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OpenTrials
Completed

NCT Number: NCT00063674

Type 2 Diabetes Primary Prevention for At Risk Girls

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Second-, third- and fourth-grade girls, aged 7-10 years of age enrolled in one of the participating schools will be eligible. Our goal is to be as inclusive as possible. However, girls will not be eligible to participate if they:

  • have been diagnosed with a chronic illness that affects their growth and/or weight (e.g., type 1 diabetes, hypothyroidism, inflammatory bowel disease)
  • are taking medications potentially affecting their growth and/or weight (e.g., methylphenidate HCl, systemic steroids)
  • have Asthma (not exclusionary alone) but have taken systemic steroids (oral, intravenous, or intramuscular) for a period of more than 21 days in the past year
  • have a condition that limits their participation in physical activity enough that they are not able to participate in Physical Education at school (e.g., significant structural heart disease)
  • are pregnant
  • are unable to complete the informed consent process.

Treatment and study plan

Nutrition Education

Behavioral

After-school dance class

Behavioral

Primary outcomes

  1. Change in Body Mass Index (BMI)

    Time frame: 24 months

    Change in body mass index (BMI) over the 2-year intervention period. BMI was calculated as weight in kilograms divided by height in meters squared.

Secondary outcomes

  1. Change in Waist Circumference

    Time frame: 24 months

    Change in waist circumference measured in centimeters over the 24-month intervention period.

  2. Change in Total Cholesterol

    Time frame: 24 months

    Change in fasting serum total cholesterol level over the 24-month intervention period.

  3. Change in LDL Cholesterol Level

    Time frame: 24 months

    Change in fasting low-density lipoprotein (LDL) cholesterol level over the 24-month intervention period.

  4. Change in HDL Cholesterol Level

    Time frame: 24 months

    Change in fasting high-density lipoprotein (HDL) cholesterol level over the 24-month intervention period.

  5. Change in Fasting Glucose

    Time frame: 24 months

    Change in fasting serum glucose level over the 24-month intervention period.

  6. Change in Fasting Insulin

    Time frame: 24 months

    Change in fasting serum insulin level over the 24-month intervention period.

Sponsors and collaborators

Lead sponsor

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

Nih

Collaborators

  • Stanford University

Registry information

Important dates

Study start
2003
First posted
Jul 3, 2003
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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