Cardiovascular HealthNCT03119792
Salud Integral Colombia
A study testing Education Intervention in people with Cardiovascular Health, run by Icahn School of Medicine at Mount Sinai at 1 site in Colombia.
Trial summary
In May 2009 in Bogota, Colombia, the Si! program conducted a cluster randomized trial in 1216 children between the ages of 3 and 6 years old, and 928 parents with the aim of evaluating a five month education intervention to change knowledge, attitudes and habits related to a healthy diet and active lifestyle in… Read more about this study
- Who is it for?
- Ages 9 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Health
- What is being tested?
- Education Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,216 participants
- Where
- 1 siteColombia
- Study dates
- Nov 2016to 13 Feb 2018
- Phase
- Interventional
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 9 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children 9-13 years old from the original Usaquen's cohort
- Children 9-13 years old who are not included in the original cohort (comparable cohort)
- Parents of participating children
Who cannot join
- Participant unable to consent
- Parents of non-participating children
- Siblings of the Original Usaquen cohort's children that do not belong to the original cohort
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Salud Integral Colombia (SI! Colombia II).
In May 2009 in Bogota, Colombia, the Si! program conducted a cluster randomized trial in 1216 children between the ages of 3 and 6 years old, and 928 parents with the aim of evaluating a five month education intervention to change knowledge, attitudes and habits related to a healthy diet and active lifestyle in preschoolers. The results showed that the program was feasible and effective. The Si! Program will perform a new follow up of its original children cohort, now between the ages of 9 and 13 years. The original cohort will be compared to a new comparable cohort to assess baseline knowledge, attitudes and habits of healthy lifestyles in knowledge, attitudes, habits and emotions towards a healthy lifestyles . A community pedagogical intervention in healthy lifestyles on cardiovascular health will be implemented in the intervention group.
Read the detailed description
Cardiovascular disease (CVD) is a leading cause of mortality worldwide. Negative health behaviors initiated in childhood that persist through adulthood can be risk factors that predict CVD. In Colombia, poor lifestyle factors affecting childhood are very prevalent: 50% live a sedentary lifestyle, 48% have high fat and carbohydrate consumption, 30% are exposed to passive smoking, 14% are overweight or obese, 15.8% have hypercholesteremia, and 5% have hypertension.
Negative health behaviors initiated in childhood that persist through adulthood can be risk factors that predict CVD. In Colombia, poor lifestyle factors affecting childhood are very prevalent: 50% live a sedentary lifestyle, 48% have high fat and carbohydrate consumption, 30% are exposed to passive smoking, 14% are overweight or obese, 15.8% have hypercholesterolemia, and 5% have hypertension. In May 2009, in Bogota, Colombia, was conducted a cluster randomized trial (kindergartens) in 1216 children between 3 and 6 years old, and 928 parents with the aim of evaluate a five months educational intervention to change knowledge, attitudes and habits related to a healthy diet and active lifestyle in preschoolers. The results showed that the intervention was feasible and effective . Finally every 1216 children "cohort Usaquén" received the intervention, performing a follow-up at 18 and 36 months showing that the changes persisted over time
In 2016 the SI! Program will perform a new follow up of this cohort, in children between 9 and 13 years old, and under the assumption that the effects of this intervention have decreased, the researchers plan to evaluate through a randomized control trial the impact of a four months community educational intervention, in the cardiovascular health of these children and in knowledge, attitudes, habits and emotions towards a healthy lifestyle. The study will include children from the Usaquen´s cohort who are contacted and children of a comparable cohort (n = 1200), in order to achieve sustainable changes in the cardiovascular health of children, that impact the burden of disease in their adulthood.
Due to the high rate of migration within the country, given the social and economic difficulties faced by many Colombians, in 2015 the study population was scattered from 1 to 15 localities and from 14 kindergartens to more than 200 public and private schools, mostly in the Usaquen´s locality, with great variability ranging from the facilities, resources, length of the school day, number of children in each classroom, to the training of teachers and their low motivation and availability time to perform any initiative (data obtained from focus groups conducted in schools). For these reasons, it is not feasible to carry out a second educational intervention in schools. However, the investigators believe that a community-based intervention is an excellent choice for tracking this population.
The objective of this project is two-fold. First, it is to assess differences at baseline in healthy lifestyles between children from Usaquen's cohort and a comparable cohort. The study will also assess differences at baseline in cardiovascular health between parents from Usaquen's cohort, and a comparable cohort. Second, it is to assess the impact of a community pedagogical intervention in healthy lifestyles in children nine to thirteen years old.
- Conditions
- Cardiovascular Health
- Being tested
- Education Intervention, Control
- Keywords
- Behavioral Modification, Health Community, Community Intervention, Prevention, Cardiovascular Health, Education Intervention, Colombia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education InterventionOther
The education intervention will help increase the children's knowledge of attitudes, and habits of healthy lifestyles. The program will cover self care of the body and heart, emotional management, healthy diet, and physical activity.
ControlOther
The control will not receive an education program relating to knowledge, attitudes, nor habits of healthy lifestyles. Instead, these sessions will occur twice a month, and will last an hour and forty-five minutes. The control program is titled "Life's Challenges", which will focus on helping children develop skills necessary for day to day life, is divided into four modules: Person, Family, School, and Environment. There will be four different types of activities used throughout the program including: "Lets Think," "Lets Experiment," "We will finish with...or synthesis," and "Not here."
| Study group | Role | What they receive |
|---|---|---|
| Investigational | Experimental | An education intervention will be implemented for 600 children from the original cohort (300) and comparable cohort (300) over a four month period at community centers. These sessions will occur twice a month on the weekends. The education intervention will help increase the children's knowledge of attitudes, and habits of healthy lifestyles. Receives: Other: Education Intervention |
| Control | Active comparator | The control group will consist of 600 children from the original cohort (300) and comparable cohort (300). The control group will meet twice a month for four months at community centers. During these sessions, investigators will teach a curriculum that is not related to knowledge, attitudes, and habits towards healthy lifestyles. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ideal Cardiovascular Health Score (ICH)
Using the metrics and criteria for individual ideal health factors and behaviors, the ideal cardiovascular health score (ICH) will be calculated for each metric (poor=0, intermediate=1, ideal=2 points; range=0-14 points for all seven metrics) and categorized them into three groups: poor (0-4 points), intermediate (5-9 points), and ideal (10-14 points). Higher values represent a better outcome.
Measured: Baseline and 6 months
Change in KAH score in Children of the Original and Comparable Cohort
Mean and standard deviation of the score of knowledge, attitudes, habits and emotions towards a healthy lifestyle in children will be determined, calculating the difference found between the baseline measurement and the measurement at the end of the study in intervened and control groups in the Original and comparable cohort. Possible differences between changes in means will be assessed using test t-test. Multi-variable models will be performed to adjust for potential con-founders.
Measured: Baseline and 6 months
Secondary outcomes (3)
Change in ICH score in Children of the Original and Comparable Cohort
Mean difference in scores and standard deviations in cardiovascular health (ICH) at the end of the study between intervened children in the Usaquen´s cohort and intervened children in the comparable cohort, will be determined, using a t-test. Multivariable models will be performed to adjust for potential confounders. The prevalence (CI 95%) of each of the 7 components of cardiovascular health rated as poor (risk factor) will be determined, calculating the difference found between the baseline measurement and the measurement at the end of the study in intervened children in the Usaquen´s cohort and intervened children in the comparable cohort. Possible differences between changes in prevalences will be evaluated using the chi-squared test.
Measured: Baseline and 6 months
Change in KAH score in Children of the Usaquen Cohort and Comparable Cohort
Mean and standard deviation of the score of knowledge, attitudes, habits and emotions towards a healthy lifestyle will be determined, calculating the difference found between the baseline measurement and the measurement at the end of the study in intervened children in the Usaquen´s cohort and intervened children in the comparable cohort. Multivariable models will be performed to adjust for potential confounders. Possible differences between changes in means will be assessed using a t-test.
Measured: Baseline and 6 months
Change in ICH score in Parents of the Original and Comparable Cohort
In parents, mean difference in scores and standard deviations in cardiovascular health (ICH) at the end of the study between intervened and control groups will be determined, using a t-test, differentiating between parents in the Usaquén´s cohort and a comparable cohort. Multivariable models will be performed to adjust for potential confounders. The prevalence (CI 95%) of each of the 7 components of cardiovascular health rated as poor (risk factor) will be determined, calculating the difference found between the baseline measurement and the measurement at the end of the study in intervened and control groups differentiating between parents in the Usaquén´s cohort and a comparable cohort. Possible differences between changes in prevalences will be evaluated using the chi-square test.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study startNov 2016
- Primary completion13 Feb 2018
- Study completion13 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular HealthStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- 1,216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Cardioinfantil Instituto de Cardiología, Fundación Mario Santo Domingo, Mobilizarte Social, SHE Foundation
- Responsible party
- Principal investigator, Valentin Fuster, Icahn School of Medicine at Mount Sinai
- Investigators
- Valentin Fuster, MD, PhD, Principal investigator, Icahn School of Medicine at Mount SinaiJorge Baxter, PhD, Study chair, Mobilizarte SocialJaime Cespedes, MD, Study director, Fundación CardioInfantil de Cardiologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03119792
- Sponsor's protocol ID
- GCO 16-1354
- Status last verified
- Mar 2019
- First submitted
- 21 Mar 2017
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fernandez-Jimenez R, Briceno G, Cespedes J, Vargas S, Guijarro J, Baxter J, Hunn M, Santos-Beneit G, Rodriguez C, Cespedes MP, Bagiella E, Moreno Z, Carvajal I, Fuster V. Sustainability of and Adherence to Preschool Health Promotion Among Children 9 to 13 Years Old. J Am Coll Cardiol. 2020 Apr 7;75(13):1565-1578. doi: 10.1016/j.jacc.2020.01.051.
PubMed 32241373