Diabetes
Conditions
Keywords
Mindful eating, Mindfulness, Mindfulness-Based Eating Awareness Training, Diabetes, Obesity, Digital technology, Randomized Controlled Trial, Glycaemic control, Eating behaviours, Psychological health
Brief summary
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
BEHAVIORALMB-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 home mindfulness practice tasks to be completed within 10 weeks.
BEHAVIORALcontrol 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 during the study. To ensure they do not miss out on the benefits of the MB-EAT, participants will receive a training session on how to use MB-EAT and will gain full access to the program after completing the 12-month follow-up.
Sponsors
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anthropometric measures | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | HbA1c |
| 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 | Validated scales in Chinese will be used: 30-item Dutch Eating Behaviour Questionnaire; 16-item Binge Eating Scale; 20-item Salzburg Stress eating Scale; 23-item Mindful Eating Questionnaire; and 60-item Food Frequency Questionnaire |
| 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 | Validated scales in Chinese will be used: 20-item Problem Areas in Diabetes Scale, the 21-item Beck Depression Inventory-II, the 21-item Beck Anxiety Inventory, and the 10-item Perceived Stress Scale |
| 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 | serum concentrations of cortisol, ghrelin and leptin |
Countries
Hong Kong
Contacts
CONTACTLo Ka Hei Kenneth, PhD
Outcome results
None listed