Exercise-Targeted Smart Lifestyle Management
Study on the Improvement Effects of Intelligent Lifestyle Management, Targeting Exercise Capacity Enhancement, on Overweight/Obesity With Metabolic Syndrome
1 other identifier
interventional
435
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2026
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2026
CompletedFirst Posted
Study publicly available on registry
April 17, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
April 17, 2026
April 1, 2026
7 months
January 6, 2026
April 9, 2026
Conditions
Keywords
Outcome Measures
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.
From enrollment to the end of treatment at 3 months and 6 months
Secondary Outcomes (5)
Cardiorespiratory fitness and exercise performance
From enrollment to the end of treatment at 3 months and 6months
Metabolic syndrome indicator values
From enrollment to the end of treatment at 3 months and 6months.
Body composition parameters
From enrollment to the end of treatment at 6 months and 12 months.
Glycometabolism metabolism related indicators
From enrollment to the end of treatment at 3months and 6 months.
Lipid metabolism indicators
From enrollment to the end of treatment at 3months and 6 months.
Study Arms (3)
Control
PLACEBO COMPARATORRoutine 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.
Diet-Enhanced Group: Dietary Prescription + Exercise Advice
EXPERIMENTALDietary 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.
Comprehensive Lifestyle Intervention Group: Dietary Prescription + Personalized Exercise Prescriptio
EXPERIMENTALDietary 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2026
First Posted
April 17, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
June 1, 2027
Last Updated
April 17, 2026
Record last verified: 2026-04