NCT07535333Not yet recruiting
Exercise-Targeted Smart Lifestyle Management
Study on the Improvement Effects of Intelligent Lifestyle Management, Targeting Exercise Capacity Enhancement, on Overweight/Obesity With Metabolic Syndrome
Source: ClinicalTrials.gov · Last updated 17 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 435 (estimated)
- First submitted
- 6 Jan 2026
- Start date
- May 2026
- Primary completion date
- Dec 2026
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Diseases
- Obesity
- NCT number
- NCT07535333
What you commit to
- Study type: Interventional
- Planned participants: 435
- From May 2026 to the primary completion date, Dec 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in other weight-loss programs (\> 5 kg weight loss) within the six months prior to the screening visit.
- Alcoholism, addiction, or drug abuse in the past six months (or daily alcohol consumption \> 50 g).
- Concomitant use of immunosuppressive or cytotoxic medications.
- Current use of systemic corticosteroids.
- Current use of weight-loss medications.
Other illness
- 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.
- Contraindications to exercise, such as orthopedic disorders.
- 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.
- History of major organ transplantation.
- Patients with acute infection or inflammation (e.g., pneumonia) may -participate 3 months after resolution of the condition.
- Any other condition that may interfere with protocol compliance.
Other
- Religious restrictions or dysphagia preventing adherence to the recommended diet.
- Currently participating in another randomized clinical trial.
- Pregnant or planning to become pregnant during the study period.
- Refusal to sign the informed consent document.
Who the study is looking for
- 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.
Age in the registry: 20 years to 60 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.