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The Multi-domain Lifestyle Intervention for Cognitive Impairment in Community-Dwelling Older Adults in Hangzhou (The Heritage Study): Study Design and Protocol

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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.

Design, Setting, Participants

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.

Intervention, Measurements, Results

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.

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Acknowledgement

We would like to acknowledge the Medical and Healthcare Bureau of Gongshu District, Hangzhou, China for the support. We also acknowledge Huawei Ltd., for the development and optimization of the device and HUAWEI Research platform to this study.

Funding

Funding: The project is funded by grant No. 72274170 from Natural Science Foundation of China (Dr Xu Xin) and grant AARG-22-928604 from the Alzheimer’s Association (Dr Yuan).

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Authors and Affiliations

  1. School of Public Health, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China, 310058

    Xin Xu, T. Pang, Y. Zhou, H. Zhang, A. Ma, C. Yuan, H. Chen & X. Xu

  2. The Key Laboratory of Intelligent Preventive Medicine of Zhejiang Province, Hangzhou, Zhejiang, China

    Xin Xu, T. Pang, Y. Zhou, H. Zhang, A. Ma, C. Yuan, H. Chen & X. Xu

  3. College of Education, Zhejiang University, Hangzhou, Zhejiang, China

    X. Wen

  4. School of Public Health and the Department of Geriatrics, the Fourth Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China

    Q. Yang

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  1. Xin Xu
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Corresponding author

Correspondence to Xin Xu.

Ethics declarations

Conflict of interest: On behalf of all authors, the corresponding author states that there is no conflict of interest.

Ethical standards: The Heritage study has been approved by ZGL20230123-5 and is registered under ClinicalTrial.gov (ID: NCT05886114). Written informed consent will be obtained from all participants before enrolment into the study. The study will be conducted in accordance with Good Clinical Practice guidelines.

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Xu, X., Pang, T., Zhou, Y. et al. The Multi-domain Lifestyle Intervention for Cognitive Impairment in Community-Dwelling Older Adults in Hangzhou (The Heritage Study): Study Design and Protocol. J Prev Alzheimers Dis (2024). https://doi.org/10.14283/jpad.2024.59

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