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）证明，通过改变体力活动和饮食来减轻体重比药物干预更有效地预防2型糖尿病（DM）;然而，由于多种原因，DPP在社区中的应用滞后。健康生活伙伴关系，以预防糖尿病（帮助PD）试验（资助9月。2006 - 2011年8月）是一项转化研究，300名超重或肥胖的糖尿病前期患者随机接受常规护理（UC）或基于小组的生活方式干预（LI），由社区卫生工作者（CHW）促进，并由糖尿病护理中心的工作人员提供支持。到目前为止，招募，保留，干预和评估都很出色，6个月的体重平均减轻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。随访的资助时间统一为2年;因此，最早入组的受试者（2007年8月入组）将于2009年8月完成HELP PD的随访。本次竞争性更新的主要目的是通过将LI组随机分配至持续组维持（GM）或自我指导维持（SM），并随访UC组以进行额外比较，从而检测HELP PD干预的长期降糖作用。需要额外的资金，部分与当前的资金重叠，以便在参与者完成初始随访时重新招募他们，从而为那些继续GM的人提供无缝干预，并有机会在最终HELP PD访视后6个月开始开始新的随访访视，为期36-48个月。我们将测试长期GM与初始2年干预后SM的价值，以及真正的对照组（UC）的附加值，以确定生物学效应。次要结果包括其他生物学参数（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来评价HELP PD方法在维持血糖和体重变化以及其他生物学效应方面的有效性。值得注意的是，DPP的平均随访时间为3.2年。如果该申请获得批准，该队列的随访时间将从24个月延长至60-72个月，我们将能够过渡到延长维持期，而不会出现干预间隙;因此，我们完全有能力检验提出的假设。证明HELP PD的长期有效性是确定这种方法将DM预防转化为社区的价值的关键一步。这一关键证据将用于支持糖尿病预防的报销政策，HELP PD CHW方法的传播以及对其他行为影响的慢性病的推广。 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。该项目正在测试现有糖尿病预防转化研究（HELP PD）后长期维持方法对糖尿病风险测量的影响。虽然初步数据表明，HELP PD已成功地诱导短期减肥，但拟议的项目旨在研究长期维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.