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| Name | Class |
|---|---|
| David Grant U.S. Air Force Medical Center | FED |
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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.
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:
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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Risk Assessment (SRA) | Active Comparator | 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. |
|
| SRA plus Health Coaching (HC) | Experimental | In addition to the standard risk assessment for CHD and T2D subjects will receive health coaching intervention for 6 months |
|
| SRA plus Genetic Risk Counseling (GRC) | Experimental | 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. |
|
| SRA+HC+GRC | Experimental | In addition to the standard risk assessment for CHD and T2D subjects will receive genetic risk counseling and health coaching intervention for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health coaching | Behavioral | Telephonic health coaching sessions with a trained certified health coach for a period of 6 months (total of 10 biweekly calls). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dietary Intake as Measured by Percent Energy From Fat | Dietary intake as measured by percent energy from fat, adjusted for baseline | 12 months |
| Dietary Intake as Measured by Daily Grams of Fiber | Dietary intake as measured by daily grams of fiber, adjusted for baseline | 12 months |
| 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. | 12 months |
| Smoking Status | 12 months | |
| 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. | 12 months |
| Weight | Weight in kg | 12 months |
| Waist Circumference |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Blood Glucose | Adjusted for baseline | 12 months |
| Body Mass Index (BMI) | 12 months | |
| Total Cholesterol |
Not provided
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):
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:
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| Name | Affiliation | Role |
|---|---|---|
| Allison Vorderstrasse, DNSc | Duke University, School of Nursing | Principal Investigator |
| Ruth Wolever, PhD | Duke University, Duke Intergrative Medicina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| David Grant Medical Center | Fairfield | California | 94535 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20159873 | Background | Palomaki GE, Melillo S, Bradley LA. Association between 9p21 genomic markers and heart disease: a meta-analysis. JAMA. 2010 Feb 17;303(7):648-56. doi: 10.1001/jama.2010.118. | |
| 21142536 | Background | McCarthy MI. Genomics, type 2 diabetes, and obesity. N Engl J Med. 2010 Dec 9;363(24):2339-50. doi: 10.1056/NEJMra0906948. No abstract available. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Dietary Intake as Measured by Percent Energy From Fat | Dietary intake as measured by percent energy from fat, adjusted for baseline | Randomization Arms/Groups were regrouped as pre-specified in the study protocol | Posted | Mean | Standard Deviation | percent energy from fat | 12 months |
|
date of consent to 12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastric Hemorrhage | Gastrointestinal disorders | CTCAE v.4 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Allison A. Vorderstrasse, DNSc, APRN, FAAN | NYU Rory Meyers College of Nursing | 212-998-5786 | allisonvorderstrasse@nyu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2017 | Jan 31, 2018 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D011236 | Prediabetic State |
| D006331 | Heart Diseases |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D003920 | Diabetes Mellitus |
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| Genetic risk counseling | Genetic | 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 | Behavioral | 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. |
|
Waist circumference in cm
| 12 months |
| Systolic Blood Pressure | Systolic blood pressure in mmHg | 12 months |
| Diastolic Blood Pressure | Diastolic blood pressure in mmHg | 12 months |
| High-density Lipoprotein (HDL) | High-density lipoprotein (HDL) in mg/dL | 12 months |
| Low-density Lipoprotein (LDL) | Low-density lipoprotein (LDL) in mg/dL | 12 months |
| Triglycerides | Triglycerides in mg/dL | 12 months |
Adjusted for baseline |
| 12 months |
| AF Composite Fitness Scores | Last annual fitness exam result, collected as pass or fail | 12 months |
| Framingham Risk Score (FRS) | 12 months |
