BackgroundTraditional Chinese medicine (TCM) theories assert that body constitution and meridian energy lay the foundation for disease prevention. TCM-based health concepts have not yet been incorporated into mobile health (mHealth) apps for individuals with prediabetes.ObjectiveThe aim of this study was to examine the effectiveness of a TCM mHealth app for individuals with prediabetes.MethodsThis 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 group (n=42), ordinary mHealth app group (n=41), or control group (n=38). All participants received the usual care that included 15-20 minutes of health education about the disease, along with healthy diet and exercise encouragement. The ordinary mHealth app included physical activity (PA), diet, and disease education, along with individual records. The TCM mHealth app additionally includedqiand body constitution information, along with constitution-based PA and diet advice. The control group received the usual care alone and did not have access to any app. Data were collected at baseline, at the end of the 12-week intervention, and 1 month after the intervention. Body constitution, includingyang-deficiency,yin-deficiency, and phlegm-stasis, was measured according to the Body Constitution Questionnaire, with higher scores indicating a greater deficiency. Body energy was examined using the Meridian Energy Analysis Device. The Short-Form 36 questionnaire was used to evaluate health-related quality of life (HRQOL), which yielded physical component scores and mental component scores, with higher scores indicating better physical and mental aspects of HRQOL, respectively.ResultsCompared to the control group, the TCM mHealth app group showed greater improvement in hemoglobin A1c(HbA1c),yang-deficiency and phlegm-stasis body constitution, and BMI; however, no significant differences were found in these outcomes between the TCM mHealth app and ordinary mHealth app groups. The TCM mHealth app group showed better improvement in body energy and mental component scores than the ordinary mHealth app group. 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.ConclusionsUse of either the ordinary or TCM mHealth app improved HRQOL among individuals with prediabetes. Compared to the outcomes of controls not using any app, use of the TCM mHealth app was effective at improving HbA1c, BMI,yang-deficiency and phlegm-stasis body constitution, and HRQOL. Moreover, using the TCM mHealth app seemed to improve the body energy and HRQOL more than when using the ordinary mHealth app. Further studies with a larger sample size and longer follow-up period may be necessary to determine whether the differences favoring the TCM app are clinically meaningful.Trial RegistrationClinicalTrials.gov NCT04096989; https://clinicaltrials.gov/ct2/show/NCT04096989