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Effectiveness of lifestyle flexible intervention on metabolic management of overweight/obese employees with chronic metabolic diseases in shift scene: an open label, non randomized controlled study

Effectiveness of lifestyle flexible intervention on metabolic management of overweight/obese employees with chronic metabolic diseases in shift scene: an open label, non randomized controlled study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058483
Enrollment
Unknown
Registered
2022-04-09
Start date
2022-05-01
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic diseases, including type 2 diabetes mellitus, hypertension, lipid metabolism disorders and hyperuricemia

Interventions

Experimental group:Lifestyle flexible intervention
Control group:Continuous canteen diet intervention + exercise prescription suggestions

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Employees who belong to the three Guangxi China Resources Cement Companies covered by this study; 2. Body mass index (BMI) >= 24.0 Kg/m2; 3. Meet any of the following clinical conditions: (1) Diagnosed with type 2 diabetes, or glycosylated hemoglobin (HbA1c) >= 6.5% in the latest annual physical examination; (2) Hypertension was diagnosed, or the latest annual physical examination revealed abnormal blood pressure and the follow-up monitoring satisfied the resting blood pressure >= 140/90 mmHg for 3 times on different days; (3) Diagnosed with lipid metabolism disorder, or triglyceride (TG) >= 2.26 mmol/L and/or low-density lipoprotein cholesterol (LDL-c) >= 3.37 mmol/L in the latest annual physical examination; (4) Diagnosed with hyperuricemia or gout, or the latest annual physical examination showed abnormal uric acid and the follow-up reexamination met the blood uric acid >= 420 umol/L twice on different days; 4. Estimated glomerular filtration rate (eGFR) >= 60, alanine aminotransferase (ALT) < 120 U/L; 5. No acute metabolic disorder state.

Exclusion criteria

Exclusion criteria: 1. Other types of diabetes other than type 2 diabetes: including type 1 diabetes, pancreatic disease, diabetes caused by drugs or chemical agents; 2. Secondary hypertension: including endocrine hypertension, renal hypertension, etc.; 3. Acute complications of uncorrected metabolic disease (eg, diabetic ketoacidosis (DKA), hyperosmolar hyperglycemic state (HHS), lactic acidosis, malignant hypertension, hypertensive encephalopathy, hypertensive crisis, acute pancreatitis (considered associated with hypertriglyceridemia), severe gouty arthritis attacks); 4. Positive exercise treadmill test; 5. eGFR = 120 U/L; 6. History of kidney transplantation; 7. Cardiac function class (NYHA) III-VI; 8. Stroke, myocardial infarction in the past 12 months; 9. A history of severe mental disorders; 10. Hemoglobinopathies or uncorrected severe anemia; 11. Unexplained hypoglycemia with disturbance of consciousness occurred in the past 6 months; 12. No smartphone or no access to mobile software; 13. Potential failure to comply with protocol requirements: including communication barriers, uncooperative attitudes, inability to follow up and inability to complete the study; 14. There are conditions that may endanger the safety of patients or fail to participate in the research: including medical, psychological, geographical factors, etc.; 15. Participated in a clinical trial within 8 weeks before randomization, could not complete the 12-month study follow-up, and needed elective treatment such as surgery within 12 months.

Design outcomes

Primary

MeasureTime frame
Body mass index and body fat percentage;Glycosylated hemoglobin, HbA1c;Blood pressure;Triglycerides or low density lipoprotein cholesterol;Blood uric acid;

Secondary

MeasureTime frame
Exercise self-efficacy;Research direct cost;Long term cost effectiveness;

Countries

China

Contacts

Public ContactAng Li

Peking University First Hospital

liang850513@hotmail.com+86 13681338795

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026