Coronary Heart Disease, Susceptibility to, 5, Prediabetic State
Conditions
Keywords
heart disease, type 2 diabetes, genetic testing, health coaching, risk assessment
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 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.
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 outcomes. In short, using a 4-group (2X2) randomized controlled trial (RCT) design, this study will determine whether incorporating multiple-marker genetic testing into risk counseling for CHD and T2D, coupled with a health coaching intervention will lead to greater changes in physical fitness, health behaviors, risk status and clinical outcomes in active-duty Air Force (ADAF), beneficiaries or dependents and AF retiree patients (N=400). The study will address the following task objectives: 1. Determine the main and interactive effects of multiple-marker genetic risk information incorporated into standard CHD and T2D risk counseling (Standard Risk Assessment, or SRA) and an established, structured telephonic health coaching intervention on health behavior change (diet, exercise habits, smoking cessation) over 12 months, with a focus on ADAF patients, as well as their beneficiaries and retirees. 2. Determine the main and interactive effects of genetic risk information incorporated into standard CHD and T2D risk counseling and a telephonic health coaching intervention on clinical outcomes (fasting blood glucose, blood pressure, BMI, LDL, triglycerides, total cholesterol, AF composite fitness scores) over 12 months in this AF cohort. Given the lack of RCTs on the effects of differing genetic test results, such as false reassurance and genetic determinism, we will also pursue a third, exploratory task objective: 3. Examine the differential effects of level of CHD and T2D genetic risk (# of risk alleles) on behavior change (diet, exercise habits, smoking cessation) and AF fitness scores at 12 months post baseline. Baseline data collection: After screening and informed consent, height and weight, SBP, waist circumference, current lab results (FPG, total cholesterol, triglycerides, LDL, HbA1c, and HDL) and current PHA (physical health assessment) data with fitness scores ( for active duty personnel only) will be obtained from the medical records. Subjects randomized to the two genetic arms will have blood collected for testing of investigational CHD and T2D risk markers. Randomization will take place to one of the following: SRA only; SRA plus genetic risk information (SRA+G); SRA plus health coaching (SRA+HC); or SRA, genetic risk information, and health coaching (SRA+G+HC). Risk Counseling Visit: Within four weeks after the baseline visit all participants will receive risk counseling with trained provider(s) at each clinic site. Health coaching intervention: Participants in the two groups that include health coaching will be assigned to a trained health coach for a period of 6 months (n=200). IHC (Integrative Health Coaching) sessions will be provided by telephone using a structure that has evolved in multiple trials and clinical programs at Duke Integrative Medicine. Six week, 3-, and 6-month follow-ups: At 6 weeks, 3 months and 6 months after the baseline visit, participants will be asked to complete selected surveys online. 6month and 12 month study visits: 12 months from the baseline visit, active duty participants will complete their annual PHA, required annual AF fitness testing; and all participants will complete study visits at 6 and 12 months for weight, waist circumference, BP, fasting glucose or HbA1c and lipid panels to be re-assessed. Surveys will be completed at or prior to the final 12 month visit as well.
Interventions
BEHAVIORALHealth coaching
Telephonic health coaching sessions with a trained certified health coach for a period of 6 months (total of 10 biweekly calls).
GENETICGenetic risk counseling
In addition to the SRA subjects will receive genetic risk counseling at the risk counseling visit with a clinic provider. Genetic test results for CHD (rs10757274) and T2D (rs7903146, rs1801282, rs5219) risk variants will be incorporated into the risk profile reviewed with subjects.
BEHAVIORALStandard risk assessment
Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject.
Sponsors
David Grant U.S. Air Force Medical Center
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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): 1. Blood pressure 2. Height and weight 3. Fasting blood glucose or Hemoglobin A1C (HbA1c) 4. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dietary Intake as Measured by Percent Energy From Fat | 12 months | Dietary intake as measured by percent energy from fat, adjusted for baseline |
| Dietary Intake as Measured by Daily Grams of Fiber | 12 months | Dietary intake as measured by daily grams of fiber, adjusted for baseline |
| Physical Activity, as Measured by the Stanford Brief Activity Survey (SBAS) | 12 months | The Stanford Brief Activity Survey is a 2-item survey that assesses two categories of physical activity - work and leisure. There are five options for degree of activity to choose from in each of the two areas of activity. Activity categories (inactive, light-intensity activity, moderate-intensity activity, hard-intensity activity, and very hard-intensity) are represented in a table of different patterns. Degree of work activity is represented on the vertical axis and degree of leisure activity is represented on the horizontal axis. The overall activity level category is determined by where the two responses intersect. |
| Smoking Status | 12 months | — |
| Medication Adherence as Measured by Morisky Adherence Survey MMAS8 | 12 months | Scores of the MMAS-8 range from 0 to 8. A score below 6 indicates low adherence, a score between 6 \< 8 medium adherence and a score of 8 high adherence. |
| Weight | 12 months | Weight in kg |
| Waist Circumference | 12 months | Waist circumference in cm |
| Systolic Blood Pressure | 12 months | Systolic blood pressure in mmHg |
| Diastolic Blood Pressure | 12 months | Diastolic blood pressure in mmHg |
| High-density Lipoprotein (HDL) | 12 months | High-density lipoprotein (HDL) in mg/dL |
| Low-density Lipoprotein (LDL) | 12 months | Low-density lipoprotein (LDL) in mg/dL |
| Triglycerides | 12 months | Triglycerides in mg/dL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting Blood Glucose | 12 months | Adjusted for baseline |
| Social Isolation | 6 months | Single item to assess for availability of support person, where No=no support person. |
| Body Mass Index (BMI) | 12 months | — |
| Total Cholesterol | 12 months | Adjusted for baseline |
| AF Composite Fitness Scores | 12 months | Last annual fitness exam result, collected as pass or fail |
| Framingham Risk Score (FRS) | 12 months | — |
| Diabetes Risk Score | 12 months | — |
| Perceived Risk for Coronary Heart Disease (CHD) | 6 months | Investigator developed questions assessing level of personal perceived risk, fear, anger, worry regarding CHD risk. The consequences subscale ranges from 6-30. Higher scores on the consequences represent strongly held beliefs about negative consequences of the illness. The personal control subscale ranges from 6-30 and the treatment control subscale ranges from 2-10. Higher scores on the personal control and treatment control represent positive beliefs about the controllability of the illness. The emotional representations scores range from 6-30. Higher score indicates higher levels of worry or anxiety about risk of illness. |
| Perceived Risk for Type 2 Diabetes (T2D) | 6 months | Investigator developed questions assessing level of personal perceived risk, fear, anger, worry regarding T2D risk. The consequences subscale ranges from 6-30. Higher scores on the consequences represent strongly held beliefs about negative consequences of the illness. The personal control subscale ranges from 6-30 and the treatment control subscale ranges from 2-10. Higher scores on the personal control and treatment control represent positive beliefs about the controllability of the illness. The emotional representations scores range from 6-30. Higher score indicates higher levels of worry or anxiety about risk of illness. |
| Patient Activation Score | 12 months | Patient activation is the degree to which patients accept an active role in their healthcare, and have the knowledge, skills and confidence to take care of their health. When scored as a continuous variable, the range is from 0 to 100, with higher numbers indicating greater levels of patient activation. |
| Stages of Change | 6 months | These evidence-based questions are validated and based upon the Transtheoretical Model and assess an individual's readiness to make behavioral change in 5 health behavior domains (dietary intake, exercise, weight loss, smoking cessation, and medication adherence). |
| Depression, as Measured by the Beck Depression Inventory (BDI) | 6 months | The Beck Depression Inventory is a 21-item measure that assesses self-reported symptoms of depression. It has been heavily used in research linking depression to heart disease. Scores range from 0-63, with 0 = minimal depression and 63 = severe depression. |
| Unmanaged Stress as Measured by the Perceived Stress Scale (PSS) | 6 months | The PSS is a 10 item survey assessing feelings and thoughts of stress. Scores range from 0-40 with higher scores indicating higher perceived stress. |
Countries
United States
Participant flow
Pre-assignment details
220 subjects were consented. Prior to randomization 9 subjects withdrew from the study, 10 were lost to follow up, and 1 did not meet inclusion criteria. 200 participants were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Standard Risk Assessment (SRA) Subjects will receive a standard risk assessment only for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject.
Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject. | 50 |
| SRA Plus Health Coaching (HC) In addition to the standard risk assessment for CHD and T2D subjects will receive health coaching intervention for 6 months
Health coaching: Telephonic health coaching sessions with a trained certified health coach for a period of 6 months (total of 10 biweekly calls).
Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject. | 49 |
| SRA Plus Genetic Risk Counseling (GRC) In addition to the SRA subjects will receive genetic risk counseling at the risk counseling visit with a clinic provider. Genetic test results for CHD (rs10757274) and T2D (rs7903146, rs1801282, rs5219) risk variants will be incorporated into the risk profile reviewed with subjects.
Genetic risk counseling: In addition to the SRA subjects will receive genetic risk counseling at the risk counseling visit with a clinic provider. Genetic test results for CHD (rs10757274) and T2D (rs7903146, rs1801282, rs5219) risk variants will be incorporated into the risk profile reviewed with subjects.
Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject. | 49 |
| SRA+HC+GRC In addition to the standard risk assessment for CHD and T2D subjects will receive genetic risk counseling and health coaching intervention for 6 months.
Health coaching: Telephonic health coaching sessions with a trained certified health coach for a period of 6 months (total of 10 biweekly calls).
Genetic risk counseling: In addition to the SRA subjects will receive genetic risk counseling at the risk counseling visit with a clinic provider. Genetic test results for CHD (rs10757274) and T2D (rs7903146, rs1801282, rs5219) risk variants will be incorporated into the risk profile reviewed with subjects.
Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject. | 52 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 4 | 9 | 4 |
| Overall Study | Non-adherence | 0 | 2 | 0 | 0 |
| Overall Study | Patient withdrawn | 7 | 12 | 5 | 5 |
Baseline characteristics
| Characteristic | Total | SRA+HC+GRC | SRA Plus Genetic Risk Counseling (GRC) | SRA Plus Health Coaching (HC) | Standard Risk Assessment (SRA) |
|---|---|---|---|---|---|
| Age, Continuous | 47.72 years STANDARD_DEVIATION 11.56 | 44.85 years STANDARD_DEVIATION 11.85 | 48.35 years STANDARD_DEVIATION 10.51 | 48.67 years STANDARD_DEVIATION 12.67 | 49.16 years STANDARD_DEVIATION 10.92 |
| Diastolic Blood Pressure | 80.12 mmHg STANDARD_DEVIATION 9.63 | 80.62 mmHg STANDARD_DEVIATION 10.7 | 78.26 mmHg STANDARD_DEVIATION 8.36 | 80.77 mmHg STANDARD_DEVIATION 10.38 | 80.78 mmHg STANDARD_DEVIATION 8.89 |
| Dietary Intake (Daily grams of fiber) | 16.46 grams STANDARD_DEVIATION 6.73 | 18.27 grams STANDARD_DEVIATION 8.68 | 15.75 grams STANDARD_DEVIATION 5.83 | 14.94 grams STANDARD_DEVIATION 5.57 | 16.65 grams STANDARD_DEVIATION 5.82 |
| Dietary Intake (Percent energy from fat) | 34.81 percent STANDARD_DEVIATION 4.14 | 35.66 percent STANDARD_DEVIATION 4.91 | 34.13 percent STANDARD_DEVIATION 4.55 | 34.87 percent STANDARD_DEVIATION 3.17 | 34.50 percent STANDARD_DEVIATION 3.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants | 5 Participants | 2 Participants | 3 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 179 Participants | 47 Participants | 47 Participants | 45 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| High-density Lipoprotein (HDL) | 52.53 mg/dL STANDARD_DEVIATION 16.62 | 50.50 mg/dL STANDARD_DEVIATION 16.41 | 49.59 mg/dL STANDARD_DEVIATION 13.5 | 56.45 mg/dL STANDARD_DEVIATION 18.62 | 53.66 mg/dL STANDARD_DEVIATION 17.15 |
| Low-density Lipoprotein (LDL) | 134.05 mg/dL STANDARD_DEVIATION 36.12 | 136.95 mg/dL STANDARD_DEVIATION 37.15 | 131.94 mg/dL STANDARD_DEVIATION 32.9 | 133.51 mg/dL STANDARD_DEVIATION 42.4 | 133.63 mg/dL STANDARD_DEVIATION 32.05 |
| Medication Adherence (Morisky 4) High Adherence | 56 Participants | 15 Participants | 11 Participants | 17 Participants | 13 Participants |
| Medication Adherence (Morisky 4) Low Adherence | 61 Participants | 14 Participants | 19 Participants | 12 Participants | 16 Participants |
| Medication Adherence (Morisky 4) Medium Adherence | 52 Participants | 15 Participants | 12 Participants | 12 Participants | 13 Participants |
| Medication Adherence (Morisky 4) Not applicable (patient not taking medication) | 30 Participants | 8 Participants | 7 Participants | 7 Participants | 8 Participants |
| Physical Activity Inactive/light intensity activity | 96 Participants | 25 Participants | 25 Participants | 20 Participants | 26 Participants |
| Physical Activity Moderate/ hard/very hard intensity activity | 104 Participants | 27 Participants | 24 Participants | 29 Participants | 24 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 39 Participants | 5 Participants | 13 Participants | 12 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 29 Participants | 6 Participants | 7 Participants | 8 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 3 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 119 Participants | 36 Participants | 25 Participants | 29 Participants | 29 Participants |
| Region of Enrollment United States | 200 Participants | 52 Participants | 49 Participants | 49 Participants | 50 Participants |
| Sex: Female, Male Female | 98 Participants | 20 Participants | 31 Participants | 25 Participants | 22 Participants |
