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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
Sponsor:
Information provided by (Responsible Party):
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

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.

Condition or disease Intervention/treatment Phase
PreDiabetes Other: Traditional Chinese medicine regimen-based lifestyle mobile health APP Other: Lifestyle mobile health APP Not Applicable

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 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arm Intervention/treatment
No Intervention: Control group
Routine care.
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.




Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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).
  2. Aged 20 and above.
  3. Provided informed consent.

Exclusion Criteria:

  1. Use of hypoglycemic agent,βblocker, thiazide diuretics, nicotinic acid or steroids within the past 3 months.
  2. 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).
  3. Endocrine diseases like hyperthyroidism or autoimmune disease.
  4. Psychosis or other major neurocognitive disorder; (e) pregnancy and/or lactation.

(f) Individuals with pacemakers.


Information from the National Library of Medicine

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


Contacts
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Contact: Hsueh-Wen Chung +886-0978127103 snow721103@gmail.com

Sponsors and Collaborators
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

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Responsible Party: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
ClinicalTrials.gov Identifier: NCT04096989     History of Changes
Other Study ID Numbers: 08-X-026
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation:
prediabetes
TCM
body constitution
meridian energy
APP
Additional relevant MeSH terms:
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Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia