Genetic Risk and Health Coaching for Type 2 Diabetes and Coronary Heart Disease

Summary

The purpose of this study is to examine whether the use of genetic test information and/or health coaching in patient risk counseling for heart disease and diabetes affect health behaviors and health outcomes in active-duty Air Force (ADAF), beneficiaries or dependents and Air Force retiree patients.

Total of 400 subjects will be enrolled. They will be randomly(like flipping a coin)assigned to 4 groups: 1)Standard risk assessment (SRA)only; 2)SRA plus genetic risk information (SRA+G); 3)SRA plus health coaching (SRA+HC); or 4)SRA, genetic risk information, and health coaching (SRA+G+HC). Subjects randomized to the two genetic arms will have blood collected for testing of investigational coronary heart disease (CHD) and type 2 diabetes (T2D) risk markers. Participants in the two groups that include health coaching will be assigned to a trained certified health coach for a period of 6 months. The duration of the study is 12 months with 3 in person visits (baseline, 6 months and 12 months) and completion of surveys at 6 weeks and 3 month time points.

Conditions

• Coronary Heart Disease, Susceptibility to, 5
• Prediabetic State

Interventions

BEHAVIORAL

Health coaching

Telephonic health coaching sessions with a trained certified health coach for a period of 6 months (total of 10 biweekly calls).

GENETIC

Genetic risk counseling

In addition to the SRA subjects will receive genetic risk counseling at the risk counseling visit with a clinic provider. Genetic test results for CHD (rs10757274) and T2D (rs7903146, rs1801282, rs5219) risk variants will be incorporated into the risk profile reviewed with subjects.

BEHAVIORAL

Standard risk assessment

Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject.

Sponsors & Collaborators

• David Grant U.S. Air Force Medical Center

  collaborator FED

• Duke University

  lead OTHER

Principal Investigators

• Allison Vorderstrasse, DNSc · Duke University, School of Nursing

• Ruth Wolever, PhD · Duke University, Duke Intergrative Medicina

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-07-31

Primary Completion

2017-02-01

Completion

2017-02-01

Countries

• United States

Study Locations