NCT00541879

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,909

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Aug 2001

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 10, 2007

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

November 7, 2014

Status Verified

November 1, 2014

Enrollment Period

10.1 years

First QC Date

October 9, 2007

Last Update Submit

November 5, 2014

Conditions

Keywords

ChildhoodPreventionEnergy balanceGlucose regulationHealthy lifestyleHealthy eatingActive living

Outcome Measures

Primary Outcomes (1)

  • Diabetes knowledge and prevention behaviors in elementary school children

    one-three school year(s)

Secondary Outcomes (1)

  • Parental diabetes knowledge, self-reported physical activity

    one -three school year(s)

Study Arms (2)

I

EXPERIMENTAL

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

Behavioral: Program ENERGY

II

SHAM COMPARATOR

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

Other: comparison

Interventions

Program ENERGYBEHAVIORAL

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

I
II

Eligibility Criteria

Age6 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Putnam, Tavelli, Bennett and Dunn Elementary Schools

Fort Collins, Colorado, 80524, United States

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Obesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • L. Arthur Campfield, PhD

    Colorado State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2007

First Posted

October 10, 2007

Study Start

August 1, 2001

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

November 7, 2014

Record last verified: 2014-11

Locations