NCT00836446

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Aug 2008

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2009

Completed
Last Updated

March 11, 2009

Status Verified

March 1, 2009

Enrollment Period

3 months

First QC Date

February 3, 2009

Last Update Submit

March 10, 2009

Conditions

ObesityCardiovascular Disease

Keywords

school-agedchildrenobesitycardiovascular riskphysical activity

Outcome Measures

Primary Outcomes (1)

  • Evaluate the effect of physical activity routine on cardiovascular risk markers

    3 months

Secondary Outcomes (1)

  • measure heart rate to evaluate the intensity of physical activity routines

    3 months

Study Arms (2)

Group 1

ACTIVE COMPARATOR

20 min. physical activity routine

Other: physical activity

Group 2

EXPERIMENTAL

40 min. aerobic physical activity routine

Other: physical activity

Interventions

physical activityOTHER

physical activity routines 5 times a weeks for 12 weeks.

Group 1Group 2

Eligibility Criteria

Age8 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Autonoma del Estado de Mexico

México, Toluca, Estado de Mexico, Mexico

Location

MeSH Terms

Conditions

ObesityCardiovascular DiseasesMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • 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

    STUDY CHAIR

  • Margie Balas-Nakash, B.S

    Instituto Nacional de Perinatología Isidro Espionosa de los Reyes

    PRINCIPAL INVESTIGATOR

  • Roxana Valdes-Ramos, D.Sc

    Universidad Autónoma del Estado de México. Facultad de Medicina

    STUDY DIRECTOR

  • Alejandra D Benitez-Arciniega, M.Ph

    Universidad Autónoma del Estado de México. Facultad de Medicina

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

February 3, 2009

First Posted

February 4, 2009

Study Start

August 1, 2008

Primary Completion

November 1, 2008

Study Completion

December 1, 2008

Last Updated

March 11, 2009

Record last verified: 2009-03

Locations

ME(1)