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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01766271
First received: October 15, 2012
Last updated: March 5, 2014
Last verified: March 2014
  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:


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 ]

Estimated Enrollment: 40
Study Start Date: October 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 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: March 5, 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
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 27, 2014