Exercise-Targeted Smart Lifestyle Management

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-60
SponsorChina National Center for Cardiovascular Diseases

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged between 20 and 60 years.

Overweight or obese, with a Body Mass Index (BMI) ≥ 24 kg/m² and < 40 kg/m².

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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: 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.

  • 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.

Treatment groups

435 Participants
are divided into 3 treatment groups
Group A: ControlPlacebo comparator 1 intervention
Group B: Diet-Enhanced Group: Dietary Prescription + Exercise AdviceExperimental treatment 1 intervention
Group C: Comprehensive Lifestyle Intervention Group: Dietary Prescription + Personalized Exercise PrescriptioExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment to the end of treatment at 3 months and 6 months

Secondary outcomes

1

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.

Time frame
From enrollment to the end of treatment at 3 months and 6months
2

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.

Time frame
From enrollment to the end of treatment at 3 months and 6months.
3

Body composition parameters

including body weight and calculate BMI at each follow-up visit, compared to the baseline

Time frame
From enrollment to the end of treatment at 6 months and 12 months.
4

Glycometabolism metabolism related indicators

including glycated hemoglobin (HbA1c) at each follow-up visit, compared to the baseline

Time frame
From enrollment to the end of treatment at 3months and 6 months.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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