Coronary Heart Disease RiskNCT01766271
GENErating Behavior Change, An Integrative Health Coaching and Genetic Risk Testing Pilot
A study testing Health Coaching, 9p21 and Standard Risk Assessment in people with Coronary Heart Disease Risk, run by Duke University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Heart Disease Risk
- What is being tested?
- Health Coaching, 9p21 and Standard Risk Assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18+,
- presence of at least one of the following:
- FPG > 100,
- HbA1c > 5.7%,
- diabetic,
- LDL > 129,
Show all 12Show fewer
- triglycerides > 150,
- total cholesterol > 200,
- SBP > 130,
- BMI > 25,
- able to speak and understand English,
- able and willing to give informed consent
Who cannot join
- 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,
About this study
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
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.
- Conditions
- Coronary Heart Disease Risk
- Being tested
- Health Coaching, 9p21, Standard Risk Assessment
- Keywords
- Coronary heart disease, cardiovascular disease, risk
- Medical subject headings
- Coronary Disease, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health CoachingBehavioural
biweekly health coaching for 5 months
9p21Genetic
Genetic testing results of 9p21
Standard Risk AssessmentOther
All 4 arms are assigned to receive standard assessment on coronary heart disease risk
| Study group | Role | What they receive |
|---|---|---|
| Standard Risk Assessment (SRA) Only | Experimental | Not described Receives: Other: Standard Risk Assessment |
| SRA plus Health Coaching | Experimental | Not described Receives: Behavioral: Health Coaching; Other: Standard Risk Assessment |
| SRA plus Genetic Testing | Experimental | Not described Receives: Genetic: 9p21; Other: Standard Risk Assessment |
| SRA plus Health Coaching plus Genetic Testing | Experimental | Not described Receives: Behavioral: Health Coaching; Genetic: 9p21; Other: Standard Risk Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet
National Cancer Institute (NCI) Multifactor Screener
Measured: 6 months
Physical Activity
Stanford Brief Activity Scale (SBAS)
Measured: 6 months
Secondary outcomes (7)
Fasting blood glucose
Measured: 6 months
Systolic blood pressure
Measured: 6 months
Body mass index
Measured: 6 months
Waist circumference
Measured: 6 months
Low Density Cholesterol (LDL)
Measured: 6 months
Triglyceride
Measured: 6 months
Total cholesterol
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startOct 2012
- Primary completionMay 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart Disease RiskStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01766271
- Sponsor's protocol ID
- Pro00029973
- Status last verified
- Nov 2014
- First submitted
- 15 Oct 2012
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01766271
- Acronym / sponsor ID
- Pro00029973
- Conditions
- Coronary Heart Disease Risk
- Keywords
- Coronary heart disease, cardiovascular disease, risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 11 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard Risk Assessment (SRA) Only | Experimental | Other: Standard Risk Assessment |
| SRA plus Health Coaching | Experimental | Behavioral: Health Coaching, Other: Standard Risk Assessment |
| SRA plus Genetic Testing | Experimental | Genetic: 9p21, Other: Standard Risk Assessment |
| SRA plus Health Coaching plus Genetic Testing | Experimental | Behavioral: Health Coaching, Genetic: 9p21, Other: Standard Risk Assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- age 18+,
- presence of at least one of the following:
- able to speak and understand English,
- able and willing to give informed consent
Key exclusion criteria (4 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Coachingbiweekly health coaching for 5 months | Behavioural | SRA plus Health Coaching, SRA plus Health Coaching plus Genetic Testing |
| 9p21Genetic testing results of 9p21 | Genetic | SRA plus Genetic Testing, SRA plus Health Coaching plus Genetic Testing |
| Standard Risk AssessmentAll 4 arms are assigned to receive standard assessment on coronary heart disease risk | Other | SRA plus Genetic Testing, SRA plus Health Coaching, SRA plus Health Coaching plus Genetic Testing, Standard Risk Assessment (SRA) Only |
Primary outcome
Diet
Time frame: 6 months
National Cancer Institute (NCI) Multifactor Screener
Physical Activity
Time frame: 6 months
Stanford Brief Activity Scale (SBAS)
7 secondary outcomes
Fasting blood glucose
Time frame: 6 months
Systolic blood pressure
Time frame: 6 months
Body mass index
Time frame: 6 months
Waist circumference
Time frame: 6 months
Low Density Cholesterol (LDL)
Time frame: 6 months
Triglyceride
Time frame: 6 months
Total cholesterol
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Health Coaching, 9p21 and Standard Risk Assessment in people with Coronary Heart Disease Risk, run by Duke University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diet (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.