| Diabetes Risk Score | 12 months |
| 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. | 6 months |
| 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. | 6 months |
| 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. | 12 months |
| 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). | 6 months |
| 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. | 6 months |
| 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. | 6 months |
| Social Isolation | Single item to assess for availability of support person, where No=no support person. | 6 months |
| 16855264 | Background | Florez JC, Jablonski KA, Bayley N, Pollin TI, de Bakker PI, Shuldiner AR, Knowler WC, Nathan DM, Altshuler D; Diabetes Prevention Program Research Group. TCF7L2 polymorphisms and progression to diabetes in the Diabetes Prevention Program. N Engl J Med. 2006 Jul 20;355(3):241-50. doi: 10.1056/NEJMoa062418. |
| 20142567 | Background | Sheridan SL, Viera AJ, Krantz MJ, Ice CL, Steinman LE, Peters KE, Kopin LA, Lungelow D; Cardiovascular Health Intervention Research and Translation Network Work Group on Global Coronary Heart Disease Risk. The effect of giving global coronary risk information to adults: a systematic review. Arch Intern Med. 2010 Feb 8;170(3):230-9. doi: 10.1001/archinternmed.2009.516. |
| 20031596 | Background | Brautbar A, Ballantyne CM, Lawson K, Nambi V, Chambless L, Folsom AR, Willerson JT, Boerwinkle E. Impact of adding a single allele in the 9p21 locus to traditional risk factors on reclassification of coronary heart disease risk and implications for lipid-modifying therapy in the Atherosclerosis Risk in Communities study. Circ Cardiovasc Genet. 2009 Jun;2(3):279-85. doi: 10.1161/CIRCGENETICS.108.817338. Epub 2009 Apr 21. |
| 24416670 | Result | Vorderstrasse AA, Ginsburg GS, Kraus WE, Maldonado MC, Wolever RQ. Health coaching and genomics-potential avenues to elicit behavior change in those at risk for chronic disease: protocol for personalized medicine effectiveness study in air force primary care. Glob Adv Health Med. 2013 May;2(3):26-38. doi: 10.7453/gahmj.2013.035. |
| 39454076 | Derived | Lee C, Yang Q, Vorderstrasse A, Wolever RQ. Health Coaching Impacts Stage-Specific Transitions in Multiple Health Behaviors for Patients at High Risk for Coronary Heart Disease and Type 2 Diabetes: A Multigroup Latent Transition Analysis. J Cardiovasc Nurs. 2025 Sep-Oct 01;40(5):E220-E230. doi: 10.1097/JCN.0000000000001154. Epub 2024 Oct 24. |
| 37249540 | Derived | Lee C, Wolever RQ, Min SH, Vorderstrasse AA, Yang Q. Network Psychometrics of the 10-Item Perceived Stress Scale Among Patients With High Cardiovascular and Type 2 Diabetes Risk Using Exploratory Graph Analysis. J Cardiovasc Nurs. 2024 Mar-Apr 01;39(2):E36-E43. doi: 10.1097/JCN.0000000000000996. Epub 2023 May 29. Dutch, English. |
| 35417442 | Derived | Yang Q, Zhao A, Lee C, Wang X, Vorderstrasse A, Wolever RQ. Latent Profile/Class Analysis Identifying Differentiated Intervention Effects. Nurs Res. 2022 Sep-Oct 01;71(5):394-403. doi: 10.1097/NNR.0000000000000597. Epub 2022 Apr 14. |
| Patient withdrawn |
|
| Non-adherence |
|
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Dietary Intake (Percent energy from fat) | Mean | Standard Deviation | percent |
|
| Dietary Intake (Daily grams of fiber) | Mean | Standard Deviation | grams |
|
| Physical Activity | Count of Participants | Participants |
|
| Smoking Status | Count of Participants | Participants |
|
| Medication Adherence (Morisky 4) | The Medication Adherence (Morisky 4) data was only collected for patients who were taking medication | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Waist Circumference | Mean | Standard Deviation | cm |
|
| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| High-density Lipoprotein (HDL) | Mean | Standard Deviation | mg/dL |
|
| Low-density Lipoprotein (LDL) | Mean | Standard Deviation | mg/dL |
|
| Triglycerides | Mean | Standard Deviation | mg/dL |
|
Patients who received genetic risk counseling |
| OG003 | Non-Genetic Risk Counseling | Patients who did not receive genetic risk counseling |
|
|
|
| Primary | Dietary Intake as Measured by Daily Grams of Fiber | Dietary intake as measured by daily grams of fiber, adjusted for baseline | Randomization Arms/Groups were regrouped as pre-specified in the study protocol | Posted | Mean | Standard Deviation | grams | 12 months |
|
|
|
|
| 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. | Randomization Arms/Groups were regrouped as pre-specified in the study protocol. Some participants were not analyzed because data were missing. | Posted | Count of Participants | Participants | 12 months |
