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

Coronary Heart Disease Risk Clinical Trial

Official title:

GENErating Change, An Integrative Health Coaching and Genetic Risk Testing Pilot in Primary Care: A Multidisciplinary Approach to Personalized Medicine Targeting CHD Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01766271
• Other study ID #: Pro00029973
• Status: Completed
• Phase: N/A
• First received: October 15, 2012
• Last updated: November 6, 2014
• Start date: October 2012
• Est. completion date: October 2014

Study information

• Verified date: November 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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,

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease Risk
• Heart Diseases
• Myocardial Ischemia

Intervention

Behavioral:
• Health Coaching
biweekly health coaching for 5 months

Genetic:
• 9p21
Genetic testing results of 9p21

Other:
• Standard Risk Assessment
All 4 arms are assigned to receive standard assessment on coronary heart disease risk

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diet	National Cancer Institute (NCI) Multifactor Screener	6 months	No
Primary	Physical Activity	Stanford Brief Activity Scale (SBAS)	6 months	No
Secondary	Fasting blood glucose		6 months	Yes
Secondary	Systolic blood pressure		6 months	No
Secondary	Body mass index		6 months	No
Secondary	Waist circumference		6 months	No
Secondary	Low Density Cholesterol (LDL)		6 months	No
Secondary	Triglyceride		6 months	No
Secondary	Total cholesterol		6 months	No