Lifestyle Improvement Through Food and Exercise (LIFE)Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

211 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2015-12-02

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard of care

Group Type ACTIVE_COMPARATOR

Standard of Care control group

Intervention Type BEHAVIORAL

Participants receive 2 diabetes education classes taught by a Certified Diabetes Educator. They also receive diabetes education newsletters every 2 months.

Intensive education and support

Group Type EXPERIMENTAL

Intensive education and lifestyle support

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No