Abstract
PURPOSE: In Germany, knowledge of pregnant women as well as standards for health workers to conduct consultations on lifestyle-related risk factors (LRRFs) are suboptimal. This study aimed to identify factors influencing implementation of the "AOK Family Happiness Plus", a counselling intervention for LRRFs during pregnancy within a health insurance setting. PATIENTS AND METHODS: This process evaluation included semi-structured interviews and a focus group with n = 16 consultants involved in delivering the intervention. Interviews lasted approximately 30-60 minutes. Interviews were conducted in autumn 2023 during and the focus group at the end of the intervention phase, in summer 2024. Data were analysed using thematic analysis using the Consolidated Framework for Implementation Research (CFIR). RESULTS: Consultants highlighted the perceived benefits of the one-on-one counselling format including the four main topics of LRRF prevention during pregnancy: healthy diet, physical exercise, alcohol and tobacco use, and mental health. A strong alignment with existing prevention activities within the health insurance setting was noticed, while recruitment challenges and technical barriers in digital consultations were reported. Consultants mainly saw themselves in the role of innovation deliverers with strong self-efficacy and high capability. The involvement of gynaecologists and midwives was perceived as crucial for engaging innovation participants. Participating pregnant women were largely described as having prior knowledge of LRRF prevention. Consultants perceived that the consultation contributed to improving participants' understanding of LRRFs during pregnancy. The intervention deliverers faced significant obstacles, including technical difficulties and recruitment issues. Suggested adaptations included the introduction of group and online formats and including postnatal follow-up. CONCLUSION: The findings suggest that lifestyle counselling during pregnancy can be implemented within a health insurance setting, while highlighting important implementation challenges and contextual determinants. However, the findings reflect the perspectives of consultants delivering the intervention and should therefore be interpreted with caution. Future research should examine its effectiveness.