| Sex: Female, Male Male | 102 Participants | 32 Participants | 18 Participants | 24 Participants | 28 Participants |
| Smoking Status No | 178 Participants | 43 Participants | 44 Participants | 46 Participants | 45 Participants |
| Smoking Status Yes | 22 Participants | 9 Participants | 5 Participants | 3 Participants | 5 Participants |
| Systolic Blood Pressure | 126.77 mmHg STANDARD_DEVIATION 12.24 | 128.68 mmHg STANDARD_DEVIATION 13.3 | 123.24 mmHg STANDARD_DEVIATION 10.87 | 126.41 mmHg STANDARD_DEVIATION 13.03 | 128.60 mmHg STANDARD_DEVIATION 11.06 |
| Triglycerides | 160.24 mg/dL STANDARD_DEVIATION 90.33 | 156.60 mg/dL STANDARD_DEVIATION 69.44 | 157.35 mg/dL STANDARD_DEVIATION 87.76 | 150.73 mg/dL STANDARD_DEVIATION 70.53 | 176.19 mg/dL STANDARD_DEVIATION 123.8 |
| Waist Circumference | 98.30 cm STANDARD_DEVIATION 13.23 | 98.56 cm STANDARD_DEVIATION 12.09 | 97.23 cm STANDARD_DEVIATION 13.5 | 98.51 cm STANDARD_DEVIATION 16.42 | 98.86 cm STANDARD_DEVIATION 10.73 |
| Weight | 85.58 kg STANDARD_DEVIATION 18.15 | 89.07 kg STANDARD_DEVIATION 17.76 | 84.96 kg STANDARD_DEVIATION 20.66 | 82.15 kg STANDARD_DEVIATION 16.75 | 85.94 kg STANDARD_DEVIATION 17.05 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 49 | 0 / 49 | 0 / 52 |
| other Total, other adverse events | 0 / 50 | 0 / 49 | 0 / 49 | 0 / 52 |
| serious Total, serious adverse events | 0 / 50 | 1 / 49 | 0 / 49 | 0 / 52 |
Outcome results
Primary
Diastolic Blood Pressure
Diastolic blood pressure in mmHg
Time frame: 12 months
Population: Randomization Arms/Groups were regrouped as pre-specified in the study protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching | Diastolic Blood Pressure | 79.79 mmHg | Standard Deviation 0.95 |
| Non-Health Coaching | Diastolic Blood Pressure | 79.38 mmHg | Standard Deviation 0.98 |
| Genetic Risk Counseling | Diastolic Blood Pressure | 79.59 mmHg | Standard Deviation 0.95 |
| Non-Genetic Risk Counseling | Diastolic Blood Pressure | 79.59 mmHg | Standard Deviation 0.99 |
p-value: 0.7639Regression, Linear
p-value: 0.9999Regression, Linear
Primary
Dietary Intake as Measured by Daily Grams of Fiber
Dietary intake as measured by daily grams of fiber, adjusted for baseline
Time frame: 12 months
Population: Randomization Arms/Groups were regrouped as pre-specified in the study protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching | Dietary Intake as Measured by Daily Grams of Fiber | 15.69 grams | Standard Deviation 0.51 |
| Non-Health Coaching | Dietary Intake as Measured by Daily Grams of Fiber | 15.38 grams | Standard Deviation 0.51 |
| Genetic Risk Counseling | Dietary Intake as Measured by Daily Grams of Fiber | 15.24 grams | Standard Deviation 0.49 |
| Non-Genetic Risk Counseling | Dietary Intake as Measured by Daily Grams of Fiber | 15.89 grams | Standard Deviation 0.54 |
p-value: 0.6732Regression, Linear
p-value: 0.3754Regression, Linear
Primary
Dietary Intake as Measured by Percent Energy From Fat
Dietary intake as measured by percent energy from fat, adjusted for baseline
Time frame: 12 months
Population: Randomization Arms/Groups were regrouped as pre-specified in the study protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching | Dietary Intake as Measured by Percent Energy From Fat | 33.75 percent energy from fat | Standard Deviation 0.5 |
| Non-Health Coaching | Dietary Intake as Measured by Percent Energy From Fat | 34.9 percent energy from fat | Standard Deviation 0.5 |
| Genetic Risk Counseling | Dietary Intake as Measured by Percent Energy From Fat | 33.72 percent energy from fat | Standard Deviation 0.47 |
| Non-Genetic Risk Counseling | Dietary Intake as Measured by Percent Energy From Fat | 35.05 percent energy from fat | Standard Deviation 0.52 |
p-value: 0.1073Regression, Linear
p-value: 0.0615Regression, Linear
Primary
High-density Lipoprotein (HDL)
High-density lipoprotein (HDL) in mg/dL
Time frame: 12 months
Population: Randomization Arms/Groups were regrouped as pre-specified in the study protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching | High-density Lipoprotein (HDL) | 54.27 mg/dL | Standard Deviation 0.93 |
| Non-Health Coaching | High-density Lipoprotein (HDL) | 53.3 mg/dL | Standard Deviation 0.96 |
| Genetic Risk Counseling | High-density Lipoprotein (HDL) | 53.02 mg/dL | Standard Deviation 0.93 |
| Non-Genetic Risk Counseling | High-density Lipoprotein (HDL) | 54.67 mg/dL | Standard Deviation 0.99 |
p-value: 0.4673Regression, Linear
p-value: 0.2297Regression, Linear
Primary
Low-density Lipoprotein (LDL)
Low-density lipoprotein (LDL) in mg/dL
Time frame: 12 months
Population: Randomization Arms/Groups were regrouped as pre-specified in the study protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching | Low-density Lipoprotein (LDL) | 128.62 mg/dL | Standard Deviation 3.5 |
| Non-Health Coaching | Low-density Lipoprotein (LDL) | 122.42 mg/dL | Standard Deviation 3.6 |
| Genetic Risk Counseling | Low-density Lipoprotein (LDL) | 125.33 mg/dL | Standard Deviation 3.47 |
| Non-Genetic Risk Counseling | Low-density Lipoprotein (LDL) | 125.93 mg/dL | Standard Deviation 3.68 |
p-value: 0.2192Regression, Linear
p-value: 0.9062Regression, Linear
Primary
Medication Adherence as Measured by Morisky Adherence Survey MMAS8
Scores of the MMAS-8 range from 0 to 8. A score below 6 indicates low adherence, a score between 6 \< 8 medium adherence and a score of 8 high adherence.
