Status:
COMPLETED
Genetic Risk and Health Coaching for Type 2 Diabetes and Coronary Heart Disease
Lead Sponsor:
Duke University
Collaborating Sponsors:
David Grant U.S. Air Force Medical Center
Conditions:
Coronary Heart Disease, Susceptibility to, 5
Prediabetic State
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 ...
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 ...
Eligibility Criteria
Inclusion
- 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):
- Blood pressure
- Height and weight
- Fasting blood glucose or Hemoglobin A1C (HbA1c)
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2017
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT01884545
Start Date
July 1 2013
End Date
February 1 2017
Last Update
April 24 2018
Active Locations (1)
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1
David Grant Medical Center
Fairfield, California, United States, 94535