Víctor de la O, M Teresa Barrio-López, Jose Luis Ibañez-Criado, Miguel Ángel Martínez-González, Alicia Ibáñez Criado, Luis Tercedor, Jesús Almendral, Rosa Macías Ruiz, Leticia Goni, Miguel Ruiz-Canela, Ignacio García-Bolao, Pablo Ramos, Eduardo Castellanos, [Goni,L, de la O,V, Martínez-González,MA, Ruiz-Canela,M] Department of Preventive Medicine and Public Health, University of Navarra, Instituto de Investigación Sanitaria de Navarra, Pamplona, Spain. [Goni,L, Martínez-González,MA] Fisiopatología de la Obesidad y Nutrición, Centro de Investigación Biomédica en Red, Instituto de Salud Carlos III, Madrid, Spain. [Barrio-López,MT, Castellanos,E, Almendral,J] Electrophysiology Laboratory and Arrhythmia Unit, Hospital Montepríncipe, Grupo HM Hospitales, University CEU-San Pablo, Madrid, Spain. [Ramos,P, García-Bolao,I] Arrhythmia Unit, Department of Cardiology and Cardiac Surgery, Clínica Universidad de Navarra, Pamplona, Spain. [Tercedor,L, Macias Ruiz,R] Department of Cardiology, Virgen de las Nieves University Hospital, Granada, Spain. [Tercedor,L] Biosanitary Research Institute of Granada (ibs.GRANADA), Granada, Spain. [Ibañez Criado,A] Arrhythmia Unit, Cardiology Service, Alicante Institute of Health and Biomedical Research (ISABIAL-FISABIO Foundation), University General Hospital of Alicante, Alicante, Spain. [Martínez-González,MA] Department of Nutrition, Harvard TH Chan School of Public Health, Harvard University, Boston, MA, United States., and This work was funded by the Spanish Government Official Agency for funding biomedical research—Instituto de Salud Carlos III (ISCIII), with competitive grants through the Fondo de Investigación Sanitaria y Fondo Europeo de Desarrollo Regional (PI17/00718, PI17/00748, PI17/01870), the Regional Government of Navarra (46/2016), and the Spanish Society of Cardiology (FEC/2016).
Background The Prevention With Mediterranean Diet (PREDIMED) trial supported the effectiveness of a nutritional intervention conducted by a dietitian to prevent cardiovascular disease. However, the effect of a remote intervention to follow the Mediterranean diet has been less explored. Objective This study aims to assess the effectiveness of a remotely provided Mediterranean diet–based nutritional intervention in obtaining favorable dietary changes in the context of a secondary prevention trial of atrial fibrillation (AF). Methods The PREvention of recurrent arrhythmias with Mediterranean diet (PREDIMAR) study is a 2-year multicenter, randomized, controlled, single-blinded trial to assess the effect of the Mediterranean diet enriched with extra virgin olive oil (EVOO) on the prevention of atrial tachyarrhythmia recurrence after catheter ablation. Participants in sinus rhythm after ablation were randomly assigned to an intervention group (Mediterranean diet enriched with EVOO) or a control group (usual clinical care). The remote nutritional intervention included phone contacts (1 per 3 months) and web-based interventions with provision of dietary recommendations, and participants had access to a web page, a mobile app, and printed resources. The information is divided into 6 areas: Recommended foods, Menus, News and Online resources, Practical tips, Mediterranean diet classroom, and Your personal experience. At baseline and at 1-year and 2-year follow-up, the 14-item Mediterranean Diet Adherence Screener (MEDAS) questionnaire and a semiquantitative food frequency questionnaire were collected by a dietitian by phone. Results A total of 720 subjects were randomized (365 to the intervention group, 355 to the control group). Up to September 2020, 560 subjects completed the first year (560/574, retention rate 95.6%) and 304 completed the second year (304/322, retention rate 94.4%) of the intervention. After 24 months of follow-up, increased adherence to the Mediterranean diet was observed in both groups, but the improvement was significantly higher in the intervention group than in the control group (net between-group difference: 1.8 points in the MEDAS questionnaire (95% CI 1.4-2.2; P Conclusions The remote nutritional intervention using a website and phone calls seems to be effective in increasing adherence to the Mediterranean diet pattern among AF patients treated with catheter ablation. Trial Registration ClinicalTrials.gov NCT03053843; https://www.clinicaltrials.gov/ct2/show/NCT03053843