GENErating Behavior Change, An Integrative Health Coaching and Genetic Risk Testing Pilot

Duke University

Status: Completed

Conditions: Coronary Heart Disease Risk

Treatments: Genetic: 9p21; Behavioral: Health Coaching; Other: Standard Risk Assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT01766271

Pro00029973

Details and patient eligibility

About

The purpose of this 4 group (2x2) pilot randomized controlled trial is to test the feasibility and logistics of incorporating genetic risk information (9p21)into standard Coronary Heart Disease (CHD) risk counseling or health coaching intervention (or both) in primary care at 2 Duke Clinics.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age 18+,

• presence of at least one of the following:

  • FPG > 100,
  • HbA1c > 5.7%,
  • diabetic,
  • LDL > 129,
  • triglycerides > 150,
  • total cholesterol > 200,
  • SBP > 130,
  • BMI > 25,

• able to speak and understand English,

• able and willing to give informed consent

Exclusion criteria

• diagnosed CHD (MI or documented coronary artery disease),
• inability to ambulate or participate in physical activity,
• serious chronic disease related complications,
• current participation in a risk communication study for chronic disease,

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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31 participants in 4 patient groups

Standard Risk Assessment (SRA) Only

Experimental group

Treatment:

Other: Standard Risk Assessment

SRA plus Health Coaching

Experimental group

Treatment:

Behavioral: Health Coaching

Other: Standard Risk Assessment

SRA plus Genetic Testing

Experimental group

Treatment:

Genetic: 9p21

Other: Standard Risk Assessment

SRA plus Health Coaching plus Genetic Testing

Experimental group

Treatment:

Genetic: 9p21

Behavioral: Health Coaching

Other: Standard Risk Assessment