Clinical trial NCT00836446: Effects of Physical Activity on Cardiovascular Risk Markers in School-Aged Mexican Children
Official title: Effects of Physical Activity on Cardiovascular Risk Markers in School-Aged Mexican Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Cardiovascular Disease
Keywords: school-aged
children
obesity
cardiovascular risk
physical activity
Lead sponsor: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Sponsor class: OTHER_GOV
Collaborators: name: Universidad Autonoma del Estado de Mexico
First posted: 2009-02-04
Enrollment: 214
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Evaluate the effect of physical activity routine on cardiovascular risk markers
timeFrame: 3 months
Secondary outcomes:
measure: measure heart rate to evaluate the intensity of physical activity routines
timeFrame: 3 months
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Universidad Autonoma del Estado de Mexico
state: Toluca, Estado de Mexico
Study officials:
affiliation: Instituto Nacional de Perinatología Isidro Espionosa de los Reyes
name: Otilia Perichart-Perera, M.S, RD
role: STUDY_CHAIR
affiliation: Instituto Nacional de Perinatología Isidro Espionosa de los Reyes
name: Felipe Vadillo-Ortega, PhD
role: STUDY_CHAIR
affiliation: Instituto Nacional de Perinatología Isidro Espionosa de los Reyes
name: Margie Balas-Nakash, B.S
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Autónoma del Estado de México. Facultad de Medicina
name: Roxana Valdes-Ramos, D.Sc
role: STUDY_DIRECTOR
affiliation: Universidad Autónoma del Estado de México. Facultad de Medicina
name: Alejandra D Benitez-Arciniega, M.Ph
role: STUDY_CHAIR
References: