Efficacy of Different Dietary Pattern in Long-term Weight Management

NCT07773558 | Not Yet Recruiting

• 1 other identifier: CCEMD-20250510
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity and Overweight; Dietary Intervention

Keywords

dietary; weight; obesity

Outcome Measures

Primary Outcomes (1)

• Percentage of body weight loss from baseline to 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.

  Baseline and 12 months

Secondary Outcomes (38)

• Percentage of participants achieving more than 5% body weight loss at 12 months

  12 months

• Change in body mass index from baseline to 12 months

  Baseline and 12 months

• Change in waist circumference from baseline to 12 months

  Baseline and 12 months

• Change in body fat percentage from baseline to 12 months

  Baseline and 12 months

• Change in total lean body mass from baseline to 12 months

  Baseline and 12 months

Other Outcomes (2)

• Number of participants with diet-intervention-related adverse events

  From the first dietary intervention through 24 months

• Number of participants with serious adverse events

  From enrollment through 24 months

Study Arms (2)

Individualized dietary intervention

EXPERIMENTAL

Individualized dietary intervention guided by refined obesity phenotyping and based on digital management tools was adopted. 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.

Behavioral: Individualized dietary intervention

Traditional energy-restricted balanced diet

EXPERIMENTAL

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.

Behavioral: Traditional energy-restricted balanced diet

Interventions

Individualized dietary intervention BEHAVIORAL

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.

Individualized dietary intervention

Traditional energy-restricted balanced diet BEHAVIORAL

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.

Traditional energy-restricted balanced diet

Eligibility Criteria

• Age: 20 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, aged 20-59 years
• Obesity defined by BMI≥28 kg/m²;
• With willingness to undergo dietary intervention for weight loss.

You may not qualify if:

• BMI≥40 kg/m²;
• 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;
• 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.);
• 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.);
• Having been diagnosed with clinical cardiovascular disease (coronary heart disease, stroke, heart failure, etc.) or malignancy;
• Suffering from severe liver or kidney disease (alanine aminotransferase or serum creatinine levels exceeding 2 times the upper limit of normal);
• Pregnant, breastfeeding, or women of childbearing potential who are not using contraception;
• Any condition deemed by the investigator to affect study compliance;
• Currently participating in another interventional study or having participated in another drug clinical trial within the past 3 months.

Sponsors & Collaborators

• Guang Ning: lead

Study Sites (1)

Ruijin hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Obesity; Overweight; Body Weight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jieli Lu, MD, PhD

CONTACT

+86-15921591766; jielilu@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: August 19, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): May 20, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)