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

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  • Voils, Corrine I
    • Other Affiliation: Durham Veterans Affairs Medical Center
  • Coffman, Cynthia J
    • Other Affiliation: Durham Veterans Affairs Medical Center
  • Edelman, David
    • Other Affiliation: Durham Veterans Affairs Medical Center
  • Maciejewski, Matthew L
    • Other Affiliation: Durham Veterans Affairs Medical Center
  • Grubber, Janet M
    • Other Affiliation: Durham Veterans Affairs Medical Center
  • Sadeghpour, Azita
    • Other Affiliation: Durham Veterans Affairs Medical Center
  • Cho, Alex
    • Other Affiliation: Duke University Medical Center
  • McKenzie, Jamiyla
    • Other Affiliation: Durham Veterans Affairs Medical Center
  • Blanpain, Francoise
    • Other Affiliation: Duke University Medical Center
  • Scheuner, Maren
    • Other Affiliation: VA Greater Los Angeles Healthcare System
  • Sandelowski, Margarete
    • Affiliation: School of Nursing
  • Gallagher, M Patrick
    • Other Affiliation: Durham Veterans Affairs Medical Center
  • Ginsburg, Geoffrey S
    • Other Affiliation: Duke University Medical Center
  • Yancy, William S
    • Other Affiliation: Durham Veterans Affairs Medical Center
Abstract
  • Abstract 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/m2 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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Resource type
  • Article
Rights statement
  • In Copyright
Rights holder
  • Corrine I Voils et al.; licensee BioMed Central Ltd.
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Journal title
  • Trials
Journal volume
  • 13
Journal issue
  • 1
Page start
  • 121
Language
  • English
Is the article or chapter peer-reviewed?
  • Yes
ISSN
  • 1745-6215
Bibliographic citation
  • Trials. 2012 Aug 01;13(1):121
Publisher
  • BioMed Central Ltd
Access right
  • Open Access
Date uploaded
  • July 9, 2016

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