Cardiovascular HealthNCT03579810
Impact of a Pedagogical Intervention on Children Cardiovascular Risk Factors
A study testing Investigational in people with Cardiovascular Health, run by Fundación Cardioinfantil Instituto de Cardiología at 1 site in Colombia.
Trial summary
In Bogotá, Colombia, the Fundación Cadioinfantil performed a randomized and controlled community trial, to evaluate the impact of a pedagogical intervention (PI) on cardiovascular health towards an active lifestyle and healthy eating in 9 schools of the city, including children from kindergarten to second grade of… Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Health
- What is being tested?
- Investigational
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 870 participants
- Where
- 1 siteColombia
- Study dates
- Feb 2013to Dec 2017
- 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 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Private schools located in the urban area of Bogotá
- Schools with an appropriate physical activity space and infrastructure.
- Schools that allow the study conduction.
Who cannot join
- Schools that have received interventions of more than 1 month in healthy habits (nutrition and / or physical activity) during the year prior to the start of the study.
- Schools that plan to receive interventions of more than 1 month in healthy habits (nutrition and / or physical activity) during the time of follow-up of the study.
- Schools with a history of annual dropout of their students or teachers greater than 10%.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Fundacion Cardioinfantil Instituto de Cardiologia
Bogotá, Bogota D.C.
About this study
In Bogotá, Colombia, the Fundación Cadioinfantil performed a randomized and controlled community trial, to evaluate the impact of a pedagogical intervention (PI) on cardiovascular health towards an active lifestyle and healthy eating in 9 schools of the city, including children from kindergarten to second grade of elementary school, their parents and teachers.
Read the detailed description
Cardiovascular disease (CVD) is a leading cause of mortality worldwide and Colombia is not an exception. Epidemiological studies have demonstrated that CVD risk factors are identifiable in childhood and they are predictor of CDV risk in adulthood. Worldwide, CDV primary prevention that begins in childhood is identified as a strategy that decreases the burden of this disease.
Programs developed in educational communities (EC), that include in their planning and implementation students, teachers and parents, with training to food personnel, are the most effective strategies to create healthy school environments and reduce the burden of chronic diseases. However recent studies that evaluate physical activity through accelerometers have not shown effectiveness.
In 2009, the Si! program and Fundación CardioInfantil performed a randomized and controlled community trial in facilities of the Colombian Family welfare Institute, ICBF, from Usaquen locality in Bogotá, finding that a pedagogical intervention (PI) in preschool children, their parents and teachers is effective in improving knowledge, attitudes and habits towards an active lifestyle and healthy diet.
The construction of the proposed intervention is based on the best available evidence about programs, policies and practices that positively impact in healthy eating and physical activity habits in EC.
The objectives of this project are to evaluate changes in healthy foods consumption and energy expenditure in children from kindergarten to second grade of elementary school that receives pedagogical intervention (PI) adapted to its context, compared to another EC that develops its habitual curriculum. In addition, this study evaluates changes on cardiovascular risk factors in children. Also, it evaluates changes in healthy foods consumption in their parents and teachers.
- Conditions
- Cardiovascular Health
- Being tested
- Investigational, Control
- Keywords
- Behavioral Modification, Health Community, Community Intervention, Prevention, Education Intervention, Cardiovascular Health, Colombia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InvestigationalOther
The educational intervention helped to increase the knowledge of attitudes, and habits of healthy lifestyle in children, parents and teachers and it was based on health promotion models and social cognitive theory, to be articulated with the Institutional Educational Project through the pedagogical component that integrates three areas, physical activity, healthy eating, and the knowledge of the body and the heart with the dynamics of the educative community.
The program covered self-care of the body and heart, healthy diet, and physical activity
ControlOther
The control group did not receive an educational intervention in areas of physical activity, healthy eating, and the knowledge of the body and the heart. Instead, children received the standard curriculum in health and physical activity of the national Ministry of Education.
| Study group | Role | What they receive |
|---|---|---|
| Investigational | Experimental | An education intervention was implemented in 5 schools including 516 children, 360 parents and 240 teachers.
The Pedagogical Intervention last two and a half years. In children, the intervention included class activities (1/week) and the use of educational materials for the development of pedagogical activities (posters and educative guide).
In parents included 3 workshops/year (2 hours each) about the areas of the intervention; sending healthy notes (1/month) and celebration of healthy family day (1/year).
In teachers included 3 workshops/year (2 hours each) about the areas of the intervention; planning and realization of pedagogical activities to develop with the students (1/week) and follow-up visits to school (1/month). Receives: Other: Investigational |
| Control | Active comparator | The control group consisted of 4 schools including 354 children, 305 parents and 110 teachers.
The activities in control group last two and a half years. Children received the standard curriculum in health and physical activity of the national Ministry of Education.
In parents and teachers included 3 workshops/year (2 hours each) about the first aid and accident prevention. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in active energy expenditure in children
The energy expenditure (Kilocalories/day), in children from Kindergarten to grade 2 of elementary school, generated by physical activity was evaluated using accelerometers during 4 consecutive days, 24hours/day (2 weekend days and two schooldays) through an Actiheart® 4 type accelerometer.
Possible differences between changes in active energy expenditure means was assessed using test t-test. Multi-variable models were performed to adjust for potential con-founders.
Measured: Baseline and 2.5 years
Changes in healthy foods consumption in children
A food frequency survey (ENSIN 2010) was used in children from Kindergarten to grade 2 of elementary school.
Healthy foods consumptions were defined as the accomplishment of 3-4 of the 4 measured components (intake of Fruits and vegetables ≥3 times a day, Fiber: ≥3 times a day, Fish: ≥2 times a week, Sugary beverages: ≤ 1 time a day).
Possible differences between changes in the proportion of children with healthy foods consumption was assessed using chi2 test. Multi-variable models were performed to adjust for potential con-founders.
Measured: Baseline and 2.5 years
Secondary outcomes (8)
Changes in the Body Mass Index in children
Using the Quetelet index, that considers the BMI as the relationship between the body weight given in kg and the square size taken in meters.
Possible differences between changes in BMI means was assessed using test t-test. Multi-variable models were performed to adjust for potential con-founders.
Measured: Baseline and 2.5 years
Changes in the perimeter of the waist in children
Using a tape measure on the skin just above the iliac crest, in feet position. Possible differences between changes in perimeter of the waist means was assessed using test t-test. Multi-variable models were performed to adjust for potential con-founders.
Measured: Baseline and 2.5 years
Changes in total cholesterol in children
Possible differences between changes in total cholesterol means was assessed using test t-test. Multi-variable models were performed to adjust for potential con-founders.
Measured: Baseline and 2.5 years
Changes in triglycerides in children
Possible differences between changes triglycerides means was assessed using test t-test. Multi-variable models were performed to adjust for potential con-founders
Measured: Baseline and 2.5 years
Changes in fasting glycemia in children
Possible differences between changes in fasting glycemia means was assessed using test t-test. Multi-variable models were performed to adjust for potential con-founders
Measured: Baseline and 2.5 years
Change in blood pressure in children
Three measurements were made using a standardized technique. Possible differences between changes in both systolic and diastolic blood pressure means was assessed using test t-test. Multi-variable models were performed to adjust for potential con-founders.
Measured: Baseline and 2.5 years
Changes in the consumption of healthy foods in teachers
A food frequency survey (ENSIN 2010) was used in teachers. Healthy foods consumptions were defined as the accomplishment of 3-4 of the 4 measured components (intake of Fruits and vegetables ≥3 times a day, Fiber: ≥3 times a day, Fish: ≥2 times a week, Sugary beverages: ≤ 1 time a day).
Possible differences between changes in the proportion of teachers with healthy foods consumption was assessed using chi2 test. Multi-variable models were performed to adjust for potential con-founders.
Measured: Baseline and 2.5 years
Changes in the consumption of healthy foods in parents
A food frequency survey (ENSIN 2010) was used in parents. Healthy foods consumptions were defined as the accomplishment of 3-4 of the 4 measured components (intake of Fruits and vegetables ≥3 times a day, Fiber: ≥3 times a day, Fish: ≥2 times a week, Sugary beverages: ≤ 1 time a day).
Possible differences between changes in the proportion of parents with healthy foods consumption was assessed using chi2 test. Multi-variable models were performed to adjust for potential con-founders.
