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Obesity and Diabetes Prevention Through Science Enrichment (DKENERGY)

Primary Purpose

Type 2 Diabetes, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Program ENERGY
comparison
Sponsored by
Colorado State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes focused on measuring Childhood, Prevention, Energy balance, Glucose regulation, Healthy lifestyle, Healthy eating, Active living

Eligibility Criteria

6 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Sites / Locations

  • Putnam, Tavelli, Bennett and Dunn Elementary Schools

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

I

II

Arm Description

Elementary school children -grades 2-6 participating in Program ENERGY

Elementary school children in grades 2-6 matched to the intervention classes not receiving any intervention

Outcomes

Primary Outcome Measures

Diabetes knowledge and prevention behaviors in elementary school children

Secondary Outcome Measures

Parental diabetes knowledge, self-reported physical activity

Full Information

First Posted
October 9, 2007
Last Updated
November 5, 2014
Sponsor
Colorado State University
Collaborators
National Center for Research Resources (NCRR), Poudre School District, Fort Collins, CO
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1. Study Identification

Unique Protocol Identification Number
NCT00541879
Brief Title
Obesity and Diabetes Prevention Through Science Enrichment
Acronym
DKENERGY
Official Title
Type 2 Diabetes Knowledge: Obesity and Diabetes Prevention Through Science Enrichment
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Colorado State University
Collaborators
National Center for Research Resources (NCRR), Poudre School District, Fort Collins, CO

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Obesity
Keywords
Childhood, Prevention, Energy balance, Glucose regulation, Healthy lifestyle, Healthy eating, Active living

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2909 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Experimental
Arm Description
Elementary school children -grades 2-6 participating in Program ENERGY
Arm Title
II
Arm Type
Sham Comparator
Arm Description
Elementary school children in grades 2-6 matched to the intervention classes not receiving any intervention
Intervention Type
Behavioral
Intervention Name(s)
Program ENERGY
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
comparison
Primary Outcome Measure Information:
Title
Diabetes knowledge and prevention behaviors in elementary school children
Time Frame
one-three school year(s)
Secondary Outcome Measure Information:
Title
Parental diabetes knowledge, self-reported physical activity
Time Frame
one -three school year(s)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Elementary school child in selected intervention or comparison classes/schools
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
L. Arthur Campfield, PhD
Organizational Affiliation
Colorado State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Putnam, Tavelli, Bennett and Dunn Elementary Schools
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80524
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.ProgramENERGY.org
Description
Program ENERGY website

Learn more about this trial

Obesity and Diabetes Prevention Through Science Enrichment

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