2.7. Data Management and Analysis
All the data were collected in a database. The analysis of efficacy of the trial was made per protocol and not by intention to treat, because not all the outcome variables were available for dropouts. Descriptive statistics, including means and S.D., range and proportions, whenever appropriate, were reported for each group separately.Analysis of covariance (ANCOVA) with a baseline value as a covariate was performed for testing the changes in PREDIMED, IPAQ, and EPIC data between the baseline (t0) and end of the intervention (t4) and between the baseline (t0) and end of follow-up times (t8), as it is one of the most effective methods for the analysis of pre–post continuous measures in randomized controlled trials [All the statistical tests were two-sided with a threshold of 0.05 for rejecting the null hypothesis. Data analysis was carried out using the Stata 14.2 software (Stata Corp, College Station, TX, USA).