GENErating Behavior Change, An Integrative Health Coachin... | NCT01766271

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

NCT01766271

Sponsor

Duke University

Status

Completed

Last Update Posted

May 18, 2026Actual

Enrollment

31Actual

Phase

Not Applicable

Conditions

Coronary Heart Disease Risk

Interventions

Health Coaching
9p21
Standard Risk Assessment

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

May 2014Actual

Completion Date

Oct 2014Actual

First Submitted Date

Oct 15, 2012

First Submission Date that Met QC Criteria

Jan 9, 2013

First Posted Date

Jan 11, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 14, 2026

Last Update Posted Date

May 18, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Health Coaching	Behavioral	biweekly health coaching for 5 months	SRA plus Health Coaching SRA plus Health Coaching plus Genetic Testing

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Fasting blood glucose		6 months
Systolic blood pressure		6 months
Body mass index

Other Outcomes

Not provided

Eligibility Module

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,

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003327	Coronary Disease
D002318	Cardiovascular Diseases

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided