Obesity in children or adolescents
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 6–18 years, with no restriction on sex. 2. Primary obesity, defined as body mass index (BMI) at or above the 95th percentile for age and sex. 3. Patients presenting for medical consultation due to obesity for the first time. 4. The participant’s legal guardian is able to fully understand the purpose of the trial, is willing to follow weight-loss treatment guidance from physicians, dietitians, and other healthcare professionals throughout the study period, and voluntarily provides written informed consent.
Exclusion criteria
Exclusion criteria: 1. Weight change >10 kg within 90 days prior to screening due to specific causes. 2. History of bariatric surgery or use of weight-loss medications. 3. History of familial hyperlipidemia or type 1 diabetes, or presence of major organ/system dysfunction such as congenital heart disease, hepatic or renal impairment/failure, or hematologic disorders. 4. Secondary causes of obesity, including but not limited to Williams syndrome, primary hyperaldosteronism, or long-term (continuous >3 months) use of medications associated with weight gain (e.g., glucocorticoids, certain antipsychotics). 5. A psychiatric diagnosis within the past 2 years of mental disorders such as depression, bulimia nervosa, or anorexia nervosa, and currently requiring pharmacological treatment or psychological intervention. 6. Currently participating in another clinical study or having participated in another clinical study within the past 3 months. 7. The investigator judges that the participant has poor compliance and is unable to complete the study as required, or has any other condition that may affect study completion or the interpretation of results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in age-specific BMI percentile and BMI z-score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in model interaction frequency;Change in model interaction quality;Change in anthropometric indicators;Change in glucose metabolism indicators;Change in behavioral and lifestyle indicators;Change in lipid profile and liver/renal function indicators;Change in echocardiographic and abdominal ultrasound indicators; | — |
Countries
China
Contacts
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine