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Middle-School Based Primary Prevention Trial of Type 2 Diabetes (HEALTHY)

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00458029
First received: April 5, 2007
Last updated: May 31, 2011
Last verified: May 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
 Behavioral: integrated program of nutrition, activity, behavior, and promotion
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Studies to Treat Or Prevent Pediatric Type 2 Diabetes (STOPP-T2D) Middle-School Based Primary Prevention Trial (HEALTHY)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Body mass index (BMI) >= 85th percentile, adjusted for gender and age [ Time Frame: baseline, end of 7th grade, end of study ] [ Designated as safety issue: No ]
  • Fasting glucose (mg/dL) [ Time Frame: baseline, end of study ] [ Designated as safety issue: No ]
  • Fasting insulin (mU/mL) [ Time Frame: baseline, end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lipids (total cholesterol, HDL, LDL, triglycerides) [ Time Frame: baseline, end of study ] [ Designated as safety issue: No ]
  • Other laboratory indicators of diabetes and obesity risk, such as HbA1c [ Time Frame: baseline, end of study ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: baseline, end of study ] [ Designated as safety issue: No ]
  • Waist circumference [ Time Frame: baseline, end of study ] [ Designated as safety issue: No ]
  • Physical activity [ Time Frame: baseline, end of study ] [ Designated as safety issue: No ]
  • Sedentary behavior [ Time Frame: baseline, end of study ] [ Designated as safety issue: No ]
  • Fitness [ Time Frame: baseline, end of study ] [ Designated as safety issue: No ]
  • Daily nutritional intake [ Time Frame: baseline, end of study ] [ Designated as safety issue: No ]
  • PE class activity level (MVPA by heart rate monitor) [ Time Frame: baseline, end of 7th grade, end of study ] [ Designated as safety issue: No ]
  • Quality-adjusted life years saved (QALYS) [ Time Frame: baseline, end of 7th grade, end of study ] [ Designated as safety issue: No ]
  • Total school food environment amounts and nutrients [ Time Frame: baseline, end of 7th grade, end of study ] [ Designated as safety issue: No ]
  • Grade and school level state standardized test score pass rates [ Time Frame: end of 6th, 7th, 8th grades ] [ Designated as safety issue: No ]
  • Grade and school level attendance rates [ Time Frame: end of 6th, 7th, 8th grades ] [ Designated as safety issue: No ]
  • Grade and school level comportment rates (i.e., referral to administrative offices for disciplinary action) [ Time Frame: end of 6th, 7th, 8th grades ] [ Designated as safety issue: No ]
  • Costs associated with intervention delivery and administration [ Time Frame: once per intervention semester (5 x) ] [ Designated as safety issue: No ]
  • Decisions, policies, and activities at the school, local, state, or federal level that influence the school environment for nutrition and physical activity [ Time Frame: once per year (3 x) ] [ Designated as safety issue: No ]

Enrollment: 4603
Study Start Date: August 2006
Study Completion Date: February 2011
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
integration of activities, events, and programs affecting total school food service environment, physical education class, behavior change, promotion, and communications
 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
No Intervention: 2
observational control

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   10 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00458029

Locations
United States, California
University of California at Irvine
Irvine, California, United States, 92868
United States, Maryland
George Washington University Biostatistics Center
Rockville, Maryland, United States, 20852
United States, North Carolina
University of North Carolina at Chapel Hill
Chapell Hill, North Carolina, United States, 27599
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19140
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
University of Texas Health Science Center
San Antonio, Texas, United States, 78210
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Gary D Foster, PhD Temple University
Principal Investigator: Kathryn Hirst, PhD George Washington University Biostatistics Center
  More Information

Additional Information:
public access to HEALTHY intervention program materials  This link exits the ClinicalTrials.gov site

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kathryn Hirst/Coordinating Center Principal Investigator, George Washington University Biostatistics Center
ClinicalTrials.gov Identifier: NCT00458029     History of Changes
Other Study ID Numbers: IND - DK61230-HEALTHY, DK61223, DK61231, DK61249
Study First Received: April 5, 2007
Last Updated: May 31, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
type 2 diabetes risk factors
obesity
prevention
adolescence
school based

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 13, 2013