Time frame: 12 months
Population: Randomization Arms/Groups were regrouped as pre-specified in the study protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching | Medication Adherence as Measured by Morisky Adherence Survey MMAS8 | 6.66 units on a scale | Standard Deviation 0.19 |
| Non-Health Coaching | Medication Adherence as Measured by Morisky Adherence Survey MMAS8 | 6.59 units on a scale | Standard Deviation 0.18 |
| Genetic Risk Counseling | Medication Adherence as Measured by Morisky Adherence Survey MMAS8 | 6.79 units on a scale | Standard Deviation 0.17 |
| Non-Genetic Risk Counseling | Medication Adherence as Measured by Morisky Adherence Survey MMAS8 | 6.43 units on a scale | Standard Deviation 0.19 |
p-value: 0.7985Regression, Linear
p-value: 0.1642Regression, Linear
Primary
Physical Activity, as Measured by the Stanford Brief Activity Survey (SBAS)
The Stanford Brief Activity Survey is a 2-item survey that assesses two categories of physical activity - work and leisure. There are five options for degree of activity to choose from in each of the two areas of activity. Activity categories (inactive, light-intensity activity, moderate-intensity activity, hard-intensity activity, and very hard-intensity) are represented in a table of different patterns. Degree of work activity is represented on the vertical axis and degree of leisure activity is represented on the horizontal axis. The overall activity level category is determined by where the two responses intersect.
Time frame: 12 months
Population: Randomization Arms/Groups were regrouped as pre-specified in the study protocol. Some participants were not analyzed because data were missing.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Health Coaching | Physical Activity, as Measured by the Stanford Brief Activity Survey (SBAS) | Inative/light intensity activity | 25 Participants |
| Health Coaching | Physical Activity, as Measured by the Stanford Brief Activity Survey (SBAS) | hard/very hard intensity activity | 17 Participants |
| Health Coaching | Physical Activity, as Measured by the Stanford Brief Activity Survey (SBAS) | moderate intensity activity | 30 Participants |
| Non-Health Coaching | Physical Activity, as Measured by the Stanford Brief Activity Survey (SBAS) | Inative/light intensity activity | 41 Participants |
| Non-Health Coaching | Physical Activity, as Measured by the Stanford Brief Activity Survey (SBAS) | hard/very hard intensity activity | 13 Participants |
| Non-Health Coaching | Physical Activity, as Measured by the Stanford Brief Activity Survey (SBAS) | moderate intensity activity | 18 Participants |
| Genetic Risk Counseling | Physical Activity, as Measured by the Stanford Brief Activity Survey (SBAS) | moderate intensity activity | 23 Participants |
| Genetic Risk Counseling | Physical Activity, as Measured by the Stanford Brief Activity Survey (SBAS) | Inative/light intensity activity | 34 Participants |
| Genetic Risk Counseling | Physical Activity, as Measured by the Stanford Brief Activity Survey (SBAS) | hard/very hard intensity activity | 20 Participants |
| Non-Genetic Risk Counseling | Physical Activity, as Measured by the Stanford Brief Activity Survey (SBAS) | Inative/light intensity activity | 32 Participants |
| Non-Genetic Risk Counseling | Physical Activity, as Measured by the Stanford Brief Activity Survey (SBAS) | hard/very hard intensity activity | 10 Participants |
| Non-Genetic Risk Counseling | Physical Activity, as Measured by the Stanford Brief Activity Survey (SBAS) | moderate intensity activity | 25 Participants |
p-value: 0.007395% CI: [1.326, 6.139]Regression, Logistic
p-value: 0.906895% CI: [0.5, 2.183]Regression, Logistic
Primary
Smoking Status
Time frame: 12 months
Population: Randomization Arms/Groups were regrouped as pre-specified in the study protocol. Some participants were not analyzed because data were missing.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Health Coaching | Smoking Status | Smoked in the last 30 days = No | 65 Participants |
| Health Coaching | Smoking Status | Smoked in the last 30 days = Yes | 4 Participants |
| Non-Health Coaching | Smoking Status | Smoked in the last 30 days = Yes | 3 Participants |
| Non-Health Coaching | Smoking Status | Smoked in the last 30 days = No | 63 Participants |
| Genetic Risk Counseling | Smoking Status | Smoked in the last 30 days = No | 67 Participants |
| Genetic Risk Counseling | Smoking Status | Smoked in the last 30 days = Yes | 4 Participants |
| Non-Genetic Risk Counseling | Smoking Status | Smoked in the last 30 days = No | 61 Participants |
| Non-Genetic Risk Counseling | Smoking Status | Smoked in the last 30 days = Yes | 3 Participants |
p-value: 0.782295% CI: [0.173, 10.254]Regression, Logistic
p-value: 0.782295% CI: [0.173, 10.254]Regression, Logistic
Primary
Systolic Blood Pressure
Systolic blood pressure in mmHg
Time frame: 12 months
Population: Randomization Arms/Groups were regrouped as pre-specified in the study protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching | Systolic Blood Pressure | 124.47 mmHg | Standard Deviation 1.21 |
| Non-Health Coaching | Systolic Blood Pressure | 127.05 mmHg | Standard Deviation 1.25 |
| Genetic Risk Counseling | Systolic Blood Pressure | 124.71 mmHg | Standard Deviation 1.2 |
| Non-Genetic Risk Counseling | Systolic Blood Pressure | 126.83 mmHg | Standard Deviation 1.26 |
p-value: 0.1439Regression, Linear
p-value: 0.2275Regression, Linear
Primary
Triglycerides
Triglycerides in mg/dL
Time frame: 12 months
Population: Randomization Arms/Groups were regrouped as pre-specified in the study protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching | Triglycerides | 149.34 mg/dL | Standard Deviation 6.67 |
| Non-Health Coaching | Triglycerides | 135.36 mg/dL | Standard Deviation 6.87 |
| Genetic Risk Counseling | Triglycerides | 148.3 mg/dL | Standard Deviation 6.59 |
| Non-Genetic Risk Counseling | Triglycerides | 136.09 mg/dL | Standard Deviation 7 |
p-value: 0.1466Regression, Linear
p-value: 0.207Regression, Linear
Primary
Waist Circumference
Waist circumference in cm
Time frame: 12 months
Population: Randomization Arms/Groups were regrouped as pre-specified in the study protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching | Waist Circumference | 97.43 cm | Standard Deviation 0.63 |
