This study was a prospective, open-label, parallel group, randomized controlled trial. The protocol of this study has been described in detail in a previous study [23]. Selected participants visited the hospital three times, including before the intervention, at the 6-week posttest follow-up (first follow-up), and at the 12-week posttest follow-up (second follow-up, end of the intervention), and the main outcome variables were measured at the first visit before the intervention and at 12 weeks after the intervention (Figure 1). This study was conducted from November 2018 to February 2019 in two hospitals (Kyung Hee University Korean Medicine Hospital in Hoegidont, Seoul, and Kyung Hee University Korean Medicine Hospital in Gangdong, Seoul) on a total of 150 healthy participants in their 30s and 40s without any particular health problems. The eligible participants were randomly allocated to either the MBBG or control group, at a 1:1 allocation ratio. The MBBG group used the app for a total of 12 weeks, while the control group received no intervention.
CONSORT diagram of the study. MBBG: MibyeongBogam.
This study was approved by the Institutional Review Board at each institution (IRB numbers KOMCIRB-2018-07-002 and KHNMCOH 2018-07-002-001), and the physicians obtained written consent after all information regarding the study was provided to the participants. The protocol was registered in the Clinical Research Information Service (CRIS number KCT0003488). The anonymity and privacy of the participants were ensured as follows. Information regarding the collection and management of personal data (ie, phone number, email address, password, nickname, IP address, cookie content, etc) was provided, and consent was obtained when participants registered for the MBBG app in accordance with the Personal Information Protection Act. Moreover, app passwords were encrypted and stored in a database, and technical and physical protection measures against personal information leakage were established. Participants were also provided with personal IDs for the purpose of the study, to ensure anonymity.
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