NCT04679246

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 22, 2020

Completed
Last Updated

December 22, 2020

Status Verified

December 1, 2020

Enrollment Period

3.1 years

First QC Date

August 28, 2020

Last Update Submit

December 17, 2020

Conditions

Keywords

Child ObesityExerciseHealthy EatingAnthropometry

Outcome Measures

Primary Outcomes (1)

  • Child overweigth and obesity

    Shift prevalence of children overweigth and obesity

    3 years

Secondary Outcomes (6)

  • Daily stepcount

    3 years

  • Physical fitness score

    3 years

  • Self-efficacy

    3 years

  • Attitudes

    3 years

  • Intention to change

    3 years

  • +1 more secondary outcomes

Study Arms (3)

General Intervention

EXPERIMENTAL

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.

Behavioral: Participatory intervention

Subsample intervention

EXPERIMENTAL

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).

Behavioral: Participatory intervention

Control

NO INTERVENTION

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.

Interventions

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

Also known as: Healthy diet, Physical activity, Nutrition literacy
General InterventionSubsample intervention

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iberoamerican Institute of Sports Science and Human Movement

Zapopan, Jalisco, 45128, Mexico

Location

Related Publications (2)

  • 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.

  • 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

    RESULT

MeSH Terms

Conditions

Sedentary BehaviorPediatric ObesityMotor Activity

Interventions

Diet, HealthyExercise

Condition Hierarchy (Ancestors)

BehaviorObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Laura Patricia Arellano Gomez, PhD

    Instituto Tecnologico y de Estudios Superiores de Occidente

    PRINCIPAL INVESTIGATOR
  • Clio Chavez Palencia, PhD

    University of Guadalajara

    PRINCIPAL INVESTIGATOR
  • Hector Ochoa Gonzalez, MSc

    Instituto Tecnologico y de Estudios Superiores de Occidente

    STUDY DIRECTOR
  • Oscar Loreto Garibay, PhD

    University of Guadalajara

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Research and Development

Study Record Dates

First Submitted

August 28, 2020

First Posted

December 22, 2020

Study Start

May 1, 2015

Primary Completion

May 31, 2018

Study Completion

November 1, 2018

Last Updated

December 22, 2020

Record last verified: 2020-12

Locations