Mindfulness-based Lifestyle Modification Programme for Caregivers of People With Neurodegenerative Disorders: A Pilot Randomised Controlled Trial (B-Mindful-Life)

The University of Hong Kong (HKU)

Status: Active, not recruiting

Conditions: Caregiver

Treatments: Behavioral: In-Person Mindfulness-based Group Sessions; Behavioral: Ecological Momentary Interventions (EMI); Behavioral: In-person Lifestyle Education Session; Device: Activity Monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT06583018

08220157

Details and patient eligibility

About

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).

Enrollment: 84 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adults who self-identify as the primary caregivers of ND patients for ≥3 months,
• experience of at least moderate stress as indicated by a PSS score ≥14,
• have a mobile device (e.g., smartphone, tablet, and laptop) with Internet access, and
• able to read and communicate in Chinese and give written consent

Exclusion criteria

• a self-reported exercise regimen of great than 150 minutes/week of MVPA (according to the American College of Sports Medicine guidelines),
• have received (within the past 6 months) or are receiving other physical and/or psychosocial interventions,
• pregnancy or within 6 months of postpartum,
• contraindications (e.g., current diagnosis of psychiatric illness according to the DSM IV-TR, DSM-V, or ICD-10) or severe comorbidities (e.g., severe hearing/vision/cognitive impairment) that might limit full participation.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 2 patient groups

Brief and Blended Mindfulness-based Lifestyle counselling programme (B-Mindful-Life)

Experimental group

Description:

(i) In-Person Mindfulness-based Group Sessions: Two 3-hour group-based session in week 1 and week 5 focused on experiential mindfulness practices. Participants will enhance their self-awareness of positive, neutral, and negative body sensations, feelings, and thoughts while engaging in healthy behaviors, particularly physical activity. (ii) Ecological Momentary Interventions (EMI): Personalized mindfulness-based lifestyle counseling delivered through instant messages, with chat-based support throughout the 8-week intervention period. (iii) Activity Monitoring: All participants will wear an accelerometer-based wristband activity tracker to monitor their physical activity in daily life.

Brief lifestyle education

Active Comparator group

Description:

(i) In-person Lifestyle Education Session: A 3-hour group-based session in week 1 focused on general education on lifestyle modification. (ii) Activity Monitoring: All participants will wear an accelerometer-based wristband activity tracker to monitor their physical activity in daily life.

Treatment:

Device: Activity Monitoring

Behavioral: In-person Lifestyle Education Session