|
|
|
|
| Primary | Smoking Status | Randomization Arms/Groups were regrouped as pre-specified in the study protocol. Some participants were not analyzed because data were missing. | Posted | Count of Participants | Participants | 12 months |
|
|
|
|
| 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. | Randomization Arms/Groups were regrouped as pre-specified in the study protocol | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
|
| Primary | Weight | Weight in kg | Randomization Arms/Groups were regrouped as pre-specified in the study protocol | Posted | Mean | Standard Deviation | kg | 12 months |
|
|
|
|
| Primary | Waist Circumference | Waist circumference in cm | Randomization Arms/Groups were regrouped as pre-specified in the study protocol | Posted | Mean | Standard Deviation | cm | 12 months |
|
|
|
|
| Primary | Systolic Blood Pressure | Systolic blood pressure in mmHg | Randomization Arms/Groups were regrouped as pre-specified in the study protocol | Posted | Mean | Standard Deviation | mmHg | 12 months |
|
|
|
|
| Primary | Diastolic Blood Pressure | Diastolic blood pressure in mmHg | Randomization Arms/Groups were regrouped as pre-specified in the study protocol | Posted | Mean | Standard Deviation | mmHg | 12 months |
|
|
|
|
| Primary | High-density Lipoprotein (HDL) | High-density lipoprotein (HDL) in mg/dL | Randomization Arms/Groups were regrouped as pre-specified in the study protocol | Posted | Mean | Standard Deviation | mg/dL | 12 months |
|
|
|
|
| Primary | Low-density Lipoprotein (LDL) | Low-density lipoprotein (LDL) in mg/dL | Randomization Arms/Groups were regrouped as pre-specified in the study protocol | Posted | Mean | Standard Deviation | mg/dL | 12 months |
|
|
|
|
| Primary | Triglycerides | Triglycerides in mg/dL | Randomization Arms/Groups were regrouped as pre-specified in the study protocol | Posted | Mean | Standard Deviation | mg/dL | 12 months |
|
|
|
|
| Secondary | Fasting Blood Glucose | Adjusted for baseline | Randomization Arms/Groups were regrouped as pre-specified in the study protocol | Posted | Mean | Standard Deviation | mg/dL | 12 months |
|
|
|
|
| Secondary | Body Mass Index (BMI) | Randomization Arms/Groups were regrouped as pre-specified in the study protocol | Posted | Mean | Standard Deviation | kg/m2 | 12 months |
|
|
|
|
| Secondary | Total Cholesterol | Adjusted for baseline | Randomization Arms/Groups were regrouped as pre-specified in the study protocol | Posted | Mean | Standard Deviation | mg/dL | 12 months |
|
|
|
|
| Secondary | AF Composite Fitness Scores | Last annual fitness exam result, collected as pass or fail | 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. | Posted | Count of Participants | Participants | 12 months |
|
|
|
|
| Secondary | Framingham Risk Score (FRS) | risk score data was only collected and calculated at baseline | Posted | 12 months |
|
|
| Secondary | Diabetes Risk Score | risk score data was only collected and calculated at baseline | Posted | 12 months |
|
|
| 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. | Randomization Arms/Groups were regrouped as pre-specified in the study protocol | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
|
| 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. | Randomization Arms/Groups were regrouped as pre-specified in the study protocol | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
|
| 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. | Randomization Arms/Groups were regrouped as pre-specified in the study protocol | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
|
| 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). | Randomization Arms/Groups were regrouped as pre-specified in the study protocol | Posted | Count of Participants | Participants | 6 months |
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| 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. | Randomization Arms/Groups were regrouped as pre-specified in the study protocol | Posted | Mean | Standard Deviation | units on a scale | 6 months |
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| 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. | Randomization Arms/Groups were regrouped as pre-specified in the study protocol | Posted | Mean | Standard Deviation | units on a scale | 6 months |
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| Secondary | Social Isolation | Single item to assess for availability of support person, where No=no support person. | 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. | Posted | Count of Participants | Participants | 6 months |
