GENErating Behavior Change, An Integrative Health Coaching and Genetic Risk Testing Pilot - Full Text View

Purpose

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.

Condition	Intervention
Coronary Heart Disease Risk	Behavioral: Health Coaching Genetic: 9p21 Other: Standard Risk Assessment


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Health Services Research
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

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Health Checkup Heart Diseases

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:

Diet [ Time Frame: 6 months ] [ Designated as safety issue: No ]
National Cancer Institute (NCI) Multifactor Screener
Physical Activity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Stanford Brief Activity Scale (SBAS)

Secondary Outcome Measures:

Fasting blood glucose [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Systolic blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Body mass index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Waist circumference [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Low Density Cholesterol (LDL) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Triglyceride [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Total cholesterol [ Time Frame: 6 months ] [ Designated as safety issue: No ]


Enrollment:	31
Study Start Date:	October 2012
Study Completion Date:	October 2014
Primary Completion Date:	May 2014 (Final data collection date for primary outcome measure)

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

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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,

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided

More Information

No publications provided


Responsible Party:	Duke University
ClinicalTrials.gov Identifier:	NCT01766271 History of Changes
Other Study ID Numbers:	Pro00029973
Study First Received:	October 15, 2012
Last Updated:	November 6, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by Duke University:


Coronary heart disease cardiovascular disease risk

Additional relevant MeSH terms:


Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia	Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases

ClinicalTrials.gov processed this record on February 27, 2015