Status:
COMPLETED
Lifestyle Improvement Through Food and Exercise (LIFE)Study
Lead Sponsor:
Rush University Medical Center
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Cook County Health
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 con...
Detailed Description
This project is a randomized controlled trial to test an innovative lifestyle intervention to achieve sustained improvements in glycemic control among low-income African American diabetes patients. Th...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2015
Estimated Enrollment :
211 Patients enrolled
Trial Details
Trial ID
NCT01901952
Start Date
March 1 2012
End Date
December 2 2015
Last Update
May 10 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cook County Health Clinics
Chicago, Illinois, United States