Measured: Baseline and 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2018
- Study startFeb 2013
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular HealthStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 870 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Cardioinfantil Instituto de Cardiología
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
- Responsible party
- Principal investigator, CespedesJ_PI, Fundación Cardioinfantil Instituto de Cardiología
- Investigators
- Jaime Cespedes, MD, Principal investigator, Fundación Cardioinfantil Instituto de Cardiología
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03579810
- Sponsor's protocol ID
- IM-564-2012
- Status last verified
- Jul 2018
- First submitted
- 26 Jun 2018
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cespedes J, Briceno G, Farkouh ME, Vedanthan R, Baxter J, Leal M, Boffetta P, Woodward M, Hunn M, Dennis R, Fuster V. Targeting preschool children to promote cardiovascular health: cluster randomized trial. Am J Med. 2013 Jan;126(1):27-35.e3. doi: 10.1016/j.amjmed.2012.04.045. Epub 2012 Oct 9.
PubMed 23062403Neil-Sztramko SE, Caldwell H, Dobbins M. School-based physical activity programs for promoting physical activity and fitness in children and adolescents aged 6 to 18. Cochrane Database Syst Rev. 2021 Sep 23;9(9):CD007651. doi: 10.1002/14651858.CD007651.pub3.
PubMed 34555181
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Pedagogical Intervention on Children Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT03579810
- Acronym / sponsor ID
- IM-564-2012
- Conditions
- Cardiovascular Health
- Keywords
- Behavioral Modification, Health Community, Community Intervention, Prevention, Education Intervention, Cardiovascular Health, Colombia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 870 participants (actual)
- Lead sponsor
- Fundación Cardioinfantil Instituto de CardiologíaUniversity, hospital or other
- Collaborators
- Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
- Study start
- Feb 2013 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 9 Jul 2018 (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.
In Bogotá, Colombia, the Fundación Cadioinfantil performed a randomized and controlled community trial, to evaluate the impact of a pedagogical intervention (PI) on cardiovascular health towards an active lifestyle and healthy eating in 9 schools of the city, including children from kindergarten to second grade of elementary school, their parents and teachers.
Detailed description
Cardiovascular disease (CVD) is a leading cause of mortality worldwide and Colombia is not an exception. Epidemiological studies have demonstrated that CVD risk factors are identifiable in childhood and they are predictor of CDV risk in adulthood. Worldwide, CDV primary prevention that begins in childhood is identified as a strategy that decreases the burden of this disease.
Programs developed in educational communities (EC), that include in their planning and implementation students, teachers and parents, with training to food personnel, are the most effective strategies to create healthy school environments and reduce the burden of chronic diseases. However recent studies that evaluate physical activity through accelerometers have not shown effectiveness.
In 2009, the Si! program and Fundación CardioInfantil performed a randomized and controlled community trial in facilities of the Colombian Family welfare Institute, ICBF, from Usaquen locality in Bogotá, finding that a pedagogical intervention (PI) in preschool children, their parents and teachers is effective in improving knowledge, attitudes and habits towards an active lifestyle and healthy diet.
The construction of the proposed intervention is based on the best available evidence about programs, policies and practices that positively impact in healthy eating and physical activity habits in EC.
The objectives of this project are to evaluate changes in healthy foods consumption and energy expenditure in children from kindergarten to second grade of elementary school that receives pedagogical intervention (PI) adapted to its context, compared to another EC that develops its habitual curriculum. In addition, this study evaluates changes on cardiovascular risk factors in children. Also, it evaluates changes in healthy foods consumption in their parents and teachers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational | Experimental | Other: InvestigationalAn education intervention was implemented in 5 schools including 516 children, 360 parents and 240 teachers. The Pedagogical Intervention last two and a half years. In children, the intervention included class activities (1/week) and the use of educational materials for the development of pedagogical activities (posters and educative guide). In parents included 3 workshops/year (2 hours each) about the areas of the intervention; sending healthy notes (1/month) and celebration of healthy family day (1/year). In teachers included 3 workshops/year (2 hours each) about the areas of the intervention; planning and realization of pedagogical activities to develop with the students (1/week) and follow-up visits to school (1/month). |
| Control | Active comparator | Other: ControlThe control group consisted of 4 schools including 354 children, 305 parents and 110 teachers. The activities in control group last two and a half years. Children received the standard curriculum in health and physical activity of the national Ministry of Education. In parents and teachers included 3 workshops/year (2 hours each) about the first aid and accident prevention. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Private schools located in the urban area of Bogotá
- Schools with an appropriate physical activity space and infrastructure.
