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

Not Applicable
Completed
Conditions
Coronary Heart Disease Risk
Registration Number
NCT01766271
Lead Sponsor
Duke University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
31
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,

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Primary Outcome Measures
NameTimeMethod
Diet6 months

National Cancer Institute (NCI) Multifactor Screener

Physical Activity6 months

Stanford Brief Activity Scale (SBAS)

Secondary Outcome Measures
NameTimeMethod
Fasting blood glucose6 months
Systolic blood pressure6 months
Body mass index6 months
Waist circumference6 months
Low Density Cholesterol (LDL)6 months
Triglyceride6 months
Total cholesterol6 months

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