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BIBTEX RIS

Latin American Initiative for Lifestyle Intervention to Prevent Cognitive Decline (LatAm‐FINGERS): Study design and harmonization

2023; Wiley; Volume: 19; Issue: 9 Linguagem: Inglês

10.1002/alz.13101

1552-5279

Lucía Crivelli, Ismael Luis Calandri, Cláudia Kimie Suemoto, Rosa María Salinas, Lina Velilla, Mônica Sanches Yassuda, Paulo Caramelli, Francisco Lopera, Ricardo Nitríni, Gustavo Sevlever, Ana Luisa Sosa, Daisy Acosta, Ana María Charamelo Baietti, María Isabel Cusicanqui, Nilton Custodio, Sergio Dansilio De Simone, Carolina Delgado, Lissette Duque‐Peñailillo, Juan Carlos Durán, Ivonne Z. Jiménez‐Velázquez, Jorge M Leon‐Salas, Yanina Bérgamo, María Florencia Clarens, Andrés Damián, Ignacio Demey, María Belén Helou, Carlos Márquez, María Martín, Maria da Graça Morais Martin, Diego Querze, Ezequiel Surace, Sabrina Acosta‐Egea, Esteban Aguirre–Salvador, Leonardo Cruz de Souza, Gustavo Henrique da Cunha Peixoto Cançado, Sônia Maria Dozzi Brucki, Clarisse Vasconcelos Friedlaender, Karina Braga Gomes, Myriam Gutiérrez, Carlos Laforcada Ríos, Joyce Graciela Martinez Galindo, Rosa Montesinos, Alberto Nuñez‐Herrera, Sebastián Ospina‐Henao, Guillermina Rodríguez, V Masson, Mónica Delgado Sánchez, Christian E. Schenk, Ligia Soto, Maira Tonidandel Barbosa, Jéssica Abdo Gonçalves Tosatti, Yosselin Vicuña, Mark A. Espeland, Krister Håkansson, Miia Kivipelto, Laura D. Baker, Heather M. Snyder, María C. Carrillo, Ricardo Allegri,

Cardiac Health and Mental Health

Abstract INTRODUCTION Latin 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. METHODS This 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. RESULTS Currently, 1549 participants have been screened, and 815 randomized. Participants are ethnically diverse (56% are Nestizo) and have high cardiovascular risk (39% have metabolic syndrome). DISCUSSION LatAm‐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.