Alayli Adrienne, Krebs Franziska, Lorenz Laura, Nawabi Farah, Bau Anne-Madeleine, Lück Isabel, Moreira Andrea, Kuchenbecker Judith, Tschiltschke Elena, John Michael, Klose Stefan, Häusler Benny, Giertz Christian, Korsten-Reck Ulrike, Stock Stephanie
Institute of Health Economics and Clinical Epidemiology, University Hospital of Cologne (IGKE), Cologne, Germany.
Federal Centre for Health Education (BZgA), Cologne, Germany.
BMC Public Health. 2020 Apr 15;20(1):482. doi: 10.1186/s12889-020-8200-4.
The first 1000 days after conception are a critical period to encourage lifestyle changes to reduce the risk of childhood obesity and early programming of chronic diseases. A healthy lifestyle during pregnancy is also crucial to avoid high post-partum weight retention. Currently, lifestyle changes are not consistently discussed during routine health services in Germany. The objective of this study is to evaluate a novel computer-assisted lifestyle intervention embedded in prenatal visits and infant check-ups. The intervention seeks to reduce lifestyle-related risk factors for overweight and obesity among expecting mothers and their infants.
The study is designed as a hybrid effectiveness-implementation trial to simultaneously collect data on the effectiveness and implementation of the lifestyle intervention. The trial will take place in eight regions of the German state Baden-Wuerttemberg. Region were matched using propensity score matching. Expecting mothers (n = 1860) will be recruited before 12 weeks of gestation through gynecological practices and followed for 18 months. During 11 routine prenatal visits and infant check-ups gynecologists, midwives and pediatricians provide lifestyle counseling using Motivational Interviewing techniques. The primary outcome measure is the proportion of expecting mothers with gestational weight gain within the recommended range. To understand the process of implementation (focus group) interviews will be conducted with providers and participants of the lifestyle intervention. Additionally, an analysis of administrative data and documents will be carried out. An economic analysis will provide insights into cost and consequences compared to routine health services.
Findings of this study will add to the evidence on lifestyle interventions to reduce risk for overweight and obesity commenced during pregnancy. Insights gained will contribute to the prevention of early programming of chronic disease. Study results regarding implementation fidelity, adoption, reach and cost-effectiveness of the lifestyle intervention will inform decisions about scale up and public funding.
German Clinical Trials Register (DRKS00013173). Registered 3rd of January 2019, https://www.drks.de.
受孕后的头1000天是鼓励改变生活方式以降低儿童肥胖风险和慢性疾病早期编程的关键时期。孕期保持健康的生活方式对于避免产后体重过度滞留也至关重要。目前，德国的常规健康服务中并未始终如一地讨论生活方式的改变。本研究的目的是评估一种嵌入产前检查和婴儿体检中的新型计算机辅助生活方式干预措施。该干预措施旨在降低准妈妈及其婴儿中与生活方式相关的超重和肥胖风险因素。
本研究设计为一项混合有效性-实施试验，以同时收集有关生活方式干预有效性和实施情况的数据。试验将在德国巴登-符腾堡州的八个地区进行。使用倾向得分匹配法对地区进行匹配。将通过妇科诊所招募妊娠12周前的准妈妈（n = 1860），并对其进行18个月的随访。在11次常规产前检查和婴儿体检期间，妇科医生、助产士和儿科医生使用动机性访谈技术提供生活方式咨询。主要结局指标是孕期体重增加在推荐范围内的准妈妈比例。为了解实施过程，将对生活方式干预的提供者和参与者进行访谈（焦点小组）。此外，还将对行政数据和文件进行分析。经济分析将提供与常规健康服务相比的成本和结果方面的见解。
本研究的结果将补充有关孕期开始的生活方式干预以降低超重和肥胖风险的证据。所获得的见解将有助于预防慢性疾病的早期编程。关于生活方式干预的实施保真度、采用率、覆盖面和成本效益的研究结果将为扩大规模和公共资金的决策提供依据。
德国临床试验注册中心（DRKS00013173）。2019年1月3日注册，https://www.drks.de。
