NCT00542113

Brief Summary

The purpose of this study was to evaluate the effectiveness of a school-to-home education program for it's ability to increase knowledge about, and ability to prevent type two diabetes in children and parents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,703

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Sep 2001

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

2 active sites

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

September 1, 2001

Completed
6.1 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
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

November 7, 2014

Status Verified

November 1, 2014

Enrollment Period

6.8 years

First QC Date

October 9, 2007

Last Update Submit

November 5, 2014

Conditions

Keywords

ParentalParentsPreventionEnergy balanceGlucose regulationHealthy lifestylesHealthy familiesActive living

Outcome Measures

Primary Outcomes (1)

  • Diabetes knowledge and prevention of parents of elementary school children

    one-three school year(s)

Secondary Outcomes (1)

  • Self-reported parental physical activity

    one -three school year(s)

Study Arms (3)

1

EXPERIMENTAL

Parents of elementary school children in grades 2-6 participating in Program ENERGY -Intervention 1

Behavioral: DvtProgram ENERGY

2

EXPERIMENTAL

Parents of elementary school children in grades 2-6 participating in Program ENERGY -Intervention 2

Behavioral: DvtProgram ENERGY

3

SHAM COMPARATOR

Parents of elementary school children in grades 2-6 participating in Program ENERGY matched to the intervention groups

Behavioral: DvtProgramENERGY

Interventions

11 - weekly or biweekly newsletters about diabetes and its prevention and family challenges sent home with children

2

Children participating in Program ENERGY but no newsletters or family challenges sent home to parents

3

Eligibility Criteria

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

You may qualify if:

  • Elementary school children in grade 2-6 in intervention or comparison classes/schools

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Montezuma-Cortez School District

Cortez, Colorado, 81321, United States

Location

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

September 1, 2001

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

November 7, 2014

Record last verified: 2014-11

Locations