Obesity and Diabetes Prevention Through Science Enrichment

Obesity Clinical Trial

— DKENERGY  

Official title:

Type 2 Diabetes Knowledge: Obesity and Diabetes Prevention Through Science Enrichment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00541879
• Other study ID #: H 04-257 RR25 RR 020469
• Secondary ID: R 25 RR 020469R
• Status: Completed
• Phase: N/A
• First received: October 9, 2007
• Last updated: November 5, 2014
• Start date: August 2001
• Est. completion date: September 2011

Study information

• Verified date: November 2014
• Source: Colorado State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2909
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 13 Years

Eligibility

Inclusion Criteria:

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
United States	Putnam, Tavelli, Bennett and Dunn Elementary Schools	Fort Collins	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
Colorado State University	National Center for Research Resources (NCRR), Poudre School District, Fort Collins, CO

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diabetes knowledge and prevention behaviors in elementary school children		one-three school year(s)	No
Secondary	Parental diabetes knowledge, self-reported physical activity		one -three school year(s)	No

External Links

•   Program ENERGY website