Echeverría Guadalupe, Samith Bárbara, von Schultzendorf Andrea, Pinto Victoria, Martínez Ximena, Sara Daniela, Calzada Mariana, Pacheco Josefina, Plaza Gianella, Scott Francesca, Romero Javiera, Mateo Camila, Julio María Verónica, Utreras-Mendoza Yildy, Binder María Victoria, Gutiérrez Florencia, Riquelme María Emilia, Cuevas Margarita, Willatt Rosario, Sánchez Omayra, Keilendt Aracelli, Butrón Patricia, Jarufe Alessandra, Huete Isidora, Tobar Josefina, Martin Sofía, Alfaro Valentina, Olivos Matilde, Pedrals Nuria, Bitran Marcela, Ávalos Ivette, Ruini Chiara, Ryff Carol, Pérez Druso, Berkowitz Loni, Rigotti Attilio
Centro de Nutrición Molecular y Enfermedades Crónicas, Escuela de Medicina, Pontificia Universidad Católica, Santiago, Chile.
Departamento de Nutrición, Diabetes y Metabolismo, Escuela de Medicina, Pontificia Universidad Católica, Santiago, Chile.
Contemp Clin Trials Commun. 2023 Jun 26;35:101167. doi: 10.1016/j.conctc.2023.101167. eCollection 2023 Oct.
Psychosocial status and lifestyle are key risk factors of non-communicable diseases (NCDs), which, in turn, are main drivers of healthcare costs and morbimortality worldwide, including Chile. Mediterranean diet (MedDiet) is one of the healthiest dietary patterns under study. However, its impact on high-risk conditions, such as metabolic syndrome (MetS), and NCDs outside the Mediterranean Basin remains mostly unexplored. Even though Central Chile has an environment, food production, and culinary traditions comparable to those present in Mediterranean countries, few studies -some with significant methodological limitations- have evaluated the effect of MedDiet on health and/or disease in Chilean subjects. Importantly, a Mediterranean lifestyle is a that integrates physical health with mental and social well-being. Psychological well-being (PWB) is associated with healthy behaviors, positive health outcomes, and longevity, thereby emerging as a novel healthcare goal. We report here an ongoing randomized controlled clinical trial in Chilean patients with MetS seeking to test whether (1) a PWB theory-based intervention facilitates induction to and increases long-term adherence to a locally adapted MedDiet, and (2) a MedDiet intervention -implemented alone or combined with well-being promotion- is more effective at reversing MetS compared to individuals following a low-fat diet without psychological support. The CHILEan MEDiterranean (CHILEMED) diet intervention study is a 1-year trial including patients with MetS living in Chile. Participants will be assigned randomly by a computer-generated random number sequence to one of the three intervention arms: a) low-fat diet as control group, b) MedDiet alone, and c) MedDiet plus well-being support. Patients will be followed-up by individual and/or group online nutritional sessions or phone cal as well as 6- and 12-month in-person re-assessment of medical history, medication use, food intake, PWB, anthropometrics/physical exam, and blood collection for laboratory analysis. The primary outcome of the trial will be the effect of the MedDiet -with or without PWB intervention- on overall reversal of MetS compared to low-fat diet alone. Based on a statistical superiority trial, expected impact, and patient loss, the estimated study sample is 339 subjects (113 individuals per arm in 3 equal-sized groups). Currently, we have enrolled 179 patients, predominantly women, evenly distributed by age (group means ranging from 45.7 to 48,9 years-old), 3/4 are obese with almost all of them showing abdominal obesity, 70% are hypertensive, whereas <10% exhibit diabetes. If findings turn out as expected (e.g., MedDiet -with or without PWB intervention- is better than the low-fat diet for reversion of MetS at 1-year follow-up), CHILEMED will provide further beneficial evidence of the MedDiet on NCD risk conditions beyond the Mediterranean region.
心理社会状况和生活方式是非传染性疾病（NCDs）的关键风险因素，而这些疾病反过来又是全球（包括智利）医疗成本和发病率及死亡率的主要驱动因素。地中海饮食（MedDiet）是正在研究的最健康的饮食模式之一。然而，其对诸如代谢综合征（MetS）等高风险状况以及地中海盆地以外地区非传染性疾病的影响仍大多未被探索。尽管智利中部的环境、食品生产和烹饪传统与地中海国家相似，但很少有研究（其中一些存在重大方法学局限性）评估地中海饮食对智利受试者健康和/或疾病的影响。重要的是，地中海生活方式是一种将身体健康与心理和社会福祉相结合的生活方式。心理健康（PWB）与健康行为、积极的健康结果和长寿相关，因此成为一个新的医疗保健目标。我们在此报告一项正在进行的针对智利代谢综合征患者的随机对照临床试验，旨在测试：（1）基于心理健康理论的干预措施是否有助于引入并提高对当地调整后的地中海饮食的长期依从性；（2）与在没有心理支持的情况下遵循低脂饮食的个体相比，单独实施或与促进福祉相结合的地中海饮食干预措施在逆转代谢综合征方面是否更有效。智利地中海（CHILEMED）饮食干预研究是一项为期1年的试验，纳入了生活在智利的代谢综合征患者。参与者将通过计算机生成的随机数字序列随机分配到三个干预组之一：a）低脂饮食作为对照组；b）单独的地中海饮食；c）地中海饮食加福祉支持。将通过个人和/或小组在线营养课程或电话随访患者，并在6个月和12个月时进行面对面的重新评估，内容包括病史、药物使用、食物摄入、心理健康、人体测量学/体格检查以及采集血液进行实验室分析。该试验的主要结果将是与单独的低脂饮食相比，地中海饮食（无论是否有心理健康干预）对代谢综合征总体逆转的影响。基于一项统计优势试验、预期影响和患者流失情况，估计研究样本为339名受试者（3个等规模组，每组113人）。目前，我们已招募了179名患者，主要为女性，年龄分布均匀（组均值在45.7至48.9岁之间），四分之三为肥胖患者，几乎所有人都有腹部肥胖，70%为高血压患者，而糖尿病患者不到10%。如果研究结果如预期所示（例如，在1年随访时，无论是否有心理健康干预，地中海饮食在逆转代谢综合征方面都优于低脂饮食），CHILEMED将为地中海饮食对地中海地区以外非传染性疾病风险状况的进一步有益证据提供支持。
