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Middle-School Based Primary Prevention Trial of Type 2 Diabetes

NCT00458029 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4603

Last updated 2020-04-30

No results posted yet for this study

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 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.

Conditions

Interventions

BEHAVIORAL

integrated program of nutrition, activity, behavior, and promotion

implemented across 5 half-year periods: winter/spring 2007, fall 2007, winter/spring 2007, fall 2008, winter/spring 2008

Sponsors & Collaborators

  • George Washington University

    collaborator OTHER

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

    lead NIH

Principal Investigators

  • Gary D Foster, PhD · Temple University

  • Kathryn Hirst, PhD · George Washington University Biostatistics Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2009-06-30
Completion
2011-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00458029 on ClinicalTrials.gov