Evidence-based Lifestyle Interventions for the Delay of Cognitive Decline Among Older Singaporeans

Not Applicable

Recruiting

• Conditions: Non Demented

• Registration Number: NCT06661486
• Lead Sponsor: National University of Singapore

Brief Summary

The investigators aim to investigate the relationship between lifestyle factors and cognitive decline among older Singaporeans and assess the feasibility and preliminary efficacy of a lifestyle intervention programme in delaying cognitive decline. Healthy lifestyle is a way of living that can lower down disease risk and promote health and wellbeing. Accumulating evidences support that lifestyle factors contribute to the development of dementia and hence modifying lifestyle could be a promising approach for dementia prevention. The intervention will focus on the promotion of a brain-healthy lifestyle, with special attention paid to common problems among local older adults. The investigators will assess cognitive and biological changes using the following outcome measures. Primary outcome: the processing speed domain Z score derived from raw scores of three tests including the symbol digit modality test, Colour trial test, and Stroop test (condition 2). Secondary outcome: i. epigenetic age (DNA methylation), ii. plasma-based markers of inflammation, iii. activities of daily living and instrumental activities of daily living, iv. Health-related quality of life measured by the EQ-5D-5L scale, v. wellbeing measured by the ICECAP-O (ICEpop CAPability measure for Older people), vi. other neurocognitive assessment tests. The investigators hypothesize that:

1. Lifestyle factors are associated with cognitive decline, epigenetic age, and systematic chronic inflammation.

2. Evidence-based lifestyle intervention focusing on common problems among local population can delay cognitive decline, slow epigenetic ageing, and produce favorable changes on chronic systemic inflammation.

3. Changes in biological markers will correlate with changes in cognitive function, and hence partially explains the observed clinical efficacy.

4. The interventions may also improve daily functioning, health-related quality of life, and wellbeing.

5. Interventions delivered in an individualized manner would produce more benefits than interventions delivered uniformly without considering individual's risk profile and personal and social context.

Detailed Description

The investigators have 3 arms in the trial, control group, uniformed intervention group, and individualised intervention group. The control group will not receive any intervention, while the intervention groups will receive group-based health education for 2 years. Within the 2 years, the health education will be conducted weekly in group-setting during the first month, and monthly on the months to follow. It will consist of short-talks on health-related topics that promote the lifestyle factors. Participants in individualized intervention group will undergo one-on-one health coaching session for every 3 months in addition to the group sessions. These will primarily serve to review what has been taught during the group interventions, and help the participants in addressing any questions and concerns they may have.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-24
• Study Start: 2024-10-01
• Study First Submitted QC: 2024-10-25
• Last Update Submitted: 2024-10-25
• Study First Posted: 2024-10-28
• Last Update Posted: 2024-10-28
• Primary Completion: 2026-12
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• (1) Age 60-75 years;
• (2) Singapore Modified Mini-Mental State Examination total score lower than locally validated education-specific cutoffs: < 25, 27 and 29 for those with nil, primary and secondary school and above education levels, respectively66.
• (3) Non-demented (Clinical Dementia Rating global score = 0).

Read More

Exclusion Criteria

Conditions preventing effective engagement in the intervention

• (1) Terminal illness, aphasia
• (2) Marked hearing impairment
• (3) Participation in another interventional study

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Standard Neuropsychological Tests of Information Processing Speed	Cognitive assessment will be conducted at three timepoints within 2 years period, baseline, 12 months and 24 months	The primary outcome of the trial is the processing speed, measured using the average of domain Z score derived from raw scores of three tests including the symbol digit modality test, colour trial test (Condition A) and Stroop test (Condition 2). The average of Z scores standardised to the baseline mean and standard deviation of trial participants, with higher scores representing better processing speed.

Secondary Outcome Measures

Name	Time	Method
Biological Outcome	All of the outcome meausures will be measured at three timepoints including baseline, 12 months and 24 months	Secondary outcome measures include biological outcome: ii. plasma-based markers of inflammation
Quality of life Outcome	All of the outcome measures will be measured at three timepoints including baseline, 12 months and 24 months	Quality-of-life questionnaires: ICEpop CAPability measure for Older adults ICECAP-O. The result will not derive a summary score, "1" represents no ability, "4" represents no problem.
Social Support Outcome	All of the outcome measures will be measured at three timepoints including baseline, 12 months and 24 months	Duke Social Support Index DSSI-11. The sum of 11 items, a higher score represents better social support. Minimum 11, maximum 33.
Capability-related Outcome	All of the outcome measures will be measured at three timepoints including baseline, 12 months and 24 months	Capability-related questionnaires: Instrumental Activities of Daily Living IADL.The sum of 8 items, a higher score represents better capability: minimum 0, maximum 8.
Sleep Quality Outcome	All of the outcome measures will be measured at three timepoints including baseline, 12 months and 24 months	Pittsburgh Sleep Quality Index PSQI. A sum of 7 components, with global scores ranging from 0-21, a higher score represents worse sleep quality.
Mental Health Outcome	All of the outcome measures will be measured at three timepoints including baseline, 12 months and 24 months	Mental health outcome: Perceived Stress Scale PSS. A sum score of 10 items, a lower score represents lower stress: Minimum 0, maximum 40.
Cognitive Outcome	All of the outcome measures will be measured at three timepoints including baseline, 12 months and 24 months	Clinical Dementia Rating (CDR), a higher score higher impairment in cognitive function, high risk in dementia, global score ranged from 0 to 3.
Neurocognitive Tests Outcome	All of the outcome measures will be measured at three timepoints including baseline, 12 months and 24 months	Neuropsychological test: Boston Naming Test (BNT) . Higher scores represent better cognitive performance: Minimum 0, maximum 30.

Trial Locations

Locations (2)

National University Singapore, Tahir Foundation Building; 🇸🇬 Singapore, Singapore

National University Singapore; 🇸🇬 Singapore, Singapore