The Effect of Traditional Chinese Medicine Regimen-based Lifestyle Mobile Health APP in Prediabetes
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|ClinicalTrials.gov Identifier: NCT04096989|
Recruitment Status : Not yet recruiting
First Posted : September 20, 2019
Last Update Posted : September 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|PreDiabetes||Other: Traditional Chinese medicine regimen-based lifestyle mobile health APP Other: Lifestyle mobile health APP||Not Applicable|
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 100 participants, who were recruited at a teaching hospital in northern Taiwan. The study variables include socio-demographics, disease history, and lifestyle, the physiological indicators from the blood-test will be obtained from the oneline medical charts. Physical activity was measured by International Physical Activity Questionnaire Self-Administered Short Version (IPAQ-SS). Health related quality of life was assessed by the SF-36, which yielded physical component score (PCS) and mental component scores (MCS) covering 8 subscales: physical functioning (PF), role physical (RP), body pain (BP), general health (GH), vitality (VT), role emotional (RE), social function (SF), and mental health (MH), 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 point and balance of meridian energy measurements (metabolism, musculoskeletal & circulation, mental health, and autonomic nervous system status).
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Development and Effectiveness of Traditional Chinese Medicine Regimen-based Lifestyle and Mobile Health Application Intervention for People With Prediabetes|
|Estimated Study Start Date :||October 1, 2019|
|Estimated Primary Completion Date :||July 31, 2020|
|Estimated Study Completion Date :||October 30, 2020|
No Intervention: Control group
Experimental: Experimental group
The participants accept TCM regimen-based lifestyle mobile health application intervention.
Other: Traditional Chinese medicine regimen-based lifestyle mobile health APP
The Experimental group receives TCM regimen-based lifestyle mobile health application intervention.
Sham Comparator: Sham comparator group
The participants accept mobile health application intervention.
Other: Lifestyle mobile health APP
Sham comparator group receives mobile health application, but there is no traditional Chinese medicine information.
- Meridian energy of Meridian energy device [ Time Frame: Change before, through intervention completion (average of 6 months)and after 1 month intervention. ]The meridian energy device captures data regarding the individual's balance of meridian energy. Balance was measured by the values of physical, metabolism, musculoskeletal and circulation, mental health, and autonomic nervous system status ratios. To achieve the appropriate balance for the energy results, a ratio of close to one was preferred.
- Body constitution of body constitution questionnaire (BCQ) [ Time Frame: Change before, through intervention completion (average of 6 months)and after 1 month intervention. ]The scale range from 44 to 220, with higher scores indicating larger deficiencies
- Physical activity of international physical activity questionnaire self-administered short version (IPAQ-SS) [ Time Frame: Change before, through intervention completion (average of 6 months)and after 1 month intervention. ]The unit of measurement is metabolic equivalent (METs), with higher METs indicating more physical activity
- Health-related quality of life of short form 36 (SF-36) [ Time Frame: Change before, through intervention completion (average of 6 months)and after 1 month intervention. ]The scale range from 0 to 100, with higher scores indicating better quality of life
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04096989
|Contact: Hsueh-Wen Chungfirstname.lastname@example.org|