Cardiovascular Health Clinical Trial
Official title:
Evaluation of an Intervention to Promote Healthy Heart Habits in Pre-School Children
As part of the Colombian Hearty Health Initiative program led by Mount Sinai Cardiovascular Institute, a multidisciplinary team design and implemented a pedagogic and communication strategies for the promotion of healthy heart habits (PPHH) in preschoolers. This included educational materials, pedagogical activities and the use of Sesame Workshop healthy habits for life materials. For Colombia, the latter were largely developed in collaboration with the Colombian Society of Pediatrics, Colombian Society of Cardiology and Cardiovascular Surgery, Colsubsidio and Fundación Cardioinfantil-Instituto de Cardiología.
Background Increased levels of risk factors during childhood create an important life-long
burden that favors the development of cardiovascular (CVD) disease in adulthood.
Epidemiologic studies have demonstrated that cardiovascular disease risk factors are
identifiable in childhood and persist through to adulthood. It is unknown whether
interventions targeting preschoolers may change knowledge, attitudes and habits (KAH)
towards healthy lifestyles and, eventually, reduce the burden of CVD.
The goal of the proposed study is to assess over a five month intervention period, the
impact of an educational intervention on preschooler's knowledge of, habits and attitudes
towards healthy eating and living an active lifestyle. The impact of the intervention will
be also assessed in parents and teachers.
Methods The investigators will conduct a cluster, randomized controlled trial in 1216
pre-school children 3 to 5 years of age, 928 parents, and 120 teachers from 14 preschool
facilities in Bogotá, Colombia in a low socioeconomic and underprivileged community.
Randomization will occur at the facility level. The intervention will include classroom
activities and use of printed material (books, posters, teachers' guides, games) and videos.
Meanwhile, children in the control facilities will continue with their usual curriculum. A
structured survey will be used at baseline and end of study to evaluate changes in KAH and
the authors a priori give differential weights (70-20-10, respectively) to the scores to
compose a standardized weighted total score (WTS). The primary outcome will be the change in
children's WTS and the secondary outcomes will be the changes in parents' and teachers´ WTS.
Potential Impact of the Trial If found to be effective in improving the short-term changes
in knowledge, attitudes and habits, the educational intervention may have the potential to
influence the children's' diet and physical activity patterns throughout their lifetimes by
early interventions when attitudes and habits are formed. The program also targets parents
and teachers who contribute to shape children's attitudes and habits and who are often at
high risk for health problems associated with unhealthy diet and limited physical activity
themselves. The program aims to empower local partners in the health, education, media and
government sectors to build up the capacities to ensure sustainability. If proven
efficacious in the short term, further evaluative studies should test the hypothesis that
this program will serve as an effective and sustainable model to improve children's health
worldwide.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05986058 -
Preliminary Efficacy of a Technology-based Physical Activity Intervention for Older Korean Adults During the COVID-19 Pandemic
|
N/A | |
Completed |
NCT01235390 -
Effects of the Consumption of California Walnuts on Cardiovascular Health
|
Phase 1 | |
Active, not recruiting |
NCT04811885 -
The Effects of Covid-19 Pandemic on the Cardiovascular Heath of Children With Autism Spectrum Disorder
|
||
Recruiting |
NCT05122689 -
Dietary Inorganic Nitrate and the Enteral Microbiome
|
N/A | |
Completed |
NCT03119792 -
Salud Integral Colombia
|
N/A | |
Completed |
NCT01767051 -
Children Follow-up of PCOS Women
|
N/A | |
Recruiting |
NCT05695586 -
Effects of the Mindful Self-Compassion (MSC) Program
|
N/A | |
Recruiting |
NCT06260579 -
Home-based Exercise and Physical Activity Intervention After Kidney Transplantation: Impact of Exercise Intensity
|
N/A | |
Withdrawn |
NCT02202707 -
Vasomotor Symptoms and Cardiovascular Control
|
N/A | |
Active, not recruiting |
NCT04791618 -
MECA Clinical Intervention ( MECA Health360x)
|
N/A | |
Completed |
NCT03187704 -
Boston Puerto Rican Health Study
|
N/A | |
Completed |
NCT02453217 -
The Potential Efficacy of the Chinese Health Improvement Profile- A Pilot Clustered Randomised Controlled Trial
|
N/A | |
Recruiting |
NCT03090321 -
MyHeart Counts Cardiovascular Health Study
|
N/A | |
Completed |
NCT01293253 -
Effect of Daily Stair Walking on Cardiovascular Health
|
N/A | |
Active, not recruiting |
NCT03504059 -
School-based Behavioural Intervention to Face Obesity and Promote Cardiovascular Health Among Spanish Adolescents
|
N/A | |
Completed |
NCT05004454 -
Effect of Bacillus Subtilis BS50 Supplementation on Gastrointestinal Symptoms in Healthy Adults
|
N/A | |
Recruiting |
NCT05887622 -
The Potassium Supplementation Study
|
N/A | |
Active, not recruiting |
NCT04121741 -
Singing and Cardiovascular Health in Older Adults
|
N/A | |
Completed |
NCT04715126 -
Evaluate Efficacy of Oxyjun on Cardiovascular Health in Healthy Individuals.
|
N/A | |
Completed |
NCT03467061 -
The Effect of Dietary Nitrate on the Oral Microbiome
|
N/A |