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

描述（由申请人提供）：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至4倍。血糖控制可以降低糖尿病并发症和住院的风险，并且可以通过药物治疗和生活方式的改变来改善。没有一项关于生活方式的试验在低收入的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，以实现低收入非洲裔美国糖尿病患者血糖控制的持续改善。LIFE（通过饮食和锻炼改善生活方式）项目是一项糖尿病自我管理项目，重点关注饮食和锻炼，其依据是对低收入非洲裔美国人饮食和健康模式的人类学研究。试点工作表明，LIFE项目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。当前研究的主要目的是确定LIFE项目是否能在12个月内实现血糖控制的持续改善。该试验将把患有糖尿病的低收入非洲裔美国成年人随机分为对照组和干预组，对照组接受标准的糖尿病教育，干预组接受LIFE项目，干预期为6个月（20个小组会议，有同伴支持电话），然后是18个月的维持期（每月一次的同伴支持电话和每季度一次的小组会议）。本研究的主要目的是比较接受LIFE项目的低收入非裔美国糖尿病患者与标准护理对照组患者在12个月时血糖控制的变化。我们的主要假设是，干预组患者的A1c从基线变化比对照组患者小。次要目的是比较接受LIFE项目的低收入非洲裔美国糖尿病患者与标准护理对照组的患者在24个月时血糖控制的变化；(b) 12个月时身体活动和总能量摄入的变化；(c) 24个月时身体活动和总能量摄入的变化；(d)获得后续试验所需的估计值，包括体重、血压和与糖尿病相关的住院情况。对于次要目标，我们假设：a)干预组的糖化血红蛋白在24个月内的平均变化小于对照组；B)在12个月时，更大比例的干预患者将达到每周150分钟适度活动的活动目标，干预组的平均总能量摄入将比对照组从基线减少更多；c)在24个月时，更大比例的干预患者将达到每周150分钟适度活动的活动目标，干预组的平均总能量摄入将比对照组从基线减少更多。

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.