T2DM Intensity Lifestyle Intervention
Condition: Diabetes Mellitus, Type 2; Overweight or Obesity
MeSH terms: Overweight; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): lifestyle intervention
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment