MELI-POP Study: MEditerranean LIfestyle in Pediatric Obesity Prevention. Study protocol for a randomized controlled trial

De Miguel-Etayo, Pilar ; Flores-Rojas, Katherine ; Vázquez-Cobela, Rocío ; Jurado-Castro, Jose Manuel ; Larruy-García, Alicia ; Picans-Leis, Rosaura ; Castro-Collado, Cristina ; Pastor-Villaescusa, Belén ; Llorente-Cantarero, Francisco Jesus ; Aguilera, Concepción M. ; Gil-Campos, Mercedes ; Leis, Rosaura ; Moreno, Luis A. (Universidad de Zaragoza) ; Vucinic, V. ; Miguel Berges, M. L. ; Maneschy, I. ; Jimeno-Martinez, A. ; Córdoba, D. ; Ayala-Marín, A. ; Seral-Cortés, M. ; Benedicto, I. ; Bueno Lozano, G. ; Blasco Pérez-Aramendia, M. J. ; Bartolomé Lalanza, M. L. ; Lobera, P. ; López-Campos, M. ; Martinez, N. ; Lostal, I. ; Ramírez, A. I. ; Gastón Faci, A. I. ; Atance Melendo, E. ; Zapata Mallen, E. ; Pardos Romano, R. ; Alutiz Lapeña, L. M. ; Viñas, C. ; Olmo Pérez, E. ; Santaliestra-Pasías, A. ; Matute Llorente, Á ; Agüero González de Lafuente, A. ; Rico Díaz, J. ; García García, E. M. ; Fernández Seijas, O. ; Izquierdo López, I. ; Romero Agrelo, A. ; Rivas Rodríguez, L. ; Mosteiro Losada, S. ; De la Torre-Aguilar, MJ. ; Alarcón-Roldán, MA. ; Cortés Sillero, M. J. ; Carmona Priego, A. ; Babio, N. ; De las Heras-Delgado, S. ; Gil-Segura, M. ; Mena-Sánchez, G. ; Pedraza, A. ; Salas-Salvadó, J. ; Salvadó, O. ; Valverde-Aguilera, I. ; Bustos-Aibar, M. ; Torres-Martos, Á. ; Rico, M. C. ; Sánchez-Rodríguez, E. ; Rueda-De Torre, I.

Resumen: Background
Childhood obesity is a significant public health challenge, with Mediterranean countries showing high prevalence rates. While genetic factors play a role, diet and physical activity (PA) are critical modifiable influences. Emphasizing healthy dietary patterns, like the Mediterranean diet, and promoting regular PA can help mitigate obesity risk.

Methods
MELI-POP is a randomized controlled multi-center clinical trial in a cohort of children aged 3 to 6 years at baseline and being at obesity risk. The main objective consists on assessing the efficacy of an intervention during early childhood, considering a healthy lifestyle based on the promotion of a Mediterranean dietary pattern and regular PA, compared with a control group, on decreasing obesity incidence 5 and 10 years after the beginning of the intervention. It is expected to include 310 children, aged 3 to 6 years, having at baseline a normal weight or overweight according to the International Obesity Task Force (IOTF) criteria, and at least one parent having a body mass index > 25 kg/m2. The clinical trial has two arms and is performed in Spanish Primary Health Care centers. The control group receive usual care by healthcare professionals. The intervention group receive education on Mediterranean diet and PA, combined with the provision of extra-virgin olive oil and fish, in order to be consumed at least 2 times per week. Free PA sessions with a physical education teacher are also offered for the children (3 sessions of 60 min of moderate-vigorous PA per week). The participants’ adherence to the intervention is periodically monitored. The study primarily focuses on adiposity as the main outcome, with secondary outcomes encompassing dietary intake and eating habits, physical activity and lifestyle behaviors (including extracurricular sports, screen time, and sleep duration), physical fitness, biochemical parameters (such as inflammation and cardiometabolic biomarkers, fatty acids, and oxidation), as well as microbiota, genetic, omic and metabolomic analyses.

Discussion
Beneficial results are expected by preventing obesity during childhood, and associated comorbidities.

Idioma: Inglés

DOI: 10.1186/s12889-025-24351-2

Año: 2025

Publicado en: BMC PUBLIC HEALTH 25, 3791 (2025), [13 pp.]
ISSN: 1471-2458

Financiación: info:eu-repo/grantAgreement/ES/ISCIII/PI18-00666
Financiación: info:eu-repo/grantAgreement/ES/ISCIII/PI18-00930
Financiación: info:eu-repo/grantAgreement/ES/ISCIII/PI22-00912
Financiación: info:eu-repo/grantAgreement/ES/ISCIII/PI22-01337

Tipo y forma: Article (Published version)

Área (Departamento): Área Enfermería (Dpto. Fisiatría y Enfermería)