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

Study acronym: B-Mindful-Life
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Notable Primary endpoints: details revised at 1 of 5 entries Show 6 more changesShow less
    • Trial completed
    • Primary completion date changed from estimate of Jan 31, 2026 to Dec 10, 2025
    • Enrollment target: estimated 84 to confirmed 87
    • Study completion date changed from estimate of Jul 31, 2026 to Mar 10, 2026
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 15 of 15 entries
  2. Notable Enrollment target: 202 to 84v4 Show 5 more changesShow less
    • Primary endpoints: 1 to 5
    • Trial status: Recruiting to Active, Not Recruiting
    • Secondary endpoints: details revised at 1 of 15 entries
    • Site details revised
    • Study title expanded, about 5 words
  3. Minor Site contact updated
    • Eligibility criteria shortened, about 1 word
    v3
  4. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
    • Enrollment target: 84 to 202
    • Primary endpoint revised
    • Interventions: Activity Monitoring (Device), Ecological Momentary Interventions (EMI) (Behavioral), In-Person Mindfulness-based Group Session… to Activity Monitoring (Device), Ecological Momentary Interventions (EMI) (Behavioral), In-Person Mindfulness-based Group Sessions…
    • Secondary endpoints: 12 to 15
    • Site details revised
    • Eligibility criteria expanded, about 1 word
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06583018
Lead Sponsor The University of Hong Kong
Collaborators: health bureau, hong kong
Conditions
(from sponsor)
Caregiver
Related terms Motor Activity, Neurodegenerative Diseases
Enrollment 87 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov