Hong Kong register and 3-year integrated care program for Chinese adults with diabesity

Establishment of Hong Kong Diabesity Register and a 3-year Randomized Clinical Trial for the Investigation of the Effectiveness of a Multicomponent Integrated Care Program in Chinese With Diabesity

This program will test whether a 3-year team-based approach (medical therapy, dietitian and psychologist support, e-care with an AI chatbot, biofeedback and peer support) helps Chinese adults aged 18–50 with type 2 diabetes and obesity lose weight and improve physical and mental health.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Chinese University of Hong Kong (other)
• Locations: 1 site (Hong Kong)
• Trial ID: NCT07039279 on ClinicalTrials.gov

What this trial studies

The project first creates a Hong Kong register of Chinese adults with diabesity and then recruits participants from that register into a 3-year randomized clinical trial. Enrolled participants at the Prince of Wales Hospital will be randomized to a multicomponent integrated care program delivered by an endocrinologist, dietitian, psychologist and research assistant, using medical therapy, cognitive behavioural therapy, e-care tools (TourHeart+), an AI chatbot, biofeedback and peer support, versus usual care. The primary outcome is weight reduction over three years, and secondary outcomes include cardiometabolic risk factors, diabetes distress, lifestyle behaviours and sleep hygiene. The design is pragmatic and leverages digital platforms to deliver interventions and collect clinical and patient-reported data in a real-world setting.

Who should consider this trial

Good fit: Ideal candidates are Hong Kong Chinese adults aged 18–50 with type 2 diabetes and obesity (BMI ≥27.5 kg/m2 and/or waist circumference ≥80 cm for women or ≥90 cm for men) who can read Chinese and use smartphone/web-based programs.

Not a fit: Patients with type 1 diabetes, active or recent malignancy, life expectancy under 12 months, those unable to use smartphone/web tools or who cannot read Chinese, and anyone judged by investigators as medically ineligible are unlikely to benefit from this program.

Why it matters

Potential benefit: If successful, the program could help people with diabesity lose meaningful weight, improve metabolic health and reduce diabetes-related emotional distress, potentially lowering long-term complications.

How similar studies have performed: Multidisciplinary programs combining medical, nutritional and psychological care have shown benefits for weight and glycemic control, but long-term randomized trials that combine e-care, AI chatbots and biofeedback in diabesity are relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Type 2 diabetes;
2. Obesity reaching action level as defined as body mass index (BMI) ³27.5 kg/m2 and/or waist circumference (WC) ³80cm in women and ³90cm in men;
3. Age between 18 and 50 years;
4. Able to conversate with smartphone technology and web-based program.
5. Able to read Chinese and communicate using Chinese.

Exclusion Criteria:

1. Type 1 diabetes;
2. Active malignant disease including those with history of malignant disease less than 5 years of disease-free duration;
3. Life expectancy less than 12 months;
4. Any medical illness or condition as judged by the investigators as ineligible to participate the study.

Where this trial is running

Hong Kong

• Department of Medicine and Therapeutics, The Chinese University of Hong Kong (CUHK), Ward 3M, Diabetes and Endocrine Research Centre, 3/F Day Treatment Block and Children Wards (Old Block), Prince of Wales Hospital — Hong Kong, Hong Kong (RECRUITING)

Study contacts

• Study coordinator: Alice Pik Shan Kong, MD

Conditions: Diabesity