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

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.

Study Overview

• Status: Completed
• Conditions: PreDiabetes
• Intervention / Treatment: Other: Traditional Chinese medicine regimen-based lifestyle mobile health APP; Other: Lifestyle mobile health APP

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 Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 231
    • Taipei Tzu Chi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	Change before, through intervention completion (average of 3 months)and after 1 month intervention.

Collaborators and Investigators

• Sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 17, 2020
• Primary Completion (ACTUAL): May 20, 2021
• Study Completion (ACTUAL): May 31, 2021

Study Registration Dates

• First Submitted: September 10, 2019
• First Submitted That Met QC Criteria: September 19, 2019
• First Posted (ACTUAL): September 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 30, 2022
• Last Update Submitted That Met QC Criteria: August 25, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: prediabetes; TCM; body constitution; meridian energy; APP
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hyperglycemia; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: 08-X-026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No