Study on the Improvement Effects of Intelligent Lifestyle Management, Targeting Exercise Capacity Enhancement, on Overweight/Obesity With Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 435
- 主要终点
- metabolic syndrome prevalence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •Central obesity: Waist circumference ≥ 90 cm for males or ≥ 85 cm for females.
- •Hyperglycemia: Fasting plasma glucose (FPG) ≥ 6.1 mmol/L, or 2-hour plasma glucose ≥ 7.8 mmol/L during an oral glucose tolerance test (OGTT), and/or currently receiving treatment for previously diagnosed diabetes.
- •Hypertension: Blood pressure ≥ 130/85 mmHg, and/or currently receiving treatment for previously diagnosed hypertension.
- •Elevated fasting triglycerides (TG): ≥ 1.7 mmol/L.
- •Reduced fasting high-density lipoprotein cholesterol (HDL-C): < 1.04 mmol/L.
排除标准
- •History of cardiovascular or cerebrovascular disease, or in the acute phase, including: angina pectoris, myocardial infarction, coronary revascularization surgery, stroke (ischemic or hemorrhagic, including transient ischemic attack), symptomatic peripheral artery disease requiring surgery or diagnosed via angiographic techniques, ventricular arrhythmias, uncontrolled atrial fibrillation, congestive heart failure (New York Heart Association class III or IV), hypertrophic cardiomyopathy, history of aneurysm with diameter ≥ 5.5 cm, or history of aneurysm surgery.
- •Malignancy or history of malignancy within the past five years.
- •Religious restrictions or dysphagia preventing adherence to the recommended diet.
- •Contraindications to exercise, such as orthopedic disorders.
- •Participation in other weight-loss programs (> 5 kg weight loss) within the six months prior to the screening visit.
- •History of bariatric surgery or intention to undergo bariatric surgery within the next 12 months.
- •History of small or large bowel resection or inflammatory bowel disease.
- •Obesity due to endocrine disorders of unknown cause (excluding treated hypothyroidism).
- •Allergy to any food components of the Mediterranean diet.
- •Immunodeficiency or HIV positive status.
- •Cirrhosis or liver failure.
- •Severe psychiatric disorders, including schizophrenia, bipolar disorder, eating disorders, or depression requiring hospitalization in the past 6 months.
- •Severe comorbidities with a life expectancy of less than 24 months.
- •Alcoholism, addiction, or drug abuse in the past six months (or daily alcohol consumption > 50 g).
- •History of major organ transplantation.
- •Concomitant use of immunosuppressive or cytotoxic medications.
- •Current use of systemic corticosteroids.
- •Current use of weight-loss medications.
- •Currently participating in another randomized clinical trial.
- •Patients with acute infection or inflammation (e.g., pneumonia) may -participate 3 months after resolution of the condition.
- •Pregnant or planning to become pregnant during the study period.
- •Any other condition that may interfere with protocol compliance.
- •Refusal to sign the informed consent document.
研究组 & 干预措施
Control
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.
干预措施: Metabolic Syndrome Prevention and Education (Behavioral)
Diet-Enhanced Group: Dietary Prescription + Exercise Advice
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:
- Energy and Macronutrient Intake: The daily energy intake standard will be estimated according to each participant's Basal Metabolic Rate (BMR) and physical activity level. The macronutrient ratio will be personalized by the dietitian based on the participant's metabolic indicators.
- Personalized Dietary Guidance: Based on the baseline dietary assessment and specific metabolic syndrome indicators, dietitians will develop personalized dietary prescriptions. The diet encourages the consumption of raw nuts, fruits, vegetables (including dark-colored vegetables such as spinach, rape, leeks, broccoli, etc.), whole grains, legumes, lean meats, fish, and low-fat dairy products.
干预措施: Dietary Prescription (Behavioral)
Comprehensive Lifestyle Intervention Group: Dietary Prescription + Personalized Exercise Prescriptio
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.
干预措施: Dietary Prescription (Behavioral)
Comprehensive Lifestyle Intervention Group: Dietary Prescription + Personalized Exercise Prescriptio
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.
干预措施: Personalized Exercise Prescription (Behavioral)
结局指标
主要结局
metabolic syndrome prevalence
时间窗: From enrollment to the end of treatment at 3 months and 6 months
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.
次要结局
- Cardiorespiratory fitness and exercise performance(From enrollment to the end of treatment at 3 months and 6months)
- Metabolic syndrome indicator values(From enrollment to the end of treatment at 3 months and 6months.)
- Body composition parameters(From enrollment to the end of treatment at 6 months and 12 months.)
- Glycometabolism metabolism related indicators(From enrollment to the end of treatment at 3months and 6 months.)
- Lipid metabolism indicators(From enrollment to the end of treatment at 3months and 6 months.)