TY - JOUR
T1 - A Cluster Randomized Controlled Trial of the Archena Infancia Saludable Project on 24-h Movement Behaviors and Adherence to the Mediterranean Diet among Schoolchildren
T2 - A Pilot Study Protocol
AU - López-Gil, José Francisco
AU - García-Hermoso, Antonio
AU - Smith, Lee
AU - Gallego, Alejandra
AU - Victoria-Montesinos, Desirée
AU - Ezzatvar, Yasmin
AU - Hershey, Maria S.
AU - Gutiérrez-Espinoza, Héctor
AU - Mesas, Arthur Eumann
AU - Jiménez-López, Estela
AU - Sánchez-Miguel, Pedro Antonio
AU - López-Benavente, Alba
AU - Moreno-Galarraga, Laura
AU - Chen, Sitong
AU - Brazo-Sayavera, Javier
AU - Fernandez-Montero, Alejandro
AU - Alcaraz, Pedro Emilio
AU - Panisello Royo, Josefa María
AU - Tárraga-López, Pedro J.
AU - Kales, Stefanos N.
N1 - Publisher Copyright:
© 2023 by the authors.
PY - 2023/4
Y1 - 2023/4
N2 - 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.
AB - 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.
KW - children
KW - family
KW - lifestyle
KW - movement guidelines
KW - movement recommendations
KW - parents
KW - physical activity
KW - screen time
KW - sedentary behavior
KW - sleep duration
UR - https://www.scopus.com/pages/publications/85153678094
U2 - 10.3390/children10040738
DO - 10.3390/children10040738
M3 - Artículo
AN - SCOPUS:85153678094
SN - 2227-9067
VL - 10
JO - Children
JF - Children
IS - 4
M1 - 738
ER -
