The Effectiveness of a Traditional Chinese Medicine-based Mobile Health Application for Individuals with Prediabetes: A Randomized Controlled Trial (Preprint)

BACKGROUND Traditional Chinese medicine (TCM) theories assert that body constitution and meridian energy lay the foundation for disease prevention. TCM-based health concepts have not been incorporated into the mobile health application (mHealth app) for individuals with prediabetes. OBJECTIVE This study aimed to examine the effectiveness of a TCM mHealth app for individuals with prediabetes. METHODS This randomized controlled trial recruited 121 individuals with prediabetes at a teaching hospital in New Taipei City between February 2020 and May 2021. The participants were randomly assigned to the TCM mHealth app (TCMG; n=42), ordinary mHealth app (OMG; n=41), or control groups (CG; n=38). All participants received the usual care that included 15–20 minutes of health education about disease explanation, healthy diet, and exercise encouragement. The ordinary mHealth app included physical activity (PA), diet, disease education, and individual records. The TCM mHealth app additionally included qi and body constitution as well as constitution-based PA and diet advices. The CG received the usual care alone and did not use apps. Data were collected at baseline, the end of the 12-week intervention, and 1 month after the intervention. Body constitution, including yang-deficiency, yin-deficiency, and phlegm-stasis, was measured by the body constitution questionnaire, with higher scores indicating a greater deficiency. Body energy was examined by using the Meridian Energy Analysis Device. The Short-Form 36 was used to evaluate health-related quality of life (HRQOL), which yielded physical component scores (PCS) and mental component scores (MCS), with higher scores indicating better physical and mental aspects of HRQOL, respectively. RESULTS Compared to the CG, the TCMG improved more in hemoglobin A1c (HbA1c), yang-deficiency and phlegm-stasis body constitution, and body mass index (BMI); but no significant differences were found in those outcomes when the TCMG was compared to the OMG. The TCMG had better improvement in body energy and MCS than the OMG. There were no significant differences in fasting plasma glucose, yin-deficiency body constitution, Dietary Approaches to Stop Hypertension dietary behavior, and total PA among the three groups after the intervention. CONCLUSIONS Use of either the ordinary or TCM mHealth app improves HRQOL among individuals with prediabetes. Comparing to controls not using app, use of the TCM mHealth app is effective in improving HbA1c, BMI, yang-deficiency and phlegm-stasis body constitution, and HRQOL. Moreover, using the TCM mHealth app seems to improve the body energy and HRQOL more than using the ordinary mHealth app. Whether the differences favoring the TCM app were clinically meaningful may need further studies with a larger sample size and a longer follow-up period. CLINICALTRIAL ClinicalTrials.gov NCT04096989; https://clinicaltrials.gov/ct2/show/NCT04096989