Coronary Heart Disease, Susceptibility to, 5NCT01884545

Genetic Risk and Health Coaching for Type 2 Diabetes and Coronary Heart Disease

A study testing Health coaching, Genetic risk counseling and Standard risk assessment in people with Coronary Heart Disease, Susceptibility to, 5 and Prediabetic State, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Coronary Heart Disease, Susceptibility to, 5, Prediabetic State
What is being tested?: Health coaching, Genetic risk counseling and Standard risk assessment
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 220 participants
Where: 1 siteUnited States
Study dates: Jul 2013to 1 Feb 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age 18 to 65 years
Willingness and ability to provide informed consent
Have an active email address and internet access
Physical exam in the last 12 months with the following documented evaluations in EMR (Electronic Medical record):
Blood pressure
Height and weight

Show all 15Show fewer

Fasting blood glucose or Hemoglobin A1C (HbA1c)
Lipid panel (TC, LDL, HDL, TRIG) with at least one of them outside of the normal ranges defined as:
i.BMI ≥ 25 kg/m2 (BMI = weight [kg] / ht [m]2)
ii.FPG > 100 AND ≤ 125 mg/dL
iii.HbA1c > 5.7% ≤ 6.4%
iv.SBP ≥ 130 mmHg
v.TC ≥ 200 mg/dL
vi.TRIG ≥ 150 mg/dL
vii.LDL ≥ 129 mg/dL

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

David Grant Medical Center
Fairfield, California, 94535

Other trials in United States

About this study

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.

Read the 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:

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.

Conditions: Coronary Heart Disease, Susceptibility to, 5, Prediabetic State
Being tested: Health coaching, Genetic risk counseling, Standard risk assessment
Keywords: heart disease, type 2 diabetes, genetic testing, health coaching, risk assessment
Medical subject headings: Coronary Disease, Prediabetic State, Heart Diseases, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Health coachingBehavioural
Telephonic health coaching sessions with a trained certified health coach for a period of 6 months (total of 10 biweekly calls).
Genetic risk counselingGenetic
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 assessmentBehavioural
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.

Study groups in NCT01884545
Study group	Role	What they receive
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. Receives: Behavioral: Standard risk assessment
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 Receives: Behavioral: Health coaching; Behavioral: Standard risk assessment
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. Receives: Genetic: Genetic risk counseling; Behavioral: Standard risk assessment
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. Receives: Behavioral: Health coaching; Genetic: Genetic risk counseling; Behavioral: Standard risk assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

Dietary Intake as Measured by Percent Energy From Fat
Dietary intake as measured by percent energy from fat, adjusted for baseline
Measured: 12 months
Dietary Intake as Measured by Daily Grams of Fiber
Dietary intake as measured by daily grams of fiber, adjusted for baseline
Measured: 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.
Measured: 12 months
Smoking Status
Measured: 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.
Measured: 12 months
Weight
Weight in kg
Measured: 12 months
Waist Circumference
Waist circumference in cm
Measured: 12 months
Systolic Blood Pressure
Systolic blood pressure in mmHg
Measured: 12 months
Diastolic Blood Pressure
Diastolic blood pressure in mmHg
Measured: 12 months
High-density Lipoprotein (HDL)
High-density lipoprotein (HDL) in mg/dL
Measured: 12 months
Low-density Lipoprotein (LDL)
Low-density lipoprotein (LDL) in mg/dL
Measured: 12 months
Triglycerides
Triglycerides in mg/dL
Measured: 12 months

Secondary outcomes (13)

Fasting Blood Glucose
Adjusted for baseline
Measured: 12 months
Body Mass Index (BMI)
Measured: 12 months
Total Cholesterol
Adjusted for baseline
Measured: 12 months
AF Composite Fitness Scores
Last annual fitness exam result, collected as pass or fail
Measured: 12 months
Framingham Risk Score (FRS)
Measured: 12 months
Diabetes Risk Score
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 6 months
Social Isolation
Single item to assess for availability of support person, where No=no support person.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 20131 Feb 2017

First posted24 Jun 2013 (estimated)
Study startJul 2013
Primary completion1 Feb 2017
Study completion1 Feb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Coronary Heart Disease, Susceptibility to, 5Studies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 220 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01884545
Sponsor's protocol ID: Pro00039569
Status last verified: Mar 2017
First submitted: 19 Jun 2013
Last updated: 24 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No

