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

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ClinicalTrials.gov Identifier: NCT01884545

Recruitment Status : Completed

First Posted : June 24, 2013

Results First Posted : April 24, 2018

Last Update Posted : April 24, 2018

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

David Grant U.S. Air Force Medical Center

Information provided by (Responsible Party):

Duke University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Coronary Heart Disease, Susceptibility to, 5 Prediabetic State	Behavioral: Health coaching Genetic: Genetic risk counseling Behavioral: Standard risk assessment	Not Applicable

Show detailed description

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	220 participants
Allocation:	Randomized
Intervention Model:	Factorial Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Genetic Risk and Health Coaching for Type 2 Diabetes and Coronary Heart Disease
Study Start Date :	July 2013
Actual Primary Completion Date :	February 1, 2017
Actual Study Completion Date :	February 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Type 2 diabetes

MedlinePlus related topics: Coronary Artery Disease Heart Diseases

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	Behavioral: 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.
Experimental: 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	Behavioral: Health coaching Telephonic health coaching sessions with a trained certified health coach for a period of 6 months (total of 10 biweekly calls). Behavioral: 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.
Experimental: 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: 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. Behavioral: 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.
Experimental: 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.	Behavioral: Health coaching Telephonic health coaching sessions with a trained certified health coach for a period of 6 months (total of 10 biweekly calls). Genetic: 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. Behavioral: 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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01884545

Locations

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United States, California
David Grant Medical Center
Fairfield, California, United States, 94535

Sponsors and Collaborators

Duke University

David Grant U.S. Air Force Medical Center

Investigators

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Principal Investigator:	Allison Vorderstrasse, DNSc	Duke University, School of Nursing
Principal Investigator:	Ruth Wolever, PhD	Duke University, Duke Intergrative Medicina

Study Documents (Full-Text)

Documents provided by Duke University:

Study Protocol and Statistical Analysis Plan [PDF] June 1, 2017

More Information

Publications of Results:

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.

Other 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.

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.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Duke University
ClinicalTrials.gov Identifier:	NCT01884545
Other Study ID Numbers:	Pro00039569
First Posted:	June 24, 2013 Key Record Dates
Results First Posted:	April 24, 2018
Last Update Posted:	April 24, 2018
Last Verified:	March 2017

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Studies a U.S. FDA-regulated Drug Product:	No

Keywords provided by Duke University:


heart disease type 2 diabetes genetic testing health coaching risk assessment

Additional relevant MeSH terms:

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Heart Diseases Coronary Disease Coronary Artery Disease Myocardial Ischemia Diabetes Mellitus, Type 2 Prediabetic State Disease Susceptibility Diabetes Mellitus Glucose Metabolism Disorders	Metabolic Diseases Endocrine System Diseases Cardiovascular Diseases Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases Disease Attributes Pathologic Processes

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