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Type 2 Diabetes Primary Prevention for At Risk Girls - Article


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School Health Index


Clinical Trial: Type 2 Diabetes Primary Prevention for At Risk Girls

This study is currently recruiting patients.

Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Purpose

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 Treatment or Intervention Phase
Obesity
Diabetes Mellitus
Prediabetic State
 Behavior: Nutrition Education
 Behavior: After-school dance class
Phase II
Phase III

MedlinePlus related topics:  Diabetes;   Obesity

Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Further Study Details: 

Expected Total Enrollment:  240

Study start: April 2003

Eligibility

Ages Eligible for Study:  7 Years   -   10 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

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.

Location and Contact Information

Erika Takada, MPH      650-724-7742    etakada@stanford.edu

California
      Stanford University School of Medicine, Palo Alto,  California,  94304,  United States; Recruiting
Thomas N Robinson, MD, MPH,  Principal Investigator
Joel D. Killen, PhD,  Sub-Investigator
Darrell M. Wilson, MD,  Sub-Investigator
William Haskell, PhD,  Sub-Investigator
Donna Matheson, PhD,  Sub-Investigator
Leslie Pruitt, PhD,  Sub-Investigator
Helena C. Kraemer, PhD,  Sub-Investigator

More Information

Study ID Numbers:  T2DPPG
Record last reviewed:  January 2005
Last Updated:  January 4, 2005
Record first received:  July 2, 2003
ClinicalTrials.gov Identifier:  NCT00063674
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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Page Updated: November 22, 2004
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