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

NCT07039279 | Recruiting

• 1 other identifier: CRE 2025.324
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabesity

Outcome Measures

Primary Outcomes (1)

• 5% body weight reduction from baseline at year 1

  12 months

Secondary Outcomes (1)

• 10% body weight reduction from baseline at year 1

  12 months

Other Outcomes (28)

• Changes in body weight

  24 months and 36 months

• Blood pressure

  12 months, 24 months and 36 months

• Lipid profile

  12 months, 24 months and 36 month

Study Arms (2)

Multicomponent Integrated Care Program

EXPERIMENTAL

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.

Behavioral: Multicomponent Integrated Care Program; Other: TourHeart + platform

Control (Usual Care)

OTHER

Control

Other: TourHeart + platform

Interventions

Multicomponent Integrated Care Program BEHAVIORAL

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

Multicomponent Integrated Care Program

TourHeart + platform OTHER

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.

Control (Usual Care); Multicomponent Integrated Care Program

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (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

RECRUITING

MeSH Terms

Conditions

Diabesity

Condition Hierarchy (Ancestors)

Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Obesity; Overweight; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Alice Pik Shan Kong, MD

CONTACT

+852 3505 2648; alicekong@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 26, 2025
• Study Start: October 22, 2025
• Primary Completion (Estimated): October 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: March 3, 2026

Record last verified: 2026-03

Locations

HK (1)