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

Abstract

[eng] IMPORTANCE High-quality dietary patterns may help prevent chronic disease, but limited</p><p>data exist from randomized trials about the effects of nutritional and behavioral interventions</p><p>on dietary changes.</p><p>OBJECTIVE To assess the effect of a nutritional and physical activity education program on</p><p>dietary quality.</p><p>DESIGN, SETTING, AND PARTICIPANTS Preliminary exploratory interim analysis of an ongoing</p><p>randomized trial. In 23 research centers in Spain, 6874 men and women aged 55 to 75 years</p><p>with metabolic syndrome and no cardiovascular disease were enrolled in the trial between</p><p>September 2013 and December 2016, with final data collection in March 2019.</p><p>INTERVENTIONS Participants were randomized to an intervention group that encouraged an</p><p>energy-reduced Mediterranean diet, promoted physical activity, and provided behavioral</p><p>support (n = 3406) or to a control group that encouraged an energy-unrestricted</p><p>Mediterranean diet (n = 3468). All participants received allotments of extra-virgin olive oil</p><p>(1 L/mo) and nuts (125 g/mo) for free.</p><p>MAIN OUTCOMES AND MEASURES The primary outcomewas 12-month change in adherence</p><p>based on the energy-reduced Mediterranean diet (er-MedDiet) score (range, 0-17; higher</p><p>scores indicate greater adherence; minimal clinically important difference, 1 point).</p><p>RESULTS Among 6874 randomized participants (mean [SD] age, 65.0 [4.9] years; 3406</p><p>[52%] men), 6583 (96%) completed the 12-month follow-up and were included in the main</p><p>analysis. The mean (SD) er-MedDiet score was 8.5 (2.6) at baseline and 13.2 (2.7) at 12 months</p><p>in the intervention group (increase, 4.7 [95%CI, 4.6-4.8]) and 8.6 (2.7) at baseline and 11.1</p><p>(2.8) at 12 months in the control group (increase, 2.5 [95%CI, 2.3-2.6]) (between-group</p><p>difference, 2.2 [95%CI, 2.1-2.4]; P < .001).</p><p>CONCLUSIONS AND RELEVANCE In this preliminary analysis of an ongoing trial, an intervention</p><p>that encouraged an energy-reduced Mediterranean diet and physical activity, compared with</p><p>advice to follow an energy-unrestricted Mediterranean diet, resulted in a significantly greater</p><p>increase in diet adherence after 12 months. Further evaluation of long-term cardiovascular</p><p>effects is needed.</p><p>TRIAL REGISTRATION isrctn.com Identifier: ISRCTN89898870</p>