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To investigate the effects of simple dietary management and diet combined with exercise capacity-targeted intelligent lifestyle management on improving metabolic indicators in patients with overweight/obesity and metabolic syndrome.
This study aims to conduct a randomized controlled clinical trial among occupational populations with overweight/obesity and metabolic syndrome. By implementing a healthy dietary pattern with energy restriction and personalized exercise training interventions, we aim to investigate their effects on improving metabolic syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Routine Clinical Treatment Protocol:Metabolic Syndrome Prevention and Education: Maintain an ideal body weight, engage in appropriate exercise, modify dietary structure to reduce caloric intake, restrict salt consumption, reduce intake of sugar-sweetened or artificially sweetened beverages, quit smoking, avoid excessive alcohol consumption, and maintain a positive emotional state. |
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| Diet-Enhanced Group: Dietary Prescription + Exercise Advice | Experimental | Dietary Prescription: Using the Mediterranean diet or DASH diet as reference models, dietary prescriptions will be formulated based on the nutritional assessment results of the participants:
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| Comprehensive Lifestyle Intervention Group: Dietary Prescription + Personalized Exercise Prescriptio | Experimental | Dietary Prescription(same with arm 2)+Personalized Exercise Prescription: Based on the baseline functional fitness tests and cardiopulmonary exercise testing (CPET) results, a personalized exercise training regimen will be established. The program will be primarily delivered through instructional videos and monitored via an APP-based exercise log. The specific exercise components include: respiratory muscle training, aerobic training, upper and lower limb resistance training, and flexibility training. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Prescription | Behavioral | Dietary Prescription: Using the Mediterranean diet or DASH diet as reference models, dietary prescriptions will be formulated based on the nutritional assessment results of the participants:
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| Measure | Description | Time Frame |
|---|---|---|
| metabolic syndrome prevalence | The change in metabolic syndrome prevalence before and after the intervention in the diet-enhanced group, and a comparison of the changes in metabolic syndrome prevalence before and after the intervention between the comprehensive lifestyle intervention group and the diet-enhanced group. | From enrollment to the end of treatment at 3 months and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiorespiratory fitness and exercise performance | We will conduct a cardiopulmonary exercise test to obtain the maximal oxygen uptake ( VO2max ) as an indicator of changes in cardiopulmonary fitness and exercise performance at each follow-up visit, compared to the baseline. | From enrollment to the end of treatment at 3 months and 6months |
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Inclusion Criteria:
Aged between 20 and 60 years.
Overweight or obese, with a Body Mass Index (BMI) ≥ 24 kg/m² and < 40 kg/m².
Patients with impaired metabolic parameters regarding glucose, lipids, and blood pressure,meet at least two of the following criteria:
Exclusion Criteria:
Severe comorbidities with a life expectancy of less than 24 months.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yifan Wu, master | Contact | 01088398069 | wuyifan1127@126.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29650080 | Result | Diabetes Canada Clinical Practice Guidelines Expert Committee; Punthakee Z, Goldenberg R, Katz P. Definition, Classification and Diagnosis of Diabetes, Prediabetes and Metabolic Syndrome. Can J Diabetes. 2018 Apr;42 Suppl 1:S10-S15. doi: 10.1016/j.jcjd.2017.10.003. No abstract available. |
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| Personalized Exercise Prescription | Behavioral | Based on the baseline functional fitness tests and cardiopulmonary exercise testing (CPET) results, a personalized exercise training regimen will be established. The program will be primarily delivered through instructional videos and monitored via an APP-based exercise log. The specific exercise components include: respiratory muscle training, aerobic training, upper and lower limb resistance training, and flexibility training. |
|
| Metabolic Syndrome Prevention and Education | Behavioral | Maintain an ideal body weight, engage in appropriate exercise, modify dietary structure to reduce caloric intake, restrict salt consumption, reduce intake of sugar-sweetened or artificially sweetened beverages, quit smoking, avoid excessive alcohol consumption, and maintain a positive emotional state. |
|
| Metabolic syndrome indicator values |
the number of abnormal indicators (including blood pressure, fasting blood glucose, waist circumference, triglycerides (TG), and high-density lipoprotein cholesterol (HDL-C)) at each follow-up visit, compared to the baseline. |
| From enrollment to the end of treatment at 3 months and 6months. |
| Body composition parameters | including body weight and calculate BMI at each follow-up visit, compared to the baseline | From enrollment to the end of treatment at 6 months and 12 months. |
| Glycometabolism metabolism related indicators | including glycated hemoglobin (HbA1c) at each follow-up visit, compared to the baseline | From enrollment to the end of treatment at 3months and 6 months. |
| Lipid metabolism indicators | including low-density lipoprotein cholesterol (LDL-C)) at each follow-up visit, compared to the baseline | From enrollment to the end of treatment at 3months and 6 months. |
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D057185 | Sedentary Behavior |
| D009043 | Motor Activity |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001519 | Behavior |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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