Lifestyle Improvement Through Food and Exercise (LIFE) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 1
- 主要终点
- Hemoglobin A1c
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Hemoglobin A1c
时间窗: change from baseline to 12 months
Finger prick on Afinion machine
次要结局
- Physical Activity(change from baseline to 12 months)
- Total Energy Intake(change from baseline to 12 months)
- Medications(change from baseline to 12 months)
- Physical Measures(change from baseline to 12 months)