| Non-Health Coaching | Waist Circumference | 96.9 cm | Standard Deviation 0.64 |
| Genetic Risk Counseling | Waist Circumference | 97.29 cm | Standard Deviation 0.62 |
| Non-Genetic Risk Counseling | Waist Circumference | 97.04 cm | Standard Deviation 0.65 |
p-value: 0.5557Regression, Linear
p-value: 0.7834Regression, Linear
Primary
Weight
Weight in kg
Time frame: 12 months
Population: Randomization Arms/Groups were regrouped as pre-specified in the study protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching | Weight | 86.61 kg | Standard Deviation 0.43 |
| Non-Health Coaching | Weight | 86.76 kg | Standard Deviation 0.45 |
| Genetic Risk Counseling | Weight | 86.77 kg | Standard Deviation 0.43 |
| Non-Genetic Risk Counseling | Weight | 86.59 kg | Standard Deviation 0.45 |
p-value: 0.8027Regression, Linear
p-value: 0.7751Regression, Linear
Secondary
AF Composite Fitness Scores
Last annual fitness exam result, collected as pass or fail
Time frame: 12 months
Population: Data only collected on active duty participants as part of their annual assessment. Randomization Arms/Groups were regrouped as pre-specified in the study protocol.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Health Coaching | AF Composite Fitness Scores | Pass | 22 Participants |
| Health Coaching | AF Composite Fitness Scores | Fail | 0 Participants |
| Non-Health Coaching | AF Composite Fitness Scores | Fail | 1 Participants |
| Non-Health Coaching | AF Composite Fitness Scores | Pass | 5 Participants |
| Genetic Risk Counseling | AF Composite Fitness Scores | Fail | 1 Participants |
| Genetic Risk Counseling | AF Composite Fitness Scores | Pass | 17 Participants |
| Non-Genetic Risk Counseling | AF Composite Fitness Scores | Pass | 10 Participants |
| Non-Genetic Risk Counseling | AF Composite Fitness Scores | Fail | 0 Participants |
p-value: 0.0512Chi-squared
p-value: 0.4478Chi-squared
Secondary
Body Mass Index (BMI)
Time frame: 12 months
Population: Randomization Arms/Groups were regrouped as pre-specified in the study protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching | Body Mass Index (BMI) | 28.97 kg/m2 | Standard Deviation 0.25 |
| Non-Health Coaching | Body Mass Index (BMI) | 29.4 kg/m2 | Standard Deviation 0.25 |
| Genetic Risk Counseling | Body Mass Index (BMI) | 29.22 kg/m2 | Standard Deviation 0.25 |
| Non-Genetic Risk Counseling | Body Mass Index (BMI) | 29.14 kg/m2 | Standard Deviation 0.26 |
p-value: 0.2313Regression, Linear
p-value: 0.8029Regression, Linear
Secondary
Depression, as Measured by the Beck Depression Inventory (BDI)
The Beck Depression Inventory is a 21-item measure that assesses self-reported symptoms of depression. It has been heavily used in research linking depression to heart disease. Scores range from 0-63, with 0 = minimal depression and 63 = severe depression.
Time frame: 6 months
Population: Randomization Arms/Groups were regrouped as pre-specified in the study protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching | Depression, as Measured by the Beck Depression Inventory (BDI) | 3.85 units on a scale | Standard Deviation 0.37 |
| Non-Health Coaching | Depression, as Measured by the Beck Depression Inventory (BDI) | 5.1 units on a scale | Standard Deviation 0.37 |
| Genetic Risk Counseling | Depression, as Measured by the Beck Depression Inventory (BDI) | 4.52 units on a scale | Standard Deviation 0.37 |
| Non-Genetic Risk Counseling | Depression, as Measured by the Beck Depression Inventory (BDI) | 4.43 units on a scale | Standard Deviation 0.38 |
p-value: 0.0174Regression, Linear
p-value: 0.8694Regression, Linear
Secondary
Diabetes Risk Score
Time frame: 12 months
Population: risk score data was only collected and calculated at baseline
Secondary
Fasting Blood Glucose
Adjusted for baseline
Time frame: 12 months
Population: Randomization Arms/Groups were regrouped as pre-specified in the study protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching | Fasting Blood Glucose | 99.62 mg/dL | Standard Deviation 1.54 |
| Non-Health Coaching | Fasting Blood Glucose | 100.64 mg/dL | Standard Deviation 1.42 |
| Genetic Risk Counseling | Fasting Blood Glucose | 100.13 mg/dL | Standard Deviation 1.44 |
| Non-Genetic Risk Counseling | Fasting Blood Glucose | 100.23 mg/dL | Standard Deviation 1.56 |
p-value: 0.6289Regression, Linear
p-value: 0.9631Regression, Linear
Secondary
Framingham Risk Score (FRS)
Time frame: 12 months
Population: risk score data was only collected and calculated at baseline
Secondary
Patient Activation Score
Patient activation is the degree to which patients accept an active role in their healthcare, and have the knowledge, skills and confidence to take care of their health. When scored as a continuous variable, the range is from 0 to 100, with higher numbers indicating greater levels of patient activation.
Time frame: 12 months
Population: Randomization Arms/Groups were regrouped as pre-specified in the study protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching | Patient Activation Score | 73.13 units on a scale | Standard Deviation 1.5 |
| Non-Health Coaching | Patient Activation Score | 70.95 units on a scale | Standard Deviation 1.53 |
| Genetic Risk Counseling | Patient Activation Score | 72.3 units on a scale | Standard Deviation 1.45 |
| Non-Genetic Risk Counseling | Patient Activation Score | 71.51 units on a scale | Standard Deviation 1.55 |
p-value: 0.3106Regression, Linear
p-value: 0.7087Regression, Linear
Secondary
Perceived Risk for Coronary Heart Disease (CHD)
Investigator developed questions assessing level of personal perceived risk, fear, anger, worry regarding CHD risk. The consequences subscale ranges from 6-30. Higher scores on the consequences represent strongly held beliefs about negative consequences of the illness. The personal control subscale ranges from 6-30 and the treatment control subscale ranges from 2-10. Higher scores on the personal control and treatment control represent positive beliefs about the controllability of the illness. The emotional representations scores range from 6-30. Higher score indicates higher levels of worry or anxiety about risk of illness.
