Multidimensional Intervention to Improve Healthy Lifestyle Practices and Nutrition and Health Status in Mexican Schoolchildren: Development of an Intervention Platform, Randomized Clinical Trial and Scaling Proposal

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 9
Maximum Age: 12
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Mexico
Instituto Nacional de Salud Pública
RECRUITING
Cuernavaca
Contact Information
Primary
EDGAR DENOVA GUTIERREZ, PhD
edenovag@gmail.com
5554322986
Time Frame
Start Date: 2023-11-07
Estimated Completion Date: 2026-03-30
Participants
Target number of participants: 200
Treatments
Active_comparator: Intervención Multidimensional
The multidimensional intervention will be received in 10 schools in 3 states of Mexico (Campeche, Mexico City and Morelos). In these schools, an initial diagnosis of the environment, monitoring and evaluation of the implemented strategies will be carried out. Subsequently, a baseline measurement will be carried out, where anthropometric, behavioral and environmental modification indicators will be evaluated, including the measurement of body composition through dual x-ray absorption densitometry (DXA), cardiometabolic health indicators such as glycated hemoglobin (HbA1c), lipid profile, liver function and biological markers; inflammation markers. The intervention will include activities related to: A) Healthy and sustainable eating; B) Movement behaviors; C) Psychosocial determinants. Finally, a final measurement will be carried out where the same variables as in the initial measurement will be evaluated.
No_intervention: Control
Multidimensional intervention will not be received. In these schools, an initial diagnosis of the environment will be carried out, monitoring and evaluation of the strategies implemented and a more in-depth initial and basal measurement will be carried out, using anthropometric, behavioral and environmental modification indicators, including the measurement of body composition through dual x-ray absorption densitometry (DXA), cardiometabolic health indicators such as glycated hemoglobin (HbA1c), lipid profile, liver function and biological markers; inflammation markers.~A final measurement will be carried out to compare the results.
Related Therapeutic Areas
Sponsors
Leads: Mexican National Institute of Public Health

This content was sourced from clinicaltrials.gov