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

Prediabetic State Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01884545
• Other study ID #: Pro00039569
• Status: Completed
• Phase: N/A
• First received: June 19, 2013
• Last updated: March 24, 2018
• Start date: July 2013
• Est. completion date: February 1, 2017

Study information

• Verified date: March 2017
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Description:

This study will examine the impact of providing genetic CHD and T2D risk information, with or without a supportive behavioral intervention, on promoting risk-reducing behaviors and improving clinical outcomes. In short, using a 4-group (2X2) randomized controlled trial (RCT) design, this study will determine whether incorporating multiple-marker genetic testing into risk counseling for CHD and T2D, coupled with a health coaching intervention will lead to greater changes in physical fitness, health behaviors, risk status and clinical outcomes in active-duty Air Force (ADAF), beneficiaries or dependents and AF retiree patients (N=400).

The study will address the following task objectives:

1. Determine the main and interactive effects of multiple-marker genetic risk information incorporated into standard CHD and T2D risk counseling (Standard Risk Assessment, or SRA) and an established, structured telephonic health coaching intervention on health behavior change (diet, exercise habits, smoking cessation) over 12 months, with a focus on ADAF patients, as well as their beneficiaries and retirees.

2. Determine the main and interactive effects of genetic risk information incorporated into standard CHD and T2D risk counseling and a telephonic health coaching intervention on clinical outcomes (fasting blood glucose, blood pressure, BMI, LDL, triglycerides, total cholesterol, AF composite fitness scores) over 12 months in this AF cohort.

Given the lack of RCTs on the effects of differing genetic test results, such as false reassurance and genetic determinism, we will also pursue a third, exploratory task objective:

3. Examine the differential effects of level of CHD and T2D genetic risk (# of risk alleles) on behavior change (diet, exercise habits, smoking cessation) and AF fitness scores at 12 months post baseline.

Baseline data collection: After screening and informed consent, height and weight, SBP, waist circumference, current lab results (FPG, total cholesterol, triglycerides, LDL, HbA1c, and HDL) and current PHA (physical health assessment) data with fitness scores ( for active duty personnel only) will be obtained from the medical records. Subjects randomized to the two genetic arms will have blood collected for testing of investigational CHD and T2D risk markers.

Randomization will take place to one of the following: SRA only; SRA plus genetic risk information (SRA+G); SRA plus health coaching (SRA+HC); or SRA, genetic risk information, and health coaching (SRA+G+HC).

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

Health coaching intervention: Participants in the two groups that include health coaching will be assigned to a trained health coach for a period of 6 months (n=200). IHC (Integrative Health Coaching) sessions will be provided by telephone using a structure that has evolved in multiple trials and clinical programs at Duke Integrative Medicine.

Six week, 3-, and 6-month follow-ups: At 6 weeks, 3 months and 6 months after the baseline visit, participants will be asked to complete selected surveys online.

6month and 12 month study visits: 12 months from the baseline visit, active duty participants will complete their annual PHA, required annual AF fitness testing; and all participants will complete study visits at 6 and 12 months for weight, waist circumference, BP, fasting glucose or HbA1c and lipid panels to be re-assessed. Surveys will be completed at or prior to the final 12 month visit as well.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: February 1, 2017
• Est. primary completion date: February 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease, Susceptibility to, 5
• Diabetes Mellitus, Type 2
• Disease Susceptibility
• Heart Diseases
• Myocardial Ischemia
• Prediabetic State

Intervention

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.

Locations

Country	Name	City	State
United States	David Grant Medical Center	Fairfield	California

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	David Grant U.S. Air Force Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

McCarthy MI. Genomics, type 2 diabetes, and obesity. N Engl J Med. 2010 Dec 9;363(24):2339-50. doi: 10.1056/NEJMra0906948. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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 c — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dietary Intake as Measured by Percent Energy From Fat	Dietary intake as measured by percent energy from fat, adjusted for baseline	12 months
Primary	Dietary Intake as Measured by Daily Grams of Fiber	Dietary intake as measured by daily grams of fiber, adjusted for baseline	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.	12 months
Primary	Smoking Status		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.	12 months
Primary	Weight	Weight in kg	12 months
Primary	Waist Circumference	Waist circumference in cm	12 months
Primary	Systolic Blood Pressure	Systolic blood pressure in mmHg	12 months
Primary	Diastolic Blood Pressure	Diastolic blood pressure in mmHg	12 months
Primary	High-density Lipoprotein (HDL)	High-density lipoprotein (HDL) in mg/dL	12 months
Primary	Low-density Lipoprotein (LDL)	Low-density lipoprotein (LDL) in mg/dL	12 months
Primary	Triglycerides	Triglycerides in mg/dL	12 months
Secondary	Fasting Blood Glucose	Adjusted for baseline	12 months
Secondary	Body Mass Index (BMI)		12 months
Secondary	Total Cholesterol	Adjusted for baseline	12 months
Secondary	AF Composite Fitness Scores	Last annual fitness exam result, collected as pass or fail	12 months
Secondary	Framingham Risk Score (FRS)		12 months
Secondary	Diabetes Risk Score		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.	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.	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.	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).	6 months
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.	6 months
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.	6 months
Secondary	Social Isolation	Single item to assess for availability of support person, where No=no support person.	6 months