Latin American Initiative for Lifestyle Intervention to Prevent Cognitive Decline (LatAm-FINGERS): Study design and harmonization.
Latin American Initiative for Lifestyle Intervention to Prevent Cognitive Decline (LatAm-FINGERS): Study design and harmonization.
复制标题
拉丁美洲预防认知衰退生活方式干预倡议 (LatAm-FINGERS)：研究设计和协调。
DOI：
10.1002/alz.13101
复制
发表时间：
2023
期刊：
影响因子：
--
通讯作者：
Baietti,
中科院分区：
文献类型：
--
作者：
Crivelli,Lucia;Calandri,IsmaelLuis;Suemoto,ClaudiaKimie;Salinas,RosaMaría;Velilla,LinaMarcela;Yassuda,MônicaSanches;Caramelli,Paulo;Lopera,Francisco;Nitrini,Ricardo;Sevlever,GustavoEmilio;Sosa,AnaLuisa;Acosta,Daisy;Baietti,
简介拉丁美洲生活方式干预预防认知衰退倡议 (LatAm-FINGERS) 是拉丁美洲 (LA) 首个预防认知障碍的非药物多中心随机临床试验 (RCT)。我们的目的是展示研究设计并讨论用于多元文化协调的策略。方法这项为期 1 年的随机对照试验（正在进行为期 1 年的扩展）调查了洛杉矶多领域生活方式干预的可行性以及干预的有效性，主要是针对认知功能。遵循 FINGER 模型进行了外部协调过程，并进行了内部协调，以确保本研究在 12 个参与的洛杉矶国家中可行且具有可比性。 结果 目前，已对 1549 名参与者进行了筛选，并对 815 名参与者进行了随机分组。参与者来自不同种族（56% 是 Nestizo），心血管风险较高（39% 患有代谢综合征）。 讨论LatAm-FINGERS 克服了一项重大挑战，将该地区的多样性融入到在整个洛杉矶可行的多领域风险降低干预措施中，同时保留了原始的 FINGER 设计。
INTRODUCTIONLatin American Initiative for Lifestyle Intervention to Prevent Cognitive Decline (LatAm‐FINGERS) is the first non‐pharmacological multicenter randomized clinical trial (RCT) to prevent cognitive impairment in Latin America (LA). Our aim is to present the study design and discuss the strategies used for multicultural harmonization.METHODSThis 1‐year RCT (working on a 1‐year extension) investigates the feasibility of a multi‐domain lifestyle intervention in LA and the efficacy of the intervention, primarily on cognitive function. An external harmonization process was carried out to follow the FINGER model, and an internal harmonization was performed to ensure this study was feasible and comparable across the 12 participating LA countries.RESULTSCurrently, 1549 participants have been screened, and 815 randomized. Participants are ethnically diverse (56% are Nestizo) and have high cardiovascular risk (39% have metabolic syndrome).DISCUSSIONLatAm‐FINGERS overcame a significant challenge to combine the region's diversity into a multi‐domain risk reduction intervention feasible across LA while preserving the original FINGER design.