Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06661486

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

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
120 (estimated)
Sponsor
National University of Singapore · Academic / Other
Sex
All
Age
60 Years – 75 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALUniformed intervention groupThe 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 groupOn 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.

Timeline

Start date
2024-10-01
Primary completion
2026-04-01
Completion
2028-04-01
First posted
2024-10-28
Last updated
2026-04-08

Locations

2 sites across 1 country: Singapore

Source: ClinicalTrials.gov record NCT06661486. Inclusion in this directory is not an endorsement.