Individualized dietary intervention: The participants will take a individualized dietary intervention guided by refined obesity phenotyping and based on digital management tools. Dietitians will use the decision tree algorithm of the digital management tool to first set the macronutrient ratios and dietary pattern recommendations based on ①metabolic health status and ②body composition characteristics, then set the eating rhythm recommendations based on ③emotional characteristics and ④individual behavioral characteristics，and then set the food recommendations based on ⑤dietary preferences.
Traditional energy-restricted balanced diet: The participants will take a traditional energy-restricted balanced diet based on the resting energy expenditure measured at baseline for each participant. A daily caloric deficit of 500 kcal was set for each individual. Dietitians provided dietary guidance plans and recommended sample menus in accordance with the traditional general dietary recommendations from the "Dietary Reference Intakes for Chinese Residents." The overall dietary principles emphasized a diet rich in whole grains, low in fat, with ample vegetables and fruits, and avoiding added sugars.
Study summary
This study is a nationwide multi-center, long-term randomized controlled clinical trial, aiming to evaluate the effects of individualized dietary pattern management programs compared to traditional energy-restricted diets in weight management.
Eligibility
Sex
ALL
Min age
20 Years
Max age
59 Years
Healthy volunteers
No
Inclusion Criteria:
1. Male or female, aged 20-59 years
2. Obesity defined by BMI≥28 kg/m²;
3. With willingness to undergo dietary intervention for weight loss.
Exclusion Criteria:
1. BMI≥40 kg/m²;
2. Suffering from gastrointestinal diseases that affect food digestion and absorption (such as functional bowel disorders, etc.), or having a known history of food allergies, or having a history of previous gastrointestinal surgery that affects dietary intervention;
3. Suffering from diseases that affect body weight or glucose and lipid metabolism (such as uncontrolled hyponatremia, thyroid dysfunction, secondary hypertension, type 1 diabetes, Cushing's syndrome, etc.);
4. Currently undergoing pharmacological treatment that affects body weight or glucose and lipid metabolism (such as thyroid medications, corticosteroids, antidiabetic drugs, lipid-lowering drugs, diuretics, etc.);
5. Having been diagnosed with clinical cardiovascular disease (coronary heart disease, stroke, heart failure, etc.) or malignancy;
6. Suffering from severe liver or kidney disease (alanine aminotransferase or serum creatinine levels exceeding 2 times the upper limit of normal);
7. Pregnant, breastfeeding, or women of childbearing potential who are not using contraception;
8. Any condition deemed by the investigator to affect study compliance;
9. Currently participating in another interventional study or having participated in another drug clinical trial within the past 3 months.
Primary outcome measure(s)
Percentage of body weight loss from baseline to 12 months — Baseline and 12 months Body weight will be measured in kilograms using a standardized calibrated scale. Percentage of body weight loss will be calculated as \[(baseline body weight - body weight at 12 months) / baseline body weight\] × 100. Higher values indicate greater weight loss. The between-group difference will be evaluated.
Trial sites (1)
Facility
City
Region
Status
Ruijin hospital, Shanghai Jiaotong University School of Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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