Evidence map›Paper›PMID 38890726›Full record

ArticleTrials2024

A counselling intervention for individual strategies to prevent complications and strengthen resources during pregnancy in gynaecological care (AOK-Family +): study protocol for a cluster-randomised controlled trial.

Mareike Krämer, Laura Wohlhüter, Lina Hermeling, Jan Koetsenruijter, Martina Kamradt, Michel Wensing, Manuela Bombana

Abstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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

2 citing papers in PubMed.

  1. Article
  2. Article
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

7 authors.

Mareike Krämer *Department of General Practice and Health Service Research, University Hospital Heidelberg, Im Neuenheimer Feld 130.3, Heidelberg, 69120, Germany.
Laura Wohlhüter *Department of General Practice and Health Service Research, University Hospital Heidelberg, Im Neuenheimer Feld 130.3, Heidelberg, 69120, Germany.
Lina HermelingDepartment of Health Promotion, AOK Baden-Wuerttemberg, Presselstrasse 19, Stuttgart, 70191, Germany.
Jan KoetsenruijterDepartment of General Practice and Health Service Research, University Hospital Heidelberg, Im Neuenheimer Feld 130.3, Heidelberg, 69120, Germany.
Martina KamradtDepartment of General Practice and Health Service Research, University Hospital Heidelberg, Im Neuenheimer Feld 130.3, Heidelberg, 69120, Germany.
Michel WensingDepartment of General Practice and Health Service Research, University Hospital Heidelberg, Im Neuenheimer Feld 130.3, Heidelberg, 69120, Germany.
Manuela BombanaDepartment of General Practice and Health Service Research, University Hospital Heidelberg, Im Neuenheimer Feld 130.3, Heidelberg, 69120, Germany. dr.manuela.bombana@bw.aok.de.

Funding

AOK Baden-Württemberg 16112020
6 · The paper itself

Abstract

backgroundLifestyle-related risk factors can increase complications during pregnancy and negatively impact the health of a mother and her child. Knowledge about these compliances among many pregnant women and women of childbearing age is lacking. In the study AOK-Family + , we propose the evaluation of a newly developed counselling intervention. The intervention aims to raise awareness and to provide relevant information about the impact of lifestyle-related risk factors during pregnancy. The aim of the proposed study is to evaluate the effect of this counselling intervention on women's knowledge of lifestyle-related risk factors during pregnancy and the concomitant healthy behaviours.

methodsA cluster-randomised trial with three arms in Baden-Wuerttemberg, Germany, is proposed. Pregnant women and women of childbearing age will be allocated to one of three groups: online intervention, on-site intervention, or a waiting-list control. Trained counsellors from AOK Baden-Wuerttemberg, a German statutory health insurer, will conduct the counselling sessions. Data collection is conducted throughout validated questionnaires administered at three intervals: before counselling (t0), directly after counselling (t1), and at a 6-week follow-up (t2). The primary outcomes will be health knowledge and healthy behaviours relating to LRFFs during pregnancy. A process evaluation will examine the processes, used resources, and future implementations through additional quantitative questions and qualitative interviews and focus groups. DISCUSSION: Based on this study, an implementation strategy for future conduction of lifestyle consultation during pregnancy could be developed with the aim of reducing pre- and post-mortem mobility and mortality.

trial registrationThe German Clinical Trials Register DRKS00027804. Registered on 2022/01/12.

Indexed as

CounselingHealth Knowledge, Attitudes, PracticePregnancy ComplicationsRandomized Controlled Trials as TopicAdultFemaleGermanyHealth BehaviorHumansPregnancyRisk FactorsRisk Reduction BehaviorHealth behavioursHealth knowledgeHealth literacyPregnancyPrevention

Identifiers

PMID38890726
PMCPMC11186123

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Registered trials

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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.