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| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | 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. | 0 | 49 | 1 | 49 | 0 | 49 |
| EG002 | 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. | 0 | 49 | 0 | 49 | 0 | 49 |
| EG003 | 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. | 0 | 52 | 0 | 52 | 0 | 52 |
Not provided
Not provided
| D044882 |
| Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| Superiority |
| moderate intensity activity |
|
| hard/very hard intensity activity |
|
| Odds Ratio (OR) |
| 1.045 |
| 2-Sided |
| 95 |
| 0.5 |
| 2.183 |
| Superiority |
| Smoked in the last 30 days = Yes |
|
| Odds Ratio (OR) |
| 1.333 |
| 2-Sided |
| 95 |
| 0.173 |
| 10.254 |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Pass |
|
| Superiority |
| Personal control |
|
| Treatment control |
|
| Emotional representations |
|
| 0.0636 |
| Superiority |
| Perceived Risk for CHD, Treatment control | Regression, Linear | 0.2063 | Superiority |
| Perceived Risk for CHD, Emotional representations | Regression, Linear | 0.2529 | Superiority |
| Perceived Risk for coronary heart disease (CHD), Consequences subscale | Regression, Linear | 0.1085 | Superiority |
| Perceived Risk for coronary heart disease (CHD), personal control subscale | Regression, Linear | 0.3370 | Superiority |
| Perceived Risk for coronary heart disease (CHD), treatment control subscale | Regression, Linear | 0.3483 | Superiority |
| Perceived Risk for coronary heart disease (CHD), emotional representations | Regression, Linear | 0.5384 | Superiority |
| Personal control |
|
| Treatment control |
|
| Emotional representations |
|
| 0.6378 |
| Superiority |
| Perceived Risk for T2D, Treatment control | Regression, Linear | 0.3209 | Superiority |
| Perceived Risk for T2D, Emotional representations | Regression, Linear | 0.0058 | Superiority |
| Perceived Risk for type 2 diabetes (T2D), Consequences subscale | Regression, Linear | 0.3769 | Superiority |
| Perceived Risk for type 2 diabetes (T2D), personal control | Regression, Linear | 0.0872 | Superiority |
| Perceived Risk for type 2 diabetes (T2D), treatment control | Regression, Linear | 0.4302 | Superiority |
| Perceived Risk for type 2 diabetes (T2D), emotional representations | Regression, Linear | 0.4133 | Superiority |
| Superiority |
| Weight reduction: Contemplation |
|
| Weight reduction: Preparation |
|
| Weight reduction: Action |
|
| Weight reduction: Maintenance |
|
| Exercise behavior: Pre-contemplation |
|
| Exercise behavior: Contemplation |
|
| Exercise Behavior: Preparation |
|
| Exercise Behavior: Action |
|
| Exercise Behavior: Maintenance |
|
| Smoking behavior: Pre-contemplation |
|
| Smoking behavior: Contemplation |
|
| Smoking behavior: Preparation |
|
| Smoking behavior: Action |
|
| Healthier eating behavior: Pre-contemplation |
|
| Healthier eating behavior: Contemplation |
|
| Healthier eating behavior: Preparation |
|
| Healthier eating behavior: Action |
|
| Healthier eating behavior: Maintenance |
|
| Stress behavior: Pre-contemplation |
|
| Stress behavior: Contemplation |
|
| Stress behavior: Preparation |
|
| Stress behavior: Action |
|
| Stress behavior: Maintenance |
|
| 0.0082 |
| Odds Ratio (OR) |
| 2.252 |
| 2-Sided |
| 95 |
| 1.234 |
| 4.111 |
| Superiority |
| Stages of Change, Smoking behavior | Regression, Logistic | 0.2954 | Odds Ratio (OR) | 0.423 | 2-Sided | 95 | 0.084 | 2.120 | Superiority |
| Stages of Change, Healthier eating behavior | Regression, Logistic | 0.5669 | Odds Ratio (OR) | 1.216 | 2-Sided | 95 | 0.622 | 2.376 | Superiority |
| Stages of Change, Stress behavior | Regression, Logistic | 0.1210 | Odds Ratio (OR) | 0.622 | 2-Sided | 95 | 0.341 | 1.134 | Superiority |
| Weight reduction | Regression, Logistic | 0.8355 | Odds Ratio (OR) | 0.928 | 2-Sided | 95 | 0.461 | 1.872 | Superiority |
| Exercise behavior | Regression, Logistic | 0.0459 | Odds Ratio (OR) | 1.830 | 2-Sided | 95 | 1.011 | 3.311 | Superiority |
| Smoking behavior | Regression, Logistic | 0.4650 | Odds Ratio (OR) | 0.563 | 2-Sided | 95 | 0.121 | 2.629 | Superiority |
| Healthier eating behavior | Regression, Logistic | 0.8303 | Odds Ratio (OR) | 0.930 | 2-Sided | 95 | 0.478 | 1.808 | Superiority |
| Stress behavior | Regression, Logistic | 0.3254 | Odds Ratio (OR) | 1.347 | 2-Sided | 95 | 0.744 | 2.439 | Superiority |
| Superiority |
| Superiority |
| Social Support=Yes |
|