N/A
N=200
Genetic Risk and Health Coaching for Type 2 Diabetes and Coronary Heart Disease
Coronary Heart Disease, Susceptibility to, 5 · Prediabetic State
Bottom Line
View on ClinicalTrials.gov: NCT01884545 ↗Enrolled (actual)
200
Serious AEs
0.5%
Results posted
Apr 2018
Primary outcome: Primary: Dietary Intake as Measured by Percent Energy From Fat — 33.75; 34.9; 33.72; 35.05 percent energy from fat — p=0.1073
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Health coaching (Behavioral); Genetic risk counseling (Genetic); Standard risk assessment (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dietary Intake as Measured by Percent Energy From Fat |
33.75; 34.9; 33.72; 35.05 | 0.1073 |
| PRIMARY Dietary Intake as Measured by Daily Grams of Fiber |
15.69; 15.38; 15.24; 15.89 | 0.6732 |
| PRIMARY Physical Activity, as Measured by the Stanford Brief Activity Survey (SBAS) |
25; 41; 34; 32; 30; 18 | 0.0073 sig |
| PRIMARY Smoking Status |
65; 63; 67; 61; 4; 3 | 0.7822 |
| PRIMARY Medication Adherence as Measured by Morisky Adherence Survey MMAS8 |
6.66; 6.59; 6.79; 6.43 | 0.7985 |
| PRIMARY Weight |
86.61; 86.76; 86.77; 86.59 | 0.8027 |
| PRIMARY Waist Circumference |
97.43; 96.9; 97.29; 97.04 | 0.5557 |
| PRIMARY Systolic Blood Pressure |
124.47; 127.05; 124.71; 126.83 | 0.1439 |
| PRIMARY Diastolic Blood Pressure |
79.79; 79.38; 79.59; 79.59 | 0.7639 |
| PRIMARY High-density Lipoprotein (HDL) |
54.27; 53.3; 53.02; 54.67 | 0.4673 |
| PRIMARY Low-density Lipoprotein (LDL) |
128.62; 122.42; 125.33; 125.93 | 0.2192 |
| PRIMARY Triglycerides |
149.34; 135.36; 148.3; 136.09 | 0.1466 |
| SECONDARY Fasting Blood Glucose |
99.62; 100.64; 100.13; 100.23 | 0.6289 |
| SECONDARY Body Mass Index (BMI) |
28.97; 29.4; 29.22; 29.14 | 0.2313 |
| SECONDARY Total Cholesterol |
212.86; 202.39; 207.07; 208.51 | 0.0710 |
| SECONDARY AF Composite Fitness Scores |
0; 1; 1; 0; 22; 5 | 0.0512 |
| SECONDARY Framingham Risk Score (FRS) |
— | — |
| SECONDARY Diabetes Risk Score |
— | — |
| SECONDARY Perceived Risk for Coronary Heart Disease (CHD) |
23.35; 23.55; 24.03; 22.83; 25.44; 24.42 | 0.7923 |
| SECONDARY Perceived Risk for Type 2 Diabetes (T2D) |
22.05; 21.79; 22.32; 21.63; 24.79; 24.55 | 0.7447 |
| SECONDARY Patient Activation Score |
73.13; 70.95; 72.3; 71.51 | 0.3106 |
| SECONDARY Stages of Change |
2; 1; 1; 2; 8; 10 | 0.9259 |
| SECONDARY Depression, as Measured by the Beck Depression Inventory (BDI) |
3.85; 5.1; 4.52; 4.43 | 0.0174 sig |
| SECONDARY Unmanaged Stress as Measured by the Perceived Stress Scale (PSS) |
10.86; 11.43; 11.07; 11.22 | 0.4768 |
| SECONDARY Social Isolation |
3; 7; 8; 2; 72; 69 | 0.5589 |
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 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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01884545). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.