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Understanding of Genetic Risk Information for Type 2 Diabetes

NCT ID: NCT01186354

Last Updated: 2012-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Keywords

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Type 2 diabetes health literacy genetic literacy genetic risk

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Receiving results via genetic counselor

Intervention Type BEHAVIORAL

participants will receive genetic risk information for Type 2 diabetes from a board certified genetic counselor

Interventions

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Receiving results via genetic counselor

participants will receive genetic risk information for Type 2 diabetes from a board certified genetic counselor

Intervention Type BEHAVIORAL

Other Intervention Names

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genetic counseling

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susanne B Haga, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University Medical Center, Institute for Genome Sciences and Policy

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 24927802 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24577154 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23406207 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22302620 (View on PubMed)

Other Identifiers

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1R21HL096573-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00021370

Identifier Type: -

Identifier Source: org_study_id