ObesityNCT00836446
Effects of Physical Activity on Cardiovascular Risk Markers in School-Aged Mexican Children
A study testing physical activity in people with Obesity and Cardiovascular Disease, run by Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Obesity, Cardiovascular Disease
- What is being tested?
- physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteMexico
- Study dates
- Aug 2008to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All children from 4th to 6th grade, from 2 public urban schools in Toluca, Estado de México
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Universidad Autonoma del Estado de Mexico
México, Toluca, Estado de Mexico
About this study
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.
- Conditions
- Obesity, Cardiovascular Disease
- Being tested
- physical activity
- Keywords
- school-aged, children, obesity, cardiovascular risk, physical activity
- Medical subject headings
- Obesity, Cardiovascular Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical activityOther
physical activity routines 5 times a weeks for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | 20 min. physical activity routine Receives: Other: physical activity |
| Group 2 | Experimental | 40 min. aerobic physical activity routine Receives: Other: physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effect of physical activity routine on cardiovascular risk markers
Measured: 3 months
Secondary outcomes (1)
measure heart rate to evaluate the intensity of physical activity routines
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startAug 2008
- Primary completionNov 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
- Sponsor type
- Other government
- Collaborators
- Universidad Autonoma del Estado de Mexico
- Investigators
- Otilia Perichart-Perera, M.S, RD, Study chair, Instituto Nacional de Perinatología Isidro Espionosa de los ReyesFelipe Vadillo-Ortega, PhD, Study chair, Instituto Nacional de Perinatología Isidro Espionosa de los ReyesMargie Balas-Nakash, B.S, Principal investigator, Instituto Nacional de Perinatología Isidro Espionosa de los ReyesRoxana Valdes-Ramos, D.Sc, Study director, Universidad Autónoma del Estado de México. Facultad de MedicinaAlejandra D Benitez-Arciniega, M.Ph, Study chair, Universidad Autónoma del Estado de México. Facultad de Medicina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00836446
- Sponsor's protocol ID
- 212250-02211
- Status last verified
- Mar 2009
- First submitted
- 3 Feb 2009
- Last updated
- 11 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical Activity on Cardiovascular Risk Markers in School-Aged Mexican Children
- ClinicalTrials.gov ID
- NCT00836446
- Acronym / sponsor ID
- 212250-02211
- Conditions
- Obesity, Cardiovascular Disease
- Keywords
- school-aged, children, obesity, cardiovascular risk, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Instituto Nacional de Perinatologia Isidro Espinosa de los ReyesOther government
- Collaborators
- Universidad Autonoma del Estado de Mexico
- Study start
- Aug 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 4 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: physical activity20 min. physical activity routine |
| Group 2 | Experimental | Other: physical activity40 min. aerobic physical activity routine |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children from 4th to 6th grade, from 2 public urban schools in Toluca, Estado de México
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical activityphysical activity routines 5 times a weeks for 12 weeks. | Other | Group 1, Group 2 |
Primary outcome
Evaluate the effect of physical activity routine on cardiovascular risk markers
Time frame: 3 months
1 secondary outcome
measure heart rate to evaluate the intensity of physical activity routines
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Otilia Perichart-Perera, M.S, RD study chair
Instituto Nacional de Perinatología Isidro Espionosa de los Reyes
Felipe Vadillo-Ortega, PhD study chair
Instituto Nacional de Perinatología Isidro Espionosa de los Reyes
Margie Balas-Nakash, B.S principal investigator
Instituto Nacional de Perinatología Isidro Espionosa de los Reyes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical activity in people with Obesity and Cardiovascular Disease, run by Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effect of physical activity routine on cardiovascular risk markers (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2009.