[TRAMOMTANA (Multidisciplinary treatment of morbid obesity: medication, behavioral therapy, nutritional support, and physical activity). From question to reality in an investigator-initiated clinical trial (II)].

Implementation of an intensive, multidisciplinary weight loss program in patients with morbid obesity is reported. This program is based on behavioral changes, lifestyle intervention, medication, and group therapy sessions. Our objective is to show that the results achieved with this two-year weight loss program will be at least similar to those achieved with bariatric surgery in patients with morbid obesity.

[Key points in the start and conduct of a clinical trial. From question to reality in an investigator-initiated clinical trial (I)].

Evidence-based clinical practice requires integration of individual professional experience with the best objective data to make the best therapeutic decision. The best degree of scientific evidence derives from controlled, randomized clinical trials and post-marketing drug surveillance studies and meta-analyses. During our clinical activities, we often search unsuccessfully for a clinical trial which answers our scientific questions.