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.
Diabetes mellitus is a chronic systemic metabolic disease caused by the long-term interaction of genetic factors and environmental factors. It is characterized by an increase in plasma glucose levels and is mainly due to metabolic disorders in glucose, fat, and protein caused by insufficient insulin secretion and/or dysfunction in the body, which affects normal physiological activities. As of 2019, 463 million people are suffering from diabetes in the world, of which 90% to 95% have type 2 diabetes mellitus (T2DM), with an average of 1 patient in every 11 adults (aged 20-79). The number of patients with T2DM will jump to 700 million by 2045. There is a close relationship between T2DM and overweight and obesity. The prevalence of diabetes in overweight and obese people in China was 12.8% and 18.5%, respectively. Among T2DM patients, the proportions of overweight and obesity were 41% and 24.3%, respectively.The two kinds of diseases share a common key pathophysiological mechanism, which will have a devastating long-term impact on patients' health and bring serious disease and economic burden to the family. Given the various harms, it is urgent to carry out relevant intervention research and formulate effective intervention strategies. With the development of artificial intelligence technology, the combination of mHealth and multidisciplinary lifestyle intervention may become an efficient and easy-to-popularize management mode for the prevention and treatment of T2DM with obesity. Given the relative lack of high-quality interventions for T2DM overweight/obesity, the investigators designed a randomized controlled trial to assess the effectiveness of a multicomponent intervention in Ningbo First Hospital. This study plans to adopt the online and offline combination method based on mHealth technology to carry out lifestyle intervention aimed at formulating a set of feasible and effective intervention strategies. The study aims to identify: 1) whether the mHealth-based intensive lifestyle intervention will be effective for weight and glycated hemoglobin management to reverse or slow down the disease process among T2DM patients with overweight/obesity; 2) whether the intervention will be beneficial for improving biochemical indicators, body composition indicators, and exercise capacity among T2DM patients with overweight/obesity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
During the 3-month lifestyle intervention period, the participants need to complete the weight monitoring, behavioral goal recording, diet and exercise recording, online course learning by using the WeChat official account module of "Weight Loss and Glucose Control".They will receive corresponding feedback and integral rewards every week, and receive monthly follow-ups to complete health education, goal review, motivational interview as well as collecting medication changes and blood glucose monitoring data.
Ningbo First Hospital
Ningbo, Zhejiang, China
Weight change from baseline
measured in kilograms (kg) and calculate the change percentage(%)
Time frame: at end of the 3-month intervention
The change of HbA1c from baseline
measured in percent (%)
Time frame: at end of the 3-month intervention
The change in body mass index (BMI) from baseline
Weight and height will be combined to report BMI in kg/m\^2.
Time frame: at end of the 3-month intervention
The change of waist circumference from baseline
measured in centimetre (cm)
Time frame: at end of the 3-month intervention
The change of waist-to-hip circumference ratio from baseline
measure waist circumference and hip circumference to calculate waist-to-hip circumference ratio
Time frame: at end of the 3-month intervention
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
Time frame: at end of the 3-month intervention
The change of body fat percentage from baseline
measure body fat percentage (%) by bioelectrical impedance analysis
Time frame: at end of the 3-month intervention
The change of blood lipids from baseline
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measure total cholesterol, triglyceride, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol in milligram/deciliter (mg/dL)
Time frame: at end of the 3-month intervention
The change in muscle strength from baseline
measure grip strength in kilograms (kg) by hand dynamometer
Time frame: at end of the 3-month intervention
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.
Time frame: at end of the 3-month intervention
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.
Time frame: at end of the 3-month intervention
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.
Time frame: at end of the 3-month intervention
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.
Time frame: at end of the 3-month intervention