Salud Integral Colombia
Condition: Cardiovascular Health
Study type: Interventional

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 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.
    

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.
    

Intervention name(s): Education Intervention; Control
Intervention type(s): Other; Other
Intervention description(s): 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.; 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."
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Behavioral Modification; Health Community; Community Intervention; Prevention; Cardiovascular Health; Education Intervention; Colombia