Lifestyle Improvement Through Food and Exercise (LIFE)Study

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. The LIFE (Lifestyle Improvement through Food and Exercise) program is a
diabetes self-management program focused on diet and exercise, informed by anthropological
research on models of food and health among low-income African-Americans. Pilot work
demonstrated that the LIFE Program is effective in improving glycemic control among
low-income African Americans at 6-months. The main goal of the current study is to determine
whether the LIFE Program can achieve sustained improvements in glycemic control for 12
months. The trial will randomize low-income African American adults with diabetes to a
control group, which receives standard diabetes education, or an intervention group, which
receives the LIFE Program (28 group meetings with peer support telephone calls) followed by
a 6-month maintenance phase (quarterly group sessions with monthly peer support phone
calls). The primary aim of the proposed research is to compare low-income African American
diabetes patients receiving the LIFE Program with those in a standard of care control group
on change in glycemic control at 12 months. Our primary hypothesis is that patients in the
intervention group will achieve a change in A1c from baseline that is less than patients in
the control group. Secondary aims are to compare low-income African American diabetes
patients receiving the LIFE Program with those in a standard of care control group on (a)
change in glycemic control at 18 months; (b) change in physical activity and total energy
intake at 12 months; (c) change in physical activity and total energy intake at 18 months;
and (d) to obtain estimates needed for a subsequent trial, including weight, blood pressure,
and diabetes-related hospitalizations. For secondary aims we hypothesize that a) the
intervention group will achieve a mean 18-month change in A1C that is less than the change
in the control group; b) at 12 months, a greater proportion of intervention patients will
have achieved the activity goal of 150 minutes of moderate activity per week, and the
intervention group will achieve a greater reduction from baseline in mean total energy
intake than the control group; and c) at 18 months, a greater proportion of intervention
patients will have achieved the activity goal of 150 minutes of moderate activity per week,
and the intervention group will achieve a greater reduction from baseline in mean total
energy intake than the control group.

Inclusion Criteria:

- 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 Criteria:

- 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