## Protocol Section
### Identification Module
**NCT ID:** NCT00541879

**Acronym:** DKENERGY

**Brief Title:** Obesity and Diabetes Prevention Through Science Enrichment

**Official Title:** Type 2 Diabetes Knowledge: Obesity and Diabetes Prevention Through Science Enrichment

#### Organization Study ID Info
**ID:** H 04-257 RR25 RR 020469
#### Organization
**Class:** OTHER
**Full Name:** Colorado State University
#### Secondary ID Infos
**ID:** R 25 RR 020469
**ID:** R 25 RR 015646
### Status Module
#### Completion Date
**Date:** 2011-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2014-11-07

**Type:** ESTIMATED

**Last Update Submit Date:** 2014-11-05

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2011-09

**Type:** ACTUAL

#### Start Date
**Date:** 2001-08

**Status Verified Date:** 2014-11

#### Study First Post Date
**Date:** 2007-10-10
**Type:** ESTIMATED
**Study First Submit Date:** 2007-10-09
**Study First Submit QC Date:** 2007-10-09
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Center for Research Resources (NCRR)

**Class:** UNKNOWN

**Name:** Poudre School District, Fort Collins, CO

#### Lead Sponsor

**Class:** OTHER

**Name:** Colorado State University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Type 2 Diabetes

- Obesity

**Keywords:**

- Childhood

- Prevention

- Energy balance

- Glucose regulation

- Healthy lifestyle

- Healthy eating

- Active living

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 2909

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Elementary school children -grades 2-6 participating in Program ENERGY

**Intervention Names:**

- Behavioral: Program ENERGY

**Label:** I

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Other: comparison

**Label:** II

**Type:** SHAM_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- I

**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

**Name:** Program ENERGY

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- II

**Name:** comparison

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** Diabetes knowledge and prevention behaviors in elementary school children

**Time Frame:** one-three school year(s)

#### Secondary Outcomes

**Measure:** Parental diabetes knowledge, self-reported physical activity

**Time Frame:** one -three school year(s)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

**Healthy Volunteers:** True

**Maximum Age:** 13 Years

**Minimum Age:** 6 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Fort Collins

**Country:** United States

**Facility:** Putnam, Tavelli, Bennett and Dunn Elementary Schools

**State:** Colorado

**Zip:** 80524

#### Overall Officials

**Official 1:**

**Affiliation:** Colorado State University

**Name:** L. Arthur Campfield, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### See Also Links

**Label:** Program ENERGY website

**URL:** http://www.ProgramENERGY.org

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000050177

- Term: Overweight

- ID: D000044343

- Term: Overnutrition

- ID: D000009748

- Term: Nutrition Disorders

- ID: D000001835

- Term: Body Weight

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes

- ID: M7119

- Name: Diabetes Mellitus, Type 2

- Relevance: HIGH

- As Found: Type 2 Diabetes

- ID: M12701

- Name: Obesity

- Relevance: HIGH

- As Found: Obesity

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M26186

- Name: Overweight

- Relevance: LOW

- As Found: Unknown

- ID: M25307

- Name: Overnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000009765

- Term: Obesity

- ID: D000003924

- Term: Diabetes Mellitus, Type 2

### Misc Info Module

- Version Holder: 2024-05-24
