Coronary Heart Disease Risk
Conditions
Keywords
Coronary heart disease, cardiovascular disease, risk
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.
Interventions
BEHAVIORALHealth Coaching
biweekly health coaching for 5 months
GENETIC9p21
Genetic testing results of 9p21
All 4 arms are assigned to receive standard assessment on coronary heart disease risk
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diet | 6 months | National Cancer Institute (NCI) Multifactor Screener |
| Physical Activity | 6 months | Stanford Brief Activity Scale (SBAS) |
Secondary
| Measure | 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 |
Outcome results
None listed