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

National University of Singapore

Status: Enrolling

Conditions: Non Demented

Treatments: Behavioral: Individualised intervention group; Behavioral: Uniformed intervention group

Study type: Interventional

Funder types: Other

Identifiers

NCT06661486

NUS-IRB-2023-219

MOH-001290 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 60 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups

Control group

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: Uniformed intervention group

Individualised intervention group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Individualised intervention group