Protocol of a study to evaluate a lifestyle intervention during pregnancy
Abstract Background The risk of developing obesity and chronic diseases (e.g. diabetes mellitus) in children is influenced by the mother's lifestyle during pregnancy (prenatal programming). This study evaluates a computer-assisted preventive lifestyle counseling carried out during prenatal visits and infant check-ups. GeMuKi (acronym for 'strengthening health promotion: enhanced check-up visits for mother and child') is a complex intervention consisting of multiple components implemented by different cooperating healthcare providers. Methods GeMuKi supplements regular prenatal visits and infant check-ups with an additional counseling regarding physical activity, nutrition and alcohol and tobacco use. Providers, who carry out the counseling, receive communication training using motivational interviewing techniques. Pregnant women in 4 intervention regions in Germany receive GeMuKi from gynecologists, midwives and pediatricians, while participants in the 4 control regions receive standard care. As part of a hybrid effectiveness-implementation trial with 1860 participants, questionnaires are filled in at 4 time points. Weight development and health data of the mother and child are recorded. Health services use will be analyzed using statutory health insurance claims data. Interviews will be conducted to evaluate the implementation process. Results Targeted preventive measures at the beginning of pregnancy intend to reduce the risk of inadequate gestational weight gain (primary outcome). Secondary endpoints are amongst others maternal lifestyle, infant weight development and body composition. Conclusions GeMuKi is set up as a long-term, low-threshold, multimodal intervention in living environments and existing structures. Findings will add to the evidence on lifestyle interventions during pregnancy to reduce the risk for overweight and obesity. Results will contribute to the prevention of early programming of chronic disease and will inform decisions about scale up and public funding. Key messages Lifestyle interventions provided from the beginning of pregnancy intent to be beneficial for the health of both mother and child to prevent obesity and chronic diseases. Low-threshold interventions embedded in regular prenatal visits are accessible for the complete pregnant population, including vulnerable groups.