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

Phase 4

Completed

• Conditions: Obesity; Cardiovascular Diseases

• Registration Number: NCT01418872
• Lead Sponsor: Agencia Lain Entralgo

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-12
• Study First Submitted QC: 2011-08-16
• Study First Posted: 2011-08-17
• Study Start: 2012-01
• Status Verified: 2015-01
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Last Update Submitted: 2015-01-13
• Last Update Posted: 2015-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1730

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Knowledge and attitudes in Cardiovascular Health	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 Outcome Measures

Name	Time	Method
Body Mass Index (BMI)	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.

Trial Locations

Locations (1)

Agencia Lain Entralgo; 🇪🇸 Madrid, Spain