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基于可穿戴设备的身体活动干预对朝鲜难民的影响: 初步随机对照试验。

Effect of a Wearable Device-Based Physical Activity Intervention in North Korean Refugees: Pilot Randomized Controlled Trial.

机构信息

Division of Endocrinology and Metabolism, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.

Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.

出版信息

J Med Internet Res. 2023 Jul 19;25:e45975. doi: 10.2196/45975.

Abstract

BACKGROUND

Effective health interventions for North Korean refugees vulnerable to metabolic disorders are currently unelucidated.

OBJECTIVE

This study aimed to evaluate the effects of digital health interventions in North Korean refugees using a wearable activity tracker (Fitbit device).

METHODS

We conducted a prospective, randomized, open-label study on North Korean refugees aged 19-59 years between June 2020 and October 2021 with a 12-week follow-up period. The participants were randomly assigned to either an intervention group or a control group in a 1:1 ratio. The intervention group received individualized health counseling based on Fitbit data every 4 weeks, whereas the control group wore the Fitbit device but did not receive individualized counseling. The primary and secondary outcomes were the change in the mean daily step count and changes in the metabolic parameters, respectively.

RESULTS

The trial was completed by 52 North Korean refugees, of whom 27 and 25 were in the intervention and control groups, respectively. The mean age was 43 (SD 10) years, and 41 (78.8%) participants were women. Most participants (44/52, 95.7%) had a low socioeconomic status. After the intervention, the daily step count in the intervention group increased, whereas that in the control group decreased. However, there were no significant differences between the 2 groups (+83 and -521 steps in the intervention and control groups, respectively; P=.500). The effects of the intervention were more prominent in the participants with a lower-than-average daily step count at baseline (<11,667 steps/day). After the 12-week study period, 85.7% (12/14) and 46.7% (7/15) of the participants in the intervention and control groups, respectively, had an increased daily step count (P=.05). The intervention prevented the worsening of the metabolic parameters, including BMI, waist circumference, fasting blood glucose level, and glycated hemoglobin level, during the study period.

CONCLUSIONS

The wearable device-based physical activity intervention did not significantly increase the average daily step count in the North Korean refugees in this study. However, the intervention was effective among the North Korean refugees with a lower-than-average daily step count; therefore, a large-scale, long-term study of this intervention type in an underserved population is warranted.

TRIAL REGISTRATION

Clinical Research Information Service KCT0007999; https://cris.nih.go.kr/cris/search/detailSearch.do/23622.

摘要

背景

目前,针对易患代谢紊乱的朝鲜难民,尚未明确有效的健康干预措施。

目的

本研究旨在评估可穿戴活动追踪器(Fitbit 设备)在朝鲜难民中的数字健康干预效果。

方法

我们于 2020 年 6 月至 2021 年 10 月期间对年龄在 19-59 岁之间的朝鲜难民进行了一项前瞻性、随机、开放标签研究,随访时间为 12 周。参与者按照 1:1 的比例随机分配到干预组或对照组。干预组每 4 周根据 Fitbit 数据接受个性化健康咨询,而对照组佩戴 Fitbit 设备但不接受个性化咨询。主要和次要结局分别为平均每日步数的变化和代谢参数的变化。

结果

共有 52 名朝鲜难民完成了试验,其中干预组和对照组各有 27 名和 25 名参与者。平均年龄为 43(10)岁,41 名(78.8%)参与者为女性。大多数参与者(44/52,95.7%)社会经济地位较低。干预后,干预组的每日步数增加,而对照组的每日步数减少。然而,两组之间没有显著差异(干预组增加 83 步,对照组减少 521 步;P=.500)。在基线每日步数低于平均水平(<11667 步/天)的参与者中,干预的效果更为明显。在 12 周的研究期间,干预组和对照组分别有 85.7%(12/14)和 46.7%(7/15)的参与者每日步数增加(P=.05)。干预措施防止了研究期间代谢参数的恶化,包括 BMI、腰围、空腹血糖水平和糖化血红蛋白水平。

结论

在本研究中,基于可穿戴设备的体力活动干预并未显著增加朝鲜难民的平均每日步数。然而,该干预措施对每日步数低于平均水平的朝鲜难民有效;因此,有必要在服务不足的人群中进行此类干预类型的大规模、长期研究。

试验注册

临床研究信息服务 KCT0007999;https://cris.nih.go.kr/cris/search/detailSearch.do/23622。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba92/10398363/c223e4358f94/jmir_v25i1e45975_fig1.jpg

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