Chinese, Overweight or Obesity, Real-World Registry Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorChinese PLA General Hospital

About this trial

This study will enroll 10,000 patients with obesity, with the participation of approximately 50 medical institutions nationwide. At baseline, demographic data, physical examinations, multiple laboratory tests (including complete blood count, urinalysis, liver/renal function, electrolytes, thyroid function panel \[3 items\], urine albumin/creatinine ratio, fasting glucose, fasting C-peptide, fasting insulin, HbA1c, blood lipids, etc.) and hepatic elasticity ultrasound will be performed. Patients will receive weight-loss therapy in routine clinical practice. Data on clinic visits, adverse events, and changes in therapeutic regimens will be centrally collected by investigators or their authorized representatives at Week 26 and Week 52.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female patients aged 18 years or above

Diagnosed with overweight or obesity, with a BMI of ≥ 24 kg/m²

Willing and able to use weight management apps

Willing and able to provide a written informed consent for participating in the study

Disqualifiers

Having life-threatening comorbidities, with an expected lifespan of less than one year.

Participating in an interventional trial that requires informed consent.

Engaging in other organized weight loss programs or other clinical trials.

Researchers identify any situation that may endanger the safety or compliance of the subjects.

Trial population

1. Male or female patients over 18 years old 2. Diagnosed as overweight or obese, with a BMI of ≥ 24 kg/m² 3. Willing and able to use weight management apps 4. Willing and able to provide a written informed consent for participating in the study 5. Patients who meet the instructions for weight loss medication and have no contraindications to medication

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

The treatment model for overweight and obese individuals in China at present.

Time frame
1 year

Secondary outcomes

1

Observe the changes in liver fat content and liver stiffness in Chinese overweight and obese patients after 6 months and 12 months of follow-up: Liver stiffness measurement (LSM) and control attenuation index (Cap)

Time frame
6 months and 12 months
2

Observe the changes in body weight after 6 months and 12 months of follow-up: BMI

Time frame
6 months and 12 months
3

Evaluation of risk factors related to fatty liver disease in obesity combined with metabolic dysfunction

Time frame
6 months and 12 months
4

Observe the changes in related metabolic indicators over 6 months and 12 months, including changes in indicators such as blood lipids, blood pressure, and blood sugar.

Time frame
6 months and 12 months

Other outcomes

1

Analyze the impact of the frequency of patient usage and the use of different items (such as weight recording, body fat recording, recipe registration, exercise registration, etc.) on the outcome of the patient's weight management.

Time frame
1 year

Sponsors and contacts

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