The rationale for a new randomized trial (‘PREDIMEDPlus’) is to go beyond the previous PREDIMED trial, and to answer one of the most important questions in current medical practice: is an intentional body mass reduction through PA promotion and energy reduction, able to bring about in the long term a substantial reduction in hard cardiovascular clinical events? Our main hypothesis is that by addressing three lifestyle aspects (energy reduction with a high-quality
dietary pattern, recommendations on PA and motivational behaviour changes, based on providing persuasion and tools for solving problems, potentially derived from avoiding high calorie foods and sedentary lifestyles), an even stronger reduction in the risk of hard cardiovascular events will be attained, as compared with that observed with only a MedDiet.