Lifestyle Alteration, Lifestyle (Sedentary Behavior and Physical Activity), Metabolic Syndrome, M-health, Overweight , Obesity
Conditions
Keywords
mhealth, Metabolic Syndrome, Lifestyle (sedentary behavior and physical activity), Mediterranean Diet, Overweight , Obesity
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALDietary 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.
BEHAVIORALPersonalized 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.
BEHAVIORALMetabolic 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.
Sponsors
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| metabolic syndrome prevalence | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiorespiratory fitness and exercise performance | From enrollment to the end of treatment at 3 months and 6months | 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. |
| Metabolic syndrome indicator values | From enrollment to the end of treatment at 3 months and 6months. | 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. |
| Body composition parameters | From enrollment to the end of treatment at 6 months and 12 months. | including body weight and calculate BMI at each follow-up visit, compared to the baseline |
| Glycometabolism metabolism related indicators | From enrollment to the end of treatment at 3months and 6 months. | including glycated hemoglobin (HbA1c) at each follow-up visit, compared to the baseline |
| Lipid metabolism indicators | From enrollment to the end of treatment at 3months and 6 months. | including low-density lipoprotein cholesterol (LDL-C)) at each follow-up visit, compared to the baseline |
Contacts
CONTACTYifan Wu, master
Outcome results
None listed