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

ConditionNon Demented
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-75
SponsorNational University of Singapore

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

(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).

Disqualifiers

(1) Terminal illness, aphasia

(2) Marked hearing impairment

(3) Participation in another interventional study

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Control groupNo intervention 0 interventions
Group B: Uniformed intervention groupExperimental treatment 1 intervention
Group C: Individualised intervention groupActive comparator 1 intervention

Trial outcomes

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.

Time frame
Cognitive assessment will be conducted at three timepoints within 2 years period, baseline, 12 months and 24 months

Secondary outcomes

1

Biological Outcome

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

Time frame
All of the outcome measures will be measured at three timepoints including baseline, 12 months and 24 months
2

Biological Outcome

Secondary outcome measures include biological outcome: ii. plasma-based markers of inflammation

Time frame
All of the outcome meausures will be measured at three timepoints including baseline, 12 months and 24 months
3

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.

Time frame
All of the outcome measures will be measured at three timepoints including baseline, 12 months and 24 months
4

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.

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

Other outcomes

Sponsors and contacts

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