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

Not Applicable

Completed

• Conditions: Coronary Heart Disease Risk
• Interventions: Behavioral: Health Coaching; Other: Standard Risk Assessment; Genetic: 9p21

• Registration Number: NCT01766271
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-15
• Study First Submitted QC: 2013-01-09
• Study First Posted: 2013-01-11
• Primary Completion: 2014-05
• Study Completion: 2014-10
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-06
• Last Update Posted: 2014-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

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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,

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
SRA plus Health Coaching	Health Coaching	-
Standard Risk Assessment (SRA) Only	Standard Risk Assessment	-
SRA plus Genetic Testing	9p21	-
SRA plus Health Coaching	Standard Risk Assessment	-
SRA plus Genetic Testing	Standard Risk Assessment	-
SRA plus Health Coaching plus Genetic Testing	Health Coaching	-
SRA plus Health Coaching plus Genetic Testing	9p21	-
SRA plus Health Coaching plus Genetic Testing	Standard Risk Assessment	-

Primary Outcome Measures

Name	Time	Method
Diet	6 months	National Cancer Institute (NCI) Multifactor Screener
Physical Activity	6 months	Stanford Brief Activity Scale (SBAS)

Secondary Outcome Measures

Name	Time	Method
Fasting blood glucose	6 months
Systolic blood pressure	6 months
Body mass index	6 months
Waist circumference	6 months
Low Density Cholesterol (LDL)	6 months
Triglyceride	6 months
Total cholesterol	6 months