PreDiabetesNCT04096989
The Effect of Traditional Chinese Medicine Regimen-based Lifestyle Mobile Health APP in Prediabetes
A study testing Traditional Chinese medicine regimen-based lifestyle mobile health APP and Lifestyle mobile health APP in people with PreDiabetes, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes
- What is being tested?
- Traditional Chinese medicine regimen-based lifestyle mobile health APP and Lifestyle mobile health APP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Feb 2020to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Individuals with pacemakers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Development and Effectiveness of Traditional Chinese Medicine Regimen-based Lifestyle and Mobile Health Application Intervention for People With Prediabetes
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.
Read the 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
- Being tested
- Traditional Chinese medicine regimen-based lifestyle mobile health APP, Lifestyle mobile health APP
- Keywords
- prediabetes, TCM, body constitution, meridian energy, APP
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Chinese medicine regimen-based lifestyle mobile health APPOther
The Experimental group receives TCM regimen-based lifestyle mobile health application intervention.
Lifestyle mobile health APPOther
Sham comparator group receives mobile health application, but there is no traditional Chinese medicine information.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Routine care. |
| Experimental group | Experimental | The participants accept TCM regimen-based lifestyle mobile health application intervention. Receives: Other: Traditional Chinese medicine regimen-based lifestyle mobile health APP |
| Sham comparator group | Sham comparator | The participants accept mobile health application intervention. Receives: Other: Lifestyle mobile health APP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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%.
Measured: 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
Measured: 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)
The unit of measurement is metabolic equivalent (METs), with higher METs indicating more physical activity
Measured: Change before, through intervention completion (average of 3 months)and after 1 month intervention.
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.
Measured: Change before, through intervention completion (average of 3 months)and after 1 month intervention.
Body mass index (BMI)
The normal range of BMI from 18.5-24.9 kg/m2.
Measured: Change before, through intervention completion (average of 3 months)and after 1 month intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start17 Feb 2020
- Primary completion20 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096989
- Sponsor's protocol ID
- 08-X-026
- Status last verified
- Aug 2021
- First submitted
- 10 Sep 2019
- Last updated
- 30 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37338977
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Effectiveness of Traditional Chinese Medicine Regimen-based Lifestyle and Mobile Health Application Intervention for People With Prediabetes
- ClinicalTrials.gov ID
- NCT04096989
- Acronym / sponsor ID
- 08-X-026
- Conditions
- PreDiabetes
- Keywords
- prediabetes, TCM, body constitution, meridian energy, APP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationUniversity, hospital or other
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 20 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 20 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Routine care. |
| Experimental group | Experimental | Other: Traditional Chinese medicine regimen-based lifestyle mobile health APPThe participants accept TCM regimen-based lifestyle mobile health application intervention. |
| Sham comparator group | Sham comparator | Other: Lifestyle mobile health APPThe participants accept mobile health application intervention. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
- Individuals with pacemakers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Chinese medicine regimen-based lifestyle mobile health APPThe Experimental group receives TCM regimen-based lifestyle mobile health application intervention. | Other | Experimental group |
| Lifestyle mobile health APPSham comparator group receives mobile health application, but there is no traditional Chinese medicine information. | Other | Sham comparator group |
Primary outcome
Meridian energy of Meridian energy device
Time frame: Change before, through intervention completion (average of 3 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 3 months)and after 1 month intervention.
The scale range from 44 to 220, with higher scores indicating larger deficiencies
Blood sugar control of fasting plasma glucose (FPG)
Time frame: Change before, through intervention completion (average of 3 months)and after 1 month intervention.
The normal range of FPG from 70-99mg/dL.
Blood sugar control of HbA1c
Time frame: Change before, through intervention completion (average of 3 months)and after 1 month intervention.
The normal range of HbA1c from 4-5.6%.
Health-related quality of life of short form 36 (SF-36)
Time frame: Change before, through intervention completion (average of 3 months)and after 1 month intervention.
The scale range from 0 to 100, with higher scores indicating better quality of life
3 secondary outcomes
Physical activity of international physical activity questionnaire self-administered short version (IPAQ-SS)
Time frame: Change before, through intervention completion (average of 3 months)and after 1 month intervention.
Dietary behavior of the dietary behavior questionnaire
Time frame: Change before, through intervention completion (average of 3 months)and after 1 month intervention.
Body mass index (BMI)
Time frame: Change before, through intervention completion (average of 3 months)and after 1 month intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
- Derived from this study: PubMed 37338977Chung 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Chinese medicine regimen-based lifestyle mobile health APP and Lifestyle mobile health APP in people with PreDiabetes, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Meridian energy of Meridian energy device (time frame: Change before, through intervention completion (average of 3 months)and after 1 month intervention.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04096989, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2022.