Middle-School Based Primary Prevention Trial of Type 2 Diabetes

Completed · Not applicable

Conditions studied: Type 2 Diabetes

In brief

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 grade (fall 2006) and followed to end of 8th grade (spring 2009). Half of the schools were randomized to receive an intervention that integrated four components: the school nutrition environment, physical education class activities, behavior change initiatives, and educational and promotional communications activities.

Key facts

Study ID

NCT00458029

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

People needed

4603

Starts

2006-08-01

Expected to finish

2011-02-01

Last updated by the study team

2020-04-30

Who can join

Age: 10 and older, up to 16. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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 Criteria: (none specified)

Where it is running

• University of California at Irvine — Irvine, California, United States
• George Washington University Biostatistics Center — Rockville, Maryland, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Temple University — Philadelphia, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Baylor College of Medicine — Houston, Texas, United States
• University of Texas Health Science Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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