Mindfulness-based Eating Awareness Training (MB-EAT) Intervention for Patients With Diabetes and Obesity: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Anthropometric measures
研究概览
简要总结
Objectives: To assess the effect of a digital Mindfulness-Based Eating Awareness Training (MB-EAT) intervention on anthropometric measures, glycaemic control, eating behaviours, psychological health and hormones regulating stress and appetite in individuals with diabetes and obesity. Design: A randomized waitlist-controlled trial. Participants: A total of 120 participants (60 each in the intervention and control groups) with diabetes and obesity will be recruited via community partners and partnering endocrinology clinics. Interventions: The intervention group will be provided with an integrated programme of a 10-week digital MB-EAT course, alongside three individualized dietary consultations (scheduled at weeks 2, 5, and 10, each lasting one hour). This course will be delivered weekly through videos, audio tracks, and a series of mindfulness practice tasks to be completed at home. Outcome measures and data analysis: The primary outcomes will focus on changes in anthropometric measures, including weight loss, body mass index, waist circumference, and body fat percentage. Secondary outcomes will assess glycaemic control (measured by glycated haemoglobin), eating behaviours (including binge eating, eating control, mindful eating, food cravings, and dietary intake), psychological health (including diabetes-related distress, stress, anxiety, and depression), and hormones regulating stress and appetite (cortisol, ghrelin, leptin). The intervention's effects on these variables will be analysed at baseline, 3-month, and 6-month follow-ups using linear mixed model analysis. Expected results: It is anticipated that the MB-EAT group will demonstrate significant improvements in both primary and secondary outcomes compared to the waitlist group at both post-intervention and follow-up assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to read and understand Chinese and/or Cantonese
- •With physician-diagnosed T2D for at least 1 year
- •Aged 45 to 64 years
- •Have a mobile phone or laptop
- •Having overweight/obesity (BMI ≥ 23.0 kg/m2) based on Asian criteria
排除标准
- •BMI < 23.0 kg/m2
- •Poor glycaemic control (HbA1c ≥9.0%)
- •Requiring insulin therapy, GLP-1 receptor agonists, or GLP-1 and GIP receptors dual agonist for glucose management
- •Have engaged in any form of mindfulness-based practice (e.g., meditation, yoga, etc.) within the past month before enrolment
- •With medical diagnosis of any neurological/psychiatric disorders (stroke, depression, generalized anxiety disorder, and epilepsy)
- •With active gastrointestinal diseases, renal failure, chronic kidney disease, undergoing renal replacement therapy, renal replacement therapy or cancer
- •With self-reported alcohol or drug addiction
- •Intake of medications (sedatives, antiepileptics, and antidepressants) that may affect cognition
研究组 & 干预措施
Control group
As an active control, participants in the control arm will receive three 1-hour personalized dietary consultations with a nutritionist/dietitian via Zoom or other online platforms at weeks 2, 5, and 10. Diabetes-specific dietary goals will be established according to clinical practice guidelines.
干预措施: control group (Behavioral)
Intervention group
After randomisation, participants will be provided with an information sheet that contains information about the study, materials needed for the video-assisted practice (e.g., food for mindful eating exercises) and details of the contact person. In the orientation session, participants will be instructed on using REDCap, and an instruction video will be provided afterwards. The intervention will be delivered through 10 weekly videos (each ranged from 1-1.5 hours), audio tracks and a series of home mindfulness practice tasks to be completed within 10 weeks.
干预措施: MB-EAT (Behavioral)
结局指标
主要结局
Anthropometric measures
时间窗: At baseline (T0) and each follow-up assessment at 10-week (T1), 6-month (T2), and 12-month follow-up (T3) since baseline
Body weight, BMI and WC will be measured using calibrated equipment. Percentage body fat and muscle mass will be measured by using a multi-frequency segmental body composition analyzer (TANITA MC-780MA, Japan). Changes in muscle mass will be measured as a proxy for the safety of the intervention.
次要结局
- Glycaemic control(At baseline (T0) and each follow-up assessment at 10-week (T1), 6-month (T2), and 12-month follow-up (T3) since baseline)
- Eating Behaviour(At baseline (T0) and each follow-up assessment at 10-week (T1), 6-month (T2), and 12-month follow-up (T3) since baseline)
- Psychological health(At baseline (T0) and each follow-up assessment at 10-week (T1), 6-month (T2), and 12-month follow-up (T3) since baseline)
- Hormones regulating stress and appetite(At baseline (T0) and each follow-up assessment at 10-week (T1), 6-month (T2), and 12-month follow-up (T3) since baseline)