Overweight and Obesity
Conditions
Interventions
Intervention group:Acupuncture point embedding
Control Group:Sham Acupoint Embedding
Sponsors
Shandong University of Traditional Chinese Medicine Affiliated Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Meet the diagnostic criteria for overweight/obesity according to the Chinese Guidelines for Obesity Diagnosis and Treatment (2024 Edition) (BMI =24 kg/m²); 2) Aged =18 and <65 years; 3) Voluntarily participate in the study and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1) Meet the diagnostic criteria for overweight/obesity according to the Chinese Guidelines for Obesity Diagnosis and Treatment (2024 Edition) (BMI =24 kg/m²); 2) Aged =18 and 5 kg within 3 months prior to screening; 4) Use of other weight loss interventions within 3 months prior to screening, including medications, surgery, traditional Chinese medicine, acupuncture, or nutritionist-supervised diet programs; 5) Use of medications known to significantly affect weight or appetite within the past 3 months, such as corticosteroids, non-stable-dose antidepressants, antipsychotics, non-selective antihistamines, or nicotine replacement products; 6) Plans to use other weight loss interventions during the study and follow-up period; 7) Allergy or history of allergy to catgut, collagen, or other absorbable suture materials; 8) Skin infection, ulceration, or scars at proposed acupoint embedding sites; 9) Coagulation disorders, active infectious diseases (e.g., tuberculosis, HIV/AIDS), or malignancy; 10) Severe psychiatric disorders affecting informed consent or treatment adherence (e.g., schizophrenia, uncontrolled bipolar disorder, major depressive disorder with psychotic features); 11) Pregnancy, lactation, or planning pregnancy during the study and follow-up period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage Change in Body Weight from Baseline to Week 9; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Body Weight from Baseline;Proportion of Participants Achieving =5% Weight Loss from Baseline;Proportion of Participants Achieving =10% Weight Loss from Baseline;Proportion of Participants Achieving =15% Weight Loss from Baseline;Change in Waist Circumference from Baseline;Trajectory of Body Weight Change Over Time;Trajectory of Waist Circumference Change Over Time;Change in Systolic Blood Pressure from Baseline;Change in Diastolic Blood Pressure from Baseline;Change in Fasting Plasma Glucose from Baseline;Change in Fasting Insulin from Baseline;Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) from Baseline;Change in Total Cholesterol from Baseline;Change in High-Density Lipoprotein Cholesterol (HDL-C) from Baseline;Change in Low-Density Lipoprotein Cholesterol (LDL-C) from Baseline;Change in Triglycerides from Baseline;Change in Alanine Aminotransferase (ALT) from Baseline;Change in Aspartate Aminotransferase (AST) from Baseline;Change in Serum Albumin from Baseline;Change in Non-Alcoholic Fatty Liver Disease Fibrosis Score (NFS) from Baseline;Change in Fibrosis-4 (FIB-4) Index from Baseline;Change in Serum Creatinine from Baseline;Change in Serum Uric Acid from Baseline;Change in Estimated Glomerular Filtration Rate (eGFR) from Baseline;Proportion of Participants with Sarcopenia Risk;Change in BODY-Q Obesity Module Score from Baseline;Change in EQ-5D-5L Index Score from Baseline;Proportion of Participants with Regular Menstrual Cycles (Female Participants Only);Change in Dysmenorrhea Severity (Visual Analog Scale) from Baseline (Female Participants Only); | — |
Countries
China
Contacts
Public ContactJing Han
Shandong University of Traditional Chinese Medicine Affiliated Hospital
Outcome results
None listed