Department of General Practice and Health Service Research, University Hospital Heidelberg, Im Neuenheimer Feld 130.3, Heidelberg, 69120, Germany.
Department of Health Promotion, AOK Baden-Wuerttemberg, Presselstrasse 19, Stuttgart, 70191, Germany.
Trials. 2024 Jun 18;25(1):393. doi: 10.1186/s13063-024-08215-5.
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.
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.
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.
The German Clinical Trials Register DRKS00027804. Registered on 2022/01/12.
与生活方式相关的风险因素会增加妊娠期间的并发症，并对母婴健康产生负面影响。许多孕妇和育龄妇女对这些风险因素知之甚少。在 AOK-Family ⁇ + 研究中，我们提出了评估一种新开发的咨询干预措施的建议。该干预措施旨在提高对生活方式相关风险因素在妊娠期间的影响的认识，并提供相关信息。拟议研究的目的是评估该咨询干预措施对女性妊娠期间生活方式相关风险因素知识和相应健康行为的影响。
在德国巴登-符腾堡州提出了一项具有三个组的集群随机试验。将孕妇和育龄妇女分配到三个组之一：在线干预组、现场干预组或候补对照组。德国法定健康保险公司 AOK Baden-Wuerttemberg 的经过培训的顾问将进行咨询。通过在三个时间点（咨询前（t0）、咨询后立即（t1）和 6 周随访（t2））进行的经过验证的问卷进行数据收集。主要结果将是与妊娠期间 LRFF 相关的健康知识和健康行为。通过额外的定量问题和定性访谈和焦点小组，将进行过程评估，以检查所使用的过程、资源和未来实施情况。
基于这项研究，可以制定一种未来在妊娠期间进行生活方式咨询的实施策略，旨在减少围产期的流动性和死亡率。
德国临床试验注册处 DRKS00027804。于 2022 年 1 月 12 日注册。
