RT Journal Article T1 Cohort Profile: Design and methods of the PREDIMED-Plus randomized trial. A1 Martinez-Gonzalez, Miguel A A1 Buil-Cosiales, Pilar A1 Corella, Dolores A1 Bullo, Monica A1 Fito, Montserrat A1 Vioque, Jesus A1 Romaguera, Dora A1 Martinez, J Alfredo A1 Wärnberg, Julia A1 Lopez-Miranda, Jose A1 Estruch, Ramon A1 Bueno-Cavanillas, Aurora A1 Aros, Fernando A1 Tur, Josep A A1 Tinahones, Francisco A1 Serra-Majem, Lluis A1 Martin, Vicente A1 Lapetra, Jose A1 Vazquez, Clotilde A1 Pinto, Xavier A1 Vidal, Josep A1 Daimiel, Lidia A1 Delgado-Rodriguez, Miguel A1 Matia, Pilar A1 Ros, Emilio A1 Fernandez-Aranda, Fernando A1 Botella, Cristina A1 Puy-Portillo, Maria A1 Lamuela-Raventos, Rosa M A1 Marcos, Ascension A1 Saez, Guillermo A1 Gomez-Gracia, Enrique A1 Ruiz-Canela, Miguel A1 Toledo, Estefania A1 Alvarez-Alvarez, Ismael A1 Diez-Espino, Javier A1 Sorli, Jose V A1 Basora, Josep A1 Castañer, Olga A1 Schröder, Helmut A1 Navarrete-Muñoz, Eva Maria A1 Zulet, Maria Angeles A1 Garcia-Rios, Antonio A1 Salas-Salvado, Jordi K1 Cardiovascular Diseases K1 Evidence-Based Medicine K1 Humans K1 Multicenter Studies as Topic K1 Risk Assessment K1 Sample Size K1 Time Factors AB The PREDIMED (in Spanish: PREvención con DIeta MEDiterránea ) primary prevention trial1–3 reported in 2013 that long-term adherence to an energy-unrestricted Mediterranean diet (MedDiet), supplemented with either extra-virgin olive oil (EVOO) or nuts , reduced cardiovascular disease (CVD). PREDIMED showed a 30% relative reduction in the composite cardiovascular primary endpoint ( stroke , myocardial infarction or cardiovascular death ).2,,3 However, the PREDIMED trial tested only the composition of the diet , but did not test other lifestyle interventions (i.e. energy reduction, increased physical activity (PA) and behavioural modification) frequently applied in the context of the current unprecedented obesity pandemic .4,,5 With the exception of the null results of the Look-AHEAD trial,6 and the successful results of the EXERDIET-HTA study that found improvements in blood pressure , cardio-respiratory fitness and body composition (though they encouraged adherence to an hypocaloric DASH diet , instead of a Mediterranean diet ),7 lifestyle interventions including such components have never been tested in long-term randomized trials using hard cardiovascular events as endpoints. PB Oxford University Press YR 2019 FD 2019-04-02 LK https://hdl.handle.net/10668/24502 UL https://hdl.handle.net/10668/24502 LA en NO Martínez-González MA, Buil-Cosiales P, Corella D, Bulló M, Fitó M, Vioque J, et al. Cohort Profile: Design and methods of the PREDIMED-Plus randomized trial. Int J Epidemiol. 2019 Apr 1;48(2):387-388o. DS RISalud RD Apr 7, 2025