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
Background: Lifestyle-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 evaluati...
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| Main Authors: | , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
18 June 2024
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| In: |
Trials
Year: 2024, Volume: 25, Pages: 1-12 |
| ISSN: | 1468-6694 |
| DOI: | 10.1186/s13063-024-08215-5 |
| Online Access: | Verlag, kostenfrei, Volltext: https://doi.org/10.1186/s13063-024-08215-5
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| Author Notes: | Mareike Krämer, Laura Wohlhüter, Lina Hermeling, Jan Koetsenruijter, Martina Kamradt, Michel Wensing and Manuela Bombana |
| Summary: | Background: Lifestyle-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. Methods: A 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 registration: The German Clinical Trials Register DRKS00027804. Registered on 2022/01/12. |
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| Item Description: | Gesehen am 15.11.2024 |
| Physical Description: | Online Resource |
| ISSN: | 1468-6694 |
| DOI: | 10.1186/s13063-024-08215-5 |