A Counselling Intervention for Individual Strategies to Prevent Complications and Strengthen Resources during Pregnancy in the Gynaecological Care (AOK-Family+): Study Protocol for a Cluster-Randomised Controlled Trial

Abstract

Abstract 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 six-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 This study is registered in the German Clinical Trials Register, https://www.bfarm.de/DE/Das-BfArM/Aufgaben/Deutsches-Register-Klinischer-Studien/_node.html, as DRKS00027804, 2022/01/12.