Enhancing the Diabetes Prevention Program to promote weight loss among non-responders in a community based lifestyle intervention

项目摘要 肥胖是头号和最可预防的2型糖尿病（T2 D）的危险因素，尽管有200亿美元， 每年花费在饮食和减肥上的努力，87%的美国成年人超重或肥胖。差异也 持续存在，因为非西班牙裔黑人成年人的肥胖患病率（46.8%）高于非西班牙裔白人 (37.9 2型糖尿病（T2 D）的发病率较高。糖尿病预防计划（DPP）生活方式 生活方式干预（LI）证明了生活方式干预的临床益处，并获得了疾病中心 控制（CDC）认可为美国成年人的黄金标准LI计划。由中心报销 医疗保险和医疗补助服务（CMS），DPP LI目前在全国范围内传播，国家DPP。 虽然DPP LI是有效的，但在目前的研究中，危重人群没有达到临床显著的体重减轻。 基于群体的翻译范式这对于民进党的黑人参与者来说尤其如此， 在所有种族/民族群体中调整的体重减轻百分比（3.2%）。早期缺乏减肥 干预周数是治疗后结果的已知预测因素，并且仍然是治疗的主要障碍。 黑人参与者的减肥。关于早期干预的更多研究，重点是 经验差距，迫切需要作为新的CMS支付结构（基于减肥指标） 可能会进一步限制黑人进入DPP。本项目提出了一项整群随机对照试验， 500名黑人参与者居住在20个社区，主要是教堂。社区保健培训 工作人员将提供一个基于组，为期6个月的DPP组生活方式平衡（DPP-GLB）超过18届会议 而无反应者将在四周内被确定。干预组中的无应答者仅接受 社区卫生工作者每周提供电话支持，提供个人层面的强化治疗，以帮助他们 克服阻碍实现计划目标的障碍。这些活动将达到以下具体目标：1） 为了评估体重的主要结局和次要结局（即，物理 活动水平，血压和饮食行为）之间的干预组无应答者 与活性对照组的无应答者相比。2)检查潜在的中介者（社会支持， 自我效能、动机、压力）与调节因子（年龄、性别、社会经济地位）之间的关系 治疗组和无应答者和应答者的早期体重减轻反应。 通过比较与主动控制臂相比的增量成本和重量损失，确定干预臂的成本。 结果指标包括体重（主要）;次要结果包括血压、体力活动、 饮食行为、中介效应和调节效应以及成本。如果发现有效， 对于无应答者，可以标准化为与国家DPP一起使用的补充， 目前民进党的支持。

PROJECT SUMMARY Obesity is the number one and most preventable Type 2 diabetes (T2D) risk factor yet despite a $20 billion annual expenditure on diet and weight loss efforts, 87% of US adults are overweight or obese. Disparities also persist, as Non-Hispanic Black adults have a higher obesity prevalence (46.8%) than non-Hispanic Whites (37.9%) and suffer higher rates of Type 2 diabetes (T2D). The Diabetes Prevention Program (DPP) lifestyle intervention (LI) demonstrated the clinical benefits of lifestyle intervention and garnered the Center for Disease Control (CDC) endorsement as the gold standard LI program for US adults. Reimbursable by the Center for Medicare and Medicaid Services (CMS), the DPP LI is currently disseminated nationally and the national DPP. While the DPP LI is effective, critical populations don’t achieve clinically significant weight loss in the current group-based translation paradigm. This is particularly true for Black DPP participants, who show the lowest adjusted percent weight loss across (3.2%) among all racial/ethnic groups. A lack of weight loss in the early weeks of intervention is a known predictor of post-treatment outcomes and continues to be a major barrier to weight loss for Black participants. Additional research on early intervention, with a focus on populations that experience disparities, is urgently needed as the new CMS payment structure (based on weight loss metrics) may further limit access to the DPP for Blacks. This project proposes a cluster randomized control trial with 500 Black participants who are nested in 20 community sites, primarily churches. Trained community health workers will deliver a group-based, 6-month long DPP Group Lifestyle Balance (DPP-GLB) over 18 sessions and nonresponders will be identified at four weeks. Nonresponders in the intervention group only will receive weekly telephone support from the CHWs to provide individual-level enhanced treatment to help them overcome barriers to adherence to the program goals. These activities will meet the following Specific Aims: 1) To evaluate differences over time in the primary outcome of weight, and secondary outcomes (i.e., physical activity level, blood pressure, and dietary behaviors) between nonresponders in the intervention group compared to nonresponders in the active control group. 2) To examine potential mediators (social support, self-efficacy, motivation, stress) and moderators (age, sex, socioeconomic status) of the relationship between treatment group and early weight loss response in the both nonresponders and responders.3) To evaluate the cost of the intervention arm by comparing the incremental cost and weight loss with the active control arm. Outcome measures include weight (primary); secondary outcomes include blood pressure, physical activity, dietary behaviors, mediation and moderator effects and cost. If found to efficacious, the enhanced strategies for nonresponders could be standardized as a supplement for use with the national DPP and may be supported by current DPP payers.