Obesity & OverweightNCT07448090
Real-World Case Registry Study on Obesity
An observational study of Obesity & Overweight and Obesity (Disorder), run by Hubei Hospital of Traditional Chinese Medicine at 1 site in China.
Trial summary
Obesity is a major risk factor for cardiovascular disease, diabetes, cancer, and other chronic conditions. Due to its complex etiology and frequent comorbidities, effective obesity management requires comprehensive and individualized approaches. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity & Overweight, Obesity (Disorder)
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2024to 31 Jul 2028
- How long will I take part?
- 24 Weeks
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients aged 18 years or older with obesity (body mass index ≥28.0 kg/m²), diagnosed according to the Chinese clinical guidelines for obesity. Eligible participants have relatively stable body weight within the past three months and provide written informed consent. Patients with severe organ dysfunction, secondary or drug-induced obesity, pregnancy or lactation, or other conditions deemed unsuitable by investigators are excluded.
Who may be able to join
- Age 18 years and above, gender not restricted;
- Weight fluctuation within the last 3 months is ≤ 5% and BMI is ≥ 28.0 kg/m2;
- Good compliance, willing to follow the follow-up principles;
- Agree to sign the informed consent form.
Who cannot join
- Co-existing severe diseases of the heart, liver, lungs, kidneys, brain, blood, neuro-psychiatric system, or other vital organs.
- Secondary obesity (obesity attributable to another clearly diagnosed disorder, e.g., hypothalamic or pituitary inflammation, tumours or trauma, Cushing's syndrome, hypothyroidism, hypogonadism, polycystic ovary syndrome, etc.).
- Iatrogenic obesity (obesity resulting from drugs or therapeutic interventions administered for other conditions).
- Pregnant or lactating women.
- Subjects whom the investigator deems unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hubei Provincial Hospital of Traditional Chinese Medicine
Wuhan, Hubei, 430000
Zhuhui Zhuhui, Doctor, 13545094802, 865057084@qq.com
About this study
Obesity is a major risk factor for cardiovascular disease, diabetes, cancer, and other chronic conditions. Due to its complex etiology and frequent comorbidities, effective obesity management requires comprehensive and individualized approaches. This study is a multicenter, prospective, real-world registry designed to evaluate integrated traditional Chinese medicine (TCM) and Western medicine interventions for obesity.
The study will enroll at least 10,000 individuals with obesity from urban and rural populations. Multimodal data, including electronic medical records, laboratory test results, imaging data, and lifestyle information, will be collected. The effectiveness of integrated TCM and Western medicine interventions will be assessed across different age groups, disease stages, and obesity-related constitution types. In addition, disease progression patterns and key prevention and treatment points will be explored. Health economic analyses will be conducted to evaluate the cost-effectiveness of different obesity management strategies, providing real-world evidence to support public health policy and the optimization of integrated obesity prevention and management approaches.
Read the detailed description
Obesity is a major public health challenge and a well-established risk factor for cardiovascular and cerebrovascular diseases, diabetes, cancer, and other chronic non-communicable diseases. Its complex etiology, heterogeneous clinical manifestations, and frequent coexistence with multiple comorbidities make obesity difficult to manage using single-modality interventions. Integrated traditional Chinese medicine (TCM) and Western medicine approaches are widely used in clinical practice in China and have shown potential advantages in the management of complex chronic conditions. However, high-quality real-world evidence evaluating their effectiveness, safety, and economic value in obesity management remains limited.
This study is a multicenter, prospective, observational real-world registry designed to systematically collect and analyze clinical data from individuals with obesity receiving routine care. The study will enroll no fewer than 10,000 adult participants with obesity from urban and rural populations. Participants will be consecutively registered and followed according to routine clinical practice without assignment of specific interventions by the study protocol.
Comprehensive multimodal data will be collected, including demographic characteristics, medical history, physical examination findings, laboratory test results, imaging reports, and lifestyle-related information. Details of obesity management strategies used in real-world practice, including integrated TCM and Western medicine interventions as well as lifestyle management measures, will be recorded. Follow-up assessments will be conducted at predefined time points to capture changes in body weight, obesity-related clinical indicators, comorbid conditions, and safety outcomes.
