AzTrials
AzTrials

CaregiverB-Mindful-LifeNCT06583018

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

A study testing In-Person Mindfulness-based Group Sessions, Ecological Momentary Interventions (EMI) and In-person Lifestyle Education Session in people with Caregiver, run by The University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Caregiver
What is being tested?
In-Person Mindfulness-based Group Sessions, Ecological Momentary Interventions (EMI) and In-person Lifestyle Education Session
Could I receive a placebo?
No, everyone receives an active treatment
How many people
87 participants
Where
1 siteHong Kong
Study dates
6 Sep 2024to 10 Mar 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Hong Kong1 site
  • School of Nursing, LKS Faculty of Medicine, The University of Hong Kong

    Pokfulam

Other trials in Hong Kong

About this study

Official title: A Brief and Blended Mindfulness-based Lifestyle Counselling Programme (B-Mindful-Life) for Behavioural Risk Modification Among Caregivers of People With Neurodegenerative Disorders: A Pilot Randomised Controlled Trial

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.

Read more

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
Being tested
In-Person Mindfulness-based Group Sessions, Ecological Momentary Interventions (EMI), In-person Lifestyle Education Session, Activity Monitoring
Keywords
caregivers, behavioral risk, physical activity, mindfulness, ecological momentary, neurodegenerative diseases, lifestyle
Medical subject headings
Motor Activity, Neurodegenerative Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • In-Person Mindfulness-based Group SessionsBehavioural

    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)Behavioural

    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 SessionBehavioural

    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.

  • Activity MonitoringDevice

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

Study groups in NCT06583018
Study groupRoleWhat they receive
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 educationActive 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.
Receives: Behavioral: In-person Lifestyle Education Session; Device: Activity Monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline

  2. 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.

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

  3. Retention rate

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

    Measured: Baseline, 2 months, and 5 months

  4. 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.

    Measured: From baseline to the end of intervention at 2 months

  5. 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.

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

Secondary outcomes (15)
  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.

    Measured: Baseline, 2 months, and 5 months

  2. Mean change of time spent on total 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.

    Measured: Baseline, 2 months, 5 months

  3. Mean change of time spent on sporadic 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.

    Measured: Baseline, 2 months, 5 months

  4. Mean change of average steps per day 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.

    Measured: Baseline, 2 month, 5 months

  5. Health-related quality of life

    For both caregivers and care recipients, measured by EuroQol 5-dimension 5-level questionnaire (EQ-5D-5L). The questionnaire comprises two main components: a description of health status across 5 dimensions (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression), and a numeric value representing the overall health status perceived by the respondents (EQ-VAS). Each dimension is rated from 0 (no problems) to 4 (extreme problems). The scores across the 5 dimensions will be transformed into a utility score based on a validated EQ-5D-5L value set for the Chinese population, with a higher utility score indicating a better health state.

    The EQ-VAS records an individual's self-rated health on a numeric analogue visual scale, ranging from 0 (the worst health) to 100 (the best health).

    Measured: Baseline, 2 months, and 5 months

  6. Self-reported level of physical activity

    For caregivers only, measured by International Physical Activity Questionnaire - Short Form. Continuous scores will be calculated according to the standard scoring protocol, which transforms various physical activities into metabolic equivalent (MET)-minutes/week. A higher MET-minutes/week indicates a higher level of physical activity Based on the duration of different physical activities and the calculated MET-minutes/week, participants can also be classified into three categories: Low, Moderate, and High levels of physical activity.

    Measured: Baseline, 2 months, and 5 months

  7. Percieved stress level

    For caregivers only, measured by Perceived Stress Scale. Each item is rated on a 0-4 scale (0=never, 4=very often). The total score ranges from 0-40. Higher score indicates higher level of stress. A total score ≥14 indicates moderate level of perceived stress, and a total score ≥27 indicates high level of perceived stress.

    Measured: Baseline, 2 months, and 5 months

  8. Caregiver burden

    For caregivers only, measured by the 12-item Zarit Burden Interview - Short Version (ZBI-SV). Each item is rated on a 0-4 scale (0=Never, 4=Very Often). The total score ranges from 0-48. Higher score indicates heavier caregiver burden. Three domains of ZBI-SV perceived role strain, self-criticism, and negative emotion will also be assessed.

    Measured: Baseline, 2 months, and 5 months

  9. Anxiety

    For caregivers only, measured by General Anxiety Disoder - 7 (GAD-7). Each item is rated on a 0-3 scale (0=not at all, 4=nearly every day). The total score ranges from 0-21. Higher score indicates higher level of anxiety. A total score ≥10 indicates possible anxiety.

    Measured: Baseline, 2 months, and 5 months

  10. Depression

    For caregivers only, measured by Patient Health Questionnaire - 9 (PHQ-9). Each item is rated on a 0-3 scale (0=not at all, 4=nearly every day). The total score ranges from 0-27. Higher score indicates higher level of depression. A total score ≥10 indicates possible major depression.

    Measured: Baseline, 2 months, and 5 months

  11. Mindfulness

    For caregivers only, measured by 20-item Five-facet Mindfulness Questionnaire - Short Form (FFMQ-SF). Each item is rated on 1-5 scale (1=Never, 5=Very Often). The total score ranges from 20-100. Higher score indicates higher level of trait mindfulness. In addition, five domains of the FFMQ-SF, namely observing, describing, acting with awareness, non-judgment of inner experience, and non-reaction to inner experience will be assessed.

    Measured: Baseline, 2 months, and 5 months

  12. Self-care behaviors

    For caregivers only, measured by 20-item Self-Care Inventory (SCI). Each item is rated on a 1 to 5 scale (1=Never, 5=Always). 3 domains of the SCI, namely self-care maintenance, self-care monitoring, and self-care management will be assessed. The score of each domain is derived from the raw summative score using the scoring algorithm proposed by the scale developer, which ranges from 0 to 100. A higher score on the SCI indicates better engagement in self-care in the corresponding domain.

    Measured: Baseline, 2 months, and 5 months

  13. Self-care efficacy

    For caregivers only, measured by the 10-item Self-Care Self-Efficacy Scale (SCSES). Each item is rated on a 1 to 5 scale (1=No Confident, 5=Extremely Confident). The total score ranges from 10-50. Higher score in SCSES indicates higher level of self-care efficacy.

    Measured: Baseline, 2 months, and 5 months

  14. Attention and meditation levels

    For caregivers only, measured using a validated electroencephalogram-based headband tracker. Participants will wear the headband with assistance from the outcome assessor before following a standardized audio-guided protocol. Attention and meditation levels will be assessed using a 0-100 rating scale, where a higher score indicates increased focused attention and meditation status, respectively.

    Measured: Baseline, 2 months, and 5 months

  15. Support care needs

    For care recipients only, meausred by the 10-item Palliative care Outcome Scale (POS). The 10 items assess physical symptoms, emotional, psychosocial and spiritual needs, provision of information and practical concerns. Each item is rated on a 0 - 4 scale (0=No burden, 4=Overwhelming problems). The total score ranges from 0-40. Higher score indicates greater unmet support care needs.

    Measured: Baseline, 2 months, and 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2024
  2. Study start6 Sep 2024
  3. Primary completion10 Dec 2025
  4. Study completion10 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06583018
Sponsor's protocol ID
08220157
Acronym
B-Mindful-Life
Status last verified
Sep 2026
First submitted
30 Aug 2024
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data supporting the findings of this study are available upon request from the principal investigator, Dr. Kwok. These data are not publicly available, as they contain information that could compromise the privacy of research participants.

Questions about this trial

What is this clinical trial studying?

A study testing In-Person Mindfulness-based Group Sessions, Ecological Momentary Interventions (EMI) and In-person Lifestyle Education Session in people with Caregiver, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment rate (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in