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WithdrawnNCT04507100Updated Sep 28, 2023

Comprehensive Analysis of the Program:Salud Escolar

An interventional study of World Health Organization Health Promoting Schools in Obesity, sponsored by Instituto Nacional de Salud Publica, Mexico. Withdrawn at 1 site in Mexico. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2023-09-28.

Sponsored by Instituto Nacional de Salud Publica, Mexico · Not applicable, Interventional, and Prevention

Why this study was withdrawn
Trial twithdrawn due to the COVID-19 pandemic

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Feb 2020, registered Aug 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
6 Years to 12 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Obesity

Keywords

  • physical activity
  • healthy eating
  • hydration
  • school intervention
  • health policy
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

Browse Obesity studies →

Lead sponsor

Instituto Nacional de Salud Publica, Mexico is the lead sponsor of 31 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Lifestyle and environment intervention

    Schools will receive the components of Salud Escolar

    Behavioral: World Health Organization Health Promoting Schools

  • No intervention
    Wait-list control

    Wait-list control of schools without intervention.

Interventions

  • BehavioralWorld Health Organization Health Promoting Schools

    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.

    Also known as: Salud Escolar, Whole-of-school approach to healthy lifestyles

06

What researchers measure

Primary outcomes

  1. Physical activity

    Accelerometer-based moderate to vigorous intensity physical activity

    Time frame: Change from baseline to 10 months

  2. Water consumption

    School children's water consumption measured using a 24h dietary recall

    Time frame: Change from baseline to 10 months

  3. Vegetable intake

    School children's vegetable intake measured using a 24h dietary recall

    Time frame: Change from baseline to 10 months

  4. Fruit intake

    School children's fruit intake measured using a 24h dietary recall

    Time frame: Change from baseline to 10 months

Secondary outcomes

  1. Self-reported knowledge

    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.

    Time frame: Change from baseline to 10 months

  2. Self-reported attitudes

    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.

    Time frame: Change from baseline to 10 months

  3. Perceived behavioral control

    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.

    Time frame: Change from baseline to 10 months

  4. Self-reported physical activity

    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.

    Time frame: Change from baseline to 10 months

  5. Self-reported fruit and vegetable intake

    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.

    Time frame: Change from baseline to 10 months

  6. Self-reported junk food intake

    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.

    Time frame: Change from baseline to 10 months

  7. Self-reported water consumption

    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.

    Time frame: Change from baseline to 10 months

07

Study locations

1 site
  • Instituto Nacional de Salud Pública
    Mexico City, 14080, Mexico
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided — Data access requests will be reviewed by the principal investigator. Requestors will be required to sign a Data Access agreement.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04507100
Lead sponsor
Instituto Nacional de Salud Publica, Mexico
Collaborators
UNICEF, Ministry of Education, Mexico, Ministry of Health, Mexico
Responsible party
Alejandra Jáuregui de la Mota (Chair of the Department of Physical Activity and Healthy Lifestyles, Instituto Nacional de Salud Publica, Mexico) — Principal investigator
First posted
Aug 11, 2020
Start date
Feb 17, 2020
Primary completion
Mar 30, 2020
Completion
Mar 30, 2022
Last update
Sep 28, 2023

Study contacts

Alejandra Jáuregui, ScD
principal investigator · National Institute of public Health

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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