Real-World Case Registry Study on Obesity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorHubei Hospital of Traditional Chinese Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
10,000 Participants
are grouped into 1 trial groupGroup A: Obesity Patients Cohort
Trial outcomes
Primary outcomes
1
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%.
Time frame
Baseline, 12 weeks after treatment, 24 weeks after treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hubei Hospital of Traditional Chinese Medicine
Lead sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
Heilongjiang Quanle Pharmaceutical Co., Ltd.
Collaborator
Huazhong University of Science and Technology
Collaborator
Source ClinicalTrials.gov