Dietary Intervention, Obesity and Overweight
Conditions
Keywords
dietary, weight, obesity
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.
Interventions
BEHAVIORALIndividualized 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.
BEHAVIORALTraditional 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.
Sponsors
Guang Ning
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in total cholesterol concentration from baseline to 12 months | Baseline and 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. |
| Change in triglyceride concentration from baseline to 12 months | Baseline and 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. |
| Change in low-density lipoprotein cholesterol concentration from baseline to 12 months | Baseline and 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. |
| Change in high-density lipoprotein cholesterol concentration from baseline to 12 months | Baseline and 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. |
| Change in systolic blood pressure from baseline to 12 months | Baseline and 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. |
| Change in diastolic blood pressure from baseline to 12 months | Baseline and 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. |
| Change in total physical activity assessed by the International Physical Activity Questionnaire from baseline to 12 months | Baseline and 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. |
| Change in sleep quality assessed by the Pittsburgh Sleep Quality Index from baseline to 12 months | Baseline and 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. |
| Change in health-related quality of life assessed by the EQ-5D-5L index from baseline to 12 months | Baseline and 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. |
| Change in self-rated health assessed by the EQ visual analogue scale from baseline to 12 months | Baseline and 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. |
| Change in emotional eating assessed by the Three-Factor Eating Questionnaire-R21 from baseline to 12 months | Baseline and 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. |
| Change in cognitive restraint assessed by the Three-Factor Eating Questionnaire-R21 from baseline to 12 months | Baseline and 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. |
| Change in uncontrolled eating assessed by the Three-Factor Eating Questionnaire-R21 from baseline to 12 months | Baseline and 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. |
| Change in hunger assessed by a visual analogue scale from baseline to 12 months | Baseline and 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. |
| Change in fullness assessed by a visual analogue scale from baseline to 12 months | Baseline and 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. |
| Change in desire to eat assessed by a visual analogue scale from baseline to 12 months | Baseline and 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. |
| Change in prospective food consumption assessed by a visual analogue scale from baseline to 12 months | Baseline and 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. |
| Dietary-recording adherence during the 12-month intervention | From baseline through 12 months | 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. |
| Change in body weight from 12 months to 24 months | 12 months and 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. |
| Change in body mass index from 12 months to 24 months | 12 months and 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. |
| Change in waist circumference from 12 months to 24 months | 12 months and 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. |
| Change in body fat percentage from 12 months to 24 months | 12 months and 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. |
| Change in total lean body mass from 12 months to 24 months | 12 months and 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. |
| Change in liver proton density fat fraction from 12 months to 24 months | 12 months and 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. |
| Change in fasting blood glucose concentration from 12 months to 24 months | 12 months and 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. |
| Change in total cholesterol concentration from 12 months to 24 months | 12 months and 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. |
| Change in triglyceride concentration from 12 months to 24 months | 12 months and 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. |
| Change in low-density lipoprotein cholesterol concentration from 12 months to 24 months | 12 months and 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. |
| Change in high-density lipoprotein cholesterol concentration from 12 months to 24 months | 12 months and 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. |
| Change in systolic blood pressure from 12 months to 24 months | 12 months and 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. |
| Change in diastolic blood pressure from 12 months to 24 months | 12 months and 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. |
| Percentage of participants achieving more than 5% body weight loss at 12 months | 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. |
| Change in body mass index from baseline to 12 months | Baseline and 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. |
| Change in waist circumference from baseline to 12 months | Baseline and 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. |
| Change in body fat percentage from baseline to 12 months | Baseline and 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. |
| Change in total lean body mass from baseline to 12 months | Baseline and 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. |
| Change in fasting blood glucose concentration from baseline to 12 months | Baseline and 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. |
| Change in liver proton density fat fraction from baseline to 12 months | Baseline and 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. |
Countries
China
Contacts
CONTACTJieli Lu, MD, PhD
Outcome results
None listed