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Examining the impact of genetic testing for type 2 diabetes on health behaviors: study protocol for a randomized controlled trial.

Publication ,  Journal Article
Voils, CI; Coffman, CJ; Edelman, D; Maciejewski, ML; Grubber, JM; Sadeghpour, A; Cho, A; McKenzie, J; Blanpain, F; Scheuner, M; Sandelowski, M ...
Published in: Trials
August 1, 2012

BACKGROUND: We describe the study design, procedures, and development of the risk counseling protocol used in a randomized controlled trial to evaluate the impact of genetic testing for diabetes mellitus (DM) on psychological, health behavior, and clinical outcomes. METHODS/DESIGN: Eligible patients are aged 21 to 65 years with body mass index (BMI) ≥27 kg/m(2) and no prior diagnosis of DM. At baseline, conventional DM risk factors are assessed, and blood is drawn for possible genetic testing. Participants are randomized to receive conventional risk counseling for DM with eye disease counseling or with genetic test results. The counseling protocol was pilot tested to identify an acceptable graphical format for conveying risk estimates and match the length of the eye disease to genetic counseling. Risk estimates are presented with a vertical bar graph denoting risk level with colors and descriptors. After receiving either genetic counseling regarding risk for DM or control counseling on eye disease, brief lifestyle counseling for prevention of DM is provided to all participants. DISCUSSION: A standardized risk counseling protocol is being used in a randomized trial of 600 participants. Results of this trial will inform policy about whether risk counseling should include genetic counseling. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT01060540.

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Published In

Trials

DOI

EISSN

1745-6215

Publication Date

August 1, 2012

Volume

13

Start / End Page

121

Location

England

Related Subject Headings

  • Young Adult
  • Time Factors
  • Risk Reduction Behavior
  • Risk Factors
  • Risk Assessment
  • Research Design
  • Predictive Value of Tests
  • Patient Selection
  • North Carolina
  • Middle Aged
 

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Voils, C. I., Coffman, C. J., Edelman, D., Maciejewski, M. L., Grubber, J. M., Sadeghpour, A., … Yancy, W. S. (2012). Examining the impact of genetic testing for type 2 diabetes on health behaviors: study protocol for a randomized controlled trial. Trials, 13, 121. https://doi.org/10.1186/1745-6215-13-121
Voils, Corrine I., Cynthia J. Coffman, David Edelman, Matthew L. Maciejewski, Janet M. Grubber, Azita Sadeghpour, Alex Cho, et al. “Examining the impact of genetic testing for type 2 diabetes on health behaviors: study protocol for a randomized controlled trial.Trials 13 (August 1, 2012): 121. https://doi.org/10.1186/1745-6215-13-121.
Voils CI, Coffman CJ, Edelman D, Maciejewski ML, Grubber JM, Sadeghpour A, et al. Examining the impact of genetic testing for type 2 diabetes on health behaviors: study protocol for a randomized controlled trial. Trials. 2012 Aug 1;13:121.
Voils, Corrine I., et al. “Examining the impact of genetic testing for type 2 diabetes on health behaviors: study protocol for a randomized controlled trial.Trials, vol. 13, Aug. 2012, p. 121. Pubmed, doi:10.1186/1745-6215-13-121.
Voils CI, Coffman CJ, Edelman D, Maciejewski ML, Grubber JM, Sadeghpour A, Cho A, McKenzie J, Blanpain F, Scheuner M, Sandelowski M, Gallagher MP, Ginsburg GS, Yancy WS. Examining the impact of genetic testing for type 2 diabetes on health behaviors: study protocol for a randomized controlled trial. Trials. 2012 Aug 1;13:121.
Journal cover image

Published In

Trials

DOI

EISSN

1745-6215

Publication Date

August 1, 2012

Volume

13

Start / End Page

121

Location

England

Related Subject Headings

  • Young Adult
  • Time Factors
  • Risk Reduction Behavior
  • Risk Factors
  • Risk Assessment
  • Research Design
  • Predictive Value of Tests
  • Patient Selection
  • North Carolina
  • Middle Aged