CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,279 enrolled
Drug / intervention
Children-Multicomponent interventionbehavioral
Likely dose
Not stated in record
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Search/NCT01551355
NCT01551355Phase 3Completed

Evaluation of an Intervention to Promote Healthy Heart Habits in Pre-School Children

Valentin Fuster·interventional·Posted Mar 12, 2012·Updated Jan 9, 2017

In Brief

A Phase 3 clinical trial evaluating Children-Multicomponent intervention for Cardiovascular Health. Completed, enrolled 2,279 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesColombia

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 12, 2012
Enrollment StartJul 1, 2009
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 14.3 years ago

Interventions

Children-Multicomponent interventionbehavioral

The intervened children were provided classroom educational and playful activities during 5 months, which included Sesame Workshop Healthy Habits storybooks, posters, videos, games, and songs (1 hour daily); a "Healthy family day" workshop (1 hour); and weekly health notes. Parents participated in 3 workshops and weekly notes containing positive health messages about nutrition and active lifestyles to share with their children. Teachers also participated in 3 centralized training sessions, plus personalized working sessions with a research supervisor (2 hours every 15 days), and received a teacher's guide.