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.

项目总结/摘要 严重精神疾病（SMI），包括精神分裂症、双相情感障碍和情感障碍， 与糖尿病和心血管疾病的合并症和过早死亡率增加有关 疾病不健康的生活方式，包括高能量（肥胖）饮食，久坐不动的行为和吸烟 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 可能是可修改的。有大量文献记载了预防战略的有效性， 并管理一般人群的糖尿病;然而，这些干预措施很少提供给SMI患者。 住宅护理设施（RCF），在加州称为寄宿和护理之家，是一种常见的住房 模式与SMI患者;他们提供了一个场所，可以最大限度地提高效率和可持续性的 生活方式干预拟议的四年研究的目标是量身定制一个多组成部分的干预， 这个高危人群。本研究将是一项混合有效性-实施（混合1型）试验， 在圣地亚哥有执照的RCF中，对成年SMI患者（MIDAS）进行糖尿病风险降低干预 县作为混合1型研究，主要重点是确定 采取干预措施，以实现预期的健康成果，同时系统地收集有关实施情况的数据， 在区域合作框架内，这将为实施战略的完善提供信息。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）在设施和居民层面的饮食干预，（3）增加 （4）戒烟/戒烟。我们将采用一个修改的集群随机步进 楔形和适应性试验设计，涉及210名患有SMI的居民和来自12个RCF的120名工作人员。的 RCF将随机分为4个队列，每个队列3个RCF。每个队列将在15- 一个月的时间，包括三个阶段：三个月的初始控制阶段（无干预，从基线 第0个月至第3个月结束）、6个月干预阶段（第4个月至第9个月）和6个月随访 阶段（无干预，10 - 15个月）。所有研究参与者将在研究期间接受季度评估。 15-月期间。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）， 体育活动和减少吸烟，并在居民中实施健康的饮食调整， 使用基于证据的干预措施。在干预阶段，区域合作框架活动主任将 每周两次关于糖尿病、营养、锻炼和吸烟教育的手册化小组会议 停止/减少，以提供一个多组成部分的群体干预。我们还将探讨是否有 RCF居民胰岛素抵抗和炎症的血液研究生物标志物的改善 关于SMI本项目响应RFA-MH-17 - 608，并与NIMH战略目标#3.3B：测试相关 在社区实践环境中进行有效干预。如果取得成功，将维持MIDAS， 扩散，并将导致减少与SMI相关的过度医疗并发症和死亡率。