Genetic Risk and Health Coaching for Type 2 Diabetes and Coronary Heart Disease
Completed · Not applicable
Conditions studied: Coronary Heart Disease, Susceptibility to, 5, Prediabetic State
In brief
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.
Key facts
- Study ID
- NCT01884545
- Run by
- Duke University
- People needed
- 220
- Starts
- 2013-07-01
- Expected to finish
- 2017-02-01
- Last updated by the study team
- 2018-04-24
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- David Grant Medical Center — Fairfield, California, United States
Full record on ClinicalTrials.gov
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