To investigate the effects of simple dietary management and diet combined with exercisecapacity-targeted intelligent lifestyle management on improving metabolic indicators inpatients 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.
Behavioral: Dietary Prescription
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:
1. 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.
2. 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.
Behavioral: 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.
Behavioral: 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.
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:
- 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.
Exclusion Criteria:
- 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.
Not Provided
Yifan Wu, master
01088398069
wuyifan1127@126.com
Not Provided