Study Design
prediabetes
ADVERSE EVENTS, MAY, PREDIABETES
This study was an open-label, parallel-group RCT (ClinicalTrials.gov NCT04096989) with a three-group design. We cooperated with the health examination center and outpatient clinics at a teaching hospital in northern Taiwan to recruit individuals diagnosed with prediabetes from February 2020 to May 2021. The inclusion criteria were (1) having been diagnosed with prediabetes (according to an HbAParticipants were randomly assigned to three groups: TCM mHealth app, ordinary mHealth app, or control group. A statistician drew up a computer-generated randomization list. The allocation sequence was kept in an opaque, sealed, and stapled envelope, and a staff member in the outpatient clinic who was not involved in the study held the sealed envelopes. After the participants agreed to participate in the study, the researcher opened the envelope to reveal their group assignment.The informed consent form was signed by all participants before enrollment in the study. The informed consent form stated that the risk of participation in this study was low. If the participants felt physically or mentally unwell due to their participation, they had to contact the researchers and had the right to withdraw at any time. No adverse events were reported during the study period.