Multidimensional Intervention in Mexican Schoolchildren

NCT07185789 | Recruiting

• 1 other identifier: MexicanNIPH
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.Is there a relationship between risky eating behaviors and the body mass index of schoolchildren?
3. 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. 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?

Conditions

Childhood Obesity; Pediatric Obesity; Childhood Overweight

Keywords

Childhood obesity; School children

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline and after 6 moths

• 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 (%).

  Baseline and after 6 months

Study Arms (2)

Intervención Multidimensional

ACTIVE COMPARATOR

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.

Behavioral: Healthy and Sustainable Eating; Behavioral: Movement behaviors; Behavioral: Psychosocial determinants

Control

NO INTERVENTION

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.

Interventions

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.

Also known as: Movement behaviors, Psychosocial determinants

Intervención Multidimensional

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.

Intervención Multidimensional

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.

Intervención Multidimensional

Eligibility Criteria

• Age: 9 Years - 12 Years
• Gender Eligibility Details: girls and boys have similiar proportion
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Children that don´t correspond to the selected shifts.

Sponsors & Collaborators

• Mexican National Institute of Public Health: lead

Study Sites (1)

Instituto Nacional de Salud Pública

Cuernavaca, Morelos, 62100, Mexico

RECRUITING

Related Publications (7)

• Bonvecchio A, Safdie M, Monterrubio EA, Gust T, Villalpando S, Rivera JA. Overweight and obesity trends in Mexican children 2 to 18 years of age from 1988 to 2006. Salud Publica Mex. 2009;51 Suppl 4:S586-94. doi: 10.1590/s0036-36342009001000013.

  PMID: 20464234 BACKGROUND

• Barquera S, Campos I, Rivera JA. Mexico attempts to tackle obesity: the process, results, push backs and future challenges. Obes Rev. 2013 Nov;14 Suppl 2:69-78. doi: 10.1111/obr.12096.

  PMID: 24103026 BACKGROUND

• Rivera JA, Irizarry LM, Gonzalez-de Cossio T. Overview of the nutritional status of the Mexican population in the last two decades. Salud Publica Mex. 2009;51 Suppl 4:S645-56. doi: 10.1590/s0036-36342009001000020. No abstract available.

  PMID: 20464241 BACKGROUND

• Hernandez-Cordero S, Cuevas-Nasu L, Moran-Ruan MC, Mendez-Gomez Humaran I, Avila-Arcos MA, Rivera-Dommarco JA. Overweight and obesity in Mexican children and adolescents during the last 25 years. Nutr Diabetes. 2017 Mar 13;7(3):e247. doi: 10.1038/nutd.2016.52.

  PMID: 28287630 BACKGROUND

• Incledon E, Wake M, Hay M. Psychological predictors of adiposity: systematic review of longitudinal studies. Int J Pediatr Obes. 2011 Jun;6(2-2):e1-11. doi: 10.3109/17477166.2010.549491. Epub 2011 Jan 19.

  PMID: 21247271 BACKGROUND

• O'Dea JA, Caputi P. Association between socioeconomic status, weight, age and gender, and the body image and weight control practices of 6- to 19-year-old children and adolescents. Health Educ Res. 2001 Oct;16(5):521-32. doi: 10.1093/her/16.5.521.

  PMID: 11675800 BACKGROUND

• Palma-Coca O, Hernandez-Serrato MI, Villalobos-Hernandez A, Unikel-Santoncini C, Olaiz-Fernandez G, Bojorquez-Chapela I. Association of socioeconomic status, problem behaviors, and disordered eating in Mexican adolescents: results of the Mexican National Health and Nutrition Survey 2006. J Adolesc Health. 2011 Oct;49(4):400-6. doi: 10.1016/j.jadohealth.2011.01.019. Epub 2011 May 20.

  PMID: 21939871 BACKGROUND

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Simon Barquera Cervera, PhD

  National Institute of public Health

  STUDY DIRECTOR

Central Study Contacts

EDGAR DENOVA GUTIERREZ, PhD

CONTACT

5554322986; edenovag@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The children who participate are not aware of being a control or intervention group, as well as their parents, teachers and school cooperative staff.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 7, 2024
• First Posted: September 22, 2025
• Study Start: November 7, 2023
• Primary Completion: July 28, 2025
• Study Completion: March 30, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)