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Effect of genetic testing for risk of type 2 diabetes mellitus on health behaviors and outcomes: study rationale, development and design.

Publication ,  Journal Article
Cho, AH; Killeya-Jones, LA; O'Daniel, JM; Kawamoto, K; Gallagher, P; Haga, S; Lucas, JE; Trujillo, GM; Joy, SV; Ginsburg, GS
Published in: BMC Health Serv Res
January 18, 2012

BACKGROUND: Type 2 diabetes is a prevalent chronic condition globally that results in extensive morbidity, decreased quality of life, and increased health services utilization. Lifestyle changes can prevent the development of diabetes, but require patient engagement. Genetic risk testing might represent a new tool to increase patients' motivation for lifestyle changes. Here we describe the rationale, development, and design of a randomized controlled trial (RCT) assessing the clinical and personal utility of incorporating type 2 diabetes genetic risk testing into comprehensive diabetes risk assessments performed in a primary care setting. METHODS/DESIGN: Patients are recruited in the laboratory waiting areas of two primary care clinics and enrolled into one of three study arms. Those interested in genetic risk testing are randomized to receive either a standard risk assessment (SRA) for type 2 diabetes incorporating conventional risk factors plus upfront disclosure of the results of genetic risk testing ("SRA+G" arm), or the SRA alone ("SRA" arm). Participants not interested in genetic risk testing will not receive the test, but will receive SRA (forming a third, "no-test" arm). Risk counseling is provided by clinic staff (not study staff external to the clinic). Fasting plasma glucose, insulin levels, body mass index (BMI), and waist circumference are measured at baseline and 12 months, as are patients' self-reported behavioral and emotional responses to diabetes risk information. Primary outcomes are changes in insulin resistance and BMI after 12 months; secondary outcomes include changes in diet patterns, physical activity, waist circumference, and perceived risk of developing diabetes. DISCUSSION: The utility, feasibility, and efficacy of providing patients with genetic risk information for common chronic diseases in primary care remain unknown. The study described here will help to establish whether providing type 2 diabetes genetic risk information in a primary care setting can help improve patients' clinical outcomes, risk perceptions, and/or their engagement in healthy behavior change. In addition, study design features such as the use of existing clinic personnel for risk counseling could inform the future development and implementation of care models for the use of individual genetic risk information in primary care. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00849563.

Duke Scholars

Published In

BMC Health Serv Res

DOI

EISSN

1472-6963

Publication Date

January 18, 2012

Volume

12

Start / End Page

16

Location

England

Related Subject Headings

  • Young Adult
  • Risk Factors
  • Risk Assessment
  • Research Design
  • Prospective Studies
  • Primary Health Care
  • Patient Education as Topic
  • Outcome Assessment, Health Care
  • Middle Aged
  • Humans
 

Citation

APA
Chicago
ICMJE
MLA
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Cho, A. H., Killeya-Jones, L. A., O’Daniel, J. M., Kawamoto, K., Gallagher, P., Haga, S., … Ginsburg, G. S. (2012). Effect of genetic testing for risk of type 2 diabetes mellitus on health behaviors and outcomes: study rationale, development and design. BMC Health Serv Res, 12, 16. https://doi.org/10.1186/1472-6963-12-16
Cho, Alex H., Ley A. Killeya-Jones, Julianne M. O’Daniel, Kensaku Kawamoto, Patrick Gallagher, Susanne Haga, Joseph E. Lucas, Gloria M. Trujillo, Scott V. Joy, and Geoffrey S. Ginsburg. “Effect of genetic testing for risk of type 2 diabetes mellitus on health behaviors and outcomes: study rationale, development and design.BMC Health Serv Res 12 (January 18, 2012): 16. https://doi.org/10.1186/1472-6963-12-16.
Cho AH, Killeya-Jones LA, O’Daniel JM, Kawamoto K, Gallagher P, Haga S, et al. Effect of genetic testing for risk of type 2 diabetes mellitus on health behaviors and outcomes: study rationale, development and design. BMC Health Serv Res. 2012 Jan 18;12:16.
Cho, Alex H., et al. “Effect of genetic testing for risk of type 2 diabetes mellitus on health behaviors and outcomes: study rationale, development and design.BMC Health Serv Res, vol. 12, Jan. 2012, p. 16. Pubmed, doi:10.1186/1472-6963-12-16.
Cho AH, Killeya-Jones LA, O’Daniel JM, Kawamoto K, Gallagher P, Haga S, Lucas JE, Trujillo GM, Joy SV, Ginsburg GS. Effect of genetic testing for risk of type 2 diabetes mellitus on health behaviors and outcomes: study rationale, development and design. BMC Health Serv Res. 2012 Jan 18;12:16.
Journal cover image

Published In

BMC Health Serv Res

DOI

EISSN

1472-6963

Publication Date

January 18, 2012

Volume

12

Start / End Page

16

Location

England

Related Subject Headings

  • Young Adult
  • Risk Factors
  • Risk Assessment
  • Research Design
  • Prospective Studies
  • Primary Health Care
  • Patient Education as Topic
  • Outcome Assessment, Health Care
  • Middle Aged
  • Humans