NCT04507100

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
withdrawn

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

February 17, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 11, 2020

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

1 month

First QC Date

August 4, 2020

Last Update Submit

September 26, 2023

Conditions

Keywords

physical activityhealthy eatinghydrationschool interventionhealth policy

Outcome Measures

Primary Outcomes (4)

  • Physical activity

    Accelerometer-based moderate to vigorous intensity physical activity

    Change from baseline to 10 months

  • Water consumption

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

    Change from baseline to 10 months

  • Vegetable intake

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

    Change from baseline to 10 months

  • Fruit intake

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

    Change from baseline to 10 months

Secondary Outcomes (7)

  • Self-reported knowledge

    Change from baseline to 10 months

  • Self-reported attitudes

    Change from baseline to 10 months

  • Perceived behavioral control

    Change from baseline to 10 months

  • Self-reported physical activity

    Change from baseline to 10 months

  • Self-reported fruit and vegetable intake

    Change from baseline to 10 months

  • +2 more secondary outcomes

Study Arms (2)

Lifestyle and environment intervention

EXPERIMENTAL

Schools will receive the components of Salud Escolar

Behavioral: World Health Organization Health Promoting Schools

Wait-list control

NO INTERVENTION

Wait-list control of schools without intervention.

Interventions

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
Lifestyle and environment intervention

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Public school
  • Minimum of 200 children

You may not qualify if:

  • \+ None
  • Children
  • 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
  • \+ Schoolchildren with a physical or mental disability not able to participate in daily physical activity or other intervention components or measures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Salud Pública

Mexico City, 14080, Mexico

Location

MeSH Terms

Conditions

ObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Alejandra Jáuregui, ScD

    National Institute of public Health

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Masking is not possible because the Ministry of Education specifically announces the implementation of Salud Escolar in each school.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair of the Department of Physical Activity and Healthy Lifestyles

Study Record Dates

First Submitted

August 4, 2020

First Posted

August 11, 2020

Study Start

February 17, 2020

Primary Completion

March 30, 2020

Study Completion

March 30, 2022

Last Updated

September 28, 2023

Record last verified: 2023-09

Locations