RecruitingNot ApplicableNCT07039279

Hong Kong Diabesity Register & 3-Year Trial on Integrated Care for Chinese 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


Sponsor

Chinese University of Hong Kong

Enrollment

200 participants

Start Date

Oct 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 50 Years

Inclusion Criteria5

  • 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 Criteria4

  • 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.

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Interventions

BEHAVIORALMulticomponent Integrated Care Program

The multicomponent integrated care program is supported by a team of endocrinologist, dietitian, psychologist and research assistant with elements including medical therapy, cognitive behavioural therapy, e-care (TourHeart + platform), artificial intelligence chatbot, biofeedback, peer support

OTHERTourHeart + platform

TourHeart+ is a web-based program that provides mental health services that integrate both online and offline elements, opening up new possibilities for mental well-being. Participants will be introduced to the platform but the control group will not receive follow-up action. The platform is part of the multi-intervention care program and the participants in the intervention will receive follow-up action to engage their usage of the platform.


Locations(1)

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

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NCT07039279


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