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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00542113
Other study ID # H 00-301H R25 015646
Secondary ID R25RR015646R25RR
Status Completed
Phase N/A
First received October 9, 2007
Last updated November 5, 2014
Start date September 2001
Est. completion date June 2008

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

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.


Description:

The study involved pre and post testing of parent's knowledge and behaviors relating to the prevention of type two diabetes, before and after a school based intervention designed to encourage school to home communication. Parents/Guardians and children, grades 2-6, from schools with high Hispanic enrollment during the 2001-2005 school year were used for both comparison and intervention groups.


Recruitment information / eligibility

Status Completed
Enrollment 1703
Est. completion date June 2008
Est. primary completion date June 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Years to 13 Years
Eligibility Inclusion Criteria:

- Elementary school children in grade 2-6 in 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


Intervention

Behavioral:
DvtProgram ENERGY
11 - weekly or biweekly newsletters about diabetes and its prevention and family challenges sent home with children
DvtProgram ENERGY
6 - weekly or biweekly newsletters about diabetes and its prevention and family challenges sent home with children
DvtProgramENERGY
Children participating in Program ENERGY but no newsletters or family challenges sent home to parents

Locations

Country Name City State
United States Montezuma-Cortez School District Cortez Colorado
United States Putnam, Tavelli, Bennett and Dunn Elementary Schools Fort Collins Colorado

Sponsors (3)

Lead Sponsor Collaborator
Colorado State University Montezuma-Cortez School District, Cortez, CO, 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 of parents of elementary school children one-three school year(s) No
Secondary Self-reported parental physical activity one -three school year(s) No
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