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NCT00061841 Clinical Trial

Medical College of Georgia FitKid Project

Healthy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00061841
Other study ID # FITKID (DK63391) (completed)
Secondary ID
Status Completed
Phase Phase 2
First received June 5, 2003
Last updated January 12, 2010

Study information
Verified date January 2010
Source National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 685
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 8 Years to 9 Years
Eligibility 3rd graders in schools chosen to participate.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Behavioral:
• exercise

Locations
Country Name City State
United States Medical College of Georgia Augusta Georgia

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

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