- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04507100
Comprehensive Analysis of the Program:Salud Escolar
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study aims is to comprehensively analyze the design, implementation, results, and impact of Salud Escolar, a program led by the Mexican Ministries of Health and Education, during the first phase of implementation, from August 2020 to July 2021. Salud Escolar considers the World Health Organization (WHO) health promoting framework to foster a healthy environment and enhance children's physical activity, healthy eating and hydration. Salud Escolar consists on several activities aligned in the following components: healthy eating, healthy hydration, physical activity and additional cross sectional strategies.
The first phase of implementation will be conducted in a total of 58 schools located in Mexico City purposively selected by the Ministry of Education.
The design evaluation will use available policy documents and program implementation guidelines, scientific literature, to investigate wether the design of Salud Escolar is adequate to achieve the proposed objectives.
The implementation evaluation will be conducted in a sub-sample of 6 intervention schools using qualitative methodologies among key informants.
The results evaluation will be conducted in the 58 intervention schools and pre-post changes in self-reported knowledge, attitudes and practices related to healthy eating, hydration and being physically active will be measured.
The impact evaluation aims to evaluate the effect of Salud Escolar on the consumption of fruits, vegetables and plain water and daily moderate to vigorous physical activity. A sample of 1200 children (6-12 years old) in 15 intervention schools- randomly selected from the sample of 58 intervention schools-, and 15 comparison schools - randomly selected from the waiting list of available schools in the city will be recruited.
Based on the results derived from this analysis, a set of recommendations will be provided to improve the feasibility of scaling up the program at the national level during the second and third phases of Salud Escolar.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Mexico City, Mexico, 14080
- Instituto Nacional de Salud Publica
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
School
Inclusion criteria:
- Public school
- Minimum of 200 children
Exclusion criteria:
+ None
Children
Inclusion Criteria:
- Aged 6 to 12 years
- Grades 1-6
- Attending school on the day of recruitment at the included schools in Mexico City, Mexico during the school-year 2020/2021
Exclusion Criteria:
+ Schoolchildren with a physical or mental disability not able to participate in daily physical activity or other intervention components or measures.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lifestyle and environment intervention
Schools will receive the components of Salud Escolar
|
Healthy eating: regulation and monitoring of food sold in school cafeterias, healthy eating behavior change campaign, provision of healthy breakfasts. Physical activity: hourly active breaks during classes, quality physical education, active recess, and extra-curricular leisure activities and tournaments. Healthy hydration: access to water fountains and regular monitoring of water safety, regulation and monitoring of beverages sold in the school, and social marketing campaign promoting drinking plain water. Other cross-sectional activities: Referral of children identified as living with underweight, overweight, or obesity, training for school directors, teachers and parents, establishment of school objectives to become a health promoting school, monitoring progress, and publicly acknowledging school progress in becoming a health promoting school.
Other Names:
|
No Intervention: Wait-list control
Wait-list control of schools without intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical activity
Time Frame: Change from baseline to 10 months
|
Accelerometer-based moderate to vigorous intensity physical activity
|
Change from baseline to 10 months
|
Water consumption
Time Frame: Change from baseline to 10 months
|
School children's water consumption measured using a 24h dietary recall
|
Change from baseline to 10 months
|
Vegetable intake
Time Frame: Change from baseline to 10 months
|
School children's vegetable intake measured using a 24h dietary recall
|
Change from baseline to 10 months
|
Fruit intake
Time Frame: Change from baseline to 10 months
|
School children's fruit intake measured using a 24h dietary recall
|
Change from baseline to 10 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported knowledge
Time Frame: Change from baseline to 10 months
|
A questionnaire based on the theory of planned behavior was used to collect relevant knowledge related to healthy eating, drinking plain water and being physically.
There are a total of 8 statements and each statement is rated on a 4 point Likert scale.
A knowledge score is calculated by estimating the mean score of the responses.
Assessed at baseline and 10 months later to estimate change.
|
Change from baseline to 10 months
|
Self-reported attitudes
Time Frame: Change from baseline to 10 months
|
A questionnaire based on the theory of planned behavior was used to collect relevant attitudes related to healthy eating, drinking plain water and being physically.
There are a total of 11 statements and each statement is rated on a 4 point Likert scale.
An attitude score is calculated by estimating the mean score of the responses.
Assessed at baseline and 10 months later to estimate change.
|
Change from baseline to 10 months
|
Perceived behavioral control
Time Frame: Change from baseline to 10 months
|
A questionnaire based on the theory of planned behavior is used to collect perceived behavioral control (i.e., self-efficacy) related to healthy eating, drinking plain water and being physically.
There are a total of 9 statements and each statement is rated on a 4 point Likert scale.
A perceived behavioral control score is calculated by estimating the mean score of the responses.
Assessed at baseline and 10 months later to estimate change.
|
Change from baseline to 10 months
|
Self-reported physical activity
Time Frame: Change from baseline to 10 months
|
The physical activity question of the Health Behaviour in School-aged Children questionnaire is used to rate the proportion of children engaging in at least 60 minutes of moderate to vigorous physical activity per day.
Assessed at baseline and 10 months later to estimate change.
|
Change from baseline to 10 months
|
Self-reported fruit and vegetable intake
Time Frame: Change from baseline to 10 months
|
A questionnaire based on the theory of planned behavior is used to collect practices related to fruit and vegetable intake.
There are a total of 3 statements and each statement is rated on a 4 point Likert scale.
A fruit and vegetable intake score is calculated by estimating the mean score of the responses.
Assessed at baseline and 10 months later to estimate change.
|
Change from baseline to 10 months
|
Self-reported junk food intake
Time Frame: Change from baseline to 10 months
|
A questionnaire based on the theory of planned behavior is used to collect practices related to junk food consumption (i.e., sweets, candies, pastries, and sugar sweetened beverages).
There are a total of 3 statements and each statement is rated on a 4 point Likert scale.
A junk food intake score is calculated by estimating the mean score of the responses.
Assessed at baseline and 10 months later to estimate change.
|
Change from baseline to 10 months
|
Self-reported water consumption
Time Frame: Change from baseline to 10 months
|
A questionnaire based on the theory of planned behavior is used to collect practices related to water consumption.
There are a total of 2 statements and each statement is rated on a 4 point Likert scale.
A water intake score is calculated by estimating the mean score of the responses.
Assessed at baseline and 10 months later to estimate change.
|
Change from baseline to 10 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Alejandra Jáuregui, ScD, National Institute of Public Health
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
Other Study ID Numbers
- P86-19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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