Obesity and OverweightEDI-WeightNCT07773558
Efficacy of Different Dietary Pattern in Long-term Weight Management
A study testing Individualized dietary intervention and Traditional energy-restricted balanced diet in people with Obesity and Overweight and Dietary Intervention, run by Guang Ning at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 59 years
- Conditions the study is for
- Obesity and Overweight, Dietary Intervention
- What is being tested?
- Individualized dietary intervention and Traditional energy-restricted balanced diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 1 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female, aged 20-59 years
- Obesity defined by BMI≥28 kg/m²;
- With willingness to undergo dietary intervention for weight loss.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Ruijin hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
Official title: A Multicenter Randomized Controlled Trial Evaluating the Efficacy of Different Dietary Pattern Management Programs in Long-term Weight Management
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
- Being tested
- Individualized dietary intervention, Traditional energy-restricted balanced diet
- Keywords
- dietary, weight, obesity
- Medical subject headings
- Obesity, Overweight, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized dietary interventionBehavioural
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 dietBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Traditional energy-restricted balanced diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 months
Secondary outcomes (38)
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.
Measured: 12 months
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.
Measured: Baseline and 12 months
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.
Measured: Baseline and 12 months
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.
Measured: Baseline and 12 months
Change in total lean body mass from baseline to 12 months
Total lean body mass will be assessed by dual-energy X-ray absorptiometry and reported in kilograms. The change from baseline to 12 months will be compared between the two study groups.
Measured: Baseline and 12 months
Change in liver proton density fat fraction from baseline to 12 months
Liver proton density fat fraction will be quantified by abdominal magnetic resonance imaging using the mDixon-Quant technique and reported as a percentage. The change from baseline to 12 months will be compared between the two study groups.
Measured: Baseline and 12 months
Change in fasting blood glucose concentration from baseline to 12 months
Fasting blood glucose concentration will be measured by a local clinical laboratory and reported in mmol/L. The change from baseline to 12 months will be compared between the two study groups.
Measured: Baseline and 12 months
Change in total cholesterol concentration from baseline to 12 months
Serum total cholesterol concentration will be measured by a clinical laboratory and reported in mmol/L. The change from baseline to 12 months will be compared between the two study groups.
Measured: Baseline and 12 months
Change in triglyceride concentration from baseline to 12 months
Serum triglyceride concentration will be measured by a clinical laboratory and reported in mmol/L. The change from baseline to 12 months will be compared between the two study groups.
Measured: Baseline and 12 months
Change in low-density lipoprotein cholesterol concentration from baseline to 12 months
Serum low-density lipoprotein cholesterol concentration will be measured by a clinical laboratory and reported in mmol/L. The change from baseline to 12 months will be compared between the two study groups.
Measured: Baseline and 12 months
Change in high-density lipoprotein cholesterol concentration from baseline to 12 months
Serum high-density lipoprotein cholesterol concentration will be measured by a clinical laboratory and reported in mmol/L. The change from baseline to 12 months will be compared between the two study groups.
Measured: Baseline and 12 months
Change in systolic blood pressure from baseline to 12 months
Seated systolic blood pressure will be measured three times using a standardized procedure. The mean of the three readings will be reported in mmHg, and the change from baseline to 12 months will be compared between the two study groups.
Measured: Baseline and 12 months
Change in diastolic blood pressure from baseline to 12 months
Seated diastolic blood pressure will be measured three times using a standardized procedure. The mean of the three readings will be reported in mmHg, and the change from baseline to 12 months will be compared between the two study groups.
Measured: Baseline and 12 months
Change in total physical activity assessed by the International Physical Activity Questionnaire from baseline to 12 months
Total physical activity will be calculated from self-reported walking, moderate-intensity activity, and vigorous-intensity activity using the International Physical Activity Questionnaire scoring method and expressed in MET-minutes/week. Higher values indicate greater physical activity.
Measured: Baseline and 12 months
Change in sleep quality assessed by the Pittsburgh Sleep Quality Index from baseline to 12 months
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index global score, ranging from 0 to 21. Higher scores indicate poorer sleep quality. The change from baseline to 12 months will be compared between the two study groups.
