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OpenTrials
Completed

NCT Number: NCT01766271

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

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.

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Key information

Conditions

Coronary Heart Disease Risk Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Health Coaching

Behavioral

biweekly health coaching for 5 months

9p21

Genetic

Genetic testing results of 9p21

Standard Risk Assessment

Other

All 4 arms are assigned to receive standard assessment on coronary heart disease risk

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 11, 2013
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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