An interventional study of Individualized dietary intervention and Traditional energy-restricted balanced diet in Obesity and Overweight and Dietary Intervention, sponsored by Guang Ning. Not yet recruiting at 1 site in China. Open to participants aged 20 Years to 59 Years. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Guang Ning · Not applicable, Interventional, and Treatment
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 800 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Guang Ning is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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
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
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
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
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months and 24 months
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
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
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for May 2028, 20 months later.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 20 months is below that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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