Clinical trial NCT06583018: Mindfulness-based Lifestyle Modification Programme for Caregivers of People With Neurodegenerative Disorders
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Caregiver
Keywords: caregivers
behavioral risk
physical activity
mindfulness
ecological momentary
neurodegenerative diseases
lifestyle
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: health bureau, hong kong
First posted: 2024-09-03
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 randomized clinical trial aims to evaluate the effects 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 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Mean change of time spent on 10-minute bout MVPA over a 7-day period
timeFrame: Baseline and 2 months
Secondary outcomes:
measure: Mean change of time spent on 10-minute bout MVPA over a 7-day period
timeFrame: Baseline and 5 months
measure: Mean change of time spent on total MVPA over a 7-day period
timeFrame: Baseline, 2 months, 5 months
measure: Mean change of time spent on sporadic MVPA over a 7-day period
timeFrame: Baseline, 2 months, 5 months
measure: Mean change of average steps per day over a 7-day period
timeFrame: Baseline, 2 month, 5 months
measure: Health-related quality of life
timeFrame: Baseline, 2 months, and 5 months
measure: Self-reported level of physical activity
timeFrame: Baseline, 2 months, and 5 months
measure: Percieved stress level
timeFrame: Baseline, 2 months, and 5 months
measure: Caregiver burden
timeFrame: Baseline, 2 months, and 5 months
measure: Anxiety
timeFrame: Baseline, 2 months, and 5 months
measure: Depression
timeFrame: Baseline, 2 months, and 5 months
measure: Mindfulness
timeFrame: Baseline, 2 months, and 5 months
measure: Self-care behaviors
timeFrame: Baseline, 2 months, and 5 months
measure: Self-care efficacy
timeFrame: Baseline, 2 months, and 5 months
measure: Attention and meditation levels
timeFrame: Baseline, 2 months, and 5 months
measure: Support care needs
timeFrame: Baseline, 2 months, and 5 months
Other outcomes:
measure: Recruitment rate
timeFrame: Baseline
measure: Retention rate
timeFrame: Baseline, 2 months, and 5 months
measure: Adherence/ engagement rate
timeFrame: From baseline to the end of intervention at 2 months
measure: Incidence of adverse events
timeFrame: From baseline to the end of the study period at 5 months.
measure: Satisfaction with intervention
timeFrame: 1-week (the end of the group session), 2-month (the end of the EMI-intervention, for experimental group only)
measure: Participant expereince and perception of the intervention
timeFrame: Within three months after the end of the intervention
Locations:
city: Pokfulam
country: Hong Kong
facility: School of Nursing, LKS Faculty of Medicine, The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Jojo Yan Yan Kwok, BNurs, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: