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ObesityPhase 4SAVINHEARTSNCT01418872

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

A Phase 4 study testing Didactic Concerts in people with Obesity and Cardiovascular Diseases, run by Agencia Lain Entralgo at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 7 to 9 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Cardiovascular Diseases
What is being tested?
Didactic Concerts
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,730 participants
Where
1 siteSpain
Study dates
Jan 2012to Jan 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 9 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Agencia Lain Entralgo

    Madrid, Madrid, 28013

Other trials in Spain

About this study

Official title: 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 .

Read more

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.

Being tested
Didactic Concerts
Keywords
Obesity, Cardiovascular Diseases Prevention, Paediatrics
Medical subject headings
Obesity, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Didactic ConcertsOther

    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 groups in NCT01418872
Study groupRoleWhat they receive
Healthy BreakfastActive comparatorThe 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.
Receives: Other: Didactic Concerts
Didactic concertsExperimentalThe 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.
Receives: Other: Didactic Concerts

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Before the intervention (baseline) and 7 days after and 6 months after the intervention.

Secondary outcomes (1)

  1. Body Mass Index (BMI)

    The secondary outcome variable will be BMI measured at the moment of the intervention and 6 months after it.

    Measured: before the intervention (baseline) and 6 months after them.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2011 (estimated)
  2. Study startJan 2012
  3. Primary completionJan 2015
  4. Study completionJan 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,730 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01418872
Sponsor's protocol ID
1668-BK-148
Acronym
SAVINHEARTS
Status last verified
Jan 2015
First submitted
12 Aug 2011
Last updated
14 Jan 2015
Results posted
No
Data monitoring committee
No

Publications

  • Sanchez-Gomez LM, Fernandez-Luque MJ, Ruiz-Diaz L, Sanchez-Alcalde R, Sierra-Garcia B, Mayayo-Vicente S, Ruiz-Lopez M, Loeches-Belinchon P, Lopez-Gonzalez J, Gonzalez-Gamarra A, Gallego-Arenas A, Cubillo-Serna A, Gil-Juberias G, Perez-Cayuela P, Canedo-Arguelles CA, Garcia-Pascual JN, Ruiz-Chercoles E, Suarez-Fernandez C, Garcia-Polo I, Abad-Perez D, Ballesteros-Arribas JM, Izquierdo-Martinez M, Salvador-Alcaide E, Arribas-Vela AB, Alonso-Perez JM, Veja-Piris L, Rodriguez-Salvanes F, Novella-Arribas B. A cluster-randomised clinical trial comparing two cardiovascular health education strategies in a child population: the Savinghearts project. BMC Public Health. 2012 Nov 23;12:1024. doi: 10.1186/1471-2458-12-1024.

    PubMed 23176593

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Didactic Concerts in people with Obesity and Cardiovascular Diseases, run by Agencia Lain Entralgo at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Knowledge and attitudes in Cardiovascular Health (time frame: Before the intervention (baseline) and 7 days after and 6 months after the intervention.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01418872, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2015.

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