Primary Prevention of Cardiovascular Diseases in Childhood and Adolescence: the Role of Physical Activity

Obesity Clinical Trial

Official title:

Outpatient Strategy of Primary Prevention of Cardiovascular Diseases in Childhood and Adolescence: the Role of Physical Activity

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01580319
• Other study ID #: 2994/01
• Status: Terminated
• Phase: N/A
• First received: June 30, 2011
• Last updated: May 7, 2012
• Start date: April 2009
• Est. completion date: December 2011

Study information

• Verified date: May 2012
• Source: Instituto de Cardiologia do Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

This research project is about a physical activity intervention in pediatric outpatients to try control and prevent heart diseases such as hypertension, obesity, high cholesterol.

Description:

Control Group: receive information about health lifestyle Interventional Group: receive a structured plan with exercises to do 3 times per week within 50 minutes.

It is a randomized clinical trial and population are children and adolescents.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: December 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

Inclusion Criteria:

• 6 to 17 years

• obesity

• high cholesterol

Exclusion Criteria:

• congenital heart diseases

• less than 6 or more than 17 years old

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• High Blood Pressure
• Hypercholesterolemia
• Hypertension
• Obesity
• Sedentary Lifestyle

Intervention

Other:
• physical exercise
150 minutes per week

Locations

Country	Name	City	State
Brazil	Instituto de Cardiologia / Fundação Universitária de Cardiologia	Porto Alegre	Rio Grande do Sul

Sponsors (2)

Lead Sponsor	Collaborator
Instituto de Cardiologia do Rio Grande do Sul	Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction on risk factors for a cardiovascular diseases (reduction on BMI, cholesterol, LDL, glucose, high-sensitivity C-reactive protein, blood pressure and/or increase on HDL)	These measurement (taken at end of study) are assessed for a external research (blind for randomization) to judge the individual outcome.	These measurement were taken at end of followup (27th week)	No