Cohort Profile: Design and methods of the PREDIMED study

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How did the PREDIMED study come about?

A call for grants was issued in 2002 by the Spanish Government (Instituto de Salud Carlos III). This call was specifically designed to initiate networking research among Spanish biomedical investigators. During 2002, Ramón Estruch—the leader of our initiative—contacted different Spanish investigators (the rest of us) working in nutrition from different perspectives. We applied together for a grant to start a large randomized trial to test the effectiveness of a Mediterranean diet (MeDiet) on the ‘primary’ prevention of cardiovascular disease (CVD) and to continue the study as an observational cohort of high-risk participants to be followed-up in the long term. On 6 January 2003 our project was funded.

From January to June 2003, we developed the protocol: logistics, manual of operations, instruments, forms and data entry/management systems. The needed personnel (a minimum of a dietician and a nurse for each of the 11 field centres, FCs) were then hired, trained and certified. Each FC contacted approximately 20 primary care practices (PCPs) to recruit participants. The recruitment of participants started in October 2003. The name PREDIMED (in Spanish: PREvención con DIeta MEDiterránea) was proposed by Dolores Corella. This name is applied to both the cohort study and the networking group.