The LIFE Program: A Behavioral Approach to Glycemic Control in African Americans

描述(由申请者提供)：非洲裔美国人的糖尿病并发症和住院率是白人患者的1.5到4倍。血糖控制可以降低糖尿病并发症和住院的风险，并可以通过药物治疗和改变生活方式来改善。没有一种生活方式的试验在低收入非裔美国人的血糖控制方面取得了持续的改善。该项目是一项随机对照试验，旨在测试一种创新的生活方式干预措施，以实现低收入非裔美国糖尿病患者血糖控制的持续改善。LIFE(通过食物和锻炼改善生活方式)计划是一个糖尿病自我管理计划，专注于饮食和锻炼，借鉴了对低收入非裔美国人的食物和健康模式的人类学研究。试点工作表明，LIFE计划在改善低收入非裔美国人6个月时的血糖控制方面是有效的。目前这项研究的主要目标是确定LIFE计划是否能在12个月内实现血糖控制的持续改善。这项试验将把患有糖尿病的低收入非裔美国成年人随机分成对照组和干预组，对照组接受标准的糖尿病教育，干预组接受LIFE计划，干预的特点是6个月的干预(20个小组会议与同伴支持电话)，然后是18个月的维持阶段(每月的同伴支持电话和季度的小组会议)。这项拟议研究的主要目的是比较接受LIFE计划的低收入非裔美国人糖尿病患者和接受标准护理控制组的患者在12个月后血糖控制的变化。我们的基本假设是，干预组患者的糖化血红蛋白水平较基线水平的变化小于对照组患者。第二个目标是比较接受LIFE计划的低收入非裔美国人糖尿病患者和标准护理控制组的患者：(A)24个月时血糖控制的变化；(B)12个月时体力活动和总能量摄入量的变化；(C)24个月时体力活动和总能量摄入量的变化；以及(D)获得后续试验所需的估计，包括体重、血压和与糖尿病相关的住院治疗。对于次要目标，我们假设a)干预组A1C的平均24个月变化小于对照组；b)在12个月时，较大比例的干预患者将实现每周150分钟适度活动的活动目标，并且干预组将比对照组实现比基线更大的总能量摄入量的减少；以及c)在24个月时，较大比例的干预患者将达到每周150分钟的适度活动的活动目标，并且干预组的平均总能量摄入量将比对照组比基线更大的减少。

DESCRIPTION (provided by applicant): African Americans experience rates of diabetes complications and hospitalization which are between 1.5 and 4 times greater than white patients. Glycemic control reduces risk of diabetes complications and hospitalization, and can be improved through medication as well as lifestyle changes. No trial of lifestyle has achieved sustained improvements in glycemic control in low-income African Americans. 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, featuring a 6-month intervention (20 group meetings with peer support telephone calls) followed by an 18-month maintenance phase (monthly peer support phone calls and quarterly group sessions). 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 24 months; (b) change in physical activity and total energy intake at 12 months; (c) change in physical activity and total energy intake at 24 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 24- 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 24 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.