Multidimensional Intervention in Mexican Schoolchildren
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-12
SponsorMexican National Institute of Public Health
About this trial
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?
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Children that don´t correspond to the selected shifts.
Trial design
Design model
Parallel
Treatments tested in this trial
Healthy and Sustainable Eating
BehavioralAnimated 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
BehavioralAnimated 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
BehavioralWorkshops on key topics of psychosocial determinants in children, virtual workshops on topics of psychosocial determinants such as obesity and healthy eating.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Intervención MultidimensionalActive comparator 3 interventions
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Metabolic and Lipid Profile
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.
Time frame
Baseline and after 6 moths2
Markers of Inflammation
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 (%).
Time frame
Baseline and after 6 monthsSponsors and contacts
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Source ClinicalTrials.gov