ObesityNCT04507100
Comprehensive Analysis of the Program:Salud Escolar
A study testing World Health Organization Health Promoting Schools in people with Obesity, run by Instituto Nacional de Salud Publica, Mexico at 1 site in Mexico.
Trial 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 more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Obesity
- What is being tested?
- World Health Organization Health Promoting Schools
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- 17 Feb 2020to 30 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Public school
- Minimum of 200 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
Who cannot join
- + None
- Children
- + Schoolchildren with a physical or mental disability not able to participate in daily physical activity or other intervention components or measures.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Obesity
- Being tested
- World Health Organization Health Promoting Schools
- Keywords
- physical activity, healthy eating, hydration, school intervention, health policy
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
World Health Organization Health Promoting SchoolsBehavioural
Also called Salud Escolar, Whole-of-school approach to healthy lifestyles
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.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle and environment intervention | Experimental | Schools will receive the components of Salud Escolar Receives: Behavioral: World Health Organization Health Promoting Schools |
| Wait-list control | No intervention | Wait-list control of schools without intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
Accelerometer-based moderate to vigorous intensity physical activity
Measured: Change from baseline to 10 months
Water consumption
School children's water consumption measured using a 24h dietary recall
Measured: Change from baseline to 10 months
Vegetable intake
School children's vegetable intake measured using a 24h dietary recall
Measured: Change from baseline to 10 months
Fruit intake
School children's fruit intake measured using a 24h dietary recall
Measured: Change from baseline to 10 months
Secondary outcomes (7)
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.
Measured: Change from baseline to 10 months
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.
Measured: Change from baseline to 10 months
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.
Measured: Change from baseline to 10 months
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.
Measured: Change from baseline to 10 months
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.
Measured: Change from baseline to 10 months
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.
Measured: Change from baseline to 10 months
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.
Measured: Change from baseline to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start17 Feb 2020
- Primary completion30 Mar 2020
- Study completion30 Mar 2022
Why it stopped: Trial twithdrawn due to the COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Salud Publica, Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- UNICEF, Ministry of Education, Mexico, Ministry of Health, Mexico
- Responsible party
- Principal investigator, Alejandra Jáuregui de la Mota, Instituto Nacional de Salud Publica, Mexico
- Investigators
- Alejandra Jáuregui, ScD, Principal investigator, National Institute of public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04507100
- Sponsor's protocol ID
- P86-19
- Status last verified
- Sep 2023
- First submitted
- 4 Aug 2020
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data access requests will be reviewed by the principal investigator. Requestors will be required to sign a Data Access agreement.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Analysis of the Program:Salud Escolar
- ClinicalTrials.gov ID
- NCT04507100
- Acronym / sponsor ID
- P86-19
- Conditions
- Obesity
- Keywords
- physical activity, healthy eating, hydration, school intervention, health policy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Trial twithdrawn due to the COVID-19 pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Instituto Nacional de Salud Publica, MexicoUniversity, hospital or other
- Collaborators
- UNICEF, Ministry of Education, Mexico, Ministry of Health, Mexico
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 11 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle and environment intervention | Experimental | Behavioral: World Health Organization Health Promoting SchoolsSchools will receive the components of Salud Escolar |
| Wait-list control | No intervention | –Wait-list control of schools without intervention. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Public school
- Minimum of 200 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
Key exclusion criteria (3 listed)
- + None
- Children
- + Schoolchildren with a physical or mental disability not able to participate in daily physical activity or other intervention components or measures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| World Health Organization Health Promoting SchoolsAlso: Salud Escolar, Whole-of-school approach to healthy lifestylesHealthy 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. | Behavioural | Lifestyle and environment intervention |
Primary outcome
Physical activity
Time frame: Change from baseline to 10 months
Accelerometer-based moderate to vigorous intensity physical activity
Water consumption
Time frame: Change from baseline to 10 months
School children's water consumption measured using a 24h dietary recall
Vegetable intake
Time frame: Change from baseline to 10 months
School children's vegetable intake measured using a 24h dietary recall
Fruit intake
Time frame: Change from baseline to 10 months
School children's fruit intake measured using a 24h dietary recall
7 secondary outcomes
Self-reported knowledge
Time frame: Change from baseline to 10 months
Self-reported attitudes
Time frame: Change from baseline to 10 months
Perceived behavioral control
Time frame: Change from baseline to 10 months
Self-reported physical activity
Time frame: Change from baseline to 10 months
Self-reported fruit and vegetable intake
Time frame: Change from baseline to 10 months
Self-reported junk food intake
Time frame: Change from baseline to 10 months
Self-reported water consumption
Time frame: Change from baseline to 10 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: Undecided. Data access requests will be reviewed by the principal investigator. Requestors will be required to sign a Data Access agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandra Jáuregui, ScD principal investigator
National Institute of public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing World Health Organization Health Promoting Schools in people with Obesity, run by Instituto Nacional de Salud Publica, Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity (time frame: Change from baseline to 10 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.