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NCT Number: NCT06661486

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

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.

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Key information

Conditions

Non Demented

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National University Singapore, Singapore

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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.

Primary outcomes

  1. Standard Neuropsychological Tests of Information Processing Speed

    Time frame: 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 outcomes

  1. Biological Outcome

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

    Secondary outcome measures include biological outcome: i. epigenetic age (DNA methylation)

  2. Biological Outcome

    Time frame: 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

  3. Quality of life Outcome

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

    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.

  4. Quality of life Outcome

    Time frame: 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.

  5. Social Support Outcome

    Time frame: 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.

  6. Capability-related Outcome

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

    Capability-related questionnaires: Basic Activities of Daily Living ADL The sum of 10 items. A higher score represents better capability: minimum 0, maximum 20.

  7. Capability-related Outcome

    Time frame: 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.

  8. Sleep Quality Outcome

    Time frame: 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.

  9. Mental Health Outcome

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

    Mental health outcome: Geriatric Depression Scale GDS. A sum score of 15 items, a lower score represents lesser depression: Minimum 0, maximum 15.

  10. Mental Health Outcome

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

    Mental health outcome: Geriatric Anxiety Inventory GAI. A sum score of 20 items, a lower score represents lesser anxiety: Minimum 0, maximum 20.

  11. Mental Health Outcome

    Time frame: 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.

  12. Cognitive Outcome

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

    Mini-Mental State Examination (MMSE), total score of 30 items, a higher score better cognitive: Minimum 0, maximum 30.

  13. Cognitive Outcome

    Time frame: 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.

  14. Neurocognitive Tests Outcome

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

    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.

  15. Neurocognitive Tests Outcome

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

    Neuropsychological tests: Digit Span Task. Higher scores represent better cognitive performance.

  16. Neurocognitive Tests Outcome

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

    Neuropsychological test: Block Design (BD). Higher scores represent better cognitive performance: Minimum 0, Maximum 68.

  17. Neurocognitive Tests Outcome

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kai Xuan Lim, Bachelor Degree in Psy

CONTACT

[email protected]

6593895639

Sponsors and collaborators

Lead sponsor

National University of Singapore

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Oct 28, 2024
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.