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临床试验/NCT07185789
NCT07185789招募中不适用

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

Mexican National Institute of Public Health2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年11月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
2
主要终点
Metabolic and Lipid Profile

研究概览

简要总结

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?

详细描述

This is a project designed and approved to be carried out in 4 stages. The project has financing from the health sector fund and also an extension to end on January 11, 2025. The objective is to evaluate the effects of a multidimensional intervention (MI) on the physical-built and social environment around schools, as well as, on the nutritional status of the school population, through a community trial in schools in 3 states of the Mexican Republic (Campeche, Mexico City and Morelos). The impact will be measured through anthropometric, biological, psychological, behavioral and environmental indicators. The target population of the intervention will be students between 9-12 years old who are in the 4th grade of primary school.

Stage 1. Situational diagnosis. Duration: 12 months. In the design of health promotion interventions, situational diagnostic assessment is necessary to be able to design an intervention adapted to the context and real needs of the target population. This stage of the project also allows us to identify previous experiences and derive from them available evidence on interventions that have been implemented in other populations. Likewise, it is necessary to identify the health problems of the population to which the intervention to be designed is directed, as well as the existing policies and programs and the participation of the target population to which the intervention to be designed is aimed.

Stage 2. Design and development of the multidimensional intervention and evaluation instruments. Duration: 12 months. The information generated from the situational diagnosis will serve to design the multidimensional intervention of this proposal, which will include different levels of intervention such as school, around school, home and community. The components of this stage are the following: 1) Final design of the multidimensional intervention; and 2) Definition of the components of the multidimensional intervention, which include: a) Actions to ensure a healthy food environment; b) Comprehensive Physical Activity Program; c) Teacher training; d) Motivation of teachers; e) Educational materials with a social marketing focus, short or simple message service (SMS), printed or audiovisual material; f) Implementation logistics; g) Development of instruments necessary for intervention; h) Validation or pilot testing of the intervention materials.

Stage 3. Implementation, monitoring and evaluation of the multidimensional intervention. Duration: 10 months. The final design of the multidimensional intervention that will be implemented during this stage will depend on the modifications made in the stages described above. This stage consists of the following phases: 1) Randomization, 2) Initial evaluation, 3) Beginning of the intervention, 4) Monitoring and evaluation of the process and 5) Final evaluation.

Stage 4. Institutionalization of the intervention. Duration: 12 months. In the final stage, an analysis and formulation of recommendations will be carried out for the escalation and incorporation of the intervention to the Ministry of Public Education (SEP, for its acronym in Spanish).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

The children who participate are not aware of being a control or intervention group, as well as their parents, teachers and school cooperative staff.

入排标准

年龄范围
9 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Metabolic and Lipid Profile

时间窗: Baseline 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 Inflammation

时间窗: Baseline 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 (%).

次要结局

未报告次要终点

研究者

发起方
Mexican National Institute of Public Health
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Edgar Denova Gutierrez

Principal Investigator

Mexican National Institute of Public Health

研究点 (2)

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