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

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• dc.contributor.author Sayón-Orea, Carmen
• dc.contributor.author Schröder, Helmut, 1958-
• dc.contributor.author Martínez-González, Miguel Ángel, 1957-
• dc.date.accessioned 2021-11-08T07:34:36Z
• dc.date.available 2021-11-08T07:34:36Z
• dc.date.issued 2019
• dc.description.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: isrctn.com Identifier: ISRCTN89898870.
• dc.description.sponsorship This work was supported by the European Research Council (Advanced Research grant 2014-2019; agreement #340918; granted to Dr Martínez-González); the official Spanish institutions for funding scientific biomedical research, CIBER Fisiopatología de la Obesidad y Nutrición (CIBERobn) and Instituto de Salud Carlos III (ISCIII) through the Fondo de Investigación para la Salud (FIS), which is cofunded by the European Regional Development Fund (coordinated FIS projects led by Drs Salas-Salvadó and Vidal, including the following projects: PI13/00673, PI13/00492, PI13/00272, PI13/01123, PI13/00462, PI13/00233, PI13/02184, PI13/00728, PI13/01090, PI13/01056, PI14/01722, PI14/00636, PI14/00618, PI14/00696, PI14/01206, PI14/01919, PI14/00853, PI14/01374, PI14/00972, PI14/00728, PI14/01471, PI16/00473, PI16/00662, PI16/01873, PI16/01094, PI16/00501, PI16/00533, PI16/00381, PI16/00366, PI16/01522, PI16/01120, PI17/00764, PI17/01183, PI17/00855, PI17/01347, PI17/00525, PI17/01827, PI17/00532, PI17/00215, PI17/01441, PI17/00508, PI17/01732, PI17/00926, PI19/00957, PI19/00386, PI19/00309, PI19/01032, PI19/00576, PI19/00017, PI19/01226, PI19/00781, PI19/01560, PI19/01332) and the Especial Action Project “Implementación y evaluación de una intervención intensivasobre la actividad física Cohorte PREDIMED-Plus” (Dr Salas-Salvadó); the Recercaixa (grant number 2013ACUP00194) (Dr Salas-Salvadó); the SEMERGEN grant; International Nut and Dried Fruit Council–FESNAD (Long-term effects of an energy-restricted Mediterranean diet on mortality and cardiovascular disease 2014 –2015; No. 201302) (Dr Martinez-Gonzalez); the AstraZeneca Young Investigators Award in Category of Obesity and T2D 2017 (Dr Romaguera); grants from the Consejería de Salud de la Junta de Andalucía (PI0458/2013; PS0358/2016; PI0137/2018), the PROMETEO/2017/017 grant from the Generalitat Valenciana, the SEMERGEN grant; grant of support to research groups 35/2011 (Balearic Islands Gov; FEDER funds) (Drs Tur and Bouzas).
• dc.format.mimetype application/pdf
• dc.identifier.citation Sayón-Orea C, Razquin C, Bulló M, Corella D, Fitó M, Romaguera D et al. 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. JAMA. 2019;322(15):1486-99. DOI: 10.1001/jama.2019.14630
• dc.identifier.doi http://dx.doi.org/10.1001/jama.2019.14630
• dc.identifier.issn 0098-7484
• dc.identifier.uri http://hdl.handle.net/10230/48925
• dc.language.iso eng
• dc.publisher American Medical Association
• dc.relation.ispartof JAMA. 2019;322(15):1486-99
• dc.relation.projectID info:eu-repo/grantAgreement/EC/FP7/340918
• dc.rights © American Medical Association. All Rights Reserved. http://dx.doi.org/10.1001/jama.2019.14630
• dc.rights.accessRights info:eu-repo/semantics/openAccess
• dc.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
• dc.type info:eu-repo/semantics/article
• dc.type.version info:eu-repo/semantics/acceptedVersion