Healthy Living Partnership to Prevent Diabetes (HELP PD) Phase 3 (formerly TRIP)

描述(由申请人提供)：糖尿病预防计划(DPP)表明，通过改变体力活动和饮食来实现减肥在预防2型糖尿病(DM)方面比药物干预更有效；然而，由于多种原因，DPP在社区的翻译工作一直滞后。预防糖尿病健康生活伙伴关系(HELP PD)试验(资助于9月2006年8月至2011年8月)是一项转化性研究，涉及300名患有糖尿病前期的超重或肥胖患者，他们被随机分为两组，分别接受常规护理(UC)或由社区卫生工作者(CHW)协助、糖尿病护理中心工作人员支持的团体生活方式干预(LI)。到目前为止，招募、保留、干预和评估都很好，6个月的体重平均下降了6.4%。自2007年8月以来，我们已经招募了258名参与者，我们计划在2009年3月之前再招募42名参与者。跟进资助为期2年；因此，最早登记的参加者(于2007年8月登记)将于2009年8月完成对HELP PD的跟进。这项竞争性更新的主要目标是通过随机将LI组分为持续组维护(GM)或自我指导维护(SM)，并跟踪UC组进行额外比较，来测试Help PD干预的长期降糖效果。与现有资金部分重叠的额外资金被要求在参与者完成初步后续行动后重新招收他们，从而使那些继续接受全球机制干预的人有机会在最后的Help PD访问后6个月开始新的后续访问，再延长36-48个月的时间。我们将测试长期GM的价值与最初两年干预后SM的价值，并使用真实对照组(UC)的附加值来确定生物学效应。次要结果包括其他生物参数(胰岛素、血脂、血压、体重、腰围)、行为和成本效益。我们将有很好的能力评估帮助PD方法在维持血糖和体重变化以及其他生物效应方面的有效性。值得注意的是，民进党的平均随访时间为3.2年。如果这项申请获得批准，这个队列的随访时间将从24个月延长到60-72个月，我们将能够过渡到延长维护，而不会出现干预缺口；因此，我们处于有利地位，可以检验拟议的假设。证明HELP PD的长期有效性是确定这一方法将糖尿病预防转化为社区的价值的关键一步。这一关键证据将被用来支持糖尿病预防的补偿政策，传播HELP PD CHW方法，并推广到其他行为影响的慢性病。 公共卫生相关性：鉴于发病率、患病率和总体公共卫生负担的增加，预防糖尿病是一个关键的公共卫生问题。该项目正在测试一项现有的糖尿病预防转换研究(HELP PD)对衡量糖尿病风险的长期维持方法的影响。虽然初步数据表明，帮助PD已经成功地诱导了短期的体重减轻，但拟议的项目旨在研究长期保持减肥对糖尿病预防的影响。

DESCRIPTION (provided by applicant): The Diabetes Prevention Program (DPP) demonstrated that weight loss achieved through changes in physical activity and diet was more effective at preventing type 2 diabetes mellitus (DM) than a pharmacologic intervention; however, translation of the DPP into the community has lagged for multiple reasons. The Healthy Living Partnership to Prevent Diabetes (HELP PD) Trial (funded Sept. 2006 - Aug. 2011) is a translational study of 300 overweight or obese persons with pre-diabetes randomized to usual care (UC) or a group-based lifestyle intervention (LI) facilitated by community health workers (CHWs) and supported by staff of a Diabetes Care Center. To date, recruitment, retention, intervention, and assessment have been excellent and 6-month weight loss is averaging 6.4%. Since Aug. 2007, we have enrolled 258 participants, and we plan to enroll 42 more by Mar. 2009. Follow-up was funded for a uniform 2 years; hence, the earliest-enrolled participants (enrolled in Aug. 2007) will complete follow-up for HELP PD in Aug. 2009. The primary goal of this competitive renewal is to test the long-term glucose lowering effects of the HELP PD intervention by randomizing the LI group to continued group maintenance (GM) or self-directed maintenance (SM) and following the UC group for additional comparison purposes. Additional funding, partially overlapping with current funding, is requested to re-enroll participants as they complete initial follow-up, thus giving those who continue GM a seamless intervention and the opportunity to begin new follow-up visits 6 months after the final HELP PD visit for an additional 36-48 months. We will test the value of long-term GM versus an initial 2-year intervention followed by SM, with the added value of a true comparison group (UC) to define biological effects. Secondary outcomes include other biologic parameters (insulin, lipids, blood pressure, weight, waist), behaviors, and cost-effectiveness. We will have good power to evaluate the effectiveness of the HELP PD approach in maintaining glucose and weight change, and other biologic effects. Notably, follow-up in DPP was, on average, 3.2 years. If this application is approved, follow-up will be extended from 24 to 60-72 months for this cohort, and we will be able to transition into extended maintenance without a gap in intervention; hence, we are well positioned to test the proposed hypotheses. Demonstrating the longer term effectiveness of HELP PD represents a key step in establishing the value of this approach to translation of DM prevention into the community. This crucial evidence will be used to support reimbursement policy for DM prevention, dissemination of the HELP PD CHW approach and generalization to other behaviorally influenced chronic diseases. PUBLIC HEALTH RELEVANCE: In light of the increasing rates of incidence, prevalence, and overall public health burden, the prevention of diabetes is a critical public health issue. This project is testing the impact of a long-term maintenance approach following an existing diabetes prevention translational study (HELP PD) on measures of diabetes risk. Although preliminary data indicate that HELP PD has been successful at inducing short-term weight loss, the proposed project aims to examine the impact of long-term maintenance of weight loss on diabetes prevention.