The Effect of Traditional Chinese Medicine Regimen-based Lifestyle Mobile Health APP in Prediabetes
Primary Purpose
PreDiabetes
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Traditional Chinese medicine regimen-based lifestyle mobile health APP
Lifestyle mobile health APP
Sponsored by
About this trial
This is an interventional prevention trial for PreDiabetes focused on measuring prediabetes, TCM, body constitution, meridian energy, APP
Eligibility Criteria
Inclusion Criteria:
- Previously diagnosed with prediabetes with an HbA1c of 5.7% to 6.4% and an FPG level of 100 mg/dl to < 126 mg/dl (ADA, 2011, 2014).
- Aged 20 and above.
- Provided informed consent.
Exclusion Criteria:
- Use of hypoglycemic agent,βblocker, thiazide diuretics, nicotinic acid or steroids within the past 3 months.
- Self-reported catastrophic illness in the last 6 months (e.g. stroke, cardiovascular disease, renal and liver insufficiency, heart failure, chronic obstructive pulmonary disease and cancer).
- Endocrine diseases like hyperthyroidism or autoimmune disease.
- Psychosis or other major neurocognitive disorder; (e) pregnancy and/or lactation.
(f) Individuals with pacemakers.
Sites / Locations
- Taipei Tzu Chi Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Sham Comparator
Arm Label
Control group
Experimental group
Sham comparator group
Arm Description
Routine care.
The participants accept TCM regimen-based lifestyle mobile health application intervention.
The participants accept mobile health application intervention.
Outcomes
Primary Outcome Measures
Meridian energy of Meridian energy device
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)
The scale range from 44 to 220, with higher scores indicating larger deficiencies
Blood sugar control of fasting plasma glucose (FPG)
The normal range of FPG from 70-99mg/dL.
Blood sugar control of HbA1c
The normal range of HbA1c from 4-5.6%.
Health-related quality of life of short form 36 (SF-36)
The scale range from 0 to 100, with higher scores indicating better quality of life
Secondary Outcome Measures
Physical activity of international physical activity questionnaire self-administered short version (IPAQ-SS)
The unit of measurement is metabolic equivalent (METs), with higher METs indicating more physical activity
Dietary behavior of the dietary behavior questionnaire
The scores ranged from 14 to 56, with higher scores indicating a better corresponding to the Dietary Approaches to Stop Hypertension (DASH) diet.
Body mass index (BMI)
The normal range of BMI from 18.5-24.9 kg/m2.
Full Information
NCT ID
NCT04096989
First Posted
September 10, 2019
Last Updated
August 25, 2022
Sponsor
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04096989
Brief Title
The Effect of Traditional Chinese Medicine Regimen-based Lifestyle Mobile Health APP in Prediabetes
Official Title
The Development and Effectiveness of Traditional Chinese Medicine Regimen-based Lifestyle and Mobile Health Application Intervention for People With Prediabetes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 17, 2020 (Actual)
Primary Completion Date
May 20, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes
Keywords
prediabetes, TCM, body constitution, meridian energy, APP
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Routine care.
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
The participants accept TCM regimen-based lifestyle mobile health application intervention.
Arm Title
Sham comparator group
Arm Type
Sham Comparator
Arm Description
The participants accept mobile health application intervention.
Intervention Type
Other
Intervention Name(s)
Traditional Chinese medicine regimen-based lifestyle mobile health APP
Intervention Description
The Experimental group receives TCM regimen-based lifestyle mobile health application intervention.
Intervention Type
Other
Intervention Name(s)
Lifestyle mobile health APP
Intervention Description
Sham comparator group receives mobile health application, but there is no traditional Chinese medicine information.
Primary Outcome Measure Information:
Title
Meridian energy of Meridian energy device
Description
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.
Time Frame
Change before, through intervention completion (average of 3 months)and after 1 month intervention.
Title
Body constitution of body constitution questionnaire (BCQ)
Description
The scale range from 44 to 220, with higher scores indicating larger deficiencies
Time Frame
Change before, through intervention completion (average of 3 months)and after 1 month intervention.
Title
Blood sugar control of fasting plasma glucose (FPG)
Description
The normal range of FPG from 70-99mg/dL.
Time Frame
Change before, through intervention completion (average of 3 months)and after 1 month intervention.
Title
Blood sugar control of HbA1c
Description
The normal range of HbA1c from 4-5.6%.
Time Frame
Change before, through intervention completion (average of 3 months)and after 1 month intervention.
Title
Health-related quality of life of short form 36 (SF-36)
Description
The scale range from 0 to 100, with higher scores indicating better quality of life
Time Frame
Change before, through intervention completion (average of 3 months)and after 1 month intervention.
Secondary Outcome Measure Information:
Title
Physical activity of international physical activity questionnaire self-administered short version (IPAQ-SS)
Description
The unit of measurement is metabolic equivalent (METs), with higher METs indicating more physical activity
Time Frame
Change before, through intervention completion (average of 3 months)and after 1 month intervention.
Title
Dietary behavior of the dietary behavior questionnaire
Description
The scores ranged from 14 to 56, with higher scores indicating a better corresponding to the Dietary Approaches to Stop Hypertension (DASH) diet.
Time Frame
Change before, through intervention completion (average of 3 months)and after 1 month intervention.
Title
Body mass index (BMI)
Description
The normal range of BMI from 18.5-24.9 kg/m2.
Time Frame
Change before, through intervention completion (average of 3 months)and after 1 month intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Previously diagnosed with prediabetes with an HbA1c of 5.7% to 6.4% and an FPG level of 100 mg/dl to < 126 mg/dl (ADA, 2011, 2014).
Aged 20 and above.
Provided informed consent.
Exclusion Criteria:
Use of hypoglycemic agent,βblocker, thiazide diuretics, nicotinic acid or steroids within the past 3 months.
Self-reported catastrophic illness in the last 6 months (e.g. stroke, cardiovascular disease, renal and liver insufficiency, heart failure, chronic obstructive pulmonary disease and cancer).
Endocrine diseases like hyperthyroidism or autoimmune disease.
Psychosis or other major neurocognitive disorder; (e) pregnancy and/or lactation.
(f) Individuals with pacemakers.
Facility Information:
Facility Name
Taipei Tzu Chi Hospital
City
New Taipei City
ZIP/Postal Code
231
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Traditional Chinese Medicine Regimen-based Lifestyle Mobile Health APP in Prediabetes
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