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Understanding of Genetic Risk Information for Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01186354
First received: July 22, 2010
Last updated: December 12, 2012
Last verified: December 2012
History of Changes
  Purpose

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: Open Label
Primary Purpose: Health Services Research
Official Title: Implications of Health and Genetic Literacy for Genomic Medicine

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Impact on behavior change [ Time Frame: assessed upon follow-up (3 mon, 6 mon) ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01186354

Locations
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)
Investigators
Principal Investigator: Susanne B Haga, PhD Duke University Medical Center, Institute for Genome Sciences and Policy
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided by Duke University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01186354     History of Changes
Other Study ID Numbers: Pro00021370, 1R21HL096573-01A1
Study First Received: July 22, 2010
Last Updated: December 12, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 22, 2013