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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 236
- 试验地点
- 2
- 主要终点
- Mean change of time spent on 10-minute bout MVPA over a 7-day period
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. 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.
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 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.
排除标准
- •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.
研究组 & 干预措施
Brief lifestyle education
(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.
干预措施: In-person Lifestyle Education Session (Behavioral)
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.
干预措施: Ecological Momentary Interventions (EMI) (Behavioral)
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.
干预措施: Activity Monitoring (Behavioral)
Brief lifestyle education
(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.
干预措施: Activity Monitoring (Behavioral)
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.
干预措施: In-Person Mindfulness-based Group Sessions (Behavioral)
结局指标
主要结局
Mean change of time spent on 10-minute bout MVPA over a 7-day period
时间窗: 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.
次要结局
- Mean change of time spent on 10-minute bout MVPA 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(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(Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3))
- Health-related quality of life(Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3))
- Self-reported level of physical activity(Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3))
- Negative emotions(Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3))
- Caregiver burden(Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3))
- Caregiving gains(Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3))
- Mindfulness(Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3))
- Self-care behaviors(Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3))
- Self-care efficacy(Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3))
- Attention and meditation levels(Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3))
- Support care needs(Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3))
研究者
Kwok Yan Yan
Assistant Professor
The University of Hong Kong