Mindfulness-based Lifestyle Modification Programme for Caregivers of People With Neurological Disorders

NCT07342140 | Not Yet Recruiting DMC

• 1 other identifier: 23244201
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

Brief Summary

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. Mindfulness-based lifestyle modification might help caregivers better manage physical discomfort, stress, and self-limiting beliefs, thereby supporting sustained PA by improving attentional regulation and psychological flexibility. 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. A pilot RCT was conducted to compare B-Mindful-Life to brief lifestyle education program in Chinese neurodegenerative disease caregivers, demonstrating promising acceptability, engagement, and effect for increasing PA (NCT06583018). Therefore, this full-power randomized clinical trial aims to rigorously examine its effectiveness and broader impact on this underserved population with several advancement: (i) broaden the population into all neurological disorder caregivers to test for the generalizability of the B-Mindful-Life program; (ii) conduct a 12-month follow-up to assess long-term effects of B-Mindful-Life intervention in real-life settings; (iii) modify outcome measures for targeted assessment. The primary outcome will measure the change in accelerometer-determined, 10-minute bout moderate-to-vigorous physical activity (MVPA) over a 7-day period from baseline to post-intervention.

Conditions

Caregiver

Keywords

caregivers; behavioral risk; physical activity; mindfulness; ecological momentary; neurological disorders; lifestyle modification; self-care

Outcome Measures

Primary Outcomes (1)

• Mean change of time spent on 10-minute bout MVPA over a 7-day period

  For caregivers only, measured by the accelerometer-based wristband activity tracker. The data will be considered valid if the participants wear the activity tracker for ≥10 hours/day for ≥5 days over a 7-day period.

  Baseline (T0) and 2 months (T1)

Secondary Outcomes (13)

• Mean change of time spent on 10-minute bout MVPA over a 7-day period

  Baseline (T0), 6 months (T2), and 12 months (T3)

• Mean change of time spent on total MVPA over a 7-day period

  Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3)

• Mean change of time spent on sporadic MVPA over a 7-day period

  Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3)

• Health-related quality of life

  Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3)

• Self-reported level of physical activity

  Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3)

Other Outcomes (1)

• Participant experience of the intervention

  6-month (T2)

Study Arms (2)

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

EXPERIMENTAL

(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.

Behavioral: In-Person Mindfulness-based Group Sessions; Behavioral: Ecological Momentary Interventions (EMI); Behavioral: Activity Monitoring

Brief lifestyle education

ACTIVE COMPARATOR

(i) In-person Lifestyle Education Session: Two 3-hour group-based session in week 1 and week 5 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.

Behavioral: In-person Lifestyle Education Session; Behavioral: Activity Monitoring

Interventions

In-Person Mindfulness-based Group Sessions BEHAVIORAL

The 3-hour group-based session in week 1 focuses on experiential mindfulness practices, and a booster session in week 5 further consolidates these mindfulness techniques, reinforces mindful, healthy lifestyle, and provides peer support. Participants will enhance their self-awareness of positive, neutral, and negative body sensations, feelings, and thoughts while engaging in healthy behaviors, particularly physical activity.

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

Ecological Momentary Interventions (EMI) BEHAVIORAL

Participants will receive personalized instant messages with chat-based support throughout the 8-week intervention period. The message content is guided by existing international lifestyle modification guidelines and the Integrated Body-Mind-Spirit Model. The pre-set frequency of regular message delivery is five times per week. The schedule of message delivery will be personalized according to the participants' on-going needs/preferences over the intervention period. Chat-based support will be provided by trained research assistants, who will utilize motivational interviewing techniques to enhance participant compliance and effectiveness.

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

In-person Lifestyle Education Session BEHAVIORAL

A 3-hour group-based session in week 1 focused on general education on lifestyle modification based on the HEARTS technical package as recommended by the WHO, and will only receive reminder messages for the two assessment follow-ups. No chat-based support will be provided.

Brief lifestyle education

Activity Monitoring BEHAVIORAL

All participants will wear an accelerometer-based wristband activity tracker to monitor their physical activity in daily life.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults who self-identify as the primary co-residing caregivers of ND patients for ≥3 months. ND is defined as any long-term disorder affecting the nervous system, such as stroke, epilepsy, multiple sclerosis, Parkinson's disease, Alzheimer's disease, traumatic brain injury, migraines, amyotrophic lateral sclerosis, and Huntington's disease;
• Experience of at least mild negative emotions, as indicated by DASS-21 score of Depression subscale ≥10, Anxiety subscale ≥8, or Stress subscale ≥15);
• 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.

You may not qualify if:

• 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; and
• Presence of contraindications, such as a current diagnosis of psychiatric illness (according to the DSM IV-TR, DSM-V, or ICD-10) or severe comorbidities (e.g., severe hearing, vision, or cognitive impairment) that might limit full participation.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

School of Nursing, LKS Faculty of Medicine, The University of Hong Kong

Hong Kong, 000, Hong Kong

Location

MeSH Terms

Conditions

Motor Activity; Nervous System Diseases

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Jojo Yan Yan Kwok, BNurs, MPH, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wilfred Wing Fung Sin, BNurs

CONTACT

+85265004023; u3010478@connect.hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 15, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)