Promotora Intervention for Metabolic and MentalHealth (PRIME2)

项目概要 该 R03 提案的总体目标是开发一种有效且具有潜在可扩展性的干预措施，以 预防抑郁症状（EDS）升高和糖尿病前期人群的糖尿病。这项研究的重点是 拉丁美洲人是这些相关疾病风险特别高的人口群体。经验来自 糖尿病预防计划 (DPP) 和相关转化研究表明，基于证据的 DPP 生活方式干预在抑郁症患者中效果较差。许多研究将抑郁症状联系起来 糖尿病前期患者的抑郁症状与糖尿病相关，但尚无研究尝试将糖尿病前期成人的抑郁症状治疗为 糖尿病预防策略的一部分。拟议的代谢和心理健康 Promotora 干预措施 （PRIME2）将是 DPP 生活方式干预措施的首个调整，以同时解决抑郁问题 由promotoras或社区卫生工作者提供的计划中的症状和糖尿病前期。在第一阶段， 研究人员将开发 PRIME2 干预措施，该干预措施整合了来自认知- 基于 DPP 的现有材料中的行为疗法。拟议的干预措施包括 18 组—— 由一名促销员用西班牙语主持的为期 6 个月的会议。第 2 阶段涉及混合方法评估 PRIME2。 2A 期是 PRIME2 与常规护理 (UC) 的试点随机试验，随后将进行 参与者焦点小组以及对 2B 阶段 PRIME2 发起人的个人访谈。这个 定性评估将在干预之前更深入地了解干预的可接受性和效果 对 PRIME2 的全面研究。目标人群是患有 EDS 和糖尿病前期的拉丁裔成年人（n=40，其中 20 人 每个手臂）。我们假设： 1) PRIME2 参与者将有更大的体重减轻和改善 与 UC 相比，心脏代谢标志物（腰围和血红蛋白 A1C）；和 2) PRIME2 参与者的抑郁症状将得到更大程度的减轻（基于贝克抑郁症 库存）高于 UC 参与者。该试点研究的所有数据将用于开发一项新型临床试验 探索有共病风险的拉丁裔人群的抑郁症状与代谢健康之间的关系 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.