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
1 other identifier
interventional
121
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2019
CompletedFirst Posted
Study publicly available on registry
September 20, 2019
CompletedStudy Start
First participant enrolled
February 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2021
CompletedAugust 30, 2022
August 1, 2021
1.3 years
September 10, 2019
August 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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.
Change before, through intervention completion (average of 3 months)and after 1 month intervention.
Body constitution of body constitution questionnaire (BCQ)
The scale range from 44 to 220, with higher scores indicating larger deficiencies
Change before, through intervention completion (average of 3 months)and after 1 month intervention.
Blood sugar control of fasting plasma glucose (FPG)
The normal range of FPG from 70-99mg/dL.
Change before, through intervention completion (average of 3 months)and after 1 month intervention.
Blood sugar control of HbA1c
The normal range of HbA1c from 4-5.6%.
Change before, through intervention completion (average of 3 months)and after 1 month intervention.
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
Change before, through intervention completion (average of 3 months)and after 1 month intervention.
Secondary Outcomes (3)
Physical activity of international physical activity questionnaire self-administered short version (IPAQ-SS)
Change before, through intervention completion (average of 3 months)and after 1 month intervention.
Dietary behavior of the dietary behavior questionnaire
Change before, through intervention completion (average of 3 months)and after 1 month intervention.
Body mass index (BMI)
Change before, through intervention completion (average of 3 months)and after 1 month intervention.
Study Arms (3)
Control group
NO INTERVENTIONRoutine care.
Experimental group
EXPERIMENTALThe participants accept TCM regimen-based lifestyle mobile health application intervention.
Sham comparator group
SHAM COMPARATORThe participants accept mobile health application intervention.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taipei Tzu Chi Hospital
New Taipei City, 231, Taiwan
Related Publications (1)
Chung HW, Tai CJ, Chang P, Su WL, Chien LY. The Effectiveness of a Traditional Chinese Medicine-Based Mobile Health App for Individuals With Prediabetes: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2023 Jun 20;11:e41099. doi: 10.2196/41099.
PMID: 37338977DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2019
First Posted
September 20, 2019
Study Start
February 17, 2020
Primary Completion
May 20, 2021
Study Completion
May 31, 2021
Last Updated
August 30, 2022
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share