The Effectiveness of a Traditional Chinese Medicine-Based Mobile Health App for Individuals With Prediabetes: Randomized Controlled Trial

Abstract

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 yet been incorporated into mobile health (mHealth) apps for individuals with prediabetes.

Objective: The aim of this study was 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 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 included qi and 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, including yang-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.

Results: Compared to the control group, the TCM mHealth app group showed greater improvement in hemoglobin A_1c (HbA_1c), 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.

Conclusions: Use 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 HbA_1c, 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 registration: ClinicalTrials.gov NCT04096989; https://clinicaltrials.gov/ct2/show/NCT04096989.

Keywords: body constitution; health-related quality of life; mHealth app; meridian energy; prediabetes; traditional Chinese medicine.

Figure 1

Participant flow diagram. mHealth: mobile health; T1: baseline; T2: end of the intervention; T2DM: type 2 diabetes mellitus; T3: 1 month after the intervention; TCM: traditional Chinese medicine.

Figure 2

Changes in primary outcomes. (A) Fasting plasma glucose. (B) HbA_1c. (C) Yang deficiency body constitution. (D) Ying deficiency body constitution. (E) Phlegm stasis body constitution. (F) Body energy. (G) Physical component score. (H) Mental component score. Within-group across-time comparisons were made from a paired t test with T1 as the reference. Between-group comparisons were based on one-way ANOVA with the Scheffe posthoc test, with the results presented below graphs. mHealth: mobile health; T1: baseline; T2: end of the intervention; T3: 1 month after the intervention; TCM: traditional Chinese medicine. *P<.05, #P<.001.

Figure 3

Changes in secondary outcomes. (A) BMI. (B) DASH dietary behavior. (C) Total physical activity. Within-group across-time comparisons were made from a paired t test with T1 as the reference. Between-group comparisons were based on one-way ANOVA with the Scheffe posthoc test, with the results presented below the graph in (C). mHealth: mobile health; T1: baseline; T2: end of the intervention; T3: 1 month after the intervention; TCM: traditional Chinese medicine. *P<.05, #P<.001.