M-healthNCT07535333
Exercise-Targeted Smart Lifestyle Management
A study testing Dietary Prescription, Personalized Exercise Prescription and Metabolic Syndrome Prevention and Education in people with M-health and Metabolic Syndrome, run by China National Center for Cardiovascular Diseases.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- M-health, Metabolic Syndrome, Lifestyle Alteration
- What is being tested?
- Dietary Prescription, Personalized Exercise Prescription and Metabolic Syndrome Prevention and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 435 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- M-health, Metabolic Syndrome, Lifestyle Alteration, Lifestyle (Sedentary Behavior and Physical Activity), Overweight , Obesity
- Being tested
- Dietary Prescription, Personalized Exercise Prescription, Metabolic Syndrome Prevention and Education
- Keywords
- mhealth, Metabolic Syndrome, Lifestyle (sedentary behavior and physical activity), Mediterranean Diet, Overweight , Obesity
- Medical subject headings
- Metabolic Syndrome, Sedentary Behavior, Motor Activity, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary PrescriptionBehavioural
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 PrescriptionBehavioural
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 EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | 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. Receives: Behavioral: Metabolic Syndrome Prevention and Education |
| Diet-Enhanced Group: Dietary Prescription + Exercise Advice | Experimental | 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. Receives: Behavioral: Dietary Prescription |
| Comprehensive Lifestyle Intervention Group: Dietary Prescription + Personalized Exercise Prescriptio | Experimental | 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. Receives: Behavioral: Dietary Prescription; Behavioral: Personalized Exercise Prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 3 months and 6 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: From enrollment to the end of treatment at 3months and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for M-healthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 435 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07535333
- Sponsor's protocol ID
- 2023-2230
- Status last verified
- Apr 2026
- First submitted
- 6 Jan 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 29650080
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Improvement Effects of Intelligent Lifestyle Management, Targeting Exercise Capacity Enhancement, on Overweight/Obesity With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT07535333
- Acronym / sponsor ID
- 2023-2230
- Conditions
- M-health, Metabolic Syndrome, Lifestyle Alteration, Lifestyle (Sedentary Behavior and Physical Activity), Overweight , Obesity
- Keywords
- mhealth, Metabolic Syndrome, Lifestyle (sedentary behavior and physical activity), Mediterranean Diet, Overweight , Obesity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 435 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- May 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Behavioral: Metabolic Syndrome Prevention and EducationRoutine 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 | Experimental | Behavioral: Dietary PrescriptionDietary 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 | Experimental | Behavioral: Dietary Prescription, Behavioral: Personalized Exercise PrescriptionDietary 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary PrescriptionDietary 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. | Behavioural | Comprehensive Lifestyle Intervention Group: Dietary Prescription + Personalized Exercise Prescriptio, Diet-Enhanced Group: Dietary Prescription + Exercise Advice |
| Personalized Exercise PrescriptionBased 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. | Behavioural | Comprehensive Lifestyle Intervention Group: Dietary Prescription + Personalized Exercise Prescriptio |
| Metabolic Syndrome Prevention and EducationMaintain 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. | Behavioural | Control |
Primary outcome
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.
5 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Results publication: PubMed 29650080Diabetes 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Prescription, Personalized Exercise Prescription and Metabolic Syndrome Prevention and Education in people with M-health and Metabolic Syndrome, run by China National Center for Cardiovascular Diseases.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yifan Wu, master (01088398069, wuyifan1127@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
metabolic syndrome prevalence (time frame: From enrollment to the end of treatment at 3 months and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07535333, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.