Lifestyle Improvement Through Food and Exercise (LIFE)Study
Completed · Not applicable
Conditions studied: Type 2 Diabetes
In brief
The primary aim of the LIFE study is to compare low-income African American diabetes patients in a lifestyle intervention group with those in a standard of care control group on change in glycemic control at 12-months. We hypothesize that, on average, participants in the intervention group will achieve greater glycemic control at 12-months relative to their baseline A1c, than those in the control group.
Key facts
- Study ID
- NCT01901952
- Run by
- Rush University Medical Center
- People needed
- 211
- Starts
- 2012-03-01
- Expected to finish
- 2015-12-02
- Last updated by the study team
- 2017-05-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of type 2 diabetes mellitus (T2DM) and HbA1c > 7%;
- Patients must identify themselves as African American;
- Patients must be patients of Cook County Hospital ambulatory clinics;
- Primary care physician gives clearance for patient to participate in study and engage in moderate level physical activity.
You may not qualify if…
- BMI<18.5;
- Patient not on diabetes medication and with a HbA1c reading less than 7%
- End-stage renal disease, stroke with paresis, congestive heart failure (NYHA class 2-4), or other major end-organ complication of diabetes;
- Comorbid conditions limiting probable life span to <4 years (e.g. cancer, AIDS) or indication of end-stage complications of diabetes (kidney dialysis, or transplant, blindness, or lower extremity amputation);
- Receiving treatment for a major psychiatric disorder (i.e. schizophrenia);
- Unable to give informed consent;
- Under the age of 18;
- Has no access to a telephone (Phone contact is a critical component of the intervention).
- Cannot walk 2 blocks without stopping and resting.
- Impaired cognitive function as determined by mini-mental test.
- Lives in the same household as an active LIFE participant.
- Presence of sickle cell trait
Where it is running
- Cook County Health Clinics — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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