Obesity
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria (All requirements must be met for eligibility): 1) Age 18 <= years < 70, regardless of gender; 2) Simple obesity with 28 <= BMI < 40 kg/m²; demonstrating active willingness to improve weight for health benefits, with motivation and physical capability to participate in exercise programs; 3) Capable of wearing and operating smart wearable devices and smartphones; 4) Able to complete 12-month clinical follow-up, including adherence to intervention protocols and scheduled visits; 5) Not concurrently participating in any other clinical trials.
Exclusion criteria
Exclusion criteria: All conditions must be "No" for eligibility: 1) Self-reported weight fluctuation >5% during the 12 weeks prior to screening; 2) Presence of psychiatric disorders (e.g., binge eating disorder, anorexia nervosa, history or current substance/alcohol abuse), depression, pregnancy or planned pregnancy, malignancy, or other active infectious/consumptive diseases; 3) Cardiovascular/cerebrovascular events within the past 6 months (including acute myocardial infarction, unstable angina, CABG, coronary stenting, TIA, stroke, etc.); 4) Symptomatic heart failure or arrhythmia; or severe hepatic impairment (ALT/AST >5× ULN) or severe renal dysfunction (eGFR <30 mL/min/1.73m²); 5) Any other severe active/uncontrolled medical condition per investigator’s judgment that may confound efficacy/safety assessments during the trial period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Body Weight from Baseline;Change in BMI from Baseline;Change in Waist Circumference from Baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Hip Circumference from Baseline;Changes in Body Composition from Baseline;Exercise adherence (number of exercise participation days per week, daily device wear time, achievement rate of target exercise intensity, etc.);Dietary adherence (completion rate of daily meals, number of days following weekly meal plan, compliance with salt/sugar/fat restrictions, etc.);Changes in metabolic parameters (blood pressure, blood glucose, and blood lipids, etc.) from baseline;Exercise-Related Injury Incidence; | — |
Countries
China
Contacts
The First Affiliated Hospital of Xi'an Jiaotong University