Clinical Trials Directory

Trials / Completed

CompletedNCT00063674

Type 2 Diabetes Primary Prevention for At Risk Girls

Status
Completed
Phase
Phase 2 / Phase 3
Study type
Interventional
Enrollment
240 (estimated)
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
Sex
Female
Age
7 Years – 10 Years
Healthy volunteers
Accepted

Summary

Purpose: To evaluate two approaches to prevent obesity and type 2 diabetes in young girls. The Need: We are experiencing an epidemic of childhood obesity. Rates of obesity have doubled to tripled in the past two decades, with the highest rates among poor and ethnic minority girls. Type 2 diabetes (what used to be called adult-onset diabetes) is now showing up in overweight children, and more children are manifesting precursors of heart disease and stroke. Our Two Approaches: 1. A state-of-the-art nutrition education program with monthly newsletters mailed to girls and their parents and quarterly evening lectures/educational events at school sites, including cooking demonstrations and games to improve nutrition and increase physical activity. 2. After-school dance classes held five days per week all year long at school sites from the time school lets out until 6PM. Dance classes will include a 1-1.5 hour supervised homework study hall each day, and emphasize both traditional ethnic dances and popular dance. Participants: Second, third and fourth grade girls and their families will be eligible to participate. All activities are free of charge. To be able to perform a valid evaluation, to be able to accommodate all girls at their own school, and to be fair about which girls receive which program, families who wish to participate will be randomly selected to participate in either one program or the other (nutrition education or dance classes). Each family will participate for two years. Evaluation: Trained Stanford staff will perform all evaluation procedures with participating families in their own homes at the beginning and every six months. Families will be compensated for their participation.

Conditions

Interventions

TypeNameDescription
BEHAVIORALNutrition Education
BEHAVIORALAfter-school dance class

Timeline

Start date
2003-04-01
First posted
2003-07-03
Last updated
2010-01-13

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00063674. Inclusion in this directory is not an endorsement.