NCT00267631

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5,392

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2005

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

April 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
6.4 years until next milestone

Results Posted

Study results publicly available

July 18, 2013

Completed
Last Updated

August 12, 2013

Status Verified

July 1, 2013

Enrollment Period

1.9 years

First QC Date

December 19, 2005

Results QC Date

February 27, 2013

Last Update Submit

July 29, 2013

Conditions

Keywords

children, obesity, emergency medicine

Outcome Measures

Primary Outcomes (1)

  • Diagnosis of Infectious Disease

    The Children visiting the ED having an infectious disease

    30 minutes

Study Arms (2)

At Risk Body Weight

Children with a BMI greater and equal to 85%

Normal Body Weight

Children with a BMI of 25 to 75%

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric Emergency Medicine Patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

MeSH Terms

Conditions

Pediatric ObesityObesity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Dr. Estevan Garcia, MD; Principal Investigator
Organization
Maimonides Medical Center

Study Officials

  • Estevan Garcia, MD

    Maimonides Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Manager

Study Record Dates

First Submitted

December 19, 2005

First Posted

December 21, 2005

Study Start

April 1, 2005

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

August 12, 2013

Results First Posted

July 18, 2013

Record last verified: 2013-07

Locations