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

Trials

William S Yancy⁶  Geoffrey S Ginsburg⁵  M Patrick Gallagher⁷  Margarete Sandelowski¹  Maren Scheuner⁴  Francoise Blanpain²  Jamiyla McKenzie⁷  Alex Cho⁵  Azita Sadeghpour⁷  Janet M Grubber⁷  Matthew L Maciejewski⁶  David Edelman⁶  Cynthia J Coffman⁸  Corrine I Voils³ 

[1] School of Nursing, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA;Clinical Molecular Diagnostics Laboratory, Duke University Medical Center, Durham, NC, USA;Veterans Affairs Medical Center (152), 508 Fulton St., Durham, NC, 27705, USA;Department of Medicine, David Geffen School of Medicine, Los Angeles, CA, USA;Institute for Genome Sciences & Policy, Duke University Medical Center, Durham, NC, USA;Department of Medicine, Duke University Medical Center, Durham, NC, USA;Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC, USA;Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, USA

关键词: Weight loss;    Type II diabetes;    Genetic testing;   

Others  :  1095439
DOI  :  10.1186/1745-6215-13-121

 received in 2012-03-23, accepted in 2012-07-18,  发布年份 2012

【 摘 要 】

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

【 授权许可】

   
2012 Voils et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

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