Type 2 Diabetes Primary Prevention for At Risk Girls

StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Notable Phase: Phase 2/3 to Not applicable
    • Enrollment target: 240 to not stated
    • Study arms: 0 to 2
    • Collaborators expanded, about 2 words
    v9
  2. Re-verified, no change to tracked fieldsv8
  3. Minor Trial status: Active, Not Recruiting to Completedv7
  4. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v6
  5. 4 versions Re-verified since Jul 5, 2005, no change to tracked fieldsv2-v5
  6. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00063674
Lead Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators: Stanford University
Conditions
(from sponsor)
Obesity, Diabetes Mellitus, Pre Diabetes
Related terms Diabetes Mellitus, Glucose Intolerance, Health Education, Motor Activity, Obesity
Start Date
Updated on ClinicalTrials.gov