Mindful Eating Study for Adults With Diabetes and Weight Concerns in Hong Kong

Официальное название

Mindfulness-based Eating Awareness Training (MB-EAT) Intervention for Patients With Diabetes and Obesity: A Randomized Controlled Trial

Обзор

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.

Вмешательства

• Поведенческое MB-EAT
  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 ho
• Поведенческое 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. Additionally, they will receive weekly general health information regarding diabetes-specific lifestyle modifications and will be instructed to refrain from engaging in any mindfulness-based practices d

Первичные конечные точки

• Anthropometric measures [Срок оценки: At baseline (T0) and each follow-up assessment at 10-week (T1), 6-month (T2), and 12-month follow-up (T3) since baseline]

Вторичные конечные точки (4)

• Glycaemic control [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: At baseline (T0) and each follow-up assessment at 10-week (T1), 6-month (T2), and 12-month follow-up (T3) since baseline]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• The Hong Kong Polytechnic University — Гонконг

Идентификаторы

NCT: NCT07692386 · 23241041

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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