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

NCT ID: NCT06661486

Last Updated: 2024-10-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2027-06-30

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.

Conditions

Non Demented

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Uniformed intervention group

Intervention Type: 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).

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.

Group Type: ACTIVE_COMPARATOR

Individualised intervention group

Intervention Type: 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.

Interventions

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).

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National University of Singapore

OTHER

Sponsor Role: lead

Responsible Party

Feng Lei

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National University Singapore, Tahir Foundation Building

Singapore, Singapore, Singapore

Site Status: RECRUITING

National University Singapore

Singapore, Singapore, Singapore

Site Status: RECRUITING

Countries

Singapore

Central Contacts

Kai Xuan Lim, Bachelor Degree in Psy

Role: CONTACT

kaixuan@nus.edu.sg

6593895639

Facility Contacts

Kai Xuan Lim

Role: primary

kaixuan@nus.edu.sg

93895693

Lei Feng, PhD

Role: backup

Kai Xuan Lim

Role: primary

kaixuan@nus.edu.sg

6593895693

Lei Feng, PhD

Role: backup

References

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.

Reference Type: BACKGROUND

PMID: 34894520 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37321363 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26360390 (View on PubMed)

Other Identifiers

MOH-001290

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NUS-IRB-2023-219

Identifier Type: -

Identifier Source: org_study_id