Multi-component Intervention for Diabetes in Adults with Serious Mental Illness (MIDAS)

项目摘要/摘要 严重精神疾病(SMI)，包括精神分裂症、双相情感障碍和分裂情感障碍， 与糖尿病和心血管疾病的医疗合并症和过早死亡增加相关 疾病。不健康的生活方式，包括高能量(肥胖)饮食、久坐行为和吸烟 吸烟是糖尿病和加速生物衰老的重要危险因素。所有这些风险因素都是 可能是可以修改的。有相当多的文献记载了预防战略的有效性 并在普通人群中管理糖尿病；然而，这些干预措施很少提供给患有SMI的人。 住宅护理设施(RCFs)，在加利福尼亚州被称为董事会和护理之家，是一种常见的住房 SMI患者的医疗模式；他们提供了一个可以最大限度地提高效率和可持续性的场所 生活方式干预。这项拟议的为期四年的研究的目标是量身定做一项多成分干预措施，以 这个高危人群。这项研究将是一项混合有效性-实施(混合类型1)试验， 成分干预降低圣地亚哥有执照RCFs中SMI(MIDAS)成人的糖尿病风险 县里。作为一项混合类型1的研究，主要重点将是确定 干预措施以实现预期的健康结果，同时系统地收集其执行情况的数据 在区域合作框架内，这将为实施战略的改进提供信息。MIDAS的主要组成部分包括：(1) 关于糖尿病和生活方式的教育，(2)设施和居民一级的饮食干预，(3)增加 体力活动，以及(4)戒烟/减少吸烟。我们将采用一种改进的群随机化步骤 楔形和适应性试验设计，包括210名患有SMI的居民和来自12个RCFs的120名工作人员。这个 RCFs将被随机分为四组，每组三个RCFs。每个队列将接受超过15个测试- 包括三个阶段的一个月期间：为期三个月的初始控制阶段(从基线开始无干预 0个月至3个月末)，为期6个月的干预阶段(4个月至9个月)，以及6个月的随访 阶段(无干预，10至15个月)。所有研究参与者将在季度期间接受评估 15个月。我们的调查人员将培训RCF工作人员(特别是活动总监和厨师)，以增加 体育锻炼和减少吸烟，并在居民中实施健康的饮食修改， 使用循证干预。在干预阶段，区域合作框架活动主任将进行 每周两次关于糖尿病、营养、锻炼和吸烟的教育小组会议 停止/减少，以提供多组分的团体干预。我们还将探索是否有 RCF居民胰岛素抵抗和炎症的血液研究生物标记物的改进 与SMI合作。本项目响应RFA-MH-17-608，并与NIMH战略目标#3.3B：测试相关 社区实践环境中的有效性干预措施。如果成功，迈达斯将持续下去， 传播，并将导致减少与SMI相关的过度医疗合并症和死亡率。

Project Summary/Abstract Serious mental illnesses (SMI), including schizophrenia, bipolar disorder, and schizoaffective disorder, are associated with increased medical comorbidity and premature mortality from diabetes and cardiovascular disease. Unhealthy lifestyles, including energy-dense (obesogenic) diet, sedentary behavior, and cigarette smoking are important risk factors for diabetes and accelerated biological aging. All of these risk factors are potentially modifiable. There is considerable literature documenting the effectiveness of strategies to prevent and manage diabetes in the general population; yet, these interventions are rarely offered to people with SMI. Residential Care Facilities (RCFs), called Board-and-Care Homes in California, are a common housing modality for patients with SMI; they provide a venue that can maximize efficiency and sustainability of a lifestyle intervention. The goals of the proposed four-year study are to tailor a multi-component intervention to this high-risk group. The study will be a hybrid effectiveness-implementation (Hybrid Type 1) trial of a Multi- component Intervention for Diabetes risk reduction in Adults with SMI (MIDAS) in licensed RCFs in San Diego county. As a Hybrid Type 1 study, the primary emphasis will be on determining the effectiveness of the intervention to achieve desired health outcomes while also systematically collecting data on its implementation within RCFs that will inform implementation strategy refinement. Main components of MIDAS include: (1) Education about diabetes and lifestyle, (2) Dietary intervention at the facility and resident level, (3) Increased physical activity, and (4) Smoking cessation / reduction. We will employ a modified cluster-randomized stepped wedge and adaptive trial design involving 210 residents with SMI and 120 staff members from 12 RCFs. The RCFs will be divided randomly into four cohorts of three RCFs each. Each cohort will be tested over a 15- month period that includes three phases: a three-month initial control phase (no intervention, from baseline month 0 to end of month 3), a six-month intervention phase (months 4 through 9), and a six-month follow-up phase (no intervention, months 10 through 15). All the study participants will be assessed quarterly during the 15-month period. Our investigators will train RCF staff (especially the Activity Director and cook) to increase physical activity and reduce smoking, and to implement healthful dietary modifications among the residents, using evidence-based interventions. During the intervention phase, the RCF Activity Director will conduct twice-weekly manualized group sessions on education about diabetes, nutrition, exercise, and smoking cessation/reduction, to deliver a multi-component group intervention. We will also explore if there are improvements in blood-based research biomarkers of insulin resistance and inflammation in the RCF residents with SMI. This project is responsive to RFA-MH-17-608, and related to NIMH Strategic Objective #3.3B: testing interventions for effectiveness in community practice settings. If successful, MIDAS will be sustained and disseminated, and would lead to reduction in excess medical comorbidity and mortality associated with SMI.