Supplementary Material for: OBEDIS Core Variables Project: European Expert Guidelines on a Minimal Core Set of Variables to Include in Randomized, Controlled Clinical Trials of Obesity Interventions

Heterogeneity of interindividual and intraindividual responses to interventions is often observed in randomized, controlled trials for obesity. To address the global epidemic of obesity and move toward more personalized treatment regimens, the global research community must come together to identify factors that may drive these heterogeneous responses to interventions. This project, called OBEDIS (OBEsity Diverse Interventions Sharing – focusing on dietary and other interventions), provides a set of European guidelines for a minimal set of variables to include in future clinical trials on obesity, regardless of the specific endpoints. Broad adoption of these guidelines will enable researchers to harmonize and merge data from multiple intervention studies, allowing stratification of patients according to precise phenotyping criteria which are measured using standardized methods. In this way, studies across Europe may be pooled for better prediction of individuals’ responses to an intervention for obesity – ultimately leading to better patient care and improved obesity outcomes.

在肥胖症随机对照试验中，常可观察到个体间与个体内对干预措施的应答异质性。为应对肥胖症全球流行态势，并推进更具个性化的治疗方案，全球科研界需携手合作，明确可能驱动此类干预应答异质性的相关因素。本项目名为OBEDIS（OBEsity Diverse Interventions Sharing——聚焦膳食与其他干预手段），其制定了一套欧洲指南，明确了未来肥胖症临床试验需纳入的最小变量集，不受特定终点指标限制。若广泛采用该指南，研究人员将能够统一并整合多项干预研究的数据，进而可通过标准化方法测得的精准表型分型标准对患者进行分层。通过此种方式，欧洲各地的研究可实现合并汇总，以更精准地预测个体对肥胖干预措施的应答效果，最终改善患者诊疗质量与肥胖症转归。