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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
Hong Kong1 site, 1 recruiting
- 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
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Multicomponent Integrated Care Program; Other: TourHeart + platform |
| Control (Usual Care) | Other | Control Receives: Other: TourHeart + platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
5% body weight reduction from baseline at year 1
Measured: 12 months
Secondary outcomes (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.
- First posted26 Jun 2025
- Study start22 Oct 2025
- Primary completion31 Oct 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabesityStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alice Pik Shan KONG, Chinese University of Hong Kong
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07039279
- Acronym / sponsor ID
- CRE 2025.324
- Conditions
- Diabesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- 31 Oct 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multicomponent Integrated Care Program | Experimental | Behavioral: Multicomponent Integrated Care Program, Other: TourHeart + platformThe 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. |
| Control (Usual Care) | Other | Other: TourHeart + platformControl |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicomponent Integrated Care ProgramThe 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 | Behavioural | Multicomponent Integrated Care Program |
| TourHeart + platformTourHeart+ 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. | Other | Control (Usual Care), Multicomponent Integrated Care Program |
Primary outcome
5% body weight reduction from baseline at year 1
Time frame: 12 months
1 secondary outcome
10% body weight reduction from baseline at year 1
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.