GENErating Behavior Change, An Integrative Health Coaching and Genetic Risk Testing Pilot
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ClinicalTrials.gov Identifier: NCT01766271 |
Recruitment Status :
Completed
First Posted : January 11, 2013
Last Update Posted : November 7, 2014
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Sponsor:
Duke University
Information provided by (Responsible Party):
Duke University
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronary Heart Disease Risk | Behavioral: Health Coaching Genetic: 9p21 Other: Standard Risk Assessment | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 31 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Health Services Research |
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 |
Study Start Date : | October 2012 |
Actual Primary Completion Date : | May 2014 |
Actual Study Completion Date : | October 2014 |
Resource links provided by the National Library of Medicine

Arm | Intervention/treatment |
---|---|
Experimental: Standard Risk Assessment (SRA) Only |
Other: Standard Risk Assessment
All 4 arms are assigned to receive standard assessment on coronary heart disease risk |
Experimental: SRA plus Health Coaching |
Behavioral: Health Coaching
biweekly health coaching for 5 months Other: Standard Risk Assessment All 4 arms are assigned to receive standard assessment on coronary heart disease risk |
Experimental: SRA plus Genetic Testing |
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 |
Experimental: SRA plus Health Coaching plus Genetic Testing |
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 |
Primary Outcome Measures :
- Diet [ Time Frame: 6 months ]National Cancer Institute (NCI) Multifactor Screener
- Physical Activity [ Time Frame: 6 months ]Stanford Brief Activity Scale (SBAS)
Secondary Outcome Measures :
- Fasting blood glucose [ Time Frame: 6 months ]
- Systolic blood pressure [ Time Frame: 6 months ]
- Body mass index [ Time Frame: 6 months ]
- Waist circumference [ Time Frame: 6 months ]
- Low Density Cholesterol (LDL) [ Time Frame: 6 months ]
- Triglyceride [ Time Frame: 6 months ]
- Total cholesterol [ Time Frame: 6 months ]
Information from the National Library of Medicine

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Criteria
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,
No Contacts or Locations Provided
Responsible Party: | Duke University |
ClinicalTrials.gov Identifier: | NCT01766271 |
Other Study ID Numbers: |
Pro00029973 |
First Posted: | January 11, 2013 Key Record Dates |
Last Update Posted: | November 7, 2014 |
Last Verified: | November 2014 |
Keywords provided by Duke University:
Coronary heart disease cardiovascular disease risk |
Additional relevant MeSH terms:
Heart Diseases Coronary Disease Coronary Artery Disease Myocardial Ischemia |
Cardiovascular Diseases Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases |