Promotora Intervention for Metabolic and MentalHealth (PRIME2)

项目摘要 本R 03提案的总体目标是制定一项有效且可能可扩展的干预措施， 预防抑郁症状（EDS）和前驱糖尿病患者的糖尿病。本研究着重于 拉丁美洲人是这些相关疾病风险特别高的人口群体。的经验 糖尿病预防计划（DPP）和相关的转化研究表明，循证DPP 生活方式干预对抑郁症患者的效果较差。许多研究将抑郁症状 糖尿病患者，但没有研究试图治疗糖尿病前期成年人的抑郁症状， 糖尿病预防策略的一部分。拟议的Promotora干预代谢和心理健康 （PRIME 2）将是DPP生活方式干预的第一个适应，同时解决抑郁症 症状和前驱糖尿病在promotoras或社区卫生工作者提供的程序。在第一阶段， 研究人员将开发PRIME 2干预，它整合了认知- 行为疗法融入现有的材料的基础上DPP。该项目包括18个项目， 由一名推广人用西班牙语主持为期6个月的会议。第二阶段包括混合方法评价， PRIME2. 2A期是PRIME 2与常规治疗（UC）的初步随机试验，随后将进行 参与者焦点小组和与在2B阶段提供PRIME 2的发起人的单独访谈。这 定性评估将在干预之前对干预的可接受性和效果有更深入的了解， 对PRIME 2的全面研究目标人群是患有EDS和前驱糖尿病的拉丁美洲成年人（n=40，20例在 每个手臂）。我们假设：1）PRIME 2参与者将有更大的体重减轻和改善， 与UC相比的心脏代谢标志物（腰围和血红蛋白A1 C）;和2）PRIME 2 参与者将经历抑郁症状的更大减少（基于贝克抑郁症 比UC参与者。这项初步研究的所有数据将用于开发一项新的临床试验 探索抑郁症状和代谢健康之间的接口在拉丁美洲人的风险共病 抑郁症和糖尿病。

Project Summary The overall goal of this R03 proposal is to develop an effective and potentially scalable intervention to prevent diabetes in people with elevated depressive symptoms (EDS) and prediabetes. This study focuses on Latinos, a demographic group at particularly high risk for these related conditions. Experience from the Diabetes Prevention Program (DPP), and related translational studies, suggests that the evidence-based DPP lifestyle intervention is less effective among depressed individuals. Many studies link depressive symptoms with incident diabetes, yet no studies have attempted to treat depressive symptoms in prediabetic adults as part of a diabetes prevention strategy. The proposed Promotora Intervention for Metabolic and Mental Health (PRIME2) will be the first adaptation of the DPP lifestyle intervention to simultaneously address depressive symptoms and prediabetes in a program delivered by promotoras, or community health workers. In Phase 1, the investigators will develop the PRIME2 intervention, which integrates proven principles from cognitive- behavioral therapy into existing materials based on the DPP. The proposed intervention includes 18 group- based sessions led by a promotora in Spanish over 6 months. Phase 2 involves a mixed-methods evaluation of PRIME2. Phase 2A is a pilot randomized trial of PRIME2 vs. usual care (UC), which will be followed by participant focus groups and individual interviews with promotoras delivering PRIME2 in Phase 2B. This qualitative evaluation will develop a deeper understanding of the intervention’s acceptability and effects prior to a full-scale study of PRIME2. The target population is Latino adults with EDS and prediabetes (n=40, 20 in each arm). We hypothesize that: 1) PRIME2 participants will have greater weight loss and improvement in cardiometabolic markers (waist circumference and hemoglobin A1C) compared to UC; and 2) PRIME2 participants will experience a greater reduction in depressive symptoms (based on the Beck Depression Inventory) than UC participants. All data from this pilot study will be used to develop a novel clinical trial exploring the interface between depressive symptoms and metabolic health among Latinos at-risk for comorbid depression and diabetes.