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

NCT06583018 | Active Not Recruiting DMC

• 1 other identifier: 08220157
• Study Type: interventional
• Target: 84
• 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. 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).

Conditions

Caregiver

Keywords

caregivers; behavioral risk; physical activity; mindfulness; ecological momentary; neurodegenerative diseases; lifestyle

Outcome Measures

Primary Outcomes (5)

• Recruitment rate

  Recruitment rate will be calculated as the number of participants who consented to participate in the study divided by the number of eligible participants

  Baseline

• Incidence of adverse events

  The incidence of adverse events refers to the occurrence of undesirable experiences or side effects that arise during a clinical trial. It is measured by the number of new adverse events reported during the study period relative to the total number of participants in the study. Adverse events are defined as any negative reactions or complications that participants experience, which may be related to the intervention, including but not limited to physical, psychological, or emotional effects.

  From baseline to the end of the study period at 5 months.

• Retention rate

  Retention rate will be calculated as the number of participants providing the outcomes of interest divided by the number of randomised participants.

  Baseline, 2 months, and 5 months

• Adherence/ engagement rate

  For both groups, the adherence rate will be calculated as the number of participants who attend the group sessions divided by the number of randomized participants. For the experimental group, the engagement rate will be calculated as the percentage or frequency of regular messages that are received or replied to by participants using the quick reply button, emojis, or free-text responses. Additionally, it will include the time spent, frequency, and percentage of participants who utilize the chat-based support during the 8-week intervention period.

  From baseline to the end of intervention at 2 months

• Satisfaction with intervention

  Satisfaction will be measured quantitatively by a questionnaire rating on four key domains: usefulness of treatment, opinion of the intervener, perceived improvement and likelihood to recommend the treatment to others, on a 5-point scale. High scores indicating high satisfaction.

  1-week (the end of the group session), 2-month (the end of the EMI-intervention, for experimental group only)

Secondary Outcomes (15)

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

  Baseline, 2 months, and 5 months

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

  Baseline, 2 months, 5 months

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

  Baseline, 2 months, 5 months

• Mean change of average steps per day over a 7-day period

  Baseline, 2 month, 5 months

• Health-related quality of life

  Baseline, 2 months, and 5 months

Other Outcomes (1)

• Participant expereince and perception of the intervention

  Within three months after the end of the intervention

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.

Brief lifestyle education

ACTIVE COMPARATOR

(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.

Behavioral: In-person Lifestyle Education Session; Device: 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.

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.

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 DEVICE

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead
• health bureau, hong kong: collaborator

Study Sites (1)

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

Pokfulam, Hong Kong

Location

MeSH Terms

Conditions

Motor Activity; Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Behavior; Nervous System Diseases

Study Officials

• Jojo Yan Yan Kwok, BNurs, MPH, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

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: August 30, 2024
• First Posted: September 3, 2024
• Study Start: September 6, 2024
• Primary Completion: January 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)