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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01766271
Recruitment Status : Completed
First Posted : January 11, 2013
Last Update Posted : November 7, 2014
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Description
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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 Design
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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


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Diet [ Time Frame: 6 months ]
    National Cancer Institute (NCI) Multifactor Screener

  2. Physical Activity [ Time Frame: 6 months ]
    Stanford Brief Activity Scale (SBAS)


Secondary Outcome Measures :
  1. Fasting blood glucose [ Time Frame: 6 months ]
  2. Systolic blood pressure [ Time Frame: 6 months ]
  3. Body mass index [ Time Frame: 6 months ]
  4. Waist circumference [ Time Frame: 6 months ]
  5. Low Density Cholesterol (LDL) [ Time Frame: 6 months ]
  6. Triglyceride [ Time Frame: 6 months ]
  7. Total cholesterol [ Time Frame: 6 months ]

Eligibility Criteria
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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,
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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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:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
 Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases