Non Demented
Conditions
Keywords
Lifestyle Intervention, MMSE, CDR
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.
Interventions
BEHAVIORALUniformed 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).
BEHAVIORALIndividualised 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.
Sponsors
National University of Singapore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
the participants will be randomly assigned to one of the three arms, uniformed intervention, individualized intervention or the control group.
Eligibility
Sex/Gender
ALL
Age
60 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standard Neuropsychological Tests of Information Processing Speed | 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
| Measure | Time frame | Description |
|---|---|---|
| Biological Outcome | 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) |
| Quality of life Outcome | 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. |
| Social Support Outcome | 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. |
| Capability-related Outcome | 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. |
| Sleep Quality Outcome | 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. |
| Mental Health Outcome | 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. |
| Cognitive Outcome | 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. |
| Neurocognitive Tests Outcome | 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. |
Countries
Singapore
Outcome results
None listed