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Type 2 Diabetes Primary Prevention for At Risk Girls

Type 2 Diabetes Primary Prevention for At Risk Girls

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00063674
Enrollment
Unknown
Registered
2003-07-03
Start date
2003-04-01
Completion date
Unknown
Last updated
2026-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Obesity, Pre Diabetes

Keywords

exercise, eating, dance, health education, obesity prevention, diabetes prevention, children

Brief 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.

Interventions

BEHAVIORALNutrition Education
BEHAVIORALAfter-school dance class

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Lead SponsorNIH
Stanford University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
7 Years to 10 Years
Healthy volunteers
Yes

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Body Mass Index (BMI)24 monthsChange 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

MeasureTime frameDescription
Change in Waist Circumference24 monthsChange in waist circumference measured in centimeters over the 24-month intervention period.
Change in Total Cholesterol24 monthsChange in fasting serum total cholesterol level over the 24-month intervention period.
Change in LDL Cholesterol Level24 monthsChange in fasting low-density lipoprotein (LDL) cholesterol level over the 24-month intervention period.
Change in HDL Cholesterol Level24 monthsChange in fasting high-density lipoprotein (HDL) cholesterol level over the 24-month intervention period.
Change in Fasting Glucose24 monthsChange in fasting serum glucose level over the 24-month intervention period.
Change in Fasting Insulin24 monthsChange in fasting serum insulin level over the 24-month intervention period.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORThomas N Robinson, MD, MPH

Stanford University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 15, 2026