Status:
COMPLETED
CREATION Health Lifestyle Intervention
Lead Sponsor:
AdventHealth
Conditions:
Cardiovascular Risk
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The CREATION Health Lifestyle Intervention (CHLI) will study the effect of a lifestyle intervention program on the cardiovascular risk profile (blood pressure, BMI, and Hemoglobin A1C) of participants...
Detailed Description
The CREATION Health Lifestyle intervention is targeted at improving the cardiovascular risk profiles (blood pressure, BMI, and Hemoglobin A1C) of participants diagnosed with hypertension and/or type 2...
Eligibility Criteria
Inclusion
- Diagnosis of Type 2 Diabetes, fasting glucose \>125, or Hg A1C \>6.5% and/or
- Diagnosis of Hypertension
- Age 18 or older
- Agree to participate in all aspects of study intervention and assessments
- Able to give informed consent
- Access to home phone or mobile phone
Exclusion
- Current use of oral corticosteroids
- Current use of psychotropics for psychosis or bipolar disorder
- Use of weight-loss medication in the past 3 months
- Psychiatric hospitalization in the past 3 years
- Cancer diagnosis or treatment in the past 3 years
- History of MI, CABG, stroke, PTCA, balloon pump, etc in past 2 years
- Hemoglobin A1C 12% or more on two occasion in the past 6 months
- Pregnancy
- Severe debilitating medical condition that would interfere with completion of intervention
- Unable to speak, read, and understand English
Key Trial Info
Start Date :
May 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2018
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT03412175
Start Date
May 1 2016
End Date
August 1 2018
Last Update
August 29 2018
Active Locations (1)
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1
Florida Hospital
Orlando, Florida, United States, 32804