Time frame: 6 months
Population: Randomization Arms/Groups were regrouped as pre-specified in the study protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Health Coaching | Perceived Risk for Coronary Heart Disease (CHD) | Consequences subscale | 23.35 units on a scale | Standard Deviation 0.53 |
| Health Coaching | Perceived Risk for Coronary Heart Disease (CHD) | Personal control | 25.44 units on a scale | Standard Deviation 0.38 |
| Health Coaching | Perceived Risk for Coronary Heart Disease (CHD) | Treatment control | 8.44 units on a scale | Standard Deviation 0.13 |
| Health Coaching | Perceived Risk for Coronary Heart Disease (CHD) | Emotional representations | 13.54 units on a scale | Standard Deviation 0.37 |
| Non-Health Coaching | Perceived Risk for Coronary Heart Disease (CHD) | Personal control | 24.42 units on a scale | Standard Deviation 0.39 |
| Non-Health Coaching | Perceived Risk for Coronary Heart Disease (CHD) | Treatment control | 8.21 units on a scale | Standard Deviation 0.13 |
| Non-Health Coaching | Perceived Risk for Coronary Heart Disease (CHD) | Emotional representations | 14.15 units on a scale | Standard Deviation 0.37 |
| Non-Health Coaching | Perceived Risk for Coronary Heart Disease (CHD) | Consequences subscale | 23.55 units on a scale | Standard Deviation 0.53 |
| Genetic Risk Counseling | Perceived Risk for Coronary Heart Disease (CHD) | Treatment control | 8.39 units on a scale | Standard Deviation 0.12 |
| Genetic Risk Counseling | Perceived Risk for Coronary Heart Disease (CHD) | Personal control | 25.15 units on a scale | Standard Deviation 0.38 |
| Genetic Risk Counseling | Perceived Risk for Coronary Heart Disease (CHD) | Emotional representations | 13.68 units on a scale | Standard Deviation 0.36 |
| Genetic Risk Counseling | Perceived Risk for Coronary Heart Disease (CHD) | Consequences subscale | 24.03 units on a scale | Standard Deviation 0.52 |
| Non-Genetic Risk Counseling | Perceived Risk for Coronary Heart Disease (CHD) | Emotional representations | 14 units on a scale | Standard Deviation 0.37 |
| Non-Genetic Risk Counseling | Perceived Risk for Coronary Heart Disease (CHD) | Personal control | 24.62 units on a scale | Standard Deviation 0.39 |
| Non-Genetic Risk Counseling | Perceived Risk for Coronary Heart Disease (CHD) | Consequences subscale | 22.83 units on a scale | Standard Deviation 0.53 |
| Non-Genetic Risk Counseling | Perceived Risk for Coronary Heart Disease (CHD) | Treatment control | 8.23 units on a scale | Standard Deviation 0.13 |
Comparison: Perceived Risk for CHD, Consequences subscalep-value: 0.7923Regression, Linear
Comparison: Perceived Risk for CHD, Personal controlp-value: 0.0636Regression, Linear
Comparison: Perceived Risk for CHD, Treatment controlp-value: 0.2063Regression, Linear
Comparison: Perceived Risk for CHD, Emotional representationsp-value: 0.2529Regression, Linear
Comparison: Perceived Risk for coronary heart disease (CHD), Consequences subscalep-value: 0.1085Regression, Linear
Comparison: Perceived Risk for coronary heart disease (CHD), personal control subscalep-value: 0.337Regression, Linear
Comparison: Perceived Risk for coronary heart disease (CHD), treatment control subscalep-value: 0.3483Regression, Linear
Comparison: Perceived Risk for coronary heart disease (CHD), emotional representationsp-value: 0.5384Regression, Linear
Secondary
Perceived Risk for Type 2 Diabetes (T2D)
Investigator developed questions assessing level of personal perceived risk, fear, anger, worry regarding T2D risk. The consequences subscale ranges from 6-30. Higher scores on the consequences represent strongly held beliefs about negative consequences of the illness. The personal control subscale ranges from 6-30 and the treatment control subscale ranges from 2-10. Higher scores on the personal control and treatment control represent positive beliefs about the controllability of the illness. The emotional representations scores range from 6-30. Higher score indicates higher levels of worry or anxiety about risk of illness.
Time frame: 6 months
Population: Randomization Arms/Groups were regrouped as pre-specified in the study protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Health Coaching | Perceived Risk for Type 2 Diabetes (T2D) | Consequences subscale | 22.05 units on a scale | Standard Deviation 0.55 |
| Health Coaching | Perceived Risk for Type 2 Diabetes (T2D) | Personal control | 24.79 units on a scale | Standard Deviation 0.36 |
| Health Coaching | Perceived Risk for Type 2 Diabetes (T2D) | Treatment control | 8.37 units on a scale | Standard Deviation 0.14 |
| Health Coaching | Perceived Risk for Type 2 Diabetes (T2D) | Emotional representations | 13.23 units on a scale | Standard Deviation 0.36 |
| Non-Health Coaching | Perceived Risk for Type 2 Diabetes (T2D) | Personal control | 24.55 units on a scale | Standard Deviation 0.36 |
| Non-Health Coaching | Perceived Risk for Type 2 Diabetes (T2D) | Treatment control | 8.18 units on a scale | Standard Deviation 0.14 |
| Non-Health Coaching | Perceived Risk for Type 2 Diabetes (T2D) | Emotional representations | 14.66 units on a scale | Standard Deviation 0.37 |
| Non-Health Coaching | Perceived Risk for Type 2 Diabetes (T2D) | Consequences subscale | 21.79 units on a scale | Standard Deviation 0.56 |
| Genetic Risk Counseling | Perceived Risk for Type 2 Diabetes (T2D) | Treatment control | 8.35 units on a scale | Standard Deviation 0.13 |
| Genetic Risk Counseling | Perceived Risk for Type 2 Diabetes (T2D) | Personal control | 25.14 units on a scale | Standard Deviation 0.35 |
| Genetic Risk Counseling | Perceived Risk for Type 2 Diabetes (T2D) | Emotional representations | 13.75 units on a scale | Standard Deviation 0.37 |
| Genetic Risk Counseling | Perceived Risk for Type 2 Diabetes (T2D) | Consequences subscale | 22.32 units on a scale | Standard Deviation 0.54 |
| Non-Genetic Risk Counseling | Perceived Risk for Type 2 Diabetes (T2D) | Emotional representations | 14.18 units on a scale | Standard Deviation 0.37 |
| Non-Genetic Risk Counseling | Perceived Risk for Type 2 Diabetes (T2D) | Personal control | 24.28 units on a scale | Standard Deviation 0.36 |
| Non-Genetic Risk Counseling | Perceived Risk for Type 2 Diabetes (T2D) | Consequences subscale | 21.63 units on a scale | Standard Deviation 0.56 |
| Non-Genetic Risk Counseling | Perceived Risk for Type 2 Diabetes (T2D) | Treatment control | 8.2 units on a scale | Standard Deviation 0.14 |
Comparison: Perceived Risk for T2D, Consequences subscalep-value: 0.7447Regression, Linear
Comparison: Perceived Risk for T2D, Personal controlp-value: 0.6378Regression, Linear
Comparison: Perceived Risk for T2D, Treatment controlp-value: 0.3209Regression, Linear
Comparison: Perceived Risk for T2D, Emotional representationsp-value: 0.0058Regression, Linear
Comparison: Perceived Risk for type 2 diabetes (T2D), Consequences subscalep-value: 0.3769Regression, Linear
Comparison: Perceived Risk for type 2 diabetes (T2D), personal controlp-value: 0.0872Regression, Linear
Comparison: Perceived Risk for type 2 diabetes (T2D), treatment controlp-value: 0.4302Regression, Linear
Comparison: Perceived Risk for type 2 diabetes (T2D), emotional representationsp-value: 0.4133Regression, Linear
Secondary
Social Isolation
Single item to assess for availability of support person, where No=no support person.
