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

January 13, 2015 updated by: Blanca Novella, Agencia Lain Entralgo

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1730

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28013
        • Agencia Lain Entralgo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years to 9 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Healthy Breakfast

The activity will be performed at the school dining hall, scheduling 1 hour for breakfast,within the school hours, with maximum 50 children per turn It involves placing a table mat, a cup, a plate and two slices of bread per child, plus 1-liter bottle of milk for each four children and 1-liter bottle of oil for each twelve. The dining hall will be all set up before the students come in.

Participatory lesson : 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, The role of dairy products at breakfast,The role of fruits at breakfast, Importance of exercise for cardiovascular health, The role of unhealthy habits: sedentary lifestyle.

The students will be invited to take the table mat and the cup, in which is inscribed: "I am a heart-saver", so that they take them home and serve as a reminder of the activity.

A pamphlet of the NAOS strategy will also be delivered.
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.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Before the intervention (baseline) and 7 days after and 6 months after the intervention.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
before the intervention (baseline) and 6 months after them.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Agencia Lain Entralgo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Instituto de Salud Carlos III
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Ministerio de Sanidad, Servicios Sociales e Igualdad
Comunidad de Madrid
Gerencia de Atención Primaria, Madrid

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Blanca Novella, PhD, SERMAS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1668-BK-148

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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