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NCT06583018: B-Mindful-Life

Mindfulness-based Lifestyle Modification Programme for Caregivers of People With Neurodegenerative Disorders: A Pilot Randomised Controlled Trial

Active, enrolled NA Last updated 18 December 2025
What this trial tests

NA trial testing In-Person Mindfulness-based Group Sessions in Caregiver in 84 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
6 September 2024
Primary endpoint
31 January 2026
31 July 2026

Quick facts

Lead sponsorThe University of Hong Kong
PhaseNA
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposesupportive care
Enrollment84
Start date6 September 2024
Primary completion31 January 2026
Estimated completion31 July 2026
Sites1 location across Hong Kong

Drugs / interventions tested

Conditions studied

Sponsor

The University of Hong Kong

Who can join

18 and older, any sex, with Caregiver. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Over 80% of caregivers for individuals with neurodegenerative diseases (ND) engage in significant risk behaviors, particularly physical inactivity, which increases the risk of cardiometabolic diseases (CMD) by 30% and reduces life expectancy by 4-8 years. Despite the health benefits of maintaining healthy behaviors, awareness of behavioral risk management among healthcare professionals and the public is low, and research on this topic for ND caregivers is limited. Given that physical activity (PA) is the most prevalent modifiable risk factor, timely intervention is essential. International guidelines prioritize PA as a key strategy for caregiver health. However, existing PA interventions often struggle with low compliance due to the physical and emotional challenges caregivers face. Our research group actively explores the health-regulating and enhancing effects of integrative mind-body modalities, particularly mindfulness, which may promote and sustain healthy behaviors by improving attentional regulation and psychological flexibility. Mindfulness-based lifestyle modification might help caregivers better manage physical discomfort, stress, and self-limiting beliefs, thereby supporting sustained PA. The World Health Organization advocates for non-communicable disease (NCD) prevention through brief lifestyle interventions, such as ecological momentary interventions (EMI), which use mobile messaging (e.g., WhatsApp) to deliver personalized health content. This method is particularly valuable for caregivers who find it difficult to access traditional services due to their responsibilities. This pilot randomized clinical trial aims to evaluate the feasibility and acceptability of an EMI-enhanced "Brief and Blended Mindfulness-based Lifestyle Counselling Programme" (B-Mindful-Life) compared to brief lifestyle education for increasing PA among Chinese ND caregivers. The primary outcome will be the feasibility (rates of recruitment, eligibility, refusal, and retention at 2 and 5 months), and acceptability measures (adherence, incidence of adverse events, and satisfaction with intervention).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of In-Person Mindfulness-based Group Sessions

Trials testing the same drug.

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Other The University of Hong Kong trials

Trials by the same sponsor.

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Data sources for this page

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