Back to resultsUnderstanding of Genetic Risk Information for Type 2 Diabetes
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Receiving results via genetic counselor
Sponsored by
About this trial
This is an interventional health services research trial for Diabetes Mellitus, Type 2 focused on measuring Type 2 diabetes, health literacy, genetic literacy, genetic risk
Eligibility Criteria
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:
-
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Receiving results via web-based program
Arm Description
participants will receive genetic risk results for Type 2 diabetes via a web-based program that they access on their own
Outcomes
Primary Outcome Measures
Accurate understanding of genetic risk information
Secondary Outcome Measures
Impact on behavior change
Full Information
NCT ID
NCT01186354
First Posted
July 22, 2010
Last Updated
December 12, 2012
Sponsor
Duke University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT01186354
Brief Title
Understanding of Genetic Risk Information for Type 2 Diabetes
Official Title
Implications of Health and Genetic Literacy for Genomic Medicine
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Type 2 diabetes, health literacy, genetic literacy, genetic risk
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Receiving results via web-based program
Arm Type
Experimental
Arm Description
participants will receive genetic risk results for Type 2 diabetes via a web-based program that they access on their own
Intervention Type
Behavioral
Intervention Name(s)
Receiving results via genetic counselor
Other Intervention Name(s)
genetic counseling
Intervention Description
participants will receive genetic risk information for Type 2 diabetes from a board certified genetic counselor
Primary Outcome Measure Information:
Title
Accurate understanding of genetic risk information
Time Frame
assessed at follow-up 1 week, 3 months and 6 months after receiving results
Secondary Outcome Measure Information:
Title
Impact on behavior change
Time Frame
assessed upon follow-up (3 mon, 6 mon)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanne B Haga, PhD
Organizational Affiliation
Duke University Medical Center, Institute for Genome Sciences and Policy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27708
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24927802
Citation
Mills R, Powell J, Barry W, Haga SB. Information-seeking and sharing behavior following genomic testing for diabetes risk. J Genet Couns. 2015 Feb;24(1):58-66. doi: 10.1007/s10897-014-9736-1. Epub 2014 Jun 14.
Results Reference
derived
PubMed Identifier
24577154
Citation
Haga SB, Barry WT, Mills R, Svetkey L, Suchindran S, Willard HF, Ginsburg GS. Impact of delivery models on understanding genomic risk for type 2 diabetes. Public Health Genomics. 2014;17(2):95-104. doi: 10.1159/000358413. Epub 2014 Feb 27.
Results Reference
derived
PubMed Identifier
23406207
Citation
Haga SB, Barry WT, Mills R, Ginsburg GS, Svetkey L, Sullivan J, Willard HF. Public knowledge of and attitudes toward genetics and genetic testing. Genet Test Mol Biomarkers. 2013 Apr;17(4):327-35. doi: 10.1089/gtmb.2012.0350. Epub 2013 Feb 13.
Results Reference
derived
PubMed Identifier
22302620
Citation
Waxler JL, O'Brien KE, Delahanty LM, Meigs JB, Florez JC, Park ER, Pober BR, Grant RW. Genetic counseling as a tool for type 2 diabetes prevention: a genetic counseling framework for common polygenetic disorders. J Genet Couns. 2012 Oct;21(5):684-91. doi: 10.1007/s10897-012-9486-x.
Results Reference
derived
Links:
URL
http://www.genome.duke.edu/
Description
Related Info
Learn more about this trial
Understanding of Genetic Risk Information for Type 2 Diabetes
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