Impact of Body Weight on the Immediate Health of the Pedi... | NCT00267631

Studies
Impact of Body Weight on the Immediate Health of the Pediatric Population

NCT00267631

Sponsor

Antonios Likourezos

Status

Completed

Last Update Posted

Aug 12, 2013Estimated

Enrollment

5,392Actual

Phase

Not provided

Conditions

Childhood Obesity

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

Participant Flow Module

Pre-assignment Details

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2005

Primary Completion Date

Mar 2007Actual

Completion Date

Mar 2007Actual

First Submitted Date

Dec 19, 2005

First Submission Date that Met QC Criteria

Dec 19, 2005

First Posted Date

Dec 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Feb 27, 2013

Results First Submitted that Met QC Criteria

Apr 23, 2013

Results First Posted Date

Jul 18, 2013Estimated

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2013

Last Update Posted Date

Aug 12, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Antonios Likourezos, Research Manager, Maimonides Medical CenterSponsor-Investigator

Lead Sponsor

Antonios LikourezosOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

A. 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.

B. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,392Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
At Risk Body Weight		Children with a BMI greater and equal to 85%
Normal Body Weight		Children with a BMI of 25 to 75%

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnosis of Infectious Disease	The Children visiting the ED having an infectious disease	30 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Pediatric Emergency Medicine Patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Estevan Garcia, MD	Maimonides Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maimonides Medical Center		Brooklyn	New York	11219	United States

Arm/Group Information

ID	Title	Description
FG000	At Risk Body Weight	Children with BMI greater and equal to 85%
FG001	NOrmal Body Weight	Children with BMI of 25-75%

Baseline Characteristics Module

Baseline Analysis Population Description

Not provided

Type of Units Analyzed

Not provided

Arm/Group Information

ID	Title	Description
BG000	At Risk Body Weight	Children with BMI greater adn equal to 85%
BG001	Normal Body Weight	Children with a BMI of 25 to 75%

Denominators

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Diagnosis of Infectious Disease

The Children visiting the ED having an infectious disease

Posted

Number

Participants

30 minutes

ID	Title	Description
OG000	At Risk Body Weight	Children with BMI greater and equal to 85%
OG001	Normal Body Weight	Children with BMI of 25-75%

Units	Counts
Participants

Adverse Events Module

Frequency Threshold

Time Frame

Not provided

Description

Not provided

All-Cause Mortality Comment

Not provided

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	At Risk Body Weight	Children with a BMI greater and equal to 85%

Serious Adverse Events

Not provided

Other Adverse Events

Not provided

More Info Module

Limitations and Caveats

Not provided

Certain Agreements

Are all PI(s) employees of the sponsor?

Restriction Type

Point of Contact

Title	Organization	Phone	Extension	Email
Dr. Estevan Garcia, MD; Principal Investigator	Maimonides Medical Center	718-283-6352		EsGarcia@maimonidesmed.org

Condition Browse Module

MeSH Terms

ID	Term
D063766	Pediatric Obesity
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided