Clinical trial

Multidimensional Intervention in Mexican Schoolchildren

Recruiting now · Not applicable · 1 countries · Registry ID NCT07185789

Recruiting nowNot applicableInterventional

What this study is about

The aims is to evaluate the effects of an multidimensional intervention on the physical-built and social environment around schools and the nutritional status of the school population, through a randomized community trial, in schools in 3 states of the Mexican Republic, using anthropometric indicators, biological, psychological, behavioral and environmental. The main questions it aims to answer are: 1. What are the main risk and protective factors for overweight and obesity in the school environment and in the environments around schools in primary education schools in three states of the Mexican Republic? 2. Is there a relationship between risky eating behaviors and the body mass index of schoolchildren? 3. Are the strategies that are being implemented effective in reducing the presence of risk factors and increasing the presence of protective factors for overweight and obesity in the school environment and in the environments around schools? 4. Are the strategies that are being implemented effective in reducing the presence of risk factors and increasing the protective factors for overweight and obesity in the family environment?

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age9 Years to 12 Years
SexAll
Healthy volunteersAccepted
ConditionChildhood Obesity, Pediatric Obesity, Childhood Overweight

Full registry criteria

Inclusion Criteria: * Fourth grade elementary schools children from schools that belong to Federal entities: Campeche, Morelos and Mexico City, with morning schedule, from 8:00 to 12:30 or extended schedule, from 8:00 to 14:00hrs. * For Morelos State, elementary schools will be sought to be private, with at least 1000 enrollement students, with morning schedule, from 8:00 to 12:30 or extended schedule, from 8:00 to 14:00hrs. Exclusion Criteria: * Children that don´t correspond to the selected shifts.

Treatments and study arms

Healthy and Sustainable Eating

Behavioral

Animated projections, snacks that incorporate fruits and/or vegetables, measuring their hydration status through images where they can observe the color of their urine and relate it to the amount of plain water they have consumed, as well as activities through the mobile messaging platform, WhatsApp.

Movement behaviors

Behavioral

Animated projections, snacks that incorporate fruits and/or vegetables, measuring their hydration status through images where they can observe the color of their urine and relate it to the amount of plain water they have consumed, as well as activities through the mobile messaging platform, WhatsApp.

Psychosocial determinants

Behavioral

Workshops on key topics of psychosocial determinants in children, virtual workshops on topics of psychosocial determinants such as obesity and healthy eating.

Primary outcomes

Metabolic and Lipid ProfileBaseline and after 6 moths

This outcome is designed to provide a fundamental assessment of the participant's cardiometabolic health status at the beginning of the study. It focuses on measuring key circulating molecules that are central to energy metabolism and cardiovascular risk. To achieve this, we will collect blood samples and analyze them for the core analytes that constitute a standard lipid panel and metabolic check: Glucose (mg/dL) Total Cholesterol (mg/dL) HDL-c (%) Triglycerides (mg/dL) The concentration of each of these analytes will be determined using Enzymatic Spectrophotometry.

Markers of InflammationBaseline and after 6 months

We will measure the levels of Leptin, Adiponectin, IL-6, Galectin-3, HbA1c. We ELISA for the proteins, HPLC for HbA1c. Units: The results for the proteins will be reported in ng/mL, HbA1c as a percentage (%).

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Instituto Nacional de Salud Pública🇲🇽 Cuernavaca, Morelos, Mexico
SIMON BARQUERA, PhDContact