The Effect of Traditional Chinese Medicine Regimen-based Lifestyle Mobile Health APP in Prediabetes
Condition: PreDiabetes
MeSH terms: Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      Prediabetes is a major risk factor for diabetes. The Lifestyle Modification Mobile Health
      Application (APP) could not only help to decrease blood sugar among individuals with
      prediabetes but it could also prevent a later occurrence of diabetes. While many people use
      traditional Chinese medicine (TCM) to improve the participants body constitution in Chinese
      culture, it rarely if ever obtained through a mobile device. There are very few apps that
      provide effective TCM regimen-based lifestyle advice for prediabetes. Therefore, the
      investigators want to develop and evaluate the effectiveness of receiving TCM regimen-based
      lifestyle advice from a mobile device designed to improve the applicant's health status.
    

Detailed description: 
      Background: People with prediabetes have an increased risk of Type 2 diabetes. Traditional
      Chinese medicine (TCM) lifestyle modification has been shown to be effective in achieving a
      balanced status and decreasing the risk of prediabetes progressing to diabetes. TCM theories
      note that Body constitution (BC) lays the foundation for diagnosis, treatment and disease
      prevention. The measurement and regulation of an individual's body constitution might prevent
      disease. TCM practitioners give individualized interventions according to each person's body
      constitution. Qi (energy) also is a core concept in TCM. Both body constitution and meridian
      energy (ME) can be used to determine deviated and abnormal body function. The Lifestyle
      Modification Mobile Health Application (APP) could help to decrease blood sugar among
      individuals with prediabetes, it could also prevent a later occurrence of diabetes. But, a
      few studies to development a TCM regimen-based lifestyle APP, and evaluate the effectiveness
      of receiving TCM regimen-based lifestyle APP in prediabetes. In this study, the objective was
      to development a TCM regimen-based lifestyle APP, and evaluate the effectiveness of receiving
      TCM regimen-based lifestyle APP in prediabetes.

      Aims of the study: To development a TCM regimen-based lifestyle APP, and evaluate the
      effectiveness of receiving TCM regimen-based lifestyle APP in prediabetes.

      Materials and Methods: A three-arm randomized controlled trail. The study was carried out
      involving 121 participants, who were recruited at a teaching hospital in northern Taiwan. The
      study variables include socio-demographics, disease history, and lifestyle, the blood glucose
      and BMI data from the blood-test will be obtained from the online medical charts. Physical
      activity was measured by International Physical Activity Questionnaire Self-Administered
      Taiwan Version. Health related quality of life was assessed by the SF-36, which yielded
      physical component score (PCS) and mental component scores (MCS), with higher score
      indicating better quality of life. The Body Constitution questionnaire (BCQ) was used to
      measure neutral, Yang-deficiency, Ying-deficiency, and Phlegm-stasis, with higher scores
      indicating larger deficiencies. Meridian energy was examined by using the Meridian energy
      device, which included individual meridian energy.

      Possible effect: There is no TCM regimen-based lifestyle mobile health APP among people with
      prediabetes. Through the study, The investigators hope to develop a TCM regimen-based
      lifestyle mobile health APP, and evaluation it. By TCM regimen-based lifestyle using and use
      of APP, health management of the could be improved. The results could serve as a reference
      for promotion of traditional Chinese preventive medicine.
    

Intervention name(s): Traditional Chinese medicine regimen-based lifestyle mobile health APP; Lifestyle mobile health APP
Intervention type(s): Other; Other
Intervention description(s): The Experimental group receives TCM regimen-based lifestyle mobile health application intervention.; Sham comparator group receives mobile health application, but there is no traditional Chinese medicine information.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: prediabetes; TCM; body constitution; meridian energy; APP