Status:
COMPLETED
Middle-School Based Primary Prevention Trial of Type 2 Diabetes
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsors:
George Washington University
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
10-16 years
Phase:
NA
Brief Summary
HEALTHY was a primary prevention trial conducted in 42 middle schools at 7 locations across the US to impact risk factors for type 2 diabetes in adolescents. Students were recruited at start of 6th gr...
Detailed Description
In response to increases in incident cases of type 2 diabetes in American children and youth, NIDDK funded a multi-site primary prevention trial designed to moderate risk for type 2 diabetes in middle...
Eligibility Criteria
Inclusion
- Middle school student body is at least 50% minority (defined as African American, Hispanic/Latino, and/or Native American) and/or greater than 50% eligible for free or reduced lunch.
- Middle school annual school-wide attrition from all causes is \<= 25% (estimate determined from data provided by the school).
- Middle school expected cohort size at end of study is at least 50 per school determined by applying 50% anticipated enrollment rate and annual school-wide attrition rate over 3 years.
- Student able to participate in the school's standard PE program.
- Student's parent/guardian has provided informed consent for the child to participate in data collection and evaluation procedures.
- Student has provided informed assent to participate in data collection and evaluation procedures.
Exclusion
- (none specified)
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
4603 Patients enrolled
Trial Details
Trial ID
NCT00458029
Start Date
August 1 2006
End Date
February 1 2011
Last Update
April 30 2020
Active Locations (8)
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1
University of California at Irvine
Irvine, California, United States, 92868
2
George Washington University Biostatistics Center
Rockville, Maryland, United States, 20852
3
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
4
Oregon Health & Science University
Portland, Oregon, United States, 97239