Multidimensional Intervention in Mexican Schoolchildren

Официальное название

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

Обзор

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?

Подробное описание

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).

The study consists of a community trial in 24 schools in 3 states of the Mexican Republic (Campeche, Morelos and Mexico City) and a parallel randomized clinical trial in 4 of the schools in Cuernavaca, Morelos. Both studies together will address the questions raised in the previous section.

Вмешательства

• Поведенческое Healthy and Sustainable Eating
  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.
• Поведенческое Movement behaviors
  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.
• Поведенческое Psychosocial determinants
  Workshops on key topics of psychosocial determinants in children, virtual workshops on topics of psychosocial determinants such as obesity and healthy eating.

Первичные конечные точки

• Metabolic and Lipid Profile [Срок оценки: Baseline and after 6 moths]
• Markers of Inflammation [Срок оценки: Baseline and after 6 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Мексика · 1 центр

• Instituto Nacional de Salud Pública — Cuernavaca

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07185789 · MexicanNIPH

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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