- Schools that allow the study conduction.
Key exclusion criteria (3 listed)
- Schools that have received interventions of more than 1 month in healthy habits (nutrition and / or physical activity) during the year prior to the start of the study.
- Schools that plan to receive interventions of more than 1 month in healthy habits (nutrition and / or physical activity) during the time of follow-up of the study.
- Schools with a history of annual dropout of their students or teachers greater than 10%.
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 |
|---|---|---|
| InvestigationalThe educational intervention helped to increase the knowledge of attitudes, and habits of healthy lifestyle in children, parents and teachers and it was based on health promotion models and social cognitive theory, to be articulated with the Institutional Educational Project through the pedagogical component that integrates three areas, physical activity, healthy eating, and the knowledge of the body and the heart with the dynamics of the educative community. The program covered self-care of the body and heart, healthy diet, and physical activity | Other | Investigational |
| ControlThe control group did not receive an educational intervention in areas of physical activity, healthy eating, and the knowledge of the body and the heart. Instead, children received the standard curriculum in health and physical activity of the national Ministry of Education. | Other | Control |
Primary outcome
Change in active energy expenditure in children
Time frame: Baseline and 2.5 years
The energy expenditure (Kilocalories/day), in children from Kindergarten to grade 2 of elementary school, generated by physical activity was evaluated using accelerometers during 4 consecutive days, 24hours/day (2 weekend days and two schooldays) through an Actiheart® 4 type accelerometer. Possible differences between changes in active energy expenditure means was assessed using test t-test. Multi-variable models were performed to adjust for potential con-founders.
Changes in healthy foods consumption in children
Time frame: Baseline and 2.5 years
A food frequency survey (ENSIN 2010) was used in children from Kindergarten to grade 2 of elementary school. Healthy foods consumptions were defined as the accomplishment of 3-4 of the 4 measured components (intake of Fruits and vegetables ≥3 times a day, Fiber: ≥3 times a day, Fish: ≥2 times a week, Sugary beverages: ≤ 1 time a day). Possible differences between changes in the proportion of children with healthy foods consumption was assessed using chi2 test. Multi-variable models were performed to adjust for potential con-founders.
8 secondary outcomes
Changes in the Body Mass Index in children
Time frame: Baseline and 2.5 years
Changes in the perimeter of the waist in children
Time frame: Baseline and 2.5 years
Changes in total cholesterol in children
Time frame: Baseline and 2.5 years
Changes in triglycerides in children
Time frame: Baseline and 2.5 years
Changes in fasting glycemia in children
Time frame: Baseline and 2.5 years
Change in blood pressure in children
Time frame: Baseline and 2.5 years
Changes in the consumption of healthy foods in teachers
Time frame: Baseline and 2.5 years
Changes in the consumption of healthy foods in parents
Time frame: Baseline and 2.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
- Results publication: PubMed 23062403Cespedes J, Briceno G, Farkouh ME, Vedanthan R, Baxter J, Leal M, Boffetta P, Woodward M, Hunn M, Dennis R, Fuster V. Targeting preschool children to promote cardiovascular health: cluster randomized trial. Am J Med. 2013 Jan;126(1):27-35.e3. doi: 10.1016/j.amjmed.2012.04.045. Epub 2012 Oct 9.
- Derived from this study: PubMed 34555181Neil-Sztramko SE, Caldwell H, Dobbins M. School-based physical activity programs for promoting physical activity and fitness in children and adolescents aged 6 to 18. Cochrane Database Syst Rev. 2021 Sep 23;9(9):CD007651. doi: 10.1002/14651858.CD007651.pub3.
- Individual participant dataSharing planned: No
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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.
Jaime Cespedes, MD principal investigator
Fundación Cardioinfantil Instituto de Cardiología
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational in people with Cardiovascular Health, run by Fundación Cardioinfantil Instituto de Cardiología at 1 site in Colombia.
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 3 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: finished, as of the sponsor's last update on 19 Jul 2018. 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 Colombia. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in active energy expenditure in children (time frame: Baseline and 2.5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03579810, which also lists 2 linked publications.
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 19 Jul 2018.