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Open Access 01-12-2012 | Study protocol

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

Authors: 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, William S Yancy Jr

Published in: Trials | Issue 1/2012

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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Title: Examining the impact of genetic testing for type 2 diabetes on health behaviors: study protocol for a randomized controlled trial
Authors: 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
William S Yancy Jr
Publication date: 01-12-2012
Publisher: BioMed Central
Published in: Trials / Issue 1/2012
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/1745-6215-13-121

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Background

Methods/Design

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods/Design

Discussion

Trial registration

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