Real-World Case Registry Study on Obesity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Percentage reduction in body weight relative to baseline
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
结局指标
主要结局
Percentage reduction in body weight relative to baseline
时间窗: 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%.
次要结局
未报告次要终点
研究者
Hui Zhu
Doctor
Hubei Hospital of Traditional Chinese Medicine