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

NCT ID: NCT01766271

Last Updated: 2014-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-10-31

Brief Summary

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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

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Conditions

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Coronary Heart Disease Risk

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Standard Risk Assessment (SRA) Only

Group Type EXPERIMENTAL

Standard Risk Assessment

Intervention Type OTHER

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

SRA plus Health Coaching

Group Type EXPERIMENTAL

Health Coaching

Intervention Type BEHAVIORAL

biweekly health coaching for 5 months

Standard Risk Assessment

Intervention Type OTHER

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

SRA plus Genetic Testing

Group Type EXPERIMENTAL

9p21

Intervention Type GENETIC

Genetic testing results of 9p21

Standard Risk Assessment

Intervention Type OTHER

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

SRA plus Health Coaching plus Genetic Testing

Group Type EXPERIMENTAL

Health Coaching

Intervention Type BEHAVIORAL

biweekly health coaching for 5 months

9p21

Intervention Type GENETIC

Genetic testing results of 9p21

Standard Risk Assessment

Intervention Type OTHER

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

Interventions

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Health Coaching

biweekly health coaching for 5 months

Intervention Type BEHAVIORAL

9p21

Genetic testing results of 9p21

Intervention Type GENETIC

Standard Risk Assessment

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

Intervention Type OTHER

Eligibility Criteria

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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,
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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Pro00029973

Identifier Type: -

Identifier Source: org_study_id