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/DESIGN: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. 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.

journal_name

Trials

journal_title

Trials

authors

Voils CI,Coffman CJ,Edelman D,Maciejewski ML,Grubber JM,Sadeghpour A,Cho A,McKenzie J,Blanpain F,Scheuner M,Sandelowski M,Gallagher MP,Ginsburg GS,Yancy WS Jr

doi

10.1186/1745-6215-13-121

subject

Has Abstract

pub_date

2012-08-01 00:00:00

pages

121

issn

1745-6215

pii

1745-6215-13-121

journal_volume

13

pub_type

杂志文章,随机对照试验

相关文献

Trials文献大全