Diabetes Mellitus, Type 2 Clinical Trial
Official title:
The Effect of mHealth-Based Lifestyle Intervention on Overweight or Obese Patients With Type 2 Diabetes: A Randomized Controlled Trial
Verified date | November 2023 |
Source | Ningbo No. 1 Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This RCT study will evaluate the effect of a lifestyle intervention on overweight or obese patients with type 2 diabetes mellitus. The primary hypothesis is that the mHealth-based intensive lifestyle intervention is sufficient to achieve weight loss and maintain glycated hemoglobin control.
Status | Completed |
Enrollment | 120 |
Est. completion date | July 1, 2023 |
Est. primary completion date | June 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Meet the WHO diagnostic criteria for type 2 diabetes; 2. The duration of diabetes is less than 5 years; 3. HbA1c was between 6.5-11% in recent 3 months; 4. 18-65 years old; 5. 24kg/m2=BMI#40kg/m2; 6. Weight loss within the past 3 months did not exceed 5% of initial weight; 7. Currently using a smartphone; 8. Voluntary participation. Exclusion Criteria: 1. Pregnant or lactating woman, or planning a pregnancy within 6 months after recruitment; 2. Uncontrolled hypertension (resting blood pressure = 160/100mmHg); 3. Treatment with insulin; 4. Acute complications of diabetes (diabetic ketoacidosis, hyperosmolar state, infection. etc) have occurred within the past 3 months, or one or more severe chronic complications of diabetes have existed, such as severe cardiovascular or cerebrovascular pathology (angina pectoris, myocardial infarction, grade III-IV heart failure, severe arrhythmia, transient cerebral ischemic attack, stroke, etc.), massive proteinuria (urinary albumin/creatinine ratio =300 mg/g), and severe diabetic foot, severe neuropathy, blurred vision. 5. Currently using weight-reducing products such as orlistat, or other medications that can significantly affect weight such as diuretics and hormones; 6. Severe cardiovascular and cerebrovascular diseases, respiratory diseases, hepatic and renal insufficiency, malignant tumors and other chronic consumptive diseases, active infections, and surgical history involving important organs within 3 months; 7. Contraindications to physical activity; 8. The presence of mental or cognitive impairment; 9. Current participation in other clinical trial projects; 10. Having the same family member involved in the research. |
Country | Name | City | State |
---|---|---|---|
China | Ningbo First Hospital | Ningbo | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Ningbo No. 1 Hospital | Peking University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Weight change from baseline | measured in kilograms (kg) and calculate the change percentage(%) | at end of the 3-month intervention | |
Primary | The change of HbA1c from baseline | measured in percent (%) | at end of the 3-month intervention | |
Secondary | The change in body mass index (BMI) from baseline | Weight and height will be combined to report BMI in kg/m^2. | at end of the 3-month intervention | |
Secondary | The change of waist circumference from baseline | measured in centimetre (cm) | at end of the 3-month intervention | |
Secondary | The change of waist-to-hip circumference ratio from baseline | measure waist circumference and hip circumference to calculate waist-to-hip circumference ratio | at end of the 3-month intervention | |
Secondary | The change of both systolic and diastolic blood pressures from baseline | measure systolic and diastolic blood pressure in millimeters of mercury (mmHg) by using electronic sphygmomanometer | at end of the 3-month intervention | |
Secondary | The change of body fat percentage from baseline | measure body fat percentage (%) by bioelectrical impedance analysis | at end of the 3-month intervention | |
Secondary | The change of blood lipids from baseline | measure total cholesterol, triglyceride, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol in milligram/deciliter (mg/dL) | at end of the 3-month intervention | |
Secondary | The change in muscle strength from baseline | measure grip strength in kilograms (kg) by hand dynamometer | at end of the 3-month intervention | |
Secondary | The change in exercise capacity from baseline | The 3-Minute Step Test is an assessment for Cardiorespiratory Fitness. At the end of the 3 minutes, sit down and monitor the pulse for one full minute. Calculate step-test index with the recovery heart rate. The fitter you are, the quicker the heart rate will return to normal after exercise. | at end of the 3-month intervention | |
Secondary | The change in life quality from baseline | It is measured in the form of the Short form health survey (SF-36), scored from 0 to 100, with higher scores associated with better quality of life. | at end of the 3-month intervention | |
Secondary | The change in sleep quality from baseline | It is measured in the form of the Pittsburgh Sleep Quality Index (PSQI), scored from 0 to 21, with higher scores associated with worse quality of sleep. | at end of the 3-month intervention | |
Secondary | The change in depression severity from baseline | It is measured in the form of the Pittsburgh Sleep Quality Index (PSQI), scored from 0 to 27, with higher scores associated with greater degree of depression. | at end of the 3-month intervention |
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