title: Examining the impact of genetic testing for type 2 diabetes on health behaviors: study protocol for a randomized controlled trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier NCT01060540.
authors.affiliation: Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC, USA. corrine.voils@dm.duke.edu
authors.forename: Corrine I
authors.initials: CI
authors.lastname: Voils
authors.forename: Cynthia J
authors.initials: CJ
authors.lastname: Coffman
authors.forename: David
authors.initials: D
authors.lastname: Edelman
authors.forename: Matthew L
authors.initials: ML
authors.lastname: Maciejewski
authors.forename: Janet M
authors.initials: JM
authors.lastname: Grubber
authors.forename: Azita
authors.initials: A
authors.lastname: Sadeghpour
authors.forename: Alex
authors.initials: A
authors.lastname: Cho
authors.forename: Jamiyla
authors.initials: J
authors.lastname: McKenzie
authors.forename: Francoise
authors.initials: F
authors.lastname: Blanpain
authors.forename: Maren
authors.initials: M
authors.lastname: Scheuner
authors.forename: Margarete
authors.initials: M
authors.lastname: Sandelowski
authors.forename: M Patrick
authors.initials: MP
authors.lastname: Gallagher
authors.forename: Geoffrey S
authors.initials: GS
authors.lastname: Ginsburg
authors.forename: William S
authors.initials: WS
authors.lastname: Yancy
mesh_terms: D000328:Adult; D000368:Aged; D003924:Diabetes Mellitus, Type 2 / Q000175:diagnosis* / Q000235:genetics / Q000517:prevention & control / Q000523:psychology; D005260:Female; D005817:Genetic Counseling; D020022:Genetic Predisposition to Disease; D005820:Genetic Testing; D015438:Health Behavior; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008297:Male; D008875:Middle Aged; D009657:North Carolina; D018579:Patient Selection; D011237:Predictive Value of Tests; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D040242:Risk Reduction Behavior; D013997:Time Factors; D055815:Young Adult