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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00836446
First Posted: February 4, 2009
Last Update Posted: March 11, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Universidad Autonoma del Estado de Mexico
Information provided by:
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
  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: None (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 ]

Secondary Outcome Measures:
  • measure heart rate to evaluate the intensity of physical activity routines [ Time Frame: 3 months ]

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

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Ages Eligible for Study:   8 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: February 3, 2009
First Posted: February 4, 2009
Last Update Posted: March 11, 2009
Last Verified: March 2009

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