Department of Preventive Medicine and Public Health, University of Navarra, Instituto de Investigación Sanitaria de Navarra, Pamplona, Spain.
Fisiopatología de la Obesidad y Nutrición, Centro de Investigación Biomédica en Red, Instituto de Salud Carlos III, Madrid, Spain.
J Med Internet Res. 2020 Dec 7;22(12):e21436. doi: 10.2196/21436.
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.
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).
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.
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<.001). Compared with the control group, the Mediterranean diet intervention group showed a significant increase in the consumption of fruits (P<.001), olive oil (P<.001), whole grain cereals (P=.002), pulses (P<.001), nuts (P<.001), white fish (P<.001), fatty fish (P<.001), and white meat (P=.007), and a significant reduction in refined cereals (P<.001), red and processed meat (P<.001), and sweets (P<.001) at 2 years of intervention. In terms of nutrients, the intervention group significantly increased their intake of omega-3 (P<.001) and fiber (P<.001), and they decreased their intake of carbohydrates (P=.02) and saturated fatty acids (P<.001) compared with the control group.
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.
ClinicalTrials.gov NCT03053843; https://www.clinicaltrials.gov/ct2/show/NCT03053843.
地中海饮食预防（PREDIMED）试验支持营养师进行的营养干预在预防心血管疾病方面的有效性。然而，远程干预遵循地中海饮食的效果研究较少。
本研究旨在评估远程提供基于地中海饮食的营养干预在心房颤动（AF）二级预防试验中获得有利饮食变化的效果。
PREvention of recurrent arrhythmias with Mediterranean diet（PREDIMAR）研究是一项为期 2 年的多中心、随机、对照、单盲试验，旨在评估富含特级初榨橄榄油（EVOO）的地中海饮食对导管消融后心房心动过速复发的预防作用。消融后窦性心律的参与者被随机分配到干预组（富含 EVOO 的地中海饮食）或对照组（常规临床护理）。远程营养干预包括电话联系（每 3 个月 1 次）和基于网络的干预，提供饮食建议，参与者可以访问网页、移动应用程序和印刷资源。信息分为 6 个领域：推荐食物、菜单、新闻和在线资源、实用提示、地中海饮食课堂和个人经验。在基线和 1 年及 2 年随访时，由营养师通过电话收集 14 项地中海饮食依从性筛查器（MEDAS）问卷和半定量食物频率问卷。
共随机分配 720 名受试者（干预组 365 名，对照组 355 名）。截至 2020 年 9 月，560 名受试者完成了第 1 年（560/574，保留率 95.6%）和 304 名受试者完成了第 2 年（304/322，保留率 94.4%）的干预。随访 24 个月后，两组的地中海饮食依从性均有所提高，但干预组的改善明显高于对照组（MEDAS 问卷中的净组间差异：1.8 分（95%CI 1.4-2.2；P<.001）。与对照组相比，地中海饮食干预组水果（P<.001）、橄榄油（P<.001）、全谷物（P=.002）、豆类（P<.001）、坚果（P<.001）、白鱼（P<.001）、多脂鱼（P<.001）和白肉（P=.007）的摄入量显著增加，精制谷物（P<.001）、红肉和加工肉（P<.001）和甜食（P<.001）的摄入量显著减少，干预 2 年后。在营养方面，与对照组相比，干预组的 omega-3（P<.001）和纤维（P<.001）摄入量显著增加，碳水化合物（P=.02）和饱和脂肪酸（P<.001）摄入量显著减少。
使用网站和电话的远程营养干预似乎能有效提高接受导管消融治疗的 AF 患者对地中海饮食模式的依从性。
ClinicalTrials.gov NCT03053843；https://www.clinicaltrials.gov/ct2/show/NCT03053843.
