Effects of Physical Activity on Cardiovascular Risk Markers in School-Aged Mexican Children

Obesity Clinical Trial

Official title:

Effects of Physical Activity on Cardiovascular Risk Markers in School-Aged Mexican Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00836446
• Other study ID #: 212250-02211
• Status: Completed
• Phase: N/A
• First received: February 3, 2009
• Last updated: March 10, 2009
• Start date: August 2008
• Est. completion date: December 2008

Study information

• Verified date: March 2009
• Source: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Childhood obesity is a public health problem; in Mexican children a high prevalence of cardiovascular risk factors are present. Physical activity has been proposed as a strategy to reduce this risk. We conducted a pre-posttest intervention study of 214 school-aged Mexican children (4th to 6th grade), to assess the effects of two physical activity routines with different duration and intensity (40 minute aerobic routine vs. 20 minute routine) on cardiovascular risk markers. Physical activity routines were assigned randomly to two public schools in Toluca, Mexico (20 min: group 1 (n= 117), 40 min: group 2 (n=97)). The routines were implemented Monday through Friday for 12 weeks. Nutrition assessment was done before and after the intervention and included anthropometric measurements (weight, height, body mass index, waist circumference and body composition), blood pressure and biochemical analysis (triglycerides, total cholesterol LDL-cholesterol, HDL-Cholesterol, glucose and insulin). Heart rate was monitored 3 times during the intervention to evaluate the routine´s intensity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: December 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 13 Years

Eligibility

Inclusion Criteria:

• All children from 4th to 6th grade, from 2 public urban schools in Toluca, Estado de México

Exclusion Criteria:

• If they have a chronic disease

• If they can not do exercise

• If they have low body mass index (BMI less than 5th percentile).

• If they miss more than 20 sessions

• If they decide that they did not want to participate any more.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Obesity

Intervention

Other:
• physical activity
physical activity routines 5 times a weeks for 12 weeks.

Locations

Country	Name	City	State
Mexico	Universidad Autonoma del Estado de Mexico	Mexico	Toluca, Estado de Mexico

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes	Universidad Autonoma del Estado de Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the effect of physical activity routine on cardiovascular risk markers		3 months	No
Secondary	measure heart rate to evaluate the intensity of physical activity routines		3 months	No