Promotora Intervention for Metabolic and MentalHealth (PRIME2)

项目摘要 此R03提案的总体目标是开发一种有效且潜在可扩展的干预措施，以 预防抑郁症状(EDS)升高的人和糖尿病前期患者的糖尿病。这项研究的重点是 拉丁美洲人，这是一个患这些相关疾病的风险特别高的人口群体。来自世界各地 糖尿病预防计划(DPP)和相关的翻译研究表明，循证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与 随着糖尿病的发生，还没有研究试图将糖尿病前期成年人的抑郁症状治疗为 这是糖尿病预防策略的一部分。拟议的促进新陈代谢和心理健康的干预 (Prime2)将是DPP生活方式干预的第一个改编，同时解决抑郁问题 由推广者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，它整合了来自认知- 将行为疗法纳入现有的基于DPP的材料中。拟议的干预措施包括18组- 6个月以上由一名推广人用西班牙语主持的课程。第二阶段涉及混合方法评估 PRIME 2.阶段2A是Prime2与常规护理(UC)的试点随机试验，随后将 参与者焦点小组和与推广者的个别访谈，这些推广者在2B阶段提供Prime2。这 定性评估将加深对干预措施的可接受性和效果的理解 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=40，20in 每只手臂)。我们假设：1)第一组参与者的体重会有更大的减轻和改善 心脏代谢标志物(腰围和血红蛋白A1C)与UC的比较；以及2)Prime2 参与者将体验到抑郁症状的更大程度的减轻(基于Beck抑郁症 库存)，而不是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 探讨拉丁裔共病高危人群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.