Exercise-Targeted Smart Lifestyle Management

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Metabolic Syndrome; M-health; Lifestyle Alteration; Lifestyle (Sedentary Behavior and Physical Activity); Overweight , Obesity
• Intervention / Treatment: Behavioral: Metabolic Syndrome Prevention and Education; Behavioral: Dietary Prescription; Behavioral: Personalized Exercise Prescription

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.

• Study Type: Interventional
• Enrollment (Estimated): 435
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yifan Wu, master; Phone Number: 01088398069; Email: wuyifan1127@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; Routine Clinical Treatment Protocol：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.	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.
Experimental: Diet-Enhanced Group: Dietary Prescription + Exercise Advice; 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.	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: 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.
Experimental: Comprehensive Lifestyle Intervention Group: Dietary Prescription + Personalized Exercise Prescriptio; Dietary Prescription（same with arm 2）+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: 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: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the end of treatment at 3 months and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the end of treatment at 3 months and 6months
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.	From enrollment to the end of treatment at 3 months and 6months.
Body composition parameters	including body weight and calculate BMI at each follow-up visit, compared to the baseline	From enrollment to the end of treatment at 6 months and 12 months.
Glycometabolism metabolism related indicators	including glycated hemoglobin (HbA1c) at each follow-up visit, compared to the baseline	From enrollment to the end of treatment at 3months and 6 months.
Lipid metabolism indicators	including low-density lipoprotein cholesterol (LDL-C)) at each follow-up visit, compared to the baseline	From enrollment to the end of treatment at 3months and 6 months.

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases

Publications and helpful links

General Publications

• PUNTHAKEE Z, GOLDENBERG R, KATZ P, et al. Definition, Classification and Diagnosis of Diabetes, Prediabetes and Metabolic Syndrome [J]. Can J Diabetes, 2018, 42 Suppl 1: S10-S5.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: January 6, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Metabolic Syndrome; mhealth; Mediterranean Diet; Lifestyle (sedentary behavior and physical activity); Overweight , Obesity
• Additional Relevant MeSH Terms: Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Metabolic Syndrome; Motor Activity; Sedentary Behavior; Socioeconomic Factors; Population Characteristics; Educational Status
• Other Study ID Numbers: 2023-2230

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No