Status:
COMPLETED
Improving Heart Health in Appalachia
Lead Sponsor:
Debra Moser
Collaborating Sponsors:
University of Kentucky Center for Excellence in Rural Health-Hazard
Conditions:
Obesity
Hypertension
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
Individuals in Appalachian Kentucky are vulnerable to cardiovascular disease (CVD) by virtue of having high rates of multiple CVD risk factors. There is a critical need to develop and test CVD risk re...
Eligibility Criteria
Inclusion
- residents of eastern Appalachian Kentucky
- do not have a primary care provider
- at risk for CVD as reflected by having two or more of the following modifiable risk factors
- clinical diagnosis of hypertension or taking medications diagnosed for hypertension or found to be hypertensive on screening;
- clinical diagnosis of hyperlipidemia or taking medication for treating abnormal lipid levels, or any lipid abnormality found on screening that indicates hyperlipidemia;
- diagnosis of type 2 diabetes or HgA1c \> 7% found on screening;
- overweight or obese (body mass index ≥ 25 kg/m2);
- waist circumference \> 40 inches in men or \> 35 inches in women;
- clinical diagnosis of depression, on medications for depression or found to have depressive symptoms (score of \> 9 on the Patient Health Questionnaire-9) by baseline screening;
- sedentary lifestyle meaning that the individual does not engage in at least 30 minutes of moderate activity for at least 4 days per week
Exclusion
- known coronary artery disease, cerebrovascular disease, history of acute coronary syndrome or peripheral arterial disease;
- taking medications (e.g., protease inhibitors) that interfere with lipid metabolism;
- cognitive impairment that precludes an individual from understanding the consent process, answering questionnaires, or participating in the intervention;
- chronic drug abuse;
- end-stage renal or liver or pulmonary disease;
- current active cancer (i.e., undergoing active treatment for cancer) other than isolated skin cancer treatable by simple excision;
- gastrointestinal disease that requires special diets (e.g., Crohn's disease; celiac disease)
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2016
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT01884246
Start Date
August 1 2013
End Date
December 31 2016
Last Update
March 10 2017
Active Locations (1)
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1
University of Kentucky
Lexington, Kentucky, United States, 40535