Childhood obesity
Conditions
Interventions
The group of gastric volume-occupying food combined with diet and exercise intervention:gastric volume-occupying food combined with diet and exercise intervention
Diet and exercise intervention group:Diet and exercise intervention
Sponsors
West China Second University Hospital of Sichuan University (WCSUH- SCU)
Eligibility
Sex/Gender
All
Age
6 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. School-age children, 6-12 years; 2. obese children were clinically diagnosed with obesity by referring to the "Expert Consensus on the Diagnosis, Assessment and Management of Childhood Obesity in China (2022)"; 3. there was a clear will to reduce weight; 4. the children and their parents agreed to take part in the study and signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Secondary obesity/genetic obesity syndromes, etc. (e.g., Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity, etc.); 2. Severe hepatic dysfunction (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) and glutamic acid aminotransferase = 3 times the upper limit of normal) or severe chronic kidney disease; 3. A diagnosis of type 1 or type 2 diabetes; 4. Inability to cooperate such as severe comprehension impairment or mental illness; 5. Being involved in other research studies, or having taken medication that affects metabolism and has a weight loss effect within the last 3 months; 6. After weight loss surgery; history of severe gastrointestinal disease or gastrointestinal surgery; 7. Self-reported (or by a parent/legally acceptable representative) weight change of more than 5 kg in the 90 days prior to screening; 8. Other reasons for being unsuitable for participation in this study as assessed by the clinician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in BMI between pre-intervention and post-intervention week 12 between the two groups of children; | — |
Secondary
| Measure | Time frame |
|---|---|
| fasting blood sugar;high density lipoprotein (HDL) cholesterol;glycosylated hemoglobin;liver function;Insulin 2 hours after meal;fasting insulin;2-hour postprandial blood glucose;uric acid;low density lipoprotein (LDL) cholesterol;diastolic blood pressure;total cholesterol;intestinal flora;Incidence of adverse reactions;kidney function;triglyceride;Insulin Resistance Index;systolic blood pressure; | — |
Countries
China
Contacts
Public ContactYang Fan
West China Second University Hospital of Sichuan University (WCSUH- SCU)
Outcome results
None listed