We are pleased to announce the publication of European expert guidelines on a minimal core set of variables to include in randomized, controlled clinical trials of obesity interventions in Obesity Facts, the European Journal of Obesity. Martine Laville, author, has kindly agreed to an interview with EASO.
Professor Laville, thank you for speaking with us and congratulations on the new guidelines. Please tell us a bit about the OBEDIS project:
This has been a really rewarding experience, a unique collaboration with 30 European renowned experts working in the field of obesity to make a breakthrough for future clinical trials. In clinical practice we all know that there is not one but numerous obesity phenotypes. It is also widely accepted that most obesity RCTs include patients that despite meeting inclusion criteria vary remarkably when it comes to their medical history of the disease, their associated complications and many other factors (genetics, lifestyle, interventional and psychosocial factors) that may drive the varying responses to the same intervention. The challenge we were facing in @OBEDIS project, funded by the JPI HDHL and supported by EASO, was to decipher the heterogeneity of patients living with obesity in order to improve the stratification of patients living with obesity.
Have you observed increasing interest in methodological coherence in obesity focused research in recent years?
Yes, many factors are involved in this new interest 1) most clinical guidelines on obesity treatments are not enough supported by evidence based medicine, 2) the precision medicine, which is certainly the medicine of the future, requires an accurate phenotyping approach, 3) the reuse, merging and linking of standardized and high quality of clinical data are now mandatory to open the door to new innovative medicine approaches.
And the outcomes of @OBEDIS will greatly contribute to these new methodological approaches.
Can you share a top-line summary of the new guidelines with our readers?
The @OBEDIS experts have agreed on the minimum core set of variables and their related assessment methods that should be systematically included in all clinical intervention involving patients living with obesity. The variables are related to: the environment and context, lifestyle and behavior, subject characteristics, comorbidities. We have paid attention that the selected variables could be easily collected (low cost, less invasive, quick to implement). The widely adoption of @OBEDIS core set will be a major step forward to the patients stratification and ultimately precision medicine.
How do you believe these guidelines will impact obesity research and clinical trials in years to come?
We see that these guidelines will pave the way to future medical care for patients living with obesity. @OBEDIS is a first methodological step to the data sharing, allowing to standardize the data collection in clinical interventions across Europe.
We hope that, in the near future, the collection at the European level of the minimal core set will allow to easily share and combine high quality and standardized large amount of data at the European level, as a large data base helping to optimize the treatments and clinical care management of patients living with obesity to deliver the right treatment, to the right person at the right moment.
M Laville, MD-PhD, Professor of Nutrition at the Medical school in Lyon University. She is involved in teaching nutrition and in diabetes and obesity care.
She is the president of CENS (Center European for Nutrition and Health). She is the leader of FORCE (French Obesity Centre of Excellence) a network devoted to development of trials for obesity treatment. She is involved in of European infrastructure projects ECRIN (WP Nutrition leader), and coordinates JPI HDHL ( healthy diet for healthy life) initiatives like @OBEDIS on phenotyping in obesity. Past president from the French Society for Obesity (AFERO) she organised the ECO meeting in 2012. Her major research interest is about the mechanisms involved in obese and diabetic patients with different approaches from food habits to molecular biology. She is investigator and co-investigator in many clinical trials on obesity and diabetes.. She has published 300 + papers in peer reviewed journals with a h index of 65.