Trial record 15 of 18654 for:    coronary heart disease

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Duke University
Sponsor:
Collaborator:
David Grant U.S. Air Force Medical Center
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01884545
First received: June 19, 2013
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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 Intervention
Coronary Heart Disease, Susceptibility to, 5
Prediabetic State
Behavioral: Health coaching
Genetic: Genetic risk counseling
Behavioral: Standard risk assessment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Genetic Risk and Health Coaching for Type 2 Diabetes and Coronary Heart Disease

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Health behavior change [ Time Frame: 3, 6, 12 months ] [ Designated as safety issue: No ]
    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 (HC) intervention on health behavior change (diet, exercise habits, smoking cessation) over 12 months, with a focus on ADAF primary care patients.


Secondary Outcome Measures:
  • Clinical markers [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Determine the main and interactive effects of genetic risk information incorporated into standard CHD and T2D risk counseling and a telephonic HC intervention on clinical outcomes (fasting blood glucose (FBG), systolic blood pressure (SBP), body mass index (BMI), Low-density lipoprotein cholesterol (LDL), triglycerides (TRIG), total cholesterol (TC), AF composite fitness scores, Framingham risk score (FRS), Diabetes risk score.

  • Fitness status [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Assessment of fitness status per 2013 Air force fitness scores

  • Mediators of behavioral change [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    Following potential mediators of behavioral change will be assessed:

    • variables that may be affected by the presentation of genetic risk (perceived risk, worry and self‐efficacy specific to CHD and T2D)
    • level of CHD/T2D genetic risk (number of risk alleles) and consequent reclassification of FRS or Diabetes Risk Score (decreased, neutral, or increased)
    • patient activation
    • stages of change for behaviors of interest
    • psychosocial risk factors for CHD and/or T2D (depression, unmanaged stress, and social isolation)


Estimated Enrollment: 400
Study Start Date: July 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01884545

Locations
United States, California
David Grant Medical Center Recruiting
Fairfield, California, United States, 94535
Contact: Lacey Hess, RN,BSN    (707) 423-5396    lacey.hess.1.ctr@us.af.mil   
Contact: Eduardo Sevillia, BS    (707) 423-7263    eduardo.sevilla.ctr@us.af.mil   
Principal Investigator: Nicole Armitage, Lt Col,USAF,PhD         
McClellan Outpatient Satelite Clinic/VA Not yet recruiting
Sacremento, California, United States, 95652
Contact: Lacey Hess, RN, BSN    (707) 423-5396    lacey.hess.1.ctr@us.af.mil   
Principal Investigator: Nicole Armitage, Lt Col,USAF, PhD         
Sponsors and Collaborators
Duke University
David Grant U.S. Air Force Medical Center
Investigators
Principal Investigator: Allison Vorderstrasse, DNSc Duke University, School of Nursing
Principal Investigator: Ruth Wolever, PhD Duke University, Duke Intergrative Medicina
  More Information

Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01884545     History of Changes
Other Study ID Numbers: Pro00039569
Study First Received: June 19, 2013
Last Updated: August 14, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Duke University:
heart disease
type 2 diabetes
genetic testing
health coaching
risk assessment

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

ClinicalTrials.gov processed this record on August 21, 2014