obesity
Conditions
Interventions
Control group:Behavioral Intervention (Routine Dietary Intervention for Weight Management)
ASER group:Behavioral Intervention (After-school Energy Restriction, ASER)
Sponsors
The First Affiliated Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
8 Years to 11 Years
Inclusion criteria
Inclusion criteria: 1.Children aged 8-11 years who are in grades 3-6 of primary school at the time of signing the informed consent. 2.Diagnosed as obese according to the obesity diagnostic criteria in the Chinese Health Industry Standard (WS/T586-2018): Screening for Overweight and Obesity in School-Age Children and Adolescents. 3.Have a clear willingness to lose weight. 4.The child and parent agree to participate in the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Mental disorders such as intellectual disability or depression 2.Weight change >5kg within 3 months prior to enrollment 3.Currently participating in other weight-loss programs, or having taken medications affecting metabolism or weight (such as glucocorticoids or antibiotics) within the past 3 months 4.Diagnosis of diabetes, impaired liver function or active liver disease, impaired renal function or chronic kidney disease, active malignant tumors or those in remission but less than 5 years since the last treatment, malabsorption, functional enteropathy, uncontrolled hyponatremia, hyperthyroidism, hypothyroidism, Cushing's syndrome, eating disorders such as (anorexia nervosa) or (bulimia nervosa), and other diseases affecting body weight 5.History of food allergies, history of weight-loss surgery, history of severe gastrointestinal diseases or gastrointestinal surgery within 12 months prior to randomization, smoking, known or suspected alcohol or recreational drug abuse, HIV infection or immunodeficiency, and other conditions inconsistent with trial eligibility 6.Any other medical condition deemed by the clinician to be unsuitable for trial participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body mass index z-score (BMIz); | — |
Secondary
| Measure | Time frame |
|---|---|
| Body mass index z-score (BMIz);Reduction in %BMI95 (>= 5%, >= 10%, >= 15%); Waist-to-height ratio;Body composition parameters;Height;Tanner stage;Annual growth velocity;Height SDS;IGF-1;Blood pressure;Serum biochemical indicators (renal and liver function, uric acid);High-sensitivity C-reactive protein;Lipid profile;Blood glucose at 0, 60, and 120 minutes during the oral glucose tolerance test (OGTT);Area under the curve (AUC) for OGTT;Insulin release test; Area under the curve (AUC) for insulin release test;Homeostasis model assessment of ß-cell function (HOMA-B); Homeostasis model assessment of insulin resistance (HOMA-IR);Dietary quality;Dietary patterns;Sleep levels;Physical activity levels;Anxiety levels;Adverse events; | — |
Countries
China
Contacts
Public ContactXinghuan Liang
The First Affiliated Hospital of Guangxi Medical University
Outcome results
None listed