Medical College of Georgia FitKid Project | NCT00061841

Studies
Medical College of Georgia FitKid Project

NCT00061841

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Status

Completed

Last Update Posted

Jan 13, 2010Estimated

Enrollment

685Estimated

Phase

Phase 2

Conditions

Healthy

Interventions

exercise

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

Status Module

Record Verification Date

Jan 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

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 5, 2003

First Submission Date that Met QC Criteria

Jun 5, 2003

First Posted Date

Jun 6, 2003Estimated

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

Jan 12, 2010

Last Update Posted Date

Jan 13, 2010Estimated

Description Module

Brief Summary

This project will determine whether exposing youths to a "fitogenic" after-school environment that emphasizes vigorous exercise and healthy snacks will have a favorable effect on body composition (i.e., less fat tissue and more lean tissue), cardiovascular fitness and cardiovascular disease risk profile. The environmental intervention will be provided in nine schools in Augusta, Georgia, with another nine schools serving as non-intervention comparison schools. Children in the 3rd grade will be recruited to participate. They will be followed for 3 years, through the 5th grade. Measurements will be made at the beginning and end of each school year. The 2-hour after-school intervention will be offered every school day. It will consist of three components: (1) homework assistance; (2) a healthy snack; and (3) exercise designed to improve skills and fitness.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

685Estimated

Name	Type	Description	Arm Group Labels	Other Names
exercise	Behavioral

Eligibility Module

Eligibility Criteria

3rd graders in schools chosen to participate.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

9 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Medical College of Georgia		Augusta	Georgia	30912	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22799482	Derived	Yin Z, Moore JB, Johnson MH, Vernon MM, Gutin B. The impact of a 3-year after-school obesity prevention program in elementary school children. Child Obes. 2012 Feb;8(1):60-70. doi: 10.1089/chi.2011.0085.

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena