CREATION Health Lifestyle Intervention

Completed · Not applicable

Conditions studied: Cardiovascular Risk

In brief

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 diagnosed with hypertension and/or type 2 diabetes.

Key facts

Study ID

NCT03412175

Run by

AdventHealth

People needed

184

Starts

2016-05-01

Expected to finish

2018-08-01

Last updated by the study team

2018-08-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Florida Hospital — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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