The primary outcome of the study is the proportion of participants achieving a relative reduction of at least 5% in body weight from baseline. Secondary outcomes include changes in anthropometric measures, incidence or progression of obesity-related comorbidities, metabolic indicators, mental health-related measures, and other clinically relevant outcomes. Health economic evaluations will be performed to assess medical costs and cost-effectiveness of different obesity management strategies.
By characterizing obesity progression patterns and treatment outcomes across different age groups, disease stages, and obesity-related constitution types, this study aims to identify key points for obesity prevention and management. The findings are expected to provide robust real-world evidence to support the optimization and broader implementation of integrated TCM and Western medicine approaches in obesity management and to inform public health policy development.
- Conditions
- Obesity & Overweight, Obesity (Disorder)
- Keywords
- Obesity, Real-World Study, Integrated Traditional Chinese and Western Medicine, Prospective Cohort, Registry Study
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Obesity Patients Cohort | A prospective real-world observational cohort including adult patients with obesity (BMI ≥28 kg/m²). Participants receive routine clinical care and may be exposed to integrated traditional Chinese and Western medicine interventions, pharmacologic treatments, lifestyle interventions, or other standard-of-care approaches. No randomization or predefined intervention assignment is applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage reduction in body weight relative to baseline
Percentage change in body weight from baseline to 12 weeks and 24 weeks after treatment, calculated as [(body weight at each follow-up time point - baseline body weight) / baseline body weight] × 100%.
Measured: Baseline, 12 weeks after treatment, 24 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start31 Aug 2024
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 24 Weeks
Sponsor and investigators
- Lead sponsor
- Hubei Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Heilongjiang Quanle Pharmaceutical Co., Ltd., Huazhong University of Science and Technology
- Responsible party
- Principal investigator, Hui Zhu, Hubei Hospital of Traditional Chinese Medicine
- Investigators
- ChenGang ChenGang, Doctor, Principal investigator, Hubei College of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07448090
- Sponsor's protocol ID
- HBZY2024-C60-03
- Status last verified
- Jun 2026
- First submitted
- 26 Feb 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared publicly. The dataset contains detailed clinical information and real-world medical records, and public sharing may pose potential risks to participant privacy. De-identified and aggregated data may be made available upon reasonable request for academic research purposes, subject to approval by the study steering committee and relevant ethics committees.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Case Registry Study on Obesity
- ClinicalTrials.gov ID
- NCT07448090
- Acronym / sponsor ID
- HBZY2024-C60-03
- Conditions
- Obesity & Overweight, Obesity (Disorder)
- Keywords
- Obesity, Real-World Study, Integrated Traditional Chinese and Western Medicine, Prospective Cohort, Registry Study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Hubei Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Heilongjiang Quanle Pharmaceutical Co., Ltd., Huazhong University of Science and Technology
- Study start
- 31 Aug 2024 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 4 Mar 2026 (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.
Obesity is a major risk factor for cardiovascular disease, diabetes, cancer, and other chronic conditions. Due to its complex etiology and frequent comorbidities, effective obesity management requires comprehensive and individualized approaches. This study is a multicenter, prospective, real-world registry designed to evaluate integrated traditional Chinese medicine (TCM) and Western medicine interventions for obesity.
The study will enroll at least 10,000 individuals with obesity from urban and rural populations. Multimodal data, including electronic medical records, laboratory test results, imaging data, and lifestyle information, will be collected. The effectiveness of integrated TCM and Western medicine interventions will be assessed across different age groups, disease stages, and obesity-related constitution types. In addition, disease progression patterns and key prevention and treatment points will be explored. Health economic analyses will be conducted to evaluate the cost-effectiveness of different obesity management strategies, providing real-world evidence to support public health policy and the optimization of integrated obesity prevention and management approaches.
Detailed description
Obesity is a major public health challenge and a well-established risk factor for cardiovascular and cerebrovascular diseases, diabetes, cancer, and other chronic non-communicable diseases. Its complex etiology, heterogeneous clinical manifestations, and frequent coexistence with multiple comorbidities make obesity difficult to manage using single-modality interventions. Integrated traditional Chinese medicine (TCM) and Western medicine approaches are widely used in clinical practice in China and have shown potential advantages in the management of complex chronic conditions. However, high-quality real-world evidence evaluating their effectiveness, safety, and economic value in obesity management remains limited.
This study is a multicenter, prospective, observational real-world registry designed to systematically collect and analyze clinical data from individuals with obesity receiving routine care. The study will enroll no fewer than 10,000 adult participants with obesity from urban and rural populations. Participants will be consecutively registered and followed according to routine clinical practice without assignment of specific interventions by the study protocol.
Comprehensive multimodal data will be collected, including demographic characteristics, medical history, physical examination findings, laboratory test results, imaging reports, and lifestyle-related information. Details of obesity management strategies used in real-world practice, including integrated TCM and Western medicine interventions as well as lifestyle management measures, will be recorded. Follow-up assessments will be conducted at predefined time points to capture changes in body weight, obesity-related clinical indicators, comorbid conditions, and safety outcomes.
The primary outcome of the study is the proportion of participants achieving a relative reduction of at least 5% in body weight from baseline. Secondary outcomes include changes in anthropometric measures, incidence or progression of obesity-related comorbidities, metabolic indicators, mental health-related measures, and other clinically relevant outcomes. Health economic evaluations will be performed to assess medical costs and cost-effectiveness of different obesity management strategies.
By characterizing obesity progression patterns and treatment outcomes across different age groups, disease stages, and obesity-related constitution types, this study aims to identify key points for obesity prevention and management. The findings are expected to provide robust real-world evidence to support the optimization and broader implementation of integrated TCM and Western medicine approaches in obesity management and to inform public health policy development.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obesity Patients Cohort | – | –A prospective real-world observational cohort including adult patients with obesity (BMI ≥28 kg/m²). Participants receive routine clinical care and may be exposed to integrated traditional Chinese and Western medicine interventions, pharmacologic treatments, lifestyle interventions, or other standard-of-care approaches. No randomization or predefined intervention assignment is applied. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 18 years or older with obesity (body mass index ≥28.0 kg/m²), diagnosed according to the Chinese clinical guidelines for obesity. Eligible participants have relatively stable body weight within the past three months and provide written informed consent. Patients with severe organ dysfunction, secondary or drug-induced obesity, pregnancy or lactation, or other conditions deemed unsuitable by investigators are excluded.
Key inclusion criteria (4 listed)
- Age 18 years and above, gender not restricted;
- Weight fluctuation within the last 3 months is ≤ 5% and BMI is ≥ 28.0 kg/m2;
- Good compliance, willing to follow the follow-up principles;
- Agree to sign the informed consent form.
Key exclusion criteria (5 listed)
- Co-existing severe diseases of the heart, liver, lungs, kidneys, brain, blood, neuro-psychiatric system, or other vital organs.
- Secondary obesity (obesity attributable to another clearly diagnosed disorder, e.g., hypothalamic or pituitary inflammation, tumours or trauma, Cushing's syndrome, hypothyroidism, hypogonadism, polycystic ovary syndrome, etc.).
- Iatrogenic obesity (obesity resulting from drugs or therapeutic interventions administered for other conditions).
- Pregnant or lactating women.
- Subjects whom the investigator deems unsuitable for participation in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage reduction in body weight relative to baseline
Time frame: Baseline, 12 weeks after treatment, 24 weeks after treatment
Percentage change in body weight from baseline to 12 weeks and 24 weeks after treatment, calculated as [(body weight at each follow-up time point - baseline body weight) / baseline body weight] × 100%.
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 12 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared publicly. The dataset contains detailed clinical information and real-world medical records, and public sharing may pose potential risks to participant privacy. De-identified and aggregated data may be made available upon reasonable request for academic research purposes, subject to approval by the study steering committee and relevant ethics committees.
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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.
ChenGang ChenGang, Doctor principal investigator
Hubei College of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity & Overweight and Obesity (Disorder), run by Hubei Hospital of Traditional Chinese Medicine at 1 site in China.
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 4 inclusion and 5 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 12 Jun 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 China. 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 ChenGang Professor ChenGang, Doctor (+86 17720376888, 250149875@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage reduction in body weight relative to baseline (time frame: Baseline, 12 weeks after treatment, 24 weeks after treatment). 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 12 Jun 2026.