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| Tracking Information | |
|---|---|
| First Received Date ICMJE | July 2, 2003 |
| Last Updated Date | August 21, 2008 |
| Start Date ICMJE | April 2003 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00063674 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Type 2 Diabetes Primary Prevention for At Risk Girls |
| Official Title ICMJE | |
| 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:
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. |
| Detailed Description | |
| Study Phase | Phase II, Phase III |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Estimated Enrollment ICMJE | 240 |
| Completion Date | |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | 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:
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| Gender | Female |
| Ages | 7 Years to 10 Years |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00063674 |
| Responsible Party | |
| Study ID Numbers ICMJE | T2DPPG |
| Study Sponsor ICMJE | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Verification Date | August 2008 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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