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- Title
A Cluster Randomized Controlled Trial of the Archena Infancia Saludable Project on 24-h Movement Behaviors and Adherence to the Mediterranean Diet among Schoolchildren: A Pilot Study Protocol.
- Authors
López-Gil, José Francisco; García-Hermoso, Antonio; Smith, Lee; Gallego, Alejandra; Victoria-Montesinos, Desirée; Ezzatvar, Yasmin; Hershey, Maria S.; Gutiérrez-Espinoza, Héctor; Mesas, Arthur Eumann; Jiménez-López, Estela; Sánchez-Miguel, Pedro Antonio; López-Benavente, Alba; Moreno-Galarraga, Laura; Chen, Sitong; Brazo-Sayavera, Javier; Fernandez-Montero, Alejandro; Alcaraz, Pedro Emilio; Panisello Royo, Josefa María; Tárraga-López, Pedro J.; Kales, Stefanos N.
- Abstract
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.
- Subjects
SPAIN; MEDITERRANEAN diet; FOOD habits; PILOT projects; SCHOOL health services; CHILD behavior; RANDOMIZED controlled trials; BODY movement; HEALTH behavior; BEHAVIOR modification
- Publication
Children, 2023, Vol 10, Issue 4, p738
- ISSN
2227-9067
- Publication type
Article
- DOI
10.3390/children10040738