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

Evidence-based Lifestyle Interventions for the Delay of Cognitive Decline Among Older Singaporeans: Cohort Study and Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Non Demented
• Intervention / Treatment: Behavioral: Uniformed intervention group; Behavioral: Individualised intervention group

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kai Xuan Lim, Bachelor Degree in Psy; Phone Number: 6593895639; Email: kaixuan@nus.edu.sg

Study Locations

• Singapore
  • Singapore
    • Singapore, Singapore, Singapore, 117549
      • Recruiting
      • National University Singapore, Tahir Foundation Building
      • Contact: Kai Xuan Lim; Phone Number: 93895693; Email: kaixuan@nus.edu.sg
      • Principal Investigator: Lei Feng, PhD
    • Singapore, Singapore, Singapore, 119228
      • Recruiting
      • National University Singapore
      • Contact: Kai Xuan Lim; Phone Number: 6593895693; Email: kaixuan@nus.edu.sg
      • Principal Investigator: Lei Feng, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Exclusion Criteria:

Conditions preventing effective engagement in the intervention

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; The control group will not receive any intervention and, is only required to attend 3 timepoints of cognitive assessment: baseline, 12 months and 24 months.
Experimental: Uniformed intervention group; Uniformed intervention groups receive health education sessions in a group setting. Each session is one hour, and lifestyle health-related topics will be delivered to the participants for their knowledge.	Behavioral: Uniformed intervention group; The investigators provide lifestyle intervention through a health education programme which is in a group setting. The sessions consisted of short talks on a health-related topic targeting lifestyle factors associated with dementia risk, followed by group activities that required interactions, cognitive engagement, and the acquisition of certain skills (for example, how to read food labels, how to measure blood pressure, how to recognize signs of depression, et al).
Active Comparator: Individualised intervention group; The individualised intervention group receives health education sessions as the uniformed intervention group and receives additional one-on-one health coaching, which besides the group sessions, the participants receive individual sessions every three months.	Behavioral: Individualised intervention group; On top of the uniformed intervention group, the individualised intervention group receives also 1:1 sessions every 3 months within 2 years. Participants will review the knowledge taught in the group sessions individually and the investigator will address the participant's concerns and provide advice to the participant for a better lifestyle accordingly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standard Neuropsychological Tests of Information Processing Speed	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.	Cognitive assessment will be conducted at three timepoints within 2 years period, baseline, 12 months and 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biological Outcome	Secondary outcome measures include biological outcome: i. epigenetic age (DNA methylation)	All of the outcome measures will be measured at three timepoints including baseline, 12 months and 24 months
Biological Outcome	Secondary outcome measures include biological outcome: ii. plasma-based markers of inflammation	All of the outcome meausures will be measured at three timepoints including baseline, 12 months and 24 months
Quality of life Outcome	Health-related Quality-of-life questionnaires: EuroQol-5 Dimension 5 Levels EQ-5D-5L. The result will not derive a summary score, "1" represents no problem and "5" represents extreme.	All of the outcome measures will be measured at three timepoints including baseline, 12 months and 24 months
Quality of life Outcome	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.	All of the outcome measures will be measured at three timepoints including baseline, 12 months and 24 months
Social Support Outcome	Duke Social Support Index DSSI-11. The sum of 11 items, a higher score represents better social support. Minimum 11, maximum 33.	All of the outcome measures will be measured at three timepoints including baseline, 12 months and 24 months
Capability-related Outcome	Capability-related questionnaires: Basic Activities of Daily Living ADL The sum of 10 items. A higher score represents better capability: minimum 0, maximum 20.	All of the outcome measures will be measured at three timepoints including baseline, 12 months and 24 months
Capability-related Outcome	Capability-related questionnaires: Instrumental Activities of Daily Living IADL.The sum of 8 items, a higher score represents better capability: minimum 0, maximum 8.	All of the outcome measures will be measured at three timepoints including baseline, 12 months and 24 months
Sleep Quality Outcome	Pittsburgh Sleep Quality Index PSQI. A sum of 7 components, with global scores ranging from 0-21, a higher score represents worse sleep quality.	All of the outcome measures will be measured at three timepoints including baseline, 12 months and 24 months
Mental Health Outcome	Mental health outcome: Geriatric Depression Scale GDS. A sum score of 15 items, a lower score represents lesser depression: Minimum 0, maximum 15.	All of the outcome measures will be measured at three timepoints including baseline, 12 months and 24 months
Mental Health Outcome	Mental health outcome: Geriatric Anxiety Inventory GAI. A sum score of 20 items, a lower score represents lesser anxiety: Minimum 0, maximum 20.	All of the outcome measures will be measured at three timepoints including baseline, 12 months and 24 months
Mental Health Outcome	Mental health outcome: Perceived Stress Scale PSS. A sum score of 10 items, a lower score represents lower stress: Minimum 0, maximum 40.	All of the outcome measures will be measured at three timepoints including baseline, 12 months and 24 months
Cognitive Outcome	Mini-Mental State Examination (MMSE), total score of 30 items, a higher score better cognitive: Minimum 0, maximum 30.	All of the outcome measures will be measured at three timepoints including baseline, 12 months and 24 months
Cognitive Outcome	Clinical Dementia Rating (CDR), a higher score higher impairment in cognitive function, high risk in dementia, global score ranged from 0 to 3.	All of the outcome measures will be measured at three timepoints including baseline, 12 months and 24 months
Neurocognitive Tests Outcome	Neuropsychological tests: Rey Auditory Verbal Learning Test (RAVLT). Different summary scores are derived from raw RAVLT scores: Minumum 0, maximum 15. A higher score better verbal memory.	All of the outcome measures will be measured at three timepoints including baseline, 12 months and 24 months
Neurocognitive Tests Outcome	Neuropsychological tests: Digit Span Task. Higher scores represent better cognitive performance.	All of the outcome measures will be measured at three timepoints including baseline, 12 months and 24 months
Neurocognitive Tests Outcome	Neuropsychological test: Block Design (BD). Higher scores represent better cognitive performance: Minimum 0, Maximum 68.	All of the outcome measures will be measured at three timepoints including baseline, 12 months and 24 months
Neurocognitive Tests Outcome	Neuropsychological test: Boston Naming Test (BNT) . Higher scores represent better cognitive performance: Minimum 0, maximum 30.	All of the outcome measures will be measured at three timepoints including baseline, 12 months and 24 months

