GENErating Behavior Change, An Integrative Health Coaching and Genetic Risk Testing Pilot
GENErating Change, An Integrative Health Coaching and Genetic Risk Testing Pilot in Primary Care: A Multidisciplinary Approach to Personalized Medicine Targeting CHD Risk
1 other identifier
interventional
31
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2012
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 15, 2012
CompletedFirst Posted
Study publicly available on registry
January 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedNovember 7, 2014
November 1, 2014
1.6 years
October 15, 2012
November 6, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Diet
National Cancer Institute (NCI) Multifactor Screener
6 months
Physical Activity
Stanford Brief Activity Scale (SBAS)
6 months
Secondary Outcomes (7)
Fasting blood glucose
6 months
Systolic blood pressure
6 months
Body mass index
6 months
Waist circumference
6 months
Low Density Cholesterol (LDL)
6 months
- +2 more secondary outcomes
Study Arms (4)
Standard Risk Assessment (SRA) Only
EXPERIMENTALSRA plus Health Coaching
EXPERIMENTALSRA plus Genetic Testing
EXPERIMENTALSRA plus Health Coaching plus Genetic Testing
EXPERIMENTALInterventions
biweekly health coaching for 5 months
Genetic testing results of 9p21
All 4 arms are assigned to receive standard assessment on coronary heart disease risk
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2012
First Posted
January 11, 2013
Study Start
October 1, 2012
Primary Completion
May 1, 2014
Study Completion
October 1, 2014
Last Updated
November 7, 2014
Record last verified: 2014-11