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Completed

NCT Number: NCT01418872

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

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.

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Key information

Conditions

Obesity Body Weight Cardiovascular Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

7 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Agencia Lain Entralgo

Madrid, 28013, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • Students with food allergies or intolerances.
  • Students with severe hearing impairment (not corrected).
  • Students whose parents didn´t sign the informed consent to participate in the study.
  • Students with a poor understanding of oral and written language.
  • To have previously received healthy breakfasts interventions or educational concerts.

Treatment and study plan

Didactic Concerts

Other

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.

Primary outcomes

  1. Change in Knowledge and attitudes in Cardiovascular Health

    Time frame: 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 outcomes

  1. Body Mass Index (BMI)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Agencia Lain Entralgo

Other Gov

Collaborators

  • Comunidad de Madrid
  • Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
  • Gerencia de Atención Primaria, Madrid
  • Instituto de Salud Carlos III
  • Ministerio de Sanidad, Servicios Sociales e Igualdad

Registry information

Official study title

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

Acronym: SAVINHEARTS

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 17, 2011
Registry last updated
Jan 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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