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

Primary Purpose

Coronary Heart Disease Risk

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Health Coaching
9p21
Standard Risk Assessment
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Coronary Heart Disease Risk focused on measuring Coronary heart disease, cardiovascular disease, risk

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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,

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Standard Risk Assessment (SRA) Only

    SRA plus Health Coaching

    SRA plus Genetic Testing

    SRA plus Health Coaching plus Genetic Testing

    Arm Description

    Outcomes

    Primary Outcome Measures

    Diet
    National Cancer Institute (NCI) Multifactor Screener
    Physical Activity
    Stanford Brief Activity Scale (SBAS)

    Secondary Outcome Measures

    Fasting blood glucose
    Systolic blood pressure
    Body mass index
    Waist circumference
    Low Density Cholesterol (LDL)
    Triglyceride
    Total cholesterol

    Full Information

    First Posted
    October 15, 2012
    Last Updated
    November 6, 2014
    Sponsor
    Duke University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01766271
    Brief Title
    GENErating Behavior Change, An Integrative Health Coaching and Genetic Risk Testing Pilot
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2012 (undefined)
    Primary Completion Date
    May 2014 (Actual)
    Study Completion Date
    October 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Duke University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Heart Disease Risk
    Keywords
    Coronary heart disease, cardiovascular disease, risk

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    31 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard Risk Assessment (SRA) Only
    Arm Type
    Experimental
    Arm Title
    SRA plus Health Coaching
    Arm Type
    Experimental
    Arm Title
    SRA plus Genetic Testing
    Arm Type
    Experimental
    Arm Title
    SRA plus Health Coaching plus Genetic Testing
    Arm Type
    Experimental
    Intervention Type
    Behavioral
    Intervention Name(s)
    Health Coaching
    Intervention Description
    biweekly health coaching for 5 months
    Intervention Type
    Genetic
    Intervention Name(s)
    9p21
    Intervention Description
    Genetic testing results of 9p21
    Intervention Type
    Other
    Intervention Name(s)
    Standard Risk Assessment
    Intervention Description
    All 4 arms are assigned to receive standard assessment on coronary heart disease risk
    Primary Outcome Measure Information:
    Title
    Diet
    Description
    National Cancer Institute (NCI) Multifactor Screener
    Time Frame
    6 months
    Title
    Physical Activity
    Description
    Stanford Brief Activity Scale (SBAS)
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Fasting blood glucose
    Time Frame
    6 months
    Title
    Systolic blood pressure
    Time Frame
    6 months
    Title
    Body mass index
    Time Frame
    6 months
    Title
    Waist circumference
    Time Frame
    6 months
    Title
    Low Density Cholesterol (LDL)
    Time Frame
    6 months
    Title
    Triglyceride
    Time Frame
    6 months
    Title
    Total cholesterol
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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,

    12. IPD Sharing Statement

    Learn more about this trial

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

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