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

针对患有严重精神疾病的成人糖尿病的多成分干预 (MIDAS)

• 批准号: 10063409
• 负责人: DILIP V. JESTE
• 金额: $ 18.97万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-01 至 2022-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10063409
• 关键词: Adult; Age; Aging; Audiotape; Behavior; Behavioral Mechanisms; Biological Aging; Biological Markers; Bipolar Disorder; Blood; Body mass index; C-reactive protein; California; Cardiovascular Diseases; Caring; Clinical; Community Practice; County; Data; Diabetes Mellitus; Diabetic Diet; Diet; Diet Modification; Dietary Intervention; Education; Effectiveness; Effectiveness of Interventions; Environment; Evidence based intervention; Exercise; Future; General Population; Glycosylated hemoglobin A; Goals; Health; Housing; Hybrids; Individual; Inflammation; Inflammatory; Insulin Resistance; Insurance; Intervention; Knowledge; Lead; Licensing; Life Style; Literature; Longevity; Measures; Mediating; Medical; Metabolic; Modality; Modeling; Modification; National Institute of Mental Health; Non-Insulin-Dependent Diabetes Mellitus; Outcome; Outcome Measure; Participant; Patients; Persons; Phase; Physical activity; Premature Mortality; Process; Randomized; Research; Research Personnel; Risk; Risk Factors; Risk Reduction; Schizoaffective Disorders; Schizophrenia; Self Efficacy; Site; Smoking; Testing; Training; Work; base; behavior change; burnout; cigarette smoking; cohort; comorbidity; cooking; cost; diabetes management; diabetes risk; effectiveness implementation study; evidence base; fasting glucose; follow-up; group intervention; high risk; high risk population; implementation strategy; innovation; lifestyle intervention; member; mortality; multi-component intervention; multimodality; novel; obesogenic; patient home care; post intervention; practice setting; premature; prevent; primary outcome; residential care facility; sedentary lifestyle; severe mental illness; sex; smoking cessation; successful intervention; trial design; unhealthy lifestyle; waist circumference

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.

项目摘要/摘要 严重的精神疾病（SMI），包括精神分裂症，躁郁症和精神分裂症，是 与糖尿病和心血管的医疗合并症的增加和过早死亡有关 疾病。不健康的生活方式，包括能量致富（肥胖）饮食，久坐行为和香烟 吸烟是糖尿病和加速生物衰老的重要危险因素。所有这些风险因素是 可能修改。有大量文献记录了防止策略的有效性 并管理普通人群的糖尿病；但是，这些干预措施很少提供给SMI的人。 加利福尼亚州的董事会和护理房屋的住宅护理设施（RCF）是普通的住房 SMI患者的方式；他们提供了一个可以最大程度地提高效率和可持续性的场所 生活方式干预。拟议的四年研究的目标是调整多组件干预措施 这个高风险群体。该研究将是一项多重效率实现（混合1型）试验 在圣地亚哥，有执照的RCF中使用SMI（MIDAS）的成人糖尿病风险降低糖尿病的组件干预措施 县。作为一项混合1型研究，主要重点将是确定的有效性 干预以实现所需的健康成果，同时还系统地收集有关其实施的数据 在RCF中，将为实施策略改进提供信息。 MIDAS的主要组成部分包括：（1） 有关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 体育锻炼，（4）戒烟 /减少。我们将采用修改的群集随机逐步 楔形和自适应试验设计涉及210名SMI和120名RCF的工作人员的居民。这 RCF将被随机分为四个组的三个RCF。每个队列将在15- 一个月期限包括三个阶段：一个三个月的初始控制阶段（无干预，从基线起 第3个月到第3个月），六个月的干预阶段（第4个月至9个月）和六个月的随访 阶段（没有干预，第10至15个月）。所有研究参与者将在每季度进行评估 15个月。我们的调查人员将培训RCF员工（尤其是活动总监和库克）以增加 体育锻炼和减少吸烟，并在居民中实施健康的饮食改造， 使用基于证据的干预措施。在干预阶段，RCF活动总监将进行 每周两次关于糖尿病，营养，运动和吸烟的教育的手动群体会议 停止/减少，以提供多组分组干预。我们还将探索是否有 RCF居民的胰岛素抵抗和炎症的基于血液的研究生物标志物的改善 与smi。该项目对RFA-MH-17-608有反应，并且与NIMH战略目标＃3.3B相关：测试 在社区实践环境中有效性的干预措施。如果成功的话，MIDAS将会维持下去，并且 传播，并导致与SMI相关的过度医疗合并症和死亡率降低。