Overview

This trial is active, not recruiting.

Condition type 2 diabetes
Treatments intensive education and lifestyle support, standard of care control group
Sponsor Rush University Medical Center
Collaborator National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date March 2012
End date July 2015
Trial size 210 participants
Trial identifier NCT01901952, 1RO1DK092271-01, R01DK092271-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
standard of care control group
Participants receive 2 diabetes education classes taught by a Certified Diabetes Educator. They also receive diabetes education newsletters every 2 months.
(Experimental)
intensive education and lifestyle support
Group classes for 12 months (weekly for 4 months, biweekly for 4 months, monthly for 4 months), weekly peer supporter telephone calls, and diabetes education newsletters every 2 months.

Primary Outcomes

Measure
Hemoglobin A1c
time frame: change from baseline to 12 months

Secondary Outcomes

Measure
Physical Activity
time frame: change from baseline to 12 months
Total Energy Intake
time frame: change from baseline to 12 months
Physical Measures
time frame: change from baseline to 12 months
Medications
time frame: change from baseline to 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Lifestyle Improvement Through Food and Exercise (LIFE) Study
Principal investigator Elizabeth Lynch, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Rush University Medical Center.