- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00542113
Diabetes Virtual Trek: Obesity and Diabetes Prevention Through Science Enrichment (DvtENERGY)
November 5, 2014 updated by: Colorado State University
Diabetes Virtual Trek Prevention: Obesity and Diabetes Prevention Through Science Enrichment
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
1703
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Cortez, Colorado, United States, 81321
- Montezuma-Cortez School District
-
Fort Collins, Colorado, United States, 80524
- Putnam, Tavelli, Bennett and Dunn Elementary Schools
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 13 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Elementary school children in grade 2-6 in intervention or comparison classes/schools
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Parents of elementary school children in grades 2-6 participating in Program ENERGY -Intervention 1
|
11 - weekly or biweekly newsletters about diabetes and its prevention and family challenges sent home with children
6 - weekly or biweekly newsletters about diabetes and its prevention and family challenges sent home with children
|
|
Experimental: 2
Parents of elementary school children in grades 2-6 participating in Program ENERGY -Intervention 2
|
11 - weekly or biweekly newsletters about diabetes and its prevention and family challenges sent home with children
6 - weekly or biweekly newsletters about diabetes and its prevention and family challenges sent home with children
|
|
Sham Comparator: 3
Parents of elementary school children in grades 2-6 participating in Program ENERGY matched to the intervention groups
|
Children participating in Program ENERGY but no newsletters or family challenges sent home to parents
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Diabetes knowledge and prevention of parents of elementary school children
Time Frame: one-three school year(s)
|
one-three school year(s)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Self-reported parental physical activity
Time Frame: one -three school year(s)
|
one -three school year(s)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: L. Arthur Campfield, PhD, Colorado State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2001
Primary Completion (Actual)
June 1, 2008
Study Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
October 9, 2007
First Submitted That Met QC Criteria
October 9, 2007
First Posted (Estimate)
October 10, 2007
Study Record Updates
Last Update Posted (Estimate)
November 7, 2014
Last Update Submitted That Met QC Criteria
November 5, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H 00-301H R25 015646
- R25RR015646 (U.S. NIH Grant/Contract)
- R25RR020469 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.