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GENErating Behavior Change, An Integrative Health Coaching and Genetic Risk Testing Pilot
This study has been completed.
Sponsor:
Duke University
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01766271
First received: October 15, 2012
Last updated: November 6, 2014
Last verified: November 2014
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Purpose
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 | Intervention |
|---|---|
| Coronary Heart Disease Risk | Behavioral: Health Coaching Genetic: 9p21 Other: Standard Risk Assessment |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Duke University:
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 ]
| Enrollment: | 31 |
| Study Start Date: | October 2012 |
| Study Completion Date: | October 2014 |
| Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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,
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
No Contacts or Locations Provided
No Contacts or Locations Provided
More Information
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT01766271 History of Changes |
| Other Study ID Numbers: |
Pro00029973 |
| Study First Received: | October 15, 2012 |
| Last Updated: | November 6, 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 |
ClinicalTrials.gov processed this record on September 18, 2017