Participatory Intervention to Improve Nutrition and Physical Activity in Schoolchildren From Acatlán de Juárez, Jalisco (Acatlan)

December 17, 2020 updated by: Cesar Octavio Ramos Garcia, PhD, Iberoamerican Institute of Sports Science and Human Movement
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.

Study Overview

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).

Study Type

Interventional

Enrollment (Actual)

3000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Jalisco
      • Zapopan, Jalisco, Mexico, 45128
        • Iberoamerican Institute of Sports Science and Human Movement

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 12 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: General Intervention
The strategies will be implemented in the three intervention elementary schools. The schools were conveniently chosen for the size of the student population. In addition to having a sufficient population, it was important that the authorities of each school site agreed to participate.
Surveillance in compliance with the regulation of the sale of food in school buildings, according to official guidelines 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 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
Other Names:
  • Physical activity
  • Healthy diet
  • Nutrition literacy
EXPERIMENTAL: Subsample intervention
A group will be randomly selected from each school grade from the intervention schools, and within each chosen group 12 children will be randomly selected per group (48 children in total per school).
Surveillance in compliance with the regulation of the sale of food in school buildings, according to official guidelines 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 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
Other Names:
  • Physical activity
  • Healthy diet
  • Nutrition literacy
NO_INTERVENTION: Control
Three primary schools were selected from a close locality (Villa Corona, Jalisco). This was chosen because it is similar in relation to the social, economic, and geographical context to the locality of intervention. The schools were selected for the similarity in the size of the student population of the intervention schools.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child overweigth and obesity
Time Frame: 3 years
Shift prevalence of children overweigth and obesity
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily stepcount
Time Frame: 3 years
Change childrens daily average stepcount
3 years
Physical fitness score
Time Frame: 3 years
Change childrens physical fitness score measured by EUROFIT protocol
3 years
Self-efficacy
Time Frame: 3 years
Change in children's perceptions about their capability to change their eating behavior. (A self-administered validated questionnaire, Likert scale, points summary obtained)
3 years
Attitudes
Time Frame: 3 years
Change in negative or positive perceptions about target eating behaviors. (A self-administered validated questionnaire, Likert scale, points summary obtained)
3 years
Intention to change
Time Frame: 3 years
Change in short term intentions to adopt a desirable eating behavior. (A self-administered validated questionnaire, Likert scale, points summary obtained)
3 years
Fruit and vegetable intake during school recess
Time Frame: 3 years
Change in fruit and vegetable intake (g) during school recess. (Direct observation and weighted foods)
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Laura Patricia Arellano Gomez, PhD, Instituto Tecnologico y de Estudios Superiores de Occidente
  • Principal Investigator: Clio Chavez Palencia, PhD, University of Guadalajara
  • Study Director: Hector Ochoa Gonzalez, MSc, Instituto Tecnologico y de Estudios Superiores de Occidente
  • Principal Investigator: Oscar Loreto Garibay, PhD, University of Guadalajara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2015

Primary Completion (ACTUAL)

May 31, 2018

Study Completion (ACTUAL)

November 1, 2018

Study Registration Dates

First Submitted

August 28, 2020

First Submitted That Met QC Criteria

December 17, 2020

First Posted (ACTUAL)

December 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 22, 2020

Last Update Submitted That Met QC Criteria

December 17, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • IICDEM-ID-001-2015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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