A Multi-domain Lifestyle Intervention Among Aged Community-residents in Zhejiang, China
HERITAGE
1 other identifier
interventional
1,200
1 country
1
Brief Summary
A study conducted in Finland discovered that a multidomain intervention, consisting of physical activity, nutritional guidance, cognitive training, social activities, and management of vascular risk factors, effectively decelerated cognitive decline in healthy older adults who were at an increased risk of cognitive decline. The HERITAGE study is a 2-year clustered randomized controlled trial (clustered-RCT) that explores the efficacy of a multidomain intervention among 1200 elderly residents with a higher risk of cognitive decline and dementia in Zhejiang Province, China
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2023
CompletedStudy Start
First participant enrolled
May 28, 2023
CompletedFirst Posted
Study publicly available on registry
June 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 28, 2027
ExpectedJune 6, 2023
June 1, 2023
1.9 years
May 8, 2023
June 4, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Global Cognition
Globe cognitive performance (composite z-score) measured by comprehensive Neuropsychological Test Battery (NTB)
Up to 2 years
Domain-specific Cognition
NTB domain-specific cognitive performance (composite z-score) for memory, executive function, attention, language, visuomotor speed and visuoconstruction.
Up to 2 years
Secondary Outcomes (27)
Neuroimaging: MRA
Up to 2 years
Neuroimaging: MRI
Up to 2 years
Neuroimaging: fMRI
Up to 2 years
Number of participants with Laboratory Values /Blood markers
Up to 2 years
Incident dementia
Up to 2 years
- +22 more secondary outcomes
Study Arms (2)
Structured Multi-domain Intervention
EXPERIMENTALMulti-domain structured intervention will be tailored by Chinese traditional and social norms and then conducted among the intervention group. That includes: Nutritional and dietary instruction, Cognitive training, Physical exercises, and Vascular risks monitoring and control.
Self-Guided Intervention
EXPERIMENTALEvery 6-12 months, control group will receive a regular health education campaign to encourage a healthy lifestyle and a regular health monitoring and examination of blood pressure, weight, fasting blood glucose and liposome group
Interventions
Structured Multi-domain Intervention (SMI) involves providing participants with intensive structure and support by a team of trainers to increase physical exercise, adhere to a healthy diet, cognitive training, increase intellectual/social stimulation, and better manage vascular risk factors.
In the Self-Guided Intervention (SGI), education about the importance of a healthy lifestyle as a preventive strategy and support to encourage change will be provided.
Eligibility Criteria
You may qualify if:
- At risk of cognitive decline: cognitive performance at the mean level or slightly lower than expected for age with no dementia (AD8\>=3 and/or 5-min MoCA \>, \< 11)
- Free of physical disabilities that preclude participation in the study
- Willing to complete all study-related activities for 24 months
- Willing to be randomized to either lifestyle intervention group
You may not qualify if:
- Diagnosed dementia patients
- Diagnosed major depression or other neuropsychological diseases
- Malignant diseases
- Symptomatic cardiovascular disease
- Revascularization within one year
- Severe loss of vision, hearing or communicative ability
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
School of Public Health and The Second Affiliated Hospital of School of Medicine, Zhejiang University, Hangzhou, China
Hangzhou, Zhejiang, 310000, China
Related Publications (2)
Xu X, Chew KA, Wong ZX, Phua AKS, Chong EJY, Teo CKL, Sathe N, Chooi YC, Chia WPF, Henry CJ, Chew E, Wang M, Maier AB, Kandiah N, Chen CL. The SINgapore GERiatric Intervention Study to Reduce Cognitive Decline and Physical Frailty (SINGER): Study Design and Protocol. J Prev Alzheimers Dis. 2022;9(1):40-48. doi: 10.14283/jpad.2022.5.
PMID: 35098972BACKGROUNDZhao X, Hu R, Wen H, Xu G, Pang T, He X, Zhang Y, Zhang J, Chen C, Wu X, Xu X. A voice recognition-based digital cognitive screener for dementia detection in the community: Development and validation study. Front Psychiatry. 2022 Jul 22;13:899729. doi: 10.3389/fpsyt.2022.899729. eCollection 2022.
PMID: 35935417RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
May 8, 2023
First Posted
June 2, 2023
Study Start
May 28, 2023
Primary Completion
April 28, 2025
Study Completion (Estimated)
April 28, 2027
Last Updated
June 6, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share
Interested collaborators may put in a request.