A Cluster Randomized Controlled Trial of the <i>Archena Infancia Saludable</i> Project on 24-h Movement Behaviors and Adherence to the Mediterranean Diet among Schoolchildren: A Pilot Study Protocol
José Francisco López-Gil,
Antonio García-Hermoso,
Lee Smith,
Alejandra Gallego,
Desirée Victoria-Montesinos,
Yasmin Ezzatvar,
Maria S. Hershey,
Héctor Gutiérrez-Espinoza,
Arthur Eumann Mesas,
Estela Jiménez-López,
Pedro Antonio Sánchez-Miguel,
Alba López-Benavente,
Laura Moreno-Galarraga,
Sitong Chen,
Javier Brazo-Sayavera,
Alejandro Fernandez-Montero,
Pedro Emilio Alcaraz,
Josefa María Panisello Royo,
Pedro J. Tárraga-López,
Stefanos N. Kales
Affiliations
José Francisco López-Gil
Navarrabiomed, Hospital Universitario de Navarra (HUN), Universidad Pública de Navarra (UPNA), IdiSNA, 31006 Pamplona, Spain
Antonio García-Hermoso
Navarrabiomed, Hospital Universitario de Navarra (HUN), Universidad Pública de Navarra (UPNA), IdiSNA, 31006 Pamplona, Spain
Lee Smith
Centre for Health, Performance and Wellbeing, Anglia Ruskin University, Cambridge CB1 1PT, UK
Alejandra Gallego
Department of Applied Economics, Faculty of Economics and Business, University of Murcia, 30100 Murcia, Spain
Desirée Victoria-Montesinos
Faculty of Pharmacy and Nutrition, UCAM Universidad Católica San Antonio de Murcia, 30107 Murcia, Spain
Yasmin Ezzatvar
Department of Nursing, Universitat de València, 46007 Valencia, Spain
Maria S. Hershey
Department of Environmental Health, Harvard University T.H. Chan School of Public Health, Boston, MA 02138, USA
Héctor Gutiérrez-Espinoza
Escuela de Fisioterapia, Universidad de las Américas, Quito 170504, Ecuador
Arthur Eumann Mesas
Health and Social Research Center, Universidad de Castilla-La Mancha (UCLM), 16071 Cuenca, Spain
Estela Jiménez-López
Health and Social Research Center, Universidad de Castilla-La Mancha (UCLM), 16071 Cuenca, Spain
Pedro Antonio Sánchez-Miguel
Grupo Análisis Comportamental de la Actividad Física y el Deporte (ACAFYDE), Departamento de Didáctica de la Expresión Musical, Plástica y Corporal, Facultad de Formación del Profesorado, Universidad de Extremadura, 10003 Cáceres, Spain
Alba López-Benavente
Departamento de Expresión Plástica, Musical y Dinámica, Facultad de Educación, Universidad de Murcia, 30100 Espinardo, Spain
Laura Moreno-Galarraga
IdiSNA (Instituto de Investigación Sanitaria de Navarra), 31008 Pamplona, Spain
Sitong Chen
Institute for Health and Sport, Victoria University, Melbourne 8001, Australia
Javier Brazo-Sayavera
PDU EFISAL, Centro Universitario Regional Noreste, Universidad de la República (UdelaR), Rivera 40000, Uruguay
Alejandro Fernandez-Montero
Department of Environmental Health, Harvard University T.H. Chan School of Public Health, Boston, MA 02138, USA
Pedro Emilio Alcaraz
Research Center for High Performance Sport, San Antonio Catholic University of Murcia, 30830 Murcia, Spain
Josefa María Panisello Royo
Fundación para el Fomento de la Salud, 28006 Madrid, Spain
Pedro J. Tárraga-López
Departamento de Ciencias Médicas, Facultad de Medicina, Universidad Castilla-La Mancha (UCLM), 02008 Albacete, Spain
Stefanos N. Kales
Department of Environmental Health, Harvard University T.H. Chan School of Public Health, Boston, MA 02138, USA
Objective: The aim of this paper is to describe the protocol of pilot cluster randomized controlled trial (RCT) that will evaluate the effects of a lifestyle-based intervention. The Archena Infancia Saludable project will have several objectives. The primary objective of this project is to determine the 6-month effects of a lifestyle-based intervention on adherence to 24-h movement behaviors and Mediterranean diet (MedDiet) in schoolchildren. The secondary objective of this project is to test the intervention effects of this lifestyle-based intervention on a relevant set of health-related outcomes (i.e., anthropometric measurements, blood pressure, perceived physical fitness, sleep habits, and academic performance). The tertiary objective is to investigate this intervention’s “halo” effect on parents’/guardians’ 24-h movement behaviors and adherence to the MedDiet. Methods: The Archena Infancia Saludable trial will be a cluster RCT submitted to the Clinical Trials Registry. The protocol will be developed according to SPIRIT guidelines for RCTs and CONSORT statement extension for cluster RCTs. A total of 153 eligible parents/guardians with schoolchildren aged 6–13 years will be randomized into an intervention group or a control group. This project focuses on two fundamental pillars: 24-h movement behaviors and MedDiet. It will mainly focus on the relationship between parents/guardians and their children. Behavior change strategies for dietary and 24-h movement behaviors in schoolchildren will be based on healthy lifestyle education for parents/guardians through infographics, video recipes, brief video clips, and videos. Conclusions: Most of the current knowledge on 24-h movement behaviors and adherence to the MedDiet is based on cross-sectional or longitudinal cohort studies, warranting a need to design and conduct RCTs to obtain more robust evidence on the effect of a healthy lifestyle program to increase 24-h movement behaviors and to improve adherence to the MedDiet in schoolchildren.
