Mindfulness-based Lifestyle Modification Programme for Caregivers of People With Neurological Disorders (B-Mindful-Life)

January 15, 2026 updated by: Kwok Yan Yan, The University of Hong Kong

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.

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
236

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong, 000
        • School of Nursing, LKS Faculty of Medicine, The University of Hong Kong
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Brief and Blended Mindfulness-based Lifestyle counselling programme (B-Mindful-Life)
(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
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.
Behavioral: 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.
Behavioral: Activity Monitoring
All participants will wear an accelerometer-based wristband activity tracker to monitor their physical activity in daily life.
Active Comparator: Brief lifestyle education
(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
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.
Behavioral: Activity Monitoring
All participants will wear an accelerometer-based wristband activity tracker to monitor their physical activity in daily life.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (T0) and 2 months (T1)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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), 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)
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), 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)
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), 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)
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).
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)
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.
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)
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.
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)
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
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)
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
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Participant experience of the intervention
Time Frame: 6-month (T2)
For the experimental group participants, a semi-structured individual interview will be conducted to explore their experiences and identify facilitators and barriers to the implementation and acceptability of the intervention.
6-month (T2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jojo Yan Yan Kwok, BNurs, MPH, PhD, The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 8, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2026

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23244201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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