We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00458029
First Posted: April 9, 2007
Last Update Posted: June 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  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
Intervention Model: Parallel Assignment
Masking: None (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)

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 ]
  • Fasting glucose (mg/dL) [ Time Frame: baseline, end of study ]
  • Fasting insulin (mU/mL) [ Time Frame: baseline, end of study ]

Secondary Outcome Measures:
  • Lipids (total cholesterol, HDL, LDL, triglycerides) [ Time Frame: baseline, end of study ]
  • Other laboratory indicators of diabetes and obesity risk, such as HbA1c [ Time Frame: baseline, end of study ]
  • Blood pressure [ Time Frame: baseline, end of study ]
  • Waist circumference [ Time Frame: baseline, end of study ]
  • Physical activity [ Time Frame: baseline, end of study ]
  • Sedentary behavior [ Time Frame: baseline, end of study ]
  • Fitness [ Time Frame: baseline, end of study ]
  • Daily nutritional intake [ Time Frame: baseline, end of study ]
  • PE class activity level (MVPA by heart rate monitor) [ Time Frame: baseline, end of 7th grade, end of study ]
  • Quality-adjusted life years saved (QALYS) [ Time Frame: baseline, end of 7th grade, end of study ]
  • Total school food environment amounts and nutrients [ Time Frame: baseline, end of 7th grade, end of study ]
  • Grade and school level state standardized test score pass rates [ Time Frame: end of 6th, 7th, 8th grades ]
  • Grade and school level attendance rates [ Time Frame: end of 6th, 7th, 8th grades ]
  • Grade and school level comportment rates (i.e., referral to administrative offices for disciplinary action) [ Time Frame: end of 6th, 7th, 8th grades ]
  • Costs associated with intervention delivery and administration [ Time Frame: once per intervention semester (5 x) ]
  • 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) ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   10 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications:

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
First Submitted: April 5, 2007
First Posted: April 9, 2007
Last Update Posted: June 1, 2011
Last Verified: May 2011

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