Clinical trial NCT04507100: Comprehensive Analysis of the Program:Salud Escolar
Official title: Comprehensive Analysis of the Program:Salud Escolar
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obesity
Keywords: physical activity
healthy eating
hydration
school intervention
health policy
Lead sponsor: Instituto Nacional de Salud Publica, Mexico
Sponsor class: OTHER
Collaborators: name: UNICEF
name: Ministry of Education, Mexico
name: Ministry of Health, Mexico
First posted: 2020-08-11
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to comprehensively evaluate Salud Escolar (School Health), a program led by the Mexican Ministries of Health and Education. This comprehensive evaluation considers a design, implementation, results, and impact evaluation of Salud Escolar.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Physical activity
timeFrame: Change from baseline to 10 months
measure: Water consumption
timeFrame: Change from baseline to 10 months
measure: Vegetable intake
timeFrame: Change from baseline to 10 months
measure: Fruit intake
timeFrame: Change from baseline to 10 months
Secondary outcomes:
measure: Self-reported knowledge
timeFrame: Change from baseline to 10 months
measure: Self-reported attitudes
timeFrame: Change from baseline to 10 months
measure: Perceived behavioral control
timeFrame: Change from baseline to 10 months
measure: Self-reported physical activity
timeFrame: Change from baseline to 10 months
measure: Self-reported fruit and vegetable intake
timeFrame: Change from baseline to 10 months
measure: Self-reported junk food intake
timeFrame: Change from baseline to 10 months
measure: Self-reported water consumption
timeFrame: Change from baseline to 10 months
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Salud Pública
Study officials:
affiliation: National Institute of public Health
name: Alejandra Jáuregui, ScD
role: PRINCIPAL_INVESTIGATOR
References: