Clinical trial NCT01884545: Genetic Risk and Health Coaching for Type 2 Diabetes and Coronary Heart Disease
Official title: Genetic Risk and Health Coaching for Type 2 Diabetes and Coronary Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Heart Disease, Susceptibility to, 5
Prediabetic State
Keywords: heart disease
type 2 diabetes
genetic testing
health coaching
risk assessment
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: David Grant U.S. Air Force Medical Center
First posted: 2013-06-24
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to examine whether the use of genetic test information and/or health coaching in patient risk counseling for heart disease and diabetes affect health behaviors and health outcomes in active-duty Air Force (ADAF), beneficiaries or dependents and Air Force retiree patients.

Total of 400 subjects will be enrolled. They will be randomly(like flipping a coin)assigned to 4 groups: 1)Standard risk assessment (SRA)only; 2)SRA plus genetic risk information (SRA+G); 3)SRA plus health coaching (SRA+HC); or 4)SRA, genetic risk information, and health coaching (SRA+G+HC). Subjects randomized to the two genetic arms will have blood collected for testing of investigational coronary heart disease (CHD) and type 2 diabetes (T2D) risk markers. Participants in the two groups that include health coaching will be assigned to a trained certified health coach for a period of 6 months. The duration of the study is 12 months with 3 in person visits (baseline, 6 months and 12 months) and completion of surveys at 6 weeks and 3 month time points.

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

The study will address the following task objectives:

1. Determine the main and interactive effects of multiple-marker genetic risk information incorporated into standard CHD and T2D risk counseling (Standard Risk Assessment, or SRA) and an established, structured telephonic health coaching intervention on health behavior change (diet, exercise habits, smoking cessation) over 12 months, with a focus on ADAF patients, as well as their beneficiaries and retirees.
2. Determine the main and interactive effects of genetic risk information incorporated into standard CHD and T2D risk counseling and a telephonic health coaching intervention on clinical outcomes (fasting blood glucose, blood pressure, BMI, LDL, triglycerides, total cholesterol, AF composite fitness scores) over 12 months in this AF cohort.

   Given the lack of RCTs on the effects of differing genetic test results, such as false reassurance and genetic determinism, we will also pursue a third, exploratory task objective:
3. Examine the differential effects of level of CHD and T2D genetic risk (# of risk alleles) on behavior change (diet, exercise habits, smoking cessation) and AF fitness scores at 12 months post baseline.

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

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

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

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

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

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

Eligibility 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

Primary outcomes:
measure: Dietary Intake as Measured by Percent Energy From Fat
timeFrame: 12 months
measure: Dietary Intake as Measured by Daily Grams of Fiber
timeFrame: 12 months
measure: Physical Activity, as Measured by the Stanford Brief Activity Survey (SBAS)
timeFrame: 12 months
measure: Smoking Status
timeFrame: 12 months
measure: Medication Adherence as Measured by Morisky Adherence Survey MMAS8
timeFrame: 12 months
measure: Weight
timeFrame: 12 months
measure: Waist Circumference
timeFrame: 12 months
measure: Systolic Blood Pressure
timeFrame: 12 months
measure: Diastolic Blood Pressure
timeFrame: 12 months
measure: High-density Lipoprotein (HDL)
timeFrame: 12 months
measure: Low-density Lipoprotein (LDL)
timeFrame: 12 months
measure: Triglycerides
timeFrame: 12 months
Secondary outcomes:
measure: Fasting Blood Glucose
timeFrame: 12 months
measure: Body Mass Index (BMI)
timeFrame: 12 months
measure: Total Cholesterol
timeFrame: 12 months
measure: AF Composite Fitness Scores
timeFrame: 12 months
measure: Framingham Risk Score (FRS)
timeFrame: 12 months
measure: Diabetes Risk Score
timeFrame: 12 months
measure: Perceived Risk for Coronary Heart Disease (CHD)
timeFrame: 6 months
measure: Perceived Risk for Type 2 Diabetes (T2D)
timeFrame: 6 months
measure: Patient Activation Score
timeFrame: 12 months
measure: Stages of Change
timeFrame: 6 months
measure: Depression, as Measured by the Beck Depression Inventory (BDI)
timeFrame: 6 months
measure: Unmanaged Stress as Measured by the Perceived Stress Scale (PSS)
timeFrame: 6 months
measure: Social Isolation
timeFrame: 6 months
Other outcomes:
Locations:
city: Fairfield
country: United States
facility: David Grant Medical Center
state: California
Study officials:
affiliation: Duke University, School of Nursing
name: Allison Vorderstrasse, DNSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University, Duke Intergrative Medicina
name: Ruth Wolever, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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. doi: 10.1056/NEJMoa062418.
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.
citation: 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.
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 care. Glob Adv Health Med. 2013 May;2(3):26-38. doi: 10.7453/gahmj.2013.035.
citation: 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.