Abstract：
BACKGROUND: The globe has been working to promote a multi-domain lifestyle intervention for dementia prevention in older adults, referring to the Worldwide-FINGERS (Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability) initiative. In China, the multi-domain lifestyle intervention has been implemented in rural communities (MIND-China), yet the adaptability of such intervention based on the urban communities in China has not been verified.
OBJECTIVE: To examine the effectiveness and feasibility of the multi-domain lifestyle intervention on dementia prevention in at-risk community-dwelling older adults in China.
METHODS: The multi-domain lifestyle intervention study is a community-based 2-year cluster randomized controlled trial (RCT). A total of 1200 participants aged 60-80 years old will be recruited from twelve communities in Hangzhou, Zhejiang. Inclusion criteria were the Montreal Cognitive Assessment 5 minutes protocol (5 min MoCA) score of 6-9 or the Ascertain Dementia 8 (AD 8) score of ≥2, and having modifiable lifestyle factors.
UNASSIGNED: Participating communities will be randomized into either the structured multi-domain intervention (SMI) arm or the self-guided intervention (SGI, general health education) arm. The SMI consists of cognitive training, physical exercise, and nutritional and dietary instruction for the first 12 months; and vascular risks monitoring and control for 24 months. The primary outcome is the global cognitive performance, measured by the comprehensive Neuropsychological Test Battery (NTB). The secondary outcomes include domain-specific cognitive performances, physical function, mental health, physiological and biochemical indices, adherence to healthy lifestyles, and neuroimaging metrics. The feasibility of intervention will be evaluated around the five dimensions of the RE-AIM framework and in conjunction with quantitative data, operational data and results of focus group discussions.
CONCLUSIONS: Following the Worldwide-FINGERS, this cluster RCT will verify the adaptability of the multi-domain lifestyle intervention in the urban community settings in China. This study will add evidence for global dementia prevention and management among older adults.
OBJECTIVE: To examine the effectiveness and feasibility of the multi-domain lifestyle intervention on dementia prevention in at-risk community-dwelling older adults in China.
METHODS: The multi-domain lifestyle intervention study is a community-based 2-year cluster randomized controlled trial (RCT). A total of 1200 participants aged 60-80 years old will be recruited from twelve communities in Hangzhou, Zhejiang. Inclusion criteria were the Montreal Cognitive Assessment 5 minutes protocol (5 min MoCA) score of 6-9 or the Ascertain Dementia 8 (AD 8) score of ≥2, and having modifiable lifestyle factors.
UNASSIGNED: Participating communities will be randomized into either the structured multi-domain intervention (SMI) arm or the self-guided intervention (SGI, general health education) arm. The SMI consists of cognitive training, physical exercise, and nutritional and dietary instruction for the first 12 months; and vascular risks monitoring and control for 24 months. The primary outcome is the global cognitive performance, measured by the comprehensive Neuropsychological Test Battery (NTB). The secondary outcomes include domain-specific cognitive performances, physical function, mental health, physiological and biochemical indices, adherence to healthy lifestyles, and neuroimaging metrics. The feasibility of intervention will be evaluated around the five dimensions of the RE-AIM framework and in conjunction with quantitative data, operational data and results of focus group discussions.
CONCLUSIONS: Following the Worldwide-FINGERS, this cluster RCT will verify the adaptability of the multi-domain lifestyle intervention in the urban community settings in China. This study will add evidence for global dementia prevention and management among older adults.
摘要：
背景：全球一直在努力促进多领域的生活方式干预，以预防老年人的痴呆症，参考Worldwide-FINGERS（芬兰预防认知障碍和残疾的老年干预研究）倡议。在中国,多领域生活方式干预已在农村社区实施(MIND-中国)，然而，这种基于中国城市社区的干预措施的适应性尚未得到验证。
目的：研究多领域生活方式干预对中国社区高危老年人痴呆预防的有效性和可行性。
方法：多领域生活方式干预研究是一项基于社区的2年整群随机对照试验（RCT）。共招募1200名年龄在60-80岁的参与者，来自杭州的12个社区，浙江。纳入标准是蒙特利尔认知评估5分钟方案（5分钟MoCA）得分6-9或确定痴呆8（AD8）得分≥2，并且具有可改变的生活方式因素。
■参与社区将被随机分为结构化多领域干预（SMI）或自我指导干预（SGI，一般健康教育)手臂。SMI包括认知训练，体育锻炼,头12个月的营养和饮食指导；以及24个月的血管风险监测和控制。主要结果是全球认知表现，由全面的神经心理学测试电池(NTB)测量。次要结果包括特定领域的认知表现，物理功能，心理健康,生理生化指标,坚持健康的生活方式，和神经影像学指标。将围绕RE-AIM框架的五个维度,结合量化数据,对干预的可行性进行评估,焦点小组讨论的运营数据和结果。
结论：在全球FINGERS之后，该集群RCT将验证多领域生活方式干预在中国城市社区环境中的适应性。这项研究将为全球老年人痴呆症的预防和管理增加证据。
目的：研究多领域生活方式干预对中国社区高危老年人痴呆预防的有效性和可行性。
方法：多领域生活方式干预研究是一项基于社区的2年整群随机对照试验（RCT）。共招募1200名年龄在60-80岁的参与者，来自杭州的12个社区，浙江。纳入标准是蒙特利尔认知评估5分钟方案（5分钟MoCA）得分6-9或确定痴呆8（AD8）得分≥2，并且具有可改变的生活方式因素。
■参与社区将被随机分为结构化多领域干预（SMI）或自我指导干预（SGI，一般健康教育)手臂。SMI包括认知训练，体育锻炼,头12个月的营养和饮食指导；以及24个月的血管风险监测和控制。主要结果是全球认知表现，由全面的神经心理学测试电池(NTB)测量。次要结果包括特定领域的认知表现，物理功能，心理健康,生理生化指标,坚持健康的生活方式，和神经影像学指标。将围绕RE-AIM框架的五个维度,结合量化数据,对干预的可行性进行评估,焦点小组讨论的运营数据和结果。
结论：在全球FINGERS之后，该集群RCT将验证多领域生活方式干预在中国城市社区环境中的适应性。这项研究将为全球老年人痴呆症的预防和管理增加证据。
