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Obesity and Diabetes Prevention Through Science Enrichment (DKENERGY)

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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

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Obesity Behavioral: Program ENERGY Other: comparison Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 2909 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Type 2 Diabetes Knowledge: Obesity and Diabetes Prevention Through Science Enrichment
Study Start Date : August 2001
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: I
Elementary school children -grades 2-6 participating in Program ENERGY
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
Sham Comparator: II
Elementary school children in grades 2-6 matched to the intervention classes not receiving any intervention
Other: comparison



Primary Outcome Measures :
  1. Diabetes knowledge and prevention behaviors in elementary school children [ Time Frame: one-three school year(s) ]

Secondary Outcome Measures :
  1. Parental diabetes knowledge, self-reported physical activity [ Time Frame: one -three school year(s) ]


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Ages Eligible for Study:   6 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Elementary school child in selected intervention or comparison classes/schools

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): NCT00541879


Locations
United States, Colorado
Putnam, Tavelli, Bennett and Dunn Elementary Schools
Fort Collins, Colorado, United States, 80524
Sponsors and Collaborators
Colorado State University
National Center for Research Resources (NCRR)
Poudre School District, Fort Collins, CO
Investigators
Principal Investigator: L. Arthur Campfield, PhD Colorado State University

Additional Information:
Responsible Party: Colorado State University
ClinicalTrials.gov Identifier: NCT00541879     History of Changes
Other Study ID Numbers: H 04-257 RR25 RR 020469
R 25 RR 020469
R 25 RR 015646
First Posted: October 10, 2007    Key Record Dates
Last Update Posted: November 7, 2014
Last Verified: November 2014

Keywords provided by Colorado State University:
Childhood
Prevention
Energy balance
Glucose regulation
Healthy lifestyle
Healthy eating
Active living

Additional relevant MeSH terms:
Diabetes Mellitus
Obesity
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms