Real-World Registry Study of Integrated Traditional Chinese and Western Medicine for Obesity

Real-World Prospective Registry Study of Integrated Traditional Chinese and Western Medicine Interventions in Patients With Obesity

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity (Disorder); Obesity & Overweight

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 Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: ChenGang Professor ChenGang, Doctor; Phone Number: +86 17720376888; Email: 250149875@qq.com
• Study Contact Backup: Name: ZhuHui ZhuHui, Doctor; Phone Number: +86 13545094802; Email: 865057084@qq.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Recruiting
      • Hubei Provincial Hospital of Traditional Chinese Medicine
      • Contact: Zhuhui Zhuhui, Doctor; Phone Number: 13545094802; Email: 865057084@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

1. Age 18 years and above, gender not restricted;
2. Weight fluctuation within the last 3 months is ≤ 5% and BMI is ≥ 28.0 kg/m2;
3. Good compliance, willing to follow the follow-up principles;
4. Agree to sign the informed consent form.

Exclusion Criteria:

1. Co-existing severe diseases of the heart, liver, lungs, kidneys, brain, blood, neuro-psychiatric system, or other vital organs.
2. 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.).
3. Iatrogenic obesity (obesity resulting from drugs or therapeutic interventions administered for other conditions).
4. Pregnant or lactating women.
5. Subjects whom the investigator deems unsuitable for participation in this study.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%.	Baseline, 12 weeks after treatment, 24 weeks after treatment

Collaborators and Investigators

• Sponsor: Hubei Hospital of Traditional Chinese Medicine
• Collaborators: Huazhong University of Science and Technology; Union Hospital of Huazhong University of Science and Technology; Heilongjiang Quanle Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: ChenGang ChenGang, Doctor, Hubei College of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: February 26, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Obesity; Registry Study; Prospective Cohort; Real-World Study; Integrated Traditional Chinese and Western Medicine
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: HBZY2024-C60-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.