Lifestyle Improvement Through Food and Exercise (LIFE)Study

Rush

Status

Completed

Conditions

Type 2 Diabetes

Treatments

Behavioral: Standard of Care control group

Behavioral: Intensive education and lifestyle support

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01901952

R01DK092271-01 (U.S. NIH Grant/Contract)

1R01DK092271-01

Details and patient eligibility

About

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.

Full 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. 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.

Enrollment

211 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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