- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04679246
Participatory Intervention to Improve Nutrition and Physical Activity in Schoolchildren From Acatlán de Juárez, Jalisco (Acatlan)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Jalisco
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Zapopan, Jalisco, Mexico, 45128
- Iberoamerican Institute of Sports Science and Human Movement
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
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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).
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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:
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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.
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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
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3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Daily stepcount
Time Frame: 3 years
|
Change childrens daily average stepcount
|
3 years
|
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Physical fitness score
Time Frame: 3 years
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Change childrens physical fitness score measured by EUROFIT protocol
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3 years
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Self-efficacy
Time Frame: 3 years
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Change in children's perceptions about their capability to change their eating behavior.
(A self-administered validated questionnaire, Likert scale, points summary obtained)
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3 years
|
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Attitudes
Time Frame: 3 years
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Change in negative or positive perceptions about target eating behaviors.
(A self-administered validated questionnaire, Likert scale, points summary obtained)
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3 years
|
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Intention to change
Time Frame: 3 years
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Change in short term intentions to adopt a desirable eating behavior.
(A self-administered validated questionnaire, Likert scale, points summary obtained)
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3 years
|
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Fruit and vegetable intake during school recess
Time Frame: 3 years
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Change in fruit and vegetable intake (g) during school recess.
(Direct observation and weighted foods)
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3 years
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Collaborators and Investigators
Collaborators
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
General Publications
- 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
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IICDEM-ID-001-2015
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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