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Clinical Trials/NCT01766271
NCT01766271
Completed
Not Applicable

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

Duke University0 sites31 target enrollmentOctober 2012
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ConditionsCoronary Heart Disease Risk

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Heart Disease Risk
Sponsor
Duke University
Enrollment
31
Primary Endpoint
Diet
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2012
End Date
October 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •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,

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,

Outcomes

Primary Outcomes

Diet

Time Frame: 6 months

National Cancer Institute (NCI) Multifactor Screener

Physical Activity

Time Frame: 6 months

Stanford Brief Activity Scale (SBAS)

Secondary Outcomes

  • Fasting blood glucose(6 months)
  • Systolic blood pressure(6 months)
  • Body mass index(6 months)
  • Waist circumference(6 months)
  • Low Density Cholesterol (LDL)(6 months)
  • Triglyceride(6 months)
  • Total cholesterol(6 months)

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