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NCT01186354 Clinical Trial

Understanding of Genetic Risk Information for Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
Implications of Health and Genetic Literacy for Genomic Medicine

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01186354
Other study ID # Pro00021370
Secondary ID 1R21HL096573-01A
Status Completed
Phase N/A
First received July 22, 2010
Last updated December 12, 2012
Start date July 2010
Est. completion date January 2012

Study information
Verified date December 2012
Source Duke University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This research study is being conducted to learn about how health and genetic literacy (i.e., how well a person understands health and genetic information) affects a person's ability to understand genetic risk information for Type 2 diabetes and whether that person chooses to change their lifestyle and health behaviors to reduce their risk. The investigators also want to learn if the manner in which the genetic risk information is communicated affects the level of understanding and potential behavior changes. Participants will be tested for genetic risk of developing Type 2 diabetes and will received results either via a web-based computer program, or in-person from a genetic counselor.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date January 2012
Est. primary completion date January 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Ages 18 or older

- Speak fluent English

- Have an email address and access to the internet

- Not diagnosed with type 2 diabetes

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Intervention

Behavioral:
• Receiving results via genetic counselor
participants will receive genetic risk information for Type 2 diabetes from a board certified genetic counselor

Locations
Country Name City State
United States Duke University Medical Center Durham North Carolina

Sponsors (2)
Lead Sponsor Collaborator
Duke University National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Accurate understanding of genetic risk information assessed at follow-up 1 week, 3 months and 6 months after receiving results No
Secondary Impact on behavior change assessed upon follow-up (3 mon, 6 mon) No
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