Collaborators and Investigators

• Sponsor: National University of Singapore

Publications and helpful links

General Publications

• Ye KX, Sun L, Wang L, Khoo ALY, Lim KX, Lu G, Yu L, Li C, Maier AB, Feng L. The role of lifestyle factors in cognitive health and dementia in oldest-old: A systematic review. Neurosci Biobehav Rev. 2023 Sep;152:105286. doi: 10.1016/j.neubiorev.2023.105286. Epub 2023 Jun 13.
• Wu DX, Feng L, Yao SQ, Tian XF, Mahendran R, Kua EH. The early dementia prevention programme in Singapore. Lancet Psychiatry. 2014 Jun;1(1):9-11. doi: 10.1016/S2215-0366(14)70233-0. Epub 2014 Jun 4. No abstract available.
• Liu LY, Lu Y, Shen L, Li CB, Yu JT, Yuan CR, Ye KX, Chao YX, Shen QF, Mahendran R, Kua EH, Yu DH, Feng L. Prevalence, risk and protective factors for mild cognitive impairment in a population-based study of Singaporean elderly. J Psychiatr Res. 2022 Jan;145:111-117. doi: 10.1016/j.jpsychires.2021.11.041. Epub 2021 Nov 25.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: June 24, 2024
• First Submitted That Met QC Criteria: October 25, 2024
• First Posted (Actual): October 28, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Lifestyle Intervention; CDR; MMSE
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: NUS-IRB-2023-219; MOH-001290 (Other Grant/Funding Number: National Medical Research Council)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No