Childhood ObesityNCT00267631
Impact of Body Weight on the Immediate Health of the Pediatric Population
An observational study of Childhood Obesity, run by Antonios Likourezos at 1 site in United States.
Trial summary
Objective: Obesity amongst children is a public health issue in the United States and is rising at an alarming rate. The purpose of this study is to determine if there is any correlation between At Risk body weight (overweight and obese) and immediate health of the pediatric population. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- How many people
- 5,392 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Mar 2007
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Pediatric Emergency Medicine Patients
Inclusion Criteria:Age 2-18 yrs for whom a length and weight is possible -
Exclusion Criteria:Under 2 yrs or over 18 yrs of age or inability to weigh and measure pt
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Childhood Obesity on Presentation to a Pediatric Emergency Department
Objective: Obesity amongst children is a public health issue in the United States and is rising at an alarming rate. The purpose of this study is to determine if there is any correlation between At Risk body weight (overweight and obese) and immediate health of the pediatric population.
Methodology: As part of routine patient care, we measured length in addition to weight of patients 2 years to 18 years of age presenting to the pediatric emergency department. A report was run monthly to calculate the BMI of all patients for whom data is available. The data were plotted on the year 2000 gender based BMI for age percentile growth charts from CDC. A retrospective electronic chart review was conducted for patients At Risk body weight (BMI ≥ 85%), and were compared to "control" or healthy (BMI of 25 - 75 %) group for six groups of final ED diagnoses of infectious diseases.
Read the detailed description
- Background and Significance:
Obesity is a public health issue in the United States. Obesity amongst children is rising at an alarming rate. Thirty percent of US children aged 6 to 19 are over weight and 15 % are obese1. It is estimated that over 18 million US children are over weight. The long-term impact of childhood obesity on such diseases as Diabetes, Asthmaand Hypertension, is well studied. The effects of childhood obesity on the current health status of the pediatric population have not been studied.
- Methodology:
As part of routine patient care, we measured length in addition to weight of patients 2 years to 18 years of age presenting to the pediatric emergency department. A report was run monthly to calculate the BMI of all patients for whom data is available. The data were plotted on the year 2000 gender based BMI for age percentile growth charts from CDC. A retrospective electronic chart review was conducted for patients At Risk body weight (BMI ≥ 85%), and were compared to "control" or healthy (BMI of 25 - 75 %) group for six groups of final ED diagnoses of infectious disease (ID). Data were entered and analyzed via SPSS 14.0 for Windows 2000 software systems.
- Conditions
- Childhood Obesity
- Keywords
- children, obesity, emergency medicine
- Medical subject headings
- Pediatric Obesity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| At Risk Body Weight | Children with a BMI greater and equal to 85% | |
| Normal Body Weight | Children with a BMI of 25 to 75% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of Infectious Disease
The Children visiting the ED having an infectious disease
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2005 (estimated)
- Study startApr 2005
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Childhood 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,392 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antonios Likourezos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Antonios Likourezos, Maimonides Medical Center
- Investigators
- Estevan Garcia, MD, Principal investigator, Maimonides Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00267631
- Sponsor's protocol ID
- 05-02-VA10
- Status last verified
- Jul 2013
- First submitted
- 19 Dec 2005
- Last updated
- 12 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Childhood Obesity on Presentation to a Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT00267631
- Acronym / sponsor ID
- 05-02-VA10
- Conditions
- Childhood Obesity
- Keywords
- children, obesity, emergency medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,392 participants (actual)
- Lead sponsor
- Antonios LikourezosUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 21 Dec 2005 (estimated)
- Results
- Posted 18 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: Obesity amongst children is a public health issue in the United States and is rising at an alarming rate. The purpose of this study is to determine if there is any correlation between At Risk body weight (overweight and obese) and immediate health of the pediatric population.
Methodology: As part of routine patient care, we measured length in addition to weight of patients 2 years to 18 years of age presenting to the pediatric emergency department. A report was run monthly to calculate the BMI of all patients for whom data is available. The data were plotted on the year 2000 gender based BMI for age percentile growth charts from CDC. A retrospective electronic chart review was conducted for patients At Risk body weight (BMI ≥ 85%), and were compared to "control" or healthy (BMI of 25 - 75 %) group for six groups of final ED diagnoses of infectious diseases.
Detailed description
- Background and Significance:
Obesity is a public health issue in the United States. Obesity amongst children is rising at an alarming rate. Thirty percent of US children aged 6 to 19 are over weight and 15 % are obese1. It is estimated that over 18 million US children are over weight. The long-term impact of childhood obesity on such diseases as Diabetes, Asthmaand Hypertension, is well studied. The effects of childhood obesity on the current health status of the pediatric population have not been studied.
- Methodology:
As part of routine patient care, we measured length in addition to weight of patients 2 years to 18 years of age presenting to the pediatric emergency department. A report was run monthly to calculate the BMI of all patients for whom data is available. The data were plotted on the year 2000 gender based BMI for age percentile growth charts from CDC. A retrospective electronic chart review was conducted for patients At Risk body weight (BMI ≥ 85%), and were compared to "control" or healthy (BMI of 25 - 75 %) group for six groups of final ED diagnoses of infectious disease (ID). Data were entered and analyzed via SPSS 14.0 for Windows 2000 software systems.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| At Risk Body Weight | – | –Children with a BMI greater and equal to 85% |
| Normal Body Weight | – | –Children with a BMI of 25 to 75% |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Pediatric Emergency Medicine Patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnosis of Infectious Disease
Time frame: 30 minutes
The Children visiting the ED having an infectious disease
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Estevan Garcia, MD principal investigator
Maimonides Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Obesity, run by Antonios Likourezos at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 12 Aug 2013. 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 United States. 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?
Yes. Results are posted in the registry (first posted 18 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Diagnosis of Infectious Disease (time frame: 30 minutes). 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 12 Aug 2013.