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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes
• Intervention / Treatment: Behavioral: control group; Behavioral: MB-EAT

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lo Ka Hei Kenneth, PhD; Phone Number: 852-3400-8778; Email: kenneth.kh.lo@polyu.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • The Hong Kong Polytechnic University
    • Contact: Lo Ka Hei Kenneth, PhD; Phone Number: 852-3400-8778; Email: kenneth.kh.lo@polyu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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 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.
Experimental: 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.	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 home mindfulness practice tasks to be completed within 10 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anthropometric measures	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.	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

Outcome Measure	Measure Description	Time Frame
Glycaemic control	HbA1c	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	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	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	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	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	serum concentrations of cortisol, ghrelin and leptin	At baseline (T0) and each follow-up assessment at 10-week (T1), 6-month (T2), and 12-month follow-up (T3) since baseline

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2029

Study Registration Dates

• First Submitted: June 29, 2026
• First Submitted That Met QC Criteria: July 7, 2026
• First Posted (Actual): July 9, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Diabetes; Obesity; Mindfulness; Randomized Controlled Trial; Glycaemic control; Mindful eating; Psychological health; Digital technology; Eating behaviours; Mindfulness-Based Eating Awareness Training
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Overweight; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Personal Satisfaction; Obesity; Diabetes Mellitus; Psychological Well-Being; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: 23241041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No