and sustainable benefits for those involved [45]. When effectively facilitated, healthcare collaborations can enable fundamental improvements to community development and health promotion.

Strengths of this stepped-wedge cluster RCT are the diversity of the population in the participating municipalities and the tailored intervention that complies with the heterogeneity of local settings. Moreover, the detailed questionnaire investigating respondents’ lifestyle behaviours, health beliefs and the extent of planning of the current pregnancy based on validated questionnaires can be considered a strength of this study. In addition, the innovative social marketing strategy, the extensive process evaluation and the involvement of the prospective father highlight different and often neglected aspects of PCC-research.

A potential limitation of this study is the occurrence of selection bias, as participants who have actively prepared for their pregnancy are probably more eager to share their experience. However, in our previous feasibility study, response rates were high and the population characteristics were similar before and after introduction of the intervention [13]. Another limitation is the selection strategy, as the respondents of this study are pregnant while the interventions focusses on the preconceptional period. Previous studies already showed that prospective parents are very difficult to identify and recruit, therefore almost all PCC related studies obtain information retrospectively [46]. Finally, active participation of the healthcare providers is crucial to make the local PCC-pathway a success. Fortunately, the healthcare providers involved in the local PCC-pathway are driven to improve the awareness of PCC in their municipality and will be equipped to provide adequate PCC. All community midwifery practices have already been recruited and municipal policy makers are involved throughout the entire project.

With this study, we expect to effectively implement and evaluate a locally tailored PCC-approach. If this intervention will show to improve lifestyle behaviours, leading to improved pregnancy outcomes and future health of prospective parents and their offspring, it may be upscaled to (inter)national implementation.