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Obesity and Diabetes Prevention Through Science Enrichment (DKENERGY)

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.
 
ClinicalTrials.gov Identifier: NCT00541879
Recruitment Status : Completed
First Posted : October 10, 2007
Last Update Posted : November 7, 2014
Sponsor:
Collaborators:
National Center for Research Resources (NCRR)
Poudre School District, Fort Collins, CO
Information provided by (Responsible Party):
Colorado State University

Tracking Information
First Submitted Date  ICMJE October 9, 2007
First Posted Date  ICMJE October 10, 2007
Last Update Posted Date November 7, 2014
Study Start Date  ICMJE August 2001
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2007)
Diabetes knowledge and prevention behaviors in elementary school children [ Time Frame: one-three school year(s) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2007)
Parental diabetes knowledge, self-reported physical activity [ Time Frame: one -three school year(s) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Obesity and Diabetes Prevention Through Science Enrichment
Official Title  ICMJE Type 2 Diabetes Knowledge: Obesity and Diabetes Prevention Through Science Enrichment
Brief Summary Type 2 diabetes and obesity in children continue to increase at alarming rates with devastating results. However, both these metabolic diseases are largely preventable through adoption of a healthy lifestyle, an understanding of what happens to food in the body, energy balance and some simple aspects of glucose regulation. Can elementary school children be taught the knowledge and skills necessary to prevent type 2 diabetes and obesity? Children need to learn this essential knowledge and practice these important health behavior skills. Elementary school may be an ideal place to master this subject that is a direct and logical extension of current health curricula including nutrition and physical activity blended with science and math.
Detailed Description Biomedical scientists lead a classroom series of interactive, inquiry-based science and health explorations directed at type 2 diabetes, obesity and their prevention in three elementary schools serving children at high risk for type 2 diabetes. Diabetes knowledge was measured in children and parents at the beginning, end and 9 months after the end of the intervention using validated questionnaires.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Type 2 Diabetes
  • Obesity
Intervention  ICMJE
  • Behavioral: Program ENERGY
    Weekly or biweekly classroom and gym based science enrichment focused on how the body works including blood glucose regulation, healthy eating and physical activity, diabetes abd how it can be prevented
  • Other: comparison
Study Arms  ICMJE
  • Experimental: I
    Elementary school children -grades 2-6 participating in Program ENERGY
    Intervention: Behavioral: Program ENERGY
  • Sham Comparator: II
    Elementary school children in grades 2-6 matched to the intervention classes not receiving any intervention
    Intervention: Other: comparison
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 5, 2014)
2909
Original Estimated Enrollment  ICMJE
 (submitted: October 9, 2007)
1000
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Elementary school child in selected intervention or comparison classes/schools
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 13 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00541879
Other Study ID Numbers  ICMJE H 04-257 RR25 RR 020469
R 25 RR 020469
R 25 RR 015646
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Colorado State University
Study Sponsor  ICMJE Colorado State University
Collaborators  ICMJE
  • National Center for Research Resources (NCRR)
  • Poudre School District, Fort Collins, CO
Investigators  ICMJE
Principal Investigator: L. Arthur Campfield, PhD Colorado State University
PRS Account Colorado State University
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP