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

Obesity Clinical Trial

— SAVINHEARTS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01418872
• Other study ID #: 1668-BK-148
• Status: Completed
• Phase: Phase 4
• First received: August 12, 2011
• Last updated: January 13, 2015
• Start date: January 2012
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: Agencia Lain Entralgo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1730
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 9 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Obesity

Intervention

Other:
• Didactic 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.

Locations

Country	Name	City	State
Spain	Agencia Lain Entralgo	Madrid

Sponsors (6)

Lead Sponsor	Collaborator
Agencia Lain Entralgo	Comunidad de Madrid, Gerencia de Atención Primaria, Madrid, Hospital Universitario de la Princesa, Instituto de Salud Carlos III, Ministerio de Sanidad, Servicios Sociales e Igualdad

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Knowledge and attitudes in Cardiovascular Health	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	Before the intervention (baseline) and 7 days after and 6 months after the intervention.	No
Secondary	Body Mass Index (BMI)	The secondary outcome variable will be BMI measured at the moment of the intervention and 6 months after it.	before the intervention (baseline) and 6 months after them.	No