Hong Kong Diabesity Register & 3-Year Trial on Integrated Care for Chinese With Diabesity
Recruiting · NCT07039279 · Interventional (participants receive a specific treatment) · Lead sponsor: Chinese University of Hong Kong
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
People with diabetes and obesity (diabesity) are difficult to treat with many unmet needs requiring personalized treatment regimens, intensive counselling and emotional support. Here, we propose to conduct a pragmatic trial including 2 parts: (1) establishment of a register for Hong Kong Chinese with diabesity and through this register, identify participants consecutively to enter (2) a 3-year randomized clinical trial to assess the effects of multicomponent integrated care program supported by a team of endocrinologist, dietitian, psychologist and research assistant with elements including medical therapy, cognitive behavioural therapy, e-care, artificial intelligence chatbot, biofeedback, peer support to improve the physical and mental health in people with diabesity, with weight reduction as primary outcome. Other outcomes include cardiometabolic risk factors, diabetes distress, lifestyles and sleep hygiene.
Who can take part
Inclusion criteria
- Type 2 diabetes;
- 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;
- Age between 18 and 50 years;
- Able to conversate with smartphone technology and web-based program.
- Able to read Chinese and communicate using Chinese.
Exclusion criteria
- Type 1 diabetes;
- Active malignant disease including those with history of malignant disease less than 5 years of disease-free duration;
- Life expectancy less than 12 months;
- Any medical illness or condition as judged by the investigators as ineligible to participate the study.
Where it is running
1 location listed.
- 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