Publications

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.
PubMed 20159873
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.
PubMed 21142536
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.
PubMed 16855264
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.
PubMed 20142567
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.
PubMed 20031596
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.
PubMed 24416670
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.
PubMed 39454076
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.
PubMed 37249540
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.
PubMed 35417442

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Genetic Risk and Health Coaching for Type 2 Diabetes and Coronary Heart Disease
ClinicalTrials.gov ID: NCT01884545
Acronym / sponsor ID: Pro00039569
Conditions: Coronary Heart Disease, Susceptibility to, 5, Prediabetic State
Keywords: heart disease, type 2 diabetes, genetic testing, health coaching, risk assessment
Study type: Interventional
Recruitment status: Completed
Enrolment: 220 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: David Grant U.S. Air Force Medical Center
Study start: Jul 2013
Primary completion: 1 Feb 2017 (actual)
Study completion: 1 Feb 2017 (actual)
First posted: 24 Jun 2013 (estimated)
Results: Posted 24 Apr 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Risk Counseling Visit: Within four weeks after the baseline visit all participants will receive risk counseling with trained provider(s) at each clinic site.

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Standard Risk Assessment (SRA)	Active comparator	Behavioral: Standard risk assessmentSubjects 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	Behavioral: Health coaching, Behavioral: Standard risk assessmentIn 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	Genetic: Genetic risk counseling, Behavioral: Standard risk assessmentIn 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	Behavioral: Health coaching, Genetic: Genetic risk counseling, Behavioral: Standard risk assessmentIn addition to the standard risk assessment for CHD and T2D subjects will receive genetic risk counseling and health coaching intervention for 6 months.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

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)

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Health coachingTelephonic health coaching sessions with a trained certified health coach for a period of 6 months (total of 10 biweekly calls).	Behavioural	SRA plus Health Coaching (HC), SRA+HC+GRC
Genetic risk counselingIn 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	SRA plus Genetic Risk Counseling (GRC), SRA+HC+GRC
Standard risk assessmentStandard 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.	Behavioural	SRA plus Genetic Risk Counseling (GRC), SRA plus Health Coaching (HC), SRA+HC+GRC, Standard Risk Assessment (SRA)

Primary outcome

Dietary Intake as Measured by Percent Energy From Fat
Time frame: 12 months
Dietary intake as measured by percent energy from fat, adjusted for baseline
Dietary Intake as Measured by Daily Grams of Fiber
Time frame: 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)
Time frame: 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
Time frame: 12 months
Medication Adherence as Measured by Morisky Adherence Survey MMAS8
Time frame: 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
Time frame: 12 months
Weight in kg
Waist Circumference
Time frame: 12 months
Waist circumference in cm
Systolic Blood Pressure
Time frame: 12 months
Systolic blood pressure in mmHg
Diastolic Blood Pressure
Time frame: 12 months
Diastolic blood pressure in mmHg
High-density Lipoprotein (HDL)
Time frame: 12 months
High-density lipoprotein (HDL) in mg/dL
Low-density Lipoprotein (LDL)
Time frame: 12 months
Low-density lipoprotein (LDL) in mg/dL
Triglycerides
Time frame: 12 months
Triglycerides in mg/dL

13 secondary outcomes

Fasting Blood Glucose
Time frame: 12 months
Body Mass Index (BMI)
Time frame: 12 months
Total Cholesterol
Time frame: 12 months
AF Composite Fitness Scores
Time frame: 12 months
Framingham Risk Score (FRS)
Time frame: 12 months
Diabetes Risk Score
Time frame: 12 months
Perceived Risk for Coronary Heart Disease (CHD)
Time frame: 6 months
Perceived Risk for Type 2 Diabetes (T2D)
Time frame: 6 months
Patient Activation Score
Time frame: 12 months
Stages of Change
Time frame: 6 months
Depression, as Measured by the Beck Depression Inventory (BDI)
Time frame: 6 months
Unmanaged Stress as Measured by the Perceived Stress Scale (PSS)
Time frame: 6 months
Social Isolation
Time frame: 6 months

Results and safety

Results posted to the registry on 24 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Risk Assessment (SRA)	50	37
SRA Plus Health Coaching (HC)	49	31
SRA Plus Genetic Risk Counseling (GRC)	49	35
SRA+HC+GRC	52	43

