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

NCT06661486 | Recruiting

• 2 other identifiers: NUS-IRB-2023-219MOH-001290
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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. 1.Lifestyle factors are associated with cognitive decline, epigenetic age, and systematic chronic inflammation.
2. 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. 3.Changes in biological markers will correlate with changes in cognitive function, and hence partially explains the observed clinical efficacy.
4. 4.The interventions may also improve daily functioning, health-related quality of life, and wellbeing.
5. 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.

Conditions

Non Demented

Keywords

Lifestyle Intervention; MMSE; CDR

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Biological Outcome

  All of the outcome measures will be measured at three timepoints including baseline, 12 months and 24 months

• Biological Outcome

  All of the outcome meausures will be measured at three timepoints including baseline, 12 months and 24 months

• 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 Outcome

  All of the outcome measures will be measured at three timepoints including baseline, 12 months and 24 months

• Social Support Outcome

  All of the outcome measures will be measured at three timepoints including baseline, 12 months and 24 months

Study Arms (3)

Control group

NO INTERVENTION

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.

Uniformed intervention group

EXPERIMENTAL

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

Individualised intervention group

ACTIVE COMPARATOR

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

Interventions

Uniformed intervention group BEHAVIORAL

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).

Uniformed intervention group

Individualised intervention group BEHAVIORAL

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.

Individualised intervention group

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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).

You may not qualify if:

• Conditions preventing effective engagement in the intervention
• (1) Terminal illness, aphasia
• (2) Marked hearing impairment
• (3) Participation in another interventional study

Sponsors & Collaborators

• National University of Singapore: lead

Study Sites (2)

National University Singapore, Tahir Foundation Building

Singapore, Singapore, 117549, Singapore

RECRUITING

National University Singapore

Singapore, Singapore, 119228, Singapore

RECRUITING

Related Publications (3)

• 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.

  PMID: 34894520 BACKGROUND

• 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.

  PMID: 37321363 BACKGROUND

• 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.

  PMID: 26360390 BACKGROUND

Central Study Contacts

Kai Xuan Lim, Bachelor Degree in Psy

CONTACT

6593895639; kaixuan@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: the participants will be randomly assigned to one of the three arms, uniformed intervention, individualized intervention or the control group.

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: October 28, 2024
• Study Start: October 1, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

SG (2)