A Clinical Trial Of Two Educational Strategies In Cardiovascular Health In Child Population
NCT01418872 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1730
Last updated 2015-01-14
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.
Conditions
Interventions
- 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.
Sponsors & Collaborators
-
Gerencia de Atención Primaria, Madrid
collaborator OTHER_GOV -
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
collaborator OTHER -
Instituto de Salud Carlos III
collaborator OTHER_GOV -
Ministerio de Sanidad, Servicios Sociales e Igualdad
collaborator OTHER_GOV -
Comunidad de Madrid
collaborator OTHER -
Agencia Lain Entralgo
lead OTHER_GOV
Principal Investigators
-
Blanca Novella, PhD · SERMAS
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 7 Years
- Max Age
- 9 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-01-31
- Primary Completion
- 2015-01-31
- Completion
- 2015-01-31
Countries
- Spain
Study Locations
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