Time frame: 6 months
Population: Data is reported for participants who had data available at the 6 month visit. Randomization Arms/Groups were regrouped as pre-specified in the study protocol.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Health Coaching | Social Isolation | Social Support=No | 3 Participants |
| Health Coaching | Social Isolation | Social Support=Yes | 72 Participants |
| Non-Health Coaching | Social Isolation | Social Support=Yes | 69 Participants |
| Non-Health Coaching | Social Isolation | Social Support=No | 7 Participants |
| Genetic Risk Counseling | Social Isolation | Social Support=No | 8 Participants |
| Genetic Risk Counseling | Social Isolation | Social Support=Yes | 69 Participants |
| Non-Genetic Risk Counseling | Social Isolation | Social Support=No | 2 Participants |
| Non-Genetic Risk Counseling | Social Isolation | Social Support=Yes | 72 Participants |
p-value: 0.558995% CI: [0.335, 7.544]Regression, Logistic
Secondary
Stages of Change
These evidence-based questions are validated and based upon the Transtheoretical Model and assess an individual's readiness to make behavioral change in 5 health behavior domains (dietary intake, exercise, weight loss, smoking cessation, and medication adherence).
Time frame: 6 months
Population: Randomization Arms/Groups were regrouped as pre-specified in the study protocol
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Health Coaching | Stages of Change | Exercise behavior: Contemplation | 9 Participants |
| Health Coaching | Stages of Change | Weight reduction: Contemplation | 8 Participants |
| Health Coaching | Stages of Change | Weight reduction: Preparation | 4 Participants |
| Health Coaching | Stages of Change | Weight reduction: Action | 47 Participants |
| Health Coaching | Stages of Change | Weight reduction: Maintenance | 10 Participants |
| Health Coaching | Stages of Change | Exercise behavior: Pre-contemplation | 2 Participants |
| Health Coaching | Stages of Change | Weight reduction: Pre-contemplation | 2 Participants |
| Health Coaching | Stages of Change | Exercise Behavior: Preparation | 15 Participants |
| Health Coaching | Stages of Change | Exercise Behavior: Action | 29 Participants |
| Health Coaching | Stages of Change | Exercise Behavior: Maintenance | 20 Participants |
| Health Coaching | Stages of Change | Smoking behavior: Pre-contemplation | 2 Participants |
| Health Coaching | Stages of Change | Smoking behavior: Contemplation | 2 Participants |
| Health Coaching | Stages of Change | Smoking behavior: Preparation | 3 Participants |
| Health Coaching | Stages of Change | Smoking behavior: Action | 4 Participants |
| Health Coaching | Stages of Change | Healthier eating behavior: Pre-contemplation | 2 Participants |
| Health Coaching | Stages of Change | Healthier eating behavior: Contemplation | 8 Participants |
| Health Coaching | Stages of Change | Healthier eating behavior: Preparation | 6 Participants |
| Health Coaching | Stages of Change | Healthier eating behavior: Action | 41 Participants |
| Health Coaching | Stages of Change | Healthier eating behavior: Maintenance | 13 Participants |
| Health Coaching | Stages of Change | Stress behavior: Pre-contemplation | 7 Participants |
| Health Coaching | Stages of Change | Stress behavior: Contemplation | 9 Participants |
| Health Coaching | Stages of Change | Stress behavior: Preparation | 8 Participants |
| Health Coaching | Stages of Change | Stress behavior: Action | 27 Participants |
| Health Coaching | Stages of Change | Stress behavior: Maintenance | 24 Participants |
| Non-Health Coaching | Stages of Change | Stress behavior: Maintenance | 34 Participants |
| Non-Health Coaching | Stages of Change | Smoking behavior: Preparation | 2 Participants |
| Non-Health Coaching | Stages of Change | Weight reduction: Action | 43 Participants |
| Non-Health Coaching | Stages of Change | Stress behavior: Action | 23 Participants |
| Non-Health Coaching | Stages of Change | Stress behavior: Preparation | 4 Participants |
| Non-Health Coaching | Stages of Change | Smoking behavior: Action | 5 Participants |
| Non-Health Coaching | Stages of Change | Exercise Behavior: Action | 23 Participants |
| Non-Health Coaching | Stages of Change | Healthier eating behavior: Preparation | 7 Participants |
| Non-Health Coaching | Stages of Change | Exercise behavior: Pre-contemplation | 3 Participants |
| Non-Health Coaching | Stages of Change | Healthier eating behavior: Pre-contemplation | 0 Participants |
| Non-Health Coaching | Stages of Change | Weight reduction: Preparation | 3 Participants |
| Non-Health Coaching | Stages of Change | Healthier eating behavior: Contemplation | 9 Participants |
| Non-Health Coaching | Stages of Change | Stress behavior: Contemplation | 10 Participants |
| Non-Health Coaching | Stages of Change | Exercise Behavior: Maintenance | 13 Participants |
| Non-Health Coaching | Stages of Change | Stress behavior: Pre-contemplation | 4 Participants |
| Non-Health Coaching | Stages of Change | Weight reduction: Contemplation | 10 Participants |
| Non-Health Coaching | Stages of Change | Exercise Behavior: Preparation | 20 Participants |
| Non-Health Coaching | Stages of Change | Smoking behavior: Pre-contemplation | 1 Participants |
| Non-Health Coaching | Stages of Change | Exercise behavior: Contemplation | 16 Participants |
| Non-Health Coaching | Stages of Change | Healthier eating behavior: Maintenance | 11 Participants |
| Non-Health Coaching | Stages of Change | Weight reduction: Pre-contemplation | 1 Participants |
| Non-Health Coaching | Stages of Change | Smoking behavior: Contemplation | 2 Participants |
| Non-Health Coaching | Stages of Change | Weight reduction: Maintenance | 11 Participants |
| Non-Health Coaching | Stages of Change | Healthier eating behavior: Action | 44 Participants |
| Genetic Risk Counseling | Stages of Change | Smoking behavior: Pre-contemplation | 1 Participants |
| Genetic Risk Counseling | Stages of Change | Exercise behavior: Contemplation | 10 Participants |
| Genetic Risk Counseling | Stages of Change | Exercise Behavior: Preparation | 18 Participants |
| Genetic Risk Counseling | Stages of Change | Exercise Behavior: Action | 26 Participants |
| Genetic Risk Counseling | Stages of Change | Exercise Behavior: Maintenance | 21 Participants |
| Genetic Risk Counseling | Stages of Change | Stress behavior: Contemplation | 9 Participants |
| Genetic Risk Counseling | Stages of Change | Stress behavior: Pre-contemplation | 4 Participants |
| Genetic Risk Counseling | Stages of Change | Smoking behavior: Contemplation | 3 Participants |
