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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04679246
Other study ID # IICDEM-ID-001-2015
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2015
Est. completion date November 1, 2018

Study information

Verified date December 2020
Source Iberoamerican Institute of Sports Science and Human Movement
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 3000
Est. completion date November 1, 2018
Est. primary completion date May 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 12 Years
Eligibility 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 Design


Intervention

Behavioral:
Participatory intervention
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

Locations

Country Name City State
Mexico Iberoamerican Institute of Sports Science and Human Movement Zapopan Jalisco

Sponsors (4)

Lead Sponsor Collaborator
Iberoamerican Institute of Sports Science and Human Movement Instituto Tecnológico y de Estudios Superiores de Occidente, Mexican National Institute of Public Health, University of Guadalajara

Country where clinical trial is conducted

Mexico, 

References & Publications (2)

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 Cl

Valencia-Sosa E, Chávez-Palencia C, Romero-Velarde E, Larrosa-Haro A, Vásquez-Garibay EM, Ramos-García CO. Neck circumference as an indicator of elevated central adiposity in children. Public Health Nutr. 2019 Jul;22(10):1755-1761. doi: 10.1017/S136898001 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Child overweigth and obesity Shift prevalence of children overweigth and obesity 3 years
Secondary Daily stepcount Change childrens daily average stepcount 3 years
Secondary Physical fitness score Change childrens physical fitness score measured by EUROFIT protocol 3 years
Secondary Self-efficacy 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
Secondary Attitudes Change in negative or positive perceptions about target eating behaviors. (A self-administered validated questionnaire, Likert scale, points summary obtained) 3 years
Secondary Intention to change Change in short term intentions to adopt a desirable eating behavior. (A self-administered validated questionnaire, Likert scale, points summary obtained) 3 years
Secondary Fruit and vegetable intake during school recess Change in fruit and vegetable intake (g) during school recess. (Direct observation and weighted foods) 3 years
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