NCT01186354

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 23, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

December 17, 2012

Status Verified

December 1, 2012

Enrollment Period

1.5 years

First QC Date

July 22, 2010

Last Update Submit

December 12, 2012

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabeteshealth literacygenetic literacygenetic risk

Outcome Measures

Primary Outcomes (1)

  • Accurate understanding of genetic risk information

    assessed at follow-up 1 week, 3 months and 6 months after receiving results

Secondary Outcomes (1)

  • Impact on behavior change

    assessed upon follow-up (3 mon, 6 mon)

Study Arms (1)

Receiving results via web-based program

EXPERIMENTAL

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

Interventions

Receiving results via genetic counselorBEHAVIORAL

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

Also known as: genetic counseling
Receiving results via web-based program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 18 or older
  • Speak fluent English
  • Have an email address and access to the internet
  • Not diagnosed with type 2 diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27708, United States

Location

Related Publications (4)

  • 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.

    PMID: 24927802DERIVED

  • 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.

    PMID: 24577154DERIVED

  • 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.

    PMID: 23406207DERIVED

  • 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.

    PMID: 22302620DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Genetic Counseling

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Genetic ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Susanne B Haga, PhD

    Duke University Medical Center, Institute for Genome Sciences and Policy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2010

First Posted

August 23, 2010

Study Start

July 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

December 17, 2012

Record last verified: 2012-12

Locations

US(1)