Phase 3
N=2,279
Promoting Heart Health in Preschool Children
Cardiovascular Health
Bottom Line
View on ClinicalTrials.gov: NCT01551355 ↗Enrolled (actual)
2,279
Serious AEs
—
Results posted
Jan 2017
Primary outcome: Primary: Change in KAH Score for Children — 7.66; 3.76 units on a scale — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Children-Multicomponent intervention (Behavioral)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Valentin Fuster
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in KAH Score for Children |
7.66; 3.76 | <.001 sig |
| SECONDARY KAH Score for Parents |
6.12; 2.04 | <.001 sig |
| SECONDARY KAH Score for Teachers |
7.24; 1.88 | =.06 |
| SECONDARY Body Mass Index - BMI |
16.57; 16.4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Children attending one of the 14 H.I. in Usaquén
- Children who are 3, 4, or 5 years of age at the time of the beginning of the intervention
Exclusion Criteria
- Unwillingness to provide informed consent
- Children who have received formal training in healthy habits in nutrition and / or physical activity in the 6 months prior to the start of the follow-up period of the study.
- Children who plan to receive formal training in healthy habits in nutrition and / or physical activity during the follow-up study period.
Data sourced from ClinicalTrials.gov (NCT01551355). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.