Measured: Baseline and 12 months
Change in health-related quality of life assessed by the EQ-5D-5L index from baseline to 12 months
Health-related quality of life will be assessed using the EQ-5D-5L index value calculated with the applicable Chinese value set. Higher index values indicate better health status. The change from baseline to 12 months will be compared between the two study groups.
Measured: Baseline and 12 months
Change in self-rated health assessed by the EQ visual analogue scale from baseline to 12 months
Self-rated health will be assessed using the EQ visual analogue scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. The change from baseline to 12 months will be compared between the two study groups.
Measured: Baseline and 12 months
Change in emotional eating assessed by the Three-Factor Eating Questionnaire-R21 from baseline to 12 months
Emotional eating will be assessed using the emotional eating subscale of the Three-Factor Eating Questionnaire-R21 and scored according to the standardized scoring algorithm. Higher scores indicate greater emotional eating. The change from baseline to 12 months will be compared between the two study groups.
Measured: Baseline and 12 months
Change in cognitive restraint assessed by the Three-Factor Eating Questionnaire-R21 from baseline to 12 months
Cognitive restraint will be assessed using the cognitive restraint subscale of the Three-Factor Eating Questionnaire-R21 and scored according to the standardized scoring algorithm. Higher scores indicate greater cognitive restraint. The change from baseline to 12 months will be compared between the two study groups.
Measured: Baseline and 12 months
Change in uncontrolled eating assessed by the Three-Factor Eating Questionnaire-R21 from baseline to 12 months
Uncontrolled eating will be assessed using the uncontrolled eating subscale of the Three-Factor Eating Questionnaire-R21 and scored according to the standardized scoring algorithm. Higher scores indicate greater uncontrolled eating. The change from baseline to 12 months will be compared between the two study groups.
Measured: Baseline and 12 months
Change in hunger assessed by a visual analogue scale from baseline to 12 months
Hunger will be assessed using a 100-mm visual analogue scale ranging from 0 (not hungry at all) to 100 (extremely hungry). The change from baseline to 12 months will be compared between the two study groups.
Measured: Baseline and 12 months
Change in fullness assessed by a visual analogue scale from baseline to 12 months
Fullness will be assessed using a 100-mm visual analogue scale ranging from 0 (not full at all) to 100 (extremely full). The change from baseline to 12 months will be compared between the two study groups.
Measured: Baseline and 12 months
Change in desire to eat assessed by a visual analogue scale from baseline to 12 months
Desire to eat will be assessed using a 100-mm visual analogue scale ranging from 0 (no desire to eat) to 100 (very strong desire to eat). The change from baseline to 12 months will be compared between the two study groups.
Measured: Baseline and 12 months
Change in prospective food consumption assessed by a visual analogue scale from baseline to 12 months
Prospective food consumption will be assessed using a 100-mm visual analogue scale ranging from 0 (could eat nothing) to 100 (could eat a large amount). The change from baseline to 12 months will be compared between the two study groups.
Measured: Baseline and 12 months
Dietary-recording adherence during the 12-month intervention
Dietary-recording adherence will be calculated as the number of completed 24-hour dietary records divided by the number of scheduled dietary records, multiplied by 100. Participants are scheduled to complete three 24-hour dietary records per week during months 0-3 and three 24-hour dietary records per month during months 4-12.
Measured: From baseline through 12 months
Change in body weight from 12 months to 24 months
Body weight will be measured in kilograms using a standardized calibrated scale. The change from 12 months to 24 months will be used to assess weight regain after the 12-month intervention and compared between the two study groups.
Measured: 12 months and 24 months
Change in body mass index from 12 months to 24 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 12 months to 24 months will be compared between the two study groups.
Measured: 12 months and 24 months
Change in waist circumference from 12 months to 24 months
Waist circumference will be measured in centimeters using a standardized measurement protocol. The change from 12 months to 24 months will be compared between the two study groups.
Measured: 12 months and 24 months
Change in body fat percentage from 12 months to 24 months
Body fat percentage will be assessed by dual-energy X-ray absorptiometry and reported as a percentage. The change from 12 months to 24 months will be compared between the two study groups.
Measured: 12 months and 24 months
Change in total lean body mass from 12 months to 24 months
Total lean body mass will be assessed by dual-energy X-ray absorptiometry and reported in kilograms. The change from 12 months to 24 months will be compared between the two study groups.
Measured: 12 months and 24 months
Change in liver proton density fat fraction from 12 months to 24 months
Liver proton density fat fraction will be quantified by abdominal magnetic resonance imaging using the mDixon-Quant technique and reported as a percentage. The change from 12 months to 24 months will be compared between the two study groups.
Measured: 12 months and 24 months
Change in fasting blood glucose concentration from 12 months to 24 months
Fasting blood glucose concentration will be measured by a local clinical laboratory and reported in mmol/L. The change from 12 months to 24 months will be compared between the two study groups.
Measured: 12 months and 24 months
Change in total cholesterol concentration from 12 months to 24 months
Fasting serum total cholesterol concentration will be measured by the central laboratory and reported in mmol/L. The change from 12 months to 24 months will be compared between the two study groups.
Measured: 12 months and 24 months
Change in triglyceride concentration from 12 months to 24 months
Fasting serum triglyceride concentration will be measured by the central laboratory and reported in mmol/L. The change from 12 months to 24 months will be compared between the two study groups.
Measured: 12 months and 24 months
Change in low-density lipoprotein cholesterol concentration from 12 months to 24 months
Fasting serum low-density lipoprotein cholesterol concentration will be measured by the central laboratory and reported in mmol/L. The change from 12 months to 24 months will be compared between the two study groups.
Measured: 12 months and 24 months
Change in high-density lipoprotein cholesterol concentration from 12 months to 24 months
Fasting serum high-density lipoprotein cholesterol concentration will be measured by the central laboratory and reported in mmol/L. The change from 12 months to 24 months will be compared between the two study groups.
Measured: 12 months and 24 months
Change in systolic blood pressure from 12 months to 24 months
Seated systolic blood pressure will be measured three times using a standardized procedure. The mean of the three readings will be reported in mmHg, and the change from 12 months to 24 months will be compared between the two study groups.
Measured: 12 months and 24 months
Change in diastolic blood pressure from 12 months to 24 months
Seated diastolic blood pressure will be measured three times using a standardized procedure. The mean of the three readings will be reported in mmHg, and the change from 12 months to 24 months will be compared between the two study groups.
Measured: 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion20 May 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang Ning
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Guang Ning, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773558
- Sponsor's protocol ID
- CCEMD-20250510
- Acronym
- EDI-Weight
- Status last verified
- Aug 2026
- First submitted
- 23 May 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Trial Evaluating the Efficacy of Different Dietary Pattern Management Programs in Long-term Weight Management
- ClinicalTrials.gov ID
- NCT07773558
- Acronym / sponsor ID
- EDI-Weight / CCEMD-20250510
- Conditions
- Obesity and Overweight, Dietary Intervention
- Keywords
- dietary, weight, obesity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Guang NingUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 20 May 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized dietary intervention | Experimental | Behavioral: Individualized dietary interventionIndividualized 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. |
| Traditional energy-restricted balanced diet | Experimental | Behavioral: Traditional energy-restricted balanced dietA 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. |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female, aged 20-59 years
- Obesity defined by BMI≥28 kg/m²;
- With willingness to undergo dietary intervention for weight loss.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized dietary interventionThe 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. | Behavioural | Individualized dietary intervention |
| Traditional energy-restricted balanced dietThe 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. | Behavioural | Traditional energy-restricted balanced diet |
Primary outcome
Percentage of body weight loss from baseline to 12 months
Time frame: 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.
38 secondary outcomes
Percentage of participants achieving more than 5% body weight loss at 12 months
Time frame: 12 months
Change in body mass index from baseline to 12 months
Time frame: Baseline and 12 months
Change in waist circumference from baseline to 12 months
Time frame: Baseline and 12 months
Change in body fat percentage from baseline to 12 months
Time frame: Baseline and 12 months
Change in total lean body mass from baseline to 12 months
Time frame: Baseline and 12 months
Change in liver proton density fat fraction from baseline to 12 months
Time frame: Baseline and 12 months
Change in fasting blood glucose concentration from baseline to 12 months
Time frame: Baseline and 12 months
Change in total cholesterol concentration from baseline to 12 months
Time frame: Baseline and 12 months
Change in triglyceride concentration from baseline to 12 months
Time frame: Baseline and 12 months
Change in low-density lipoprotein cholesterol concentration from baseline to 12 months
Time frame: Baseline and 12 months
Change in high-density lipoprotein cholesterol concentration from baseline to 12 months
Time frame: Baseline and 12 months
Change in systolic blood pressure from baseline to 12 months
Time frame: Baseline and 12 months
Change in diastolic blood pressure from baseline to 12 months
Time frame: Baseline and 12 months
Change in total physical activity assessed by the International Physical Activity Questionnaire from baseline to 12 months
Time frame: Baseline and 12 months
Change in sleep quality assessed by the Pittsburgh Sleep Quality Index from baseline to 12 months
Time frame: Baseline and 12 months
Change in health-related quality of life assessed by the EQ-5D-5L index from baseline to 12 months
Time frame: Baseline and 12 months
Change in self-rated health assessed by the EQ visual analogue scale from baseline to 12 months
Time frame: Baseline and 12 months
Change in emotional eating assessed by the Three-Factor Eating Questionnaire-R21 from baseline to 12 months
Time frame: Baseline and 12 months
Change in cognitive restraint assessed by the Three-Factor Eating Questionnaire-R21 from baseline to 12 months
Time frame: Baseline and 12 months
Change in uncontrolled eating assessed by the Three-Factor Eating Questionnaire-R21 from baseline to 12 months
Time frame: Baseline and 12 months
Change in hunger assessed by a visual analogue scale from baseline to 12 months
Time frame: Baseline and 12 months
Change in fullness assessed by a visual analogue scale from baseline to 12 months
Time frame: Baseline and 12 months
Change in desire to eat assessed by a visual analogue scale from baseline to 12 months
Time frame: Baseline and 12 months
Change in prospective food consumption assessed by a visual analogue scale from baseline to 12 months
Time frame: Baseline and 12 months
Dietary-recording adherence during the 12-month intervention
Time frame: From baseline through 12 months
Change in body weight from 12 months to 24 months
Time frame: 12 months and 24 months
Change in body mass index from 12 months to 24 months
Time frame: 12 months and 24 months
Change in waist circumference from 12 months to 24 months
Time frame: 12 months and 24 months
Change in body fat percentage from 12 months to 24 months
Time frame: 12 months and 24 months
Change in total lean body mass from 12 months to 24 months
Time frame: 12 months and 24 months
Change in liver proton density fat fraction from 12 months to 24 months
Time frame: 12 months and 24 months
Change in fasting blood glucose concentration from 12 months to 24 months
Time frame: 12 months and 24 months
Change in total cholesterol concentration from 12 months to 24 months
Time frame: 12 months and 24 months
Change in triglyceride concentration from 12 months to 24 months
Time frame: 12 months and 24 months
Change in low-density lipoprotein cholesterol concentration from 12 months to 24 months
Time frame: 12 months and 24 months
Change in high-density lipoprotein cholesterol concentration from 12 months to 24 months
Time frame: 12 months and 24 months
Change in systolic blood pressure from 12 months to 24 months
Time frame: 12 months and 24 months
Change in diastolic blood pressure from 12 months to 24 months
Time frame: 12 months and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized dietary intervention and Traditional energy-restricted balanced diet in people with Obesity and Overweight and Dietary Intervention, run by Guang Ning at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jieli Lu, MD, PhD (+86-15921591766, jielilu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of body weight loss from baseline to 12 months (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.