NCT04096989

The Effect of Traditional Chinese Medicine Regimen-based Lifestyle Mobile Health APP in Prediabetes

The Development and Effectiveness of Traditional Chinese Medicine Regimen-based Lifestyle and Mobile Health Application Intervention for People With Prediabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• PreDiabetes

Interventions

Type	Name	Description
OTHER	Traditional Chinese medicine regimen-based lifestyle mobile health APP	The Experimental group receives TCM regimen-based lifestyle mobile health application intervention.
OTHER	Lifestyle mobile health APP	Sham comparator group receives mobile health application, but there is no traditional Chinese medicine information.

Timeline

• Start date: 2020-02-17
• Primary completion: 2021-05-20
• Completion: 2021-05-31
• First posted: 2019-09-20
• Last updated: 2022-08-30

Locations

1 site across 1 country: Taiwan