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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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).
• Поведенческое 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.

Первичные конечные точки

• Standard Neuropsychological Tests of Information Processing Speed [Срок оценки: Cognitive assessment will be conducted at three timepoints within 2 years period, baseline, 12 months and 24 months]

Вторичные конечные точки (12)

• Biological Outcome [Срок оценки: All of the outcome measures will be measured at three timepoints including baseline, 12 months and 24 months]
• Biological Outcome [Срок оценки: All of the outcome meausures will be measured at three timepoints including baseline, 12 months and 24 months]
• Quality of life Outcome [Срок оценки: All of the outcome measures will be measured at three timepoints including baseline, 12 months and 24 months]
• Quality of life Outcome [Срок оценки: All of the outcome measures will be measured at three timepoints including baseline, 12 months and 24 months]
• Social Support Outcome [Срок оценки: All of the outcome measures will be measured at three timepoints including baseline, 12 months and 24 months]
• Capability-related Outcome [Срок оценки: All of the outcome measures will be measured at three timepoints including baseline, 12 months and 24 months]
• Capability-related Outcome [Срок оценки: All of the outcome measures will be measured at three timepoints including baseline, 12 months and 24 months]
• Sleep Quality Outcome [Срок оценки: All of the outcome measures will be measured at three timepoints including baseline, 12 months and 24 months]
• Mental Health Outcome [Срок оценки: All of the outcome measures will be measured at three timepoints including baseline, 12 months and 24 months]
• Mental Health Outcome [Срок оценки: All of the outcome measures will be measured at three timepoints including baseline, 12 months and 24 months]
• Mental Health Outcome [Срок оценки: All of the outcome measures will be measured at three timepoints including baseline, 12 months and 24 months]
• Cognitive Outcome [Срок оценки: All of the outcome measures will be measured at three timepoints including baseline, 12 months and 24 months]

Критерии участия

Критерии включения

• (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).

Критерии исключения

Conditions preventing effective engagement in the intervention

• (1) Terminal illness, aphasia
• (2) Marked hearing impairment
• (3) Participation in another interventional study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Сингапур · 2 центра

• National University Singapore, Tahir Foundation Building — Singapore
• National University Singapore — Singapore

Публикации

• 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. PMID 34894520
• 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. PMID 37321363
• 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. PMID 26360390

Идентификаторы

NCT: NCT06661486 · NUS-IRB-2023-219 · MOH-001290

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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