Diet, Exercise and Body Fat in 3-5 Year Olds | NCT00615641

Studies
Diet, Exercise and Body Fat in 3-5 Year Olds

NCT00615641

Sponsor

Arkansas Children's Hospital Research Institute

Status

Completed

Last Update Posted

Feb 17, 2010Estimated

Enrollment

65Estimated

Phase

Not provided

Conditions

Healthy

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

No data available

No data is available for this block.

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

ID	Type	Description	Link
CRIS # 6251-51000-005-03S

Status Module

Record Verification Date

Feb 2010

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

Jun 2007

Primary Completion Date

Sep 2009Actual

Completion Date

Sep 2009Actual

First Submitted Date

Feb 1, 2008

First Submission Date that Met QC Criteria

Feb 13, 2008

First Posted Date

Feb 14, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

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

Feb 12, 2010

Last Update Posted Date

Feb 17, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Arkansas Children's Hospital Research InstituteOTHER

Collaborators

Name	Class
University of Arkansas	OTHER
United States Department of Agriculture (USDA)	FED
Life Measurement Inc.	INDUSTRY
Texas Woman's University

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

To determine how practical and precise different body composition methods are for measuring body fat and lean tissue in young children and to determine if certain dietary factors and physical activity patterns are related to body fat in children.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

65Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		3 year old children
2		4 year old children
3		5 year old children

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

3-5 year old children
Full term at birth
English as primary language
Weighed at least 5.5# at birth
Parent or guardian is at least 18 years of age

Exclusion Criteria:

Child has any chronic condition, metabolic disorder, pulmonary disorder, bone disorder, condition that may affect growth, ADD or ADHD
Child on any medication thought to interfere with study parameters as determined by the investigator

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

5 Years

Standard Ages

Child

Study Population

We are seeking healthy 3-5 year old children in the greater Little Rock area.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tina Crook, M.S., R.D.	Arkansas Children's Nutrition Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arkansas Children's Nutrition Center		Little Rock	Arkansas	72202	United States

Condition Browse Module

MeSH Terms

ID	Term
D009043	Motor Activity
D063766	Pediatric Obesity

Ancestor Terms

ID	Term
D001519	Behavior
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748

Browse Leaves

Not provided

Browse Branches

Not provided