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Title: Effect of a Nutritional and Behavioral Intervention on Energy-Reduced Mediterranean Diet Adherence among Patients with Metabolic Syndrome: Interim Analysis of the PREDIMED-Plus Randomized Clinical Trial
Authors: Sayón-Orea, Carmen
Razquin, Cristina
Bulló, Mónica
Corella, Dolores
Fitó, Montserrat
Romaguera, Dora
Vioque, Jesús
Alonso-Gómez, Ángel M.
Wärnberg, Julia
Martínez, J. Alfredo
Serra Majem, Luis 
Estruch, Ramón
Tinahones, Francisco J.
Lapetra, José
Pintó, Xavier
Tur, Josep A.
López-Miranda, José
Bueno-Cavanillas, Aurora
Delgado-Rodríguez, Miguel
Matía-Martín, Pilar
Daimiel, Lidia
Sánchez, Vicente Martín
Vidal, Josep
Vázquez, Clotilde
Ros, Emilio
Ruiz-Canela, Miguel
Sorlí, José V.
Castañer, Olga
Fiol, Miquel
Navarrete-Muñoz, Eva M.
Arós, Fernando
Gómez-Gracia, Enrique
Zulet, M. Angeles
Sánchez Villegas, Almudena 
Casas, Rosa
Bernal-López, Rosa
Santos-Lozano, José M.
Corbella, Emili
Bouzas, Cristina
García-Arellano, Ana
Basora, Josep
Asensio, Eva M.
Schröder, Helmut
Moñino, Manuel
García De La Hera, Manoli
Tojal-Sierra, Lucas
Toledo, Estefanía
Díaz-López, Andrés
Goday, Albert
Salas-Salvadó, Jordi
Martínez-González, Miguel A.
UNESCO Clasification: 3206 Ciencias de la nutrición
Issue Date: 2019
Project: Efecto de la Dieta Mediterránea Hopocalórica y Promoción de la Actividad Física en Prevención Primaria Cardiovascular.Estudio Piloto Sobre Marcadores Intermedios. 
Sistema Inmune Inespecífico en Dorada (Sparus Aurata): Activación Del Sistema Interferón y Papel de la Actividad Bh4. Pi042004/153 
Neuroprotección Por Bloqueo de la Capacidad de Transactivadora Nf-Kb y Factores Relacionados. 
Efecto de Una Intervención Intensiva de Pérdida de Peso Con Dieta Mediterránea Hipocalórica, Actividad Física y Tratamiento Conductual Sobre la Prevención Primaria Cardiovascular: Ensayo Predimed-Plus 
Journal: JAMA - Journal of the American Medical Association 
Abstract: Importance: High-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. Objective: To assess the effect of a nutritional and physical activity education program on dietary quality. Design, Setting, and Participants: Preliminary 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. Interventions: Participants 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 Measures: The 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). Results: Among 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 Relevance: In 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 Registration: Identifier: ISRCTN89898870.
ISSN: 0098-7484
DOI: 10.1001/jama.2019.14630
Source: JAMA - Journal of the American Medical Association [ISSN 0098-7484], v. 322 (15), p. 1486-1499
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