The ESCOLARISANO Cluster Randomized Controlled Trial: Protocol for a Comprehensive Program to Promote Healthy Lifestyles and Prevent Cardiometabolic Diseases in Low-Income Schoolchildren from Mexico (Preprint)

BACKGROUND Obesity is a serious public health problem affecting children in a progressively alarming manner. The development of nutrition education and behavior change interventions aimed to reduce risk factors for obesity and cardiometabolic diseases in childhood is a priority. Eating and physical activity behaviors of children and adolescents are mainly influenced by the environment; therefore, lifestyle changes are often successful when interventions are implemented in places such as home and school. Schools are fundamental for ensuring the development of students' personality and habits, as well as their skills, abilities, and long-term behaviors. OBJECTIVE To measure the effect of an intervention designed for low-income Mexican schoolchildren, focused on promoting healthy lifestyles for the prevention of obesity and cardiometabolic diseases. METHODS Study design is a cluster randomized clinical trial, with randomized groups (intervention) paired with groups of the same grade (control) as clusters within each school. Four elementary schools were selected based on socioeconomic level of neighborhoods. The study will be carried out for 1 year in four phases: 1) Initial measurements, including anthropometry, blood pressure, psychosocial diagnosis, family history and eating habits, and behavior variables: nutrition knowledge, dietary and sleep quality, and physical activity questionnaires, 2) Intervention implementation, which will cover topics related to nutrition and healthy eating, child health, personal hygiene, sleep, physical activity, psychosocial well-being and motivation, 3) After-intervention measurements including initial measurements and intervention indicators (effectiveness, retention, motivation to change, viability, fidelity, feasibility and acceptability), 4) 6 month-evaluation after intervention: anthropometry, blood pressure and same behavior measurements as in phase 1. Data will be analyzed baseline with t-test for independent samples by sex or ANCOVA adjusted for covariables, and multiple linear regression. For comparing changes between intervention vs. control group, we will use ANCOVA models with pre-test measurements as covariates, and to assess differences over time between multiple observations of participants in the intervention arm, the repeated measures ANOVA method will be performed. SPSS and STATA software will be used with a significance level of p<0.05. RESULTS From October, 2023 to August, 2024, a total of n=451 participants were recruited from four different elementary schools in Sonora, México. To date, the data collected are in the process of analysis and interpretation. CONCLUSIONS The protocol is a comprehensive program designed for schoolchildren in Mexico intended to be an effective strategy for promoting healthy lifestyles and preventing cardiometabolic diseases. It is important to continuously adapt the intervention and to evaluate it to ensure its sustainability and expand its impact on other elementary-school communities, improving health and well-being of scholars. CLINICALTRIAL At www.clinicaltrials.gov Protocol Record LNPAS_002, Healthy Lifestyle Promotion Program in Communities from the Yaqui Valley