Exercise-Targeted Smart Lifestyle Management

Official title

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

Overview

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

• 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 Dietar
• 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.

Primary outcome measures

• metabolic syndrome prevalence [Time frame: From enrollment to the end of treatment at 3 months and 6 months]

Secondary outcome measures (5)

• Cardiorespiratory fitness and exercise performance [Time frame: From enrollment to the end of treatment at 3 months and 6months]
• Metabolic syndrome indicator values [Time frame: From enrollment to the end of treatment at 3 months and 6months.]
• Body composition parameters [Time frame: From enrollment to the end of treatment at 6 months and 12 months.]
• Glycometabolism metabolism related indicators [Time frame: From enrollment to the end of treatment at 3months and 6 months.]
• Lipid metabolism indicators [Time frame: From enrollment to the end of treatment at 3months and 6 months.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Diabetes Canada Clinical Practice Guidelines Expert Committee; Punthakee Z, Goldenberg R, Katz P. Definition, Classification and Diagnosis of Diabetes, Prediabetes and Metabolic Syndrome. Can J Diabetes. 2018 Apr;42 Suppl 1:S10-S15. doi: 10.1016/j.jcjd.2017.10.003. No abstract available. PMID 29650080

Identifiers

NCT: NCT07535333 · 2023-2230

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