Sayón Orea, CarmenRazquin, CristinaBulló, MònicaCorella Piquer, DoloresFitó Colomer, MontserratRomaguera, DoraVioque, JesúsAlonso Gómez, Ángel M.Wärnberg, JuliaMartínez, J. Alfredo, 1957-Serra Majem, LluísEstruch Riba, RamonTinahones, Francisco J.Lapetra, JoséPintó Sala, XavierTur, Josep AntoniLópez Miranda, JoséBueno Cavanillas, AuroraDelgado Rodríguez, MiguelMatía Martín, PilarDaimiel, LidiaMartín Sánchez, VicenteVidal i Cortada, JosepVázquez, ClotildeRos Rahola, EmilioRuiz Canela, MiguelSorlí, José V.Castañer, OlgaFiol Sala, MiguelNavarrete Muñoz, Eva MariaArós, FernandoGómez Gracia, EnriqueZulet, M. AngelesSánchez-Villegas, AlmudenaCasas Rodríguez, Rosa M.Bernal López, M. RosaSantos Lozano, José ManuelCorbella, EmiliBouzas, CristinaGarcía Arellano, AnaBasora, JosepAsensio, Eva M.Schröder, Helmut, 1958-Tojal Sierra, LucasToledo Atucha, EstefaníaDíaz Lopez, AndrésGoday Arnó, AlbertSalas Salvadó, JordiMartínez-González, Miguel Ángel, 1957-2022-03-092022-03-092019-10-150098-7484https://hdl.handle.net/2445/183967Key PointsQuestionWhat is the effect of a nutritional and behavioral intervention focused on encouraging an energy-reduced Mediterranean diet and physical activity on the dietary pattern of participants after 12 months? FindingsIn this preliminary analysis of an ongoing randomized clinical trial involving 6874 participants, an intervention focused on encouraging an energy-reduced Mediterranean diet and promoting physical activity, compared with advice to follow an energy-unrestricted Mediterranean diet, resulted in a significant increase in a measure of diet adherence, the 17-item energy-reduced Mediterranean diet score, at 12 months (4.7 points vs 2.5 points; score range, 0-17; minimal clinically important difference, 1 point). MeaningA nutritional and behavioral intervention focused on encouraging an energy-reduced Mediterranean diet and physical activity led to a significant improvement in a measure of diet adherence at 12 months. Further evaluation of the effects on long-term cardiovascular and other health outcomes is needed. ImportanceHigh-quality dietary patterns may help prevent chronic disease, but limited data exist from randomized trials about the effects of nutritional and behavioral interventions on dietary changes. ObjectiveTo assess the effect of a nutritional and physical activity education program on dietary quality. Design, Setting, and ParticipantsPreliminary exploratory interim analysis of an ongoing randomized trial. In 23 research centers in Spain, 6874 men and women aged 55 to 75 years with metabolic syndrome and no cardiovascular disease were enrolled in the trial between September 2013 and December 2016, with final data collection in March 2019. InterventionsParticipants were randomized to an intervention group that encouraged an energy-reduced Mediterranean diet, promoted physical activity, and provided behavioral support (n=3406) or to a control group that encouraged an energy-unrestricted Mediterranean diet (n=3468). All participants received allotments of extra-virgin olive oil (1 L/mo) and nuts (125 g/mo) for free. Main Outcomes and MeasuresThe primary outcome was 12-month change in adherence based on the energy-reduced Mediterranean diet (er-MedDiet) score (range, 0-17; higher scores indicate greater adherence; minimal clinically important difference, 1 point). ResultsAmong 6874 randomized participants (mean [SD] age, 65.0 [4.9] years; 3406 [52%] men), 6583 (96%) completed the 12-month follow-up and were included in the main analysis. The mean (SD) er-MedDiet score was 8.5 (2.6) at baseline and 13.2 (2.7) at 12 months in the intervention group (increase, 4.7 [95% CI, 4.6-4.8]) and 8.6 (2.7) at baseline and 11.1 (2.8) at 12 months in the control group (increase, 2.5 [95% CI, 2.3-2.6]) (between-group difference, 2.2 [95% CI, 2.1-2.4]; P<.001). Conclusions and RelevanceIn this preliminary analysis of an ongoing trial, an intervention that encouraged an energy-reduced Mediterranean diet and physical activity, compared with advice to follow an energy-unrestricted Mediterranean diet, resulted in a significantly greater increase in diet adherence after 12 months. Further evaluation of long-term cardiovascular effects is needed. Trial Registrationisrctn.com Identifier: ISRCTN89898870 This preliminary exploratory analysis of the ongoing PREDIMED-Plus randomized trial reports dietary adherence among Spanish community-dwelling participants with metabolic syndrome randomized to an energy-reduced Mediterranean diet, physical activity, and behavioral support vs an energy-unrestricted Mediterranean diet alone.14 p.application/pdfeng(c) American Medical Association (AMA), 2019Cuina mediterràniaSíndrome metabòlicaMediterranean cookingMetabolic syndromeinfo:eu-repo/semantics/article6957942022-03-09info:eu-repo/semantics/openAccess