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research-project
Research project  |  PI. Arie Franx

APROPOS II Study

A steppedwedge cluster randomized controlled trial to evaluate the effect of a locally tailored approach for preconception care.

What we do

About our project

Background information

In a previous feasibility study (APROPOS) in a single municipality of the Netherlands, we showed that a locally-tailored preconception care (PCC) approach has the potential to positively affect preconceptional lifestyle behaviours. To obtain a more robust body of evidence, we designed a second study (APROPOS-II)with a larger group of respondents, involvement of more municipalities, randomization, and a more comprehensive set of (clinical) outcomes.

Objective and outcomes 

The objective of this study is to assess the effectiveness and the implementation process of a local PCC-approach on preconceptional lifestyle behaviours, health outcomes as well as its reach and uptake among prospective parents and healthcare providers. The primary outcome is change in lifestyle behaviours (e.g. folic acid use, smoking and alcohol use). Secondary outcomes are pregnancy outcomes (e.g. miscarriage, preterm birth, gestational diabetes) and the uptake of PCC. Moreover, a process evaluation will provide information on the efficacy, feasibility, barriers and facilitators regarding the implementation of the intervention.

Research method

This study is an effectiveness-implementation hybrid type 2 trial. This involves a stepped-wedge cluster randomized controlled trial design aiming to include over 2,000 future parents from six municipalities in the Netherlands. The intervention has a dual-track approach, focusing on both the uptake of PCC among future parents and the provision of PCC by healthcare providers. The PCC-approach consists of 1) a social marketing strategy called Woke Women® directed towards the prospective parent(s) and 2) a local care pathway to improve interdisciplinary collaboration. Data will be collected before and after the introduction of the intervention through questionnaires and medical records in each participating municipality.

Desirable outcome

The APROPOS-II study introduces a locally tailored PCC-approach in six municipalities in the Netherlands that will contribute to the body of evidence regarding the effectiveness of PCC and its implementation. If this intervention has a positive effect on lifestyle behaviour changes, leading to improved pregnancy outcomes and improved future health of prospective parents and their offspring, it could be upscaled to national and international implementation.

Funds & Grants

This work was supported by the Netherlands Organization for Health Research and Development (ZonMw) under grant number 50-54300-98-230.

Collaborations

Collaboration within of Erasmus MC

  • Department of Obstetrics and Gynaecology
  • Department of Nursing Science

Collaboration outside of Erasmus MC

Municipalities of:

Publications

The effect of a local promotional campaign on preconceptional lifestyle changes and the use of preconception care.
Poels M, van Stel HF, Franx A, Koster MP (2018). The European Journal of Contraception & Reproductive Health Care, 23(1), 38-44.

Our team

Principal investigator

  • Professor A. (Arie) Franx, MD, PhD

Project leaders

PhD-student

Department of Obstetrics and Gynaecology