2.6. Randomization and Masking
Patients were randomized to 1 of 6 treatment groups according to random number sequences given by the Stata user-written program Blinding was maintained in several ways. First, we assured the staff and participants that the interventions (diet and physical activity program) were based on healthy principles. Moreover, during follow-up at each visit the dietitian was assigned on a random daily basis. Furthermore, the different intervention arms were never mixed as only one was called in each day and only one patient at each date, to reduce the information exchange among participants. Physical activity training sessions were also held for only one intervention arm at a time.Staff members who assessed outcomes were unaware of the intervention assigned to each participant. Two radiologists performed the outcome measurements but only one performed the assessment each day and this order was also randomly assigned. During the outcome measurements, performed at the 45th and 90th day, the radiologists were unaware of the previous measurements.