Accepted for/Published in: JMIR Research Protocols
Date Submitted: Aug 21, 2025
Date Accepted: Feb 27, 2026
The ESCOLARISANO Randomized Controlled Trial: Protocol for a Comprehensive Program to Promote Healthy Lifestyles and Prevent Cardiometabolic Diseases in Low-Income Schoolchildren from Mexico
ABSTRACT
Background:
Obesity is a serious public health issue affecting children in a progressively alarming manner; thus, nutrition education and behavior change interventions during childhood are a priority. Eating and physical activity behaviors 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, 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 randomized clinical trial, with groups (intervention) paired with groups of the same grade (control). Four elementary schools were selected based on district socioeconomic status. The study will be carried out for 1 year in four phases: 1) Initial measurements, including anthropometry, blood pressure, psychosocial diagnosis, family medical history, and behavior variables: nutrition knowledge, dietary intake, sleep time and quality, and physical activity; 2) Intervention implementation based on the Social Cognitive Theory, the Behavior Change Wheel (BCW) with the COM-B theoretical framework, and the Transtheoretical Theory, covering topics related to nutrition and healthy eating, child health, personal and sleep hygiene, physical activity, psychosocial well-being and motivation; 3) After-intervention measurements including initial and behavioral measurements, and intervention indicators; 4) Six-month post-intervention evaluation using the same initial and behavioral measures as in Phase 1. Baseline differences by age, sex, socioeconomic status and location, will be analyzed using chi-square (qualitative) and ANCOVA (quantitative variables). Multiple linear regression will test potential baseline associations between dependent (anthropometrics and blood pressure) and independent variables (diet, exercise and sleep time, family interaction, psychosocial well-being and perception of childhood obesity). For comparing changes between experimental and control arms in pre-immediately after intervention, and in pre- six-month post-intervention in anthropometrics, blood pressure and behavioral variables, we will use ANCOVA models. To assess differences over time between multiple observations for each arm, repeated measures ANOVA will be performed. We will use multilevel (mixed-effects) models, given the hierarchical structure of participants nested within schools. 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 February 2026, 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 before implementation, and to evaluate it to ensure its sustainability and expand its impact on other elementary-schools, improving health and well-being of scholars. Clinical Trial: At www.clinicaltrials.gov Protocol Record LNPAS_002, Healthy Lifestyle Promotion Program in Communities from the Yaqui Valley
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