A Clinical Trial Of Two Educational Strategies In Cardiovascular Health In Child Population

A Cluster-Randomized Clinical Trial Of Two Educational Strategies In Cardiovascular Health (CVH) In Child Population. The Savinghearts Project

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01418872

Acronym

SAVINHEARTS

Enrollment

1730

Registered

2011-08-17

Start date

2012-01-31

Completion date

2015-01-31

Last updated

2015-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Obesity

Keywords

Obesity, Cardiovascular Diseases Prevention, Paediatrics

Brief summary

AIM: To evaluate the effectiveness of two strategies in cardiovascular risk in children 2º grade in the community of Madrid. DESIGN: cluster-randomized trial with blinded evaluator SCOPE AND SUBJECTS OF STUDY: Children of both sexes enrolled in 2º grade in public schools in the community of Madrid. Rate exclusion criteria INTERVENTION: Schools were randomly assigned to two groups: an experimental group that the investigators organized a concert teaching focused on messages cardio, a second group or control group to which they will host a healthy breakfast as it has been offering the Community of Madrid . MEASUREMENTS: The primary end result is the increase of correct answers on a standardized test to be administered before and after the activity. Secondary outcomes will be, improving the same questionnaire at 6 months and reduced overall weight and center from before the intervention at 6 months of it.

Interventions

OTHERDidactic Concerts

The activity we are going to test consists in a communication and spreading strategy. The activity will take place in the auditorium of the school, scheduling 1 hour for concert, within the school hours, and having maximum 50 children per turn. Preparation of the auditorium for the activity 5 classic musical pieces and a story as a conducting thread. Children will be asked to clap and raise hands to participate in the mission of becoming a heart-savers: Ideal number of daily meals, Importance of daily breakfast for the activity, Time for breakfast, Basic components for a healthy breakfast, The role of cereals at breakfast, dairy products in breakfast, fruits at breakfast, Importance of exercise for cardiovascular health, The role of sedentary lifestyle. Students will be invited to take the playbill as a bookmark format and a cup is inscribed: I am a heart-saver, so that they take them home and serve as a reminder of the activity. A NAOS strategy pamphlet will also be delivered.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

7 Years to 9 Years

Healthy volunteers

Yes

Inclusion criteria

* 2º grade of primary school students present the day of the activity, whose parents had signed the informed consent to participate in the study and with no

Exclusion criteria

at the moment of the intervention

Design outcomes

Primary

Measure	Time frame	Description
Change in Knowledge and attitudes in Cardiovascular Health	Before the intervention (baseline) and 7 days after and 6 months after the intervention.	The primary outcome variable will be the changes in healthy heart knowledge and attitudes in children in 2º grade of primary school. We will measure this primary outcome variable using 2 modified INUTCAM questionnaires

Secondary

Measure	Time frame	Description
Body Mass Index (BMI)	before the intervention (baseline) and 6 months after them.	The secondary outcome variable will be BMI measured at the moment of the intervention and 6 months after it.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026