This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Understanding of Genetic Risk Information for Type 2 Diabetes

This study has been completed.
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Duke University Identifier:
First received: July 22, 2010
Last updated: December 12, 2012
Last verified: December 2012
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.

Condition Intervention
Diabetes Mellitus, Type 2 Behavioral: Receiving results via genetic counselor

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Implications of Health and Genetic Literacy for Genomic Medicine

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Accurate understanding of genetic risk information [ Time Frame: assessed at follow-up 1 week, 3 months and 6 months after receiving results ]

Secondary Outcome Measures:
  • Impact on behavior change [ Time Frame: assessed upon follow-up (3 mon, 6 mon) ]

Enrollment: 300
Study Start Date: July 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Receiving results via web-based program
participants will receive genetic risk results for Type 2 diabetes via a web-based program that they access on their own
Behavioral: Receiving results via genetic counselor
participants will receive genetic risk information for Type 2 diabetes from a board certified genetic counselor
Other Name: genetic counseling


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01186354

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27708
Sponsors and Collaborators
Duke University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Susanne B Haga, PhD Duke University Medical Center, Institute for Genome Sciences and Policy
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Duke University Identifier: NCT01186354     History of Changes
Other Study ID Numbers: Pro00021370
1R21HL096573-01A1 ( U.S. NIH Grant/Contract )
Study First Received: July 22, 2010
Last Updated: December 12, 2012

Keywords provided by Duke University:
Type 2 diabetes
health literacy
genetic literacy
genetic risk

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on September 19, 2017