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DiabesityNCT07039279

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

A study testing Multicomponent Integrated Care Program and TourHeart + platform in people with Diabesity, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Diabesity
What is being tested?
Multicomponent Integrated Care Program and TourHeart + platform
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteHong Kong
Study dates
22 Oct 2025to 31 Dec 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Alice Pik Shan Kong, MD contact

+852 3505 2648

alicekong@cuhk.edu.hk

Hong Kong1 site, 1 recruiting
  • 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

    Alice Pik Shan Kong, MD, +852 3505 2648, alicekong@cuhk.edu.hk

    Recruiting

Other trials in Hong Kong

About this study

Official title: 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

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.

Read the detailed description

Diabetes is both a public and personal health disaster if not diagnosed, treated or managed properly. Over 60% of all cause deaths and disabilities including stroke, leg amputation, heart disease, cancer, kidney disease, depression to name but a few are causally linked to diabetes. In the United Kingdom Prospective Diabetes Study (UKPDS), a landmark clinical trial of patients with type 2 diabetes, 0.9% reduction in glycated hemoglobin (HbA1c) reduced diabetes-related microvascular complications by 12-25%. In the 10-year post-trial follow-up period, the benefits of attaining glycemic control early had a legacy effect in reducing all clinical outcomes including cardiovascular complications and death. Nonetheless, it is a worldwide phenomenon that majority of people with type 2 diabetes are not reaching glycemic goals due to clinical inertia with delayed escalation of therapy, poor treatment compliance and/or insufficient self management.

Since 1995, as part of a quality improvement program, patients attending our twice-weekly diabetic complication screening sessions at the Prince of Wales Hospital (PWH) underwent detailed documentations of clinical and biochemical information which formed the basis of the Hong Kong Diabetes Register. Data from this prospective cohorts and others have shown that obese people with type 2 diabetes are particularly difficult to treat with extremely high risk for future events. Weight control is a major therapeutic challenge which often requires cognitive-psychological-behavioral therapy (CBT) in addition to pharmacological which at times might call for surgical interventions. Many traditionally used glucose lowering agents, such as sulphonylurea and insulin, can cause weight gain, thus setting up a vicious cycle with increasing insulin resistance due to increasing levels of free fatty acids from adipose tissues. During a 6-month study, patients with type 2 diabetes treated with intensive insulin therapy dropped their HbA1c by 2.6% but gained an average of 8.7kg. Similarly, data from the UKPDS which recruited newly diagnosed type 2 diabetes, showed that patients had significant weight gain during a 10-year follow up period, particularly those on insulin therapy.

In a prospective analysis, insulin-treated type 2 diabetic patients with residual beta cell function as evidenced by high fasting serum C-peptide levels, had the highest rate of cardiovascular events of over 10%. This high event rate might be due to long disease duration, renal impairment and autonomic neuropathy with incresaed risk of hypoglycemia which substantially increased the risk of cardivoascular disease. People with diabesity have many unmet needs which require individualized therapy, intensive counselling and emotional support which cannot be adequately addressed in a busy clinic setting with 10-15 minute consultation. Besides, many patients with diabetes of working age tend to default due to competing priorities and silent nature of the disease and regrettably only to present with preventable complications after a few years.

In a series of randomized studies and disease management programs which has demonstrated the benefits of team approach, case management, quality improvement and patient empowerment on risk factor control, we have confirmed the marked benefits of using a interdisciplinary team to deliver protocol-driven care on clinical outcomes. Important features of this program included continuation of care through periodic reminders, decision support, empowerment, peer support and feedback. In a multicentre randomized study involving over 600 type 2 diabetic patients, we have demonstrated the benefits of a web-based disease management program,Joint Asia Diabetes Evaluation (JADE) program, which provides integrated and visual information to communicate personalized risks and treatment targets on reducing multiple risk factors, reducing treatment non-compliance, improving psychological health and enhancing self efficiacy in 20-30% of participants . Amongst those with negative emotions who accounted for 20% of the cohort, peer support further improved compliance and reduced hospitalization rates.

Against this background, we propose to conduct a study with 2 parts: 1) First, the establishment of Diabesity Register of Hong Kong Chinese, and through this Diabesity Register, identify eligible participants to enter: 2) a 3-year Randomized Clinical Trial (RCT) to evaluate the effectiveness of multicomponent integrated care (MIC) program in these people with diabesity.

Conditions
Diabesity
Being tested
Multicomponent Integrated Care Program, TourHeart + platform
Medical subject headings
Diabesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multicomponent Integrated Care ProgramBehavioural

    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

  • TourHeart + platformOther

    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.

Study groups in NCT07039279
Study groupRoleWhat they receive
Multicomponent Integrated Care ProgramExperimentalThe 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.
Receives: Behavioral: Multicomponent Integrated Care Program; Other: TourHeart + platform
Control (Usual Care)OtherControl
Receives: Other: TourHeart + platform

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 5% body weight reduction from baseline at year 1

    Measured: 12 months

Secondary outcomes (1)
  1. 10% body weight reduction from baseline at year 1

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2025
  2. Study start22 Oct 2025
  3. Primary completion31 Oct 2030 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07039279
Sponsor's protocol ID
CRE 2025.324
Status last verified
Mar 2026
First submitted
4 Jun 2025
Last updated
3 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Multicomponent Integrated Care Program and TourHeart + platform in people with Diabesity, run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alice Pik Shan Kong, MD (+852 3505 2648, alicekong@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

5% body weight reduction from baseline at year 1 (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.

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