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

NCT01884545 | Completed Results

• 1 other identifier: Pro00039569
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Heart Disease, Susceptibility to, 5; Prediabetic State

Keywords

heart disease; type 2 diabetes; genetic testing; health coaching; risk assessment

Outcome Measures

Primary Outcomes (12)

• Dietary Intake as Measured by Percent Energy From Fat

  Dietary intake as measured by percent energy from fat, adjusted for baseline

  12 months

• Dietary Intake as Measured by Daily Grams of Fiber

  Dietary intake as measured by daily grams of fiber, adjusted for baseline

  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.

  12 months

• Smoking Status

  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.

  12 months

• Weight

  Weight in kg

  12 months

• Waist Circumference

  Waist circumference in cm

  12 months

• Systolic Blood Pressure

  Systolic blood pressure in mmHg

  12 months

• Diastolic Blood Pressure

  Diastolic blood pressure in mmHg

  12 months

• High-density Lipoprotein (HDL)

  High-density lipoprotein (HDL) in mg/dL

  12 months

• Low-density Lipoprotein (LDL)

  Low-density lipoprotein (LDL) in mg/dL

  12 months

• Triglycerides

  Triglycerides in mg/dL

  12 months

Secondary Outcomes (13)

• Fasting Blood Glucose

  12 months

• Body Mass Index (BMI)

  12 months

• Total Cholesterol

  12 months

• AF Composite Fitness Scores

  12 months

• Framingham Risk Score (FRS)

  12 months

Study Arms (4)

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.

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

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.

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.

Behavioral: Health coaching; Genetic: Genetic risk counseling; Behavioral: Standard risk assessment

Interventions

Health coaching BEHAVIORAL

Telephonic health coaching sessions with a trained certified health coach for a period of 6 months (total of 10 biweekly calls).

SRA plus Health Coaching (HC); SRA+HC+GRC

Genetic risk counseling GENETIC

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.

SRA plus Genetic Risk Counseling (GRC); SRA+HC+GRC

Standard risk assessment BEHAVIORAL

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.

SRA plus Genetic Risk Counseling (GRC); SRA plus Health Coaching (HC); SRA+HC+GRC; Standard Risk Assessment (SRA)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• David Grant U.S. Air Force Medical Center: collaborator

Study Sites (1)

David Grant Medical Center

Fairfield, California, 94535, United States

Location

Related Publications (9)

• 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.

  PMID: 20159873 BACKGROUND

• 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.

  PMID: 21142536 BACKGROUND

• 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.

  PMID: 16855264 BACKGROUND

• 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.

  PMID: 20142567 BACKGROUND

• 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.

  PMID: 20031596 BACKGROUND

• 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.

  PMID: 24416670 RESULT

• 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.

  PMID: 39454076 DERIVED

• 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.

  PMID: 37249540 DERIVED

• 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.

  PMID: 35417442 DERIVED

MeSH Terms

Conditions

Coronary Disease; Prediabetic State; Heart Diseases; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Cardiovascular Diseases; Vascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Allison A. Vorderstrasse, DNSc, APRN, FAAN
• Organization: NYU Rory Meyers College of Nursing

allisonvorderstrasse@nyu.edu

212-998-5786

Study Officials

• Allison Vorderstrasse, DNSc

  Duke University, School of Nursing

  PRINCIPAL INVESTIGATOR

• Ruth Wolever, PhD

  Duke University, Duke Intergrative Medicina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2013
• First Posted: June 24, 2013
• Study Start: July 1, 2013
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: April 24, 2018
• Results First Posted: April 24, 2018

Record last verified: 2017-03

Locations

US (1)