Clinical trial NCT04679246: Participatory Intervention to Improve Nutrition and Physical Activity in Schoolchildren From Acatlán de Juárez, Jalisco
Official title: Participatory Intervention to Improve Nutrition and Physical Activity in Schoolchildren From Acatlán de Juárez, Jalisco
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Behavior
Adipose Tissue
Child Obesity
Keywords: Child Obesity
Exercise
Healthy Eating
Anthropometry
Lead sponsor: Iberoamerican Institute of Sports Science and Human Movement
Sponsor class: OTHER
Collaborators: name: University of Guadalajara
name: Mexican National Institute of Public Health
name: Instituto Tecnológico y de Estudios Superiores de Occidente
First posted: 2020-12-22
Enrollment: 3000
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Monitoring and evaluation of the impact of the intervention will be carried out through a community trial. There will be three schools in each study group (intervention and control). There will be three measurement periods: a baseline in the 2015-2016 school year, an intermediate measurement in the 2016-2017 school year, and a final measurement in the 2017-2018 school year. The measurement periods will have an estimated duration of two months.

In the measurement periods, the body composition of the children from 1st to 4th grade will be obtained, and they will be followed up for two years; The dynamics of water and food consumption, physical activity, functional physical capacities, as well as availability and accessibility of food in schools will be identified. In addition, from a sub-sample of the study subjects, questionnaires on the frequency of food consumption, additional anthropometric measurements, and venous blood will be obtained to determine glucose and blood lipid levels.
Primary purpose: PREVENTION

Brief summary: This is a community project carried out jointly by the Technological Institute of Higher Studies of the West (ITESO), the University Center of Tonalá of the University of Guadalajara (CUTonalá) and the University Center of Health Sciences of the University of Guadalajara ( CUCS) with advice from the National Institute of Public Health (INSP), financed by the Tresmontes Lucchetti company and endorsed by the Jalisco Association of Nutritionists, AC (AJANUT). This project follows the provisions of the "National Strategy for the Prevention and Control of Overweight, Obesity and Diabetes" signed by the executive branch of the Federal Government. In particular, this project is inserted within the Public Health Strategy, in the strategic axis of Health Promotion and educational communication (while still having an impact on the axes of Epidemiological Surveillance and Prevention). In addition, it follows the agreement in which the general guidelines for the expenditure and distribution of food and beverages prepared and processed in the schools of the National Educational System were obtained, proposed by the Ministries of Health and Public Education. The aforementioned referrals are intended to protect and improve the health of Mexican children.

Detailed description: The project is a community trial that will last three years, which includes an intervention group and a control group of three schools each. Acatlán de Juárez has a total of 11 elementary schools.

The strategies will be implemented in collaboration with the authorities of the Acatlán de Juárez community, the school authorities, ITESO staff, CUTonalá, CUCS, and AJANUT. Key actors from both the school and community levels will be involved through the study to adapt the strategies socially and culturally to promote community project ownership. An initial study of the viability of the project and the current conditions of food and physical activity in school facilities will be carried out, as well as the perception of the community. The research team will design the contents and materials of the intervention taking into account the opinions and suggestions of the community and the results of the initial study. The schools of the control group will be chosen from the municipality of Villa Corona, Jalisco, which is similar to Acatlán de Juárez.

The strategies proposed for intervention by the research team, which will be agreed with the community, including the following:

* Surveillance in compliance with the regulation of the sale of food in school buildings, according to official guidelines
* Sensitization of children, parents, teachers (especially those in charge of the physical education class) and personnel in charge of the food supply (school cooperative), to improve acceptance and commitment to the regulation of the sale of food
* Training for the preparation of hygienic and healthy food for the personnel in charge of food sale
* Promotion of the consumption of simple water and healthy foods
* Rescue and promotion of the consumption of regional foods
* Reconditioning of the infrastructure for the consumption of simple water, free and healthy food, and the realization of physical activity
* Organization of events and support in the coordination of groups that promote physical activity at the community level
* Optimization of physical education classes at school sites
* Implementation of health promotion and care actions in the school context
* Development of skills in the school community for health care and generation of healthy school environments
* Creation and strengthening of health and nutrition committees in schools, with the participation of directors, teachers and parents to generate necessary and permanent conditions that favor healthy environments

To achieve a greater rapprochement with the population, qualitative instruments will also be implemented before the intervention, such as focus groups and in-depth interviews, which allow the identification of barriers and possible solutions to improve eating habits and promote physical activity in the population. Likewise, during the intermediate and final measurement phases, similar qualitative strategies will be applied to rescue successes and points for improvement of the intervention.

During the implementation of the strategies, meticulous monitoring of the localities will be carried out to identify significant changes that may affect the eating habits and physical activity in either of the two groups (intervention and control).

Eligibility criteria: Inclusion Criteria:

* Children 6 to 10 years of age (completed at the beginning of the study) attending public schools.
* Mothers and fathers of school-age children.
* Responsible for cooperatives and school canteens.
* Key actors and members of the different groups involved in the implementation of the strategies.

Exclusion Criteria:

* Chronic disease with a confirmed diagnosis (cancer, type 1 or type 2 diabetes).
* Physical limitations that could affect development and normal eating patterns.
* Use of medications that can influence energy consumption and expenditure (for example, antidepressant drugs, antipsychotics, steroids).
* Children who are or were in a weight reduction program in the last year.
* Use of medications or confirmed diagnosis of diseases that could alter laboratory values.

Primary outcomes:
measure: Child overweigth and obesity
timeFrame: 3 years
Secondary outcomes:
measure: Daily stepcount
timeFrame: 3 years
measure: Physical fitness score
timeFrame: 3 years
measure: Self-efficacy
timeFrame: 3 years
measure: Attitudes
timeFrame: 3 years
measure: Intention to change
timeFrame: 3 years
measure: Fruit and vegetable intake during school recess
timeFrame: 3 years
Other outcomes:
Locations:
city: Zapopan
country: Mexico
facility: Iberoamerican Institute of Sports Science and Human Movement
state: Jalisco
Study officials:
affiliation: Instituto Tecnologico y de Estudios Superiores de Occidente
name: Laura Patricia Arellano Gomez, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Guadalajara
name: Clio Chavez Palencia, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Tecnologico y de Estudios Superiores de Occidente
name: Hector Ochoa Gonzalez, MSc
role: STUDY_DIRECTOR
affiliation: University of Guadalajara
name: Oscar Loreto Garibay, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Valencia-Sosa E, Chavez-Palencia C, Romero-Velarde E, Larrosa-Haro A, Vasquez-Garibay EM, Ramos-Garcia CO. Neck circumference as an indicator of elevated central adiposity in children. Public Health Nutr. 2019 Jul;22(10):1755-1761. doi: 10.1017/S1368980019000454. Epub 2019 Apr 2.
citation: Ramos García, C. O., Loreto Garibay, O., & Ochoa González, H. (2017). Diagnostic precision of the submandibular skinfold, minimum waist circumference and minimum waist to height ratio, as adipose overweight and obesity indicators in children. Nutricion Clinica y Dietetica Hospitalaria, 37(2). https://doi.org/10.12873/372cesarramos