Effect of genetic testing for risk of type 2 diabetes mellitus on health behaviors and outcomes: study rationale, development and design.

Cho, Alex H

Killeya-Jones, Ley A

O'Daniel, Julianne M

Kawamoto, Kensaku

Gallagher, Patrick

Haga, Susanne

Lucas, Joseph E

Trujillo, Gloria M

Joy, Scott V

Ginsburg, Geoffrey S

England

2017-02-01T14:31:59Z

2012-01-18

BACKGROUND: Type 2 diabetes is a prevalent chronic condition globally that results in extensive morbidity, decreased quality of life, and increased health services utilization. Lifestyle changes can prevent the development of diabetes, but require patient engagement. Genetic risk testing might represent a new tool to increase patients' motivation for lifestyle changes. Here we describe the rationale, development, and design of a randomized controlled trial (RCT) assessing the clinical and personal utility of incorporating type 2 diabetes genetic risk testing into comprehensive diabetes risk assessments performed in a primary care setting. METHODS/DESIGN: Patients are recruited in the laboratory waiting areas of two primary care clinics and enrolled into one of three study arms. Those interested in genetic risk testing are randomized to receive either a standard risk assessment (SRA) for type 2 diabetes incorporating conventional risk factors plus upfront disclosure of the results of genetic risk testing ("SRA+G" arm), or the SRA alone ("SRA" arm). Participants not interested in genetic risk testing will not receive the test, but will receive SRA (forming a third, "no-test" arm). Risk counseling is provided by clinic staff (not study staff external to the clinic). Fasting plasma glucose, insulin levels, body mass index (BMI), and waist circumference are measured at baseline and 12 months, as are patients' self-reported behavioral and emotional responses to diabetes risk information. Primary outcomes are changes in insulin resistance and BMI after 12 months; secondary outcomes include changes in diet patterns, physical activity, waist circumference, and perceived risk of developing diabetes. DISCUSSION: The utility, feasibility, and efficacy of providing patients with genetic risk information for common chronic diseases in primary care remain unknown. The study described here will help to establish whether providing type 2 diabetes genetic risk information in a primary care setting can help improve patients' clinical outcomes, risk perceptions, and/or their engagement in healthy behavior change. In addition, study design features such as the use of existing clinic personnel for risk counseling could inform the future development and implementation of care models for the use of individual genetic risk information in primary care. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00849563.

http://www.ncbi.nlm.nih.gov/pubmed/22257365

1472-6963-12-16

1472-6963

https://hdl.handle.net/10161/13545

eng

Springer Science and Business Media LLC

BMC Health Serv Res

10.1186/1472-6963-12-16

Adolescent

Adult

Aged

Aged, 80 and over

Attitude to Health

Diabetes Mellitus, Type 2

Genetic Predisposition to Disease

Genetic Testing

Health Behavior

Humans

Middle Aged

Outcome Assessment (Health Care)

Patient Education as Topic

Primary Health Care

Prospective Studies

Research Design

Risk Assessment

Risk Factors

Young Adult

Effect of genetic testing for risk of type 2 diabetes mellitus on health behaviors and outcomes: study rationale, development and design.

Journal article

Haga, Susanne|0000-0001-8817-7406

Ginsburg, Geoffrey S|0000-0003-4739-9808

http://www.ncbi.nlm.nih.gov/pubmed/22257365

16

Basic Science Departments

Biomedical Engineering

Biostatistics & Bioinformatics

Clinical Science Departments

Community and Family Medicine

Community and Family Medicine, Family Medicine

Duke

Duke Cancer Institute

Duke Science & Society

Global Health Institute

Initiatives

Institutes and Centers

Institutes and Provost's Academic Units

Medicine

Medicine, Cardiology

Medicine, General Internal Medicine

Pathology

Pratt School of Engineering

Sanford School of Public Policy

Sanford School of Public Policy - Secondary Group

School of Medicine

School of Nursing

School of Nursing - Secondary Group

Social Science Research Institute

University Institutes and Centers

Published online

12