Health TrialsbyHealthPanel

Efficacy of Different Dietary Pattern in Long-term Weight Management

ConditionsObesity and OverweightDietary Intervention
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-59
SponsorGuang Ning

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female, aged 20-59 years

Obesity defined by BMI≥28 kg/m²;

With willingness to undergo dietary intervention for weight loss.

Disqualifiers

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.);

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

800 Participants
are divided into 2 treatment groups
Group A: Individualized dietary interventionExperimental treatment 1 intervention
Group B: Traditional energy-restricted balanced dietExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Baseline and 12 months

Secondary outcomes

1

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

A participant will be classified as achieving more than 5% body weight loss if \[(baseline body weight - body weight at 12 months) / baseline body weight\] × 100 is greater than 5. The percentage of evaluable participants meeting this criterion will be compared between the two study groups.

Time frame
12 months
2

Change in body mass index from baseline to 12 months

Body mass index will be calculated as body weight in kilograms divided by height in meters squared and reported in kg/m². The change from baseline to 12 months will be compared between the two study groups.

Time frame
Baseline and 12 months
3

Change in waist circumference from baseline to 12 months

Waist circumference will be measured in centimeters using a standardized measurement protocol. The change from baseline to 12 months will be compared between the two study groups.

Time frame
Baseline and 12 months
4

Change in body fat percentage from baseline to 12 months

Body fat percentage will be assessed by dual-energy X-ray absorptiometry and reported as a percentage. The change from baseline to 12 months will be compared between the two study groups.

Time frame
Baseline and 12 months

Other outcomes

1

Number of participants with diet-intervention-related adverse events

Diet-intervention-related adverse events include food allergy, fatigue, dizziness, diarrhea, constipation, acid reflux, hypoglycemia, and other discomfort considered related to the dietary intervention. The number of participants experiencing at least one such event will be reported.

Time frame
From the first dietary intervention through 24 months
2

Number of participants with serious adverse events

A serious adverse event is an event that results in death, is life-threatening, requires hospitalization or prolongation of hospitalization, results in persistent or significant disability, causes a congenital anomaly, or is another medically important event. The number of participants experiencing at least one serious adverse event will be reported.

Time frame
From enrollment through 24 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guang Ning

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Sponsor institution

Source ClinicalTrials.gov

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