Overweight or obesity
Conditions
Interventions
Control group:Scheduled Weight Maintenance Nutrition Education
Experimental group:Same standardized sessions and monthly counseling as the control group, with the additional implementation of a 10-hour daily Time-Restricted Eating (TRE) regimen.
Sponsors
Harbin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. BMI >= 28.0 kg/m^2, or BMI between 24.0–27.9 kg/m^2 with at least one weight-related comorbidity; 2. Age: 18–65 years; 3. Weight Loss Plan: Willing to undergo a structured weight-loss program.
Exclusion criteria
Exclusion criteria: 1. Infectious Diseases: History of HIV/AIDS, active hepatitis B/C, or active tuberculosis; 2. Malignancy: History of any malignancy; 3. Organ Dysfunction:Severe hepatic impairment.Chronic kidney disease; 4. Cardiovascular/Cerebrovascular Events: History of angina, myocardial infarction, or stroke within the past 6 months; 5. Gastrointestinal Conditions:Severe gastrointestinal diseases (e.g., inflammatory bowel disease).Gastrointestinal surgery within the past 12 months; 6. Endocrine Disorders:Cushing’s syndrome, hypothyroidism, acromegaly, or hypothalamic obesity; 7. Medications: Use of drugs affecting weight/energy balance (e.g., antipsychotics, weight-loss medications) within the past 6 months; 8. Pregnancy/Lactation: Currently pregnant, planning pregnancy, or breastfeeding; 9. Compliance Issues: Inability to complete the study (due to health, immigration, or other reasons); 10. Informed Consent: Unwilling or unable to provide informed consent; 11. Weight Stability: >5% change in body weight within the past 6 months; 12. Individuals unable to use or operate a smartphone.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight change;Proportion of participants maintaining >=5% weight loss; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in body composition;Change in waist circumference;Change in hip circumference;Change in blood pressure (systolic pressure and diastolic pressure);Change in heart rate;Changes in glycemic parameters;Changes in liver function parameters;Changes in renal function indicators;Changes in lipid metabolism parameters;Changes in thyroid function markers;Changes in inflammation-related indicators;Changes in blood transcriptomics;Changes in metabolomics in serum and feces;Changes in anxiety or depression symptoms;Changes in sleep quality;The DISC Personality Assessment;Changes in quality of life;Changes in appetite status;Mean 24-hour glucose concentration (mmol/L);Nocturnal mean glucose and glucose variability;Postprandial glucose AUC and peak levels;Adherence to 10-hour time-restricted eating assessed by continuous glucose monitoring (CGM);Change in handgrip strength;Change in daily energy and macronutrient intake;Changes in inflammation-related markers;Changes in thyroid function markers;Changes in DNA methylation patterns; | — |
Countries
China
Contacts
Public ContactYing Li
Harbin Medical University
Outcome results
None listed