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

LIFE 计划：非洲裔美国人血糖控制的行为方法

• 批准号: 8153644
• 负责人: ELIZABETH B LYNCH
• 金额: $ 64.19万
• 依托单位: RUSH UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-01 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8153644
• 关键词: Adherence; Adult; African American; Behavioral; Blood Glucose; Blood Pressure; Cardiovascular system; Chicago; Communities; Complications of Diabetes Mellitus; Control Groups; Diabetes Mellitus; Diabetes prevention; Diabetic Retinopathy; Disadvantaged; Drops; Effectiveness; End stage renal failure; Energy Intake; Enrollment; Exercise; Food; Goals; Group Meetings; Health Food; Hospitalization; Intervention; Life Style; Low income; Lower Extremity; Maintenance; Modeling; Moderate Exercise; Morbidity - disease rate; Participant; Patients; Pharmaceutical Preparations; Phase; Physical activity; Pilot Projects; Population; Randomized; Randomized Controlled Trials; Relative (related person); Research; Risk; Screening procedure; Self Management; Telephone; Testing; Time; Weight; Work; arm; base; blood glucose regulation; diabetes education; diet and exercise; effective intervention; effectiveness trial; experience; glycemic control; group intervention; high risk; improved; innovation; intervention effect; lifestyle intervention; mortality; peer; programs; skills; standard of care; success; therapy design

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. PUBLIC HEALTH RELEVANCE: This project evaluates the effectiveness of a diabetes self-management intervention targeting diet and exercise at improving glycemic control among low-income African Americans with diabetes. Information from this study will inform the design of an intervention to reduce diabetes complications and hospitalizations among low- income African Americans, and as such, reduce black-white disparities in diabetes morbidity and mortality.

描述（由申请人提供）：非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。没有任何生活方式试验能够持续改善低收入非裔美国人的血糖控制。该项目是一项随机对照试验，旨在测试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（通过食物和运动改善生活方式）计划是一项以饮食和运动为重点的糖尿病自我管理计划，其依据是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 计划可有效改善低收入非裔美国人 6 个月时的血糖控制。当前研究的主要目标是确定 LIFE 计划是否能够实现 12 个月内血糖控制的持续改善。该试验将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，对照组接受标准糖尿病教育，干预组接受 LIFE 计划，包括为期 6 个月的干预（20 次小组会议和同伴支持电话），随后是 18 个月的维持阶段（每月同伴支持电话和每季度小组会议）。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糖尿病患者与标准护理对照组患者 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 相对于基线的变化将小于对照组患者。次要目标是将接受 LIFE 计划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进行比较：(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的变化； (c) 24个月时体力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、血压和糖尿病相关的住院治疗。对于次要目标，我们假设 a) 干预组的 A1C 24 个月平均变化将小于对照组的变化； b) 在12个月时，更大比例的干预患者将实现每周150分钟中等活动的活动目标，并且干预组将比对照组实现平均总能量摄入较基线更大的减少； c) 在 24 个月时，更大比例的干预患者将实现每周 150 分钟中等活动的活动目标，并且干预组将比对照组实现平均总能量摄入较基线的更大减少。 公共卫生相关性：该项目评估糖尿病自我管理干预措施的有效性，该干预措施针对饮食和运动，以改善低收入非裔美国人糖尿病患者的血糖控制。这项研究的信息将为干预措施的设计提供信息，以减少低收入非裔美国人的糖尿病并发症和住院治疗，从而减少糖尿病发病率和死亡率的黑人和白人差异。