Type 2 Diabetes Primary Prevention for At Risk Girls

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00063674
Recruitment Status : Completed
First Posted : July 3, 2003
Last Update Posted : January 13, 2010
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.

Condition or disease Intervention/treatment Phase
Obesity Diabetes Mellitus Prediabetic State Behavioral: Nutrition Education Behavioral: After-school dance class Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Study Start Date : April 2003

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Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 10 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00063674

United States, California
Stanford University School of Medicine
Palo Alto, California, United States, 94304
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Identifier: NCT00063674     History of Changes
Other Study ID Numbers: T2DPPG (completed)
First Posted: July 3, 2003    Key Record Dates
Last Update Posted: January 13, 2010
Last Verified: January 2010

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
health education
obesity prevention
diabetes prevention

Additional relevant MeSH terms:
Diabetes Mellitus
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases