Real-World Case Registry Study on Obesity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Obesity & Overweight, Obesity (Disorder). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Percentage reduction in body weight relative to baseline [Time frame: Baseline, 12 weeks after treatment, 24 weeks after treatment]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Hubei Provincial Hospital of Traditional Chinese Medicine — Wuhan
Identifiers
NCT: NCT07448090 · HBZY2024-C60-03