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Study on the Multidomain Interventions of cognitive function in older adults with Limited Education (SMILE)

Study on the Multidomain Interventions of cognitive function in older adults with Limited Education (SMILE)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111238
Enrollment
Unknown
Registered
2025-10-28
Start date
2025-11-03
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cognitive impairment

Interventions

Intervention group:Multidomain Interventions
Control group:Routine health education

Sponsors

West China Fourth Hospital, Sichuan University / West China School of Public Health
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged 60 years or older; 2. A score of >=18 on the Mini-Mental State Examination (MMSE); 3.Fewer than 6 years of formal education; 4. Meeting at least one of the following risk factors for cognitive decline: (1) History of hypertension; (2) History of diabetes mellitus; (3)Hyperlipidemia; (4)History of head trauma; (5)Physical inactivity; (6)Current smoking; (7)Excessive alcohol consumption; (8)Body Mass Index (BMI) >=28 kg/m^2; (9)A score between 5 and 9 on the 15-item Geriatric Depression Scale (GDS-15); (10)Infrequent social engagement; (11) Exposure to ambient air pollution; 5. Physically and mentally capable of participating in the intervention and complying with the study procedures; 6. Willing and able to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1.Diagnosis of dementia or other major neurodegenerative diseases; 2. Presence of any comorbidity that could impede participation in the multi-domain intervention, including psychiatric disorders, active malignancy, recent stroke, uncontrolled hypertension, among others; 3. Severe visual, auditory, or speech impairments; 4. Concurrent participation in any other interventional trial; 5. Plans to relocate within the 24-month study period.

Design outcomes

Primary

MeasureTime frame
Neuropsychological Test Battery, NTB Score;

Secondary

MeasureTime frame
NTB domain-specific scores;Total score and scores on each dimension of the Mini-Mental State Examination(MMSE);Obesity-related indicators;Level of physical activity;Laboratory parameters (such as blood glucose, low-density lipoprotein (LDL-C), high-density lipoprotein (HDL-C), total cholesterol (TG), triglycerides (TC), etc);Blood pressure;Bone measurement;Body fat and visceral fat percentage;Physical function;Diet;Mental health;Sleep quality;

Countries

China

Contacts

Public ContactJunmin Zhou

West China Fourth Hospital, Sichuan University / West China School of Public Health

junmin.zhou@scu.edu.cn+86 133 8818 3505

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026