Assessing Usability of Sodium Intake Controlling Mobile Application Among Hypertensive Patients: Protocol and Study Design for Intervention Study

Abstract

ObjectivesPrevious studies have proven that hypertension can be a major risk factor for cardiovascular diseases. Excessive sodium intake has been known to be a significant cause of hypertension, and studies have been conducted to develop effective methods that can assist in lowering dietary sodium intake. This study is an open-label intervention study that aims to assess the effect of the usage of a mobile application specifically designed to aid in lowering the dietary sodium intake of hypertensive patients.MethodsStudy participants will be divided into two groups, one being the mobile application group, and the other being the no application group. Recruitment and screening process is being conducted in 4 different research centers (Catholic University of Korea Eunpyeong St.Mary's Hospital, Myongji Hospital, Inje University Busan Paik Hospital, Hallym University Sacred Heart Hospital), with participants being distributed into each group randomly. Recruited participants receive a blood and urine sample test along with a measurement of their baseline systolic and diastolic blood pressure. They are then either provided with guidelines on how to use the mobile application, or a basic nutrition education session depending on which group they are positioned into. Participants are then instructed to visit their designated research centers 16 weeks after their first visit for follow-up, with the mobile application group being encouraged to use the mobile application during that time period. After the post-study follow up is finalized with every participant, blood pressure and biomarker changes between the two groups will be compared with t-test Using SAS 9.4.ResultsResult of the study applying this protocol will be provided after completion of the research.ConclusionsEvaluation of the effectiveness of this new utility for reducing sodium intake for controlling blood pressure is expected through this study.Funding SourcesThe study protocol was approved by the institutional review boards of Sookmyung Women's University (SMWU-2103-HR-009). This research is funded by the Korea Centers for Disease Control and Prevention (2020ER630401).