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

This study has been completed.
Sponsor:
Collaborator:
Universidad Autonoma del Estado de Mexico
Information provided by:
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
ClinicalTrials.gov Identifier:
NCT00836446
First received: February 3, 2009
Last updated: March 10, 2009
Last verified: March 2009
  Purpose

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.


Condition Intervention
Obesity
Cardiovascular Disease
Other: physical activity

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effects of Physical Activity on Cardiovascular Risk Markers in School-Aged Mexican Children

Resource links provided by NLM:


Further study details as provided by Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes:

Primary Outcome Measures:
  • Evaluate the effect of physical activity routine on cardiovascular risk markers [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • measure heart rate to evaluate the intensity of physical activity routines [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 214
Study Start Date: August 2008
Study Completion Date: December 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1
20 min. physical activity routine
Other: physical activity
physical activity routines 5 times a weeks for 12 weeks.
Experimental: Group 2
40 min. aerobic physical activity routine
Other: physical activity
physical activity routines 5 times a weeks for 12 weeks.

  Eligibility

Ages Eligible for Study:   8 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00836446

Locations
Mexico
Universidad Autonoma del Estado de Mexico
Mexico, Toluca, Estado de Mexico, Mexico
Sponsors and Collaborators
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Universidad Autonoma del Estado de Mexico
Investigators
Study Chair: Otilia Perichart-Perera, M.S, RD Instituto Nacional de Perinatología Isidro Espionosa de los Reyes
Study Chair: Felipe Vadillo-Ortega, PhD Instituto Nacional de Perinatología Isidro Espionosa de los Reyes
Principal Investigator: Margie Balas-Nakash, B.S Instituto Nacional de Perinatología Isidro Espionosa de los Reyes
Study Director: Roxana Valdes-Ramos, D.Sc Universidad Autónoma del Estado de México. Facultad de Medicina
Study Chair: Alejandra D Benitez-Arciniega, M.Ph Universidad Autónoma del Estado de México. Facultad de Medicina
  More Information

No publications provided

Responsible Party: Margie Balas Nakash, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
ClinicalTrials.gov Identifier: NCT00836446     History of Changes
Other Study ID Numbers: 212250-02211
Study First Received: February 3, 2009
Last Updated: March 10, 2009
Health Authority: Mexico: Ministry of Health

Keywords provided by Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes:
school-aged
children
obesity
cardiovascular risk
physical activity

Additional relevant MeSH terms:
Cardiovascular Diseases
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014