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

NCT ID: NCT00836446

Last Updated: 2009-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2008-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Cardiovascular Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

20 min. physical activity routine

Group Type ACTIVE_COMPARATOR

physical activity

Intervention Type OTHER

physical activity routines 5 times a weeks for 12 weeks.

Group 2

40 min. aerobic physical activity routine

Group Type EXPERIMENTAL

physical activity

Intervention Type OTHER

physical activity routines 5 times a weeks for 12 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

physical activity

physical activity routines 5 times a weeks for 12 weeks.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidad Autonoma del Estado de Mexico

OTHER

Sponsor Role collaborator

Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Otilia Perichart-Perera, M.S, RD

Role: STUDY_CHAIR

Instituto Nacional de Perinatología Isidro Espionosa de los Reyes

Felipe Vadillo-Ortega, PhD

Role: STUDY_CHAIR

Instituto Nacional de Perinatología Isidro Espionosa de los Reyes

Margie Balas-Nakash, B.S

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Perinatología Isidro Espionosa de los Reyes

Roxana Valdes-Ramos, D.Sc

Role: STUDY_DIRECTOR

Universidad Autónoma del Estado de México. Facultad de Medicina

Alejandra D Benitez-Arciniega, M.Ph

Role: STUDY_CHAIR

Universidad Autónoma del Estado de México. Facultad de Medicina

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universidad Autonoma del Estado de Mexico

México, Toluca, Estado de Mexico, Mexico

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Mexico

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

212250-02211

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effects of an Active Break Program at Primary School
NCT05403996 ACTIVE_NOT_RECRUITING NA
Physical Activity Intervention
NCT07029685 NOT_YET_RECRUITING NA