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

May 14, 2026 updated by: Duke University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
Other: Standard Risk Assessment
All 4 arms are assigned to receive standard assessment on coronary heart disease risk
Behavioral: Health Coaching
biweekly health coaching for 5 months
Experimental: SRA plus Genetic Testing
Other: Standard Risk Assessment
All 4 arms are assigned to receive standard assessment on coronary heart disease risk
Genetic: 9p21
Genetic testing results of 9p21
Experimental: SRA plus Health Coaching plus Genetic Testing
Other: Standard Risk Assessment
All 4 arms are assigned to receive standard assessment on coronary heart disease risk
Behavioral: Health Coaching
biweekly health coaching for 5 months
Genetic: 9p21
Genetic testing results of 9p21

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diet
Time Frame: 6 months
National Cancer Institute (NCI) Multifactor Screener
6 months
Physical Activity
Time Frame: 6 months
Stanford Brief Activity Scale (SBAS)
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Fasting blood glucose
Time Frame: 6 months
6 months
Systolic blood pressure
Time Frame: 6 months
6 months
Body mass index
Time Frame: 6 months
6 months
Waist circumference
Time Frame: 6 months
6 months
Low Density Cholesterol (LDL)
Time Frame: 6 months
6 months
Triglyceride
Time Frame: 6 months
6 months
Total cholesterol
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

October 15, 2012

First Submitted That Met QC Criteria

January 9, 2013

First Posted (Estimated)

January 11, 2013

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00029973

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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