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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Recruitment rate
时间窗: Baseline
Recruitment rate will be calculated as the number of participants who consented to participate in the study divided by the number of eligible participants
Incidence of adverse events
时间窗: From baseline to the end of the study period at 5 months.
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.
Retention rate
时间窗: Baseline, 2 months, and 5 months
Retention rate will be calculated as the number of participants providing the outcomes of interest divided by the number of randomised participants.
Adherence/ engagement rate
时间窗: From baseline to the end of intervention at 2 months
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.
Satisfaction with intervention
时间窗: 1-week (the end of the group session), 2-month (the end of the EMI-intervention, for experimental group only)
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.
次要结局
- Caregiver burden(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)
- Anxiety(Baseline, 2 months, and 5 months)
- Self-reported level of physical activity(Baseline, 2 months, and 5 months)
- Percieved stress level(Baseline, 2 months, and 5 months)
- Depression(Baseline, 2 months, and 5 months)
- Mindfulness(Baseline, 2 months, and 5 months)
- Self-care behaviors(Baseline, 2 months, and 5 months)
- Self-care efficacy(Baseline, 2 months, and 5 months)
- Attention and meditation levels(Baseline, 2 months, and 5 months)
- Support care needs(Baseline, 2 months, and 5 months)
- 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)
- Self-reported level of physical activity(Baseline, 2 months, and 5 months)
- Percieved stress level(Baseline, 2 months, and 5 months)
- Caregiver burden(Baseline, 2 months, and 5 months)
- Anxiety(Baseline, 2 months, and 5 months)
- Depression(Baseline, 2 months, and 5 months)
- Mindfulness(Baseline, 2 months, and 5 months)
- Self-care behaviors(Baseline, 2 months, and 5 months)
- Self-care efficacy(Baseline, 2 months, and 5 months)
- Attention and meditation levels(Baseline, 2 months, and 5 months)
- Support care needs(Baseline, 2 months, and 5 months)
研究者
Kwok Yan Yan
Assistant Professor
The University of Hong Kong