Mindful Eating Study for Adults With Diabetes and Weight Concerns in Hong Kong
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MB-EAT, control group.
- Who it may be relevant to
- Registry conditions: Diabetes. Basic parameters: 45 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Mindfulness-based Eating Awareness Training (MB-EAT) Intervention for Patients With Diabetes and Obesity: A Randomized Controlled Trial
Overview
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.
Interventions
- Behavioral 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 - Behavioral 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
Primary outcome measures
- Anthropometric measures [Time frame: At baseline (T0) and each follow-up assessment at 10-week (T1), 6-month (T2), and 12-month follow-up (T3) since baseline]
Secondary outcome measures (4)
- Glycaemic control [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: At baseline (T0) and each follow-up assessment at 10-week (T1), 6-month (T2), and 12-month follow-up (T3) since baseline]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Hong Kong · 1 center
- The Hong Kong Polytechnic University — Hong Kong
Identifiers
NCT: NCT07692386 · 23241041