Primary outcome: Dietary Intake as Measured by Percent Energy From Fat

Time frame: 12 months. Mean (Standard Deviation). Unit: percent energy from fat

Measure	Health Coaching n = 75	Non-Health Coaching n = 71	Genetic Risk Counseling n = 77	Non-Genetic Risk Counseling n = 69
Value	33.75 (0.5)	34.9 (0.5)	33.72 (0.47)	35.05 (0.52)

Health Coaching vs Non-Health Coaching: p = 0.1073, Regression, Linear
Genetic Risk Counseling vs Non-Genetic Risk Counseling: p = 0.0615, Regression, Linear

Population analysed: Randomization Arms/Groups were regrouped as pre-specified in the study protocol

Primary outcome: Dietary Intake as Measured by Daily Grams of Fiber

Time frame: 12 months. Mean (Standard Deviation). Unit: grams

Measure	Health Coaching n = 75	Non-Health Coaching n = 71	Genetic Risk Counseling n = 77	Non-Genetic Risk Counseling n = 69
Value	15.69 (0.51)	15.38 (0.51)	15.24 (0.49)	15.89 (0.54)

Health Coaching vs Non-Health Coaching: p = 0.6732, Regression, Linear
Genetic Risk Counseling vs Non-Genetic Risk Counseling: p = 0.3754, Regression, Linear

Population analysed: Randomization Arms/Groups were regrouped as pre-specified in the study protocol

Primary outcome: Physical Activity, as Measured by the Stanford Brief Activity Survey (SBAS)

Time frame: 12 months. Count of participants. Unit: Participants

Measure	Health Coaching n = 72	Non-Health Coaching n = 72	Genetic Risk Counseling n = 77	Non-Genetic Risk Counseling n = 67
Inative/light intensity activity	25	41	34	32
moderate intensity activity	30	18	23	25
hard/very hard intensity activity	17	13	20	10

Health Coaching vs Non-Health Coaching: Odds Ratio (OR): 2.853 (95% CI 1.326 to 6.139), p = 0.0073, Regression, Logistic
Genetic Risk Counseling vs Non-Genetic Risk Counseling: Odds Ratio (OR): 1.045 (95% CI 0.5 to 2.183), p = 0.9068, Regression, Logistic

Population analysed: Randomization Arms/Groups were regrouped as pre-specified in the study protocol. Some participants were not analyzed because data were missing.

Primary outcome: Smoking Status

Time frame: 12 months. Count of participants. Unit: Participants

Measure	Health Coaching n = 69	Non-Health Coaching n = 66	Genetic Risk Counseling n = 71	Non-Genetic Risk Counseling n = 64
Smoked in the last 30 days = No	65	63	67	61
Smoked in the last 30 days = Yes	4	3	4	3

Health Coaching vs Non-Health Coaching: Odds Ratio (OR): 1.333 (95% CI 0.173 to 10.254), p = 0.7822, Regression, Logistic
Genetic Risk Counseling vs Non-Genetic Risk Counseling: Odds Ratio (OR): 1.333 (95% CI 0.173 to 10.254), p = 0.7822, Regression, Logistic

Population analysed: Randomization Arms/Groups were regrouped as pre-specified in the study protocol. Some participants were not analyzed because data were missing.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: date of consent to 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Risk Assessment (SRA)	0 of 50 (0%)	0 of 50 (0%)	0 of 50
SRA Plus Health Coaching (HC)	1 of 49 (2%)	0 of 49 (0%)	0 of 49
SRA Plus Genetic Risk Counseling (GRC)	0 of 49 (0%)	0 of 49 (0%)	0 of 49
SRA+HC+GRC	0 of 52 (0%)	0 of 52 (0%)	0 of 52

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20159873Palomaki 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.
Background: PubMed 21142536McCarthy 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.
Background: PubMed 16855264Florez 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.
Background: PubMed 20142567Sheridan 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.
Background: PubMed 20031596Brautbar 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.
Results publication: PubMed 24416670Vorderstrasse 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.
Derived from this study: PubMed 39454076Lee 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.
Derived from this study: PubMed 37249540Lee 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.
Derived from this study: PubMed 35417442Yang 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Allison Vorderstrasse, DNSc principal investigator

Duke University, School of Nursing

Ruth Wolever, PhD principal investigator

Duke University, Duke Intergrative Medicina

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dietary Intake as Measured by Percent Energy From Fat (time frame: 12 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01884545, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2018.