Genetic Risk and Health Coaching for Type 2 Diabetes and Coronary Heart Disease
Condition: Coronary Heart Disease, Susceptibility to, 5; Prediabetic State
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Diabetes Mellitus, Type 2; Prediabetic State; Disease Susceptibility
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): Health coaching; Genetic risk counseling; Standard risk assessment
Intervention type(s): Behavioral; Genetic; Behavioral
Intervention description(s): Telephonic health coaching sessions with a trained certified health coach for a period of 6 months (total of 10 biweekly calls).; 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.; 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.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: heart disease; type 2 diabetes; genetic testing; health coaching; risk assessment