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

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,...

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Autores: Miguel Etayo, Pilar de, Flores Rojas, Katherine, Vázquez Cobela, Rocío, Jurado Castro, José Manuel, Larruy García, Alicia, Picáns Leis, Rosaura, Castro-Collado, Cristina, Pastor Villaescusa, Belén, Llorente Cantarero, Francisco Jesús, Aguilera, Concepción M., Gil Campos, Mercedes, Leis Trabazo, María Rosaura, Moreno, Luis A.
Tipo de recurso: artículo
Fecha de publicación:2025
País:España
Institución:Universidad de Santiago de Compostela (USC)
Repositorio:Minerva. Repositorio Institucional de la Universidad de Santiago de Compostela
Idioma:inglés
OAI Identifier:oai:minerva.usc.gal:10347/45267
Acceso en línea:https://hdl.handle.net/10347/45267
Access Level:acceso abierto
Palabra clave:Obesity prevention
Mediterranean Diet
Physical Activity
Pediatric obesity
3201 Ciencias clínicas
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dc.title.none.fl_str_mv MELI-POP Study: MEditerranean LIfestyle in Pediatric Obesity Prevention. Study protocol for a randomized controlled trial
title MELI-POP Study: MEditerranean LIfestyle in Pediatric Obesity Prevention. Study protocol for a randomized controlled trial
spellingShingle MELI-POP Study: MEditerranean LIfestyle in Pediatric Obesity Prevention. Study protocol for a randomized controlled trial
Miguel Etayo, Pilar de
Obesity prevention
Mediterranean Diet
Physical Activity
Pediatric obesity
3201 Ciencias clínicas
title_short MELI-POP Study: MEditerranean LIfestyle in Pediatric Obesity Prevention. Study protocol for a randomized controlled trial
title_full MELI-POP Study: MEditerranean LIfestyle in Pediatric Obesity Prevention. Study protocol for a randomized controlled trial
title_fullStr MELI-POP Study: MEditerranean LIfestyle in Pediatric Obesity Prevention. Study protocol for a randomized controlled trial
title_full_unstemmed MELI-POP Study: MEditerranean LIfestyle in Pediatric Obesity Prevention. Study protocol for a randomized controlled trial
title_sort MELI-POP Study: MEditerranean LIfestyle in Pediatric Obesity Prevention. Study protocol for a randomized controlled trial
dc.creator.none.fl_str_mv Miguel Etayo, Pilar de
Flores Rojas, Katherine
Vázquez Cobela, Rocío
Jurado Castro, José Manuel
Larruy García, Alicia
Picáns Leis, Rosaura
Castro-Collado, Cristina
Pastor Villaescusa, Belén
Llorente Cantarero, Francisco Jesús
Aguilera, Concepción M.
Gil Campos, Mercedes
Leis Trabazo, María Rosaura
Moreno, Luis A.
author Miguel Etayo, Pilar de
author_facet Miguel Etayo, Pilar de
Flores Rojas, Katherine
Vázquez Cobela, Rocío
Jurado Castro, José Manuel
Larruy García, Alicia
Picáns Leis, Rosaura
Castro-Collado, Cristina
Pastor Villaescusa, Belén
Llorente Cantarero, Francisco Jesús
Aguilera, Concepción M.
Gil Campos, Mercedes
Leis Trabazo, María Rosaura
Moreno, Luis A.
author_role author
author2 Flores Rojas, Katherine
Vázquez Cobela, Rocío
Jurado Castro, José Manuel
Larruy García, Alicia
Picáns Leis, Rosaura
Castro-Collado, Cristina
Pastor Villaescusa, Belén
Llorente Cantarero, Francisco Jesús
Aguilera, Concepción M.
Gil Campos, Mercedes
Leis Trabazo, María Rosaura
Moreno, Luis A.
author2_role author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Universidade de Santiago de Compostela. Departamento de Ciencias Forenses, Anatomía Patolóxica, Xinecoloxía e Obstetricia, e Pediatría

dc.subject.none.fl_str_mv Obesity prevention
Mediterranean Diet
Physical Activity
Pediatric obesity
3201 Ciencias clínicas
topic Obesity prevention
Mediterranean Diet
Physical Activity
Pediatric obesity
3201 Ciencias clínicas
description 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. Trial registration ClinicalTrials.gov, ID: NCT04597281.
publishDate 2025
dc.date.none.fl_str_mv 2025
2025-12-29
2025
2025-12-29
dc.type.none.fl_str_mv journal article
http://purl.org/coar/resource_type/c_6501
VoR
http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://hdl.handle.net/10347/45267
url https://hdl.handle.net/10347/45267
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
http://creativecommons.org/licenses/by-nc-nd/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
http://creativecommons.org/licenses/by-nc-nd/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv BMC
publisher.none.fl_str_mv BMC
dc.source.none.fl_str_mv reponame:Minerva. Repositorio Institucional de la Universidad de Santiago de Compostela
instname:Universidad de Santiago de Compostela (USC)
instname_str Universidad de Santiago de Compostela (USC)
reponame_str Minerva. Repositorio Institucional de la Universidad de Santiago de Compostela
collection Minerva. Repositorio Institucional de la Universidad de Santiago de Compostela
repository.name.fl_str_mv
repository.mail.fl_str_mv
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spelling MELI-POP Study: MEditerranean LIfestyle in Pediatric Obesity Prevention. Study protocol for a randomized controlled trialMiguel Etayo, Pilar deFlores Rojas, KatherineVázquez Cobela, RocíoJurado Castro, José ManuelLarruy García, AliciaPicáns Leis, RosauraCastro-Collado, CristinaPastor Villaescusa, BelénLlorente Cantarero, Francisco JesúsAguilera, Concepción M.Gil Campos, MercedesLeis Trabazo, María RosauraMoreno, Luis A.Obesity preventionMediterranean DietPhysical ActivityPediatric obesity3201 Ciencias clínicasBackground 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. Trial registration ClinicalTrials.gov, ID: NCT04597281.BMCUniversidade de Santiago de Compostela. Departamento de Ciencias Forenses, Anatomía Patolóxica, Xinecoloxía e Obstetricia, e Pediatría20252025-12-2920252025-12-29journal articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://hdl.handle.net/10347/45267reponame:Minerva. Repositorio Institucional de la Universidad de Santiago de Compostelainstname:Universidad de Santiago de Compostela (USC)Inglésengopen accesshttp://purl.org/coar/access_right/c_abf2© The Author(s) 2025. Open Access This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License, which permits any non-commercial use, sharing, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if you modified the licensed material. You do not have permission under this licence to share adapted material derived from this article or parts of it. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit h t t p : / / c r e a t i v e c o m m o n s . o r g / l i c e n s e s / b y - n c - n d / 4 . 0 /.http://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:minerva.usc.gal:10347/452672026-06-15T12:47:27Z
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