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Obesity and Diabetes Prevention Through Science Enrichment (DKENERGY)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Colorado State University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
National Center for Research Resources (NCRR)
Poudre School District, Fort Collins, CO
Information provided by:
Colorado State University
ClinicalTrials.gov Identifier:
NCT00541879
First received: October 9, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  Purpose

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 Intervention
Type 2 Diabetes
Obesity
 Behavioral: Program ENERGY
Other: comparison

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Type 2 Diabetes Knowledge: Obesity and Diabetes Prevention Through Science Enrichment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Colorado State University:

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

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

Estimated Enrollment: 1000
Study Start Date: August 2001
Estimated Study Completion Date: September 2009
Arms Assigned Interventions
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
NONE

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.

  Eligibility

Ages Eligible for Study:   6 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Elementary school child in selected intervention or comparison classes/schools
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00541879

Contacts
Contact: L Arthur - Campfield, PhD 970-491-3482 campfield@cahs.colostate.edu
Contact: Francoise J Smith, MS 970-491-7889 fsmith@cahs.colostate.edu

Locations
United States, Colorado
Putnam, Tavelli, Bennett and Dunn Elementary Schools Recruiting
Fort Collins, Colorado, United States, 80524
Principal Investigator: L. Arthur - Campfield, PhD            
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
  More Information

Additional Information:
Program ENERGY website  This link exits the ClinicalTrials.gov site

No publications provided

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
Study First Received: October 9, 2007
Last Updated: October 9, 2007
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on June 17, 2013