CaregiverB-Mindful-LifeNCT07342140
Mindfulness-based Lifestyle Modification Programme for Caregivers of People With Neurological Disorders
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.
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
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jul 2026to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 informal caregivers of people with ND 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
School of Nursing, LKS Faculty of Medicine, The University of Hong Kong
Hong Kong, 000
Wilfred Wing Fung Sin, BNurs, +85265004023, u3010478@connect.hku.hk
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 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. 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.
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.
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
- 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, neurological disorders, lifestyle modification, self-care
- Medical subject headings
- Motor Activity, Nervous System 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 MonitoringBehavioural
All participants will wear an accelerometer-based wristband activity tracker to monitor their physical activity in daily life.
| Study group | Role | What 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. Receives: 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. Receives: Behavioral: In-person Lifestyle Education Session; Behavioral: Activity Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (T0) and 2 months (T1)
Secondary outcomes (13)
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 (T0), 6 months (T2), and 12 months (T3)
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 (T0), 2 months (T1), 6 months (T2), and 12 months (T3)
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 (T0), 2 months (T1), 6 months (T2), and 12 months (T3)
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 (T0), 2 months (T1), 6 months (T2), and 12 months (T3)
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 (T0), 2 months (T1), 6 months (T2), and 12 months (T3)
Negative emotions
For caregivers only, measured by the Chinese DASS-21 using a one-week recall period, which was developed to measure three related and clinically significant negative emotional states of depression, anxiety and stress. Each item is rated on a 0-3 scale (0="Did not apply to me at all" to 3="Applied to me very much or most of the time"). The score of each subscale ranges from 0-42 and the total score ranges from 0-126, with higher score indicating greater self-reported levels of depression, anxiety and stress.
Measured: Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3)
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 (T0), 2 months (T1), 6 months (T2), and 12 months (T3)
Caregiving gains
For caregivers only, measured by the Chinese Positive Aspects of Caregiving Scale (C-PACS). Each item is rated on 1-5 scale (1= disagree a lot; 5 = agree a lot). The total score ranges from 10-50. Higher score indicates more positive appraisal towards caregiving. In addition, two domains of the C-PACS, namely enriching life and affirming self will be assessed
Measured: Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3)
Mindfulness
For caregivers only, measured by the validated Chinese 32-item Multidimensional Assessment of Interoceptive Awareness (MAIA). Each item is rated on a a 0-5 scale (0=never, 5=always). Higher score indicates higher level of mindfulness. In addition, eight domains of the MAIA, namely noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening and trusting will be assessed.
Measured: Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3)
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 (T0), 2 months (T1), 6 months (T2), and 12 months (T3)
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 (T0), 2 months (T1), 6 months (T2), and 12 months (T3)
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 (T0), 2 months (T1), 6 months (T2), and 12 months (T3)
Support care needs
For care recipients only, measured 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 (T0), 2 months (T1), 6 months (T2), and 12 months (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 Jul 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaregiverStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kwok Yan Yan, The University of Hong Kong
- Investigators
- Jojo Yan Yan Kwok, BNurs, MPH, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07342140
- Sponsor's protocol ID
- 23244201
- Acronym
- B-Mindful-Life
- Status last verified
- Oct 2026
- First submitted
- 5 Jan 2026
- Last updated
- 26 Oct 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, Prof. Kwok. These data are not publicly available, as they contain information that could compromise the privacy of research participants.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07342140
- Acronym / sponsor ID
- B-Mindful-Life / 23244201
- Conditions
- Caregiver
- Keywords
- caregivers, behavioral risk, physical activity, mindfulness, ecological momentary, neurological disorders, lifestyle modification, self-care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief and Blended Mindfulness-based Lifestyle counselling programme (B-Mindful-Life) | Experimental | Behavioral: In-Person Mindfulness-based Group Sessions, Behavioral: Ecological Momentary Interventions (EMI), Behavioral: Activity Monitoring(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 | Behavioral: In-person Lifestyle Education Session, Behavioral: Activity Monitoring(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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults who self-identify as the primary informal caregivers of people with ND 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-Person Mindfulness-based Group SessionsThe 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. | Behavioural | Brief and Blended Mindfulness-based Lifestyle counselling programme (B-Mindful-Life) |
| Ecological Momentary Interventions (EMI)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. | Behavioural | Brief and Blended Mindfulness-based Lifestyle counselling programme (B-Mindful-Life) |
| In-person Lifestyle Education SessionA 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. | Behavioural | Brief lifestyle education |
| Activity MonitoringAll participants will wear an accelerometer-based wristband activity tracker to monitor their physical activity in daily life. | Behavioural | Brief and Blended Mindfulness-based Lifestyle counselling programme (B-Mindful-Life), Brief lifestyle education |
Primary outcome
Mean change of time spent on 10-minute bout MVPA over a 7-day period
Time frame: Baseline (T0) and 2 months (T1)
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.
13 secondary outcomes
Mean change of time spent on 10-minute bout MVPA over a 7-day period
Time frame: Baseline (T0), 6 months (T2), and 12 months (T3)
Mean change of time spent on total MVPA over a 7-day period
Time frame: 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
Time frame: Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3)
Health-related quality of life
Time frame: Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3)
Self-reported level of physical activity
Time frame: Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3)
Negative emotions
Time frame: Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3)
Caregiver burden
Time frame: Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3)
Caregiving gains
Time frame: Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3)
Mindfulness
Time frame: Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3)
Self-care behaviors
Time frame: Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3)
Self-care efficacy
Time frame: Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3)
Attention and meditation levels
Time frame: Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3)
Support care needs
Time frame: Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No. The data supporting the findings of this study are available upon request from the principal investigator, Prof. Kwok. These data are not publicly available, as they contain information that could compromise the privacy of research participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jojo Yan Yan Kwok, BNurs, MPH, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
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: looking for participants now, as of the sponsor's last update on 26 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wilfred Wing Fung Sin, BNurs (+85265004023, u3010478@connect.hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change of time spent on 10-minute bout MVPA over a 7-day period (time frame: Baseline (T0) and 2 months (T1)). 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 26 Oct 2026.