Evidence map›Paper›PMID 32059663›Full record

ArticleBMC public health2020

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.

Veronique Y F Maas, Maria P H Koster, Erwin Ista, Kim L H Vanden Auweele, Renate W A de Bie, Denhard J de Smit, Bianca C Visser, Elsbeth H van Vliet-Lachotzki, Arie Franx, Marjolein Poels

Abstract readClinical Trial Protocol
In one paragraph

Article in BMC public health, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Tailored interventions to address determinants of practice.The Cochrane database of systematic reviews · 2026
    Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Review
  6. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Veronique Y F MaasDepartment of Obstetrics and Gynaecology, University Medical Centre Rotterdam, Rotterdam, Doctor Molewaterplein 40, 3015, GD, the Netherlands.
Maria P H KosterDepartment of Obstetrics and Gynaecology, University Medical Centre Rotterdam, Rotterdam, Doctor Molewaterplein 40, 3015, GD, the Netherlands.
Erwin IstaDepartment of Internal Medicine - Nursing Science, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, Doctor Molewaterplein 40, 3015, GD, the Netherlands.
Kim L H Vanden AuweeleHELLP foundation, Zwolle, Postbus 40126, 8004, DC, the Netherlands.
Renate W A de BieDepartment of Obstetrics, Diakonessenhuis hospital, Utrecht, Bosboomstraat 1, 3582, KE, the Netherlands.
Denhard J de SmitMediClara Projects, Baambrugge, Prinses Beatrixstraat 7, 1396, KD, the Netherlands.
Bianca C VisserGeboorte Concortium Midden Nederland (GCMN), Utrecht, Oudlaan 4, 3515, GA, the Netherlands.
Elsbeth H van Vliet-LachotzkiDutch Genetic Alliance, VSOP, Utrecht, Koninginnelaan 23, 3762 DA Soest, the Netherlands.
Arie FranxDepartment of Obstetrics and Gynaecology, University Medical Centre Rotterdam, Rotterdam, Doctor Molewaterplein 40, 3015, GD, the Netherlands.
Marjolein PoelsDepartment of Obstetrics and Gynaecology, University Medical Centre Rotterdam, Rotterdam, Doctor Molewaterplein 40, 3015, GD, the Netherlands. info@care2research.com.

Funding

ZonMw 50-54300-98-230
6 · The paper itself

Abstract

backgroundIn 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. Therefore, we designed a second study (APROPOS-II) to obtain a more robust body of evidence: a larger group of respondents, more municipalities, randomization, and a more comprehensive set of (clinical) outcomes. The aim of this study is to assess the effectiveness and the implementation process of a local PCC-approach on preconceptional lifestyle behaviours, health outcomes and the reach of PCC among prospective parents and healthcare providers.

methodsThis study is an effectiveness-implementation hybrid type 2 trial. This involves a stepped-wedge cluster randomized controlled trial design aiming to include over 2000 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 directed towards 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 of the participating municipalities. The primary outcome of this study 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 be performed, providing information on the efficacy, feasibility, barriers and facilitators regarding the implementation of the intervention. DISCUSSION: 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 the future health of prospective parents and their offspring, it could subsequently be upscaled to (inter)national implementation.

trial registrationDutch Trial register: NL7784 (Registered June 6th, 2019).

Indexed as

AdultCitiesFemaleHealth BehaviorHumansLife StyleMaleNetherlandsPreconception CareProgram EvaluationRandomized Controlled Trials as TopicResearch DesignSurveys and QuestionnairesBehavioural changeHealth behaviourHealthcare providersHealth promotionMaternity carePreconception carePregnancy planning

Identifiers

PMID32059663
PMCPMC7023687

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.