GENErating Behavior Change, An Integrative Health Coaching and Genetic Risk Testing Pilot

Study Overview
=================
Brief Summary
-----------------
The purpose of this 4 group (2x2) pilot randomized controlled trial is to test the feasibility and logistics of incorporating genetic risk information (9p21)into standard Coronary Heart Disease (CHD) risk counseling or health coaching intervention (or both) in primary care at 2 Duke Clinics.

Official Title
-----------------
GENErating Change, An Integrative Health Coaching and Genetic Risk Testing Pilot in Primary Care: A Multidisciplinary Approach to Personalized Medicine Targeting CHD Risk

Conditions
-----------------
Coronary Heart Disease Risk

Intervention / Treatment
-----------------
* Behavioral: Health Coaching
* Genetic: 9p21
* Other: Standard Risk Assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18+, presence of at least one of the following: FPG > 100, HbA1c > 5.7%, diabetic, LDL > 129, triglycerides > 150, total cholesterol > 200, SBP > 130, BMI > 25, able to speak and understand English, able and willing to give informed consent Exclusion Criteria: diagnosed CHD (MI or documented coronary artery disease), inability to ambulate or participate in physical activity, serious chronic disease related complications, current participation in a risk communication study for chronic disease,

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard Risk Assessment (SRA) Only<br> | Other: Standard Risk Assessment<br>* All 4 arms are assigned to receive standard assessment on coronary heart disease risk<br>|
| Experimental: SRA plus Health Coaching<br> | Behavioral: Health Coaching<br>* biweekly health coaching for 5 months<br>Other: Standard Risk Assessment<br>* All 4 arms are assigned to receive standard assessment on coronary heart disease risk<br>|
| Experimental: SRA plus Genetic Testing<br> | Genetic: 9p21<br>* Genetic testing results of 9p21<br>Other: Standard Risk Assessment<br>* All 4 arms are assigned to receive standard assessment on coronary heart disease risk<br>|
| Experimental: SRA plus Health Coaching plus Genetic Testing<br> | Behavioral: Health Coaching<br>* biweekly health coaching for 5 months<br>Genetic: 9p21<br>* Genetic testing results of 9p21<br>Other: Standard Risk Assessment<br>* All 4 arms are assigned to receive standard assessment on coronary heart disease risk<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diet | National Cancer Institute (NCI) Multifactor Screener | 6 months | 
| Physical Activity | Stanford Brief Activity Scale (SBAS) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting blood glucose |  | 6 months | 
| Systolic blood pressure |  | 6 months | 
| Body mass index |  | 6 months | 
| Waist circumference |  | 6 months | 
| Low Density Cholesterol (LDL) |  | 6 months | 
| Triglyceride |  | 6 months | 
| Total cholesterol |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary heart disease, cardiovascular disease, risk