• Corrine I Voils, Cynthia J Coffman, David Edelman, Matthew L Maciejewski, Janet M Grubber, Azita Sadeghpour, Alex Cho, Jamiyla McKenzie, Francoise Blanpain, Maren Scheuner, Margarete Sandelowski, M Patrick Gallagher, Geoffrey S Ginsburg, and William S Yancy.
• Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC, USA. corrine.voils@dm.duke.edu
• Trials. 2012 Jan 1; 13: 121.

BackgroundWe 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/DesignEligible 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.DiscussionA 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 RegistrationClinicalTrials.gov Identifier NCT01060540.

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