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

This study will examine the impact of providing genetic CHD and T2D risk information, with or
without a supportive behavioral intervention, on promoting risk-reducing behaviors and
improving clinical outcomes. In short, using a 4-group (2X2) randomized controlled trial
(RCT) design, this study will determine whether incorporating multiple-marker genetic testing
into risk counseling for CHD and T2D, coupled with a health coaching intervention will lead
to greater changes in physical fitness, health behaviors, risk status and clinical outcomes
in active-duty Air Force (ADAF), beneficiaries or dependents and AF retiree patients (N=400).

The study will address the following task objectives:

1. Determine the main and interactive effects of multiple-marker genetic risk information
incorporated into standard CHD and T2D risk counseling (Standard Risk Assessment, or
SRA) and an established, structured telephonic health coaching intervention on health
behavior change (diet, exercise habits, smoking cessation) over 12 months, with a focus
on ADAF patients, as well as their beneficiaries and retirees.

2. Determine the main and interactive effects of genetic risk information incorporated into
standard CHD and T2D risk counseling and a telephonic health coaching intervention on
clinical outcomes (fasting blood glucose, blood pressure, BMI, LDL, triglycerides, total
cholesterol, AF composite fitness scores) over 12 months in this AF cohort.

Given the lack of RCTs on the effects of differing genetic test results, such as false
reassurance and genetic determinism, we will also pursue a third, exploratory task
objective:

3. Examine the differential effects of level of CHD and T2D genetic risk (# of risk
alleles) on behavior change (diet, exercise habits, smoking cessation) and AF fitness
scores at 12 months post baseline.

Baseline data collection: After screening and informed consent, height and weight, SBP, waist
circumference, current lab results (FPG, total cholesterol, triglycerides, LDL, HbA1c, and
HDL) and current PHA (physical health assessment) data with fitness scores ( for active duty
personnel only) will be obtained from the medical records. Subjects randomized to the two
genetic arms will have blood collected for testing of investigational CHD and T2D risk
markers.

Randomization will take place to one of the following: SRA only; SRA plus genetic risk
information (SRA+G); SRA plus health coaching (SRA+HC); or SRA, genetic risk information, and
health coaching (SRA+G+HC).

Risk Counseling Visit: Within four weeks after the baseline visit all participants will
receive risk counseling with trained provider(s) at each clinic site.

Health coaching intervention: Participants in the two groups that include health coaching
will be assigned to a trained health coach for a period of 6 months (n=200). IHC (Integrative
Health Coaching) sessions will be provided by telephone using a structure that has evolved in
multiple trials and clinical programs at Duke Integrative Medicine.

Six week, 3-, and 6-month follow-ups: At 6 weeks, 3 months and 6 months after the baseline
visit, participants will be asked to complete selected surveys online.

6month and 12 month study visits: 12 months from the baseline visit, active duty participants
will complete their annual PHA, required annual AF fitness testing; and all participants will
complete study visits at 6 and 12 months for weight, waist circumference, BP, fasting glucose
or HbA1c and lipid panels to be re-assessed. Surveys will be completed at or prior to the
final 12 month visit as well.

Inclusion Criteria:

- Age 18 to 65 years

- Willingness and ability to provide informed consent

- Have an active email address and internet access

- Physical exam in the last 12 months with the following documented evaluations in EMR
(Electronic Medical record):

1. Blood pressure

2. Height and weight

3. Fasting blood glucose or Hemoglobin A1C (HbA1c)

4. Lipid panel (TC, LDL, HDL, TRIG) with at least one of them outside of the normal
ranges defined as:

i.BMI ≥ 25 kg/m2 (BMI = weight [kg] / ht [m]2)

ii.FPG > 100 AND ≤ 125 mg/dL

iii.HbA1c > 5.7% ≤ 6.4%

iv.SBP ≥ 130 mmHg

v.TC ≥ 200 mg/dL

vi.TRIG ≥ 150 mg/dL

vii.LDL ≥ 129 mg/dL

Exclusion Criteria:

- Projected deployment in the upcoming 6 months

- Diagnosed type 2 diabetes

- Diagnosed coronary heart disease (CHD) -(Myocardial Infarction, or documented CHD)

- Inability to ambulate or participate in physical activity

- Serious chronic disease related complications or conditions that could significantly
affect study outcomes [currently treated cancer, renal failure, cardiovascular
accident (CVA) with residual effects on functioning

- Current participation in another research study

- Spouse, partner or other household member already participating in this study protocol