The Effect of Traditional Chinese Medicine Regimen-based Lifestyle Mobile Health APP in Prediabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-17

Study Completion Date

2021-05-31

Brief Summary

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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.

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Detailed Description

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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

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PreDiabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control group

Routine care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental group

The participants accept TCM regimen-based lifestyle mobile health application intervention.

Group Type EXPERIMENTAL

Traditional Chinese medicine regimen-based lifestyle mobile health APP

Intervention Type OTHER

The Experimental group receives TCM regimen-based lifestyle mobile health application intervention.

Sham comparator group

The participants accept mobile health application intervention.

Group Type SHAM_COMPARATOR

Lifestyle mobile health APP

Intervention Type OTHER

Sham comparator group receives mobile health application, but there is no traditional Chinese medicine information.

Interventions

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Traditional Chinese medicine regimen-based lifestyle mobile health APP

The Experimental group receives TCM regimen-based lifestyle mobile health application intervention.

Intervention Type OTHER

Lifestyle mobile health APP

Sham comparator group receives mobile health application, but there is no traditional Chinese medicine information.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes