Discussion
depression, metabolic disease, coronavirus disease, MetS
AIDS, METABOLIC DISEASE
This prospective, open-label, randomized pilot trial demonstrated that a wearable device-based physical activity intervention did not significantly increase the average daily step count in the North Korean refugees living in South Korea. Promoting a higher level of physical activity in the North Korean refugees who already walked >10,000 steps/day was challenging. However, the physical activity intervention using the wearable device and personalized exercise education was effective in the North Korean refugees with a lower-than-average daily step count. These individuals had a reduced WC and FBS level.Refugees often have restricted access to health care services, which results in poor management of metabolic disease [Furthermore, the proportion of participants in our study who engaged in vigorous physical activity was >20%. After using the wearable device, the average daily step count was >10,000. We investigated the occupations of the North Korean refugees to determine whether they required a high level of physical activity and found that 50% (26/52) of the participants had no jobs, and 19.2% (10/52) were students. Considering that most North Korean refugees had a low SES, they likely walked instead of driving a car, making it difficult to further increase their daily step count. Most of the remaining participants were blue-collar workers, which probably led to their high level of physical activity. Only 1 person had a sedentary job (administrative assistant).Another primary concern is the cultural appropriateness of these interventions. Wearable devices and associated health programs often make implicit assumptions about users’ lifestyles and behaviors, which may not align with the unique experiences and cultural contexts of North Korean refugees [Previous studies have reported that depression could act as a barrier to performing physical activity [The North Korean Refugee Health in South Korea study aims to identify the health status of adult North Korean refugees living in South Korea. North Korean Refugee Health in South Korea study has been conducted since 2008 to evaluate the health outcomes of this population, and its results suggest that North Korean refugees have adapted to westernized South Korean society [To the best of our knowledge, our study is the first prospective randomized pilot study to evaluate whether a personalized exercise intervention using a wearable device and education can increase the average daily step count and reduce the metabolic parameters in North Korean refugees. Nevertheless, this study had several limitations. First, a relatively small number of North Korean refugees were included in this prospective pilot study, which reduces the ability to generalize the results to the entire population of North Korean refugees living in South Korea and establish concrete conclusions. Because North Korean refugees have a poor SES, they usually have insufficient time to participate in clinical research studies. Therefore, recruiting and retaining North Korean refugees as participants in this study was challenging. Second, most participants already had a high daily step count and did not have MetS before study enrollment, making it difficult to show improvements in outcome measures due to the intervention. However, a subgroup analysis of the participants with a lower-than-average daily step count showed a beneficial effect of the intervention. Despite the small number of subjects in a subgroup, the change in metabolic parameters was statistically significant. Thus, a large-scale study that only enrolls North Korean refugees with inadequate physical activity and elevated cardio-metabolic risk is needed. Third, the 12-week study period may have been too short to fully elucidate the effects of the personalized physical activity educational intervention using the wearable device. Fourth, other factors than physical activity such as nutrition could influence metabolic parameters. Last, this study was conducted between 2020 and 2021, when social distancing was enforced because of the coronavirus disease pandemic. The coronavirus disease pandemic not only officially restricted the immigration of North Koreans to South Korea but also everyone’s activities, undoubtedly influencing the study’s results, particularly the average daily step count.In this study, the wearable device–based physical activity intervention did not increase the average daily step count in the North Korean refugees, which reflects the difficulties in inducing behavioral changes in low SES populations. However, the intervention was effective in the North Korean refugees with a lower-than-average daily step count. Despite its limitations, this study has substantial clinical implications. The exploration of physical interventions in vulnerable refugee populations remains critical for understanding their unique characteristics. Moreover, this research aids in the development of effective strategies to ameliorate their health issues. Therefore, a long-term, large-scale study in an underserved population is warranted.We appreciate the participation of the North Korean refugees as well as the doctors, nurses, and volunteers who contributed to this study. This research was supported by a grant from the Korean Health Technology R&D Project through the Korea Health Industry Development Institute, funded by the Ministry of Health and Welfare, South Korea (grant number HC19C0253). The funding sources had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication.Authors' Contributions: Kyeong Jin Kim and SGK contributed to the conception and design of the study. JYK, Kyoung Jin Kim, Kyeong Jin Kim, JS, JHB, and SGK collected the data. JC and JBL analyzed the data. JYK, Kyoung Jin Kim, and Kyeong Jin Kim wrote the manuscript. All authors reviewed and revised the manuscript. SGK is the guarantor of this work and, as such, has full access to all study data and takes responsibility for the integrity and analytical accuracy of the data.Conflicts of Interest: None declared.Trial protocol.Supplementary figures and tables.CONSORT-eHealth (V 1.6.1) checklist.