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NCT Number: NCT07535333

Exercise-Targeted Smart Lifestyle Management

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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:

  • 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.

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.

Primary outcomes

  1. metabolic syndrome prevalence

    Time frame: 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 outcomes

  1. Cardiorespiratory fitness and exercise performance

    Time frame: 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.

  2. Metabolic syndrome indicator values

    Time frame: 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.

  3. Body composition parameters

    Time frame: 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

  4. Glycometabolism metabolism related indicators

    Time frame: 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

  5. Lipid metabolism indicators

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Yifan Wu, master

CONTACT

[email protected]

01088398069

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Official study title

Study on the Improvement Effects of Intelligent Lifestyle Management, Targeting Exercise Capacity Enhancement, on Overweight/Obesity With Metabolic Syndrome

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 17, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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