| Genetic Risk Counseling | Stages of Change | Smoking behavior: Preparation | 4 Participants |
| Genetic Risk Counseling | Stages of Change | Smoking behavior: Action | 5 Participants |
| Genetic Risk Counseling | Stages of Change | Stress behavior: Preparation | 8 Participants |
| Genetic Risk Counseling | Stages of Change | Healthier eating behavior: Pre-contemplation | 1 Participants |
| Genetic Risk Counseling | Stages of Change | Healthier eating behavior: Contemplation | 9 Participants |
| Genetic Risk Counseling | Stages of Change | Stress behavior: Maintenance | 33 Participants |
| Genetic Risk Counseling | Stages of Change | Healthier eating behavior: Preparation | 8 Participants |
| Genetic Risk Counseling | Stages of Change | Healthier eating behavior: Action | 41 Participants |
| Genetic Risk Counseling | Stages of Change | Stress behavior: Action | 22 Participants |
| Genetic Risk Counseling | Stages of Change | Weight reduction: Pre-contemplation | 1 Participants |
| Genetic Risk Counseling | Stages of Change | Weight reduction: Contemplation | 8 Participants |
| Genetic Risk Counseling | Stages of Change | Healthier eating behavior: Maintenance | 13 Participants |
| Genetic Risk Counseling | Stages of Change | Weight reduction: Preparation | 4 Participants |
| Genetic Risk Counseling | Stages of Change | Weight reduction: Action | 53 Participants |
| Genetic Risk Counseling | Stages of Change | Weight reduction: Maintenance | 8 Participants |
| Genetic Risk Counseling | Stages of Change | Exercise behavior: Pre-contemplation | 1 Participants |
| Non-Genetic Risk Counseling | Stages of Change | Stress behavior: Action | 28 Participants |
| Non-Genetic Risk Counseling | Stages of Change | Stress behavior: Contemplation | 10 Participants |
| Non-Genetic Risk Counseling | Stages of Change | Exercise Behavior: Preparation | 17 Participants |
| Non-Genetic Risk Counseling | Stages of Change | Weight reduction: Pre-contemplation | 2 Participants |
| Non-Genetic Risk Counseling | Stages of Change | Smoking behavior: Pre-contemplation | 2 Participants |
| Non-Genetic Risk Counseling | Stages of Change | Exercise Behavior: Maintenance | 12 Participants |
| Non-Genetic Risk Counseling | Stages of Change | Exercise behavior: Pre-contemplation | 4 Participants |
| Non-Genetic Risk Counseling | Stages of Change | Weight reduction: Contemplation | 10 Participants |
| Non-Genetic Risk Counseling | Stages of Change | Weight reduction: Maintenance | 13 Participants |
| Non-Genetic Risk Counseling | Stages of Change | Exercise Behavior: Action | 26 Participants |
| Non-Genetic Risk Counseling | Stages of Change | Stress behavior: Pre-contemplation | 7 Participants |
| Non-Genetic Risk Counseling | Stages of Change | Weight reduction: Preparation | 3 Participants |
| Non-Genetic Risk Counseling | Stages of Change | Stress behavior: Preparation | 4 Participants |
| Non-Genetic Risk Counseling | Stages of Change | Healthier eating behavior: Pre-contemplation | 1 Participants |
| Non-Genetic Risk Counseling | Stages of Change | Healthier eating behavior: Maintenance | 11 Participants |
| Non-Genetic Risk Counseling | Stages of Change | Healthier eating behavior: Contemplation | 8 Participants |
| Non-Genetic Risk Counseling | Stages of Change | Stress behavior: Maintenance | 25 Participants |
| Non-Genetic Risk Counseling | Stages of Change | Smoking behavior: Action | 4 Participants |
| Non-Genetic Risk Counseling | Stages of Change | Exercise behavior: Contemplation | 15 Participants |
| Non-Genetic Risk Counseling | Stages of Change | Healthier eating behavior: Preparation | 5 Participants |
| Non-Genetic Risk Counseling | Stages of Change | Smoking behavior: Preparation | 1 Participants |
| Non-Genetic Risk Counseling | Stages of Change | Smoking behavior: Contemplation | 1 Participants |
| Non-Genetic Risk Counseling | Stages of Change | Weight reduction: Action | 37 Participants |
| Non-Genetic Risk Counseling | Stages of Change | Healthier eating behavior: Action | 44 Participants |
Comparison: Stages of Change, Weight reductionp-value: 0.925995% CI: [0.511, 2.094]Regression, Logistic
Comparison: Stages of Change, Exercise behaviorp-value: 0.008295% CI: [1.234, 4.111]Regression, Logistic
Comparison: Stages of Change, Smoking behaviorp-value: 0.295495% CI: [0.084, 2.12]Regression, Logistic
Comparison: Stages of Change, Healthier eating behaviorp-value: 0.566995% CI: [0.622, 2.376]Regression, Logistic
Comparison: Stages of Change, Stress behaviorp-value: 0.12195% CI: [0.341, 1.134]Regression, Logistic
Comparison: Weight reductionp-value: 0.835595% CI: [0.461, 1.872]Regression, Logistic
Comparison: Exercise behaviorp-value: 0.045995% CI: [1.011, 3.311]Regression, Logistic
Comparison: Smoking behaviorp-value: 0.46595% CI: [0.121, 2.629]Regression, Logistic
Comparison: Healthier eating behaviorp-value: 0.830395% CI: [0.478, 1.808]Regression, Logistic
Comparison: Stress behaviorp-value: 0.325495% CI: [0.744, 2.439]Regression, Logistic
Secondary
Total Cholesterol
Adjusted for baseline
Time frame: 12 months
Population: Randomization Arms/Groups were regrouped as pre-specified in the study protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching | Total Cholesterol | 212.86 mg/dL | Standard Deviation 4.01 |
| Non-Health Coaching | Total Cholesterol | 202.39 mg/dL | Standard Deviation 4.1 |
| Genetic Risk Counseling | Total Cholesterol | 207.07 mg/dL | Standard Deviation 3.99 |
| Non-Genetic Risk Counseling | Total Cholesterol | 208.51 mg/dL | Standard Deviation 4.27 |
p-value: 0.071Regression, Linear
p-value: 0.8069Regression, Linear
Secondary
Unmanaged Stress as Measured by the Perceived Stress Scale (PSS)
The PSS is a 10 item survey assessing feelings and thoughts of stress. Scores range from 0-40 with higher scores indicating higher perceived stress.
Time frame: 6 months
Population: Randomization Arms/Groups were regrouped as pre-specified in the study protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching | Unmanaged Stress as Measured by the Perceived Stress Scale (PSS) | 10.86 units on a scale | Standard Deviation 0.56 |
| Non-Health Coaching | Unmanaged Stress as Measured by the Perceived Stress Scale (PSS) | 11.43 units on a scale | Standard Deviation 0.56 |
| Genetic Risk Counseling | Unmanaged Stress as Measured by the Perceived Stress Scale (PSS) | 11.07 units on a scale | Standard Deviation 0.55 |
| Non-Genetic Risk Counseling | Unmanaged Stress as Measured by the Perceived Stress Scale (PSS) | 11.22 units on a scale | Standard Deviation 0.56 |
p-value: 0.4768Regression, Linear
p-value: 0.8452Regression, Linear