lifestyle improvement through food and exercise (life)study

Conditions: Type 2 Diabetes

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 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.

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.

Eligibility criteria:
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

Keywords: self management diabetes intervention