RT info:eu-repo/semantics/article T1 An Energy-Reduced Mediterranean Diet, Physical Activity, and Body Composition A1 Konieczna, Jadwiga A1 Ruiz Canela, Miguel A1 Galmés Panadés, Aina María A1 Abete, Itziar A1 Babio, Nancy A1 Fiol, Miquel A1 Martín Sánchez, Vicente A1 Estruch, Ramón A1 Vidal, Josep A1 Buil Cosiales, Pilar A1 García Gavilán, Jesús F. A1 Moñino, Manuel A1 Marcos Delgado, Alba A1 Casas, Rosa A1 Olbeyra, Romina A1 Fitó, Montserrat A1 Hu, Frank B. A1 Martínez González, Miguel Ángel A1 Martínez, J. Alfredo A1 Romaguera, Dora A1 Salas Salvadó, Jordi A1 Romero Rodríguez, Esperanza A1 Amezcua Prieto, Carmen A1 Morales Suárez-Varela, María A1 Pérez, Carlos Ayán A1 Mateos Campos, Ramona A1 Ortíz Moncada, Rocío A1 Redondo Martín, Susana A1 Rodríguez Reinado, Carmen A1 Delgado Rodríguez, Miguel A1 Blázquez Abellán, Gemma A1 Alonso Molero, Jessica A1 Martín Peláez, Sandra A1 Cancela Carral, José María A1 Valero Juan, Luis Félix A1 Martínez Ruiz, Virginia A1 Fernández Villa, Tania A2 Medicina Preventiva K1 Medicina. Salud K1 Mediterranean diet K1 Physical activity K1 Clinical trial K1 Adherence K1 Interventions K1 Validity AB [ENG]Importance Strategies targeting body composition may help prevent chronic diseases in persons with excess weight, but randomized clinical trials evaluating lifestyle interventions have rarely reported effects on directly quantified body composition. OBJECTIVE To evaluate the effects of a lifestyle weight-loss intervention on changes in overall and regional body composition. DESIGN, SETTING, AND PARTICIPANTS The ongoing Prevención con Dieta Mediterránea-Plus (PREDIMED-Plus) randomized clinical trial is designed to test the effect of the intervention on cardiovascular disease prevention after 8 years of follow-up. The trial is being conducted in 23 Spanish research centers and includes men and women (age 55-75 years) with body mass index between 27 and 40 and metabolic syndrome. The trial reported herein is an interim subgroup analysis of the intermediate outcome body composition after 3-year follow-up, and data analysis was conducted from February 1 to November 30, 2022. Of 6874 total PREDIMED-Plus participants, a subsample of 1521 individuals, coming from centers with access to a dual energy x-ray absorptiometry device, underwent body composition measurements at 3 time points. INTERVENTION Participants were randomly allocated to a multifactorial intervention based on an energy-reduced Mediterranean diet (MedDiet) and increased physical activity (PA) or to a control group based on usual care, with advice to follow an ad libitum MedDiet, but no physical activity promotion. MAIN OUTCOMES AND MEASURES The outcomes (continuous) were 3-year changes in total fat and lean mass (expressed as percentages of body mass) and visceral fat (in grams), tested using multivariable linear mixed-effects models. Clinical relevance of changes in body components (dichotomous) was assessed based on 5% or more improvements in baseline values, using logistic regression. Main analyses were performed in the evaluable population (completers only) and in sensitivity analyses, multiple imputation was performed to include data of participants lost to follow-up (intention-to-treat analyses). RESULTS A total of 1521 individuals were included (mean [SD] age, 65.3 [5.0] years; 52.1% men). In comparison with the control group (n=761), participants in the intervention arm (n=760) showed greater reductions in the percentage of total fat (between group differences after 1-year, −0.94% [95% CI, −1.19 to −0.69]; 3 years, −0.38% [95% CI, −0.64 to −0.12] and visceral fat storage after 1 year, -126 g [95% CI, −179 to −73.3 g]; 3 years, −70.4 g [95% CI, −126 to −15.2 g] and greater increases in the percentage of total lean mass at 1 year, 0.88% [95% CI, 0.63%-1.12%]; 3-years 0.34% [95%CI, 0.09%-0.60%]). The intervention group was more likely to show improvements of 5% or more in baseline body components (absolute risk reduction after 1 year, 13% for total fat mass, 11% for total lean mass, and 14% for visceral fat mass; after 3-years: 6% for total fat mass, 6% for total lean mass, and 8% for visceral fat mass). The number of participants needed to treat was between 12 and 17 to attain at least 1 individual with possibly clinically meaningful improvements in body composition. CONCLUSIONS AND RELEVANCE The findings of this trial suggest a weight-loss lifestyle intervention based on an energy-reduced MedDiet and physical activity significantly reduced total and visceral fat and attenuated age-related losses of lean mass in older adults with overweight or obesity and metabolic syndrome. Continued follow-up is warranted to confirm the long-term consequences of these changes on cardiovascular clinical end points. PB American Medical Association LK https://hdl.handle.net/10612/18186 UL https://hdl.handle.net/10612/18186 NO Konieczna, J., Ruiz Canela, M., Galmes Panades, A. M., Abete, I., Babio, N., Fiol, M., ... y Salas-Salvadó, J. (2023). An Energy-Reduced Mediterranean Diet, Physical Activity, and Body Composition: An Interim Subgroup Analysis of the PREDIMED-Plus Randomized Clinical Trial. JAMA Network Open, 6(10), e2337994 DS BULERIA. Repositorio Institucional de la Universidad de León RD Jul 12, 2024